The Feasibility and Safety of Induction Chemotherapy Followed by Definitive Chemoradiation in Patients with Locally Advanced Cervical Cancer: A Single-Arm Phase II Clinical Trial

Ahmadloo, Niloofar; Heidarpourfard, Marzieh; Najib, Fatemeh Sadat; Shiravani, Zahra; Omidvari, Shapour; Mosalaei, Ahmad; Mohammadianpanah, Mohammad; Ansari, Mansour; Nasrollahi, Hamid; Khanjani, Nezhat; Kadkhodaei, Behnam; Hamedi, Sayed Hasan

doi:10.31557/APJCP.2023.24.4.1321

The Feasibility and Safety of Induction Chemotherapy Followed by Definitive Chemoradiation in Patients with Locally Advanced Cervical Cancer: A Single-Arm Phase II Clinical Trial

Document Type : Research Articles

Authors

¹ Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

² Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

³ Division of Oncology and Gynecology, Department of Obstetrics and Oncology, Shiraz University of Medical Sciences, Shiraz, Iran.

⁴ Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

⁵ Breast Diseases Research Center, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

⁶ Colorectal Research Center, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

10.31557/APJCP.2023.24.4.1321

Abstract

Background: The present study aimed at investigating the feasibility and safety of induction chemotherapy followed by definitive chemoradiation (dCRT) in patients with locally advanced cervical cancer. Materials and Methods: In this single-arm clinical trial, patients with cervical cancer (stages IB3-IVA) received a median four cycles of induction chemotherapy (paclitaxel and carboplatin, every three weeks) followed by dCRT (which consisted of the whole pelvis at the dose of 45-50 Gy along with weekly cisplatin (40 mg/m2) followed by intracavitary brachytherapy at the total dose of 80-90 Gy). Primary end point was local control at three months, which was assessed by gynecologic examination and pelvic MRI. The secondary outcome of the study was treatment-related toxicity. Results: Seventy-four patients with the mean age of 51.6 ± 9.5 years were included. The most frequent (51.4%) disease stage was IIB. Complete and partial clinical responses were observed in 60.8% and 14.9% of patients, respectively. The frequency of progressive disease and stable disease were 14.9% and 9.5%, respectively. Grade II and III neutropenia (during neoadjuvant chemotherapy were 13.5% and 2.7%, respectively; these figures during chemoradiation were 29.7% and 13.5%, respectively. A treatment interruption was observed for 60.8% (45 cases) of patients during chemoradiation and 31.1% during induction chemotherapy. Discussion and conclusion: Induction chemotherapy followed by chemoradiation is feasible in patients with locally advanced cervical cancer; however, the toxicity should be managed properly to avoid delayed e treatment. More than three quarters of the patients achieved complete or partial clinical response within a three-month follow-up.

Keywords

Main Subjects