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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.
MedLine Citation:
PMID:  22767317     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
C Tibaldi; A Camerini; A D'Incecco; E Vasile; A Fabbri; D Amoroso; F Cappuzzo
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-7-6
Journal Detail:
Title:  Journal of cancer research and clinical oncology     Volume:  -     ISSN:  1432-1335     ISO Abbreviation:  -     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-7-6     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7902060     Medline TA:  J Cancer Res Clin Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Division of Oncology, Department of Oncology, Civil Hospital, viale Alfieri 36, 57100, Livorno, Italy, tiby@katamail.com.
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