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Clinical Trial
. 2012 Dec;138(12):2003-8.
doi: 10.1007/s00432-012-1280-5. Epub 2012 Jul 6.

First-line chemotherapy with planned sequential administration of cisplatin/gemcitabine followed by docetaxel in elderly 'unfrail' patients with advanced non-small-cell lung cancer: a multicenter phase II study

C Tibaldi  1 , A Camerini, A D'Incecco, E Vasile, A Fabbri, D Amoroso, F Cappuzzo
Affiliations
Clinical Trial

First-line chemotherapy with planned sequential administration of cisplatin/gemcitabine followed by docetaxel in elderly 'unfrail' patients with advanced non-small-cell lung cancer: a multicenter phase II study

C Tibaldi et al. J Cancer Res Clin Oncol. 2012 Dec.

Abstract

Purpose: The role of cisplatin in the first-line treatment for elderly advanced non-small-cell lung cancer is not completely defined. We previously reported in this subset of patients an interesting efficacy and tolerability of a sequential schedule of gemcitabine followed by docetaxel.

Methods: Patients aged ≥70 years and with Eastern Cooperative Oncology Group performance status 0 or 1 received cisplatin 60 mg/m(2) on Day 1 and gemcitabine 1,000 mg/m(2) on Day 1 and 8 every 3 weeks for 3 courses followed by 3 courses of docetaxel 37.5 mg/m(2) on Day 1 and 8 every 3 weeks, provided there was no evidence of disease progression. Patients were excluded if considered 'frail' according to the Multidimensional Geriatric Assessment. The main objective of the study was the 4-month progression-free survival rate. Simon's two-stage minimax design was applied to calculate the sample size.

Results: After 30 patients were enroled into the study, the 4-month progression-free survival rate was 53.3 % and the study was closed at the first stage for futility; the overall response rate was 16.7 %; the median time to progression and median duration of survival were 5.1 and 8.6 months, respectively; the 1-year survival rate was 30 %.

Conclusion: The incorporation of cisplatin in a sequential schedule of gemcitabine followed by docetaxel is feasible but did not yield a substantial advantage to deserve further investigations.

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