“We want to apologize to the American public for recent decisions that cast doubt upon our commitment to our mission of saving women’s lives.  The events of this week have been deeply unsettling for our supporters, partners and friends and all of us at Susan G. Komen.  We have been distressed at the presumption that the changes made to our funding criteria were done for political reasons or to specifically penalize Planned Parenthood.  They were not.

Our original desire was to fulfill our fiduciary duty to our donors by not funding grant applications made by organizations under investigation.  We will amend the criteria to make clear that disqualifying investigations must be criminal and conclusive in nature and not political. That is what is right and fair.

Our only goal for our granting process is to support women and families in the fight against breast cancer.  Amending our criteria will ensure that politics has no place in our grant process.  We will continue to fund existing grants, including those of Planned Parenthood, and preserve their eligibility to apply for future grants, while maintaining the ability of our affiliates to make funding decisions that meet the needs of their communities.”

The complete statement is available at the Komen website (http://ww5.komen.org).

Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including prostate cancer—have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression, and may require treatment with surgery or radiation therapy.

Radium-223 chloride is an investigational drug that delivers very targeted doses of radiation to areas of cancer in the bone.
To assess whether radium-223 chloride improves outcomes among prostate cancer patients with bone metastases, researchers conducted a Phase III clinical trial among 922 men with hormone-refractory cancer. Patients were treated with best standard treatment plus either radium-223 or a placebo.

• Median overall survival was 14 months in the radium-223 group and 11.2 months in the placebo group.
• In addition to prolonging overall survival, radium-223 also delayed the development of bone complications such as fracture. Time to first bone complication was 13.6 months in the radium-223 group and 8.4 months in the placebo group.

The results of this study suggest that radium-223 improves outcomes among prostate cancer patients with bone metastases. Plans are underway to evaluate radium-223 in combination with other cancer treatments, and for patients with other types of cancer.

Reference: Sartor AO, Heinrich D, Helle SI et al. Radium-223 chloride impact on skeletal-related events in patients with castration-resistant prostate cancer (CRPC) with bone metastases: A phase III randomized trial (ALSYMPCA). Presented at the 2012 Genitourinary Cancers Symposium. February 2-4, 2012.San Francisco,CA. Abstract 9.

By Mia James

Melanoma is considered the deadliest form of skin cancer. Survival rates for melanoma fall dramatically once the disease has spread to other parts of the body; and because melanoma is able to spread more proficiently than other skin cancers, it’s particularly dangerous. Given the lethal nature of the disease, effective forms of treatment are greatly needed.

Quite a Breakthrough

“It’s been almost 20 years since we’ve had new drugs that proved [to be effective] in melanoma,” says Lynn N. Schuchter, MD, an official with ASCO’s Cancer Communications Committee and division chief of hematology/oncology at the Abramson Cancer Center of the University of Pennsylvania. The emergence of new therapies is particularly exciting news in the melanoma research community, where promising treatments have been limited. “We really haven’t had a very effective therapy for this disease,” Dr. Schuchter explains.

The development of two new treatments marks significant progress. “Really, what’s so exciting is that it’s sort of unprecedented to have two new approaches at the same time that are really beneficial for patients [with advanced melanoma],” says Dr. Schuchter. “This is quite a breakthrough.”

These two significant advances involve drugs that fight melanoma in two distinct ways. One drug, vemurafenib, is a targeted therapy that’s directed at a specific gene mutation associated with melanoma; the other, Yervoy, is an immunotherapy, a treatment to boost the immune system.

According to Paul B. Chapman, MD, of Memorial Sloan-Kettering Cancer Center in New York, the principal investigator on the recent trial of vemurafenib, there’s been plenty of room for improvement in the treatment of advanced melanoma. “The standard had been chemotherapy,” he says, “which can shrink melanoma in about 10 to 15 percent of patients but has never been shown to improve overall survival of patients in general.”

On Target: Vemurafenib

“In about 50 percent of melanomas, there’s a mutated or activated gene called BRAF,” Dr. Schuchter explains. The BRAF gene is known to play a part in cell growth, and mutations in BRAF are common in several types of cancer. The specific BRAF mutation associated with melanoma is known as V600E. By targeting this mutation, vemurafenib is able to shut down the pathway and reduce the size of the melanoma, which can extend a patient’s survival. “This,” she says, “is really quite a dramatic response in patients with advanced melanoma, and it has improved overall survival.”

Dr. Chapman’s Phase III trial of vemurafenib compared the drug’s performance with that of the chemotherapy drug DTIC (dacarbazine) among 675 patients with previously untreated, inoperable Stage IIIC or Stage IV melanoma. All patients had a V600E mutation in the BRAF gene. Patients who received vemurafenib experienced improved overall and progression-free survival compared with those treated with chemotherapy: overall survival was improved by 63 percent and progression-free survival by 74 percent.1

The immediate next step for vemurafenib, says Dr. Chapman, is approval by the US Food and Drug Administration (FDA). He explains that to ensure appropriate treatment, testing for the BRAF mutation must become standard among all patients diagnosed with metastatic melanoma. “This,” he says, “is going to be an important sea change in the evaluation of melanoma—and it’s long overdue.” Furthermore, Dr. Chapman explains that continued clinical trials are “critical” and will need to investigate such issues as a lack of response among some patients, a tendency to develop resistance among some, and the effects of combining vemurafenib with other drugs.

Revving Up the Immune System: Yervoy

“Immunotherapy,” says Dr. Schuchter, “is a therapy to rev up the immune system,” which is how Yervoy fights advanced melanoma. Approved by the FDA in March 2011, Yervoy has extended survival in two studies among patients with advanced melanoma.

Yervoy targets a molecule known as CTLA4, which is found on the surface of T-cells and is thought to inhibit immune responses. By targeting this molecule, Yervoy may enhance the immune system’s response to tumor cells.

“A large study was presented at ASCO [2011] that showed that ipilimumab [Yervoy] could prolong survival in patients with advanced melanoma,” Dr. Schuchter says. In this study researchers evaluated the combination of Yervoy and the chemotherapy drug DTIC for the initial treatment of advanced melanoma. The Phase III clinical trial included 502 patients with Stage III or Stage IV melanoma that could not be surgically removed. Overall survival was better in the group that received Yervoy: three-year overall survival was 20.8 percent among patients treated with chemotherapy plus Yervoy compared with 12.2 percent among patients treated with chemotherapy alone.2

This current study provides additional evidence that Yervoy is active against advanced melanoma and can improve overall survival. A study presented at ASCO in 2010 also indicated that Yervoy could improve outcomes in advanced melanoma.3

What’s Next for Melanoma Treatment?

Though these new therapies for advanced melanoma are encouraging, according to Dr. Schuchter there’s much progress still to be made and exciting possibilities on the horizon. The recent advances with vemurafenib and Yervoy stand to launch yet more significant research. “There’s a lot of momentum to build upon these results,” she says. For example, future studies that combine immunotherapy with targeted therapy as well as evaluate new combinations of targeted therapy could further change the outlook for patients with melanoma. It will also be important to find ways to identify patients who are the best candidates for these therapies so that the greatest number will benefit. As well, continued investigation into gene mutations in melanoma could yield additional targeted therapies. “BRAF is just one of the genes that can be broken [mutated] in melanoma,” Dr. Schuchter says, making the case for expanding the targeted-therapy arsenal.

Earlier, effective treatment for melanoma is also called for, says Dr. Schuchter, as these recent breakthroughs are specific to advanced disease but haven’t been tested in early stages. “Studies will be looking at whether we can apply these therapies earlier and increase the percentage of patients who are cured of melanoma,” she explains. One goal is to increase the chance of cure by treating the disease before it metastasizes.

Early treatment is made possible by early detection, which is another area in which Dr. Schuchter foresees progress. This includes, she says, methods to identify moles that have the potential to become melanoma before they are cancerous. This will require new diagnostic technology that can detect melanoma before skin changes become visible to the human eye.

With such significant progress in melanoma treatment in 2011, there’s ample reason to look forward to more breakthroughs in coming years. “There’s a lot of enthusiasm in the field,” Dr. Schuchter says of the future of melanoma research.

References

1. Chapman PB, Hauschild A, Robert C, et al. Phase III randomized, open-label, multicenter trial (BRIM3) comparing BRAF inhibitor vemurafenib with dacarbazine (DTIC) in patients with V600E BRAF-mutated melanoma. Paper presented at: 47th Annual Meeting of the American Society of Clinical Oncology; June 3-7, 2011; Chicago, IL. Abstract LBA4.

2.  Wolchok JD, Thomas L, Bondarenko IN, et al. Phase 3 randomized study of ipilimumab (IPI) plus dacarbazine (DTIC) vs. DTIC alone as first line treatment in patients with unresectable Stage III or IV melanoma. Paper presented at: 47th Annual Meeting of the American Society of Clinical Oncology; June 3-7, 2011; Chicago, IL. Abstract LBA5.

3. O’Day S, Hodi FS, McDermott DF, et al. A phase III, randomized, double-blind, multicenter study comparing monotherapy with ipilimumab or gp100 peptide vaccine and the combination in patients with previously treated, unresectable Stage III or IV melanoma. Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, IL. Abstract 4.

One Patient’s Story

With her strawberry-blond hair and blue eyes, Grace Guckin of Pennsburg, Pennsylvania, knows that she fits one of the higher-risk profiles for skin cancer. But the real awareness of her risk hit the 20-year-old hard when she was diagnosed in 2010 with Stage IIIA melanoma. Even with her pale complexion, Grace, a student at Pennsylvania College of Technology, was stunned when what she thought was a wart on her foot turned out to be melanoma. “I was completely shocked,” she says. “I had no idea at all.”

But looking back on her previous tanning practices, Grace now sees that her behavior was risky. “I never wore sunscreen,” she says. “Or if I did, I would never reapply.” And seeking to brown her ivory skin, Grace admits to lots of time in the sun and a history of frequent sunburns.

Grace had surgery to remove the cancerous spot on her foot in the spring of 2010 as well as a sentinel lymph node biopsy to determine whether the melanoma had spread to her lymph nodes. The biopsy turned up positive for lymph node involvement, so she underwent another surgery to remove about 13 nodes from her left groin.

Treatment followed with interferon, an FDA-approved therapy for patients with Stage III, lymph node–positive melanoma. Interferon stimulates the immune system to help fight cancer but is also associated with some difficult side effects. “I did have a couple of setbacks during the year,” Grace says. These included cellulitis (a skin infection), occasional severe back pain, and flulike symptoms.

Now, having experienced a cancer diagnosis and undergone a difficult year of treatment, Grace has transformed her attitude toward tanning and sun protection—or lack thereof. “Just don’t do it!” she says, noting that not only cancer but the long-term cosmetic effects of sun damage are not worth the temporary bronzing. Grace now wears high-SPF (sun protection factor) sunscreens and lotions daily, which she makes sure she reapplies.

In addition to sun-safety advice, Grace has an encouraging message for others who face a melanoma diagnosis: “Talk to people who have gone through it.” Grace adds that looking for stories of survival helped her stay optimistic, as did finding a solid support system. “You have to talk to the people around you who are always going to be there for you and love you and give you positive thoughts.” Finally, Grace says, as treatment progresses, people with melanoma have plenty of promising treatment options. “There’s so much more technology and different treatments out there right now.”

Tanning Beds: Not a Safer Alternative

According to Dr. Schuchter, recent data show that there is a rising incidence of melanoma among young women, which may be related to tanning salons. Tanning beds, she says, “are not a safe way to get a tan.” Because UV radiation is a known carcinogen, any type of exposure, natural or artificial, is dangerous.

by Mia James

We know that we need food to survive and that when we make the right choices it can give us energy and help us fight illness and support overall health. And we often just simply enjoy it. Many of us, however, have a love/hate relationship with food, as we struggle to reconcile the many positive aspects of our experience with food with the guilt, anxiety, and other negative emotions that eating can trigger.

Food and You: How Relationships Form

Our emotional connections with food run the gamut from positive associations with health, happiness, and pleasure to darker themes of anxiety and guilt. How each person arrives at his or her unique relationship with food and eating—be it blissful or turbulent—is likely a mixture of family, cultural, and social influences combined with personal emotional makeup.

According to Katherine L. Applegate, PhD, a clinical psychologist with Duke University Health System, personal history—including your family’s culture and traditions—as well as financial resources and regional influences make up your early food education. “Eating and food choices are learned behaviors,” she says.

Our attitudes toward food get more complex as we endow specific foods with meaning and purpose beyond basic nutrition. “People start to make associations with different foods and ascribe meaning to different food choices,” Dr. Applegate explains. “There are foods that we have to celebrate a birthday, to celebrate a religious holiday, foods that we eat when we’re under stress, foods that signify grief or loss of a loved one,” she says, describing some potential emotional associations with food.

Another way our attitudes about food can be shaped is through media and social influences like fad diets that promise dramatic weight loss and improved health. “Food choice is something that can definitely become disordered and affected by trends in the media,” Dr. Applegate explains. Trends, she says, such as low-fat, low-carbohydrate, and other diet fads can lead us to choose specific foods while eliminating others, and our responses to and reasons for these decisions can have emotional implications.

“When people make choices and eat certain types of food, they can have a variety of emotional reactions to those choices,” Dr. Applegate says. For example, learning that a food is “bad” or may be fattening can instill fear and avoidance of that food. These negative associations can get more pronounced when we feel guilt or shame for craving or eating “bad” foods and when we turn to food to cope with difficult emotions like stress and loneliness. As well, developing obsessions about our diet (such as which foods to avoid for health and weight management reasons) is likely to create stress and tension about eating.

It’s important to note here that while some relationships with food—like those described above—affect people negatively, many of the ways people connect emotionally with food can be entirely positive. Take, for example, the pleasure you may find in a delicious meal or the fun of preparing and sharing a favorite dish. And for some people, food may not offer any type of emotional associations but may exist only as a source of basic nutrition.

More Prone to Conflict

Certain people may be more likely to struggle with food relationships, explains Leslie A. Sim, PhD, clinical director of the eating disorders program at the Mayo Clinic in Rochester, Minnesota. “There are specific people who might be more anxious and more harm-avoidant [worry excessively],” she says. Such people might be more likely than others to interpret nutrition information rigidly and develop strict dietary rules, such as cutting out a particular food or food group. As well, people prone to anxiety may form attachments to food and often worry about their choices. “If you’re an anxious person, you start to wonder Am I doing the right thing? Is this bad?” says Dr. Sim.

When it comes to emotional overeating, Dr. Sim says that depression or sadness and easily available food can be a risky combination. “If you’re prone to depression or negative moods and are in a food-rich environment, that can put you at risk of binge eating or comfort eating,” she explains.

Developing a Healthy Relationship with Food

Despite the many conflicts and complexities that shape our relationship with food, there are ways to reshape how we think about eating and how we cope with challenging situations. By determining your own challenges when it comes to food, you can make choices to avoid negative feelings about eating and build a happier relationship.

One step, says Dr. Applegate, is to figure out what’s really behind your cravings. If you feel that you make food choices to soothe yourself when you’re upset or distressed, which you later regret, determine what you’re really feeling. It’s likely that it’s not hunger, she explains. Are you lonely? Stressed? Sad? “Try to notice if there’s a particular pattern,” Dr. Applegate says, “and address the emotion, not the hunger. Remember that your sad or stressed feelings will pass; be patient and know that food will not resolve them. Then ask yourself: What might be contributing to that pattern? Can it be changed? You may find that discussing these issues with a friend or counselor may help you become more aware of patterns as well as come up with ways to address them.”

You may also need to cut yourself some slack. Undereaters tend to establish rigid rules for their diets, which lock in their beliefs and emotional associations with food, says Dr. Sim. If this sounds familiar, you might benefit from breaking your own rules. “This can help people start seeing their thoughts or beliefs about food,” she explains. Some individuals will benefit from trying the foods they’ve labeled as “bad” and learning that, in sensible portions, there are no horrible consequences.

If you struggle with overeating or binge eating when you’re distressed, you may control this urge by keeping your belly full. “Hunger can be a big trigger, and I think it makes you more prone to emotional eating because you’re not as rational when you’re hungry,” explains Dr. Sim. She also says that many people who are prone to emotional eating also restrict their diets, so efforts to normalize eating patterns and, again, loosening the rules can help break this pattern. A regular and nutritionally balance diet can also regulate hunger.

Celebrations like holidays and weddings that promise large meals and rich desserts can be a source of anxiety for people worried about giving in to temptation and overeating. The key in these situations, says Dr. Applegate, is to make sure that the reason for the celebration or event—not the food—remains the focus of the gathering. “If you are using food to mark a special event, make sure food isn’t the only indicator of that event,” she explains. Look instead to the social aspect to share in the spirit of the gathering. Arriving with a game plan can also help: ask for just a small piece of cake or sip tea during the dessert course.

Some people worry about craving food that they consider unhealthy. Dr. Applegate says that there’s no need to feel shame or guilt. “It’s natural to have cravings,” she says. Instead of feeling guilty for wanting that milkshake or cheeseburger, learn what to do with that craving. Dr. Applegate suggests thinking about what you really want instead of acting impulsively. This may help you make a decision that you’re happy with in the long run.

You can also build a positive relationship with food through proper nutrition. Therese Shumaker, MS, RD, LD, a dietitian at the Mayo Clinic in Rochester, suggests avoiding foods high in simple sugars that only briefly satisfy your cravings and give only short bursts of energy and instead filling your plate with a proper balance of protein, carbohydrates, and fat. By choosing the right nutrients, she says, you can enjoy lasting energy and avoid the emotional ups and downs caused by an unbalanced diet.

Finding Peace in Mind and Belly

Love it, hate it, or a little of both, one thing’s certain about your relationship with food: you can’t live without it. With that in mind, one of the best things you can do for overall well-being is establish harmony between yourself and food. This solid partnership can bring you years of health and happiness.

Feed Your Relationship

Therese Shumaker, MS, RD, LD, a dietician at the Mayo Clinic in Rochester, Minnesota, says that learning about healthy food choices and taking time to plan healthful meals can help people who struggle emotionally with food get back on track and work toward a better relationship.

“I think one of the most important things is to educate people about how food works in the body,” Therese explains. “For example, foods that are high in simple sugar (such as cakes, cookies, and ice cream) give us quick energy and make us feel better only temporarily,” she says. With a balance of protein, carbohydrates, and fat, you’ll feel satisfied and energized longer. This is because protein helps regulate appetite, and together fat and protein take longer to digest than carbohydrates.

With this background knowledge to work from, the next step for those looking to transform their relationship with food is to build an individualized meal plan. “It’s a meal plan that will give the patient the right amount of calories, protein, and fat—all the nutrients that the body needs,” she says. This includes a goal of eating about six times per day (three meals and three snacks) to avoid hunger and support a healthy metabolism.

By following a meal plan that provides all the nutrients your body needs, Therese says, you’ll likely feel better physically and enjoy a more upbeat mood. With balanced food choices, she says, “We have the energy to do things that make us happy.”

Therese encourages patients to avoid strictly restricting any foods. “People who severely restrict their diets often take out foods that they really enjoy.” This tendency can trigger you to crave that food and may lead to overeating. “I always try to teach people that food restriction really creates food interest,” she explains.

Along with a meal plan, Therese encourages people to keep a food journal. “I call them ‘clue sheets,’” she says of the journals, “because they can really help patients clue into what they’re eating and how they’re feeling.” These clues can reveal the emotions behind what Therese calls “destructive eating patterns.” The journals are used to track hunger levels before and after meals and can also include mood, thoughts, and feelings when eating.

Prostate cancer is a hormonally sensitive disease that can be controlled for long periods with androgen deprivation therapy (ADT). When prostate cancer stops responding to this treatment, it is referred to as hormone-refractory prostate cancer. Advances have been made in the treatment of hormone-refractory cancer, but challenges remain and new drugs continue to be developed.

MDV3100 is an investigational drug with a new approach to hormonal therapy. The drug interferes with the ability of male hormones to bind to their receptors within a cell, and also reduces the ability of the receptors to enter the nucleus and stimulate cell growth.

To evaluate the safety and efficacy of MDV3100 in the treatment hormone-refractory prostate cancer, researchers conducted a Phase III clinical trial known as AFFIRM. The study enrolled 1,199 men with metastatic, hormone-refractory prostate cancer. All of the men had experienced a worsening of their cancer in spite of previous treatment with hormonal therapy and the chemotherapy drug Taxotere® (docetaxel). Study participants were treated with either MDV3100 or a placebo (sugar pill).

• At the time of an initial analysis part way through the study, researchers found that MDV3100 had significantly improved overall survival: median overall survival was 18.4 months among men treated with MDV3100 and 13.6 months among men treated with placebo. As a result of this benefit, the study was stopped early, and men in the placebo group were offered MDV3100.
• MDV3100 was also found to delay cancer progression: survival without cancer progression was roughly 8 months among men in the MDV3100 group and 3 months among men in the placebo group.
• MDV3100 was generally well tolerated. The most common side effects were fatigue, diarrhea, and hot flushes.

This study suggests that MDV3100 improves outcomes among men with metastatic, hormone-refractory prostate cancer. MDV3100 is also being evaluated for the treatment of earlier stages of prostate cancer.

Reference: Scher HI, Fizazi K, Saad F et al. Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer postdocetaxel: Results from the phase III AFFIRM study. Presented at the 2012 Genitourinary Cancers Symposium. February 2-4, 2012.San Francisco,CA. Abstract LBA1.

Generic Name: vismodegib

Trade Name: Erivedge™

How is this drug used? Erivedge is approved for the treatment of adults with basal cell carcinoma of the skin that has spread to other parts of the body or that has come back after surgery or cannot be treated with surgery or radiation. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Erivedge targets a specific biological pathway (the Hedgehog pathway) that is thought to play a role in more than 90% of cases of basal cell carcinoma. Erivedge inhibits the abnormal signaling in this pathway that contributes to cancer growth.

How is Erivedge given (administered)? Erivedge is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Erivedge.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may undergo physical examinations and other tests to assess side effects and response to therapy.

What are the most common side effects of treatment with Erivedge?

• Muscle spasms
• Hair loss
• Taste changes or loss of taste
• Weight loss
• Fatigue
• Nausea
• Diarrhea
• Decreased appetite
• Constipation
• Joint pain
• Vomiting

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Erivedge can cause severe birth defects and fetal death. Women should have a pregnancy test prior to starting Erivedge and should talk with their doctor about choice and duration of birth control.
• Men treated with Erivedge should use a condom and spermicide during sex (even if they’ve had a vasectomy) to avoid exposing their partner to Erivedge through semen.
• During treatment and for several months afterwards, patients should not donate blood or blood products.
• Patients should inform their physician about all other medical conditions.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 01/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.  We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: axitinib

Trade Name: Inlyta®

How is this drug used? Inlyta is FDA approved for the treatment of advanced renal cell carcinoma (kidney cancer) after one prior drug treatment has not worked. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action?  Inlyta is a type of drug known as a kinase inhibitor. It works by blocking certain proteins that play a role in cancer growth

How is Inlyta typically given (administered)? Inlyta is taken orally (by mouth), typically twice per day.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Inlyta. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Physical examinations, scans or other measures may also be utilized to assess side effects and response to therapy.

What are the most common side effects of treatment with Inlyta?

• Diarrhea
• High blood pressure
• Fatigue
• Decreased appetite
• Nausea
• Hoarseness
• Hand-foot syndrome
• Weight loss
• Vomiting
• Weakness
• Constipation

What are some of the less common side effects to be aware of?

• Blood clots
• Bleeding problems
• A tear (perforation) in the stomach or intestine
• Thyroid problems
• Reversible posterior leukoencephalopathy syndrome (a condition that involves swelling in the brain).
• Increased protein in the urine
• Changes in liver function

This is not a complete list of side effects. Some patients may experience other side effects that are not listed above. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Do not eat grapefruit or drink grapefruit juice. Grapefruit may increase the amount of Inlyta in the blood.
• Maintain adequate rest and nutrition.
• Eat small meals frequently to help alleviate nausea.
• Drink plenty of fluids (patients should ask their physician about the amount of liquid to consume during a day).

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding, or planning a family in the near future. This drug may cause birth defects. It is important to use a form of birth control while undergoing treatment.
• It is important that patients inform their physician of any pre-existing conditions, including high blood pressure, thyroid problems, liver problems, history of blood clots or bleeding problems, history of heart attack or stroke, or an unhealed wound.
• Patients should inform their physician about any planned surgery.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also call if you notice signs of thyroid problems (e.g. persistent tiredness, feeling hot or cold, weight gain or loss, voice deepening, hair loss, or muscle cramps), signs of a blood clot (e.g. chest pain or pressure; pain in arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of the body; trouble talking; headache; vision problems), signs of unusual bleeding  (e.g. bleeding that is heavy or persistent, pink or brown urine, red or black stools, unusual bruising, coughing up or vomiting blood, unexpected pain or swelling; headache or dizziness), signs of a gastrointestinal tear (e.g. severe stomach pain, bloody vomit, red or black stools), or signs of brain problems (e.g headache, seizure, weakness, confusion, high blood pressure, blindness or change in vision, problems thinking).

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug by healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics, and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 01/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: vismodegib

Trade Name: Erivedge™

How is this drug used? Erivedge is approved for the treatment of adults with basal cell carcinoma of the skin that has spread to other parts of the body or that has come back after surgery or cannot be treated with surgery or radiation. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Erivedge targets a specific biological pathway (the Hedgehog pathway) that is thought to play a role in more than 90% of cases of basal cell carcinoma. Erivedge inhibits the abnormal signaling in this pathway that contributes to cancer growth.

How is Erivedge given (administered)? Erivedge is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Erivedge.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may undergo physical examinations and other tests to assess side effects and response to therapy.

What are the most common side effects of treatment with Erivedge?

• Muscle spasms
• Hair loss
• Taste changes or loss of taste
• Weight loss
• Fatigue
• Nausea
• Diarrhea
• Decreased appetite
• Constipation
• Joint pain
• Vomiting

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Erivedge can cause severe birth defects and fetal death. Women should have a pregnancy test prior to starting Erivedge and should talk with their doctor about choice and duration of birth control.
• Men treated with Erivedge should use a condom and spermicide during sex (even if they’ve had a vasectomy) to avoid exposing their partner to Erivedge through semen.
• During treatment and for several months afterwards, patients should not donate blood or blood products.
• Patients should inform their physician about all other medical conditions.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 01/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.  We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN.  CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: vismodegib

Trade Name: Erivedge™

How is this drug used? Erivedge is approved for the treatment of adults with basal cell carcinoma of the skin that has spread to other parts of the body or that has come back after surgery or cannot be treated with surgery or radiation. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Erivedge targets a specific biological pathway (the Hedgehog pathway) that is thought to play a role in more than 90% of cases of basal cell carcinoma. Erivedge inhibits the abnormal signaling in this pathway that contributes to cancer growth.

How is Erivedge given (administered)? Erivedge is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Erivedge.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may undergo physical examinations and other tests to assess side effects and response to therapy.

What are the most common side effects of treatment with Erivedge?

• Muscle spasms
• Hair loss
• Taste changes or loss of taste
• Weight loss
• Fatigue
• Nausea
• Diarrhea
• Decreased appetite
• Constipation
• Joint pain
• Vomiting

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Erivedge can cause severe birth defects and fetal death. Women should have a pregnancy test prior to starting Erivedge and should talk with their doctor about choice and duration of birth control.
• Men treated with Erivedge should use a condom and spermicide during sex (even if they’ve had a vasectomy) to avoid exposing their partner to Erivedge through semen.
• During treatment and for several months afterwards, patients should not donate blood or blood products.
• Patients should inform their physician about all other medical conditions.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 01/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.  We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN.  CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: vismodegib

Trade Name: Erivedge™

How is this drug used? Erivedge is approved for the treatment of adults with basal cell carcinoma of the skin that has spread to other parts of the body or that has come back after surgery or cannot be treated with surgery or radiation. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Erivedge targets a specific biological pathway (the Hedgehog pathway) that is thought to play a role in more than 90% of cases of basal cell carcinoma. Erivedge inhibits the abnormal signaling in this pathway that contributes to cancer growth.

How is Erivedge given (administered)? Erivedge is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Erivedge.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may undergo physical examinations and other tests to assess side effects and response to therapy.

What are the most common side effects of treatment with Erivedge?

• Muscle spasms
• Hair loss
• Taste changes or loss of taste
• Weight loss
• Fatigue
• Nausea
• Diarrhea
• Decreased appetite
• Constipation
• Joint pain
• Vomiting

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Erivedge can cause severe birth defects and fetal death. Women should have a pregnancy test prior to starting Erivedge and should talk with their doctor about choice and duration of birth control.
• Men treated with Erivedge should use a condom and spermicide during sex (even if they’ve had a vasectomy) to avoid exposing their partner to Erivedge through semen.
• During treatment and for several months afterwards, patients should not donate blood or blood products.
• Patients should inform their physician about all other medical conditions.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 01/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.  We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN.  CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.