Document Detail

Incorporating bevacizumab and erlotinib in the combined-modality treatment of stage III non-small-cell lung cancer: results of a phase I/II trial.
MedLine Citation:
PMID:  23045594     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Bevacizumab and erlotinib have been shown to improve survival in stage IV non-small-cell lung cancer (NSCLC). This phase I/II trial was designed to incorporate these agents with induction and concurrent chemoradiotherapy in stage III NSCLC.
PATIENTS AND METHODS: Patients received induction chemotherapy (carboplatin area under the curve [AUC] 6, paclitaxel 225 mg/m(2), and bevacizumab 15 mg/kg on days 1 and 22) followed by concurrent chemotherapy (carboplatin AUC 2 and paclitaxel 45 mg/m(2) weekly with bevacizumab 10 mg/kg every other week for four doses) and thoracic conformal radiation therapy (TCRT) to 74 Gy. In the phase I portion, cohort 1 received no erlotinib, whereas cohorts 2 and 3 received erlotinib at 100 and 150 mg, respectively, Tuesday through Friday, during TCRT. Consolidation therapy with erlotinib (150 mg daily) and bevacizumab (15 mg/kg every 3 weeks) was planned 3 to 6 weeks later for six cycles.
RESULTS: Forty-five eligible patients were enrolled. The objective response rates to induction and overall treatment were 39% (95% CI, 24% to 55%) and 60% (95% CI, 44% to 75%), respectively. The median progression-free and overall survival times were 10.2 months (95% CI, 8.4 to 18.3 months) and 18.4 months (95% CI, 13.4 to 31.7 months), respectively. The principal toxicity was esophagitis (29% grade 3 or 4 esophagitis, with one patient with grade 3 tracheoesophageal fistula), which was often prolonged. Consolidation therapy with bevacizumab and erlotinib was not feasible.
CONCLUSION: The use of bevacizumab and erlotinib as administered in this trial is not recommended given the lack of an efficacy signal and the substantial risk of esophageal toxicity.
Mark A Socinski; Thomas E Stinchcombe; Dominic T Moore; Scott N Gettinger; Roy H Decker; W Jeffrey Petty; A William Blackstock; Garry Schwartz; Scott Lankford; Amir Khandani; David E Morris
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-10-08
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  30     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-09     Completed Date:  2013-01-17     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3953-9     Citation Subset:  IM    
UPMC Cancer Pavilion, 5150 Centre Avenue, 5th Floor, Pittsburgh, PA 15232, USA.
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MeSH Terms
Adenocarcinoma / drug therapy
Antibodies, Monoclonal, Humanized / administration & dosage,  adverse effects
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Carcinoma, Non-Small-Cell Lung / drug therapy*,  pathology
Chemotherapy, Adjuvant
Disease-Free Survival
Drug Administration Schedule
Esophagitis / chemically induced*
Esophagus / drug effects*
Kaplan-Meier Estimate
Lung Neoplasms / drug therapy*,  pathology
Middle Aged
Neoplasm Staging
Quinazolines / administration & dosage,  adverse effects
Radiotherapy, Conformal
Remission Induction
Tracheoesophageal Fistula / chemically induced
Treatment Failure
Reg. No./Substance:
0/Antibodies, Monoclonal, Humanized; 0/Quinazolines; 2S9ZZM9Q9V/bevacizumab; J4T82NDH7E/erlotinib
Comment In:
J Clin Oncol. 2012 Nov 10;30(32):3909-12   [PMID:  23045597 ]

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

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