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Sub-category:
Metastatic Lung Cancer
Category:
Lung Cancer--Metastatic Lung Cancer
Meeting:
2009 ASCO Annual Meeting
Session Type and Session Title:
Oral Presentation, Lung Cancer - Metastatic
Abstract No:
LBA8002
Citation:
J Clin Oncol 27:18s, 2009 (suppl; abstr LBA8002)
Author(s):
V. A. Miller, P. O'Connor, C. Soh, F. Kabbinavar, for the ATLAS Investigators; Memorial Sloan-Kettering Cancer Center, New York, NY; Genentech, Inc., South San Francisco, CA; University of California, Los Angeles, Los Angeles, CA
Abstract:
Background: B when added to chemotherapy, and E alone, each lead to improved survival in the treatment of patients (pts) with NSCLC (Sandler et al, NEJM 2006, 355:2542-2550; Shepherd et al, NEJM 2005, 353:123-132). Pre-clinical and clinical data (Herbst, J Clin Oncol 2007, 25: 4743-4750) suggest that the combination of B and E may improve the efficacy of NSCLC treatment. This potential was demonstrated in the BETA (B in combination with E compared with E alone for treatment of advanced NSCLC after failure of standard first-line chemotherapy) trial, a phase III trial in which progression free survival (PFS) was improved for patients treated with B + E (Hainsworth, Thoracic Oncol 2008, 3(11) Supp. 4:S302). Methods: The ATLAS study was designed to evaluate B + E (150 mg daily) versus B alone, following B + platin-containing doublet chemotherapy, in pts with stage IIIb/IV NSCLC. Enrolled pts were B-eligible, including pts with treated brain metastases, and pts anticoagulated with low molecular weight heparin(s). Pts with peripheral and/or extra-thoracic squamous tumors were also eligible. Pts received 4 cycles of B (15 mg/kg every 3 weeks) with chemotherapy. Pts who had not experienced disease progression (DP) or significant toxicity were then randomized to receive B + E or B + placebo (P). The primary objective of ATLAS was to compare PFS in pts receiving B + E versus B + placebo. Secondary objectives included the assessment of safety, and overall survival. A data safety monitoring committee (DSMC) monitored safety and efficacy. Results: 1,160 patients were enrolled and 768 randomized from May 2005 to May 2008. The DSMC recommended stopping the trial at the second planned interim efficacy analysis, because it met the primary endpoint. The median PFS after randomization was 4.8 mos for (B + E) vs. 3.7 mos for (B + P), HR= 0.722 (95% CI: 0.592-0.881), p = 0.0012. The safety profile for B + E was consistent with known profiles for B and E. Conclusions: E added to B treatment after chemotherapy with B significantly improves the PFS of patients treated in the first-line setting for locally advanced, recurrent, or metastatic NSCLC.
Abstract Disclosures
Faculty and Discussant Disclosures
Annual Meeting Planning Committee Disclosures
2009 Annual Meeting Proceedings Part I Errata
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
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1. A randomized, double-blind, placebo-controlled, phase IIIb trial (ATLAS) comparing bevacizumab (B) therapy with or without erlotinib (E) after completion of chemotherapy with B for first-line treatment of locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC).
Meeting:
2009 ASCO Annual Meeting
Presenter:
Vincent A Miller, MD
Session:
Lung Cancer - Metastatic
(Oral Presentation)
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Other Abstracts in this Sub-Category:
Abstracts by V. A. Miller:
Presentations by V. A. Miller:
Educational Book Manuscripts by V. A. Miller:
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