Dose-escalation study of pemetrexed in combination with carboplatin followed by pemetrexed maintenance therapy for advanced non-small cell lung cancer

Isamu Okamoto, Koji Takeda, Haruko Daga, Masaki Miyazaki, Kimio Yonesaka, Hidemi Kiyota, Junji Tsurutani, Shinya Ueda, Yasuko Ichikawa, Masayuki Takeda, Risa Sekiguchi, Kiyomi Tominaga, Sotaro Enatsu, Yoshihiro Nambu, Kazuhiko Nakagawa

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12 Citations (Scopus)

Abstract

Introduction: The primary objectives of this study were to determine the recommended dose of pemetrexed and carboplatin in patients with chemo-naive advanced non-small cell lung cancer (NSCLC). Methods: Patients received escalated doses of carboplatin area under the concentration-time curve (AUC) of 5 (cohort 1) or 6 (cohort 2) and pemetrexed 500mg/m2 every 3 weeks for six cycles. For patients with objective response and stable disease, pemetrexed were continued until disease progression or unacceptable toxicity. Results: In cohort 1, a dose-limiting toxicity (DLT) was observed in one of the six patients: grade 4 thrombocytopenia. No DLTs were seen in the first 6 patients of cohort 2, and thus the combination of pemetrexed 500mg/m2 plus carboplatin at AUC 6 was determined as the recommended dose. Among a total of 20 patients, 8 patients received a median of four cycles of pemetrexed monotherapy in a maintenance setting without unexpected or cumulative toxicities. No complete responses and 12 partial responses were observed, giving an overall response rate of 60.0% [95% confidence interval (CI), 36.1-80.9%]. Median progression-free survival time for all patients was 7.6 months (95% CI: 4.8-8.0 months). Conclusions: Pemetrexed 500mg/m2 plus carboplatin AUC 6 combination therapy followed by pemetrexed maintenance therapy, is generally tolerable, and shows encouraging antitumor activity in chemotherapy-naive patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)168-173
Number of pages6
JournalLung Cancer
Volume70
Issue number2
DOIs
Publication statusPublished - Nov 2010
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Okamoto, I., Takeda, K., Daga, H., Miyazaki, M., Yonesaka, K., Kiyota, H., Tsurutani, J., Ueda, S., Ichikawa, Y., Takeda, M., Sekiguchi, R., Tominaga, K., Enatsu, S., Nambu, Y., & Nakagawa, K. (2010). Dose-escalation study of pemetrexed in combination with carboplatin followed by pemetrexed maintenance therapy for advanced non-small cell lung cancer. Lung Cancer, 70(2), 168-173. https://doi.org/10.1016/j.lungcan.2010.02.007