Infections with certain viruses, bacteria, and parasites have been identified as strong risk factors for specific cancers. To examine the link between infections and cancer, researchers performed a systematic analysis of the proportion of cancer cases attributable to infection in 2008. They used data on cancer incidence from the GLOBOCAN project along with epidemiological data regarding the causal effects of infection on cancer. The data included information on 27 types of cancer from 182 countries.

They found that of the 12.7 million new cancer cases that occurred worldwide in 2008, 16 percent—or roughly two million—were attributable to infections. The rate of infection-related cancer was about three times higher in developing countries. For example, 3.3 percent of cancers in Australia and New Zealand were infection related, whereas 32.7 percent of cancers in sub-Saharan Africa were attributable to infections. The four main infections associated with cancer were human papillomavirus, hepatitis C, hepatitis B, and Helicobacter pylori. These infections were responsible for approximately 1.9 million cancer cases in 2008, mainly gastric, liver, and cervical cancers.

Cervical cancer accounted for about half of the infection-related cancers in women. Liver and gastric cancers accounted for more than 80 percent of the infection-related cancers in men.  About 30 percent of infection-related cancers occurred in people younger than 50 years. It’s important to note that it takes decades of chronic infection before an infection progresses to cancer.

Based on the statistics, the researchers noted that approximately two million cancer cases each year might be preventable with better public health methods for preventing infection. In an accompanying editorial, Dr. Goodarz Danaei, an assistant professor of global health at Harvard School of Public Medicine in Boston, noted that vaccines for HPV and hepatitis B are effective and that increasing their availability should be a priority for higher risk countries.[2] He suggests that increasing vaccine coverage could reduce the global burden of cancer.

References:

Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

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

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

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 about all medical conditions, including heart problems, lung problems, and history of stroke.
• 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. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

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 05/12.

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: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

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

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

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 about all medical conditions, including heart problems, lung problems, and history of stroke.
• 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. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

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 05/12.

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.

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Melanoma is a deadly type of skin cancer that arises from melanocytes, which are cells located in the upper layer of the skin that are responsible for producing pigment (skin color). Melanoma is more likely than other types of skin cancer to spread to other parts of the body. According to an editorial that accompanied the study in the Journal of Clinical Oncology, approximately 70,000 Americans were diagnosed with invasive melanoma in 2011, and about 43 percent of those were women.[2] There were approximately 8,800 melanoma-related deaths in 2011, of which only 35 percent were females.

Previous studies have observed that female melanoma patients tend to fare better than their male counterparts. To evaluate this notion, researchers from Europe analyzed follow-up data from nearly 2,700 melanoma patients enrolled in four phase III melanoma treatment trials conducted in Europe. All patients had been diagnosed with either stage I or stage 2 melanoma. Patients were tracked for disease remission, relapse, disease spread, and death.

The results indicated that women consistently had a survival advantage as well as a lower risk of metastasis (spread) when compared to men. Male melanoma patients were found to have worse disease characteristics at diagnosis and worse disease progression. In contrast, women had a 30 percent improved survival—meaning they were 30 percent more likely to survive—as well as a 30 percent lower risk of cancer spread to lymph nodes and other organs. This was true regardless of age, menopausal status, and subtype of cancer—with the only exception being head and neck melanomas, where gender differences disappeared.

The reasons for the gender differences are unclear, but the researchers speculate that their might be a biologic sex difference that causes the cancer to behave differently in men and women. They evaluated a number of possibilities, including estrogen levels, vitamin D metabolism, testosterone levels, and more—but the data could no prove or disprove any of these theories. Part of the gender difference could be the result of a somewhat true gender stereotype—women are more likely than men to detect skin changes early and see a doctor. Because early detection is critical in melanoma, this could mean a significant difference in survival.

Regardless of the reasons, the data remains—men tend to have worse outcomes with melanoma.

Reference:

Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy. Revlimid has also been evaluated in combination with other agents for the initial treatment of patients with newly diagnosed myeloma.

Clinical trials have been ongoing since Revlimid was approved and new data indicates that newly diagnosed patients treated with Revlimid have an increased risk of developing acute myelogenous leukemia (AML), myelodysplastic syndromes, and Hodgkin’s lymphoma.

One analysis included three randomized trials in which patients with newly diagnosed multiple myeloma received initial chemotherapy or chemotherapy and blood-stem-cell transplantation followed by treatment with Revlimid or placebo. The FDA reports that there was nearly a three-fold increase in new cancers in the Revlimid group compared to the placebo group, with 65 second primary cancers among 824 Revlimid patients and 19 second primary cancers among 665 placebo patients. The median time from start of Revlimid to a diagnosis of a second primary malignancy was two years.

The safety information has been added to Revlimid’s label to provide up-to-date information to healthcare professionals. The patient information is also being updated.

The FDA has recommended that doctors consider both the potential benefit of Revlimid as well as the risk of new cancers when choosing to treat patients with the drug. Patients must be closely monitored for the development of new cancers.

Reference:

FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies [FDA Safety Announcement]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm302939.htm

Lung cancer remains the leading cause of cancer death in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers.

Many NSCLC cases occur in people over the age of 65, but there is limited information about how best to treat older patients coupled with concern that older patients will not be able to tolerate aggressive treatment. As a result older patients sometimes do not receive treatment that might be of benefit; for example, older patients may be treated with single-agent chemotherapy rather than the combination chemotherapy that is commonly used in younger patients.

Previous research has indicated that older patients with NSCLC who are otherwise healthy can benefit from treatment, while those with comorbidities—or other severe illnesses—are more vulnerable to the toxicity of cancer treatments and therefore less likely to tolerate and complete a course of treatment.

To examine the effects of comorbidity and age on treatment outcomes, researchers used data from the Veterans Affairs (VA) Central Cancer Registry to analyze treatment and outcomes from more than 20,000 veterans over age 65 with NSCLC. They found that regardless of stage of cancer, treatment rates decreased more in association with older age than with comorbidity.

Younger patients—those between the ages of 65 to 74—were more likely to receive treatment, regardless of comorbidity status. In other words, those who were severely ill—and thus less likely to benefit and more likely to be harmed—received treatment at approximately the same rate as patients in the same age range who were not severely ill. In contrast, older patients—those between the ages of 75 and 84—were less likely to receive treatment, even if they had no comorbidities and a better prognosis.

The researchers concluded that physicians appear to base treatment strictly on age, while overlooking other factors. A patient’s overall state of health is an important factor when determining treatment. An otherwise healthy 75-year-old may tolerate treatment well, whereas a severely ill 65-year-old may not. In short, treatment decisions must be individualized rather than based strictly on age in order to target NSCLC treatment to older patients who may benefit.

Reference:

Wang S, Wong ML, Hamilton N, et al: Impact of age and comorbidity on non-small-cell lung cancer treatment in older veterans. Journal of Clinical Oncology. 2012; 30(13): 1447-1455.

Prostate cancer is the most commonly diagnosed type of cancer (other than skin cancer) in U.S. men. Although many prostate cancers are diagnosed at an early, curable stage, treatment of prostate cancer can cause urinary, sexual, and bowel problems that have a substantial impact on quality of life. Prevention of prostate cancer, therefore, continues to be an important research priority.

There is a great deal of interest in the relationship between diet and cancer, and some previous studies suggested that selenium and vitamin E may reduce the risk of certain types of cancer, including prostate cancer.

To further explore the relationship between selenium and vitamin E supplementation and risk of prostate cancer, researchers conducted SELECT, which was a randomized trial that enrolled more than 35,000 men from 400 study sites across the United States, Canada, and Puerto Rico. At the start of the study, all men had normal prostate-specific antigen (PSA) levels and a normal digital rectal examination. Study participants were assigned to one of four groups: selenium supplementation; vitamin E supplementation; selenium and vitamin E supplementation; or placebo.

In 2008, after approximately 5.5 years of follow-up, preliminary results indicated no benefit from supplementation and participants were instructed to stop taking the supplements. Researchers, however, continued to collect information from the men in order to continue to evaluate the long-term effects

After 7 years of follow-up (5.5 years of supplementation), researchers found that vitamin E supplementation was associated with a statistically significant increased risk of prostate cancer, whereas supplementation with selenium was not. Men in the vitamin E group were 17% more likely than men in the placebo group to be diagnosed with prostate cancer.

These results suggest that daily supplementation with vitamin E may increase the risk of prostate cancer among healthy men. It is always important to communicate with your physician about any supplements you may be taking so that you can discuss the risks and benefits.

References:

The thyroid is a gland in the throat that produces hormones mostly related to metabolic processes in the body. Overall, thyroid cancer is considered to be a highly curable cancer, with 97% of individuals alive at least five years following diagnosis. Standard treatment for well-differentiated thyroid cancer involves surgical removal of the thyroid. After surgery, some patients benefit from additional treatment with radioactive iodine. The iodine destroys any remaining cancer cells as well as the remaining healthy thyroid gland tissue.

Improvements in surgery mean that more of the thyroid gland is removed, which leaves fewer potential remaining cells to be treated with the iodine—meaning lower radiation doses are likely effective. This is important because higher doses of radiation carry added risks, including long-term complications such as secondary cancers. What’s more—patients treated with low-dose radiation can be treated as outpatients and experience fewer side effects.

The HiLo trial included 438 patients at 29 hospitals across the United Kingdom who were randomized to receive low-dose or high-dose radioiodine, each in combination with either thyrotropin alfa or thyroid hormone withdrawal before ablation.[1] The results indicated that patients who received a much lower dose of radioiodine taken in a single oral capsule had similar treatment success to those who had the high dose—but with a much lower rate of side effects. Success rates were 85.0% in the group receiving low-dose radioiodine versus 88.9% in the group receiving the high dose and 87.1% in the thyrotropin alfa group versus 86.7% in the group undergoing thyroid hormone withdrawal. The researchers concluded that the low-dose radioiodine was equally effective and that this will change the approach to treating thyroid cancer—making it more safe and reducing the risk of secondary cancers later in life.

Another randomized, phase 3 trial compared two thyrotropin-stimulation methods (thyroid hormone withdrawal and use of recombinant human thyrotropin) and two radioiodine (¹³¹I) doses in a 2-by-2 design.[2] The trial included 684 patients enrolled between 2007 and 2010. Success rates were similar between the two radiation doses and the two thyrotropin-stimulation methods, leading the researchers to conclude that the use of human thyrotropin and low-dose radioiodine may be sufficient for managing low-risk thyroid cancer.

The results of both these studies could change standard thyroid treatment—resulting in lower doses of radiation for most patients.

References:

On May 9, 2012 at 7:00PM EST you will have the opportunity to ask the expert, Dr. David Hyams, about treatment options available for DCIS and how recent advances could impact treatment decision making. Dr. Hyams is a world-renowned authority in this area. He has been actively involved in clinical research and continues to lead innovative studies designed to make personalized cancer medicine a reality.

The Web Chat is in two parts: the live Q&A will follow Dr. Hyams’ presentation. Click here to submit a question to Dr. Hyams that will be answered during the Live Web Chat. Please note, we will do our best to respond to all questions during the 30-minute live Q&A portion of the program. Thank you for your participation.

This program is sponsored by Genomic Health, Inc. Please visit Oncotype DX to learn more.

Silicone gel-filled breast implants are implanted under breast tissue or chest muscle for breast augmentation or reconstruction. They have a silicone outer shell that is filled with silicone gel and come in different sizes.

Breast reconstruction may refer to a primary reconstruction to replace breast tissue that has been removed or revision surgery to correct the result of a primary reconstruction surgery.

The FDA based its approval of Sientra’s implant on 3 years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), reoperation, implant removal, an uneven appearance (asymmetry), and infection.

Sientra’s post-approval studies will include:

• An additional 7 years of follow-up of the 1,788 clinical trial participants in their pre-market study
• A 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer
• Five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

With the addition of Sientra’s approval, there are now three FDA-approved silicone gel-filled breast implants on the market in the U.S.

Silicone gel implants have generated a fair amount of controversy regarding their safety because of the question as to whether they can trigger certain connective tissue and autoimmune diseases. In 1992, the FDA restricted the use of silicone implants in order to evaluate whether they were indeed associated with autoimmune conditions. Clinical trials have continued and the data continues to indicate that the implants are safe.

It’s important to remember that breast implants are not lifetime devices and long-term monitoring is imperative.

Reference:

FDA approves new silicone gel-filled breast implant [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437.htm”>http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437.htm