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Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial

Background Cytoreductive surgery (CRS) and administration of hyperthermic intraperitoneal chemotherapy (HIPEC) have shown their efficacy in multiple malignancies and also could offer a prognostic benefit for patients with advanced ovarian cancer. Methods A prospective, single-center, parallel-group,...

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Published in:Annals of surgical oncology 2022-04, Vol.29 (4), p.2617-2625
Main Authors: Antonio, Cascales Campos Pedro, Alida, González Gil, Elena, Gil Gómez, Rocío, González Sánchez, Jerónimo, Martínez García, Luis, Alonso Romero José, Aníbal, Nieto Díaz, Francisco, Barceló Valcárcel, Jesús, Gómez Ruiz Álvaro, Pablo, Ramírez Romero, José, Gil Martínez
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container_title Annals of surgical oncology
container_volume 29
creator Antonio, Cascales Campos Pedro
Alida, González Gil
Elena, Gil Gómez
Rocío, González Sánchez
Jerónimo, Martínez García
Luis, Alonso Romero José
Aníbal, Nieto Díaz
Francisco, Barceló Valcárcel
Jesús, Gómez Ruiz Álvaro
Pablo, Ramírez Romero
José, Gil Martínez
description Background Cytoreductive surgery (CRS) and administration of hyperthermic intraperitoneal chemotherapy (HIPEC) have shown their efficacy in multiple malignancies and also could offer a prognostic benefit for patients with advanced ovarian cancer. Methods A prospective, single-center, parallel-group, randomized phase 3 clinical trial analyzed patients with a diagnosis of carcinomatosis from ovarian cancer treated with neoadjuvant systemic chemotherapy (NACT). In this trial, 71 patients were randomized to receive CRS alone (36 patients) or CRS with HIPEC (35 patients) using cisplatin (75 mg/m 2 for 60 min at 42 °C). The primary end point was disease-free survival (DFS). Overall survival (OS), morbidity, and quality of life (QoL) were the secondary end points. Results During a median follow-up period of 32 months, the median DFS was 12 months in the control group (CRS) and 18 months in the experimental group (CRS and HIPEC). The findings showed HIPEC to be an independent protective factor against the development of recurrence (hazard ratio [HR], 0.12, 95 % confidence interval [CI], 0.02–0.89; p = 0.038). The median OS was 45 months in the control group and 52 months in the experimental group. The respective morbidity rates for any grade (1 to 5) were respectively 58.3 % and 45.7 % ( p > 0.05), with a mortality rates of 2.8 % and 2.9 % ( p > 0.05). In the dimensions evaluated, CRS with or without HIPEC had no impact on QoL. Conclusions For patients who had advanced ovarian cancer treated with NACT, CRS and HIPEC was associated with better DFS and OS, but without a difference in postoperative morbidity, mortality, or in the QoL evaluation.
doi_str_mv 10.1245/s10434-021-11087-7
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Methods A prospective, single-center, parallel-group, randomized phase 3 clinical trial analyzed patients with a diagnosis of carcinomatosis from ovarian cancer treated with neoadjuvant systemic chemotherapy (NACT). In this trial, 71 patients were randomized to receive CRS alone (36 patients) or CRS with HIPEC (35 patients) using cisplatin (75 mg/m 2 for 60 min at 42 °C). The primary end point was disease-free survival (DFS). Overall survival (OS), morbidity, and quality of life (QoL) were the secondary end points. Results During a median follow-up period of 32 months, the median DFS was 12 months in the control group (CRS) and 18 months in the experimental group (CRS and HIPEC). The findings showed HIPEC to be an independent protective factor against the development of recurrence (hazard ratio [HR], 0.12, 95 % confidence interval [CI], 0.02–0.89; p = 0.038). The median OS was 45 months in the control group and 52 months in the experimental group. The respective morbidity rates for any grade (1 to 5) were respectively 58.3 % and 45.7 % ( p &gt; 0.05), with a mortality rates of 2.8 % and 2.9 % ( p &gt; 0.05). In the dimensions evaluated, CRS with or without HIPEC had no impact on QoL. Conclusions For patients who had advanced ovarian cancer treated with NACT, CRS and HIPEC was associated with better DFS and OS, but without a difference in postoperative morbidity, mortality, or in the QoL evaluation.</description><identifier>ISSN: 1068-9265</identifier><identifier>EISSN: 1534-4681</identifier><identifier>DOI: 10.1245/s10434-021-11087-7</identifier><identifier>PMID: 34812982</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Chemotherapy ; Cisplatin ; Clinical trials ; Combined Modality Therapy ; Cytoreduction Surgical Procedures - adverse effects ; Humans ; Hyperthermia, Induced ; Hyperthermic Intraperitoneal Chemotherapy ; Medicine ; Medicine &amp; Public Health ; Morbidity ; Mortality ; Neoadjuvant Therapy ; Oncology ; Ovarian cancer ; Ovarian Neoplasms - pathology ; Patients ; Peritoneal Neoplasms - therapy ; Peritoneal Surface Malignancy ; Prospective Studies ; Quality of Life ; Surgery ; Surgical Oncology ; Survival ; Survival Rate</subject><ispartof>Annals of surgical oncology, 2022-04, Vol.29 (4), p.2617-2625</ispartof><rights>Society of Surgical Oncology 2021</rights><rights>2021. Society of Surgical Oncology.</rights><rights>Society of Surgical Oncology 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-2363ce1123fcc8e02b5e38d62692cdf3a0e1c8388affec087df5aefa54f798733</citedby><cites>FETCH-LOGICAL-c375t-2363ce1123fcc8e02b5e38d62692cdf3a0e1c8388affec087df5aefa54f798733</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34812982$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Antonio, Cascales Campos Pedro</creatorcontrib><creatorcontrib>Alida, González Gil</creatorcontrib><creatorcontrib>Elena, Gil Gómez</creatorcontrib><creatorcontrib>Rocío, González Sánchez</creatorcontrib><creatorcontrib>Jerónimo, Martínez García</creatorcontrib><creatorcontrib>Luis, Alonso Romero José</creatorcontrib><creatorcontrib>Aníbal, Nieto Díaz</creatorcontrib><creatorcontrib>Francisco, Barceló Valcárcel</creatorcontrib><creatorcontrib>Jesús, Gómez Ruiz Álvaro</creatorcontrib><creatorcontrib>Pablo, Ramírez Romero</creatorcontrib><creatorcontrib>José, Gil Martínez</creatorcontrib><title>Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial</title><title>Annals of surgical oncology</title><addtitle>Ann Surg Oncol</addtitle><addtitle>Ann Surg Oncol</addtitle><description>Background Cytoreductive surgery (CRS) and administration of hyperthermic intraperitoneal chemotherapy (HIPEC) have shown their efficacy in multiple malignancies and also could offer a prognostic benefit for patients with advanced ovarian cancer. 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The respective morbidity rates for any grade (1 to 5) were respectively 58.3 % and 45.7 % ( p &gt; 0.05), with a mortality rates of 2.8 % and 2.9 % ( p &gt; 0.05). In the dimensions evaluated, CRS with or without HIPEC had no impact on QoL. 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Methods A prospective, single-center, parallel-group, randomized phase 3 clinical trial analyzed patients with a diagnosis of carcinomatosis from ovarian cancer treated with neoadjuvant systemic chemotherapy (NACT). In this trial, 71 patients were randomized to receive CRS alone (36 patients) or CRS with HIPEC (35 patients) using cisplatin (75 mg/m 2 for 60 min at 42 °C). The primary end point was disease-free survival (DFS). Overall survival (OS), morbidity, and quality of life (QoL) were the secondary end points. Results During a median follow-up period of 32 months, the median DFS was 12 months in the control group (CRS) and 18 months in the experimental group (CRS and HIPEC). The findings showed HIPEC to be an independent protective factor against the development of recurrence (hazard ratio [HR], 0.12, 95 % confidence interval [CI], 0.02–0.89; p = 0.038). The median OS was 45 months in the control group and 52 months in the experimental group. The respective morbidity rates for any grade (1 to 5) were respectively 58.3 % and 45.7 % ( p &gt; 0.05), with a mortality rates of 2.8 % and 2.9 % ( p &gt; 0.05). In the dimensions evaluated, CRS with or without HIPEC had no impact on QoL. Conclusions For patients who had advanced ovarian cancer treated with NACT, CRS and HIPEC was associated with better DFS and OS, but without a difference in postoperative morbidity, mortality, or in the QoL evaluation.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>34812982</pmid><doi>10.1245/s10434-021-11087-7</doi><tpages>9</tpages></addata></record>
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subjects Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Chemotherapy
Cisplatin
Clinical trials
Combined Modality Therapy
Cytoreduction Surgical Procedures - adverse effects
Humans
Hyperthermia, Induced
Hyperthermic Intraperitoneal Chemotherapy
Medicine
Medicine & Public Health
Morbidity
Mortality
Neoadjuvant Therapy
Oncology
Ovarian cancer
Ovarian Neoplasms - pathology
Patients
Peritoneal Neoplasms - therapy
Peritoneal Surface Malignancy
Prospective Studies
Quality of Life
Surgery
Surgical Oncology
Survival
Survival Rate
title Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial
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