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Abstract
Background: The standard treatment for locally advanced cervical cancer is cisplatin-based chemoradiotherapy; however, the optimal dose and dosing schedule of cisplatin remain debated. The aim of this study was to compare the clinical outcomes of weekly cisplatin at 40 mg/m2 versus those of tri-weekly cisplatin at 75 mg/m2 during radiation in patients with locally advanced cervical cancer.

Patients and methods: In this prospective, randomized clinical trial, we enrolled 314 patients with stage IIB-IVA cervical cancer, randomly assigning them in a 1 : 1 ratio into two arms. The weekly arm received a weekly dose of 40 mg/m2 cisplatin for six cycles, whereas the tri-weekly arm received a tri-weekly dose of 75 mg/m2 cisplatin for three cycles, both concurrently with radiotherapy. The primary endpoints included 3-year recurrence-free survival according to a superiority design, with P < 0.05 indicative of statistical significance. Overall survival, toxicity profiles, and quality of life (QOL) were also analyzed.

Results: Chemotherapy delay was more frequent in the weekly arm than in the tri-weekly arm (P = 0.008). However, the 3-year recurrence-free survival rate between the two arms did not significantly differ (78.7% in the weekly arm, 84.1% in the tri-weekly arm; hazard ratio 0.71, 95% confidence interval 0.39-1.32, P = 0.28). The pattern of recurrence did not differ significantly between the two arms. Grade 3 and 4 hematological toxicities occurred less frequently in the tri-weekly arm (P < 0.001). Furthermore, the tri-weekly arm had better QOL scores across several domains compared with the weekly arm.

Conclusion: In this study, tri-weekly cisplatin-based chemoradiotherapy was not statistically superior to a weekly schedule in terms of survival outcomes for patients with locally advanced cervical cancer. However, the tri-weekly regimen exhibited a more favorable toxicity profile and improved QOL compared with the weekly regimen. These results suggest tri-weekly cisplatin administration as a feasible alternative for chemoradiotherapy in cervical cancer.

Affiliations

S Y Ryu 1, B H Nam 2, M H Kim 3, W I Jang 4, C Sitathanee 5, T D Linh 6, K H Lee 7, W M Lee 8, E T Kim 9, S B Kang 10, J H Kim 11, J Y Park 12, K B Lee 13, C H Cho 14, H Lou 15, Y H Kim 16, Y T Kim 17, Y H Lee 18, X Wu 19, J W Kim 20, S I Park 21, S Jeon 22, D H Thinh 6, S F Kry 23, D Gaffney 24, W Small 25, S Wilailak 26
1Department of Gynecologic Oncology, Korea Institute of Radiological & Medical Science, Seoul, Republic of Korea. Electronic address: ryu@kcch.re.kr.
2Data Management Center, Korea Gynecologic Oncology Group, Seoul, Republic of Korea.
3Department of Gynecologic Oncology, Korea Institute of Radiological & Medical Science, Seoul, Republic of Korea.
4Department of Radiation Oncology, Korea Institute of Radiological & Medical Science, Seoul, Republic of Korea.
5Department of Radiation Oncology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
6Department of Radiation Oncology, Ho Chi Minh City Oncology Hospital, Ho Chi Minh, Vietnam.
7Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, Catholic University, Seoul, Republic of Korea.
8Department of Obstetrics and Gynecology, Hanyang University, Seoul, Republic of Korea.
9Department of Obstetrics and Gynecology, Kosin University Gospel Hospital, Busan, Republic of Korea.
10Department of Obstetrics and Gynecology, Hosan Women's Hospital, Seoul, Republic of Korea.
11Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University, Seoul, Republic of Korea.
12Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
13Department of Obstetrics and Gynecology, Gachon University Gil Hospital, Incheon.
14Department of Obstetrics and Gynecology, Keimyung University, Daegu, Republic of Korea.
15Department of Obstetrics and Gynecology, Zheijiang Cancer Center, Hangzhou, China.
16Department of Obstetrics and Gynecology, Ewha Womans University College of Medicine, Seoul, Republic of Korea.
17Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
18Department of Obstetrics and Gynecology, Kyungpook National University College of Medicine, Daegu, Republic of Korea.
19Department of Gynecologic Oncology, Fudan University Cancer Institute, Shanghai, China.
20Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
21Department of Obstetrics and Gynecology, Dongnam Institute of Radiological & Medical Science, Busan, Republic of Korea.
22Department of Obstetrics and Gynecology, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea.
23Department of Radiation Physics, IROC Houston QA Center, University of Texas MD Anderson Cancer Center, Houston.
24Department of Radiation Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, USA.
25Department of Radiation Oncology, Stritch School of Medicine, Loyola University Chicago, Chicago, USA.
26Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: sarikapanw@gmail.com.