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预测局部晚期胆囊癌新辅助化疗后的临床获益反应:回顾性分析

Predicting clinical benefit response after neoadjuvant chemotherapy in locally advanced gallbladder cancer: retrospective analysis.

作者信息

Patkar Shraddha, Gundavda Kaival, Polusany Kaushik, Yelamanchi Raghav, Varty Gurudutt P, Shah Niket, Pawar Akash, Ostwal Vikas, Ramaswamy Anant, Bhargava Prabhat, Goel Mahesh

机构信息

Department of Gastrointestinal and Hepatobiliary Surgery, Department of Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.

Department of Biostatistics, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.

出版信息

BJS Open. 2025 Jul 1;9(4). doi: 10.1093/bjsopen/zraf077.

Abstract

BACKGROUND

Neoadjuvant chemotherapy is increasingly used in patients with locally advanced gallbladder cancer (LAGBC). This study investigated factors affecting clinical benefit response (CBR) to neoadjuvant chemotherapy for LAGBC.

METHODS

All consecutive patients with LAGBC following neoadjuvant chemotherapy, from January 2013 to December 2022, were analyzed for clinical and radiological responses as well as survival outcomes. CBR rates, resectability, and their impact on survival were evaluated. In addition, factors predicting CBR were identified and a predictive nomogram model was developed.

RESULTS

Of 401 patients with LAGBC undergoing neoadjuvant chemotherapy, 303 (75.5%) exhibited a CBR. The median overall survival (OS) in patients with a CBR was 25 months, compared with 8.5 months for those without a CBR. Factors predicting a worse CBR rate included age ≥ 55.5 years (hazard ratio (HR) 2.17; 95% confidence interval (c.i.) 1.29 to 3.65), Eastern Cooperative Oncology Group (ECOG) performance status ≥ 1 (HR 2.5; 95% c.i. 1.117 to 5.59), platelet count ≥ 468 × 109/l (HR 2.86; 95% c.i. 1.12 to 6.74), tumour (T) size ≥ 2.1 cm (HR 3.4; 95% c.i. 1.70 to 6.80), T stage ≥ T3 (HR 3.26; 95% c.i. 1.22 to 8.74), and a systemic immune-inflammation index (SII) ≥ 1265.90 (HR 2.34; 95% c.i. 1.27 to 4.30). Of the patients with a CBR, 86% underwent curative surgical resection, with median OS improved to 29.54 months, compared with 11.86 months for those without resection (P < 0.01).

CONCLUSION

A CBR was achieved in 75.5% of patients, with curative surgical resection in 86%. A CBR was associated with improved OS. Anatomical (T size, T stage) and immune-inflammation markers (platelet count, SII) were found to predict a CBR, and could help identify responders to neoadjuvant chemotherapy. This could have implications for treatment strategies, but requires validation in further prospective studies.

摘要

背景

新辅助化疗在局部晚期胆囊癌(LAGBC)患者中的应用日益广泛。本研究调查了影响LAGBC新辅助化疗临床获益反应(CBR)的因素。

方法

分析2013年1月至2022年12月期间所有接受新辅助化疗的连续性LAGBC患者的临床和影像学反应以及生存结局。评估CBR率、可切除性及其对生存的影响。此外,确定预测CBR的因素并建立预测列线图模型。

结果

在401例接受新辅助化疗的LAGBC患者中,303例(75.5%)表现出CBR。CBR患者的中位总生存期(OS)为25个月,而无CBR患者为8.5个月。预测CBR率较差的因素包括年龄≥55.5岁(风险比(HR)2.17;95%置信区间(c.i.)1.29至3.65)、东部肿瘤协作组(ECOG)体能状态≥1(HR 2.5;95% c.i. 1.117至5.59)、血小板计数≥468×10⁹/L(HR 2.86;95% c.i. 1.12至6.74)、肿瘤(T)大小≥2.1 cm(HR 3.4;95% c.i. 1.70至6.80)、T分期≥T3(HR 3.26;95% c.i. 1.22至8.74)以及全身免疫炎症指数(SII)≥1265.90(HR 2.34;95% c.i. 1.27至4.30)。在有CBR的患者中,86%接受了根治性手术切除,中位OS提高到29.54个月,而未切除患者为11.86个月(P<0.01)。

结论

75.5%的患者实现了CBR,其中86%接受了根治性手术切除。CBR与OS改善相关。发现解剖学(T大小、T分期)和免疫炎症标志物(血小板计数、SII)可预测CBR,并有助于识别新辅助化疗的反应者。这可能对治疗策略有影响,但需要在进一步的前瞻性研究中进行验证。

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