Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer

  • Scagliotti G
  • Parikh P
  • von Pawel J
 et al. 
  • 18

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Abstract

PURPOSE: Cisplatin plus gemcitabine is a standard regimen for first-line treatment of advanced non-small-cell lung cancer (NSCLC). Phase II studies of pemetrexed plus platinum compounds have also shown activity in this setting. PATIENTS AND METHODS: This noninferiority, phase III, randomized study compared the overall survival between treatment arms using a fixed margin method (hazard ratio [HR] < 1.176) in 1,725 chemotherapy-naive patients with stage IIIB or IV NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1. Patients received cisplatin 75 mg/m(2) on day 1 and gemcitabine 1,250 mg/m(2) on days 1 and 8 (n = 863) or cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 (n = 862) every 3 weeks for up to six cycles. RESULTS: Overall survival for cisplatin/pemetrexed was noninferior to cisplatin/gemcitabine (median survival, 10.3 v 10.3 months, respectively; HR = 0.94; 95% CI, 0.84 to 1.05). Overall survival was statistically superior for cisplatin/pemetrexed versus cisplatin/gemcitabine in patients with adenocarcinoma (n = 847; 12.6 v 10.9 months, respectively) and large-cell carcinoma histology (n = 153; 10.4 v 6.7 months, respectively). In contrast, in patients with squamous cell histology, there was a significant improvement in survival with cisplatin/gemcitabine versus cisplatin/pemetrexed (n = 473; 10.8 v 9.4 months, respectively). For cisplatin/pemetrexed, rates of grade 3 or 4 neutropenia, anemia, and thrombocytopenia (P

Author-supplied keywords

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols/*th
  • Carcinoma, Non-Small-Cell Lung/*drug therapy/morta
  • Cisplatin/administration & dosage/adverse effects
  • Deoxycytidine/administration & dosage/adverse effe
  • Female
  • Glutamates/administration & dosage/adverse effects
  • Guanine/administration & dosage/adverse effects/an
  • Humans
  • Kaplan-Meiers Estimate
  • Lung Neoplasms/*drug therapy/mortality/pathology
  • Male
  • Middle Aged
  • derivatives

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Authors

  • G V Scagliotti

  • P Parikh

  • J von Pawel

  • B Biesma

  • J Vansteenkiste

  • C Manegold

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