teresag Posted June 28, 2004 Share Posted June 28, 2004 Clinical Practice in Early Stage Lung Cancer Poised for Change Last Updated: June 07, 2004 Two phase III trials in the Oral Abstract Presentation Session, Lung Cancer I, included impressive results for adjuvant chemotherapy for patients with early stage, non-small cell lung cancer (NSCLC) that may change the course of clinical practice. Earlier trials of adjuvant chemotherapy have yielded mixed results, and surgery alone still remains the standard of care in the treatment of this disease. The two trials compared the efficacy and safety of chemotherapy, given in combination over 12-16 weeks, with observation alone (the current standard of care) for patients with stage I or stage II disease who had surgical resection. Reporting for the National Cancer Institute of Canada, Timothy L. Winton, MD, of the University of Alberta, shared data from JBR.10, which demonstrated that a 16-week course of treatment with a third-generation platinum-based therapy (vinorelbine and cisplatin) was more effective in prolonging survival for 243 patients with stage IB and stage II disease compared with observation (239 patients) (abstract #7018). Gary M. Strauss, MD, MPH, of the Rhode Island Hospital and Brown Medical School, reported that 173 patients with stage IB disease who enrolled in the Cancer and Leukemia Group B (CALGB) Protocol 9633 also benefited from 12 weeks of chemotherapy with paclitaxel and carboplatin compared with observation alone (171 patients) (abstract #7019). Data from the two studies are remarkably consistent with respect to overall survival (69% for JBR.10 and 71% for CALGB 9633) and improvement in failure-free survival (30% for JBR.10 and 31% for CALGB 9633), favoring adjuvant chemotherapy. With relative risk reduction for all-cause mortality and lung cancer-specific mortality (38% and 49%, respectively) in favor of adjuvant chemotherapy, CALGB 9633 showed that adjuvant chemotherapy reduced all-cause mortality. In addition, JBR.10 demonstrated that there was no long-term difference in global or any quality-of-life performance scores for patients who received chemotherapy. Why have these trials provided more consistent data compared with past studies? Both Dr. Winton and Dr. Strauss indicated that this might be related to the patients enrolled in the trials. Katherine M. W. Pisters, MD, of M.D. Anderson Cancer Center, who served as the discussant for these studies, concurred. “Patients in these trials had earlier stage disease, had uniform disease, and [the studies] enrolled more women. In addition, the trials involved drug regimens that were not toxic [compared with earlier trials that often used three-drug regimens] and included a third-generation agent. Compliance with therapy was better, and no radiation therapy was used.” Indeed, JBR.10 and CALGB 9633 were stringent about the type of patients who could enroll. Complete resection of the tumor and accurate disease staging was very important. CALGB 9633 was restricted to patients with documented stage IB (T2N0) disease, and although JBR.10 was restricted to patients with stage IB (T2N0) and stage II (excluding T3N0) disease, data were stratified by nodal status (N0 or N1). Typically, such patients routinely have surgical removal of the tumor and often have local or widespread recurrence of disease, leading to death. In addition, the chemotherapy regimen in JBR.10 was a better-tolerated, third-generation, platinum-based doublet. CALGB 9633 evaluated the efficacy of paclitaxel in combination with carboplatin, which has a better tolerability profile than its predecessor, cisplatin. Dr. Strauss said, “The efficacy data along with the favorable tolerability of the regimens would play a key role in having these regimens acceptable by oncologists who treat early non-small cell lung cancer.” Dr. Pisters summarized the data that indicate the benefits of adjuvant chemotherapy. These trials show an absolute survival benefit of 12% to 15% for patients receiving adjuvant chemotherapy compared with observation alone. At 5%, earlier trials showed survival benefits that were only marginal. Dr. Winton voiced a fundamentally important opinion for changing the course of clinical practice. “When adjuvant chemotherapy was adopted as standard of care in breast and colon cancers, it was based on data documenting a far less survival advantagethan these data, which show survival benefits of up to 15% at five years.” Dr. Pisters agreed, adding “Adjuvant platinum-based chemotherapy should be recommended to patients with non-small cell lung cancer with good performance status and who have undergone complete resection of the tumor.” Is adjuvant chemotherapy in early-stage non-small cell lung cancer a new standard of care? With lung cancer being the most common newly diagnosed cancer in the United States and with incidence increasing worldwide, Dr. Winton emphasized that these findings may benefit more patients in the future. “This is the best news for patientswith lung cancer in a long time,” he said. These trials provide resounding approval for adjuvant chemotherapy being the new standard of care for patients with early stage non-small cell lung cancer. Quote Link to comment Share on other sites More sharing options...
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