Universität zu Köln

Domchek, Susan M., Aghajanian, Carol, Shapira-Frommer, Ronnie, Schmutzler, Rita K., Audeh, M. William, Friedlander, Michael, Balmana, Judith ORCID: 0000-0002-0762-6415, Mitchell, Gillian, Fried, Georgeta, Stemmer, Salomon M., Hubert, Ayala, Rosengarten, Ora, Loman, Niklas, Robertson, Jane D., Mann, Helen and Kaufman, Bella (2016). Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol. Oncol., 140 (2). S. 199 - 204. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE. ISSN 1095-6859

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Abstract

Objective. The efficacy and safety of olaparib, an oral poly(ADP-ribose) polymerase (PARP) inhibitor, was investigated in a subgroup of patients with germline BRCAI/2 mutated (gBRCA1/2m) advanced ovarian cancer who had received >= 3 prior lines of chemotherapy. Primary data from this Phase II study (Study 42, ClinicalTrials.gov NCT01078662) have been reported previously. Methods. Eligible patients were treated with oral olaparib 400 mg bid capsule monotherapy until disease progression according to RECIST v1.1. Objective response rate (ORR) and duration of response (DoR) were assessed for patients with measurable disease at baseline. Safety and tolerability were assessed for all patients by adverse event (AE) incidence and changes in laboratory parameters. Platinum resistance status was obtained retrospectively, and responses to olaparib evaluated. Results. In patients with gBRCA1/2m ovarian cancer, 154/193 (80%) had received >= 3 prior lines of chemotherapy, of whom 137/154 (89%) had measurable disease at baseline. ORR was 34% (46/137; 95% confidence interval [CI] 26-42) and median DoR was 7.9 (95% CI 5.6-9.6) months. ORR in platinum-resistant tumors was 30%. Median DoR for platinum-sensitive and platinum-resistant disease was similar: 8.2 months (95% CI 5.6-13.5) compared with 8.0 months (4.8-14.8), respectively. Six of the 193 (3%) patients had an AE with an outcome of death. None of these AEs at time of occurrence was considered causally related to olaparib. Conclusion. Following >= 3 prior lines of chemotherapy, olaparib 400 mg bid (capsule form) monotherapy demonstrated notable antitumor activity in patients with gBRCA1/2m advanced ovarian cancer. No new safety signals were identified. (C) 2016 Elsevier Inc. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Domchek, Susan M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Aghajanian, Carol UNSPECIFIED UNSPECIFIED UNSPECIFIED Shapira-Frommer, Ronnie UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmutzler, Rita K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Audeh, M. William UNSPECIFIED UNSPECIFIED UNSPECIFIED Friedlander, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Balmana, Judith UNSPECIFIED orcid.org/0000-0002-0762-6415 UNSPECIFIED Mitchell, Gillian UNSPECIFIED UNSPECIFIED UNSPECIFIED Fried, Georgeta UNSPECIFIED UNSPECIFIED UNSPECIFIED Stemmer, Salomon M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hubert, Ayala UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosengarten, Ora UNSPECIFIED UNSPECIFIED UNSPECIFIED Loman, Niklas UNSPECIFIED UNSPECIFIED UNSPECIFIED Robertson, Jane D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mann, Helen UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaufman, Bella UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-286254
DOI:	10.1016/j.ygyno.2015.12.020
Journal or Publication Title:	Gynecol. Oncol.
Volume:	140
Number:	2
Page Range:	S. 199 - 204
Date:	2016
Publisher:	ACADEMIC PRESS INC ELSEVIER SCIENCE
Place of Publication:	SAN DIEGO
ISSN:	1095-6859
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PEGYLATED LIPOSOMAL DOXORUBICIN; PLATINUM-BASED CHEMOTHERAPY; POLY(ADP-RIBOSE) POLYMERASE; PLUS CARBOPLATIN; OPEN-LABEL; TRIAL; MULTICENTER; CARCINOMA; PHASE-2 Multiple languages Oncology; Obstetrics & Gynecology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28625