Clinical Research Papers:
Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma
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Lai-ping Zhong1, Chen-ping Zhang1, Guo-xin Ren1, Wei Guo1, William N. William Jr2, Christopher S. Hong3, Jian Sun1, Han-guang Zhu1, Wen-yong Tu1, Jiang Li4, Yi-li Cai1, Qiu-ming Yin1, Li-zhen Wang4, Zhong-he Wang1, Yong-jie Hu1, Tong Ji1, Wen-jun Yang1, Wei-min Ye1, Jun Li1, Yue He1, Yan-an Wang1, Li-qun Xu1, Zhengping Zhuang3, J. Jack Lee5, Jeffrey N. Myers6 and Zhi-yuan Zhang1
1 Department of Oral and Maxillofacial-Head and Neck Oncology, Ninth People’s Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, China
2 Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA
3 National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA
4 Department of Oral Pathology, Ninth People’s Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, China
5 Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA
6 Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA
Zhi-yuan Zhang, email:
Keywords: induction chemotherapy, oral squamous cell carcinoma, cisplatin, docetaxel, 5-fluorouracil
Received: March 02, 2015 Accepted: May 22, 2015 Published: June 19, 2015
Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2/day 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy; in the control group, patients received upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Among 256 enrolled patients with a median follow-up of 70 months, estimated 5-year overall survival, disease-free survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 61.1%, 52.7%, 55.2%, and 60.4%, respectively. There were no significant differences in survival rates between experimental and control groups. However, patients with favorable pathologic responses had improved outcomes compared to those with unfavorable pathologic responses and to those in the control group. Although TPF induction chemotherapy did not improve long-term survival compared to surgery upfront in patients with stage III and IVA OSCC, a favorable pathologic response after induction chemotherapy may be used as a major endpoint and prognosticator in future studies. Furthermore, the negative results observed in this trial may be represent type II error from an underpowered study. Future larger scale phase III trials are warranted to investigate whether a significant benefit exists for TPF induction chemotherapy in surgically managed OSCC.
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