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
| Autor: | Jean Luc Breton, Virginie Westeel, Elisabeth Quoix, Dominique Maraninchi, Sabine Gameroff, Radj Gervais, Jean-Louis Pujol, H. Janicot, Philippe David, Jean Genève, Marie-Laure Tanguy |
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| Přispěvatelé: | Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de pneumologie, CHU Strasbourg-Hopital Civil, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC), Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre François Baclesse, Service de biostatistiques et information médicale [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO) |
| Jazyk: | angličtina |
| Rok vydání: | 2007 |
| Předmět: |
Male
Cancer Research Lung Neoplasms medicine.medical_treatment Placebo-controlled study Gastroenterology [ SDV.CAN ] Life Sciences [q-bio]/Cancer MESH: Proportional Hazards Models 0302 clinical medicine MESH : Female MESH: Double-Blind Method Carcinoma Small Cell Etoposide 0303 health sciences MESH: Middle Aged MESH: Thalidomide MESH: Carcinoma Small Cell Middle Aged MESH : Survival Rate Thalidomide 3. Good health Survival Rate Oncology 030220 oncology & carcinogenesis MESH : Disease-Free Survival Female medicine.drug medicine.medical_specialty Cyclophosphamide MESH: Survival Rate MESH : Male [SDV.CAN]Life Sciences [q-bio]/Cancer Placebo Disease-Free Survival MESH : Thalidomide 03 medical and health sciences Double-Blind Method Internal medicine medicine Humans MESH : Double-Blind Method MESH : Middle Aged MESH : Lung Neoplasms Lung cancer Survival rate Proportional Hazards Models 030304 developmental biology Chemotherapy MESH: Humans business.industry MESH : Humans medicine.disease MESH : Proportional Hazards Models MESH: Male Surgery MESH : Carcinoma Small Cell MESH: Lung Neoplasms MESH: Disease-Free Survival business MESH: Female |
| Zdroj: | Journal of Clinical Oncology Journal of Clinical Oncology, 2007, 25 (25), pp.3945-51. ⟨10.1200/JCO.2007.11.8109⟩ Journal of Clinical Oncology, American Society of Clinical Oncology, 2007, 25 (25), pp.3945-51. 〈10.1200/JCO.2007.11.8109〉 Journal of Clinical Oncology, American Society of Clinical Oncology, 2007, 25 (25), pp.3945-51. ⟨10.1200/JCO.2007.11.8109⟩ |
| ISSN: | 0732-183X 1527-7755 |
| DOI: | 10.1200/JCO.2007.11.8109⟩ |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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