Top

Published in:

01-12-2021 | Nausea | Research

Pooled analysis of combination antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with colorectal cancer treated with oxaliplatin-based chemotherapy of moderate emetic risk

Authors: Mototsugu Shimokawa, Toshinobu Hayashi, Junichi Nishimura, Taroh Satoh, Mutsumi Fukunaga, Reiko Matsui, Yasushi Tsuji, Fumitaka Mizuki, Takahiro Kogawa

Published in: BMC Cancer | Issue 1/2021

Abstract

Background

Among patients with colorectal cancer (CRC) treated with oxaliplatin (L-OHP)-based chemotherapy, delayed chemotherapy-induced nausea and vomiting (CINV) have not been well controlled.

Methods

We pooled data from two prospective observational studies in Japan and one phase III clinical trial to assess whether delayed CINV could be controlled with a combination of three antiemetics adding a neurokinin-1 receptor antagonist and identified individual risk factors, using an inverse probability treatment-weighted analysis.

Results

A total of 661 patients were evaluable in this study (median age: 64 years; 391 male, and 270 female). 3 antiemetics controlled delayed nausea (33.18% vs. 42.25%; p = 0.0510) and vomiting (4.15% vs. 16.08%; p < 0.0001) better than with 2 antiemetics. Female and 2 antiemetics were risk factors for both delayed nausea (female—odds ratio [OR]: 1.918; 95% confidence interval [CI]: 1.292–2.848; p = 0.0012; 2 antiemetics—OR: 1.485; 95% CI: 1.000–2.204; p = 0.0498) and delayed vomiting (female—OR: 2.735; 95% CI: 1.410–5.304; p = 0.0029; 2 antiemetics—OR: 4.551; 95% CI: 2.116–9.785; p = 0.0001).

Conclusions

Identifying individual risk factors can facilitate personalized treatments for delayed CINV. We recommend a 3-antiemetic combination prophylaxis for CRC patients treated with L-OHP-based chemotherapy, especially for female patients.

World Health Organization. Cancer Fact sheet. 2021. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed 2 Jun 2021.

Cassidy J, Clarke S, Díaz-Rubio E, Scheithauer W, Figer A, Wong R, et al. Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2008;26(12):2006–12. https://doi.org/10.1200/JCO.2007.14.9898.CrossRef

Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2004;22(1):23–30. https://doi.org/10.1200/JCO.2004.09.046.CrossRef

Schmoll H-J, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, et al. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol Off J Am Soc Clin Oncol. 2007;25(1):102–9. https://doi.org/10.1200/JCO.2006.08.1075.CrossRef

de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2000;18(16):2938–47. https://doi.org/10.1200/JCO.2000.18.16.2938.CrossRef

André T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350(23):2343–51. https://doi.org/10.1056/NEJMoa032709.CrossRefPubMed

Herrstedt J. Nausea and emesis: still an unsolved problem in cancer patients? Support Care Cancer Off J Multinatl Assoc Support Care Cancer. 2002;10:85–7.

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 Off J Am Soc Clin Oncol. 2011;29(31):4189–98. https://doi.org/10.1200/JCO.2010.34.4614.CrossRef

Roila F, Warr D, Hesketh PJ, Gralla R, Herrstedt J, Jordan K, et al. 2016 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following moderately emetogenic chemotherapy. Support Care Cancer Off J Multinatl Assoc Support Care Cancer. 2017;25:289–94.

10.

National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology. Antiemesis Version 3. 2018. https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. .

11.

Japan Society of Clinical Oncology. Guidelines for appropriate use of antiemetic drugs. Version 1. Tokyo: Kanehara; 2010.

12.

Japan Society of Clinical Oncology. JSCO guidelines for antiemetics in oncology. Tokyo: Kanehara; 2015.

13.

Hesketh PJ, Sanz-Altamira P, Bushey J, Hesketh AM. Prospective evaluation of the incidence of delayed nausea and vomiting in patients with colorectal cancer receiving oxaliplatin-based chemotherapy. Support Care Cancer Off J Multinatl Assoc Support Care Cancer. 2012;20(5):1043–7. https://doi.org/10.1007/s00520-011-1180-2.CrossRef

14.

Hayashi T, Shimokawa M, Miyoshi T, Toriyama Y, Yokota C, Taniguchi J, et al. A prospective, observational, multicenter study on risk factors and prophylaxis for low emetic risk chemotherapy-induced nausea and vomiting. Support Care Cancer Off J Multinatl Assoc Support Care Cancer. 2017;25(9):2707–14. https://doi.org/10.1007/s00520-017-3679-7.CrossRef

15.

Roila F, Boschetti E, Tonato M, Basurto C, Bracarda S, Picciafuoco M, et al. Predictive factors of delayed emesis in cisplatin-treated patients and antiemetic activity and tolerability of metoclopramide or dexamethasone. A randomized single-blind study. Am J Clin Oncol. 1991;14(3):238–42. https://doi.org/10.1097/00000421-199106000-00010.CrossRefPubMed

16.

Pollera CF, Giannarelli D. Prognostic factors influencing cisplatin-induced emesis. Definition and validation of a predictive logistic model. Cancer. 1989;64(5):1117–22. https://doi.org/10.1002/1097-0142(19890901)64:5<1117::AID-CNCR2820640525>3.0.CO;2-R.

17.

Roscoe JA, Bushunow P, Morrow GR, Hickok JT, Kuebler PJ, Jacobs A, et al. Patient expectation is a strong predictor of severe nausea after chemotherapy: a University of Rochester Community Clinical Oncology Program study of patients with breast carcinoma. Cancer. 2004;101(11):2701–8. https://doi.org/10.1002/cncr.20718.CrossRefPubMed

18.

Sekine I, Segawa Y, Kubota K, Saeki T. Risk factors of chemotherapy-induced nausea and vomiting: index for personalized antiemetic prophylaxis. Cancer Sci. 2013;104(6):711–7. https://doi.org/10.1111/cas.12146.CrossRefPubMedPubMedCentral

19.

du Bois A, Meerpohl HG, Vach W, Kommoss FG, Fenzl E, Pfleiderer A. Course, patterns, and risk-factors for chemotherapy-induced emesis in cisplatin-pretreated patients: a study with ondansetron. Eur J Cancer Oxf Engl 1990. 1992;28:450–7.

20.

Osoba D, Zee B, Pater J, Warr D, Latreille J, Kaizer L. Determinants of postchemotherapy 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 Off J Am Soc Clin Oncol. 1997;15(1):116–23. https://doi.org/10.1200/JCO.1997.15.1.116.CrossRef

21.

Molassiotis A, Aapro M, Dicato M, Gascon P, Novoa SA, Isambert N, et al. Evaluation of risk factors predicting chemotherapy-related nausea and vomiting: results from a European prospective observational study. J Pain Symptom Manage. 2014;47:839–848.e4.CrossRefPubMed

22.

Tamura K, Aiba K, Saeki T, Nakanishi Y, Kamura T, Baba H, et al. Testing the effectiveness of antiemetic guidelines: results of a prospective registry by the CINV study Group of Japan. Int J Clin Oncol. 2015;20(5):855–65. https://doi.org/10.1007/s10147-015-0786-7.CrossRefPubMed

23.

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 Off J Multinatl Assoc Support Care Cancer. 1994;2(3):161–6. https://doi.org/10.1007/BF00417474.CrossRef

24.

Jordan K, Blättermann L, Hinke A, Müller-Tidow C, Jahn F. Is the addition of a neurokinin-1 receptor antagonist beneficial in moderately emetogenic chemotherapy?-a systematic review and meta-analysis. Support Care Cancer Off J Multinatl Assoc Support Care Cancer. 2018;26(1):21–32. https://doi.org/10.1007/s00520-017-3857-7.CrossRef

25.

Tsuji Y, Baba H, Takeda K, Kobayashi M, Oki E, Gotoh M, et al. Chemotherapy-induced nausea and vomiting (CINV) in 190 colorectal cancer patients: a prospective registration study by the CINV study group of Japan. Expert Opin Pharmacother. 2017;18(8):753–8. https://doi.org/10.1080/14656566.2017.1317746.CrossRefPubMed

26.

Matsui R, Suzuki K, Takiguchi T, Nishio M, Koike T, Hayashi T, et al. 5-Hydroxytryptamine-3 receptor antagonist and dexamethasone as prophylaxis for chemotherapy-induced nausea and vomiting during moderately emetic chemotherapy for solid tumors: A multicenter, prospective, observational study. BMC Pharmacol Toxicol. 2020;21:72. https://doi.org/10.1186/s40360-020-00445-y.

27.

Nishimura J, Satoh T, Fukunaga M, Takemoto H, Nakata K, Ide Y, et al. Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy (SENRI trial): a multicentre, randomised, controlled phase 3 trial. Eur J Cancer Oxf Engl 1990. 2015;51:1274–82.

28.

ABIM. Choosing Wisely: Ten Things Physicians and Patients Should Question. https://www.asrm.org/resources/choosing-wisely-ten-things-physicians-and-patients-should-question/. Accessed 2 Jun 2021.

29.

Iihara H, Ishihara M, Fujii H, Yoshimi C, Yamada M, Suzuki A, et al. Comparison of the control of nausea and vomiting among several moderately emetic-risk chemotherapy regimens. J Cancer. 2016;7(5):569–75. https://doi.org/10.7150/jca.13637.CrossRefPubMedPubMedCentral

30.

Molassiotis A, Aapro M, Herrstedt J, Gralla R, Roila F. MASCC/ESMO antiemetic guidelines: introduction to the 2016 guideline update. Support Care Cancer Off J Multinatl Assoc Support Care Cancer. 2017;25(1):267–9. https://doi.org/10.1007/s00520-016-3324-x.CrossRef

31.

Takemoto H, Nishimura J, Komori T, Kim HM, Ota H, Suzuki R, et al. 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. Int J Clin Oncol. 2017;22(1):88–95. https://doi.org/10.1007/s10147-016-1022-9.CrossRefPubMed

32.

Hayashi T, Shimokawa M, Matsuo K, Nishimura J, Iihara H, Nakano T, et al. 5HT ₃ RA plus dexamethasone plus aprepitant for controlling delayed chemotherapy-induced nausea and vomiting in colorectal cancer. Cancer Sci. 2021;112(2):744–50. https://doi.org/10.1111/cas.14757.CrossRefPubMed

33.

Wang D-S, Hu M-T, Wang Z-Q, Ren C, Qiu M-Z, Luo H-Y, et al. Effect of Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in women: a randomized clinical trial. JAMA Netw Open. 2021;4(4):e215250. https://doi.org/10.1001/jamanetworkopen.2021.5250.CrossRefPubMedPubMedCentral

Title: Pooled analysis of combination antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with colorectal cancer treated with oxaliplatin-based chemotherapy of moderate emetic risk
Authors: Mototsugu Shimokawa
Toshinobu Hayashi
Junichi Nishimura
Taroh Satoh
Mutsumi Fukunaga
Reiko Matsui
Yasushi Tsuji
Fumitaka Mizuki
Takahiro Kogawa
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Nausea
Vomiting
Antiemetic Therapy
Colorectal Cancer
Colorectal Cancer
Cytostatic Therapy
Published in: BMC Cancer / Issue 1/2021
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-021-08860-y

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 1/2021

Role of palliative radiotherapy in bleeding control in patients with unresectable advanced gastric cancer

Identification of NTRK3 as a potential prognostic biomarker associated with tumor mutation burden and immune infiltration in bladder cancer

Pan-cancer evaluation of gene expression and somatic alteration data for cancer prognosis prediction

The value of complete remission according to positron emission tomography prior to autologous stem cell transplantation in lymphoma: a population-based study showing improved outcome

Clinical characteristics and disease outcomes in ER+ breast cancer: a comparison between HER2+ patients treated with trastuzumab and HER2- patients

Circular RNA circSMARCA5 is a prognostic biomarker in patients with malignant tumor: a meta-analysis

Keynote webinar | Spotlight on antibody–drug conjugates in cancer