在晚期卵巢癌间歇性细胞切除手术中接受系统性、基于方案的全顶腹膜切除术的患者围手术期疗效和耐铂复发情况:TORPEDO 研究结果。

IF 3.4 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Journal of Gynecologic Oncology Pub Date : 2024-07-01 Epub Date: 2024-04-23 DOI:10.3802/jgo.2024.35.e95
Aditi Bhatt, Snita Sinukumar, Dileep Damodaran, Loma Parikh, Gaurav Goswami, Sanket Mehta, Praveen Kammar
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引用次数: 0

摘要

目的:TORPEDO(CTRI/2018/12/016789)是一项单臂、前瞻性、干预性研究,评估了全顶腹膜切除术(TPP)在接受间歇性细胞减灭术(iCRS)患者中的作用。在本手稿中,我们报告了参与研究的 218 例患者的围手术期结果和耐铂复发(PRR)情况:所有接受 iCRS 的患者,无论残留疾病程度如何,都要进行 TPP。根据临床医生的决定,使用 75 mg/m² 顺铂进行腹腔热化疗 (HIPEC)。维持治疗也由主治临床医生酌情决定:2018年12月9日至2022年7月31日(招募结束),印度4家医疗中心共招募了218名患者。手术腹膜癌指数中位数为 14,95.8% 的患者实现了完全大体切除。130名(59.6%)患者接受了腹腔镜腹膜切除术(HIPEC)。90天主要发病率为17.4%,2.7%的患者在手术后90天内死亡。7.3%的患者辅助化疗延迟了6周以上。中位随访时间为19个月(95%置信区间[CI]=15.9-35个月),复发101例(46.3%),死亡19例(8.7%)。无进展生存期中位数为22个月(95%置信区间=17-35个月),总生存期(OS)中位数未达到。6.4%的患者出现耐铂性复发。预计3年生存率为81.5%,在2020年5月之前接受治疗的80名患者中,3年生存率为77.5%:结论:在 iCRS 期间进行的 TPP(无论是否使用 HIPEC)的发病率和死亡率是可以接受的。PRR发生率较低。早期生存结果令人鼓舞,因此有必要进行随机对照试验,比较 TPP 与传统手术。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Perioperative outcomes and platinum resistant recurrence in patients undergoing systematic, protocol-based, total parietal peritonectomy during interval cytoreductive surgery for advanced ovarian cancer: results of the TORPEDO study.

Objective: The TORPEDO (CTRI/2018/12/016789) is the single-arm, prospective, interventional study evaluating the role of a total parietal peritonectomy (TPP) in patients undergoing interval cytoreductive surgery (iCRS). In this manuscript, we report the perioperative outcomes and platinum resistant recurrence (PRR) in 218 patients enrolled in the study.

Methods: A TPP was performed in all patients undergoing iCRS irrespective of the residual disease extent. hyperthermic intraperitoneal chemotherapy (HIPEC) was performed as per the clinician's discretion with 75 mg/m² of cisplatin. Maintenance therapy was also used at the discretion of the treating clinicians.

Results: From 9th December 2018 to 31st July 2022 (recruitment complete), 218 patients were enrolled at 4 medical centers in India. The median surgical peritoneal cancer index was 14 and a complete gross resection was achieved in 95.8%. HIPEC was performed in 130 (59.6%) patients. The 90-day major morbidity was 17.4% and 2.7% patients died within 90 days of surgery. Adjuvant chemotherapy was delayed beyond 6 weeks in 7.3%. At a median follow-up of 19 months (95% confidence interval [CI]=15.9-35 months), 101 (46.3%) recurrences and 19 (8.7%) deaths had occurred. The median progression-free survival was 22 months (95% CI=17-35 months) and the median overall survival (OS) not reached. Platinum resistant recurrence was observed in 6.4%. The projected 3-year OS was 81.5% and in 80 patients treated before may 2020, it was 77.5%.

Conclusion: The morbidity and mortality of TPP with or without HIPEC performed during iCRS is acceptable. The incidence was of PRR is low. Early survival results are encouraging and warrant conduction of a randomized controlled trial comparing TPP with conventional surgery.

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来源期刊
Journal of Gynecologic Oncology
Journal of Gynecologic Oncology ONCOLOGY-OBSTETRICS & GYNECOLOGY
CiteScore
6.00
自引率
2.60%
发文量
84
审稿时长
>12 weeks
期刊介绍: The Journal of Gynecologic Oncology (JGO) is an official publication of the Asian Society of Gynecologic Oncology. Abbreviated title is ''J Gynecol Oncol''. It was launched in 1990. The JGO''s aim is to publish the highest quality manuscripts dedicated to the advancement of care of the patients with gynecologic cancer. It is an international peer-reviewed periodical journal that is published bimonthly (January, March, May, July, September, and November). Supplement numbers are at times published. The journal publishes editorials, original and review articles, correspondence, book review, etc.
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