A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study)
| Autor: | Romain Corre, Christos Chouaid, Pierre Fournel, J.-M. Vernejoux, Henri Berard, Benoit Marin, Alain Vergnenegre, Julie Tillon, Fabrice Barlesi, Hervé Le Caer |
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| Přispěvatelé: | Service de Pathologie respiratoire et allergologie [CHU Limoges], CHU Limoges, Oncologie thoracique, Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM), Département d'Oncologie médicale, Institut de Cancérologie de la Loire Lucien Neuwirth, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de l'Information Médicale et de l'Évaluation [CHU Limoges] (SIME), Neuroépidémiologie Tropicale et Comparée (NETEC), Université de Limoges (UNILIM)-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503), Epidémiologie des maladies infectieuses et modélisation (ESIM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), SCHILLER J, J Tillon, R Corre, Barlesi F, H Berard, JM Vernejoux, H Caer Le, P Fournel, B Marin, C Chouaïd, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne) |
| Jazyk: | angličtina |
| Rok vydání: | 2009 |
| Předmět: |
Oncology
Male Lung Neoplasms medicine.medical_treatment Kaplan-Meier Estimate NSCLC Deoxycytidine MESH: Dose-Response Relationship Drug chemistry.chemical_compound 0302 clinical medicine Stable Disease Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Stage IV MESH: Treatment Outcome MESH: Aged 0303 health sciences MESH: Statistics Nonparametric MESH: Middle Aged MESH: Maximum Tolerated Dose MESH: Neoplasm Staging Middle Aged Prognosis 3. Good health MESH: Antineoplastic Combined Chemotherapy Protocols Treatment Outcome Paclitaxel Sequential chemotherapy 030220 oncology & carcinogenesis MESH: Survival Analysis Female medicine.drug Pulmonary and Respiratory Medicine Adult medicine.medical_specialty Randomization Maximum Tolerated Dose MESH: Probability MESH: Drug Administration Schedule Disease-Free Survival Drug Administration Schedule Statistics Nonparametric MESH: Prognosis 03 medical and health sciences Internal medicine medicine Humans Neoplasm Invasiveness MESH: Paclitaxel Lung cancer Adverse effect MESH: Kaplan-Meier Estimate 030304 developmental biology Aged Neoplasm Staging Probability Cisplatin Chemotherapy MESH: Humans Dose-Response Relationship Drug business.industry MESH: Deoxycytidine MESH: Quality of Life MESH: Adult MESH: Neoplasm Invasiveness medicine.disease Survival Analysis Gemcitabine MESH: Male Surgery MESH: Lung Neoplasms chemistry MESH: Cisplatin MESH: Disease-Free Survival Quality of Life [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie business MESH: Female MESH: Carcinoma Non-Small-Cell Lung |
| Zdroj: | Journal of Thoracic Oncology Journal of Thoracic Oncology, 2009, 4 (3), pp.364-70. ⟨10.1097/JTO.0b013e318197f4ff⟩ Journal of Thoracic Oncology, Lippincott, Williams & Wilkins, 2009, 4 (3), pp.364-70. ⟨10.1097/JTO.0b013e318197f4ff⟩ ResearcherID |
| ISSN: | 1556-0864 1556-1380 |
| DOI: | 10.1097/JTO.0b013e318197f4ff⟩ |
| Popis: | International audience; BACKGROUND: There is no consensus on the optimal treatment for patients with advanced non-small cell lung cancer and stable disease after cisplatin-based chemotherapy. The objective of the trial was to evaluate a switch to a different dual-agent chemotherapy. METHODS: Patients with stage IV non-small cell lung cancer and stable disease after two cycles of cisplatin (P) and gemcitabine (G) (P day1 (d(1)): 75 mg/m(2), G: 1250 mg/m(2) d(1) and d(8) every 3 weeks) were randomized to receive either two further cycles of PG (arm A) or paclitaxel (100 mg/m(2) d(1), d(8), d(15)) plus gemcitabine (1250 mg/m(2) d(1) and d(8), every 4 weeks) (arm B). RESULTS: Two-hundred-twenty-eight patients were enrolled between October 2003 and August 2006. After two cycles of PG, 98 patients (43%) had stable disease; 87 were randomized: 45 to arm A and 42 to arm B. The objective response rates were 15.6% (6.5-29.4) and 21.4% (10.3-36.8) in arms A and B. Overall survival after randomization was 9.6 months (7.0-13.8) in arm A and 9.3 months (7.4-13.3) in arm B. Adverse events were similar in the two arms for hematological and non hematological toxicities. CONCLUSIONS: Sequential first-line chemotherapy in these patients is feasible with no difference in response rates. These results do not warrant a phase III trial. |
| Databáze: | OpenAIRE |
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