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No Benefit with Addition of Platinol® to Treatment for Anal Cancer

No Benefit with Addition of Platinol® to Treatment for Anal Cancer Addition of the drug Platinol® (cisplatin) to 5-FU (5-flourouracil), mitomycin, and radiation may not improve outcomes for patients with anal cancer. These findings were recently published by the Journal of the American Medical Association. Anal cancer is a rare form of cancer that develops in the tissues of the anus. Although treatment for anal cancer if often very effective, with most patients experiencing a cure, anal cancer can be a serious condition. The American Cancer Society estimates that 680 people will die of anal cancer in 2008. Current treatment options include surgery, radiation, and chemotherapy. Current standards for treating anal cancer include chemotherapy and radiation. The five-year survival rate, however, following treatment with 5-FU, mitomycin, and radiation is only about 65%. Researchers in the current study sought to determine if the addition to standard therapy of Platinol, an alkylating agents that kills cancer cells by damaging their DNA, could improve outcomes of patients with anal cancer. Study participants included 682 patients diagnosed with anal cancer between 1998 and 2005. Patients were further categorized according to their gender and tumor features. Participants received either 5-FU, mitomycin, and radiation (341 patients) or Platinol, 5-FU, mitomycin, and radiation. The goal of the study was to measure five-year survival rates, as well as overall survival and time to relapse. Results were evaluated from 644 patients. The average patient age was 55 years; 69% were women; 27% had tumors that were greater than 5cm; and 26% had positive lymph node involvement.® Five-year survival rates were 60% among the patients treated with 5-FU and mitomycin compared with 54% among the patient treated with Platinol. Among the patients treated with 5-FU/mitomycin, the five-year local recurrence rate was 25%, and the distant metastasis rate was 15%. Among the patients treated with Platinol as well as 5-FU/mitomycin, these recurrence rates were higher at 33% and 19%. Fewer patients needed a colostomy among the 5-FU/mitomycin group than the Platinol group (10% versus 19%). Patients in the 5-FU/mitomycin treatment group, however, reported more frequent severe hematologic side effects, such as low blood counts. Researchers concluded that the addition of cisplatin to traditional treatment with 5-FU and mitomycin did not improve disease-free survival and contributed to significantly worse colostomy rates. These findings do not support the use of Platinol in addition to 5-FU and mitomycin in the treatment of anal cancer. Reference: Ajani, J., Winter, K., Gunderson, L., et al. Fluorouracil, Mitomycin and radiotherapy vs. fluorouracil, cisplatin and radiotherapy for carcinoma of the anal canal. Journal of the American Medical Association . 2008; 299(16) 1914-1921. Related News:® 5-FU/Mitomycin Remains Standard of Care for Anal Cancer (07/26/2006)

Women with CIN at Higher Risk for Anal Cancer and Other Cancers

Women with CIN at Higher Risk for Anal Cancer and Other Cancers According to an early online publication in Lancet Oncology , women diagnosed with cervical intraepithelial neoplasia (CIN) grade 3 are at an increased risk of developing vaginal, vulvar, and anal cancers. Further research into the impact of the human papillomaviruses on these risks is underway. Cervical intraepithelial neoplasia refers to pre-cancerous or abnormal cells on the surface of the cervix cell layer. The different grades of CIN refer to the severity of the cells? abnormality as viewed by a microscope as well as the depth of the abnormal cell layer. CIN3 refers to the highest grade of cellular abnormality, which is often treated in order to avoid progression to cervical cancer. Because the human papillomavirus (HPV) is thought to play an extensive role in the development of CIN3, researchers continue to evaluate HPV?s link to CIN along with the potential preventive effects of the vaccine now available against HPV. Researchers from Sweden recently conducted a clinical study to evaluate potential associations between CIN3 and increased risks of other cancers potentially caused by HPV. This study included women from Sweden between the ages of 18 and 50 years. Participants were evaluated between 1968 and 2004. Compared with women who had not been diagnosed with CIN3, women with a history of CIN3 had nearly a sevenfold increased risk of developing cancer of the vagina, more than a 4.5-fold increased risk of developing cancer of the anus, and a greater than twofold increased risk of developing cancer of the vulva. There was no increased risk for rectal cancer among women diagnosed with CIN3. The researchers concluded that women diagnosed with CIN 3 have a significantly increased risk of developing cancers of the vagina, vulva, and anus compared with the general population. The authors state, ?Further studies are needed to clarify the type of HPV associated with this increase in risk to determine the clinical applicability of the new HPV vaccines.? Women diagnosed with CIN3 may wish to speak with their physician regarding their individual risks and benefits of screening for cancers of the vagina, vulva, and anus. Reference: Edgren G, Sparen P. Risk of anogential cancer after diagnosis of cervical intraepithelial neoplasia: a prospective population-based study. Lancet Oncology [early online publication]. February 27, 2007. DOI:10.1016/S1470-2045(07)70043-8. Related News: ? American Cancer Society Develops Recommendations for HPV Vaccination (3/5/2007) HPV Test Identifies a Majority of Women with High-Grade CIN (4/13/2006)

5-FU/Mitomycin Remains Standard of Care for Anal Cancer

5-FU/Mitomycin Remains Standard of Care for Anal Cancer According to results recently reported at the 2006 semi-annual meeting of the Radiation Therapy Oncology Group (RTOG), treatment including the chemotherapy agents 5-fluorouracil?and?mitomycin-C (Mutomycin?) plus?radiation therapy remains the standard of care for patients with anal cancer. Anal cancer is a fairly uncommon cancer and refers to cancer originating at the end of the rectum. Depending on the stage of disease (extent of disease at diagnosis) and other factors, cancer of the anus may be treated with surgery, chemotherapy, and/or radiation therapy. Treatment is aimed at a cure or improving the duration of survival, as well as maintaining the ability to control bowel function (fecal continence). A colostomy is sometimes required for patients with anal cancer if bowel function is lost; a colostomy is an opening created from the skin to the bowel to help dispose of waste. Treatment for anal cancer typically consists of surgery, chemotherapy, and/or radiation therapy. The standard chemotherapy combination for the treatment of anal cancer has been mitomycin plus 5-FU. Researchers affiliated with RTOG recently conducted a clinical trial to directly compare mitomycin plus 5-FU to Platinol? (cisplatin) plus 5-FU in the hopes of improving outcomes among patients with anal cancer. This trial, referred to as the RTOG 98-11 study, was a phase III trial that included 632 patients who underwent surgery and radiation therapy with either 5-FU/mitomycin or 5-FU/Platinol. At five years, cancer-free survival was 59% for patients treated with 5-FU/mitomycin, compared with 53% for those treated with 5-FU/Platinol. At five years, overall survival was improved by nearly 30% for patients treated with 5-FU/mitomycin compared to those treated with 5-FU/Platinol. At five years, 90% of surviving patients treated with 5-FU/mitomycin did not require a colostomy, compared with 81% for those treated with 5-FU/Platinol. The researchers concluded that 5-FU/mitomycin remains the standard of care in terms of chemotherapy for treatment of anal cancer. The authors stressed that the addition of targeted agents in combination with this regimen are the next step in improving outcomes for patients with anal cancer. Patients with anal cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial evaluating new therapeutic regimens for the treatment of anal cancer. Reference: Radiation Therapy Oncology Group. A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy versus 5-Fluorouracil, Cisplatin and Radiotherapy in Carcinoma of the Anal Canal. Proceedings from the 2006 semi-annual meeting of the Radiation Therapy Oncology Group. June? 2006. Ontario, Canada. ? ?