Sequential vinorelbine and docetaxel in advanced non-small cell lung cancer patients age 70 and older and/or with a performance status of 2: A phase II trial of the Southwest Oncology Group (S0027)

Paul J. Hesketh, Kari Chansky, Derick H Lau, James H. Doroshow, Carol M. Moinpour, Robert A. Chapman, J. Wendall Goodwin, Howard M. Gross, John J. Crowley, David R Gandara

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25 Scopus citations


BACKGROUND: This phase II study (S0027) evaluated the efficacy and tolerability of planned sequential single-agent chemotherapy with vinorelbine followed by docetaxel in patients with advanced non-small cell lung cancer (NSCLC) age 70 and older and/or a performance status (PS) of 2. METHODS: Patients with stage IIIB (pleural effusion) or stage IV NSCLC, age 70 and older with a PS of 0-1 or 2, any age, received three cycles of vinorelbine 25 mg/m days 1 and 8 every 21 days followed by three cycles of docetaxel 35 mg/m days 1, 8, and 15 every 28 days. RESULTS: A total of 125 patients entered the study; 117 patients were assessable for response, survival, and toxicity. Seventy-five patients were in stratum1 (age 70 and older, PS 0-1) and 42 patients in stratum 2 (PS 2, any age). Objective response was 19% (95% confidence interval [CI]: 11%-30%) and 11% (95% CI: 3%-25%) in strata 1 and 2, respectively. Median survival was 9.1 months (95% CI: 7.1-12.7) and 5.5 months (95% CI: 3.1-6.5) in strata 1 and 2, respectively. Survival at 12 months was 41% and 13% in strata 1 and 2, respectively. Grade 3/4 neutropenia was seen in 32% and 31% of patients in strata 1 and 2, respectively. Three deaths probably related to treatment were noted: one in stratum 1 and two in stratum 2. CONCLUSION: Sequential vinorelbine and docetaxel is a well-tolerated and effective regimen in comparison with reports of other treatments tested in patients with advanced NSCLC age 70 and older and/or with a PS of 2.

Original languageEnglish (US)
Pages (from-to)537-544
Number of pages8
JournalJournal of Thoracic Oncology
Issue number6
StatePublished - Jul 2006



  • Chemotherapy
  • Elderly
  • Lung cancer
  • Performance status 2
  • Phase II clinical trial

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

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