Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: The G-Step trial

Cesare Gridelli, Ciro Gallo, Alessandro Morabito, Rosario Vincenzo Iaffaioli, Adolfo Favaretto, Luciano Isa, Santi Barbera, Teresa Gamucci, Anna Ceribelli, Virginio Filipazzi, Paolo Maione, Antonio Rossi, Emiddio Barletta, Simona Signoriello, Ermelinda De Maio, Maria Carmela Piccirillo, Massimo Di Maio, Gaetano Rocco, Aldo Vecchione, Francesco Perrone

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence. Methods: Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m 2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m 2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥60% and unacceptable toxicity ≤25% were required to define a combination worthy of further studies. Results: Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose). Conclusions: In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention.

Original languageEnglish
Pages (from-to)233-242
Number of pages10
JournalJournal of Thoracic Oncology
Volume7
Issue number1
DOIs
Publication statusPublished - Jan 2012

Keywords

  • Elderly
  • Etoposide
  • Gemcitabine
  • Platinum compounds
  • SCLC
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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