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Sub-category:
Non-Small Cell Lung Cancer
Category:
Lung Cancer
Meeting:
2007 ASCO Annual Meeting
Session Type and Session Title:
null, 2007 Best of ASCO San Francisco
null, 2007 Best of ASCO Reston
Oral Presentation, Lung Cancer I
Abstract No:
LBA7514
Citation:
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: LBA7514
Author(s):
C. Manegold, J. von Pawel, P. Zatloukal, R. Ramlau, V. Gorbounova, V. Hirsh, N. Leighl, J. Mezger, V. Archer, M. Reck, the BO17704 study group
Abstract:
Background: The ECOG 4599 phase III trial demonstrated that the addition of bevacizumab (B) to carboplatin/paclitaxel improved overall and progression-free survival (PFS) in patients (pts) with advanced NSCLC [Sandler et al. NEJM 2006]. Cisplatin/gemcitabine (CG) is a common combination in regions outside of the US.
Methods: This randomised, placebo-controlled phase III study compared two doses of B plus CG versus CG plus placebo. The primary endpoint was PFS; secondary endpoints include overall survival, response rate (RR) and safety. Eligibility criteria: histologically or cytologically documented previously untreated advanced or recurrent non-squamous NSCLC; ECOG PS 0-1; no brain metastases. Between 2/05 and 8/06 1,043 pts were randomised to: C 80mg/m2 on d1 and G 1,250mg/m2 on d1 and d8 every 3 wks for up to 6 cycles plus B continued to progression at 7.5mg/kg every 3 wks, or 15mg/kg every 3 wks or placebo. The study was designed to include the number of patients required to observe a 30% reduction in the risk of a PFS event in the B arms compared with control using a two-sided logrank test (a=2.5%) with 80% power.
Results: PFS was significantly prolonged as analysed both in a primary analysis (without censoring for non-protocol anti-neoplastic therapy [NPT] prior to progression) and in a prespecified analysis with censoring for NPT. The RR and response duration were also increased. Overall survival is immature due to short duration of follow up.
Conclusions: Both doses of B significantly improved PFS and RR, consistent with the results of the earlier phase III trial E4599. No unexpected safety signals were detected.
Results| Endpoint | Control
N=347 | B 7.5mg/kg
N=345 | B 15mg/kg
N=351 | PFS general
Hazard ratio (95%CI) | | 0.75(0.62,0.90)
P=0.002 | 0.82(0.68,0.98)
P=0.03 | | Median PFS general (mos) | 6.1 | 6.7 | 6.5 | PFS censoring for NPT
Hazard ratio (95%CI) | | 0.70(0.58,0.85)
P=0.0004 | 0.78(0.64,0.95)
P=0.0125 | | Response rate (%) | 20 | 34 | 30 | | Response duration (mos) | 4.7 | 6.1 | 6.1 | | Grade >3 AEs (%) | 75 | 76 | 81 | | Grade >3 hypertension (%) | 2 | 6 | 9 | | Grade >3 haemoptysis (%) | <1 | 1.5 | <1 | | AEs leading to death (%) | 4 | 4 | 5 |
Abstract Disclosures
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. Manegold:
Presentations by C. Manegold:
Educational Book Manuscripts by C. Manegold:
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