Universität zu Köln

Kaufman, Bella, 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, Steiner, Mariana, Loman, Niklas, Bowen, Karin, Fielding, Anitra and Domchek, Susan M. (2015). Olaparib Monotherapy in Patients With Advanced Cancer and a Germline BRCA1/2 Mutation. J. Clin. Oncol., 33 (3). S. 244 - 251. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

Purpose Olaparib is an oral poly (ADP-ribose) polymerase inhibitor with activity in germline BRCA1 and BRCA2 (BRCA1/2) -associated breast and ovarian cancers. We evaluated the efficacy and safety of olaparib in a spectrum of BRCA1/2-associated cancers. Patients and Methods This multicenter phase II study enrolled individuals with a germline BRCA1/2 mutation and recurrent cancer. Eligibility included ovarian cancer resistant to prior platinum; breast cancer with >= three chemotherapy regimens for metastatic disease; pancreatic cancer with prior gemcitabine treatment; or prostate cancer with progression on hormonal and one systemic therapy. Olaparib was administered at 400 mg twice per day. The primary efficacy end point was tumor response rate. Results A total of 298 patients received treatment and were evaluable. The tumor response rate was 26.2% (78 of 298; 95% CI, 21.3 to 31.6) overall and 31.1% (60 of 193; 95% CI, 24.6 to 38.1), 12.9% (eight of 62; 95% CI, 5.7 to 23.9), 21.7% (five of 23; 95% CI, 7.5 to 43.7), and 50.0% (four of eight; 95% CI, 15.7 to 84.3) in ovarian, breast, pancreatic, and prostate cancers, respectively. Stable disease >= 8 weeks was observed in 42% of patients (95% CI, 36.0 to 47.4), including 40% (95% CI, 33.4 to 47.7), 47% (95% CI, 34.0 to 59.9), 35% (95% CI, 16.4 to 57.3), and 25% (95% CI, 3.2 to 65.1) of those with ovarian, breast, pancreatic, or prostate cancer, respectively. The most common adverse events (AEs) were fatigue, nausea, and vomiting. Grade >= 3 AEs were reported for 54% of patients; anemia was the most common (17%). Conclusion Responses to olaparib were observed across different tumor types associated with germline BRCA1/2 mutations. Olaparib warrants further investigation in confirmatory studies. (C) 2014 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kaufman, Bella 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 Steiner, Mariana UNSPECIFIED UNSPECIFIED UNSPECIFIED Loman, Niklas UNSPECIFIED UNSPECIFIED UNSPECIFIED Bowen, Karin UNSPECIFIED UNSPECIFIED UNSPECIFIED Fielding, Anitra UNSPECIFIED UNSPECIFIED UNSPECIFIED Domchek, Susan M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-414550
DOI:	10.1200/JCO.2014.56.2728
Journal or Publication Title:	J. Clin. Oncol.
Volume:	33
Number:	3
Page Range:	S. 244 - 251
Date:	2015
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language POLY(ADP-RIBOSE) POLYMERASE; PANCREATIC-CANCER; OPEN-LABEL; PARP INHIBITORS; BREAST-CANCER; TUMORS; ADENOCARCINOMA; MULTICENTER; GEMCITABINE; FOLFIRINOX Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/41455