Rolapitant: a pooled analysis of its efficacy and safety in the prophylaxis of chemotherapy-induced nausea and vomiting.

BACKGROUND We conducted a pooled analysis of rolapitant-containing regimens versus control in the prophylaxis of chemotherapy-induced nausea and vomiting. METHODOLOGY Eligible studies included randomized studies evaluating rolapitant-containing regimens in the settings of highly emetogenic and moderately emetogenic chemotherapy. RESULTS The pooled relative risk for complete response in the overall phase was 1.23 (95% CI: 1.18-1.33; p < 0.00001), the pooled relative risk for no significant nausea in the overall phase was 1.17 (95% CI: 1.04-1.32; p = 0.008) and the pooled RR for no emesis in the overall phase was 1.24 (95% CI: 1.18-1.31; p < 0.00001). CONCLUSION Rolapitant-based regimens are associated with higher rates of complete response, no significant nausea and no emesis with highly/moderately emetogenic chemotherapy compared with control regimens.

[1]  C. Gridelli,et al.  Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials. , 2015, The Lancet. Oncology.

[2]  C. Gridelli,et al.  Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial. , 2015, The Lancet. Oncology.

[3]  H. Elhalawani,et al.  Risk of oral and gastrointestinal mucosal injury in patients with solid tumors treated with ramucirumab: a systematic review and meta-analysis , 2015, Expert opinion on drug safety.

[4]  O. Abdel-Rahman,et al.  Risk of oral and gastrointestinal mucosal injury in patients with solid tumors treated with everolimus, temsirolimus or ridaforolimus: a comparative systematic review and meta-analysis , 2015, Expert review of anticancer therapy.

[5]  B. Rapoport,et al.  Study of rolapitant, a novel, long-acting, NK-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC) , 2015, Supportive Care in Cancer.

[6]  M. Popovic,et al.  Update on the management of chemotherapy-induced nausea and vomiting – focus on palonosetron , 2015, Therapeutics and clinical risk management.

[7]  M. Aapro,et al.  Aprepitant and fosaprepitant: a 10-year review of efficacy and safety. , 2015, The oncologist.

[8]  O. Abdel-Rahman,et al.  Risk of selected gastrointestinal toxicities in patients with advanced non-small cell lung cancer receiving erlotinib: a systematic review and meta-analysis , 2015, Expert review of anticancer therapy.

[9]  M. Aapro,et al.  Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review. , 2015, Annals of oncology : official journal of the European Society for Medical Oncology.

[10]  L. Schwartzberg.  Addressing the value of novel therapies in chemotherapy-induced nausea and vomiting , 2014, Expert review of pharmacoeconomics & outcomes research.

[11]  O. Abdel-Rahman,et al.  Risk of selected gastrointestinal toxicities in breast cancer patients treated with regimens containing lapatinib; a pooled analysis of randomized controlled studies , 2014, Expert review of anticancer therapy.

[12]  M. Peeters,et al.  Use of antiemetics in the prevention of chemotherapy-induced nausea and vomiting: review and focus on the Belgian situation. , 2014, Acta gastro-enterologica Belgica.

[13]  R. Gralla,et al.  A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy , 2014, Annals of oncology : official journal of the European Society for Medical Oncology.

[14]  H. Rugo,et al.  A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy , 2014, Annals of oncology : official journal of the European Society for Medical Oncology.

[15]  T. Tsukamoto,et al.  Molecular mechanisms of 5-HT(3) and NK(1) receptor antagonists in prevention of emesis. , 2014, European journal of pharmacology.

[16]  R. Navari,et al.  Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. , 2011, The journal of supportive oncology.

[17]  M. Kris,et al.  Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. , 2010, Annals of oncology : official journal of the European Society for Medical Oncology.

[18]  R. Ramlau,et al.  Randomized, double-blind, dose-ranging trial of the oral neurokinin-1 receptor antagonist casopitant mesylate for the prevention of cisplatin-induced nausea and vomiting. , 2009, Annals of oncology : official journal of the European Society for Medical Oncology.

[19]  D. Moher,et al.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement , 2009, BMJ.

[20]  Z. Aziz,et al.  Efficacy and safety of casopitant mesylate, a neurokinin 1 (NK1)-receptor antagonist, in prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled trial. , 2009, The Lancet. Oncology.

[21]  C. Kitagawa,et al.  Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. , 2009, The Lancet. Oncology.

[22]  R. Navari.  Fosaprepitant (MK-0517): a neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting , 2007, Expert opinion on investigational drugs.

[23]  Anup Majumdar,et al.  Tolerability of Fosaprepitant and Bioequivalency to Aprepitant in Healthy Subjects , 2007, Journal of clinical pharmacology.

[24]  A. Macciocchi,et al.  A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. , 2006, Annals of oncology : official journal of the European Society for Medical Oncology.

[25]  Keunchil Park,et al.  Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. , 2006, Annals of oncology : official journal of the European Society for Medical Oncology.

[26]  F. Roila,et al.  The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[27]  D. Altman,et al.  Measuring inconsistency in meta-analyses , 2003, BMJ : British Medical Journal.

[28]  K. Horgan,et al.  Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy‐induced nausea and vomiting , 2003, Cancer.

[29]  P. Hesketh.  Potential role of the NK1 receptor antagonists in chemotherapy-induced nausea and vomiting , 2001, Supportive Care in Cancer.

[30]  N. Laird,et al.  Meta-analysis in clinical trials. , 1986, Controlled clinical trials.