Literature DB >> 29090385

Phase II open label pilot trial of aprepitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic FOLFOX chemotherapy for the treatment of colorectal cancer.

Joseph S Bubalo1, Jon D Herrington2, Marc Takemoto3, Patricia Willman4, Michael S Edwards5, Casey Williams6, Alan Fisher7, Alison Palumbo8, Eric Chen7, Charles Blanke1, Charles D Lopez1.   

Abstract

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) causes significant morbidity among colorectal cancer patients, receiving fluorouracil, oxaliplatin, and leucovorin (FOLFOX) chemotherapy even with standard antiemetic prophylaxis. The purpose of this study is to determine if the addition of aprepitant to standard antiemetic therapy improves CINV in these patients.
METHODS: Patients receiving FOLFOX for colorectal cancer were given antiemetic prophylaxis with aprepitant 125 mg orally on day 1 and 80 mg on days 2 and 3. Palonosetron 0.25 mg was given IV push on day 1 only. Dexamethasone 12 mg was administered orally on day 1 and 8 mg each morning on days 2 through 4. Assessments including emetic events, rescue doses, nutritional intake, and appetite were recorded in a patient diary which was returned to study personnel in the following cycle.
RESULTS: Of the 53 patients screened, 50 were evaluable and had a complete dataset for cycle 1. For the first cycle, 74% of patients achieved a complete response (CR), 22% achieved a major response and 4% experienced treatment failure. The percentage of patients achieving a CR remained high throughout each cycle at 83, 83, and 86% for cycles 2, 3, and 4, respectively. Appetite and nutritional status remained largely unchanged throughout treatment. Adverse events occurring in more than 10% of patients included diarrhea (13.6%), fatigue (12.6%), and neutropenia (11%).
CONCLUSIONS: Aprepitant added to standard antiemetic therapy appears to be an effective and safe regimen for prevention of CINV in patients receiving FOLFOX.

Entities:  

Keywords:  Aprepitant; Chemotherapy; FOLFOX; Nausea; Vomiting

Mesh:

Substances:

Year:  2017        PMID: 29090385     DOI: 10.1007/s00520-017-3950-y

Source DB:  PubMed          Journal:  Support Care Cancer        ISSN: 0941-4355            Impact factor:   3.603


  18 in total

Review 1.  Impact of chemotherapy-induced nausea and vomiting on health-related quality of life and resource utilization: A systematic review.

Authors:  Silvia Sommariva; Benedetta Pongiglione; Rosanna Tarricone
Journal:  Crit Rev Oncol Hematol       Date:  2015-12-04       Impact factor: 6.312

2.  Cost-effectiveness of aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with highly emetogenic chemotherapy.

Authors:  Susan Moore; John Tumeh; Steven Wojtanowski; Christopher Flowers
Journal:  Value Health       Date:  2007 Jan-Feb       Impact factor: 5.725

3.  Defining the emetogenicity of cancer chemotherapy regimens: relevance to clinical practice.

Authors:  P J Hesketh
Journal:  Oncologist       Date:  1999

4.  Using aprepitant as secondary antiemetic prophylaxis for cancer patients with cisplatin-induced emesis.

Authors:  Chiao-En Wu; Chuang-Chi Liaw
Journal:  Support Care Cancer       Date:  2011-12-21       Impact factor: 3.603

5.  Health outcomes and cost-effectiveness of aprepitant in outpatients receiving antiemetic prophylaxis for highly emetogenic chemotherapy in Germany.

Authors:  Florian Lordick; Birgit Ehlken; Angela Ihbe-Heffinger; Karin Berger; Karl J Krobot; James Pellissier; Glenn Davies; Robert Deuson
Journal:  Eur J Cancer       Date:  2006-11-28       Impact factor: 9.162

6.  Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest.

Authors:  Alfredo Falcone; Sergio Ricci; Isa Brunetti; Elisabetta Pfanner; Giacomo Allegrini; Cecilia Barbara; Lucio Crinò; Giovanni Benedetti; Walter Evangelista; Laura Fanchini; Enrico Cortesi; Vincenzo Picone; Stefano Vitello; Silvana Chiara; Cristina Granetto; Gianfranco Porcile; Luisa Fioretto; Cinzia Orlandini; Michele Andreuccetti; Gianluca Masi
Journal:  J Clin Oncol       Date:  2007-05-01       Impact factor: 44.544

7.  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.

Authors:  Paul J Hesketh; Steven M Grunberg; Richard J Gralla; David G Warr; Fausto Roila; Ronald de Wit; Sant P Chawla; Alexandra D Carides; Juliana Ianus; Mary E Elmer; Judith K Evans; Klaus Beck; Scott Reines; Kevin J Horgan
Journal:  J Clin Oncol       Date:  2003-10-14       Impact factor: 44.544

8.  Economic analysis of aprepitant-containing regimen to prevent chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy in Hong Kong.

Authors:  Stephen L Chan; Jason Jen; Thomas Burke; James Pellissier
Journal:  Asia Pac J Clin Oncol       Date:  2014-03       Impact factor: 2.601

9.  Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy in the SENRI trial: analysis of risk factors for vomiting and nausea.

Authors:  Hiroyoshi Takemoto; Junichi Nishimura; Takamichi Komori; Ho Min Kim; Hirofumi Ota; Rei Suzuki; Masakazu Ikenaga; Masataka Ikeda; Hirofumi Yamamoto; Taroh Satoh; Taishi Hata; Ichiro Takemasa; Tsunekazu Mizushima; Yuichirou Doki; Masaki Mori
Journal:  Int J Clin Oncol       Date:  2016-07-27       Impact factor: 3.402

10.  Cost-effectiveness analysis of aprepitant in the prevention of chemotherapy-induced nausea and vomiting in Belgium.

Authors:  Lieven Annemans; Daniëlle Strens; Erica Lox; Christine Petit; Hughes Malonne
Journal:  Support Care Cancer       Date:  2007-10-27       Impact factor: 3.603

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  2 in total

1.  FLOT (a chemotherapy regimen for gastric/esophagogastric junction cancer): to be treated as a highly emetogenic regimen or a moderately emetogenic one? Comparison of the emetogenic potential of FLOT versus FOLFOX and TAC regimens.

Authors:  Marziyeh Ghorbani; Mehdi Dehghani; Noushin Fahimfar; Soha Namazi; Ali Dehshahri
Journal:  Support Care Cancer       Date:  2022-01-17       Impact factor: 3.603

2.  Anti-emetic Drugs for Prophylaxis of Postoperative Nausea and Vomiting After Craniotomy: An Updated Systematic Review and Network Meta-Analysis.

Authors:  Yijing Chen; Jing Chang
Journal:  Front Med (Lausanne)       Date:  2020-02-25
  2 in total

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