Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303)

Antonius A. Miller, Xiaofei F. Wang, Lin Gu, Philip Hoffman, Jamil Khatri, Frank Dunphy, Martin J. Edelman, Michael Bolger, Everett E. Vokes, Mark R. Green

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16 Scopus citations

Abstract

Introduction: We investigated dose-dense docetaxel and cisplatin in patients with measurable non-small cell lung cancer in a randomized phase II study without [A] or with [B] a putative chemoprotective agent, BNP7787. PATIENTS AND Methods: Chemotherapy-naive patients with stage IIIB (effusion) or IV, performance status 0 to 1, and adequate organ function were eligible. Treatment with docetaxel 75 mg/m followed by cisplatin 75 mg/m over 1 hour day 1 with darbepoetin 200 μg day 1 and pegfilgrastim 6 mg day 2 without/with BNP7787 before cisplatin was repeated every other week for up to 6 cycles. The primary end point was to differentiate between grade > 2 neurotoxicity rates of 30% on [A] and 10% on [B]. Feasibility was prospectively defined as febrile neutropenia in <10% of patients and ≤1 treatment delay per cycles 1 to 3 and 4 to 6 in <20% of patients. Results: Of 160 patients enrolled, 5 never started therapy and 4 were ineligible. Neurotoxicity grade > 2 occurred in 32% on [A] and 29% on [B]. The incidence of febrile neutropenia was 4% on [A] and 3% on [B]. Treatment delays occurred in 13% and 20% of patients on [A] and [B], respectively. Completion rates for 3/6 cycles were 84%/51% on [A] and 84%/53% on [B]. Objective response rates were 55% on [A] and 51% on [B]. Median progression-free/overall survival times were 5.5/10.7 on [A] and 6.5/14.1 month on [B]. Conclusions: This dose-dense treatment regimen is active, feasible, and tolerable. Its further investigation in the curative setting in non-small cell lung cancer should be considered. BNP7787 did not result in significant protection from neurotoxicity.

Original languageEnglish
Pages (from-to)1159-1165
Number of pages7
JournalJournal of Thoracic Oncology
Volume3
Issue number10
DOIs
StatePublished - Oct 2008

Keywords

  • Cisplatin
  • Docetaxel
  • Dose-dense
  • Non-small cell lung cancer
  • Phase II

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