Möhring Christian, Feder Jan, Mohr Raphael U, Sadeghlar Farsaneh, Bartels Alexandra, Mahn Robert, Zhou Taotao, Marinova Milka, Feldmann Georg, Brossart Peter, von Websky Martin, Matthaei Hanno, Manekeller Steffen, Glowka Tim, Kalff Jörg C, Weismüller Tobias J, Strassburg Christian P, Gonzalez-Carmona Maria A
Department of Internal Medicine I, University Hospital, Bonn, Germany.
Department of Radiology, University Hospital, Bonn, Germany.
Front Oncol. 2021 Nov 10;11:717397. doi: 10.3389/fonc.2021.717397. eCollection 2021.
Prognosis of patients with irresectable cholangiocarcinoma is still poor. The ABC-02 trial established the current first line (1L) standard systemic chemotherapy (CT) with gemcitabine/platinum derivate for advanced cholangiocarcinoma. However, the majority of patients needed therapy adaptions. Thus, the aim of this study was to evaluate 1L and second line (2L) therapy regimens and the impact of therapy adaptions in an unselected real-life cohort of patients with advanced cholangiocarcinoma.
This is a single institution retrospective analysis of patients with irresectable cholangiocarcinoma who were treated with gemcitabine/platinum derivate from 2010 to 2018. Overall survival (OS), progression-free survival (PFS) and toxicity were analyzed for all patients, especially with regard to CT de-escalation.
Fifty-eight patients receiving gemcitabine/platinum derivate were included in the analysis. Median OS and PFS were 12.2 and 6.9 months. Interestingly, 41 patients (71%) needed therapy de-escalation. However, despite reduced CT exposition, there was no-significant difference in OS (10.8 months vs. 15.6 months, p = 0.127), and patients suffered from less adverse events during CT. 21 (36%) patients reached 2L CT, most often with FOLFIRI (57%). Survival beyond the end of 1L CT was 7.1 months with 2L CT vs. 2.9 months with BSC.
In our study, the combination of gemcitabine/platinum derivate showed similar OS and PFS as randomized prospective phase II/III trials. Therapy regimen adaptions were needed in the majority of patients. However, individualized modifications of the therapy regimen allowed better tolerance as well as continuation of therapy and did not significantly influence median OS. Furthermore, our study revealed a potential survival benefit with 2L CT for selected patients.
不可切除胆管癌患者的预后仍然很差。ABC - 02试验确立了目前晚期胆管癌一线（1L）标准全身化疗（CT）方案为吉西他滨/铂类衍生物。然而，大多数患者需要调整治疗方案。因此，本研究的目的是评估未选择的晚期胆管癌真实队列患者的1L和二线（2L）治疗方案以及治疗调整的影响。
这是一项对2010年至2018年接受吉西他滨/铂类衍生物治疗的不可切除胆管癌患者的单机构回顾性分析。分析了所有患者的总生存期（OS）、无进展生存期（PFS）和毒性，尤其关注CT降阶梯治疗。
58例接受吉西他滨/铂类衍生物治疗的患者纳入分析。中位OS和PFS分别为12.2个月和6.9个月。有趣的是，41例（71%）患者需要进行治疗降阶梯。然而，尽管CT暴露减少，但OS无显著差异（10.8个月对15.6个月，p = 0.127），且患者在CT治疗期间不良事件较少。21例（36%）患者接受了2L CT治疗，最常用的方案是FOLFIRI（57%）。1L CT结束后，接受2L CT治疗的患者生存期为7.1个月，而接受最佳支持治疗（BSC）的患者为2.9个月。
在我们的研究中，吉西他滨/铂类衍生物联合方案显示出与随机前瞻性II/III期试验相似的OS和PFS。大多数患者需要调整治疗方案。然而，治疗方案的个体化调整可使耐受性更好以及治疗得以继续，且未显著影响中位OS。此外，我们的研究显示，对于部分患者，2L CT可能带来生存获益。
