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• Modified EXTREME regimen versus modified TPEx regimen as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, open-label, randomized, exploratory study (TEMPER study)

  Suzuki, M; Kishino, A; Sugasawa, M; Fujii, T; Nakanome, A; Terada, T; Hirakawa, H; Ueki, Y; Matsuo, M; Ito, R; Hotomi, M; Kanno, M; Watanabe, A; Kitamura, Y; Okami, K; Endo, K; Ono, T; Hirano, S; Omura, G; Omori, K; Yamamoto, Y; Shimokawa, M; Inohara, H

  INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY ( International Journal of Clinical Oncology )    2026.02 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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  BACKGROUND: The EXTREME regimen is the standard first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), but it is poorly tolerated in Asian patients. We aimed to compare the efficacy and safety of the modified EXTREME (mEXTREME) and modified TPEx (mTPEx) regimens in Japanese patients. METHODS: This was a multicenter, randomized, exploratory study. The dose of chemotherapeutic agents was reduced by 25% for the mEXTREME regimen compared to the EXTREME regimen and by 20% for the mTPEX regimen compared to the TPEx regimen. Six and four cycles were repeated every 21 days for the mEXTREME and mTPEx regimens, respectively. In both regimens, weekly 250 mg/m2 cetuximab was continued as maintenance therapy in case of disease control. RESULTS: Sixty-one patients were enrolled and assigned to the two treatment arms (30 to mEXTREME, 31 to mTPEx). Median PFS was 6.0 months and 5.3 months (p = 0.28), and median overall survival was 17.4 months and 18.7 months (p = 0.72) for the mEXTREME and mTPEx groups, respectively. Twenty-seven patients in the mEXTREME group and 29 patients in the mTPEx group had grade 3 or worse adverse events during chemotherapy (p = 0.61). Early tumor shrinkage was 20% in the mEXTREME group and 44% in the mTPEx group (p = 0.01). CONCLUSIONS: No significant differences in survival were observed between the two groups, with similar toxicity profiles. As early tumor shrinkage was favorable in the mTPEx group, the mTPEx regimen may be the first-line standard of care for Asian patients with R/M HNSCC, particularly those who are not candidates for up-front pembrolizumab due to CPS < 1 or the presence of immunologically related complications and those who need rapid tumor shrinkage to relieve tumor-related symptoms. TRIAL REGISTRATION: UMIN000025436.

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• Preliminary observations on peripheral inflammatory markers in NIR-PIT and ICI-treated recurrent head and neck squamous cell carcinoma

  Hitoshi Hirakawa, Taro Ikegami, Hidetoshi Kinjyo, Shinya Agena, Shunsuke Kondo, Norimoto Kise, Yuki Kayo, Hironori Nakayoshi, Takahiro Miyahira, Hiroyuki Maeda, Mikio Suzuki

  European Archives of Oto-Rhino-Laryngology     2026.02 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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• Clinical, virological, and immunohistochemical features of laryngeal papilloma with low-risk human papillomavirus infection: insights from a 13-year institutional cohort.

  Hirakawa H, Ikegami T, Kise N, Kiyuna A, Kinjyo H, Kondo S, Nakasone W, Maeda H, Agena S, Suzuki M

  World journal of surgical oncology ( World Journal of Surgical Oncology )  24 ( 1 ) 6 - 6   2026.01 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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  BACKGROUND: Laryngeal papilloma (LP) is driven primarily by infection with low-risk human papillomavirus (LR-HPV), most often types 6 and 11. However, the clinical relevance of the HPV genotype, viral load, and associated molecular markers in LP remains incompletely understood. METHODS: We retrospectively analyzed 30 patients with LP treated at the University of Ryukyu Hospital between 2010 and 2023. Their tumor samples were subjected to HPV genotyping, viral load quantification, and immunohistochemical profiling (p16, p21, p53, and Ki-67). Correlations of recurrence and remission data with virological and immunohistochemical findings were investigated. RESULTS: HPV DNA was detected in 28 of the 30 patients (92.9%), with a predominance of HPV-6 (89.3%), and with HPV-11 accounting for 10.7%. HPV-6 subtyping identified 6a, 6b, and 6vc variants. Most lesions were multifocal and localized to the glottis. Surgical resection was performed in 26 patients, among whom the recurrence rate was 87.5%; complete remission was achieved in 34.6% of these patients, more often in younger patients with juvenile-onset and in those with lower Derkay scores. The viral load did not correlate with recurrence or remission. Immunohistochemistry revealed low p16 and p53 expression, while Ki-67 was consistently positive. Of note, p21 was strongly expressed throughout the epithelium in all LP cases with HPV infection, with a significantly greater frequency, than in papillomas at other head and neck sites without LR-HPV infection (p < 0.0001). CONCLUSIONS: HPV genotype and viral burden do not predict recurrence or remission of LP. LPs have a unique molecular profile characterized by diffuse p21 expression and high proliferative activity. These findings underscore the need to consider LP as a distinct HPV-driven entity and highlight p21 as a potential biological marker of LR-HPV-associated disease. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12957-025-04130-4.

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• Two cases of favorable response to combination therapy of photoimmunotherapy after administration of immune checkpoint inhibitors for recurrent head and neck cancer

  Hayashi Yoshikazu, Hirakawa Hitoshi, Kinjyo Hidetoshi, Agena Shinya, Maeda Hiroyuki, Suzuki Mikio

  JOURNAL OF JAPAN SOCIETY FOR HEAD AND NECK SURGERY ( JAPAN SOCIETY FOR HEAD AND NECK SURGERY )  34 ( 3 ) 307 - 311   2025

  Type of publication: Research paper (scientific journal)

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  Photoimmunotherapy (PIT) is a treatment for unresectable locally advanced head and neck cancer or locally recurrent head and neck cancer that has become difficult to treat after standard therapies. PIT was approved in Japan in January 2021. PIT enhances the immune response and, when combined with immune checkpoint inhibitors (ICIs), its effectiveness is amplified. This study presents two cases where PIT was highly effective after ICI treatment. The first case was a 69-year-old male with oropharyngeal squamous cell carcinoma and the second case was a 66-year-old male with recurrent anterior neck cancer. In both cases, complete response (CR) was maintained after one course of PIT for the residual disease following ICI. The combination of PIT and ICIs showed a synergistic effect. Although there is no consensus on the optimal timing for conducting PIT, these results suggest that PIT following ICI treatment may be a highly effective option.

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• Utility of Ultrahigh-Resolution Computed Tomography for Laryngeal Reconstructive Surgery

  Kise, N; Hirakawa, H; Aniya, S; Ooshiro, T; Kondo, S; Tomoda, A; Oyakawa, Y; Kiyuna, A; Suzuki, M

  LARYNGOSCOPE ( Wiley )  134 ( 11 ) 4667 - 4673   2024.11 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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  Objective: Unilateral vocal fold paralysis (UVFP) presents as incomplete glottal closure and leads to breathy hoarseness.Various treatments, including laryngeal framework surgery (type 1 thyroplasty [TP1] and arytenoid adduction [AA]), have beendevised to correct this condition. Ultrahigh-resolution computed tomography (U-HRCT) allows detailed three-dimensionalimaging of the larynx, which aids our understanding of vocal fold motion disorders. This study assessed whether U-HRCT isbeneficial for correct diagnosis and surgical planning. Methods: The participants were 26 UVFP patients who underwent laryngeal framework surgery (TP1 and/or AA).U-HRCT was used to measure the vocal fold volume (VFV) and level difference (LD). The need to combine AA with TP1 toobtain satisfactory surgical outcomes was evaluated by U-HRCT and various voice function tests. Results: VFV was smaller in paralyzed folds than in unaffected folds. LD correlated strongly with voice parameters andshowed high intra-rater and inter-rater reliability. The surgical outcome of the laryngeal framework surgery performed wasjudged to be excellent for improving voice function. Comparison of LD between the TP1 group and TP1 + AA group indicatedthat LD is an excellent parameter to determine the need to combine AA with TP1. Conclusion: These findings underscore the value of preoperative U-HRCT, especially LD, in surgical decision-making andafford insights for optimal phonosurgery and individualized intervention. Patients with LD >1.0 mm may benefit fromthyroplasty with AA.

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Books 【 display / non-display 】

Books 【 display / non-display 】

• Practice of oro-parynx

  Hirakawa Hitoshi ( Part: Multiple Authorship )

  2015.09

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• HPV関連頭頸部癌におけるmTOR経路の検討

  近藤 俊輔, 安慶名 信也, 平川 仁, 真栄田 裕行, 鈴木 幹男

  日本癌治療学会学術集会抄録集 ( (一社)日本癌治療学会 )  59回   O40 - 1   2021.10  [Refereed]

   

• HPV非関連進行咽頭癌におけるHIF1-αの発現と予後

  安慶名 信也, 近藤 俊輔, 平川 仁, 真栄田 裕行, 鈴木 幹男

  日本癌治療学会学術集会抄録集 ( (一社)日本癌治療学会 )  59回   O40 - 3   2021.10  [Refereed]

   

• Symptom prevalence and functional status in patient with terminal phase of head and neck cancer-multi-institutional research

  Hirakawa H.

  Journal of Otolaryngology of Japan ( Journal of Otolaryngology of Japan )  123 ( 4 ) 937   2020  [Refereed]

   

  DOI

• DNA修復酵素遺伝子多型による導入化学療法の効果予測

  平川 仁, 山下 懐, 上原 貴行, 安慶名 信也, 上里 迅, 金城 秀俊, 真栄田 裕行, 鈴木 幹男

  頭頸部癌 ( (一社)日本頭頸部癌学会 )  45 ( 2 ) 220 - 220   2019.05

   

• 頭頸部扁平上皮癌再発例に対する動注療法の検討

  安慶名 信也, 平川 仁, 真栄田 裕行, 鈴木 幹男, 平安名 常一

  頭頸部癌 ( (一社)日本頭頸部癌学会 )  45 ( 2 ) 238 - 238   2019.05

   

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• Surgical Leadership Program, Team Assigment Awards

  2023.03   Harvard Medical School  

• Best Paper Award of JSHNC

  2019.06   Japan Society for Head and Neck Cancer   Symptom prevalence and functional status in patient with terminal phase of head and neck cancer: multi-institutional research

  Winner: Hirakawa Hitoshi

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  There have been a limited number of studies about clinical symptoms in patients with terminal phase of head and neck cancers. The aim of this prospective multi-institutional study (11 institutes) was to assess the prevalence of symptoms and functional status among patients with advanced head and neck cancer. Of the 100 patients who met the inclusion criteria, 72 patients were observed until their death. Neck dressing treatment was needed for skin-infiltration symptoms, such as bleeding, infection, and exudation in 30.6% of patients at study entry and in 36.1% just before death. Severe bleeding causing death was observed in 6.9% of patients and the lethal rupture of carotid artery was in only one case (1.4%). At the time of study entry, 75% of patients kept enteral nutrition, and 61.1% still received enteral nutrition just before death. Laryngeal phonation ability was not kept in 44.4% of patients at the time of study entry and 50% just before death. Edema in head and neck region was observed in 23.6% of patients at entry and 36.1% at the time of death. Since the above mentioned symptoms in patients with terminal phase were not mild, these symptoms sometimes cause uneasiness in head and neck patients, their families, and the medical staffs. To relieve anxiety of patients, families, and the medical staffs, further large scale prospective studies are needed to establish care management of head and neck cancer patients with terminal phase and bring the better quality of life at terminal phase.

• Award for life science project

  2018.10     Prognostic impact of DNA repair gene polymorphism in head and neck cancer patients

  Winner: Hirakawa Hitoshi

• Award for achievements, Ryukyu university medical faculty

  2018.01   University of Ryukyus  

  Winner: Hirakawa Hitoshi

Grant-in-Aid for Scientific Research 【 display / non-display 】

Grant-in-Aid for Scientific Research 【 display / non-display 】

• Grant-in-Aid for Scientific Research(C)

  Project Year: 2024.04  -  2029.03 

  Direct: 3,600,000 (YEN)  Overheads: 4,680,000 (YEN)  Total: 1,080,000 (YEN)

• Grant-in-Aid for Scientific Research(C)

  Project Year: 2024.04  -  2029.03 

  Direct: 3,600,000 (YEN)  Overheads: 4,680,000 (YEN)  Total: 1,080,000 (YEN)

• Grant-in-Aid for Scientific Research(C)

  Project Year: 2024.04  -  2029.03 

  Direct: 3,600,000 (YEN)  Overheads: 4,680,000 (YEN)  Total: 1,080,000 (YEN)

• Development of novel minimally invasive therapy in head and neck cancer

  Grant-in-Aid for Scientific Research(C)

  Project Year: 2024.04  -  2028.03 

  Direct: 3,700,000 (YEN)  Overheads: 4,810,000 (YEN)  Total: 1,110,000 (YEN)

• Development of novel minimally invasive therapy in head and neck cancer

  Grant-in-Aid for Scientific Research(C)

  Project Year: 2024.04  -  2028.03 

  Direct: 3,700,000 (YEN)  Overheads: 4,810,000 (YEN)  Total: 1,110,000 (YEN)

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