Sequential therapy of neoadjuvant biochemotherapy with cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bioradiotherapy in high-risk locally advanced oral squamous cell carcinoma: Final analysis of a phase 2 clinical trial
Corresponding Author
Chia-Jui Yen MD, PhD
Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Correspondence
Kwang-Yu Chang, National Institute of Cancer Research, National Health Research Institutes, No. 367, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Chia-Jui Yen, Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Search for more papers by this authorHsiao-Hui Tsou PhD
Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan
Graduate Institute of Biostatistics, College of Public Health, China Medical University, Taichung, Taiwan
Hsiao-Hui Tsou, Ching-Yun Hsieh, and Chang-Yao Chu contributed equally to this study.Search for more papers by this authorChing-Yun Hsieh MD, PhD
Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
Hsiao-Hui Tsou, Ching-Yun Hsieh, and Chang-Yao Chu contributed equally to this study.Search for more papers by this authorChang-Yao Chu MD
Department of Pathology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Hsiao-Hui Tsou, Ching-Yun Hsieh, and Chang-Yao Chu contributed equally to this study.Search for more papers by this authorChang-Fang Chiu MD
Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
Search for more papers by this authorChih-Cheng Chen MD
Department of Hematology and Oncology, Chang Gung Memorial Hospital at Chiayi, Chiayi, Taiwan
Search for more papers by this authorChao-Jung Tsao MD, PhD
Division of Hematology and Oncology, Department of Internal Medicine, Chi-Mei Medical Center, Tainan, Taiwan
Search for more papers by this authorKuo-Yang Tsai MD
Department of Oral and Maxillofacial Surgery, Changhua Christian Hospital, Changhua, Taiwan
Search for more papers by this authorSen-Tien Tsai MD
Department of Otolaryngology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Search for more papers by this authorJang-Yang Chang MD
Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan
Search for more papers by this authorCorresponding Author
Kwang-Yu Chang MD, PhD
Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan
Correspondence
Kwang-Yu Chang, National Institute of Cancer Research, National Health Research Institutes, No. 367, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Chia-Jui Yen, Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Search for more papers by this authorCorresponding Author
Chia-Jui Yen MD, PhD
Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Correspondence
Kwang-Yu Chang, National Institute of Cancer Research, National Health Research Institutes, No. 367, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Chia-Jui Yen, Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Search for more papers by this authorHsiao-Hui Tsou PhD
Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan
Graduate Institute of Biostatistics, College of Public Health, China Medical University, Taichung, Taiwan
Hsiao-Hui Tsou, Ching-Yun Hsieh, and Chang-Yao Chu contributed equally to this study.Search for more papers by this authorChing-Yun Hsieh MD, PhD
Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
Hsiao-Hui Tsou, Ching-Yun Hsieh, and Chang-Yao Chu contributed equally to this study.Search for more papers by this authorChang-Yao Chu MD
Department of Pathology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Hsiao-Hui Tsou, Ching-Yun Hsieh, and Chang-Yao Chu contributed equally to this study.Search for more papers by this authorChang-Fang Chiu MD
Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
Search for more papers by this authorChih-Cheng Chen MD
Department of Hematology and Oncology, Chang Gung Memorial Hospital at Chiayi, Chiayi, Taiwan
Search for more papers by this authorChao-Jung Tsao MD, PhD
Division of Hematology and Oncology, Department of Internal Medicine, Chi-Mei Medical Center, Tainan, Taiwan
Search for more papers by this authorKuo-Yang Tsai MD
Department of Oral and Maxillofacial Surgery, Changhua Christian Hospital, Changhua, Taiwan
Search for more papers by this authorSen-Tien Tsai MD
Department of Otolaryngology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Search for more papers by this authorJang-Yang Chang MD
Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan
Search for more papers by this authorCorresponding Author
Kwang-Yu Chang MD, PhD
Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan
Correspondence
Kwang-Yu Chang, National Institute of Cancer Research, National Health Research Institutes, No. 367, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Chia-Jui Yen, Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng Li Road, Tainan 704, Taiwan.
Email: [email protected]
Search for more papers by this authorFunding information: National Health Research Institutes, Grant/Award Number: CA-107-PP-08; Taiwan Cooperative Oncology Group, Grant/Award Number: 98A1-CAPP34-014
Abstract
Background
The prognosis of advanced oral squamous cell carcinoma is poor. We investigated the effect of cetuximab-based sequential therapy as a primary treatment.
Methods
Forty-seven treatment-naive patients with advanced tumors originating from the oral cavity or oropharynx were enrolled. Neoadjuvant cetuximab, paclitaxel, and cisplatin were administered, followed by cetuximab-based radiotherapy. Immunohistochemical staining was applied to study the tissues.
Results
The best overall response rate was 70.2%, including 4 patients with a complete response and 29 with a partial response. The median progression-free and overall survival rates were 10.3 and 15.2 months, respectively. Patients with more than 50% tumor reduction with neoadjuvant therapy had better survival outcomes. Twenty-two patients had severe adverse events with mostly dermatological complications. Of the 16 patients who received operations, 9 had increased PD-L1 staining compared to pretreatment biopsy in the post hoc study.
Conclusion
The regimen was effective in selected patients. Increased PD-L1 suggested altered tumor features.
Supporting Information
| Filename | Description |
|---|---|
| hed25640-sup-0001-SupplData1.docWord document, 85.5 KB | Supplemental Data 1 Summary of the clinical stage of the patients classified with neoadjuvant biochemotherapy response was listed |
| hed25640-sup-0002-SupplData2.docxWord 2007 document , 23.1 KB | Supplementary Data 2 Clinical characteristics of 16 patients with PD-L1 expression in pre- and post-treatment specimens |
| hed25640-sup-0003-SupplData3.docWord document, 73.5 KB | Supplemental Data 3 The clinical relevance according to p16 expression. (A) Kaplan-Meier plot of the overall survival by subgroup category. Patients were categorized according to the p16 expression. Note that the vertical tick marks indicate censored data. (B) The statistical survival data of p16 postive and negative groups was summarized |
| hed25640-sup-0004-SupplData4.docxWord 2007 document , 56.4 KB | Supplemental Data 4 The clinical relevance according to the change of PD-L1 expression after treatment. (A) Kaplan-Meier plot of the overall survival by subgroup category. Patients were categorized according to the change of PD-L1 expression. Note that the vertical tick marks indicate censored data. (B) The statistical survival data according to the change of PD-L1 expression was summarized |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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