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Biotech / Medical : Indications -- Cancer -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (519)	6/8/2004 3:33:34 AM
From: Icebrg	Read Replies (2) \| Respond to of 1840

Adjuvant Chemotherapy Associated With Survival Benefit for Early-Stage NSCLC [Medscape's take on the same subject]. Peggy Peck June 7, 2004 (New Orleans) — Two studies widely praised as "landmark findings" confirm that adjuvant chemotherapy using a platinum-based regimen can increase five-year survival by 12% to 15% in patients with resectable early-stage non-small cell lung cancer (NSCLC). The studies — one from Canada and one from the U.S. — were the centerpiece of the lung cancer oral presentations before a packed auditorium here at the 40th annual meeting of the American Society of Clinical Oncology (ASCO). In the Canadian study, patients randomized to adjuvant vinorelbine and cisplatin (VIN/CIS) had a 69% survival rate, while patients who did not receive adjuvant chemotherapy had a 54% survival rate at five years, said lead investigator Timothy L. Winton, MD, from the National Cancer Institute of Canada. At an ASCO press conference, Dr. Winton told Medscape that the results were "huge" and noted that they are "comparable to results we saw earlier in the breast cancer and colon cancer adjuvant therapy trials." He said the results are likely to change the treatment landscape in lung cancer. Noting that he is a surgeon and that surgeons are often reluctant to recommend adjuvant chemotherapy, Dr. Winton said, "I think that we will no longer have that difficulty with surgeons." In the second study, from U.S. investigators from the Cancer and Leukemia Group B, a cooperative clinical trials group, adjuvant therapy with paclitaxel and carboplatin found that adjuvant chemotherapy was associated with a 38% reduction in all-cause mortality at four years and a 49% reduction in risk of death from lung cancer. Moreover, after four years the risk of dying from lung cancer was 15% in the chemotherapy group and 26% in the watchful waiting group. These studies are expected to have a much greater impact than results presented at ASCO a year ago, when researchers reported that adjuvant therapy increased survival by 4.1%, a result that many considered less than convincing. That earlier study included a more heterogeneous patient population and didn't have the advantage of "third-generation chemotherapy agents," said Bruce Johnson, MD, director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School in Boston, Massachusetts. Dr. Johnson was not involved in the studies, but he moderated an ASCO press conference where findings were presented. Dr. Johnson told Medscape that he agreed with Dr. Winton's prediction that the findings will make adjuvant therapy the standard of care. Marianna Koczywas, MD, a medical oncologist and researcher at City of Hope National Medical Center in Duarte, California, told Medscape that she was surprised by the magnitude of the outcome. "We have been trying adjuvant therapy for years and in most cases it was not really successful. Last year, the European study reported a 4.1% survival advantage, so that suggested that it was a good strategy," she said. She noted that one reason for the markedly improved results may be patient selection — both the Canadian and U.S. studies only included patients with early-stage disease (stage IB and II). Dr. Koczywas, who was not involved in the study, added that "it is also possible that the patients in these two studies had better staging." In the Canadian study, 243 patients were randomized to VIN for four cycles (25 mg/m2 weekly for 16 weeks) plus CIS 50 mg/m2 for 16 weeks and 239 patients underwent surgery alone. The mean age of patients was 61 years, and 65% were men. All patients had stage I or stage II NSCLC. Mean survival in the group randomized to VIN/CIS was 94 months while mean survival in the surgery group was 73 months. Moreover, while most of the patients in the VIN/CIS group did not experience recurrence during the study, the average time to recurrence in the surgery only group was 46.7 months. Similar results were reported in the U.S. study. Gary Strauss, MD, MPH, from Brown University and Rhode Island Hospital in Providence, said his group recruited 344 patients with stage 1B NSCLC. One hundred seventy-three patients were randomized to adjuvant chemotherapy with paclitaxel and carboplatin for 16 weeks or to observation. The average age of patients was 61 years, 64% were men, and the median follow-up was 31 months. After four years, 19 patients in the chemotherapy group died compared with 34 patients in the control group. Dr. Koczywas said it is significant that Dr. Strauss and colleagues saw a significant survival benefit using a carboplatin and paclitaxel regimen because this is the first large trial of that regimen in this patient population. In the oncology community, cisplatin is generally considered the more potent agent, "but with these data we can no longer say that. Now it is clear that both carboplatin and cisplatin are effective," she said. ASCO 2004 Annual Meeting: Abstracts 7018 and 7019. Presented June 6, 2004. Reviewed by Gary D. Vogin, MD medscape.com