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Clin Lung Cancer. 2015 Sep;16(5):340-7. doi: 10.1016/j.cllc.2014.12.014. Epub 2015 Jan 9.

A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Combination of Bevacizumab (NSC-704865) in Patients With Inoperable Locally Advanced Stage III Non-Small-Cell Lung Cancer: SWOG S0533.

Author information

1
Wayne State University/Karmanos Cancer Institute, Detroit, MI. Electronic address: wozniakt@karmanos.org.
2
SWOG Statistical Center, Seattle, WA.
3
Oregon Health and Sciences University/Knight Cancer Institute, Portland, OR.
4
University of California at Davis, Sacramento, CA.
5
University of Colorado School of Medicine, Aurora, CO.
6
Quality Assurance Review Center, Lincoln, RI.
7
University of Rochester/James P. Wilmot Cancer Center, Rochester, NY.

Abstract

BACKGROUND:

The aim of this trial was to determine feasibility of incorporating bevacizumab (B) into concurrent chemoradiotherapy (CRT) for locally advanced non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS:

Patients with unresectable stage III NSCLC, performance status of 0 to 1, and adequate organ function were accrued in 2 strata, low- and high-risk (squamous histology, hemoptysis, tumor with cavitation and/or adjacent to a major vessel). Cohort 1 patients received cisplatin 50 mg/m(2) days (d) 1 and 8, etoposide 50 mg/m(2) (d 1-5) for 2 cycles concurrent with radiotherapy (64.8 Gy) followed by docetaxel (D) 75 mg/m(2) and B 15 mg/kg for 3 cycles. If safety was established, then accrual would continue to cohort 2 (B, d 15, 36, 57) and then subsequently to cohort 3 (B, d 1, 22, 43).

RESULTS:

Twenty-nine patients (17 low- and 12 high-risk) registered to cohort 1. Twenty-six patients (including 4 squamous, 1 adenosquamous) were assessable. Twenty-five completed CRT. Grade 3/4 toxicities during CRT included acceptable rates of hematologic toxicity, esophagitis, and pneumonitis. Of 21 assessable for safety with D/B consolidation, major adverse events were pneumonitis (2 Grade 3) and 2 episodes of fatal hemoptysis in the high-risk group, resulting in closure of this stratum. The low-risk stratum subsequently closed because of slow accrual. Median overall survival was 46 months for low-risk and 17 months for high-risk strata.

CONCLUSION:

Bevacizumab was not safely integrated into CRT for stage III NSCLC in patients considered at high risk for hemoptysis. In lower risk patients, data are insufficient to determine safety or efficacy.

KEYWORDS:

Bevacizumab; Cisplatin/etoposide; Concurrent chemoradiotherapy; Locally advanced NSCLC; Non–small-cell lung cancer

PMID:
25703100
PMCID:
PMC4497941
DOI:
10.1016/j.cllc.2014.12.014
[Indexed for MEDLINE]
Free PMC Article

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