Prospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 21, 2017; 23(3): 540-546
Published online Jan 21, 2017. doi: 10.3748/wjg.v23.i3.540
Long-term results of paclitaxel plus cisplatin with concurrent radiotherapy for loco-regional esophageal squamous cell carcinoma
Han-Ting Zhu, Da-Shan Ai, Hua-Rong Tang, Harun Badakhshi, Jian-Hong Fan, Jia-Ying Deng, Jun-Hua Zhang, Yun Chen, Zhen Zhang, Yi Xia, Xiao-Mao Guo, Guo-Liang Jiang, Kuai-Le Zhao
Han-Ting Zhu, Da-Shan Ai, Jia-Ying Deng, Jun-Hua Zhang, Yun Chen, Zhen Zhang, Yi Xia, Xiao-Mao Guo, Guo-Liang Jiang, Kuai-Le Zhao, Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China
Hua-Rong Tang, Department of Radiation Oncology, Zhejiang Cancer Hospital, Zhejiang Key Laboratory of Radiation Oncology, Hangzhou 310022, Zhejiang Province, China
Harun Badakhshi, Department of Radiation Oncology, Charité School of Medicine and Centre for Cancer Medicine, 14195 Berlin, Germany
Jian-Hong Fan, Department of Gynecology, Renhe Hospital, Shanghai 443001, China
Author contributions: Zhu HT and Ai DS contributed equally to this work; Zhu HT, Ai DS, Tang HR, Badakhshi H, Fan JH, Deng JY, Zhang JH, Chen Y, Xia Y and Zhao KL designed and performed the research; Zhu HT, Ai DS, Tang HR, Badakhshi H, Fan JH, Deng JY, Zhang JH, Chen Y and Xia Y collected the data; Zhu ht and Ai ds analyzed the data and wrote the manuscript; Tang hr, Badakhshi H, Fan JH, Deng JY, Zhang JH, Chen Y, Zhang Z, Xia Y, Guo XM, Jiang GL and Zhao KL revised the manuscript.
Supported by National Natural Science Foundation of China, No. 21172043 and No. 21441010.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the Cancer Hospital Affiliated to Fudan University.
Clinical trial registration statement: As the study started 8 years ago, we did not register our clinical trial in website.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: The authors of this manuscript have no conflicts of interest to disclose.
Data sharing statement: There are no additional data available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Kuai-le Zhao, Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai 200032, China. kuaile_z@sina.com
Telephone: +86-21-64175590-6726 Fax: +86-21-64174774
Received: November 10, 2016
Peer-review started: November 13, 2016
First decision: December 2, 2016
Revised: December 16, 2016
Accepted: December 21, 2016
Article in press: December 21, 2016
Published online: January 21, 2017
Processing time: 64 Days and 19.4 Hours
Abstract
AIM

To evaluate the long-term effectiveness and late toxicities of paclitaxel (PTX) plus cisplatin (DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer.

METHODS

Between 2008 and 2011, 76 patients were enrolled in a phase II study on the treatment of loco-regionally advanced esophageal cancer with radiotherapy (68.4 Gy/44 fractions or 61.2 Gy/34 fractions) combined with 4-cycle chemotherapy consisting of DDP (25 mg/m2 per day for 3 d) and PTX (175 mg/m2 for 3 h). The primary endpoints were overall survival and progression-free survival, and the secondary endpoints were toxicity and the treatment failure pattern.

RESULTS

A total of 76 patients were enrolled in this study, of whom 63.2% finished the whole regimen. The 5-year survival rates for the per-protocol population and intent-to-treat population were 25.4% and 26.4%, respectively, and the median survival rates were 23.7 mo and 28.5 mo, respectively. Grade 3 or 4 late toxicity was observed in only one patient (heart failure). In log-rank analysis, the pretreatment stage (stage II + III: 36.1 mo vs stage IV: 14.9 mo) and the completed cycle (1-3 cycles: 16.1 mo vs 4 cycles: 35.5 mo) were significant prognostic factors (P = 0.037 < 0.05 and P = 0.013 < 0.05).

CONCLUSION

Radiotherapy combined with chemotherapy consisting of PTX and DDP is a safe and effective definitive treatment for loco-regionally advanced esophageal squamous cancer.

Keywords: Chemoradiotherapy; Long-term result; Loco-regionally advanced esophageal cancer; Phase II trial

Core tip: This was a prospective phase II trial with 76 patients to evaluate the effect of paclitaxel plus cisplatin combined with concurrent radiotherapy for locally advanced esophageal squamous cancer. Our results showed a good survival rate, which seemed comparable or even better than those of other studies of patients undergoing definitive paclitaxel-based chemoradiotherapy.