Document Detail

Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer.
MedLine Citation:
PMID:  23123509     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: This analysis evaluates safety and efficacy in elderly (≥ 70 years old) versus younger patients enrolled in a phase III advanced non-small-cell lung cancer (NSCLC) trial.
PATIENTS AND METHODS: Untreated stage IIIB/IV patients with PS 0/1 were randomly assigned (1:1) to carboplatin AUC6, day 1 every 3 weeks, and either nab-paclitaxel (Abraxane) 100 mg/m(2) weekly (nab-P/C) or solvent-based paclitaxel (Taxol) 200 mg/m(2) day 1 every 3 weeks (sb-P/C). The primary end-point was overall response rate (ORR).
RESULTS: Fifteen percent of 1052 enrolled patients were elderly: nab-P/C, n = 74; sb-P/C, n = 82. In both age cohorts, the ORR was higher with nab-P/C versus sb-P/C (age ≥ 70: 34% versus 24%, P = 0.196; age <70: 32% versus 25%, P = 0.013). In elderly patients, progression-free survival (PFS) trended in favor of nab-P/C (median 8.0 versus 6.8 months, hazard ratio (HR) 0.687, P = 0.134), and overall survival (OS) was significantly improved (median 19.9 versus 10.4 months, HR 0.583, P = 0.009). In younger patients, PFS (median 6.0 versus 5.8 months, HR 0.903, P = 0.256) and OS (median 11.4 versus 11.3 months, HR 0.999, P = 0.988) were similar in both arms. Adverse events were similar in both age groups, with less neutropenia (P = 0.015), neuropathy (P = 0.001), and arthralgia (P = 0.029), and increased anemia (P = 0.007) with nab-P/C versus sb-P/C.
CONCLUSIONS: In elderly NSCLC patients, nab-P/C as first-line therapy was well tolerated and improved the ORR and PFS, with substantially longer OS versus sb-PC.
M A Socinski; C J Langer; I Okamoto; J K Hon; V Hirsh; S R Dakhil; R D Page; J Orsini; H Zhang; M F Renschler
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-02
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  24     ISSN:  1569-8041     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-23     Completed Date:  2013-07-02     Revised Date:  2013-10-21    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  314-21     Citation Subset:  IM    
University of Pittsburgh Medical Center, Division of Hematology/Oncology, Pittsburgh, PA 15232, USA.
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MeSH Terms
Aged, 80 and over
Albumins / adverse effects,  therapeutic use*
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Carboplatin / adverse effects,  therapeutic use*
Carcinoma, Non-Small-Cell Lung / drug therapy*
Disease-Free Survival
Lung Neoplasms / drug therapy*
Middle Aged
Neutropenia / complications
Paclitaxel / adverse effects,  therapeutic use*
Survival Rate
Treatment Outcome
Reg. No./Substance:
0/130-nm albumin-bound paclitaxel; 0/Albumins; 33069-62-4/Paclitaxel; 41575-94-4/Carboplatin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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