Kaye, Stan B., Poole, Christopher, Bidzinksi, M., Gianni, L., Gorbunova, V., Novikova, E., Strauss, A., McNally, V. A., Rossi, G. and Vergote, Ignace. (2008) A randomised phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab (P) versus carboplatin-based therapy alone in patients with relapsed, platinum sensitive ovarian cancer. Journal of Clinical Oncology, Vol.26 (No.15S). p. 5520. ISSN 0732-183X

Abstract

Background: Pertuzumab is a monoclonal antibody which specifically binds HER2 and prevents its dimerisation with either another HER2 molecule or other HER family receptors like HER1 or HER3. P has been shown to have activity as a single agent in relapsed ovarian cancer. In preclinical ovarian cancer models, P enhances the activity of platinum-based treatment. P was therefore evaluated in a randomized Phase II study. Methods: Eligibility criteria included: sensitive ovarian cancer (treatment-free interval >6 months), ECOG performance status 0 or 1, left ventricular ejection fraction (LVEF) >55%) and an histological specimen for the evaluation of potential biomarkers of response. Patients were randomised to receive either P at the standard dose of 840mg iv loading dose with 420mg iv 3-weekly maintenance (for 1 year), or no therapy in addition to carboplatin with (at the investigator’s discretion) either paclitaxel or gemcitabine. The primary endpoint of the study was progression-free survival. Results: 152 Patients (Pts) were recruited. On a preliminary data review of 84 Pts; 44 received chemotherapy + P and 40 received chemotherapy alone. Tolerability has been good, with no marked increase in overall adverse events associated with P. Grade >3 neutropenia occurred in 30% vs. 38% of Pts on chemo + P vs. chemo alone. 1 Pt in the chemo + P arm experienced an asymptomatic fall in LVEF of >10% and to <50% and spontaneously recovered and continued therapy. 21 (25%) Pts overall have relapsed at the time of the preliminary review. Conclusions: The addition of P to carboplatin-based chemotherapy is well tolerated. The clinical efficacy data by treatment arm will be presented as well as subset evaluations based on biomarkers.

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