Gemcitabine as second-line treatment for advanced non-small-cell lung cancer: A phase II trial

Lucio Crinò, Anna Maria Mosconi, Giorgio Scagliotti, Giovanni Selvaggi, Silvia Novello, Massimo Rinaldi, Marina Della Giulia, Cesare Gridelli, Antonio Rossi, Cesare Calandri, Filippo De Marinis, Mariantonietta Noseda, Maurizio Tonato

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Purpose: To investigate the activity and toxicity of gemcitabine as a single agent in patients with advanced non-small-cell lung cancer (NSCLC) after recurrence or failure of previous treatment with a platinum-containing regimen. Patients and Methods: From November 1995 to October 1997, 83 patients with stage IIIB or IV NSCLC received gemcitabine 1,000 mg/m2 once a week for 3 weeks every 28 days. Responses were assessed every two treatment courses. The median age of the patients was 63 years; Eastern Cooperative Oncology Group performance status was 0 to 1 in 62 patients and 2 in 21 patients. The predominant histology was squamous (39 patients); 49 patients had stage IV disease and 34 patients had stage III disease (33 stage IIIB and one stage IlIA). Results: Sixteen patients (19%) achieved a partial response to treatment; the median duration of response was 29 weeks (range, 6 to 50 weeks). Treatment was well tolerated: grade 2 to 3 (World Health Organization standardized response criteria) leukopenia and thrombocytopenia occurred in 23% and 20% of patients, respectively. Mild asthenia was observed in 16% of patients, and peripheral edema in 5% of patients. Nausea and vomiting were present in 16% of patients. Conclusion: In this experience, gemcitabine showed significant activity without relevant toxicity, mainly in patients who were previously responsive to chemotherapy. This suggests a possible role for gemcitabine as a second-line treatment in patients who had a previous response or achieved stable disease with a platinum-containing regimen.

Original languageEnglish
Pages (from-to)2081-2085
Number of pages5
JournalJournal of Clinical Oncology
Issue number7
Publication statusPublished - 1999

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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