Risk prediction model for cisplatin-induced acute kidney injury in patients with head and neck cancer receiving chemoradiotherapy: A re-analysis of a phase II/III JCOG1008 trial

Yoshinori Imamura¹, Naomi Kiyota², Makoto Tahara³, Takeshi Kodaira⁴, Ryuichi Hayashi⁵, Hiroshi Nishino⁶, Yukinori Asada⁷, Hiroki Mitani⁸, Shigemichi Iwae⁹, Naoki Nishio¹⁰, Yusuke Onozawa¹¹, Nobuhiro Hanai¹², Akira Ohkoshi¹³, Hiroki Hara¹⁴, Nobuya Monden¹⁵, Masato Nagaoka¹⁶, Shujiro Minami¹⁷, Ryo Kitabayashi¹⁸, Keita Sasaki¹⁸, Akihiro Homma¹⁹; Head, Neck Cancer Study Group of the Japan Clinical Oncology Group (JCOG-HNCSG)

Affiliations

¹ Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
² Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan; Cancer Center, Kobe University Hospital, Kobe, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp.
³ Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: matahara@east.ncc.go.jp.
⁴ Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
⁵ Department of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
⁶ Department of Otolaryngology-Head and Neck Surgery, Jichi Medical University Hospital, Shimotsuke, Japan.
⁷ Department of Head and Neck Surgery, Miyagi Cancer Center, Natori, Japan.
⁸ Department of Head and Neck Surgery, Cancer Institute Hospital of JFCR, Tokyo, Japan.
⁹ Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.
¹⁰ Department of Otorhinolaryngology, Nagoya University Hospital, Nagoya, Japan.
¹¹ Division of Clinical Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
¹² Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
¹³ Department of Otolaryngology-Head and Neck Surgery, Tohoku University Hospital, Sendai, Japan.
¹⁴ Department of Gastroenterology, Saitama Cancer Center, Ina, Japan.
¹⁵ Department of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
¹⁶ Department of Otorhinolaryngology, Jikei University Hospital, Tokyo, Japan.
¹⁷ Department of Otorhinolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
¹⁸ Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
¹⁹ Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Hospital, Sapporo, Japan.

PMID: 38820889
DOI: 10.1016/j.oraloncology.2024.106868

Clinical Trial

Risk prediction model for cisplatin-induced acute kidney injury in patients with head and neck cancer receiving chemoradiotherapy: A re-analysis of a phase II/III JCOG1008 trial

Yoshinori Imamura et al. Oral Oncol. 2024 Jul.

. 2024 Jul:154:106868.

doi: 10.1016/j.oraloncology.2024.106868. Epub 2024 May 30.

Authors

Affiliations

¹ Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
² Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan; Cancer Center, Kobe University Hospital, Kobe, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp.
³ Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: matahara@east.ncc.go.jp.
⁴ Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
⁵ Department of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
⁶ Department of Otolaryngology-Head and Neck Surgery, Jichi Medical University Hospital, Shimotsuke, Japan.
⁷ Department of Head and Neck Surgery, Miyagi Cancer Center, Natori, Japan.
⁸ Department of Head and Neck Surgery, Cancer Institute Hospital of JFCR, Tokyo, Japan.
⁹ Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.
¹⁰ Department of Otorhinolaryngology, Nagoya University Hospital, Nagoya, Japan.
¹¹ Division of Clinical Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
¹² Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
¹³ Department of Otolaryngology-Head and Neck Surgery, Tohoku University Hospital, Sendai, Japan.
¹⁴ Department of Gastroenterology, Saitama Cancer Center, Ina, Japan.
¹⁵ Department of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
¹⁶ Department of Otorhinolaryngology, Jikei University Hospital, Tokyo, Japan.
¹⁷ Department of Otorhinolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
¹⁸ Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
¹⁹ Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Hospital, Sapporo, Japan.

PMID: 38820889
DOI: 10.1016/j.oraloncology.2024.106868

Abstract

Objectives: Acute kidney injury (AKI) represents a major toxicity associated with cisplatin. We developed a risk prediction model for cisplatin-induced AKI in patients with postoperative high-risk head and neck cancer who received chemoradiotherapy during a randomized phase II/III trial, JCOG1008.

Materials and methods: Two hundred and fifty-one patients received radiotherapy with weekly cisplatin at 40 mg/m² (weekly arm) or 3-weekly cisplatin at 100 mg/m² (3-weekly arm). AKI was defined using the AKI Network classification/staging system as increased serum creatinine of ≥0.3 mg/dL or a ≥1.5-fold increase from baseline 30 days after completing chemoradiotherapy. The Akaike information criterion was used to explore the optimal model by combining explanatory variables at registration.

Results: Among the 251 patients (210 men and 41 women (median age; 62 years)), 94 (37.5 %) developed cisplatin-induced AKI. The optimal cisplatin-induced AKI risk prediction model comprised four factors, including a primary site of hypopharynx/larynx (vs. oral cavity/oropharynx), 3-weekly arm (vs. weekly arm), serum albumin of ≤3.5 g/dL (vs. >3.5 g/dL) and creatinine clearance (CCr) of <90 mL/min (vs. ≥90 mL/min). The incidence of cisplatin-induced AKI rose with cumulative count of the four factors. When the cumulative count was ≥2, the positive predictive value for cisplatin-induced AKI was 50.3 %.

Conclusions: We developed a risk prediction model for cisplatin-induced AKI in patients with head and neck cancer who received postoperative chemoradiotherapy using primary site, cisplatin administration method, serum albumin, and CCr. Patients with risk factors unrelated to the cisplatin administration method should adopt a weekly cisplatin regimen.

Keywords: Acute kidney injury; Chemoradiotherapy; Cisplatin; Head and neck cancer; Prediction model; Weekly administration.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Yoshinori Imamura Speakers' Bureau - Daiichi Sankyo/UCB Japan; MSD Naomi Kiyota Honoraria - AstraZeneca; Bayer; Bristol-Myers Squibb Japan; Eisai; Lilly Japan; Merck Serono; MSD; Ono Pharmaceutical Consulting or Advisory Role - Adlai Nortye; Ono Pharmaceutical; Shift Zero Research Funding - Adlai Nortye (Inst); Bayer (Inst); Boehringer Ingelheim (Inst); Bristol-Myers Squibb (Inst); Lilly (Inst); Ono Pharmaceutical (Inst); Rakuten Medical (Inst) Makoto Tahara Honoraria - Bayer; Bristol-Myers Squibb; Eisai; Lilly; Merck Serono; MSD; Ono Pharmaceutical Consulting or Advisory Role - Astellas Pharma; Bayer; Boehringer Ingelheim; Bristol-Myers Squibb; Eisai; Genmab; Janssen; Lilly; MSD; Nanobiotix; Nektar; Ono Pharmaceutical; Pfizer; Rakuten Medical Research Funding - AstraZeneca (Inst); Bayer (Inst); Bristol-Myers Squibb (Inst); GlaxoSmithKline (Inst); Lilly (Inst); Merck Serono (Inst); Merck Sharp & Dohme (Inst); Novartis (Inst); Ono Pharmaceutical (Inst); Pfizer (Inst); Rakuten Medical (Inst) Takeshi Kodaira Speakers' Bureau - Accuray; AstraZeneca; Bristol-Myers Squibb; Chugai Pharma; Hitachi; Janssen; Merck Serono; Ono Pharmaceutical; Reason Why Co. Ryuichi Hayashi Consulting or Advisory Role - Rakuten Medical Japan Research Funding - Japan Agency for Medical Research and Development Hiroshi Nishino No Relationships to Disclose Yukinori Asada No Relationships to Disclose Hiroki Mitani No Relationships to Disclose Shigemichi Iwae Consulting or Advisory Role - Merck (Inst) Speakers' Bureau - Bristol-Myers Squibb Japan; Merck; MSD; Ono Pharmaceutical Research Funding - Ascent Development Services (Inst); GlaxoSmithKline (Inst); Merck (Inst); MSD (Inst); Ono Pharmaceutical (Inst) Nobuhiro Hanai Honoraria - Bristol-Meyers Squibb; Covidien; Eisai; Merck; MSD K.K; Ono Pharmaceutical; Rakuten Medical Research Funding - MSD K.K Hiroki Hara Honoraria - Asahi Kasei; Bayer; Bristol-Myers Squibb; Chugai Pharma; Daiichi Sankyo/UCB Japan; Lilly; Merck Serono; MSD; Ono Pharmaceutical; Taiho Pharmaceutical; Takeda; Yakult Honsha Consulting or Advisory Role - Boehringer Ingelheim; Bristol-Myers Squibb Japan; Chugai Pharma; MSD; Ono Pharmaceutical Research Funding - ALX Oncology (Inst); Amgen (Inst); Astellas Pharma (Inst); AstraZeneca (Inst); Bayer (Inst); BeiGene (Inst); Boehringer Ingelheim (Inst); Bristol-Myers Squibb Japan (Inst); Chugai Pharma (Inst); Daiichi Sankyo (Inst); Dainippon Sumitomo Pharma (Inst); Eisai (Inst); Janssen Oncology (Inst); Merck Serono (Inst); MSD (Inst); Ono Pharmaceutical (Inst); Taiho Pharmaceutical (Inst) Akihiro Homma Speakers' Bureau - Bayer Yakuhin; Bristol-Myers Squibb; Demant; Eisai; Kyorin; Lilly Japan; Meiji Seika Kaisha; Merck; Mitsubishi Tanabe Pharma; MSD K.K; Ono Pharmaceutical; Rakuten Medical Japan; Sanofi; Taiho Pharmaceutical Research Funding - Eisai; Iwasaki Denshi; Kyorin; Mitsubishi Tanabe Pharma; Ono Pharmaceutical; Otsuka; Taiho Pharmaceutical; Torii Pharmaceutical Others had no relationships to disclose.

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Risk prediction model for cisplatin-induced acute kidney injury in patients with head and neck cancer receiving chemoradiotherapy: A re-analysis of a phase II/III JCOG1008 trial

Affiliations

Risk prediction model for cisplatin-induced acute kidney injury in patients with head and neck cancer receiving chemoradiotherapy: A re-analysis of a phase II/III JCOG1008 trial

Authors

Affiliations

Abstract

Conflict of interest statement

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MeSH terms

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LinkOut - more resources

Full Text Sources

Medical