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abstract:
Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multi-study analysis of response rates and safety
Background The PARP inhibitor olaparib (Lynparza™) demonstrates antitumor activity in women with relapsed ovarian cancer and a germline
BRCA1/2 mutation (gBRCAm). Data from olaparib monotherapy trials were used to explore the treatment effect of olaparib in patients with gBRCAm ovarian cancer who had received multiple lines of prior chemotherapy.
Patients and methods This analysis evaluated pooled data from two Phase I trials (NCT00516373 [Study 2]; NCT00777582 [Study 24]) and four Phase II trials (NCT00494442 [Study 9]; NCT00628251 [Study 12]; NCT00679783 [Study 20]; NCT01078662 [Study 42]) that recruited women with relapsed ovarian, fallopian tube or peritoneal cancer. All patients had a documented
gBRCAm and were receiving olaparib 400
mg monotherapy twice daily (capsule formulation) at the time of relapse.
Objective response
rate (ORR) and duration of response (DoR) were
evaluated using original patient outcomes data for patients with
measurable
disease at baseline.
Results Of the 300
patients in the pooled population, 273 had measurable disease at
baseline, of whom 205 (75%) had received ≥3 lines
of prior chemotherapy. In the pooled population,
the ORR was 36% (95% CI: 30, 42) and the median DoR was 7.4 months (95%
CI:
5.7, 9.1). The ORR among patients who had
received ≥3 lines of prior chemotherapy was 31% (95% CI: 25, 38), with a
DoR of
7.8 months (95% CI: 5.6, 9.5). The safety
profile of olaparib was similar in patients who had received ≥3 lines of
prior chemotherapy
compared with the pooled population; grade ≥3
adverse events were reported in 54% and 50% of patients, respectively.
Conclusion Durable responses to olaparib were observed in patients with relapsed gBRCAm ovarian cancer who had received ≥3 lines of prior chemotherapy.
Clinical trial numbers ClinicalTrials.gov, NCT00516373; NCT00494442; NCT00628251; NCT00679783; NCT00777582; NCT01078662
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