Single-agent versus combination chemotherapy in patients with advanced non-small cell lung cancer and a performance status of 2: Prognostic factors and treatment selection based on two large randomized clinical trials

Rogerio Lilenbaum, Victoria M. Villaflor, Corey Langer, Kenneth O'Byrne, Mary O'Brien, Helen J. Ross, Mark Socinski, Fred B. Oldham, Larissa Sandilac, Jack W. Singer, Philip Bonomi

Research output: Contribution to journalArticlepeer-review

62 Scopus citations

Abstract

Purpose: Data from two randomized phase III trials were analyzed to evaluate prognostic factors and treatment selection in the first-line management of advanced non-small cell lung cancer patients with performance status (PS) 2. Patients and Methods: Patients randomized to combination chemotherapy (carboplatin and paclitaxel) in one trial and single-agent therapy (gemcitabine or vinorelbine) in the second were included in these analyses. Both studies had identical eligibility criteria and were conducted simultaneously. Comparison of efficacy and safety was performed between the two cohorts. A regression analysis identified prognostic factors and subgroups of patients that may benefit from combination or single-agent therapy. Results: Two hundred one patients were treated with combination and 190 with single-agent therapy. Objective responses were 37 and 15%, respectively. Median time to progression was 4.6 months in the combination arm and 3.5 months in the single-agent arm (p < 0.001). Median survival imes were 8.0 and 6.6 months, and 1-year survival rates were 31 and 26%, respectively. Albumin <3.5 g, extrathoracic metastases, lactate dehydrogenase ≥200 IU, and 2 comorbid conditions predicted outcome. Patients with 0-2 risk factors had similar outcomes independent of treatment, whereas patients with 3-4 factors had a nonsignificant improvement in median survival with combination chemotherapy. Conclusion: Our results show that PS2 non-small cell lung cancer patients are a heterogeneous group who have significantly different outcomes. Patients treated with first-line combination chemotherapy had a higher response and longer time to progression, whereas overall survival did not appear significantly different. A prognostic model may be helpful in selecting PS 2 patients for either treatment strategy.

Original languageEnglish (US)
Pages (from-to)869-874
Number of pages6
JournalJournal of Thoracic Oncology
Volume4
Issue number7
DOIs
StatePublished - Jul 2009

Keywords

  • Combination chemotherapy
  • Gemcitabine
  • NSCLC
  • Paclitaxel poliglumex
  • Performance status 2
  • Prognostic model
  • STELLAR
  • Single-agent chemotherapy
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Fingerprint Dive into the research topics of 'Single-agent versus combination chemotherapy in patients with advanced non-small cell lung cancer and a performance status of 2: Prognostic factors and treatment selection based on two large randomized clinical trials'. Together they form a unique fingerprint.

Cite this