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Clinical Trial
. 2015 Jan 20;33(3):244-50.
doi: 10.1200/JCO.2014.56.2728. Epub 2014 Nov 3.

Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation (V体育ios版)

Bella Kaufman  1 , Ronnie Shapira-Frommer  1 , Rita K Schmutzler  1 , M William Audeh  1 , Michael Friedlander  1 , Judith Balmaña  1 , Gillian Mitchell  1 , Georgeta Fried  1 , Salomon M Stemmer  1 , Ayala Hubert  1 , Ora Rosengarten  1 , Mariana Steiner  1 , Niklas Loman  1 , Karin Bowen  1 , Anitra Fielding  1 , Susan M Domchek  2
Affiliations
Clinical Trial

Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation

VSports最新版本 - Bella Kaufman et al. J Clin Oncol. .

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 VSports手机版. .

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 V体育安卓版. .

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 V体育ios版. 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 VSports最新版本. .

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
Progression-free survival.
Fig 2.
Fig 2.
Overall survival.
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References

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    1. Tutt A Robson M Garber JE , etal: Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: A proof-of-concept trial Lancet 376: 235– 244,2010. - V体育官网 - PubMed
    1. Audeh MW Carmichael J Penson RT , etal: Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: A proof-of-concept trial Lancet 376: 245– 251,2010. - VSports手机版 - PubMed

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