Gilda's Club Worldwide Spells 'HOPE' To Colon Cancer Patients And Survivors

Main Category: Colorectal Cancer
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 25 Dec 2008 - 1:00 PDT

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Cancer advocacy organization Gilda's Club Worldwide offers a message of hope this holiday season to the millions touched by colon cancer with a one-of-a-kind mosaic mural at its New York City headquarters. The 15X6 foot mural was created by more than 165 colon cancer survivors from around the nation as part of a new MOSAIC of Colon Cancer Survivorship program celebrating the strides that have improved colon cancer treatment. According to the American Cancer Society, death rates for colon cancer have been declining due to many factors including prevention, improved detection and better treatment options.

The mural spells "HOPE!" in celebration of the advances in prevention, screening, staging and treatment that are improving survival for people with colon cancer.

For several months, Gilda's Clubhouses from across the country have worked with colon cancer survivors and their loved ones to create inspirational murals expressing the thoughts and feelings of people nationwide touched by colon cancer. Murals were contributed by clubhouses in every region of the country - Northeast, Southeast, Midwest, Southwest and West - before heading to New York City. The MOSAIC mural of HOPE! was assembled by volunteers at Gilda's Club Worldwide where it will be on display January 12 until February 13, 2009.

"Colon cancer is a frightening diagnosis, but there is hope," said Sandy Towers, Gilda's Club Worldwide interim executive director. "Through the MOSAIC of Colon Cancer Survivorship program, survivors offered the best kind of hope that comes from those who have already gone through the experience."

At each of the local MOSAIC of Colon Cancer Survivorship events, colon cancer survivors shared what going through treatment has meant in their lives, and oncologists gave presentations on the many medical advances that are improving survival rates for patients with Stage III colon cancer, including six-year overall survival data from the large multicenter clinical trial MOSAIC.

"Today we have a wider array of tools to fight colon cancer," said Dr. Howard Hochster, Professor of Medicine and Clinical Pharmacology, New York University Clinical Cancer Institute. "Great progress in diagnosis and treatment is improving the outlook for patients. For example, the recent FDA approval to include six-year survival results from the MOSAIC trial in the prescribing information of the chemotherapy oxaliplatin marks a particularly important advancement in Stage III colon cancer treatment. The MOSAIC trial showed that after a median follow-up of 6.8 years, Stage III colon cancer patients treated with an oxaliplatin-based regimen were significantly less likely to relapse or die compared to those treated with standard chemotherapy alone."

The MOSAIC of Colon Cancer Survivorship program is sponsored by Gilda's Club Worldwide and sanofi-aventis U.S. The mosaic mural will be on display at Gilda's Club Worldwide from January 12 until February 13, 2009; photos will be posted on the Gilda's Club Web site at www.gildasclub.org.

About the MOSAIC Trial

U.S. Food and Drug Administration (FDA) recently approved the inclusion in the oxaliplatin injection prescribing information of six-year overall survival and five-year disease free survival data from the MOSAIC trial among Stage III colon cancer patients treated following surgery to remove the primary tumor. The MOSAIC trial results showed that after a median follow-up of six years, Stage III colon cancer patients treated with an oxaliplatin-based regimen had a 20% reduction in the risk of dying compared to those treated with standard chemotherapy alone (hazard ratio of 0.80, confidence interval [0.65, 0.97] p=0.023). Stratified log-rank test was not adjusted for multiple comparisons. Also, Stage III patients treated with the oxaliplatin-based regimen at 5 years were 22 percent less likely to relapse or risk of disease recurrence (HR=0.78 [CI: 0.65, 0.93], p =0.005) after 77 month follow-up.

In the MOSAIC trial, neutropenia (decrease in the number of white blood cells), was the most frequently reported side effect, affecting 78.9% of patients. Neutropenia was complicated by fever or infection in only 1.8% of cases. Peripheral sensory neuropathy ("tingling or numbness" in the fingers or toes) occurred in 92.1% of patients treated with FOLFOX4. Half (48.2%) of the episodes were grade 1, and 12% were severe (grades 3 and 4). Partial or total recovery was observed within 18 months following treatment in most patients experiencing grade 3 peripheral sensory neuropathy. Patients treated with FOLFOX4 also reported nausea (73.7%), diarrhea (56.3%) and vomiting (47.2%).

Supported by sanofi-aventis, the phase III controlled MOSAIC trial was conducted in 148 centers in 20 countries. In MOSAIC, 2,246 patients with Stage II or Stage III colon cancer whose tumor had been completely surgically removed were randomized to treatment with either the oxaliplatin-based regimen (n=1,123) or standard chemotherapy 5-FU/LV (n=1,123) every two weeks for 12 cycles.

About Colon Cancer

Every year, about one million new cases of colon cancer are diagnosed worldwide. About 150,000 new cases are detected each year in the United States. Over a lifetime, about 1 in 19 people develop colon cancer and nearly 50,000 people are expected to die from it in the U.S. this year. According to the American Cancer Society, colon cancer is the third leading cause of cancer-related death in the U.S., accounting for about 10 percent of all cancer deaths.

About Oxaliplatin

Indications and Usage

Oxaliplatin injection, used in combination with infusional 5-FU/LV, is indicated for

-- Adjuvant treatment of Stage III colon cancer patients who have undergone complete resection of the primary tumor

-- Treatment of advanced carcinoma of the colon or rectum

Clinical Safety Considerations

Anaphylactic-like reactions to oxaliplatin injection have been reported and may occur within minutes of oxaliplatin injection administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms, and discontinuation of oxaliplatin injection therapy may be required.

-- Oxaliplatin injection should not be administered to patients with a history of known allergy to oxaliplatin injection or other platinum compounds. Hypersensitivity and anaphylactic/anaphylactoid reactions to oxaliplatin injection have been reported and were similar in nature and severity to those reported with other platinum compounds (ie, rash, urticaria, erythema, pruritus, and, rarely, bronchospasm and hypotension). These reactions occur within minutes of administration and should be managed with appropriate supportive therapy. Drug-related deaths from this reaction have been reported

-- Oxaliplatin injection may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving oxaliplatin injection. It is not known whether oxaliplatin injection or its derivatives are excreted in human milk

-- Oxaliplatin injection has been associated with pulmonary fibrosis (<1% of study patients), which may be fatal. The combined incidence of cough and dyspnea was 7.4% (<1% grade 3, no grade 4) in the oxaliplatin injection plus 5-FU/LV arm compared to 4.5% (no grade 3, 0.1% grade 4) in the 5-FU/LV alone arm in the adjuvant colon cancer study. In this study, one patient died from eosinophilic pneumonia in the oxaliplatin injection combination arm. The combined incidence of cough, dyspnea, and hypoxia was 43% (7% grade 3 and 4) in the oxaliplatin injection plus 5-FU/LV arm compared to 32% (5% grade 3 and 4) in the irinotecan plus 5-FU/LV arm in patients with previously untreated colorectal cancer. In case of unexplained respiratory symptoms, oxaliplatin injection should be discontinued until pulmonary investigation excludes interstitial lung disease or pulmonary fibrosis

-- Oxaliplatin injection is associated with two types of primarily peripheral sensory neuropathy: an acute, reversible type of early onset and a persistent type (>14 days). In patients with advanced colorectal cancer paresthesias occurred in 77% (all grades) and 18% (grade 3/4) of previously untreated patients. In previously treated patients, acute neuropathy occurred in 56% (all grades) and 2% (grade 3/4) of patients; persistent neuropathy occurred in 48% (all grades) and 6% (grade 3/4) of patients. In patients with Stage II and III colon cancer, paresthesia was seen in 92% (all grades) and 13% (grade 3/4) of patients; 21% (all grades), 0.5% (grade 3/4) had residual paresthesia at 18-month follow-up

-- Hepatotoxicity, as evidenced in the adjuvant study by increase in transaminases and alkaline phosphatase was observed more commonly in the oxaliplatin injection combination arm. The incidence of increased bilirubin was similar on both arms. Changes noted on liver biopsies include: peliosis, nodular regenerative hyperplasia or sinusoidal alterations, perisinusoidal fibrosis and veno-occlusive lesions. Hepatic vascular disorders should be considered and, if appropriate, investigated in case of abnormal liver function test results or portal hypertension not explained by liver metastases.

-- Monitoring of white blood cell count with differential, hemoglobin, platelet count and blood chemistries (including ALT, AST, bilirubin and creatinine) is recommended before each oxaliplatin injection cycle

-- The safety and effectiveness of oxaliplatin injection plus 5-FU/LV in patients with renal impairment have not been evaluated. Since the primary route of platinum elimination is renal, this combination should be used with caution in patients with preexisting renal impairment. Clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds, although this has not been specifically studied

-- The incidence of diarrhea, dehydration, hypokalemia, leukopenia, fatigue and syncope were higher in patients greater than or equal to 65 years old

-- Extravasation may result in local pain and inflammation that may be severe and lead to complications, including necrosis. Injection site reaction, including redness, swelling and pain, has been reported

-- There have been reports of prolonged prothrombin time and INR occasionally associated with hemorrhage in patients receiving oxaliplatin injection plus 5-FU/LV while on anticoagulants. Patients receiving oxaliplatin injection plus 5-FU/LV and requiring oral anticoagulants may require closer monitoring

-- The most common adverse reactions in patients with Stage II or III colon cancer receiving adjuvant therapy were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. The most common adverse reactions in patients with advanced colorectal cancer were peripheral sensory neuropathy, fatigue, neutropenia, nausea, emesis, and diarrhea

For full prescribing information, including BOXED WARNING, or for more information about oxaliplatin injection visit http://www.Eloxatin.com.

About Gilda's Club

Gilda's Club is a cancer support community where men, women and children, who have any type or stage of cancer, and their families and friends come together, free of charge, for social and emotional support. At clubhouses nationwide, Gilda's Club provides support groups, lectures, workshops, and social events where people learn to live with cancer, whatever the outcome. Gilda's Club is named in honor of Saturday Night Live comedian Gilda Radner, who died of ovarian cancer in 1989. Gilda dreamed that all people affected by cancer, as well as their families and friends, would have access to the same kind of emotional and social support that she received during her illness.

About Sanofi Aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, visit: http://www.sanofi-aventis.us or http://www.sanofi-aventis.com.

Sanofi Aventis
http://www.sanofi-aventis.com