Originally published as JCO Early Release 10.1200/JCO.2003.06.099 on July 1 2003

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Gemcitabine Plus Vinorelbine Compared With Cisplatin Plus Vinorelbine or Cisplatin Plus Gemcitabine for Advanced Non–Small-Cell Lung Cancer: A Phase III Trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group

Cesare Gridelli, Ciro Gallo, Frances A. Shepherd, Alfonso Illiano, Francovito Piantedosi, Sergio Federico Robbiati, Luigi Manzione, Santi Barbera, Luciano Frontini, Enzo Veltri, Brian Findlay, Silvio Cigolari, Robert Myers, Giovanni P. Ianniello, Vittorio Gebbia, Giampietro Gasparini, Sergio Fava, Vera Hirsh, Andrea Bezjak, Lesley Seymour, Francesco Perrone

From the GEMVIN Investigators, Naples, Italy; and the National Cancer Institute of Canada Clinical Trials Group, Kingston, Canada.

Address reprint requests to Cesare Gridelli, Clinical Trials Unit, National Cancer Institute, Via M Semmola; 80131 Naples, Italy; email: cgridelli{at}libero.it.

Purpose: Platinum-containing chemotherapy regimens are the standard treatment for patients with advanced non–small-cell lung cancer (NSCLC), although toxicity is common and may significantly affect the patient’s quality of life (QoL). This trial aimed to assess whether a combination of gemcitabine and vinorelbine had benefits in terms of QoL, without influencing negatively on survival, compared with cisplatin-containing regimens.

Patients and Methods: Patients with stage IIIB (effusion and supraclavicular nodes) or IV documented NSCLC who were younger than 70 years of age were randomly assigned gemcitabine plus vinorelbine (GemVin) or either gemcitabine plus cisplatin or vinorelbine plus cisplatin (cisplatin-based). European Organization for Research and Treatment of Cancer scales were used for QoL analysis.

Results: Five hundred one patients were randomly assigned to treatment. The median age was 62 years. There were no significant differences in global QoL scores between the two arms after 2 months of treatment. However, worsening scores for appetite, vomiting, and alopecia were significantly more common in the cisplatin-based arm. Median survival was 38 v 32 weeks and median progression-free survival was 23 v 17 weeks in the cisplatin-based versus GemVin arms, respectively. For the GemVin arm the hazard ratio for death was 1.15 (90% confidence interval [CI], 0.96 to 1.37) and the hazard ratio for progression was 1.29 (90% CI, 1.10 to 1.52). Grade 3 or 4 myelosuppression, vomiting, alopecia, and ototoxicity were significantly more frequent with cisplatin-based treatment.

Conclusion: Global QoL is not improved with GemVin, although advantages in some components of QoL were apparent. GemVin is less toxic than standard cisplatin-based chemotherapy. There is a nonsignificant slight survival advantage with cisplatin-based chemotherapy. GemVin could be offered to advanced NSCLC patients who express concern about toxicity.

Partially supported by Clinical Trials Promoting Group (CTPG), Naples, Italy. The National Cancer Institute of Canada Clinical Trials Group received a grant from Eli Lilly Canada. The coordinating center (Clinical Trials Unit of the National Cancer Institute of Naples) is supported by Associazione Italiana per la Ricerca sul Cancro (AIRC).

Cesare Gridelli is member of the speaker’s bureau for Eli-Lilly (Florence, Italy), Pierre-Fabre (Cedex, France), GlaxoSmithKline (Research Triangle Park, NC, USA); Ciro Gallo received honoraria from Glaxo-Smith Kline (Verona, Italy); Frances Shepherd received research funding and honoraria from Eli-Lilly (Scarborough, Ontario, Canada); Francesco Perrone received honoraria from Glaxo-Smith Kline (Verona, Italy).

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