TY - JOUR
T1 - Emesis and nausea related to single agent trabectedin in ovarian cancer patients
T2 - a sub-study of the MITO15 project
AU - Di Napoli, Marilena
AU - Della Pepa, Chiara
AU - Arenare, Laura
AU - Scambia, Giovanni
AU - Lorusso, Domenica
AU - Raspagliesi, Francesco
AU - Ferrandina, Gabriella
AU - Salutari, Vanda
AU - Sorio, Roberto
AU - Mosconi, Anna Maria
AU - Mangili, Giorgia
AU - Borgato, Lucia
AU - Lepori, Stefano
AU - Salvino, Angela
AU - Pignata, Sandro
AU - Cecere, Sabrina Chiara
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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.
KW - Chemotherapy-induced nausea and vomiting
KW - Ovarian cancer
KW - Trabectedin
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U2 - 10.1007/s00520-016-3547-x
DO - 10.1007/s00520-016-3547-x
M3 - Article
AN - SCOPUS:85009736124
VL - 25
SP - 1743
EP - 1748
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
SN - 0941-4355
IS - 6
ER -