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Phase III Double-Blind, Placebo-Controlled Study of Thalidomide in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy: An Intergroup Study FNCLCC cleo04–IFCT 00-01

Jean Louis Pujol, Jean Luc Breton, Radj Gervais, Marie-Laure Tanguy, Elisabeth Quoix, Philippe David, Henri Janicot, Virginie Westeel, Sabine Gameroff, Jean Genève, Dominique Maraninchi

From the Centre Hospitalier Universitaire, Montpellier; Hôpital de Belfort, Belfort; Centre Régional de Lutte Contre le Cancer, François Baclesse, Caen; Service de Biostatistique et d'Information Médicale, Hôpital la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris; Hôpital du Kremlin Bicêtre, Assistance Publique des Hôpitaux de Paris; Bureau des Études Cliniques et Thérapeutiques, Fédération Nationale des Centres de Lutte Contre le Cancer, Paris; Hôpital Universitaire de Strasbourg, Strasbourg; Hôpital Universitaire de Clermont Ferrand, Clermont Ferrand; Hôpital Universitaire de Besançon, Besançon; and Institut Contre le Cancer Paoli Calmette, Marseille, France

Address reprint requests to Jean Louis Pujol, MD, PhD, Hôpital Universitaire Arnaud de Villeneuve, 34295 Montpellier Cedex 5, France; e-mail: jl-pujol{at}chu-montpellier.fr

Purpose This randomized, double-blind, placebo-controlled phase III study aimed to determine whether thalidomide prolongs survival of patients with extensive-disease small-cell lung cancer (SCLC).

Patients and Methods One hundred nineteen patients received two courses of etoposide, cisplatin, cyclophosphamide, and 4'-epidoxorubicin (PCDE). Responder patients who had recovered from chemotherapy toxicity were randomly assigned to receive four additional PCDE cycles plus thalidomide (400 mg daily) or placebo.

Results After the first two PCDE cycles, objective response rate was 81.5%, and 92 patients were randomly assigned to placebo (n = 43) or thalidomide (n = 49). Median exposure duration to placebo was 4.5 months, and median exposure to thalidomide was 4.9 months. Patients treated with thalidomide had a longer survival compared with patients who received placebo, although the difference was not statistically significant (minimal follow-up, 3 years; median survival time, 11.7 v 8.7 months, respectively; log-rank test: hazard ratio [HR] = 0.74; 95% CI, 0.49 to 1.12; P = .16). Patients with a performance status (PS) of 1 or 2 who received thalidomide had a significantly longer survival (HR = 0.59; 95% CI, 0.37 to 0.92; P = .02). The disease also progressed slower in patients with PS of 1 or 2 receiving thalidomide (HR = 0.54; 95% CI, 0.36 to 0.87; P = .02), whereas the difference did not reach statistical significance for the whole population (HR = 0.74; 95% CI, 0.49 to 1.12; P = .15). Neuropathy occurred more frequently in the thalidomide group compared with the placebo group (33% v 12%, respectively).

Conclusion Treatment with thalidomide was not associated with a significant improvement in survival of SCLC patients. There was pronounced heterogeneity in survival outcomes between groups of patients. Some benefit was observed among patients with a PS of 1 or 2 (exploratory analyses), deserving further studies targeting angiogenesis in this disease.

Supported by the French League Against Cancer.

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Related Correspondence

• Thalidomide in Small-Cell Lung Cancer: Is It a Tombstone?
  Antonio Rossi, Cesare Gridelli, and Emilio Bria
  JCO 2008 26: 160 [Full Text]

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