GLOB-1: a prospective randomised clinical phase III trial comparing vinorelbine-cisplatin with vinorelbine-ifosfamide-cisplatin in metastatic non-small-cell lung cancer patients
| Autor: | P. J. Souquet, Eng Huat Tan, R. Van Klaveren, U. Gatzemeier, M. Jaworski, Allan Price, D. Aubert, J. Rodrigues Pereira, J. P. Burillon |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Male medicine.medical_specialty Lung Neoplasms Adolescent Nausea medicine.medical_treatment Neutropenia Vinorelbine Vinblastine Gastroenterology Drug Administration Schedule Statistics Nonparametric chemistry.chemical_compound Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Confidence Intervals Humans Ifosfamide Prospective Studies Neoplasm Metastasis Lung cancer Aged Cisplatin Chemotherapy Dose-Response Relationship Drug business.industry Hematology Middle Aged medicine.disease Prognosis Survival Analysis Nitrogen mustard Surgery Treatment Outcome Oncology chemistry Quality of Life Female medicine.symptom business medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 13(12) |
| ISSN: | 0923-7534 |
| Popis: | Background The standard doublet, vinorelbine–cisplatin, was compared with a triplet of vinorelbine–ifosfamide–cisplatin, in terms of survival, in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods From February 1998 to June 1999, 259 chemonaive patients entered the study and were randomised to receive either vinorelbine–cisplatin (NP; vinorelbine 30 mg/m2 on days 1, 8 and 15 with cisplatin 80 mg/m2 on day 1) or vinorelbine–ifosfamide–cisplatin (NIP; vinorelbine 25 mg/m2 on days 1 and 8, ifosfamide 3 g/m2 on day 1 and cisplatin 75 mg/m2 on day 1), with both regimens being repeated every 3 weeks. All patients had stage IV or relapsed disease and a performance score of 0 or 1. Results The overall response rate was 34.6% for NP and 35.7% for NIP. Median and 1-year survival rates were 10.0 months and 38.4% for NP, and 8.2 months and 33.7% for NIP, respectively. A median of four cycles was administered in each arm. The major World Health Organization grade 3–4 toxicities for NP and NIP, respectively, were: neutropenia (20.3% compared with 9% of cycles), anaemia (4.1% compared with 5% of cycles), nausea and vomiting (22.2% compared with 19.4% of patients) and alopecia (5.6% compared with 29.8% of patients). Four toxic deaths occurred in the NP arm and eight in the NIP arm. Conclusions The different schedules of vinorelbine in the two arms led to a greater survival in the NP arm without impairing the tolerance profile, although this is not statistically significant. This confirms that the two-drug combination NP is a reference treatment for metastatic NSCLC. The role of three-drug combinations remains questionable in this subset of patients. |
| Databáze: | OpenAIRE |
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