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Platinum response characteristics of patients with pancreatic ductal adenocarcinoma and a germline BRCA1, BRCA2 or PALB2 mutation.
British Journal of Cancer ( IF 6.4 ) Pub Date : 2019-12-02 , DOI: 10.1038/s41416-019-0582-7 Max M Wattenberg 1 , Daniella Asch 2 , Shun Yu 1 , Peter J O'Dwyer 1 , Susan M Domchek 1, 3 , Katherine L Nathanson 1, 3 , Mark A Rosen 2 , Gregory L Beatty 1 , Evan S Siegelman 2 , Kim A Reiss 1, 3
British Journal of Cancer ( IF 6.4 ) Pub Date : 2019-12-02 , DOI: 10.1038/s41416-019-0582-7 Max M Wattenberg 1 , Daniella Asch 2 , Shun Yu 1 , Peter J O'Dwyer 1 , Susan M Domchek 1, 3 , Katherine L Nathanson 1, 3 , Mark A Rosen 2 , Gregory L Beatty 1 , Evan S Siegelman 2 , Kim A Reiss 1, 3
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BACKGROUND
Retrospective studies suggest a survival benefit when platinum-based chemotherapy is administered to patients with pancreatic cancer harbouring a germline mutation in BRCA1, BRCA2 or PALB2 (mut-positive PDAC). However, the objective response rate (ORR) and real-world progression free survival (rwPFS) achieved with such treatment remain ill-defined.
METHODS
Twenty-six patients with advanced-stage mut-positive PDAC who had been treated with platinum-based therapy were matched by age, race and sex to 52 platinum-treated control PDAC patients. Responses to therapy were determined by RECIST v1.1, performed by blinded radiology review. Measured outcomes included ORR and rwPFS.
RESULTS
The ORR in mut-positive patients was 58% compared to 21% in the control group (p = 0.0022). There was no significant difference in ORR between platinum regimens in mut-positive patients (p = 0.814), whereas in control patients, the only observed responses were to FOLFIRINOX. rwPFS was 10.1 mo. for mut-positive patients and 6.9 mo. for controls (HR 0.43; 95% CI 0.25-0.74; 0.0068).
CONCLUSION
Mut-positive PDAC has a high ORR and prolonged rwPFS to platinum-based chemotherapy. These findings may have implications particularly in the neoadjuvant setting, and for future clinical trial design, and highlight the importance of early germline testing in patients with PDAC.
中文翻译：
具有种系 BRCA1、BRCA2 或 PALB2 突变的胰腺导管腺癌患者的铂类反应特征。
背景回顾性研究表明，对携带 BRCA1、BRCA2 或 PALB2（突变阳性 PDAC）种系突变的胰腺癌患者进行铂类化疗可带来生存获益。然而，通过这种治疗实现的客观缓解率（ORR）和现实世界无进展生存期（rwPFS）仍然不明确。方法 将 26 名接受铂类治疗的晚期 mut 阳性 PDAC 患者按年龄、种族和性别与 52 名接受铂类治疗的对照 PDAC 患者进行匹配。对治疗的反应由 RECIST v1.1 确定，并通过盲法放射学审查进行。测量的结果包括 ORR 和 rwPFS。结果 mut 阳性患者的 ORR 为 58%，而对照组为 21% (p = 0.0022)。在 mut 阳性患者中，铂类治疗方案之间的 ORR 没有显着差异 (p = 0.814)，而在对照患者中，观察到的唯一反应是 FOLFIRINOX。 rwPFS 为 10.1 个月。对于 mut 阳性患者和 6.9 个月。对照组（HR 0.43；95% CI 0.25-0.74；0.0068）。结论 突变阳性 PDAC 对铂类化疗具有高 ORR 和延长的 rwPFS。这些发现可能特别对新辅助治疗以及未来的临床试验设计产生影响，并强调了 PDAC 患者早期种系检测的重要性。
更新日期：2019-12-02
中文翻译：
具有种系 BRCA1、BRCA2 或 PALB2 突变的胰腺导管腺癌患者的铂类反应特征。
背景回顾性研究表明，对携带 BRCA1、BRCA2 或 PALB2（突变阳性 PDAC）种系突变的胰腺癌患者进行铂类化疗可带来生存获益。然而，通过这种治疗实现的客观缓解率（ORR）和现实世界无进展生存期（rwPFS）仍然不明确。方法 将 26 名接受铂类治疗的晚期 mut 阳性 PDAC 患者按年龄、种族和性别与 52 名接受铂类治疗的对照 PDAC 患者进行匹配。对治疗的反应由 RECIST v1.1 确定，并通过盲法放射学审查进行。测量的结果包括 ORR 和 rwPFS。结果 mut 阳性患者的 ORR 为 58%，而对照组为 21% (p = 0.0022)。在 mut 阳性患者中，铂类治疗方案之间的 ORR 没有显着差异 (p = 0.814)，而在对照患者中，观察到的唯一反应是 FOLFIRINOX。 rwPFS 为 10.1 个月。对于 mut 阳性患者和 6.9 个月。对照组（HR 0.43；95% CI 0.25-0.74；0.0068）。结论 突变阳性 PDAC 对铂类化疗具有高 ORR 和延长的 rwPFS。这些发现可能特别对新辅助治疗以及未来的临床试验设计产生影响，并强调了 PDAC 患者早期种系检测的重要性。
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