Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer

Cesare Gridelli, Francesco Perrone, Ciro Gallo, Antonio Rossi, Francesco Scognamiglio, Cesare Guida, Silvio Monfardini, Giovanni Pietro Ianniello, Vincenza Tinessa, Maria Grazia Caprio, Antonio Santoro, Luigi Maiorino, Massimiliano Santoro, Francovito Piantedosi, Luigi Brancaccio, Carlo Crispino, Silvio Cigolari, Maria Di Lanno, Valentina Angelini, Luigi ManzioneDomenico Bilancia, Angelo Dinota, Giuseppe Failla, Rosa Anna Aiello, Paolo Tralongo, Franco Figoli, Ludmilla Zuccarino, Tonino Pedicini, Antonio Febbraro, Cesira Zollo, Luciano Frontini, Sabrina Zonato, Giuseppe Azzarello, Orazio Vinante, Federico Castiglione, Gianfranco Porcile, Alessandra Bearz, Roberto Sorio, Maurizio Tonato, Samir Darwish, Enzo Veltri, Modesto D'Aprile, Carlo Curcio, Matteo Vasta, Maurizia Clerici, Gino Luporini, Antonio Farris, Rosario Vincenzo Iaffaioli, Adolfo Favaretto, Giuseppe Gualtieri, The Elderly Lung Cancer Vinorelbine Italian Study Group

Research output: Contribution to journalArticlepeer-review


Background: Vinorelbine, a semisynthetic vinca alkaloid, represents a well-tolerated treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC). We explored the quality of life (QoL) of such patients in a multicenter randomized trial that compared vinorelbine treatment with supportive care alone. Methods: Eligible patients were 70 years of age or older, had stage IV or IIIB NSCLC that was ineligible for radiotherapy, and had a performance status of 0-2 (a status of fully active to a status of capable of all self-care but unable to work). Vinorelbine was given intravenously on days 1 and 8 of a 21-day treatment cycle, for a total of six cycles. QoL was evaluated with European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-LC13, and the QoL data were analyzed by fitting a linear mixed model for each QoL scale. Survival curves were plotted and were compared with the Mantel-Haenszel test. Relative hazards of death and 95% confidence intervals (CIs) were estimated by the Cox model. Results: Investigators, blinded to the results, stopped the trial early because of a low enrollment rate. (From April 1996 to November 1997, 191 of the 350 targeted patients were randomly assigned.) Data from 161 patients have been analyzed. Vinorelbine-treated patients scored better than control patients on QoL functioning scales, and they reported fewer lung cancer-related symptoms but reported worse toxicity-related symptoms. There was a statistically significant (two-sided P = .03) survival advantage for patients receiving vinorelbine; median survival increased from 21 to 28 weeks in the vinorelbine-treated group. The relative hazard of death for vinorelbine-treated patients was 0.65 (95% CI = 0.45-0.93). Conclusion: Vinorelbine improves survival of elderly patients with advanced NSCLC and possibly improves overall QoL.

Original languageEnglish
Pages (from-to)66-72
Number of pages7
JournalJournal of the National Cancer Institute
Issue number1
Publication statusPublished - Jan 6 1999

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research


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