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When less is better: the safety and efficacy of reduced intensity gemcitabine in a difficult patient population with advanced non-small-cell lung cancer.

Abstract
Treatment of elderly or poor performance status (PS) patients with advanced non-small-cell lung cancer (NSCLC) is a debated topic. To evaluate the efficacy of a modified schedule of gemcitabine, 59 patients unfit for platinum were enrolled. Mean age was 75.8 years and 41 % of patients had an ECOG PS 2. Gemcitabine was given at 1000 mg/m(2) on days 1, 8 each 28. Most of patients received gemcitabine as first-line chemotherapy, which was continued as maintenance over 6 cycles in responding and stable patients. Median overall survival (OS) and progression-free survival (PFS) were 7.2 and 5 months. In those 45 evaluable patients, treatment resulted in 1 complete remission (CR), 9 partial remissions (PR), and 20 stable diseases (SDs) with a response rate (CR + PR) of 22 % and a clinical benefit (CR + PR + SD) of 68 %. Gemcitabine was continued over 6 cycles in 16 patients (27 %). These patients were treated until progression with a mean of further 8.6 cycles. Median OS and PFS in these selected patients were 19 and 16 months. The toxicity profile was excellent with only 8 % of overall G3-G4 adverse events. None of the 16 patients under the maintenance phase reported significant toxicity. Gemcitabine given at a lower dose intensity than standard should be considered as valuable therapeutic option in elderly or poor PS patients with advanced NSCLC unfit for platinum. Extending the treatment beyond 6 cycles in responding patients is feasible and may prolong survival.
AuthorsA Nacci, N Calvani, P Rizzo, P Fedele, L Orlando, P Schiavone, M Cinefra, A Marino, F Sponziello, M D'Amico, S Cinieri
JournalMedical oncology (Northwood, London, England) (Med Oncol) Vol. 30 Issue 1 Pg. 370 (Mar 2013) ISSN: 1559-131X [Electronic] United States
PMID23322519 (Publication Type: Clinical Trial, Journal Article)
Chemical References
  • Antimetabolites, Antineoplastic
  • Deoxycytidine
  • Gemcitabine
Topics
  • Aged
  • Antimetabolites, Antineoplastic (administration & dosage, adverse effects)
  • Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
  • Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
  • Disease-Free Survival
  • Female
  • Humans
  • Lung Neoplasms (drug therapy, mortality, pathology)
  • Male
  • Middle Aged
  • Treatment Outcome
  • Gemcitabine

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