Extended field or pelvic intensity-modulated radiotherapy with concurrent cisplatin chemotherapy for the treatment of post-surgery multiple pelvic lymph node metastases in cervical cancer patients: a randomized, multi-center phase II clinical trial

Weiming Luo; Yunhai Li; Guihao Ke; Xiaohua Wu; Xiao Huang

doi:10.21037/tcr-20-2573

Extended field or pelvic intensity-modulated radiotherapy with concurrent cisplatin chemotherapy for the treatment of post-surgery multiple pelvic lymph node metastases in cervical cancer patients: a randomized, multi-center phase II clinical trial

Transl Cancer Res. 2021 Jan;10(1):361-371. doi: 10.21037/tcr-20-2573.

Authors

Weiming Luo^{1

2

3}, Yunhai Li³, Guihao Ke^{1

2}, Xiaohua Wu^{1

2}, Xiao Huang^{1

2}

Affiliations

¹ Department of Gynaecology, Fudan University, Shanghai Cancer Center, Shanghai, China.
² Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
³ Department of Radiation Oncology, Fudan University, Shanghai Cancer Center Minhang Branch, Shanghai, China.

Abstract

Background: To prospectively compare the outcomes and side effects between groups of postoperative cervical cancer patients with multiple pelvic lymph node metastases who were treated with extended field or pelvic intensity-modulated radiotherapy (IMRT) with concurrent cisplatin chemotherapy.

Methods: Cervical carcinoma patients with International Federation of Gynecology and Obstetrics (FIGO) stage Ib-IIa, who underwent radical hysterectomy and had histologically confirmed multiple (≥2) pelvic lymph node metastases, were enrolled into this study. The patients were randomly assigned to pelvic-IMRT or extended field-IMRT (45 Gy/25 Fx) group. Patients in either group received concurrent cisplatin chemotherapy (40 mg/m2) starting on the first day of irradiation.

Results: Until December 31th 2017, 129 patients were initially enrolled into this study. During the study, 3 patients were dropped out due to either incompletion of the study or exclusion by the criteria. Consequently, 64 patients completed pelvic-IMRT, and 62 patients completed extended field-IMRT. Median follow-up period was 61.30 months in the extended field-IMRT group and 60.60 months in the pelvic-IMRT group. Five-year actuarial survival probability was 0.759 (95% CI: 0.619-0.854) in the extended field-IMRT group which was not significantly different from that of the pelvic-IMRT group [0.824 (95% CI: 0.690-0.905), P=0.442]. Similarly, the five-year progression-free probability was 0.720 (95% CI: 0.576-0.822) in the extended field-IMRT group, which was not significantly different from that of the pelvic-IMRT group [0.781 (95% CI: 0.637-0.874), P=0.389]. In addition, there was no significant difference between the two groups in hematology and gastrointestinal tract toxicities.

Conclusions: Post-operative pelvic-IMRT or extended field-IMRT with concurrent cisplatin chemotherapy had similar outcomes in terms of survival rates and adverse events in cervical carcinoma patients at FIGO stage Ib-IIa with multiple pelvic lymph nodes metastases.

Keywords: Cervical carcinoma; extended field, para-aortic lymph node; intensity-modulated radiotherapy (IMRT); side effects.