Takeshi Ioroi1, Junya Furukawa2, Manabu Kume3, Sachi Hirata3, Yuko Utsubo3, Naomi Mizuta3, Hideaki Miyake4, Masato Fujisawa2, Midori Hirai3. 1. Department of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan. ioroit@med.kobe-u.ac.jp. 2. Division of Urology, Graduate School of Medicine, Kobe University, Kobe, Japan. 3. Department of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan. 4. Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Abstract
PURPOSE: This study aimed to determine the antiemetic efficacy and safety of palonosetron, aprepitant and dexamethasone in patients with testicular germ cell tumours (TGCTs) receiving 5-day cisplatin-based combination chemotherapy. METHODS: In this open-label, single-arm, single-centre study, the antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2-7 and dexamethasone 6.6 mg on days 1-7. The primary endpoint was complete response (CR; no vomiting/retching or rescue medication) in the overall period (0-240 h), and secondary endpoints included complete protection (CP; defined as CR and no more than mild nausea) and total control (TC; defined as CR and no nausea). The incidence and severity of nausea were assessed on the basis of the Common Terminology Criteria for Adverse Events v4.0 and a subjective rating scale completed by patients. RESULTS: Twenty-five patients were enrolled and evaluated for safety, and 24 patients were evaluated for efficacy. CR was achieved in 62.5% of patients (95% confidence interval [CI] = 40.6-81.2, p = 0.043) in the overall period. CP and TC were achieved in 62.5% (95% CI = 40.6-81.2) and 25.0% of patients (95% CI = 9.8-46.7), respectively, in the overall period. The primary adverse drug reaction was hiccups (48.0%). The events were expected, and none was grade 3 or 4. CONCLUSIONS: The examined combination antiemetic therapy was effective and well-tolerated in patients with TGCTs receiving 5-day cisplatin-based combination chemotherapy.
PURPOSE: This study aimed to determine the antiemetic efficacy and safety of palonosetron, aprepitant and dexamethasone in patients with testicular germ cell tumours (TGCTs) receiving 5-day cisplatin-based combination chemotherapy. METHODS: In this open-label, single-arm, single-centre study, the antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2-7 and dexamethasone 6.6 mg on days 1-7. The primary endpoint was complete response (CR; no vomiting/retching or rescue medication) in the overall period (0-240 h), and secondary endpoints included complete protection (CP; defined as CR and no more than mild nausea) and total control (TC; defined as CR and no nausea). The incidence and severity of nausea were assessed on the basis of the Common Terminology Criteria for Adverse Events v4.0 and a subjective rating scale completed by patients. RESULTS: Twenty-five patients were enrolled and evaluated for safety, and 24 patients were evaluated for efficacy. CR was achieved in 62.5% of patients (95% confidence interval [CI] = 40.6-81.2, p = 0.043) in the overall period. CP and TC were achieved in 62.5% (95% CI = 40.6-81.2) and 25.0% of patients (95% CI = 9.8-46.7), respectively, in the overall period. The primary adverse drug reaction was hiccups (48.0%). The events were expected, and none was grade 3 or 4. CONCLUSIONS: The examined combination antiemetic therapy was effective and well-tolerated in patients with TGCTs receiving 5-day cisplatin-based combination chemotherapy.
Authors: Stuart Hinton; Paul J Catalano; Lawrence H Einhorn; Craig R Nichols; E David Crawford; Nicholas Vogelzang; Donald Trump; Patrick J Loehrer Journal: Cancer Date: 2003-04-15 Impact factor: 6.860
Authors: I N Olver; P Grimison; M Chatfield; M R Stockler; G C Toner; V Gebski; R Harrup; C Underhill; G Kichenadasse; N Singhal; I D Davis; A Boland; A McDonald; D Thomson Journal: Support Care Cancer Date: 2012-12-30 Impact factor: 3.603
Authors: Lawrence H Einhorn; Bernardo Rapoport; Rudolph M Navari; Jørn Herrstedt; Mary J Brames Journal: Support Care Cancer Date: 2016-11-04 Impact factor: 3.603
Authors: Lucas Vieira dos Santos; Fabiano Hahn Souza; Andre Tesainer Brunetto; Andre Deeke Sasse; João Paulo da Silveira Nogueira Lima Journal: J Natl Cancer Inst Date: 2012-08-21 Impact factor: 13.506
Authors: Marko Popovic; David G Warr; Carlo Deangelis; May Tsao; Kelvin K W Chan; Michael Poon; Cheryl Yip; Natalie Pulenzas; Henry Lam; Liying Zhang; Edward Chow Journal: Support Care Cancer Date: 2014-03-04 Impact factor: 3.603
Authors: Nabil Adra; Costantine Albany; Mary J Brames; Somer Case-Eads; Cynthia S Johnson; Ziyue Liu; Christopher A Fausel; Timothy Breen; Nasser H Hanna; Ralph J Hauke; Joel Picus; Lawrence H Einhorn Journal: Support Care Cancer Date: 2016-02-02 Impact factor: 3.603