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
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 0732-183XFull text not available from this repository.
Official URL: http://jco.ascopubs.org
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.
|Item Type:||Journal Article|
|Subjects:||R Medicine > R Medicine (General)|
|Divisions:||Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
|Journal or Publication Title:||Journal of Clinical Oncology|
|Publisher:||American Society of Clinical Oncology|
|Date:||20 May 2008|
|Page Range:||p. 5520|
|Access rights to Published version:||Restricted or Subscription Access|
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