Related Pages Search for Clinical Trials NCI's PDQ® registry of cancer clinical trials. Lung Cancer Home Page NCI's gateway for information about lung cancer. Highlights from ASCO 2004 (Posted: 06/05/2004, Reviewed: 12/06/2005) - A collection of links to material summarizing some of the important clinical trial results announced at the 2004 annual meeting of the American Society of Clinical Oncology (ASCO).

Key Words

Lung cancer; non-small cell lung cancer; cisplatin; carboplatin; paclitaxel (Taxol®), vinorelbine. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Two large randomized studies show that in some cases of early-stage non-small cell lung cancer, treatment after surgery with chemotherapy improves overall survival compared to surgery alone. The findings help resolve a controversy over the value of post-surgical chemotherapy for certain patients with early lung cancer, and are likely to change the standard of care.

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 for certain patients.

Study 1 (Cancer and Leukemia Group B)

The 344 patients in this trial, all with stage IB 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. (See the protocol summary.)

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 had stage IB or stage II tumors that had been removed by surgery. They 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. (See the protocol summary.)

Study 2 Results

About 69 percent of participants in the chemotherapy group were alive at 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.

(Note: the final results from this trial were subsequently published in the June 23, 2005, issue of the New England Journal of Medicine; see the journal abstract.)

Comments

Taken together, the definitive results are expected to resolve the uncertainties concerning the value of chemotherapy after surgery for the selected subsets of lung cancer patients studied in these trials.

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