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

Chia-Jui Yen, Hsiao Hui Tsou, Ching Yun Hsieh, Chang-Yao Chu, Chang Fang Chiu, Chih Cheng Chen, Chao Jung Tsao, Kuo Yang Tsai, Sen-Tien Tsai, Jang-Yang Chang, Kwang Yu Chang

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)1703-1712
Number of pages10
JournalHead and Neck
Volume41
Issue number6
DOIs
Publication statusPublished - 2019 Jun 1

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Neoadjuvant Therapy
Squamous Cell Carcinoma
Clinical Trials
Staining and Labeling
Neoplasms
Oropharynx
Disease-Free Survival
Mouth
Cetuximab
TP protocol
Radiotherapy
Therapeutics
Survival Rate
Biopsy
Survival

All Science Journal Classification (ASJC) codes

  • Otorhinolaryngology

Cite this

@article{3ecde61933be413785e8deac86e1fce7,
title = "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",
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.",
author = "Chia-Jui Yen and Tsou, {Hsiao Hui} and Hsieh, {Ching Yun} and Chang-Yao Chu and Chiu, {Chang Fang} and Chen, {Chih Cheng} and Tsao, {Chao Jung} and Tsai, {Kuo Yang} and Sen-Tien Tsai and Jang-Yang Chang and Chang, {Kwang Yu}",
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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. / Yen, Chia-Jui; Tsou, Hsiao Hui; Hsieh, Ching Yun; Chu, Chang-Yao; Chiu, Chang Fang; Chen, Chih Cheng; Tsao, Chao Jung; Tsai, Kuo Yang; Tsai, Sen-Tien; Chang, Jang-Yang; Chang, Kwang Yu.

In: Head and Neck, Vol. 41, No. 6, 01.06.2019, p. 1703-1712.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

T2 - Final analysis of a phase 2 clinical trial

AU - Yen, Chia-Jui

AU - Tsou, Hsiao Hui

AU - Hsieh, Ching Yun

AU - Chu, Chang-Yao

AU - Chiu, Chang Fang

AU - Chen, Chih Cheng

AU - Tsao, Chao Jung

AU - Tsai, Kuo Yang

AU - Tsai, Sen-Tien

AU - Chang, Jang-Yang

AU - Chang, Kwang Yu

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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.

AB - 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.

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