Platinum-etoposide chemotherapy in elderly patients with small-cell lung cancer: Results of a randomized multicenter phase II study assessing attenuated-dose or full-dose with lenograstim prophylaxis - A Forza Operativa Nazionale Italiana Carcinoma Polmonare and Gruppo Studio Tumori Polmonari Veneto (FONICAP-GSTPV) study

Andrea Ardizzoni, Adolfo Favaretto, Luca Boni, Editta Baldini, Federico Castiglioni, Paola Antonelli, Franca Pari, Carmelo Tibaldi, Alfonso M. Altieri, Sante Barbera, Giancarlo Cacciani, Mario Raimondi, Lucia Tixi, Micaela Stefani, Silvio Monfardini, Antonio Antilli, Riccardo Rosso, Adriano Paccagnella

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Small-cell lung cancer (SCLC) is increasingly diagnosed in elderly patients, who are at higher risk of treatment-related morbidity and mortality. We conducted a randomized two-stage phase II study to assess the therapeutic index of two different platinum/etoposide regimens, attenuated-dose (AD) and full-dose (FD) plus prophylactic lenograstim. Patients and Methods: SCLC patients older than 70 years were randomized to receive four courses of cisplatin 25 mg/m2 on days 1 and 2, and etoposide 60 mg/m2 on days 1, 2, and 3 every 3 weeks (AD); or cisplatin 40 mg/m2 on days 1 and 2, and etoposide 100 mg/m2 on days 1, 2, and 3 every 3 weeks, plus lenograstim 5 mg/kg days 5 through 12, every 3 weeks (FD). A combined primary end point named therapeutic success (TS), which took into account activity, toxicity, and compliance, was used. Results: Ninety-five patients were enrolled. Seventy-five percent and 72% of the patients in the AD and FD arms, respectively, completed the treatment as per protocol. Response rate was 39% and 69% in the AD and FD arms, respectively, and 1-year survival probability was 18% and 39%, respectively. Treatment was well tolerated in both groups, with no grade 3 to 4 myelotoxicity in the AD arm, and 12% myelotoxicity in the FD arm. Overall, the observed TSs were 10 (36%) of 28 patients and 42 (63%) of 67 patients for AD and FD treatments, respectively. Conclusion: In elderly patients with SCLC a full-dose cisplatin/etoposide regimen combined with prophylactic lenograstim is active and feasible, while attenuated doses of the same regimen are associated with a poor therapeutic outcome.

Original languageEnglish
Pages (from-to)569-575
Number of pages7
JournalJournal of Clinical Oncology
Volume23
Issue number3
DOIs
Publication statusPublished - 2005

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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