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01-04-2015 | Original Article

Therapeutic and preventive antiemetic effect of aprepitant in Japanese patients with thoracic malignancies who truly need it

Authors: Sumiyo Ito, Ikuto Tsukiyama, Masahiko Ando, Masayo Katakami, Rie Hamanaka, Kenshi Kosaka, Ayako Matsubara, Masaki Nishimura, Hiroyuki Tanaka, Nobuhiro Asai, Norihito Yokoe, Ayumu Takahashi, Kenji Baba, Katsuhiko Matsuura, Etsuro Yamaguchi, Akihito Kubo

Published in: Supportive Care in Cancer | Issue 4/2015

Abstract

Purpose

Neurokinin-1 (NK-1) receptor antagonist is recommended for chemotherapy-induced nausea and vomiting (CINV) in highly emetogenic chemotherapy (HEC) and has recently been introduced to oncology practice in Japan. However, whether all patients undergoing HEC truly need NK-1 receptor antagonist remains unknown, and increasing medical costs due to uniform use of NK-1 receptor antagonist are a concern. This study was conducted to examine the prevalence of patients who needed aprepitant at the time of its introduction in Japan, and therapeutic and preventive effects of aprepitant on HEC or moderately emetogenic chemotherapy (MEC).

Patients and methods

Eligible patients with thoracic malignancies who were to undergo HEC or MEC received 5-hydroxytryptamine receptor antagonists and dexamethasone to prevent CINV. Aprepitant was administered to treat CINV occurring in the first course, or to prevent CINV in the second course. Frequency of vomiting, degree of nausea, and quality of life with respect to CINV were assessed.

Results

In total, 96 patients were enrolled. Aprepitant was not administered in 57 and 88 % of patients who received HEC and MEC, respectively. In patients treated with aprepitant (n = 18), therapeutic use of aprepitant after occurrence of CINV (n = 9) decreased average scores in numerical rating scale for nausea from 7.44 to 5.44 (p = 0.10), and average frequency of vomiting per day from 2.11 to 0.11 (p = 0.03). Prophylactic use of aprepitant in the second course (n = 18) increased the proportion of patients with no significant nausea from 6 % (first course) to 50 % (second course; p = 0.007), and those with no vomiting from 33 to 89 % (p = 0.002). Aprepitant use also significantly improved quality of life with respect to CINV in the second course.

Conclusion

More than half of patients receiving HEC and 88 % of patients receiving MEC did not use aprepitant. Aprepitant showed significant therapeutic and preventive effects on CINV in patients who truly needed it.

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Bayo J, Fonseca PJ, Hernando S, Servitja S, Calvo A, Falagan S, García E, González I, de Miguel MJ, Pérez Q, Milena A, Ruiz A, Barnadas A (2012) Chemotherapy-induced nausea and vomiting: pathophysiology and therapeutic principles. Clin Transl Oncol 14(6):413–422CrossRefPubMed

Navari RM (2009) Antiemetic control: toward a new standard of care for emetogenic chemotherapy. Expert Opin Pharmacother 10(4):629–644CrossRefPubMed

Baker PD, Morzorati SL, Ellett ML (2005) The pathophysiology of chemotherapy-induced nausea and vomiting. Gastroenterol Nurs 28:469–480CrossRefPubMed

dos Santos LV, Souza FH, Brunetto AT, Sasse AD, da Silveira Nogueira Lima JP (2012) Neurokinin-1 receptor antagonists for chemotherapy-induced nausea and vomiting: a systematic review. J Natl Cancer Inst 104:1280–1292CrossRefPubMed

Yeo W, Mo FK, Suen JJ, Ho WM, Chan SL, Lau W, Koh J, Yeung WK, Kwan WH, Lee KK, Mok TS, Poon AN, Lam KC, Hui EK, Zee B (2009) A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy. Breast Cancer Res Treat 113(3):529–535CrossRefPubMed

Takahashi T, Hoshi E, Takagi M, Katsumata N, Kawahara M, Eguchi K (2010) Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Sci 101(11):2455–2461CrossRefPubMed

Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, Chesney M, Clark-Snow RA, Flaherty AM, Freundlich B, Morrow G, Rao KV, Schwartz RN, Lyman GH (2011) Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 29(31):1–10CrossRef

Roila F, Hesketh PJ, Herrstedt J, Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer (2006) Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol 17:20–28CrossRefPubMed

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Antiemesis, Ver.1. 2013. Available at http://www.nccn.org/ professionals/physician_gls/pdf/antiemesis.pdf. Accessed May 15, 2013.

10.

Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, Chawla SP, Carides AD, Ianus J, Elmer ME, Evans JK, Beck K, Reines S, Horgan KJ, Aprepitant Protocol 052 Study Group (2003) The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multi-national, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin. J Clin Oncol 21(22):4112–4119CrossRefPubMed

11.

Poli-Bigelli S, Rodrigues-Pereira J, Carides AD, Julie Ma G, Eldridge K, Hipple A, Evans JK, Horgan KJ, Lawson F, Aprepitant Protocol 054 Study Group (2003) 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 97(12):3090–3098CrossRefPubMed

12.

Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, von Pawel J, Giezek H, Ahmed T, Chan CY (2006) Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol 17(6):1000–1006CrossRefPubMed

13.

Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ (2010) 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 18:423–431CrossRefPubMed

14.

Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F (2005) Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol 23(12):2822–2830CrossRefPubMed

15.

Takahashi T, Nakamura Y, Tsuya A, Murakami H, Endo M, Yamamoto N (2011) Pharmacokinetics of aprepitant and dexamethasone after administration of chemotherapeutic agents and effects of plasma substance P concentration on chemotherapy-induced nausea and vomiting in Japanese cancer patients. Cancer Chemother Pharmacol 68(3):653–659CrossRefPubMedCentralPubMed

16.

Higa GM, Auber ML, Altaha R, Piktel D, Kurian S, Hobbs G, Landreth K (2006) 5-Hydroxyindoleacetic acid and substance P profiles in patients receiving emetogenic chemotherapy. J Oncol Pharm Pract 12(4):201–209CrossRefPubMed

17.

Wood JM, Chapman K, Eilers J (2011) Tools for assessing nausea, vomiting, and retching. Cancer Nurs 34(1):14–24CrossRef

18.

Martin AR, Pearson JD, Cai B, Elmer M, Horgan K, Lindley C (2003) Assessing the impact of chemotherapy-induced nausea and vomiting on patients’ daily lives: a modified version of the Functional Living Index-Emesis (FLIE) with 5-day recall. Support Care Cancer 11(8):522–527CrossRefPubMed

19.

Hesketh PJ (2008) Chemotherapy-induced nausea and vomiting. N Engl J Med 358:2482–2494CrossRefPubMed

20.

Warr DG, Street JC, Carides AD (2011) Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of phase 3 trial of aprepitant in patients receiving Adriamycin-cyclophosphamide-based chemotherapy. Support Care Cancer 19:807–813CrossRefPubMed

21.

Hesketh PJ, Aapro M, Street JC, Carides AD (2010) Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of two phase III trials of aprepitant in patients receiving cisplatin-based chemotherapy. Support Care Cancer 18:1171–1177CrossRefPubMed

22.

Akazawa M, Hashida T, Yano I, Katsura T, Takashima S, Teramukai S, Matsumoto S, Yanagihara K, Fukushima M, Inui K (2008) Gender differences in chemotherapy-induced nausea and vomiting. Jpn J Pharm Health Care Sci 34(8):742–747CrossRef

23.

Nomura H, Kawakami H, Nagai S, Shinohara T, Imoto S, Isaka H (2008) Predictive factors of nausea/vomiting of breast cancer patients receiving FEC and AC chemotherapy. Jpn J Cancer Chemother 35(6):941–946

24.

Roila F, Tonato M, Basurto C, Bella M, Passalacqua R, Morsia D, DiCostanzo F, Donati D, Ballatori E, Tognoni G, Franzosi MG, Del Favero A (1987) Antiemetic activity of high doses of metoclopramide combined with methylprednisolone versus metoclopramide alone in cisplatin-treated cancer patients: a randomized double-blind trial of the Italian Oncology Group for Clinical Research. J Clin Oncol 5(1):141–149PubMed

25.

du Bois A, Meerpohl HG, Vach W, Kommoss FG, Fenzl E, Pfleiderer A (1992) Course, patterns, and risk-factors for chemotherapy-induced emesis in cisplatin-pretreated patients: a study with ondansetron. Eur J Cancer 28(2–3):450–457CrossRefPubMed

26.

Hesketh P, Navari R, Grote T, Gralla R, Hainsworth J, Kris M, Anthony L, Khojasteh A, Tapazoglou E, Benedict C, Hahne W (1996) Double blind, randomized comparison of the antiemetic efficacy of intravenous dolasetronmesylate and intravenous ondansetron in the prevention of acute cisplatn induced emesis in patients with cancer. J Clin Oncol 14:2242–2249PubMed

27.

Osoba D, Zee B, Pater J, Warr D, Latreille J, Kaizer L (1997) Determinants of post chemotherapy nausea and vomiting in patients with cancer. J Clin Oncol 15:116–123PubMed

28.

Roscoe JA, Bushunow P, Morrow GR, Hickok JT, Kuebler PJ, Jacobs A, Banerjee TK (2004) Patient experience is a strong predictor of severe nausea after chemotherapy: a University of Rochester Community Clinical Oncology Program study of patients with breast carcinoma. Cancer 101:2701–2708CrossRefPubMed

29.

Gomez DR, Liao KP, Giordano S, Nguyen H, Smith BD, Elting LS (2013) Adherence to national guidelines for antiemesis prophylaxis in patients undergoing chemotherapy for lung cancer: a population-based study. Cancer 119(7):1428–1436CrossRefPubMed

30.

Lordick F, Ehlken B, Ihbe-Heffinger A, Berger K, Krobot KJ, Pellissier J, Davies G, Deuson R (2007) Health outocomes and cost-effectiveness of aprepitant in outopatients receiving antiemetics prophylaxis for highly emetogenic chemotherapy in Germany. Eur J Cancer 43(2):299–307CrossRefPubMed

31.

Annemans L, Strens D, Lox E, Petit C, Malonne H (2008) Cost-effectiveness analysis of aprepitant in the prevention of chemotherapy-induced nausea and vomiting in Belgium. Support Care Cancer 16(8):905–915CrossRefPubMed

32.

Moore S, Tumeh J, Wojtanowski S, Flowers C (2007) Cost-effectiveness of aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with highly emetogenic chemotherapy. Value Health 10(1):23–31CrossRefPubMed

Title: Therapeutic and preventive antiemetic effect of aprepitant in Japanese patients with thoracic malignancies who truly need it
Authors: Sumiyo Ito
Ikuto Tsukiyama
Masahiko Ando
Masayo Katakami
Rie Hamanaka
Kenshi Kosaka
Ayako Matsubara
Masaki Nishimura
Hiroyuki Tanaka
Nobuhiro Asai
Norihito Yokoe
Ayumu Takahashi
Kenji Baba
Katsuhiko Matsuura
Etsuro Yamaguchi
Akihito Kubo
Publication date: 01-04-2015
Publisher: Springer Berlin Heidelberg
Published in: Supportive Care in Cancer / Issue 4/2015
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-014-2430-x

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