title: Emesis and nausea related to single agent trabectedin in ovarian cancer patients: a sub-study of the MITO15 project.
abstract: The MITO 15 was a prospective, single-arm trial, evaluating trabectedin monotherapy in patients with recurrent ovarian cancer (OC) who were BRCA mutation-carriers or had a BRCAness phenotype. It is largely reported that trabectedin may induce nausea and vomiting but the real emetogenic potential of the drug, in the different schedules, has never been fully described; furthermore, OC patients are known to have an enhanced risk of developing nausea and vomiting due to female gender, abdominal spreading of the disease, and major surgery experienced by most of them. We thought to carry on a sub-study in the MITO 15 context focused on chemotherapy-induced nausea and vomiting (CINV) associated with trabectedin single agent. For all patients enrolled in the trial, we evaluated the antiemetic regimen at the first cycle, acute and delayed CINV, any rescue therapy, any change in the prophylactic antiemetic regimen, and the potential relationship between dexamethasone dosage and incidence of CINV. Overall, our findings were consistent with literature and confirmed that trabectedin can be classified as moderately emetogenic. We observed slightly higher rates of both nausea and vomiting compared to previous experiences with trabectedin monotherapy, probably due to intrinsic features of our population: all females and suffering from ovarian cancer. It seems that in preventing acute CINV, the combination of three drugs was more effective than the doublet; however, the difference did not reach statistical significance; further studies are required to verify such hypothesis. Given the extreme heterogeneity of the antiemetic regimens used, it appears that a standard antiemetic protocol does not exist and more specific guidelines for clinicians are needed.
authors.affiliation: Department of Urology and Gynecology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Via Mariano Semmola, 52, 80131, Naples, Italy.
authors.forename: Marilena
authors.initials: M
authors.lastname: Di Napoli
authors.affiliation: Department of Urology and Gynecology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Via Mariano Semmola, 52, 80131, Naples, Italy. chiaradellapepa@hotmail.it.
authors.forename: Chiara
authors.identifier: 0000-0002-8664-6210
authors.initials: C
authors.lastname: Della Pepa
authors.affiliation: Department of Urology and Gynecology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Via Mariano Semmola, 52, 80131, Naples, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Arenare
authors.affiliation: Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Domenica
authors.initials: D
authors.lastname: Lorusso
authors.affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Raspagliesi
authors.affiliation: Department of Medicine and Health Sciences, University of Molise/Gynecologic Oncology Unit, Fondazione "Policlinico Universitario A. Gemelli", Rome, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.affiliation: Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Vanda
authors.initials: V
authors.lastname: Salutari
authors.affiliation: Centro di Riferimento Oncologico, IRCCS, Aviano, PN, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Sorio
authors.affiliation: Medical Oncology, Perugia Hospital, Perugia, Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Mosconi
authors.affiliation: Gynecology Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Mangili
authors.affiliation: Oncohematology Unit, Medical Science Department, ULSS 13, Mirano, Venice, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Borgato
authors.affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Lepori
authors.affiliation: Department of Experimental and Clinical Medicine, Medical Oncology, Magna Græcia University of Catanzaro, Medical School, Viale Europa, 88100, Catanzaro, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Salvino
authors.affiliation: Department of Urology and Gynecology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Via Mariano Semmola, 52, 80131, Naples, Italy.
authors.forename: Sandro
authors.initials: S
authors.lastname: Pignata
authors.affiliation: Department of Urology and Gynecology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Via Mariano Semmola, 52, 80131, Naples, Italy.
authors.forename: Sabrina Chiara
authors.initials: SC
authors.lastname: Cecere
mesh_terms: D000328:Adult; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D015331:Cohort Studies; D004149:Dioxoles / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced*; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D044005:Tetrahydroisoquinolines / Q000009:adverse effects*; D000077606:Trabectedin; D014839:Vomiting / Q000139:chemically induced*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin
keywords: Chemotherapy-induced nausea and vomiting; Ovarian cancer; Trabectedin