A randomised phase II study of docetaxel/oxaliplatin and docetaxel in patients with previously treated non-small cell lung cancer: An Alpe-Adria Thoracic Oncology Multidisciplinary group trial (ATOM 019)

Ornella Belvedere, Alessandro Follador, Ciro Rossetto, Valentina Merlo, Carlotta Defferrari, Angela M. Sibau, Marianna Aita, Maria G. Dal Bello, Stefano Meduri, Marica Gaiardo, Gianpiero Fasola, Francesco Grossi

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: To date, no combination regimen has proven superior to single agent chemotherapy as a second-line treatment for non-small cell lung cancer (NSCLC). Methods: This multicenter, non-comparative randomised phase II trial evaluated the activity of docetaxel (75 mg/m 2 on day 1) with oxaliplatin (70 mg/m 2 on day 2) every 3 weeks in previously treated NSCLC patients; the reference arm was single-agent docetaxel (75 mg/m 2 on day 1 every 3 weeks). It was designed as a one-stage, three-outcome phase II trial; 21 evaluable patients were required in each arm. The primary end-point was response rate; secondary end-points were toxicity, progression free survival (PFS) and overall survival. Results: Fifty patients were enrolled. Patient characteristics included male/female, 76/24%; median age 62 years; ECOG PS 0/1, 36/64%; previous platinum-based chemotherapy, 98%. Partial response was seen in 20% and 8%, stable disease in 52% and 32%, of patients treated with docetaxel/oxaliplatin and docetaxel, respectively. Main grade 3-4 toxicities were neutropenia 56% and 64%; febrile neutropenia 4% and 8%; diarrhoea 12% and 4% for docetaxel/oxaliplatin and docetaxel, respectively. Median PFS was 5.0 and 1.7 months, median survival 11.0 and 7.1 months, and 1-year survival 44% and 32% for docetaxel/oxaliplatin and docetaxel, respectively. Conclusions: The study met its pre-defined study end-point; docetaxel/oxaliplatin and more generally platinum-containing doublets warrant further evaluation as second-line therapy for patients with NSCLC.

Original languageEnglish
Pages (from-to)1653-1659
Number of pages7
JournalEuropean Journal of Cancer
Volume47
Issue number11
DOIs
Publication statusPublished - Jul 2011

Keywords

  • Docetaxel
  • Non-small cell lung cancer
  • Oxaliplatin
  • Phase II
  • Second-line chemotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Fingerprint Dive into the research topics of 'A randomised phase II study of docetaxel/oxaliplatin and docetaxel in patients with previously treated non-small cell lung cancer: An Alpe-Adria Thoracic Oncology Multidisciplinary group trial (ATOM 019)'. Together they form a unique fingerprint.

Cite this