Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

Abstract

This randomised phase III study in advanced non-small cell lung cancer (NSCLC) patients was conducted to compare vinorelbine/ carboplatin (VC) and gemcitabine/carboplatin (GC) regarding efficacy, health-related quality of life (HRQOL) and toxicity. Chemonaive patients with NSCLC stage IIIB/IV and WHO performance status 0 -2 were eligible. No upper age limit was defined. Patients received vinorelbine 25 mg m À2 or gemcitabine 1000 mg m À2 on days 1 and 8 and carboplatin AUC4 on day 1 and three courses with 3-week cycles. HRQOL questionnaires were completed at baseline, before chemotherapy and every 8 weeks until 49 weeks. During 14 months, 432 patients were included (VC, n ¼ 218; GC, n ¼ 214). Median survival was 7.3 vs 6.4 months, 1-year survival 28 vs 30% and 2-year survival 7 vs 7% in the VC and GC arm, respectively (P ¼ 0.89). HRQOL, represented by global QOL, nausea/vomiting, dyspnoea and pain, showed no significant differences. More grade 3 -4 anaemia (Po0.01), thrombocytopenia (Po0.01) and transfusions of blood (Po0.01) or platelets (Po0.01) were observed in the GC arm. There was more grade 3 -4 leucopoenia (Po0.01) in the VC arm, but the rate of neutropenic infections was the same (P ¼ 0.87). In conclusion, overall survival and HRQOL are similar, while grade 3 -4 toxicity requiring interventions are less frequent when VC is compared to GC in advanced NSCLC.

Muscle mass and association to quality of life in non‐small cell lung cancer patients

“…The study is based on three subsequent randomized controlled trials (RCTs), conducted between 2003 and 2009, comparing different first‐line chemotherapy regimens in advanced NSCLC 26, 27, 28. Overall survival, QoL, and toxicity were the main endpoints, and the main inclusion criteria were similar: chemonaïve patients, age ≥ 18 years, stage IIIB/IV, and performance status 0–2.…”

Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach

“…Data on progression were missing in 14 trials [35-38, 40, 41, 45, 46, 48, 55-57, 64, 66], whereas one study provided PD rates only [63].…”

“…Activity data were available for all patients included in the analysis of response (n ϭ 11,231), with the only exception being 432 patients enrolled in a trial of carboplatin plus either gemcitabine or vinorelbine [63], in which only progressing patients were clearly indicated. Thus, 32, 16, 32, and 24 comparisons contributed to the analysis for gemcitabine, docetaxel, vinorelbine, and paclitaxel, respectively.…”

“…Among the remaining 45 trials [21-25, 29 -68], ineligible treatment arms-that is, triplets [30,63], single-agent therapies [44], platinum combinations with irinotecan or first-and second-generation drugs [36,38], or sequential treatment arms [39]-were excluded from the analysis.…”

Chemotherapy and quality of life in NSCLC PS 2 patients

“…In our national multicenter phase III study in advanced NSCLC patients, three cycles of vinorelbine/carboplatin were compared to three cycles of gemcitabine/carboplatin with no significant differences in survival and HRQOL between the two treatment arms [17]. The study was designed to detect differences in survival and predefined HRQOL aspects between the two treatment arms.…”