Hyperthermic Intraperitoneal Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: A Randomized Trial on Survival Evaluation (HORSE; MITO-18).

Autor:	Fagotti A; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.; Università Cattolica del Sacro Cuore, Rome, Italy., Costantini B; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.; UniCAMILLUS, International Medical University, Rome, Italy., Fanfani F; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.; Università Cattolica del Sacro Cuore, Rome, Italy., Giannarelli D; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy., De Iaco P; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy., Chiantera V; Department of Gynecologic Oncology, Università di Palermo, Palermo, Italy., Mandato V; Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy., Giorda G; Centro Riferimento Oncologico-IRCCS, Aviano, Italy., Aletti G; Istituto Europeo di Oncologia-IRCCS, Milan, Italy.; Università Statale degli Studi di Milano, Milan, Italy., Greggi S; Istituto Nazionale Tumori, Pascale-IRCCS, Naples, Italy., Perrone AM; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy., Salutari V; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy., Trozzi R; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.; Università Cattolica del Sacro Cuore, Rome, Italy., Scambia G; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.; Università Cattolica del Sacro Cuore, Rome, Italy.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Nov 21, pp. JCO2400686. Date of Electronic Publication: 2024 Nov 21.
DOI:	10.1200/JCO.24.00686
Abstrakt:	Purpose: To investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to secondary cytoreductive surgery (SCS) without neoadjuvant chemotherapy has a benefit on progression-free survival (PFS), as opposed to SCS alone in patients with platinum-sensitive recurrent epithelial ovarian cancer (platinum-free interval, >6 months). Methods: This was a multicenter randomized phase III study. Random assignment was performed at the time of surgery in cases with residual tumor ≤0.25 cm. HIPEC with cisplatin (CDDP) 75 mg/m 2 for 60 minutes at 41.5°C was administered at the end of surgery in the experimental arm. Both groups received postoperative platinum-based chemotherapy. The primary end point was PFS. The safety profile and postrecurrence survival (PRS) were the secondary end points. Results: A total of 167 patients underwent random assignment, 82 patients to SCS plus HIPEC (experimental arm) and 85 to SCS alone (control arm). The median follow-up was 83 months (IQR, 64-102). The median PFS was 23 months (95% CI, 17 to 29) in the group that underwent surgery alone and 25 months (95% CI, 18 to 32) in the group that underwent cytoreductive surgery with HIPEC. The probability of PRS at 5 years was 61.6% (95% CI, 50.8 to 72.4) in the SCS group and 75.9% (95% CI, 66.5 to 85.3) in the SCS plus HIPEC group. The incidence of postoperative adverse events of any grade was similar between the two groups. Conclusion: The addition of HIPEC to complete or nearly complete primary SCS did not confer a benefit in terms of PFS in patients with platinum-sensitive peritoneal recurrence.
Databáze:	MEDLINE
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