Phase I-II study of gemcitabine and paclitaxel in pretreated patients with stage IIIB-IV non-small cell lung cancer

Rosario Vincenzo Iaffaioli, Anna Tortoriello, Adriano Gravina, Gaetano Facchini, Giacinto Turitto, Stefano Elia, Salvatore Griffo, Maria Gentile, Gaetano Fraioli, Adele Frattolillo, Paolo Muto, Michele Libutti, Valeria De Marino, Alfonso Illiano, Alfonso Barbarisi

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Gemcitabine and paclitaxel are among the most active new agents in non-small cell lung cancer (NSCLC) and are worth considering for second-line chemotherapy. In this phase I-II study, we combined gemcitabine and paclitaxel for second-line treatment of advanced NSCLC. Gemcitabine doses were kept fixed at 1000 mg/m2 on day 1 and 8, and paclitaxel doses were escalated from 90 mg/m2 on day 1 of the 21-day cycle. Thirty-seven patients were treated at six different dose levels. Grade 4 neutropenia was dose-limiting toxicity (DLT), since it occurred in two out of six patients treated at paclitaxel 240 mg/m2; the paclitaxel dose level just below (210 mg/m2) was selected for phase II evaluation. Non-hematologic toxicity was mild. One complete response (CR) (3%) and 13 partial responses (PR) (36%) were observed in 36 evaluable patients for an overall response rate of 39% (95% C.I., 23-57%). Median duration of response was 35 weeks (range, 8-102). All of the observed objective responses occurred in the 19 patients who had previously responded to the first-line therapy. Median survival was 40 weeks (range, 8-108 weeks). The combination of gemcitabine and paclitaxel is a feasible, well-tolerated, and active scheme for second-line treatment of advanced NSCLC; further evaluation, at least in selected patients, such as those previously responding to first-line chemotherapy, is definitely warranted.

Original languageEnglish
Pages (from-to)203-210
Number of pages8
JournalLung Cancer
Issue number3
Publication statusPublished - 2000


  • Advanced non-small cell lung cancer
  • Gemcitabine
  • Paclitaxel
  • Second-line chemotherapy

ASJC Scopus subject areas

  • Oncology


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