PDF(Pubmed)
Abstract：
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%.
CONCLUSIONS: 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.
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%.
CONCLUSIONS: 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.
摘要：
目的：TORPEDO（CTRI/2018/12/016789）是单臂，prospective,介入性研究评估全顶叶周围切除术（TPP）在接受间隔细胞减灭术（iCRS）的患者中的作用。在这份手稿中,我们报告了参与研究的218例患者的围手术期结局和铂类耐药复发(PRR).
方法：在所有接受iCRS的患者中进行TPP，而不考虑残留疾病的程度。根据临床医生的判断,采用75mg/m²顺铂进行腹腔热化疗(HIPEC).维持治疗也在治疗临床医生的判断下使用。
结果：从2018年12月9日至2022年7月31日（招聘完成），在印度的4个医疗中心招募了218名患者。手术腹膜癌指数中位数为14，完整切除率为95.8％。在130例（59.6％）患者中进行了HIPEC。90天的主要发病率为17.4%，2.7%的患者在手术后90天内死亡。辅助化疗延迟超过6周，占7.3%。中位随访19个月（95%置信区间[CI]=15.9-35个月），发生了101例（46.3％）复发和19例（8.7％）死亡。中位无进展生存期为22个月（95％CI=17-35个月），中位总生存期（OS）未达到。观察到6.4%的铂耐药复发。预计3年OS为81.5%，在2020年5月之前接受治疗的80名患者中，为77.5%。
结论：在iCRS期间进行或不进行HIPEC的TPP的发病率和死亡率是可以接受的。PRR的发生率较低。早期生存结果令人鼓舞，值得进行一项比较TPP与传统手术的随机对照试验。
方法：在所有接受iCRS的患者中进行TPP，而不考虑残留疾病的程度。根据临床医生的判断,采用75mg/m²顺铂进行腹腔热化疗(HIPEC).维持治疗也在治疗临床医生的判断下使用。
结果：从2018年12月9日至2022年7月31日（招聘完成），在印度的4个医疗中心招募了218名患者。手术腹膜癌指数中位数为14，完整切除率为95.8％。在130例（59.6％）患者中进行了HIPEC。90天的主要发病率为17.4%，2.7%的患者在手术后90天内死亡。辅助化疗延迟超过6周，占7.3%。中位随访19个月（95%置信区间[CI]=15.9-35个月），发生了101例（46.3％）复发和19例（8.7％）死亡。中位无进展生存期为22个月（95％CI=17-35个月），中位总生存期（OS）未达到。观察到6.4%的铂耐药复发。预计3年OS为81.5%，在2020年5月之前接受治疗的80名患者中，为77.5%。
结论：在iCRS期间进行或不进行HIPEC的TPP的发病率和死亡率是可以接受的。PRR的发生率较低。早期生存结果令人鼓舞，值得进行一项比较TPP与传统手术的随机对照试验。
