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A randomized controlled study of single-agent cisplatin and radiotherapy versus docetaxel/cisplatin and radiotherapy in high-risk early-stage cervical cancer after radical surgery

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Abstract

Background

This study explored whether docetaxel/cisplatin and radiotherapy (TP-R) increases overall survival (OS) and recurrence-free survival (RFS) compared to single-agent cisplatin and radiotherapy (C-R) in patients with high-risk early-stage cervical cancer post surgery.

Methods

Patients with clinical stage IB and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or the diameter of the primary tumor ≥4 cm and/or depth of interstitial infiltration ≥1/2 and/or lymphovascular space invasion were eligible for this study. Patients were randomized to receive C-R or TP-R. Radiotherapy in both groups was external radiation (46–54 Gy) followed by high-dose rate brachytherapy (12–24 Gy). Patients were given cisplatin (40 mg/m2) every week for five cycles (C-R group) or docetaxel (30 mg/m2) and cisplatin (30 mg/m2) every week for five cycles (TP-R group).

Results

Between 2003 and 2008, 320 patients were entered onto the study. Final analyses included 285 patients. One hundred and forty patients comprised the C-R group and 145 were in the TP-R group. The 5-year OS were 74.3 % in the C-R group and 82.8 % in the TP-R group. The hazard ratio (HR) for death was 0.65 in the TP-R group (95 % CI: 0.39–1.09, P = 0.098). The RFS were 69.3 % in the C-R group and 79.3 % in the TP-R group, and the HR for recurrence was 0.64 in the TP-R group (95 % CI: 0.40–1.03, P = 0.061). Recurrence rates were similar in both groups (27 in the C-R group and 18 in the TP-R group, P = 0.112). The seriousness of late side effects was similar in the two groups, with a higher rate of reversible hematological effects in the TP-R group.

Conclusions

Compared with single-agent cisplatin and radiotherapy, docetaxel/cisplatin in combination with radiotherapy does not increase OS but has the trend of increasing RFS in patients with high-risk early-stage cervical cancer. However, docetaxel/cisplatin in combination with radiotherapy is associated with a higher incidence of side effects, this effect was reversible, and the incidence of late side effects was similar in the two treatment groups.

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Acknowledgments

Supported by grants from the Science and Technology Bureau of Huai’an, Jiangsu, P. R. China (No: HAS201030). The views expressed in this article are solely those of the authors and do not necessarily represent the official views of the Science and Technology Bureau of Huaian.

Conflict of interest

The author(s) indicated no potential conflicts of interest.

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Authors and Affiliations

  1. Department of Radiation Oncology, Lianshui County People’s Hospital, Huai’an, 223300, Jiangsu, People’s Republic of China

    Juan Pu

  2. Department of Radiation Oncology, Huai’an First People’s Hospital, Nanjing Medical University, Huai’an, 223300, Jiangsu, People’s Republic of China

    Jin-xia Ding, Yan Zhang, Wei-guo Zhu, Chang-hua Yu, Tao Li, Guang-zhou Tao, Fu-zhi Ji, Xi-lei Zhou, Ji-hua Han, Ya-lin Ji & Jun-xia Sun

  3. Department of Obstetrics and Gynecology, Huai’an First People’s Hospital, Nanjing Medical University, Huai’an, 223300, Jiangsu, People’s Republic of China

    Shan-shan Qin

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  1. Juan Pu
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  4. Yan Zhang
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Correspondence to Wei-guo Zhu.

Additional information

Juan Pu and Shan-shan Qin contributed equally to this work.

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Pu, J., Qin, Ss., Ding, Jx. et al. A randomized controlled study of single-agent cisplatin and radiotherapy versus docetaxel/cisplatin and radiotherapy in high-risk early-stage cervical cancer after radical surgery. J Cancer Res Clin Oncol 139, 703–708 (2013). https://doi.org/10.1007/s00432-013-1373-9

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  • DOI: https://doi.org/10.1007/s00432-013-1373-9

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