CCO Independent Conference Coverage* of the 2016 ASCO Annual Meeting, June 3-7, 2016 GOG0213: Bevacizumab Retreatment of Recurrent Platinum-Sensitive Ovarian Cancer *CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs. This activity is supported by educational grants from Amgen, Ariad, Bayer Healthcare Pharmaceuticals, Celgene Corporation, Genentech, Incyte, Merck, and Taiho Pharmaceuticals.
GOG0213: Background GOG0213 evaluated efficacy and tolerability of bevacizumab addition to chemotherapy and secondary cytoreduction in platinum-sensitive recurrent ovarian cancer [1] –Bevacizumab maintenance following carboplatin/paclitaxel + bevacizumab reduced risk of progression or death, improved clinical response, and demonstrated equivalent health- related patient satisfaction over chemotherapy alone Current report details prespecified supplemental analysis of OS (primary trial endpoint) in patients previously receiving and subsequently retreated with bevacizumab [2] 1. Coleman RL, et al. Gynecol Oncol. 2015;137(suppl 1): Coleman RL, et al. ASCO Abstract Slide credit: clinicaloptions.comclinicaloptions.com
Bifactorial, randomized phase III trial GOG0213: Study Design Pts 18 yrs of age or older with recurrent EOC, prior CR to frontline platinum-based regimen, treatment-free ≥ 6 mos, GOG PS 0-2 (N = 674) MAINTENANCE Carboplatin AUC 5 + Paclitaxel 175 mg/m 2 Q21D (n = 337) Carboplatin AUC 5 + Paclitaxel 175 mg/m 2 + Bevacizumab 15 mg/kg Q21D (n = 337) Slide credit: clinicaloptions.comclinicaloptions.com Coleman RL, et al. ASCO Abstract Bevacizumab 15 mg/kg Q21D until PD or toxicity Surgical candidates randomized to surgery or no surgery Stratified by treatment-free interval at first recurrence (6-12 vs > 12 mos); surgical cytoreduction (yes vs no)
Prior Bevacizumab Subgroup of GOG0213: Pt Characteristics 69 (10.3%) pts in GOG0213 previously received bevacizumab as primary and/or maintenance therapy –Carboplatin/paclitaxel arm: n = 34 –Carboplatin/paclitaxel + bevacizumab arm (n = 35) Pt characteristics of prior bevacizumab subgroup similar to overall treatment population 28 pts in each arm had RECIST measurable disease to allow ORR assessment Slide credit: clinicaloptions.comclinicaloptions.com Coleman RL, et al. ASCO Abstract 5523.
11 17 Prior Bevacizumab Subgroup of GOG0213: Outcomes Outcome Carboplatin/ Paclitaxel (n = 34) Carboplatin/ Paclitaxel + Bevacizumab (n = 35) HR (95% CI)P Value Median OS, mos ( ) Median PFS, mos ( ) ORR,* % CR*, %1132<.02 Slide credit: clinicaloptions.comclinicaloptions.com Coleman RL, et al. ASCO Abstract *n = 28 evaluable in each arm n at risk CP CPB OS (%) Mos CP CPB n at risk CP CPB Mos CP CPB PFS (%)
Prior Bevacizumab Subgroup of GOG0213: Safety AEs Within 6 Mos Posttreatment, % Carboplatin/ Paclitaxel (n = 35) Carboplatin/ Paclitaxel + Bevacizumab (n = 33) Any AE of special interest Grade ≥ Non-CNS bleeding646 Hypertension Grade ≥ Proteinuria015 Neutropenia612 Gastrointestinal perforation, fistula/abscess 00 Slide credit: clinicaloptions.comclinicaloptions.com Coleman RL, et al. ASCO Abstract 5523.
Prior Bevacizumab Subgroup of GOG0213: Conclusions Prior bevacizumab use showed no negative impact on subsequent bevacizumab treatment in pts with platinum-sensitive recurrent ovarian cancer –OS, PFS in this retreated subgroup are consistent with overall GOG0213 ITT population –Additional conclusions on efficacy of bevacizumab precluded by small sample size Bevacizumab retreatment increased ORR, CR over chemotherapy alone Authors concluded previous bevacizumab did not negatively affect safety Slide credit: clinicaloptions.comclinicaloptions.com Coleman RL, et al. ASCO Abstract 5523.
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