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International Journal of Hyperthermia Volume 38, 2021 - Issue 1
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Articles

A multicenter randomized phase II trial of hyperthermia combined with TPF induction chemotherapy compared with TPF induction chemotherapy in locally advanced resectable oral squamous cell carcinoma

Guoxin Rena Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaView further author information
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Houyu Jua Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaView further author information
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Yunteng Wua Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaView further author information
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Hao Songa Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaView further author information
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Xuhui Maa Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaView further author information
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Minghua Gec Department of Head and Neck Surgery, Zhejiang Cancer Hospital, Hangzhou, ChinaView further author information
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Weiliu Qiua Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaView further author information
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Yazhu Chend Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai Med-X Engineering Center for Medical Equipment and Technology, Shanghai Jiao Tong University, Shanghai, ChinaView further author information
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Yue Hea Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaView further author information
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Qianwei Zhuange Department of Oromaxillofacial Head and Neck Surgery, College of Medicine, Affiliated Xuzhou Hospital, Southeast University, Xuzhou, ChinaView further author information
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Jian Menge Department of Oromaxillofacial Head and Neck Surgery, College of Medicine, Affiliated Xuzhou Hospital, Southeast University, Xuzhou, ChinaCorrespondence[email protected]
View further author information
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Wei Guoa Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China;b Shanghai Key Laboratory of Stomatology and Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, ChinaCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0003-1946-8765View further author information
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Pages 939-947 | Received 24 Mar 2021, Accepted 27 May 2021, Published online: 16 Jun 2021
 
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Abstract

Background

Hyperthermia has been reported to cause cancer stage regression, thus providing surgical opportunities in patients with unresectable tumors and improving the quality of life of patients by preserving certain organs.

Methods

A prospective open-label phase II trial was conducted to evaluate the efficacy of hyperthermia combined with induction chemotherapy in patients with locally advanced resectable oral squamous cell carcinoma (OSCC). Patients received hyperthermia combined with two cycles of 5-fluorouracil, cisplatin, and docetaxel (TPF) induction chemotherapy regimens or TPF induction chemotherapy alone, followed by radical surgery with postoperative radiotherapy. The primary endpoint was the clinical response rate of the induction chemotherapy. The secondary endpoints were overall survival (OS), disease-free survival (DFS), and toxicity.

Results

A total of 120 patients were enrolled, and 115 patients were included in the clinical response analysis. The clinical response rate was significantly higher in the experimental arm than in the control arm (65.45% vs. 40.00%, p = 0.0088). There were no unexpected toxicities, and hyperthermia and induction chemotherapy did not increase the perioperative morbidity rate. Moreover, there was a significant improvement in DFS, but no significant difference in OS between the two arms. In the subgroup analysis, increased OS and DFS rates were associated with patients with favorable clinical response after induction chemotherapy in the total population, experimental arm, and control arm.

Conclusions

Our study demonstrates that hyperthermia combined with induction chemotherapy is associated with a high response rate and provides a new treatment option for patients with resectable stage III or IVA OSCC.

Author contributions

Study concept and design: WG and JM. Acquisition and interpretation of the data: GXR, HYJ, YTW, HS, XHM, YH, YZC, WLQ MHG AND QWZ. Drafting of the manuscript: HYJ. Statistical analysis: GXR. Critical revision of the manuscript for important intellectual content: YZC and WLQ. Obtained funding: WG and JM.

Ethics approval and consent to participate

This study was approved by the Ethics Committee of the Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine (Shanghai, China), and informed consent was obtained from all patients (ChiCTR1800014391). The study was performed in accordance with the Declaration of Helsinki.

Consent for publication

Consent for publication was obtained from all authors.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

Our study was supported by grants from the Project of Science and Technology Commission of Shanghai Municipality [grant nos. 10410711200, 08140902100, 11495802000, 14DZ1941400, and 14DZ1941402] and the National Key Research and Development Program [grant no. 2016YFC0905003, 5000].
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