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Authors: Lee S-M et al. Reviewers: Dr. C. Butts, Dr. R. Burkes Date posted: Sept 20, 2007

A phase III, randomized, double-blind, placebo controlled trial of etoposide/carboplatin with or without thalidomide in advanced small cell lung cancer. Authors: Lee S-M et al. Reviewers: Dr. C. Butts, Dr. R. Burkes Date posted: Sept 20, 2007. Background.

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Authors: Lee S-M et al. Reviewers: Dr. C. Butts, Dr. R. Burkes Date posted: Sept 20, 2007

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  1. A phase III, randomized, double-blind, placebo controlled trial of etoposide/carboplatin with or without thalidomide in advanced small cell lung cancer Authors: Lee S-M et al. Reviewers: Dr. C. Butts, Dr. R. Burkes Date posted: Sept 20, 2007

  2. Background • Small cell lung cancer is highly angiogenic. • Previous phase II trial of thalidomide with chemotherapy was well tolerated. • Randomized phase II trial (Pujol et al) of chemo +/- thalidomide in responders to initial chemotherapy suggested a survival advantage of 3 months.

  3. Study Design • Randomized phase III, placebo controlled. • End points were OS, TTP, RR, toxicity and QoL. • Powered to show 7% improvement in 2 year survival (12%-19%). • Placebo or thalidomide to start with chemo and could continue for 2 years. • Starting dose of 100 mg, escalate to 150 mg at 1 month and 200 mg at 2 months.

  4. Patients • Limited or extensive small cell • PS 0-3 • Chemo-naive • Thoracic and PCI offered to Limited stage patients having response to chemotherapy.

  5. Treatment A: Carboplatin (AUC 5 or 6) and etoposide 100 mg/m2 Day 1 & 2 q 3 weeks, max 6 plus thaliomide daily R Treatment B: same chemo plus placebo daily Limited/extensive, PS 0-3, Chemo-naive

  6. RESULTS

  7. STUDY COMMENTARY • Significantly more thrombotic events in thalidomide arm (18% vs 11%). • 49% of patients were extensive stage. 1 year survival in ED patients ws lower in thalidomide arm (25% vs 75%) • No particular subgroup seemed to benefit. • Possible reasons for the differences between this trial and Pujol study: • Included both LD and ED • Lack of selection for responders • Lower dose of thalidomide in this study (100 mg versus 400 mg) • Should be noted that the published results of the Pujol trial (JCO Sept 2007) show no significant survival advantage.

  8. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • This trial is another in the long list of disappointing small cell trials. • These results combined with the negative result seen in the final publication of the Pujol trial may result in reconsidering further trials with newer generation thalidomide derivatives.

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