Patients with Stage II and Stage III Colon Cancer Treated with 5-FU-Based Adjuvant Therapy after 1995 Have Improved Overall Survival

(BUSINESS WIRE)--ASCO Abstract Number: 3616 - Patients with stage III colon cancer treated with 5-FU-based chemotherapy after complete surgical removal of their tumor after 1995 had improved overall survival with no change in time to recurrence compared to patients treated before 1995. In contrast, patients with stage II colon cancer treated after 1995 had longer time to recurrence and time from recurrence to death compared to those patients treated prior to 1995, according to Mayo Clinic and Gr Hospitalier Pitie-Salpetriere, Paris, researchers. They will present the study’s findings on June 4-8, 2010, at the 2010 American Society of Clinical Oncology Annual Meeting in Chicago.

“By combining information from 21 cancer treatment trials for patients with stage II and stage III colon cancer, our analysis determined that those patients treated after 1995 had improved overall survival,” says Dan Sargent, Ph.D., Mayo Clinic biostatistician, North Central Cancer Treatment Group (NCCTG) statistician and senior author on the study.

The analysis compared patient data from more than 18,000 patients with stage II and stage III colon cancer treated with 5-FU-based chemotherapy after their primary tumor had been surgically removed for the time period 1978-1995 versus 1996-2007.

“Patients with stage II colon cancer treated after 1995 had had longer time to recurrence, possibly due to improvements in surgery and pathology” says Dr. Sargent. “In addition, after 1995, both stage II and stage III colon cancer patients treated after surgery with the same 5-FU-based chemotherapy after surgery had improved overall survival. This finding provides evidence to support previous findings that access to new medical therapies introduced in the mid-1990s as well as the expanded use of surgery for patients recurrent disease have meaningfully improving overall survival for patients treated in this setting.”

The findings arise from analysis of combined data collected within an expanded database by the Adjuvant Colon Cancer End Points (ACCENT) Group, a consortium of scientists. The ACCENT database includes data from more than 33,500 patients from the United States, Canada, Australia and Europe. ACCENT, chaired by Dr. Sargent, is supported by the North Central Cancer Treatment Group.

Dr. Sargent conducted the analysis on the expanded database in concert with an international team of scientists participating in ACCENT including Qian Shi, Ph.D. and Brian Bot, from Mayo Clinic; Thierry Andre, M.D., Gr Hospitalier Pitie-Salpetriere; Greg Yothers, M.D., NSABP Statistical Center, Pittsburgh; Daniel Haller, M.D., Abramson Cancer Center, University of Pittsburgh; Eric Van Cutsem, M.D., Ph.D., University Hospital Gasthuisberg/Leuven; James Cassidy, M.D., Glasgow University; Jacqueline Benedetti, Ph.D., Fred Hutchinson Cancer Research Center, Seattle; and Michael O’Connell, M.D., National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, NSABP Operations Center, Pittsburgh.

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Sarah Cannon Research Institute Presents New Findings in Breast Cancer Treatment

BUSINESS WIRE --Sarah Cannon Research Institute (SCRI) investigators have found that “smart bomb” therapies are effective in treating breast cancer patients while minimizing side effects.

Howard A. Burris III, M.D., SCRI’s chief medical officer, presented interim Phase II clinical trial results of a drug named Trastuzumab-DM1 (T-DM1), a novel antibody drug conjugate, on September 5th at the American Society of Clinical Oncology’s Breast Cancer Symposium in Washington, D.C.

T-DM1 is built from the widely used antibody Herceptin. T-DM1 combines Herceptin’s HER2 blocking activity with a targeted intracellular delivery of a potent anti-microtubule agent directly into HER2-positive breast cancer cells. In 20 percent of breast cancer cases, the patient’s cancer has too much of the HER2 protein, which makes the cancer cells grow and divide more quickly. T-DM1 is designed to focus delivery of treatment to HER2-positive cancer cells and limit delivery to surrounding healthy tissue.

Dr. Burris and his team were the first oncologists to treat patients with T-DM1 in December 2006. Minimal toxicities have been observed in the trial to date.

“Physicians call it a ‘smart bomb’ because it’s designed to hit the target cancerous cells with minimal collateral damage to its neighboring non-cancerous cells,” Dr. Burris said.

Thirty-one patients with HER2-positive metastatic breast cancer whose tumors had progressed on prior HER2-directed therapy in the trial received 3.6 mg/kg of T-DM1 by IV every three weeks. The interim findings of the Phase II study include evidence of tumor shrinkage in some patients.

Murfreesboro, Tenn. resident Nancy Fann, 64, had been on at least three chemotherapy treatments since cancer had spread from her lung to her liver and breast, but the tumors kept coming back. In May 2007 she enrolled in the T-DM1 clinical trial.

“The tumors are considerably smaller than they were to begin with,” Fann said. “This drug doesn’t seem to affect me as much as some of the others I’ve been on. I don’t get sick and I haven’t lost my hair.”

Denise A. Yardley, M.D., SCRI’s director of breast cancer research, also presented her research on two trials. Both trials focus on targeted therapies for patients with HER2-positive metastatic breast cancer.

One trial shows preliminary results from a Phase II trial of a combination of Herceptin and the chemotherapy drug oxaliplatin. Twenty-one patients have enrolled in the trial so far, and early results show the treatment is active with little to no significant side effects seen to date.

The other trial focuses on a combination treatment of Avastin and the chemotherapy drug docetaxel for early-stage, metastatic breast cancer. A cohort of patients with HER2-positive disease also receives Herceptin as part of the study. Data for the first 138 patients enrolled indicate the treatment is reasonably well-tolerated without unexpected side effects.

“As knowledge about tumors and tumor biology grows, we’re learning that all breast cancers are not identical,” Dr. Yardley said. “These smart new drugs help target treatment specific to certain types of tumors, causing less damage to healthy cells and reducing side effects.”

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Data Presented at ASCO Finds REVLIMID as a Monotherapy is Effective and Well-Tolerated for Previously Treated Multiple Myeloma Patients

BUSINESS WIRE--The Moffitt Cancer Center today said findings from a clinical trial presented at the American Society of Clinical Oncology (ASCO) meeting evaluating REVLIMID (lenalidomide) as a monotherapy is both effective and well-tolerated in patients who have been previously treated for multiple myeloma with two or more therapies.

In the study, 26% of relapsed refractory multiple myeloma patients treated with REVLIMID as a single achieved an overall response, either complete or partial remission, and 66% of patients experienced stable disease. The median overall survival was 1.9 years with 41% of patients alive after three years. Prior to this innovative therapy the median overall survival was less than a year. Additionally, the duration of response was 13 months.

“REVLIMID is a novel, oral, targeted immune modulator cancer therapy with impressive clinical data in both newly diagnosed and previously treated multiple myeloma that shows REVLIMID can provide durable, long-lasting results for patients,” said Dr. Mohamad Hussein, Head Multiple Myeloma Section, Moffitt Cancer Center. “This study demonstrates that REVLIMID is effective in treating patients in which other therapies have failed without complimentary steroids or chemotherapy that can potentially cause serious side effects helping patients to live longer with a better quality of life.”

Multiple myeloma is a cancer of one of the immune cells that affects production of red cells, white cells and platelets. It is the second most prevalent and fastest growing of the blood cancers, affecting an estimated 750,000 people worldwide and 60,000 patients in the U.S.

REVLIMID is the newest of what are called immune modulators which have changed the outlook for patients with multiple myeloma and enable doctors to treat the previously incurable cancer as a chronic, manageable condition. It is an oral drug that can be taken at home and doesn’t have some of the difficult side effects associated with traditional chemotherapy because it targets the cancer cells directly along with the factors that support their growth.