A phase II tolerability study of cisplatin plus docetaxel as adjuvant chemotherapy for resected non-small cell lung cancer

Christopher G. Azzoli, Lee M. Krug, Vincent A. Miller, Naiyer A. Rizvi, Mark G. Kris, Megan Dunne, Amy Farmer, Barbara Pizzo, Leslie Tyson, Teresa Seeger, Barbara Coleman, Erin Moore, Lauren Lastinger, Ennapadam Venkatraman, Charles M. Rudin

Research output: Contribution to journalArticlepeer-review

Abstract

INTRODUCTION: We undertook this phase II study to measure postoperative drug delivery and toxicity of cisplatin plus docetaxel in patients with resected stage I-III non-small cell lung cancer. METHODS: The primary endpoint was amount of cisplatin delivered over a planned four cycles of adjuvant chemotherapy. Statistical design required a cohort to close if the regimen proved unlikely to improve cisplatin delivery compared with published phase III data. The first cohort was treated with docetaxel 35 mg/m intravenously (IV) on days 1, 8, and 15, and cisplatin 80 mg/m IV on day 15, every 4 weeks for four planned cycles. A second cohort was treated with docetaxel 75 mg/m IV plus cisplatin 80 mg/m IV on day 1 every 3 weeks for four planned cycles. RESULTS: Sixteen patients were treated with weekly docetaxel and cisplatin every 4 weeks, with five of 16 (31%) unable to complete three cycles. Subsequently, 11 patients were treated with docetaxel and cisplatin every 3 weeks, with six of 11 (55%) unable to complete three cycles. Among the 11 patients who failed to complete three cycles, the reasons for stopping included one or more of the following: fatigue (n = 8), nausea (n = 4), febrile neutropenia (n = 1), hypotension (n = 1), and nephrotoxicity (n = 1). CONCLUSIONS: The combination of cisplatin at 80 mg/m with docetaxel 35 mg/m weekly or 75 mg/m every 3 weeks is no better tolerated than older chemotherapy regimens. The most common reason to stop chemotherapy was intolerable fatigue. These results suggest that the most common dose-limiting toxicities are attributable to the cisplatin, given similar problems were encountered whether the docetaxel was delivered as a single dose every 3 weeks or as a lower weekly dose.

Original languageEnglish (US)
Pages (from-to)638-644
Number of pages7
JournalJournal of Thoracic Oncology
Volume2
Issue number7
DOIs
StatePublished - Jul 2007

Keywords

  • Adjuvant chemotherapy
  • Cisplatin
  • Docetaxel
  • Non-small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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