Dayyani Farshid, Stirnadel-Farrant Heide A, Hu Jenny, Lin Yian, Kebede Nehemiah, Valerio Stephen J, Ahn Daniel H
Division of Hematology/Oncology and Chao Family Comprehensive Cancer Center, University of California, Irvine, 200 S Manchester Avenue, Orange, CA 92868, USA.
Oncology Outcomes Research, AstraZeneca, Cambridge CB2 8PA, UK.
Cancers (Basel). 2025 Jan 18;17(2):305. doi: 10.3390/cancers17020305.
Historically, the standard of care for advanced biliary tract cancers (aBTCs) was gemcitabine plus cisplatin (GemCis). Immunotherapy plus GemCis is now recommended as a first-line treatment for aBTCs. Whether patients can tolerate eight cycles of GemCis in clinical practice, as per the Advanced Biliary Cancer (ABC)-02 study, remains to be assessed. We performed a retrospective observational cohort study to assess real-world treatment patterns and overall survival (OS) in patients with de novo or recurrent aBTCs treated with first-line gemcitabine-based chemotherapy in the United States. This retrospective observational cohort study used Optum's de-identified Market Clarity Data (Market Clarity). Adults diagnosed with de novo or recurrent aBTCs in the United States who began first-line gemcitabine-based chemotherapy from January 2016-March 2022 were identified and followed from index until death, the end of continuous enrolment, or the end of study period. Treatment patterns and OS were assessed. Overall, 559 patients were included (de novo, = 462; recurrent, = 97). GemCis was the most common first-line therapy received (de novo: 73.8%; recurrent: 57.7%). Most patients received approximately five cycles of GemCis; median (95% CI) time to discontinuation was 4.6 (4.3-5.1) months. Most patients died over the follow-up period (de novo: 70.3%; recurrent: 62.9%). Median OS (95% CI) was 14.2 (12.1-16.1) months (de novo) and 18.5 (15.6-26.9) months (recurrent). GemCis was the most common first-line therapy received during the study period; most patients were unable to receive eight cycles of GemCis. Survival was limited over the follow-up period, highlighting the need for new treatments for aBTCs. Future studies are warranted to understand the real-world impact of first-line immunotherapy plus GemCis for patients with aBTCs.
从历史上看，晚期胆管癌（aBTC）的标准治疗方案是吉西他滨联合顺铂（GemCis）。免疫疗法联合GemCis现在被推荐作为aBTC的一线治疗方案。在临床实践中，根据晚期胆管癌（ABC）-02研究，患者是否能够耐受八个周期的GemCis仍有待评估。我们进行了一项回顾性观察队列研究，以评估在美国接受一线基于吉西他滨的化疗的初发或复发性aBTC患者的真实世界治疗模式和总生存期（OS）。这项回顾性观察队列研究使用了Optum的去识别化市场清晰度数据（市场清晰度）。识别出2016年1月至2022年3月在美国开始一线基于吉西他滨的化疗的初发或复发性aBTC成人患者，并从索引日期开始随访直至死亡、连续入组结束或研究期结束。评估了治疗模式和OS。总体而言，纳入了559例患者（初发，n = 462；复发，n = 97）。GemCis是最常用的一线治疗方案（初发：73.8%；复发：57.7%）。大多数患者接受了大约五个周期的GemCis；停药的中位（95%CI）时间为4.6（4.3 - 5.1）个月。大多数患者在随访期间死亡（初发：70.3%；复发：62.9%）。中位OS（95%CI）为14.2（12.1 - 16.1）个月（初发）和18.5（15.6 - 26.9）个月（复发）。GemCis是研究期间最常用的一线治疗方案；大多数患者无法接受八个周期的GemCis。随访期间生存率有限，凸显了对aBTC新治疗方法的需求。有必要进行未来研究以了解一线免疫疗法联合GemCis对aBTC患者的真实世界影响。
