Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS and PUMC).
Organ Transplantation Center, The First Affiliated Hospital of Shandong First Medical University, Jinan.
Int J Surg. 2024 Aug 1;110(8):4608-4616. doi: 10.1097/JS9.0000000000001540.
BACKGROUND: The role of conversion surgery in patients with unresectable biliary tract cancer who responded positively to PD-1/PD-L1 inhibitor-based therapy remains unclear. This study aimed to assess the outcomes in patients with or without conversion surgery. METHODS: In this cohort study, patients with advanced biliary tract cancer who received combination therapy with PD-1/PD-L1 inhibitors from July 2019 to January 2023 were retrospectively. Patients who exhibited positive responses and met the criteria for conversion surgery were enrolled, and their surgical and oncological outcomes were analyzed. RESULTS: Out of 475 patients, 34 who met the conversion resection criteria were enrolled. The median follow-up was 40.5 months postinitiation of systemic therapy. Ultimately, 13 patients underwent conversion surgery, while 21 received continuation of systemic treatment alone (nonsurgical group). The median interval from the initial antitumor therapy to surgery was 6.7 [interquartile range (IQR) 4.9-9.2] months. Survival with conversion surgery was significantly longer than the nonsurgical cohort, with a median progression-free survival (PFS) [unreached vs. 12.4 months; hazard ratio 0.17 (95% CI: 0.06-0.48); P =0.001] and overall survival (OS) [unreached vs. 22.4 months; hazard ratio 0.28 (95% CI: 0.09-0.84); P =0.02], respectively. After a median postoperative follow-up of 32.2 months in the surgical cohort, eight patients survived without recurrence. The estimated 3-year OS, PFS, and recurrence-free survival rate in the surgical cohort were 59.9, 59.2, and 60.6%, respectively. The R0 resection rate reached 92.3%, with two achieving a pathological complete response. One patient experienced a Clavien-Dindo grade 3 complication without surgery-related mortality. No serious adverse events or surgical delays were observed. Multivariate analysis indicated that conversion surgery was independently associated with OS ( P =0.03) and PFS survival ( P =0.003). CONCLUSION: Conversion surgery appears safe and offers survival benefits to patients responding to immune checkpoint inhibitors-based combinations. However, further studies are required to validate this strategy in the era of immunotherapy.
背景：对于对 PD-1/PD-L1 抑制剂治疗有积极反应的不可切除胆道癌患者，转换手术的作用仍不清楚。本研究旨在评估有或没有转换手术的患者的结局。
方法：本队列研究回顾性分析了 2019 年 7 月至 2023 年 1 月期间接受 PD-1/PD-L1 抑制剂联合治疗的晚期胆道癌患者。纳入对治疗有阳性反应且符合转换手术标准的患者，并分析其手术和肿瘤学结局。
结果：在 475 名患者中，有 34 名符合转换切除标准的患者被纳入。系统治疗开始后中位随访时间为 40.5 个月。最终，13 名患者接受了转换手术，21 名患者仅接受了系统治疗（非手术组）。从初始抗肿瘤治疗到手术的中位时间为 6.7 [四分位距（IQR）4.9-9.2] 个月。转换手术后的生存时间明显长于非手术组，无进展生存期（PFS）[未达到 vs. 12.4 个月；风险比 0.17（95%CI：0.06-0.48）；P=0.001]和总生存期（OS）[未达到 vs. 22.4 个月；风险比 0.28（95%CI：0.09-0.84）；P=0.02]。在手术组中，8 名患者在手术后中位随访 32.2 个月后无复发存活。手术组的估计 3 年 OS、PFS 和无复发生存率分别为 59.9%、59.2%和 60.6%。R0 切除率达到 92.3%，2 例达到病理完全缓解。1 例发生 Clavien-Dindo 3 级并发症，无手术相关死亡。未观察到严重不良事件或手术延迟。多因素分析表明，转换手术与 OS（P=0.03）和 PFS 生存（P=0.003）独立相关。
结论：转换手术似乎是安全的，并为对免疫检查点抑制剂联合治疗有反应的患者提供生存获益。然而，在免疫治疗时代，还需要进一步的研究来验证这一策略。
Cochrane Database Syst Rev. 2018-4-6
Cochrane Database Syst Rev. 2018-2-6
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