| Incorporating bevacizumab and erlotinib in the combined-modality treatment of stage III non-small-cell lung cancer: results of a phase I/II trial. | |
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MedLine Citation:
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PMID: 23045594 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't Date: 2012-10-08 |
Journal Detail:
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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:
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Created Date: 2012-11-09 Completed Date: 2013-01-17 Revised Date: 2013-06-03 |
Medline Journal Info:
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Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: United States |
Other Details:
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Languages: eng Pagination: 3953-9 Citation Subset: IM |
Affiliation:
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UPMC Cancer Pavilion, 5150 Centre Avenue, 5th Floor, Pittsburgh, PA 15232, USA. socinskima@upmc.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adenocarcinoma
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drug therapy Adult Aged 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* Female Humans Kaplan-Meier Estimate Lung Neoplasms / drug therapy*, pathology Male Middle Aged Neoplasm Staging Quinazolines / administration & dosage, adverse effects Radiotherapy, Conformal Remission Induction Tracheoesophageal Fistula / chemically induced Treatment Failure |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal, Humanized; 0/Quinazolines; 2S9ZZM9Q9V/bevacizumab; J4T82NDH7E/erlotinib |
| Comments/Corrections | |
Comment In:
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J Clin Oncol. 2012 Nov 10;30(32):3909-12
[PMID:
23045597
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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