Background: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.Methods: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.Results:Overall, 559 patients were included (de novo,n= 462; recurrent,n= 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).Conclusions: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.
背景：历史上，晚期胆道癌（aBTCs）的标准治疗方案是吉西他滨联合顺铂（GemCis）。目前，免疫疗法联合GemCis已被推荐作为aBTCs的一线治疗方案。然而，在临床实践中，患者能否如晚期胆道癌（ABC）-02研究所示耐受八个周期的GemCis治疗，仍有待评估。为此，我们开展了一项回顾性观察队列研究，旨在评估美国初诊或复发性aBTCs患者接受一线吉西他滨为基础化疗的真实世界治疗模式及总生存期（OS）。 方法：本回顾性观察队列研究采用Optum的去标识化市场清晰数据库。研究纳入了2016年1月至2022年3月期间在美国确诊为初诊或复发性aBTCs并开始接受一线吉西他滨为基础化疗的成年患者，并从起始日期随访至患者死亡、连续参保结束或研究期结束。研究评估了患者的治疗模式和总生存期。 结果：研究共纳入559例患者（初诊患者462例；复发患者97例）。GemCis是最常见的一线治疗方案（初诊患者：73.8%；复发患者：57.7%）。大多数患者接受了约五个周期的GemCis治疗；中位停药时间（95% CI）为4.6（4.3–5.1）个月。在随访期间，大多数患者死亡（初诊患者：70.3%；复发患者：62.9%）。中位总生存期（95% CI）分别为14.2（12.1–16.1）个月（初诊患者）和18.5（15.6–26.9）个月（复发患者）。 结论：在研究期间，GemCis是最常见的一线治疗方案；但大多数患者未能完成八个周期的GemCis治疗。随访期间患者生存期有限，这凸显了aBTCs对新疗法的迫切需求。未来有必要开展进一步研究，以了解一线免疫疗法联合GemCis对aBTCs患者在真实世界中的治疗效果。
肿瘤(癌症)患者之家