Source
American Society of Clinical Oncology (ASCO) annual meeting, New Orleans, June 5, 2004.
Background
There has been controversy about whether patients with early-stage non-small cell lung cancer should have chemotherapy following surgery. These patients are at high risk for recurrence, but earlier trials of chemotherapy after surgery have had contradictory results or shown only a small benefit. However, the findings of these two large, randomized trials show conclusively that post-surgical chemotherapy does significantly improve overall survival.
Study 1 (Cancer and Leukemia Group B)
The 344 patients in this trial, all with tumors that had been completely removed, were randomized to receive either no chemotherapy after surgery or chemotherapy with paclitaxel (Taxol®) and carboplatin. The study was stopped earlier than planned when it became clear that the chemotherapy group had significantly better survival.
The study was led by Gary M. Strauss, M.D., of Rhode Island Hospital, Brown Medical School, and coordinated by one of the National Cancer Institute¿s cooperative clinical trial groups, the Cancer and Leukemia Group B.
Study 1 Results
Overall survival for patients receiving chemotherapy after surgery was significantly better than for those who had surgery without chemotherapy. After four years, 71 percent of the patients receiving chemotherapy after surgery were alive compared to 59 percent who had surgery alone. The researchers reported that this translates into a 38 percent reduced risk of deaths from all causes. The risk of death from lung cancer specifically was reduced by 49 percent in those receiving chemotherapy.
Side effects of the chemotherapy were well tolerated, according the investigators. The most severe side effect was neutropenia (a reduction in neutrophils, a kind of white blood cell that fights infection). There were no treatment-related deaths.
Study 2 (National Cancer Institute of Canada Clinical Trials Group)
The 482 patients in this trial, also with early-stage non-small cell lung cancer, were divided randomly into two groups. One group received no chemotherapy after surgery while the other received cisplatin and vinorelbine. The study was led by Timothy Winton, M.D., for the National Cancer Institute of Canada Clinical Trials Group and conducted in cooperation with clinical trial groups supported by the U.S. National Cancer Institute.
Study 2 Results
About 69 percent of participants in the chemotherapy group were alive after five years compared to 54 percent in the group that had surgery alone. Overall survival was 94 months for those receiving chemotherapy and 73 months for those in the other group. Side effects during treatment included neutropenia, fatigue, nausea, and other symptoms; side effects that persisted after treatment were hearing loss, numbness, and parasthesias (a burning or tingling sensation in the hands and feet). There were two treatment-related deaths.
Comments
Taken together, the definitive results from these two studies are expected to resolve the uncertainties concerning the value of chemotherapy after surgery in early-stage non-small cell lung cancer.
