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Author Young Seok Kim, Seong Soo Shin, Eun Kyung Choi, Jong Hoon Kim, Seung Do Ahn, Sang wook Lee, Heon Jin Park, Young Tak Kim, Jung Eun Mok, Joo Hyun Nam
Place of duty Departments of 1Radiation Oncology, 2Obstetrics and Gynecology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, 3Department of Statistics, Inha University, Incheon, Korea.
Title A Preliminary Results of a Randomized Trial Comparing Monthly 5-flourouracil and Cisplatin to Weekly Cisplatin Alone Combined with Concurrent Radiotherapy for Locally Advanced Cervical Cancer
Publicationinfo Cancer Res Treat. 2005 Feb; 037(01): 37-43.
Key_word Randomized trials,Cervical neoplasm,Concurrent chemoradiotherapy
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Abstract Purpose: To determine the superior chemotherapeutic regimen between monthly 5-FU plus cisplatin (FP) and weekly cisplatin alone in concurrent chemoradiotherapy for locally advanced cervical cancer, the compliance of treatment, response, survival and toxicities were analyzed between the two arms. Materials and Methods: Between March 1998 and December 2001, 61 patients with locally advanced cervical cancer (stage IIB through IVA) and negative para-aortic lymph nodes were randomly assigned to either 'monthly FP' (arm I, n=34) or 'weekly cisplatin' (arm II, n=27) with concurrent radiotherapy. The patients of arm I received FP (5-FU 1,000 mg/m2/day cisplatin 20 mg/m2/day, for 5 days, for 3 cycles at 4 week intervals) and those of arm II received cisplatin (30 mg/m2/day, for 6 cycles at 1 week intervals) with concurrent radiotherapy. The radiotherapy consisted of 41.4~50.4 Gy external beam irradiation in 23~28 fractions to the whole pelvis, with high dose rate brachytherapy delivering a dose of 30~35 Gy in 6~7 fractions to point A. During the brachytherapy, a parame-trial boost was delivered. The median follow-up period for survivors was 44 months. Results: The compliance of treatment in monthly FP weekly cisplatin arms were 62 and 81%, respectively. The complete response rates at 3 months were 96 and 88% in arms I and II, respectively. The 4-year overall survival and disease free survival rates were 64 and 54% in the arm I and 77 and 66% in the arm II, respectively. The incidence of hematologic toxicity more than grade 2 was 29% in the arm I and 15% in the arm II. Only one patient in arm I experienced grade 3 gastrointestinal toxicity. No severe genitourinary toxicity was observed. Conclusion: No significant difference was observed in the compliance, responses, survival rates and acute toxicities between the two treatment arms. More patients and further follow up will be required. (Cancer Research and Treatment 2005;37:37-43)