Download PDF
CC BY-NC-ND 4.0 · South Asian J Cancer 2015; 04(01): 007-010
DOI: 10.4103/2278-330X.149923
CLINICAL TRIAL : Original Article

Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens

Sachin Hingmire
Department of Medical Oncology, Deenanath Mangeshkar Hospital, Pune
,
Nirmal Raut
Department of Medical Oncology, Holy Spirit Hospital, Andheri East, Mumbai, Maharashtra, India
› Author Affiliations Source of Support: Nill.
› Further Information
Also available at
  PDF Download Permissions and Reprints

Abstract

Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian population with aprepitant containing regimens. Aims: The aim was to assess the Efficacy and Safety of Aprepitant for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy/moderately emetogenic chemotherapy (HEC/MEC) regimens. Settings and Design: Investigator initiated, multicentric, open-label, prospective, noncomparative, observational trial. Subjects and Methods: Triple drug regimen with aprepitant, palonosetron, and dexamethasaone administration was assessed for the prevention of CINV during acute, delayed, and the overall phase (OP) for HEC/MEC Regimens. The primary endpoint was complete response (CR; no emesis and no use of rescue medication) and the key secondary endpoint was the complete control (CC; no emesis, no rescue medication and no more than mild nausea) during the OP. Statistical Analysis Used: Perprotocol efficacy was analyzed for the first cycle with results represented in terms of CR/CC rates using descriptive statistics. Results: Seventy-five patients were included in the study with median age of 49.7 years and 89.7% being females. The CR rate (OP) for patients administered HEC or MEC regimens during the first cycle were 92% and 90.9%, respectively. Similarly, the CC rates (OP) were 75% and 90% for these regimens, respectively. 7 (9.2%) patients reported adverse drug reactions that were mild and transient with no reports of any serious adverse events. Conclusions: Use of aprepitant containing regimen for patients receiving HEC/MEC regimen resulted in significantly high CR and CC response rates, which further consolidate its potential role to improve patient quality of life and compliance to disease management.

Key words

Aprepitant - chemotherapy-induced nausea and vomiting - dexamethasone - highly emetogenic chemotherapy regimens, moderately emetogenic chemotherapy regimens - palonosetron


Publication History

Article published online:
31 December 2020

© 2015. MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India

 

  • References

  • 1 Roila F, Herrstedt J, Aapro M, Gralla RJ, Einhorn LH, Ballatori E, 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. Ann Oncol 2010;21 Suppl 5:v232-43.
  • 2 Dewan P, Singhal S, Harit D. Management of chemotherapy-induced nausea and vomiting. Indian Pediatr 2010;47:149-55.
  • 3 Takeshima N, Matoda M, Abe M, Hirashima Y, Kai K, Nasu K, et al. Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial. Support Care Cancer 2014;22:2891-8.
  • 4 Gilmore JW, Peacock NW, Gu A, Szabo S, Rammage M, Sharpe J, et al. Antiemetic guideline consistency and incidence of chemotherapy-induced nausea and vomiting in US community oncology practice: INSPIRE Study. J Oncol Pract 2014;10:68-74.
  • 5 Ito Y, Karayama M, Inui N, Kuroishi S, Nakano H, Nakamura Y, et al. Aprepitant in patients with advanced non-small-cell lung cancer receiving carboplatin-based chemotherapy. Lung Cancer 2014;84:259-64.
  • 6 Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, 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. J Clin Oncol 2003;21:4112-9.
  • 7 Longo F, Mansueto G, Lapadula V, Stumbo L, Del Bene G, Adua D, et al. Combination of aprepitant, palonosetron and dexamethasone as antiemetic prophylaxis in lung cancer patients receiving multiple cycles of cisplatin-based chemotherapy. Int J Clin Pract 2012;66:753-57.
  • 8 Grunberg SM, Deuson RR, Mavros P, Geling O, Hansen M, Cruciani G, et al. Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer 2004;100:2261-8.
  • 9 Jordan K, Jahn F, Jahn P, Behlendorf T, Stein A, Ruessel J, et al. The NK-1 receptor-antagonist aprepitant in high-dose chemotherapy (high-dose melphalan and high-dose T-ICE: Paclitaxel, ifosfamide, carboplatin, etoposide): Efficacy and safety of a triple antiemetic combination. Bone Marrow Transplant 2011;46:784-9.
  • 10 Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J. Delayed nausea and vomiting continue to reduce patients′ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 2006;24:4472-8.
  • 11 Poli-Bigelli S, Rodrigues-Pereira J, Carides AD, Julie Ma G, Eldridge K, Hipple A, et al. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer 2003;97:3090-8.
  • 12 Polovich M, Whitford JM, MiKaela MO. Chemotherapy and Biotherapy for Practice. 3 rd ed.. Pittsburgh, PA: Oncology Nursing Society; C 2009.
  • 13 Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, et al. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study. Support Care Cancer 2010;18:423-31.
  • 14 Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 2011;29:4189-98.
  • 15 Bouganim N, Dranitsaris G, Hopkins S, Vandermeer L, Godbout L, Dent S, et al. Prospective validation of risk prediction indexes for acute and delayed chemotherapy-induced nausea and vomiting. Curr Oncol 2012;19:e414-21.
  • 16 Maru A, Gangadharan VP, Desai CJ, Mohapatra RK, Carides AD. A phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis. Indian J Cancer 2013;50:285-91.
  • 17 Ryu JW, Park SJ, Park M, Kim JS, Lee KY. The use of aprepitant in the first cycle of moderately emetogenic chemotherapy in patients with colorectal cancer: Its preventive effect on chemotherapy-induced nausea and vomiting. Korean J Clin Oncol 2013;9:47-52.
  • 18 Grunberg S, Clark-Snow RA, Koeller J. Chemotherapy-induced nausea and vomiting: Contemporary approaches to optimal management: Proceedings from a symposium at the 2008 Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting. Support Care Cancer 2010;18 Suppl 1:1-10.
  • 19 National Comprehensive Cancer Network (NCCN): Antiemesis Guidelines; 2013. Available from:nccn.org/professionals/physician_gls/PDF/antiemesis.pdf.