Annals of Oncology 13:1853-1861, 2002
© 2002 European Society for Medical Oncology
Original Paper |
GLOB-1: a prospective randomised clinical phase III trial comparing vinorelbine–cisplatin with vinorelbine–ifosfamide–cisplatin in metastatic non-small-cell lung cancer patients
1 Centre Hospitalier Lyon-Sud, France; 2 National Cancer Centre, Singapore; 3 Instituto Arnaldo Vieira de Carvalho, Sao Paulo, Brazil; 4 Kliniek Longarts, Rotterdam, The Netherlands; 5 Western General Hospital, Edinburgh, UK; 6 Krankenhaus, Großhansdorf, Germany; 7 Institut de Recherche Pierre Fabre, France
Received 6 July 2001; revised 20 November 2001; accepted 12 June 2002
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 chemonaïve 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.
Key words: chemotherapy, doublet, non-small-cell lung cancer, quality of life, stage IV, triplet
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