Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: LBA7514
© 2007 American Society of Clinical Oncology

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Abstract

Randomised, double-blind multicentre phase III study of bevacizumab in combination with cisplatin and gemcitabine in chemotherapy-naïve patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC): BO17704

University Medical Center, Mannheim, Germany; Asklepios Klinikum Gauting, Gauting, Germany; Faculty Hospital Bulovka, Prague, Czech Republic; Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Poznan, Poland; Cancer Research Center of Russia, Moscow, Russian Federation; MUHC - Royal Victoria Hospital, Montreal, PQ, Canada; Princess Margaret Hospital, Toronto, ON, Canada; St. Vincentius-Kliniken, Karlsruhe, Germany; F. Hoffmann-La Roche, Basel, Switzerland; Krankenhaus Grosshansdorf, Grosshansdorf, Germany

LBA7514

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.

Author Disclosure

Employment Consultant Stock Honoraria Research Expert Testimony Other Remuneration Hoffman-La Roche Hoffman-La Roche Eli Lilly, Hoffman-La Roche Hoffman-La Roche

Abstract presentation from the 2007 ASCO Annual Meeting

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