A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer.

S. B. Kaye, C. J. Poole, A. Dańska-Bidzińska, L. Gianni, G. Del Conte, V. Gorbunova, E. Novikova, A. Strauss, M. Moczko, V. A. McNally, G. Ross, I. Vergote

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Abstract

Pertuzumab, a humanized monoclonal antibody targeting human epidermal growth factor receptor (HER)-mediated signalling, has shown activity in ovarian cancer in preclinical models and in the clinic. This randomized phase II study evaluated efficacy and safety of pertuzumab in combination with carboplatin-based chemotherapy in patients with platinum-sensitive, recurrent advanced ovarian cancer. Patients were randomized to receive six cycles of chemotherapy (carboplatin and either paclitaxel (Taxol) or gemcitabine) with or without pertuzumab. The primary end point was progression-free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors and/or by CA 125 measurements. Secondary end points evaluated the response rate, safety profile, duration of response, time to progression and overall survival for both treatment arms. A total of 149 patients received either chemotherapy with pertuzumab (arm A, n=74) or chemotherapy alone (arm B, n=75). There was no significant difference either in median PFS or in the secondary end points between the two arms. No differences were seen in an exploratory biomarker analysis of HER3 mRNA expression between the two arms. Pertuzumab was well tolerated, with no increase in cardiac adverse events compared with chemotherapy alone. The addition of pertuzumab to carboplatin-based chemotherapy did not substantially prolong PFS in unselected patients with platinum-sensitive ovarian cancer.

Original languageEnglish
Pages (from-to)145-152
Number of pages8
JournalAnnals of Oncology
Volume24
Issue number1
Publication statusPublished - Jan 2013

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Carboplatin
Platinum
Ovarian Neoplasms
Drug Therapy
Disease-Free Survival
gemcitabine
Paclitaxel
Therapeutics
Safety
Antibodies, Monoclonal, Humanized
Epidermal Growth Factor Receptor
Reaction Time
pertuzumab
Biomarkers
Messenger RNA
Survival

ASJC Scopus subject areas

  • Medicine(all)

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A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer. / Kaye, S. B.; Poole, C. J.; Dańska-Bidzińska, A.; Gianni, L.; Del Conte, G.; Gorbunova, V.; Novikova, E.; Strauss, A.; Moczko, M.; McNally, V. A.; Ross, G.; Vergote, I.

In: Annals of Oncology, Vol. 24, No. 1, 01.2013, p. 145-152.

Research output: Contribution to journalArticle

Kaye, SB, Poole, CJ, Dańska-Bidzińska, A, Gianni, L, Del Conte, G, Gorbunova, V, Novikova, E, Strauss, A, Moczko, M, McNally, VA, Ross, G & Vergote, I 2013, 'A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer.', Annals of Oncology, vol. 24, no. 1, pp. 145-152.
Kaye, S. B. ; Poole, C. J. ; Dańska-Bidzińska, A. ; Gianni, L. ; Del Conte, G. ; Gorbunova, V. ; Novikova, E. ; Strauss, A. ; Moczko, M. ; McNally, V. A. ; Ross, G. ; Vergote, I. / A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer. In: Annals of Oncology. 2013 ; Vol. 24, No. 1. pp. 145-152.
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