Palonosetron for the prevention of chemotherapy induced nausea and vomiting: a comparative study in a tertiary care hospital from India
Keywords:Chemotherapy induced nausea and vomiting, Functional life index-emesis, Palonosetron, Aprepitant
Background: Despite advances in symptom management, chemotherapy-induced nausea and vomiting (CINV) remains one of the most dreadful consequences of cancer therapy.
Methods: The study was carried out at Medical Oncology Department, Vydehi Institute of Medical Sciences and Research Centre, Bangalore. Hundred and forty-four cancer patients of either sex, aged 18-65 years with adequate blood counts requiring moderately emetogenic chemotherapy (MEC) as per Hesketh classification were included. The patients were prospectively divided into two groups before the initial cycle of chemotherapy. Patients in Group A (n=71) received ondansetron, and dexamethasone along with aprepitant capsules, Whereas, Group B (n=73) received palonosetron, and dexamethasone along with placebo capsules, 30 minutes before chemotherapy. Thereafter the patients were administered with the drugs and observed for nausea and vomiting. The efficiency of both regimens was assessed by adopting validated functional living index emesis (FLIE) questionnaire. Analysis of the data was done using the SPSS 21.0 software.
Results: The mean age of the patients was 40.5 years and the male to female ratio was 1:2.4. In all the patients, no changes were detected in the ECG readings after MEC. The nausea and vomiting score were comparable in both groups. No significant difference (p>0.05) was noticed between group A and group B in both mm and in FLIE points. No serious adverse events were found relating to antiemetic treatment.
Conclusions: Palonosetron in combination with corticosteroids was non inferior to ondansetron in combination with aprepitant and corticosteroids in controlling acute and delayed stages of CINV in patients requiring MEC. Thus, it can be recommended as first-line therapy for patients treated with MEC.
Roscoe JA, Morrow GR, Hickok JT, Stern RM. Nausea and vomiting remain a significant clinical problem: trends over time in controlling chemotherapy-induced nausea and vomiting in 1413 patients treated in community clinical practices. J Pain Symptom Manage. 2000;20:113-21.
Sun CC, Bodurka DC, Donato ML, Rubenstein EB, Borden CL, Basen-Engquist K, et al. Patient preferences regarding side effects of chemotherapy for ovarian cancer: do they change over time? Gynecol Oncol. 2002;87:118-28.
Morran C, Smith DC, Anderson DA, McArdle CS. Incidence of nausea and vomiting with cytotoxic chemotherapy: a prospective randomised trial of antiemetics. Br Med J. 1979;1(6174):1323.
Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H. Chemotherapy-induced nausea and vomiting—incidence and impact on patient quality of life at community oncology settings. Supportive Care Cancer. 2007;15(5):497-503.
Farrell C, Brearley SG, Pilling M, Molassiotis A. The impact of chemotherapy-related nausea on patients' nutritional status, psychological distress and quality of life. Supportive Care Cancer. 2013;21(1):59-66.
Ng TL, Hutton B, Clemons M: Chemotherapy-induced nausea and vomiting: Time for more emphasis on nausea? Oncologist. 2015;20:576-83.
Iihara H, Fujii H, Yoshimi C, Yamada M, Suzuki A, Matsuhashi N, et al. Control of chemotherapy-induced nausea in patients receiving outpatient cancer chemotherapy. Int J Clin Oncol. 2016;21(2):409-18.
Pater J, Slamet L, Zee B, Osoba D, Warr D, Rusthoven J. Inconsistency of prognostic factors for post-chemotherapy nausea and vomiting. Support Care Cancer. 1994;2:161-6.
Osoba D, Zee B, Pater J, Warr D, Latrielle J, Kaizer L. Determinants of post-chemotherapy nausea and vomiting in patients with cancer. Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1997;15:116-23.
Grunberg SM, Osoba D, Hesketh PJ, Gralla RJ, Borjeson S, Rapoport BL, et al. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity-an update. Supportive Care Cancer. 2005;13(2):80-4.
Feyer P, Jordan K. Update and new trends in antiemetic therapy:the continuing need for novel therapies. Annals of Oncology. 2010;22(1):30-8.
Jordan K, Gralla R, Jahn F, Molassiotis A. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV):content and implementation in daily routine practice. Eur J Pharmacol. 2014;722:197-202.
Perwitasari DA, Atthobari J, Mustofa M, Dwiprahasto I, Hakimi M, Gelderblom H, et al. Impact of chemotherapy-induced nausea and vomiting on quality of life in Indonesian patients with gynecologic cancer. Int J Gynecologic Cancer. 2012;22(1):139-45.
Hilarius DL, Kloeg PH, van der Wall E, van den Heuvel JJ, Gundy CM, Aaronson NK. Chemotherapy-induced nausea and vomiting in daily clinical practice:a community hospital-based study. Support Care Cancer. 2012;20:107-17.
Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E. MASCC and ESMO Consensus Guidelines for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting: ESMO clinical practice guidelines. Ann Oncol. 2016;27(5):119-33.
Massaro AM, Lenz KL. Aprepitant:a novel antiemetic for chemotherapy-induced nausea and vomiting. Ann Pharmacotherap. 2005;39(1):77-85.
Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015;16(4):385-94.
New drugs approved by Drug controller general of India. CDSCO. Available at: https://cdscoonline. gov.in/CDSCO/Drugs. Accessed on 3 June 2019.
Rubenstein EB, Slusher BS, Rojas C, Navari RM. New approaches to chemotherapy-induced nausea and vomiting: from neuropharmacology to clinical investigations. Cancer J. 2006;12(5):341-7.
Hesketh PJ. Defining the emetogenicity of cancer chemotherapy regimens: relevance to clinical practice. Oncologist. 1999;4(3):191-6.
Decker GM, DeMeyer ES, Kisko DL. Measuring the maintenance of daily life activities using the functional living index-emesis (FLIE) in patients receiving moderately emetogenic chemotherapy. J Supportive Oncol. 2006;4(1):35-41.
Geling O, Eichler HG. Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 hours after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications. J Clin Oncol. 2005;23(6):1289-94.
Miura S, Watanabe S, Sato K, Makino M, Kobayashi O, Miyao H, et al. The efficacy of triplet antiemetic therapy with 0.75 mg of palonosetron for chemotherapy-induced nausea and vomiting in lung cancer patients receiving highly emetogenic chemotherapy. Supportive Care in Cancer. 2013;21(9):2575-81.
Longo F, Mansueto G, Lapadula V, De Sanctis R, Quadrini S, Grande R, et al. Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy. Supportive Care Cancer. 2011;19(8):1159-64.
Keefe DL. The cardiotoxic potential of the 5-HT3 receptor antagonist antiemetics: is there cause for concern? Oncologist. 2002;7(1):65-72.
Kuryshev YA, Brown AM, Wang L, Benedict CR, Rampe D. Interactions of the 5-hydroxytryptamine 3 antagonist class of antiemetic drugs with human cardiac ion channels. J Pharmacol Exp Therap. 2000;295(2):614-20.
Charbit B, Albaladejo P, Funck-Brentano C, Legrand M, Samain E, Marty J. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron. Anesthesiology: J Am Society Anesthesiologists. 2005;102(6):1094-100.
Gonullu G, Demircan S, Demirag MK, Erdem D, Yucel I. Electrocardiographic findings of palonosetron in cancer patients. Support Care Cancer. 2012;20(7):1435-9.
Musso M, Scalone R, Bonanno V, Crescimanno A, Polizzi V, Porretto F, et al. Palonosetron (Aloxi®) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy. Supportive Care Cancer. 2009;17(2):205.
Gralla R, Lichinitser M, Van Der Vegt S, Sleeboom H, Mezger J, Peschel C, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy:results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14(10):1570-7.
Rubenstein EB, Gralla RJ, Eisenberg P, Sleeboom O, Vtoraya A, Macciocchi A, et al. Palonosetron (PALO) compared with ondansetron (OND) or dolasetron (DOL) for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Combined results of two Phase III trials. InProc Am Soc Clin Oncol. 2003;22:729.