Phase 2 study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with concurrent radiation therapy followed by pemetrexed consolidation in patients with favorable-prognosis inoperable stage IIIA/B non-small-cell lung cancer

Hak Choy, Lee S. Schwartzberg, Shaker R. Dakhil, Edward B. Garon, David E. Gerber, Janak K. Choksi, Ramaswamy Govindan, Guangbin Peng, Andrew Koustenis, Joseph Treat, Coleman Obasaju

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

Abstract

Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.

Original languageEnglish (US)
Pages (from-to)1308-1316
Number of pages9
JournalJournal of Thoracic Oncology
Volume8
Issue number10
DOIs
StatePublished - Jan 1 2013

Keywords

  • Chemoradiotherapy
  • Cisplatin
  • Non-small-cell lung cancer
  • Pemetrexed
  • Stage III

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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