Document Detail


Phase 2 trial of maintenance bevacizumab alone after bevacizumab plus pemetrexed and carboplatin in advanced, nonsquamous nonsmall cell lung cancer.
MedLine Citation:
PMID:  22544579     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The authors performed a phase 2 study of bevacizumab plus pemetrexed and carboplatin followed by maintenance bevacizumab in patients with advanced, nonsquamous nonsmall cell lung cancer.
METHODS: Previously untreated patients with advanced, nonsquamous nonsmall cell lung cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1 received bevacizumab 15 mg/kg, pemetrexed 500 mg/m(2) and carboplatin at an area under the concentration-time curve of 6 intravenously on day 1 every 21 days. Responding or stable patients who completed 6 cycles then received bevacizumab maintenance every 21 days until disease progression.
RESULTS: In total, 43 patients (40 who were evaluable for response) were entered on the study. Treatment-related grade 3/4 toxicities were low and included febrile neutropenia (2%), neutropenia (28%), anemia (18%), thrombocytopenia (11%), hypertension (7%), epistaxis (5%), venous thrombosis (8%), dyspnea (7%), rectovaginal fistula (2.3%), infusion reaction (2%), and cerebrovascular event (2%). One patient died from complications of venous thromboembolism and cerebrovascular accident after Cycle 2. Minimal clinically significant toxicity occurred during maintenance bevacizumab. Two complete responses (5%) were observed, and 17 patients (42%) had a partial response. Fifteen patients (38%) displayed disease stability. The overall disease control rate was 85%. At a median follow-up of 15.8 months, the median progression-free survival was 7.1 months (95% confidence interval, 5.9-8.3 months), and the median overall survival was 17.1 months (95% confidence interval, 8.8-25.5 months).
CONCLUSIONS: Combined bevacizumab, pemetrexed, and carboplatin followed by maintenance bevacizumab was well tolerated and displayed remarkable activity in patients with previously untreated, advanced, nonsquamous nonsmall cell lung cancer.
Authors:
James P Stevenson; Corey J Langer; Robert A Somer; Tracey L Evans; Kumar Rajagopalan; Kimberly Krieger; Mona Jacobs-Small; Nikolas Dyanick; Barry Milcarek; Susan Coakley; Suzanne Walker; Beth Eaby-Sandy; Alexandre Hageboutros
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-04-27
Journal Detail:
Title:  Cancer     Volume:  118     ISSN:  1097-0142     ISO Abbreviation:  Cancer     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-10-31     Completed Date:  2013-01-10     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  0374236     Medline TA:  Cancer     Country:  United States    
Other Details:
Languages:  eng     Pagination:  5580-7     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 American Cancer Society.
Affiliation:
Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA. james.stevenson@uphs.upenn.edu
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Angiogenesis Inhibitors / adverse effects,  therapeutic use
Antibodies, Monoclonal, Humanized / adverse effects,  therapeutic use*
Antineoplastic Agents / adverse effects,  therapeutic use
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Carboplatin / administration & dosage,  adverse effects
Carcinoma, Non-Small-Cell Lung / drug therapy*
Disease-Free Survival
Drug Administration Schedule
Female
Glutamates / administration & dosage,  adverse effects
Guanine / administration & dosage,  adverse effects,  analogs & derivatives
Humans
Lung Neoplasms / drug therapy*
Maintenance Chemotherapy* / adverse effects
Male
Middle Aged
Chemical
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 0/Antineoplastic Agents; 0/Glutamates; 04Q9AIZ7NO/pemetrexed; 2S9ZZM9Q9V/bevacizumab; 41575-94-4/Carboplatin; 73-40-5/Guanine

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


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