Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer

Abstract

Summary Cisplatin-based combinations are efficacious in increasing the overall survival of patients with non-small cell lung cancer (NSCLC), but their toxicity makes them unsuitable for elderly and unfit patients. The primary objective of this non-randomized phase II study was to evaluate the feasibility and activity of the gemcitabine plus vinorelbine combination in previously untreated elderly and/or unfit patients with measurable stage III or IV NSCLC. Forty-three patients aged ≥ 65 years or with contraindications against cisplatin treatment (36 males and seven females: median age 66 years; range 48-75: PS 0 = 11, PS 1 = 19, PS 2 = 13) received intravenous (i.v.) gemcitabine 1000 mg m -2 , followed by vinorelbine 25 mg m -2 i.v. on day 1 and 8 every 21 days. Fifteen patients (34.9%) achieved partial remission (confidence interval: 27.6-42.2%) for a median duration of 6 months; the median survival of these patients has not yet been reached. A further 15 had stable disease for a median of 4 months and a median survival of 7 months. The 10 patients (23.2%) who experienced disease progression had a median survival of 4 months. Three patients are not evaluable. The 1-year actuarial survival rate is 31.1%. The treatment was well tolerated: only 35% of the patients had grade 3 or 4 granulocytopenia on day 14, none experienced episodes of neutropenic fever, and there was no evidence of severe haematological toxicity upon recycling. Only 9% of the patients suffered from gastrointestinal toxicity (grade 3); increased but reversible transaminase levels were observed in 11.6%. In conclusion, the results of this phase II study show that the combination of gemcitabine and vinorelbine is active and well tolerated in NSCLC, and thus encourage its use in elderly or unfit patients.

Prognostic Factors in Elderly Patients with Advanced Non-Small Cell Lung Cancer Treated with Chemotherapy

“…In phase II trials of vinorelbine plus gemcitabine, response rates were between 18 and 35%, with a median survival time from 10 to 11 months. The regimens were generally well tolerated by elderly patients with advanced NSCLC [11, 12, 21]. Phase II studies on a combination of new cytotoxic agents with cisplatin in modified schedules or attenuated doses also revealed good activity and tolerability [22, 23].…”

Gemcitabine and vinorelbine followed by docetaxel in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial of nonplatinum sequential triplet combination chemotherapy (JMTO LC00-02)

“…In particular, a GEM/VNR combination was very well tolerated with high activity (Feliu et al, 1999;Isokangas et al, 1999;Bajetta et al, 2000;Beretta et al, 2000;Gridelli et al, 2000). The Spanish Lung Cancer Group (Alberola et al, 2001) reported on a randomised comparison of a CDDP-based three-drug combination (CDDP/ GEM/VNR) vs non-CDDP sequential doublets (GEM/VNR followed by ifosphamide/VNR) vs CDDP/GEM (reference regimen).…”

“…Among the new drugs, GEM/VNR combination is noteworthy because of their demonstrated activity and particularly their good toxicity profile. This combination can also be used for elderly or unfit patients, because of its low toxicities (Feliu et al, 1999;Isokangas et al, 1999;Bajetta et al, 2000;Beretta et al, 2000;Gridelli et al, 2000). In addition, it has been shown that a single treatment of docetaxel (DOC) is active for NSCLC, especially as a second-line treatment (Fossella et al, 2000;Shephard et al, 2000).…”

Elderly Patients with Advanced Non-Small Cell Lung Cancer

“…Phase II studies using gemcitabine and vinorelbine, either as single agents or in combination, have shown activity and a favorable toxicity profile in patients aged 70 years or older, with response rates ranging from 18.4 to 34.9% [19, 20, 21, 22, 23, 24, 25]. …”