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Clinical Trial Results

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  • Posted: 10/30/2008

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No Survival Benefit from Adjuvant Chemo in Stage 1B NSCLC

Adapted from the NCI Cancer Bulletin.

Long-term results of the only randomized trial, CALGB 9633, designed specifically to evaluate the benefits of adjuvant chemotherapy in patients with stage 1B non-small-cell lung cancer (NSCLC) show that, after a median of six years of follow up, the paclitaxel-plus-carboplatin regimen offers no survival advantage.

These findings, published online September 22, 2008, in the Journal of Clinical Oncology (see the journal abstract), contradict preliminary results of the same trial reported in 2004. The trial was terminated ahead of schedule in November 2003, based on slightly less than three years of follow-up, after data showed reductions in both lung cancer deaths and deaths from any cause in patients randomly assigned to the chemotherapy arm.

Guidelines released last November on adjuvant chemotherapy for patients being treated for NSCLC endorsed its use in patients with more advanced stages of the disease (IIA, IIB, IIIA), but concluded that the data on its use in patients with stage 1B disease were still inconclusive.

"Unfortunately, with longer follow-up, our encouraging preliminary findings have not been sustained," wrote Dr. Gary M. Strauss, of Tufts Medical Center in Boston, and colleagues. "Clearly, our results do not support routine use of adjuvant chemotherapy as standard of care in stage 1B NSCLC."

Three previous multicenter randomized trials of cisplatin-based adjuvant chemotherapy have also failed to show a survival advantage in patients with stage 1B NSCLC, although those trials did show that chemotherapy extended survival for patients with stage II or IIIA disease. In addition, a meta-analysis of five trials involving more than 4,500 patients failed to show a benefit of chemotherapy in patients with stage 1B disease.

A secondary analysis of CALGB 9633 suggests that chemotherapy did extend survival and delay disease recurrence for patients whose tumors measured at least 4 cm in diameter. A meta-analysis is now underway to further explore this observation.

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