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J Cancer 2024; 15(6):1487-1497. doi:10.7150/jca.91675 This issue Cite

Research Paper

Proposal for Classifying the Emetogenicity of Oral Anticancer Agents with a Focus on PARP Inhibitors: A Prospective, Observational, Multicenter Study (JASCC-CINV 2002)

Senri Yamamoto1,†, Masami Tsuchiya2,†, Hirotoshi Iihara1,3,4✉, Yoh Hayasaki5, Kyoko Hori6, Yasuo Kumakura7, Daichi Watanabe1,8, Hideki Sakai9, Satoshi Nakagawa10, Akiko Kudoh11, Hajime Oishi1, Nobuhiro Kado13, Makiko Go14, Kota Mashima15, Takashi Uchida2, Moeka Yasue1, Akimitsu Maeda6, Kimihiro Nishino16, Koji Matsumoto9, Shinya Sato11, Yutaka Ueda10, Kensuke Tomio12, Katsuhisa Hayashi2, Motoki Takenaka5, Masahiko Mori17, Hiroaki Kajiyama18, Yoshimasa Bomoto5, Shiro Suzuki17, Takuma Ishihara8, Akio Suzuki1,19, Masakazu Abe20

1. Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan.
2. Department of Pharmacy, Miyagi Cancer Center, 47-1 Nodayama, Medeshimashiote, Natori, Miyagi, 981-1293, Japan.
3. Patient Safety Division, Gifu University Hospital, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan.
4. Laboratory of Community Pharmaceutical Practice and Science, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu, Gifu, 501-1196, Japan.
5. Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan.
6. Department of Pharmacy, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
7. Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya Aichi, 466-8560, Japan.
8. Innovative and Clinical Research Promotion Center, Gifu University Hospital, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan.
9. Medical Oncology Division, Hyogo Cancer Center, 13-70, Kitaoji-cho, Akashi, Hyogo, 673-8558, Japan.
10. Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita Osaka, 565-0871, Japan.
11. Department of Obstetrics and Gynecology, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan.
12. Department of Obstetrics and Gynecology, Center Hospital of the National Center for Global Health and Medicine 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan.
13. Department of Gynecology, Shizuoka Cancer Center 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
14. Department of Pharmacy, Ogaki Municipal Hospital, 4-86 Minaminokawa-cho, Ogaki Gifu, 503-0896, Japan.
15. Department of Pharmacy, Fukuoka University Hospital, 7-45-1 Nanakuma, Jounanku, Fukuokashi, Fukuoka, 814-0180, Japan.
16. Department of Healthcare Administration, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
17. Department of Gynecologic Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
18. Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, 65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan
19. Laboratory of Advanced Medical Pharmacy, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu, 501-1196, Japan.
20. Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, 431-3192, Japan.
†Senri Yamamoto and Masami Tsuchiya contributed equally and are the co-first authors of this paper.

✉ Corresponding author: Hirotoshi Iihara, Ph. D., 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan; Phone: +81-58-230-7088; Fax number: +81-58-230-7084; E-mail address: iihara.hirotoshi.p7gifu-u.ac.jp.

Citation:
Yamamoto S, Tsuchiya M, Iihara H, Hayasaki Y, Hori K, Kumakura Y, Watanabe D, Sakai H, Nakagawa S, Kudoh A, Oishi H, Kado N, Go M, Mashima K, Uchida T, Yasue M, Maeda A, Nishino K, Matsumoto K, Sato S, Ueda Y, Tomio K, Hayashi K, Takenaka M, Mori M, Kajiyama H, Bomoto Y, Suzuki S, Ishihara T, Suzuki A, Abe M. Proposal for Classifying the Emetogenicity of Oral Anticancer Agents with a Focus on PARP Inhibitors: A Prospective, Observational, Multicenter Study (JASCC-CINV 2002). J Cancer 2024; 15(6):1487-1497. doi:10.7150/jca.91675. https://www.jcancer.org/v15p1487.htm
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Abstract

Graphic abstract

Background: Olaparib and niraparib (poly adenosine diphosphate [ADP]-ribose polymerase [PARP] inhibitors) have significant antitumor action in patients with ovarian cancer. However, the incidence of nausea and vomiting among patients on these drugs in clinical trials is rather high. There are no guidelines on antiemetic treatment for nausea caused by oral anticancer agents. This study aimed to investigate the incidence of nausea and vomiting caused by PARP inhibitors and the actual situation of antiemetic therapy in patients with gynecologic cancer.

Methods: Patients with gynecologic cancer who were scheduled to receive PARP inhibitors were enrolled. Data on PARP inhibitor-induced nausea and vomiting were collected from patient diaries for 21 days. The primary endpoint was the incidence of vomiting during the 21 days after starting olaparib and niraparib.

Results: Overall, between January 2020 and March 2023, 134 patients were enrolled. Of the 129 patients who were evaluated, 28 (21.7%) received prophylactic antiemetics for 21 days, and 101 (78.3%) did not. The overall incidence of PARP inhibitor-induced vomiting was 16.3%. The incidence of vomiting in the group that did not receive antiemetic prophylaxis was 13.9%. On dividing the group that did not receive antiemetic prophylaxis into the olaparib and niraparib subgroups, the incidence of vomiting was found to be 18.6% for the olaparib group and 10.3% for the niraparib group.

Conclusion: The incidence of emesis without antiemetic prophylaxis among patients on olaparib and niraparib ranged from 10% to 30%. Therefore, olaparib and niraparib can be classified in the low emetogenic risk and prophylactic antiemetic therapy at the time of treatment initiation may be unnecessary.

Keywords: olaparib, niraparib, PARP inhibitor, nausea, vomiting, gynecologic cancer

Citation styles

APA
Yamamoto, S., Tsuchiya, M., Iihara, H., Hayasaki, Y., Hori, K., Kumakura, Y., Watanabe, D., Sakai, H., Nakagawa, S., Kudoh, A., Oishi, H., Kado, N., Go, M., Mashima, K., Uchida, T., Yasue, M., Maeda, A., Nishino, K., Matsumoto, K., Sato, S., Ueda, Y., Tomio, K., Hayashi, K., Takenaka, M., Mori, M., Kajiyama, H., Bomoto, Y., Suzuki, S., Ishihara, T., Suzuki, A., Abe, M. (2024). Proposal for Classifying the Emetogenicity of Oral Anticancer Agents with a Focus on PARP Inhibitors: A Prospective, Observational, Multicenter Study (JASCC-CINV 2002). Journal of Cancer, 15(6), 1487-1497. https://doi.org/10.7150/jca.91675.

ACS
Yamamoto, S.; Tsuchiya, M.; Iihara, H.; Hayasaki, Y.; Hori, K.; Kumakura, Y.; Watanabe, D.; Sakai, H.; Nakagawa, S.; Kudoh, A.; Oishi, H.; Kado, N.; Go, M.; Mashima, K.; Uchida, T.; Yasue, M.; Maeda, A.; Nishino, K.; Matsumoto, K.; Sato, S.; Ueda, Y.; Tomio, K.; Hayashi, K.; Takenaka, M.; Mori, M.; Kajiyama, H.; Bomoto, Y.; Suzuki, S.; Ishihara, T.; Suzuki, A.; Abe, M. Proposal for Classifying the Emetogenicity of Oral Anticancer Agents with a Focus on PARP Inhibitors: A Prospective, Observational, Multicenter Study (JASCC-CINV 2002). J. Cancer 2024, 15 (6), 1487-1497. DOI: 10.7150/jca.91675.

NLM
Yamamoto S, Tsuchiya M, Iihara H, Hayasaki Y, Hori K, Kumakura Y, Watanabe D, Sakai H, Nakagawa S, Kudoh A, Oishi H, Kado N, Go M, Mashima K, Uchida T, Yasue M, Maeda A, Nishino K, Matsumoto K, Sato S, Ueda Y, Tomio K, Hayashi K, Takenaka M, Mori M, Kajiyama H, Bomoto Y, Suzuki S, Ishihara T, Suzuki A, Abe M. Proposal for Classifying the Emetogenicity of Oral Anticancer Agents with a Focus on PARP Inhibitors: A Prospective, Observational, Multicenter Study (JASCC-CINV 2002). J Cancer 2024; 15(6):1487-1497. doi:10.7150/jca.91675. https://www.jcancer.org/v15p1487.htm

CSE
Yamamoto S, Tsuchiya M, Iihara H, Hayasaki Y, Hori K, Kumakura Y, Watanabe D, Sakai H, Nakagawa S, Kudoh A, Oishi H, Kado N, Go M, Mashima K, Uchida T, Yasue M, Maeda A, Nishino K, Matsumoto K, Sato S, Ueda Y, Tomio K, Hayashi K, Takenaka M, Mori M, Kajiyama H, Bomoto Y, Suzuki S, Ishihara T, Suzuki A, Abe M. 2024. Proposal for Classifying the Emetogenicity of Oral Anticancer Agents with a Focus on PARP Inhibitors: A Prospective, Observational, Multicenter Study (JASCC-CINV 2002). J Cancer. 15(6):1487-1497.

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