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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:
CRA8000
Citation:
J Clin Oncol 27:18s, 2009 (suppl; abstr CRA8000)
Author(s):
C. P. Belani, T. Brodowicz, T. Ciuleanu, J. H. Kim, M. Krzakowski, E. Laack, Y. L. Wu, P. Peterson, K. Krejcy, C. Zielinski; Penn State Hershey Cancer Institute , Hershey, PA; Medical University Vienna General Hospital and CECOG, Vienna, Austria; Oncology Institute Ion Chiricuta and CECOG, Cluj, Romania; Yonsei Cancer Center, Seoul, Republic of Korea; Centre of Oncology-Institute and CECOG, Warsaw, Poland; University Cancer Center Hamburg, Eppendorf, Germany; Guangdong Province People's Hospital, Guangzhou, China; Eli Lilly and Company, Indianapolis, IN; Eli Lilly Regional Operations, Vienna, Austria; Medical University of Vienna and Austria and CECOG, Vienna, Austria
Abstract:
Background: Pemetrexed's efficacy, favorable tolerability profile, and ease of administration provided a strong rationale for evaluation as maintenance therapy in patients (pts) with advanced NSCLC. We present the final analyses for all outcomes, including overall survival (OS), from a phase III study of Pem vs. Plac (Ciuleanu, J Clin Oncol 26, 2008, A 8011) in pts with stage IIIB/IV NSCLC who had not progressed on four cycles of platinum-based chemotherapy. Methods: In this double-blind trial, pts were randomized 2:1 to receive Pem (500 mg/m2, day 1) plus BSC or Plac plus BSC in 21-day cycles until disease progression. All pts received vitamin B12, folic acid, and dexamethasone. The final OS analysis was performed using an unadjusted Cox model. Overall α = 0.05 for PFS and OS. Results: In the 663 randomized pts (Pem 441: Plac 222), Pem resulted in significantly better OS (13.4 vs. 10.6 mos [HR 0.79, 95% CI: 0.65-0.95, P = 0.012]). As reported earlier, Pem also had better PFS (P <0.00001) and response (P <0.001) (Table). The improvements in PFS and OS were observed primarily in patients with non-squamous histology (PFS HR = 0.47 and OS HR = 0.70). Treatment by histology interaction for OS was significant (P = 0.038). Drug-related grade 3/4 toxicities were higher for Pem (16% vs 4%; P <0.001); specifically, fatigue (5% vs 0.5%) and neutropenia (2.9% vs. 0%). Grade 3/4 toxicities did not increase significantly in pts who received ≥6 and ≥10 cycles of Pem. There were no Pem-related deaths. Fewer pts in the Pem arm (51.5% vs 67.1%; P <0.001) received systemic post-discontinuation therapy. Conclusions: Pem maintenance therapy is well tolerated and offers superior OS and PFS compared with Plac, making it a new treatment paradigm for patients with advanced NSCLC who respond to initial therapy. This trial further validates that Pem has greater efficacy in patients with non-squamous histology.
| | Median OS
months
| | Median PFS,*
months
| | CR+PR+SD,*
%
| | | Pem | Placebo | p value (HR) | Pem | Placebo | p value (HR) | Pem | Placebo | p value |
| | Overall population | 13.4 | 10.6 | 0.012
(0.79) | 4.3 | 2.6 | <0.0001
(0.50) | 51.7 | 33.3 | <0.001 | Nonsquamous
(n=482) | 15.5 | 10.3 | 0.002 (0.70) | 4.37 | 1.84 | <0.00001 (0.47) | 54.3 | 26.6 | <0.001 | | Adeno (n=329) | 16.8 | 11.5 | 0.026 (0.73) | 4.60 | 2.66 | <0.00001 (0.51) | 58.2 | 29.6 | <0.001 | Large Cell
(n=20) | 8.4 | 7.9 | 0.964 (0.98) | 4.53 | 1.45 | 0.104 (0.40) | 30.0 | 25.0 | 0.999 | | Other (n=133) | 11.3 | 7.7 | 0.025 (0.61) | 4.11 | 1.58 | 0.0001 (0.44) | 47.5 | 18.9 | 0.004 | Squamous
(n=181) | 9.9 | 10.8 | 0.678 (1.07) | 2.43 | 2.50 | 0.896 (1.03) | 33.3 | 34.5 | 1.000 |
| | * Independent review data. |
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):
Other Abstracts in this Sub-Category:
Abstracts by C. P. Belani:
Presentations by C. P. Belani:
Educational Book Manuscripts by C. P. Belani:
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