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| Gynecologic oncology. 2015 Dec 29. pii: S0090-8258(15)30230-4. doi: 10.1016/j.ygyno.2015.12.027 |
| BRCA1/2 mutations associated with progression-free survival in ovarian cancer patients in the AGO-OVAR 16 study. |
| Harter P1, Johnson T2, Berton-Rigaud D3, Park SY4, Friedlander M5, Del Campo JM6, Shimada M7, Forget F8, Mirza MR9, Colombo N10, Zamagni C11, Chan JK12, Imhof M13, Herzog TJ14, O'Donnell D15, Heitz F16, King K17, Stinnett S18, Barrett C19, Jobanputra M20, Xu CF21, du Bois A22 |
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Abstract OBJECTIVE: AGO-OVAR 16 demonstrated that pazopanib maintenance therapy significantly increased progression-free survival (PFS) in patients with ovarian cancer whose disease had not progressed after first-line therapy. In a sub-study, we evaluated the effect of clinically important germline BRCA1 and BRCA2 mutations on PFS. METHODS: Of 940 AGO-OVAR 16 participants, 664 had BRCA1/2 exon sequencing data (pazopanib, n=335; placebo, n=329). A Cox model was used to test the association between genetic variants and PFS. RESULTS: Ninety-seven of 664 patients (15%) carried clinically important BRCA1/2 mutations (BRCA1/2 carriers: pazopanib 14%, placebo 16%). Median PFS was longer in BRCA1/2 mutation carriers than in BRCA1/2 non-carriers in the placebo arm (30.3 vs 14.1months, hazard ratio, 0.48; 95% confidence interval [CI]: 0.29-0.78; P=0.0031); a similar non-significant trend was noted with pazopanib (30.2 vs 17.7months, hazard ratio, 0.64; 95% CI: 0.40-1.03; P=0.069). Among BRCA1/2 non-carriers, PFS was longer for pazopanib-treated patients than placebo-treated patients (17.7 vs 14.1months, hazard ratio, 0.77; 95% CI: 0.62-0.97; P=0.024). Among BRCA1/2 carriers, there was no significant PFS difference between treatments, although numbers were small (pazopanib, 46; placebo, 51), resulting in a wide CI (hazard ratio, 1.36; 95% CI: 0.66-2.82). CONCLUSIONS: Patients with clinically important BRCA1/2 mutations had better prognosis. BRCA1/2 mutation status might be added as strata in future trials in primary ovarian cancer. |
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Copyright © 2015. Published by Elsevier Inc. |
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KEYWORDS: GWAS, Germline BRCA mutation, Ovarian cancer, Pazopanib, Progression-free survival |
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Publikations ID: 26740259 Quelle: öffnen |
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