A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer

J. A. Treat, R. Gonin, M. A. Socinski, M. J. Edelman, R. B. Catalano, D. M. Marinucci, R. Ansari, H. H. Gillenwater, K. M. Rowland, R. L. Comis, C. K. Obasaju, C. P. Belani

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Paclitaxel-carboplatin is used as the standard regimen for patients with advanced or metastatic nonsmall-cell lung cancer (NSCLC). This trial was designed to compare gemcitabine + carboplatin or gemcitabine + paclitaxel to the standard regimen. Patients and methods: A total of 1135 chemonaive patients with stage IIIB or IV NSCLC were randomly allocated to receive gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin area under the concentration-time curve (AUC) 5.5 on day 1 (GC), gemcitabine 1000 mg/m2 on days 1 and 8 plus paclitaxel 200 mg/m2 on day 1 (GP), or paclitaxel 225 mg/m2 plus carboplatin AUC 6.0 on day 1 (PC). Stratification was based on disease stage, baseline weight loss, and presence or absence of brain metastases. Cycles were repeated every 21 days for up to six cycles or disease progression. Results: Median survival (months) with GC was 7.9 compared with 8.5 for GP and 8.7 for PC. Response rates (RRs) were as follows: GC, 25.3%; GP, 32.1%; and PC, 29.8%. The GC arm was associated with a greater incidence of grade 3 or 4 hematologic events but a lower rate of neurotoxicity and alopecia when compared with GP and PC. Conclusions: Non-platinum and non-paclitaxel gemcitabine-containing doublets demonstrate similar overall survival and RR compared with the standard PC regimen. However, the treatment arms had distinct toxicity profiles.

Original languageEnglish (US)
Article numbermdp352
Pages (from-to)540-547
Number of pages8
JournalAnnals of Oncology
Volume21
Issue number3
DOIs
StatePublished - Oct 15 2009
Externally publishedYes

Keywords

  • Carboplatin
  • Gemcitabine
  • NSCLC
  • Non-platinum doublets
  • Paclitaxel
  • Phase III

ASJC Scopus subject areas

  • Hematology
  • Oncology

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