Issue 1 - San Antonio Breast Cancer Symposium

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6 Revised Abstracts Revisions of the following abstracts were received and accepted too late for inclusion in the SABCS abstract book. They will be published in the January issue of Cancer Research. Abstract 41 Final overall survival (OS) results from the randomized, double-blind, placebo-controlled, phase 3 AvADO study of bevacizumab (Bv) plus docetaxel (D) compared with placebo (PL) plus D for the first-line treatment of locally recurrent (LR) or metastatic breast cancer (mBC) Miles DW, Chan A, Romieu G, Dirix LY, Cortés J, Pivot X, Tomczak P, Juozaityte E, Harbeck N, Steger GG, the BO17708 study group. Mount Vernon Cancer Centre, Middlesex, United Kingdom; Mount Hospital, Mount Breast Group, Perth, Australia; CRLCC Val d’Aurelle, P. Lamarque Service Chimioimmunotherapie, Montpellier, France; Algemeen Ziekenhuis St. Augustinus, Wilrijk, Belgium; University Hospital Vall d’Hebron Oncology, Barcelona, Spain; University Hospital of Besancon, France; Klinika Onkologii Oddzial Chemioterapii, Poznań, Poland; Kaunas Medical University Hospital, Oncology Clinic, Kaunas, Lithuania; Breast Centre, University of Cologne, Cologne, Germany; Medical University of Vienna, Department of Internal Medicine I-Oncology, Vienna, Austria Background: Anti-VEGF monoclonal antibody BV significantly improves efficacy in combination with standard therapies in multiple tumor types, with limited impact on toxicity. Three randomized phase 3 trials (E2100, AVADO, and RIBBON-1) in mBC have demonstrated that BV + 1st-line chemotherapy (CTx) significantly improves progression-free survival (PFS) and overall response rates (ORR). We present mature OS data from AVADO. Methods: Patients (pts) with HER2-negative LR/mBC were randomized to D 100 mg/m 2 + PL, D + BV 7.5 mg/kg or D + BV 15 mg/kg. D was given q3w for ≤9 cycles. BV or PL was given q3w until disease progression/unacceptable toxicity. After progression, pts were offered BV with 2nd-line anticancer therapy in a post-study treatment phase. The primary endpoint was PFS; secondary endpoints included OS, time to treatment failure, ORR, duration of response and safety. An exploratory analysis conducted in pts receiving post-progression CTx compared OS in pts receiving 2nd-line BV with those who did not. Results: 736 pts were enrolled March 2006–April 2007. The primary analysis (data cut-off October 2007; median follow-up 10.2 months) showed significant improvements in PFS and ORR for both BV-containing arms compared with PL + D. Mature OS data (data cut-off April 2009; median follow-up 25 months) are shown (Table). There was no difference in median OS between the study arms (range 30–32 months). Recognizing the limitations of the non-randomized comparison in exploratory analyses, results suggest that use of BV with 2nd-line therapy is a possible reason for lack of OS difference. Updated PFS and ORR were superior for the 15 mg/kg BV arm compared with PL + D. Results for the 7.5 mg/kg BV arm also indicated a less pronounced treatment benefit. BV had limited impact on the safety profile of docetaxel. Increased SAEs in the 15 mg/kg BV arm may be due to more pts receiving 9 cycles of D than in the PL arm (51% vs 42%). Conclusions: There was no difference in OS between study arms. Exploratory analyses suggest that use of 2nd-line BV with CTx may influence OS. These mature data confirm the improvement in PFS and ORR with BV 15 mg/kg combined with D compared with PL + D.
Abstract 41 PL + D (n=241) BV 7.5 mg/kg + D (n=248) BV 15 mg/kg + D (n=247) Deaths, % 44.8 47.6 47.0 OS HR 1.05 1.03 95% CI 0.81–1.36 0.79–1.33 P value P value P value 0.7198 0.8528 Median 31.9 30.8 30.2 Stratified PFS* HR 0.80 0.67 95% CI 0.65–1.00 0.54–0.83 P value † 0.0450 0.0002 Median 8.1 9.0 10.0 ORR ‡ , % 46.4 55.2 64.1 0.0739 0.0003 1-y survival, % 76 81 84 PL + D (n=231) 0.198 0.02 BV 7.5 mg/kg + D (n=252) BV 15 mg/kg + D (n=247) SAEs, % 32.5 37.3 42.9 Pts discontinuing treatment due to AE, % BV/PL 11.7 8.7 13.8 D 24.7 20.6 24.3 AEs leading to death, % 2.6 1.6 1.6 *Pts were censored if they had started non-protocol therapy before disease progression. † Exploratory. ‡ Pts with measurable disease at baseline. NR, not reached.
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