Di Napoli Marilena, Della Pepa Chiara, Arenare Laura, Scambia Giovanni, Lorusso Domenica, Raspagliesi Francesco, Ferrandina Gabriella, Salutari Vanda, Sorio Roberto, Mosconi Anna Maria, Mangili Giorgia, Borgato Lucia, Lepori Stefano, Salvino Angela, Pignata Sandro, Cecere Sabrina Chiara
Department of Urology and Gynecology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Via Mariano Semmola, 52, 80131, Naples, Italy.
Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy.
Support Care Cancer. 2017 Jun;25(6):1743-1748. doi: 10.1007/s00520-016-3547-x. Epub 2017 Jan 19.
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.
MITO 15是一项前瞻性单臂试验，评估曲贝替定单药治疗携带BRCA突变或具有BRCA样表型的复发性卵巢癌（OC）患者的疗效。大量报道称曲贝替定可能会引起恶心和呕吐，但该药物在不同给药方案下的实际致吐潜力从未得到充分描述；此外，已知OC患者由于女性性别、疾病的腹部扩散以及大多数患者经历的大手术，发生恶心和呕吐的风险增加。我们认为在MITO 15试验背景下开展一项子研究，重点关注与曲贝替定单药相关的化疗引起的恶心和呕吐（CINV）。对于所有纳入该试验的患者，我们评估了第一个周期的止吐方案、急性和延迟性CINV、任何救援治疗、预防性止吐方案的任何变化以及地塞米松剂量与CINV发生率之间的潜在关系。总体而言，我们的研究结果与文献一致，并证实曲贝替定可归类为中度致吐性药物。与之前曲贝替定单药治疗的经验相比，我们观察到恶心和呕吐的发生率略高，这可能是由于我们研究人群的内在特征：均为女性且患有卵巢癌。在预防急性CINV方面，三联药物组合似乎比双联药物更有效；然而，差异未达到统计学意义；需要进一步研究来验证这一假设。鉴于所使用的止吐方案存在极大异质性，似乎不存在标准的止吐方案，需要为临床医生提供更具体的指南。
