Prospective randomized comparison of monthly fluorouracil and cisplatin versus weekly cisplatin concurrent with pelvic radiotherapy and high-dose rate brachytherapy for locally advanced cervical cancer.

Kim, Young Seok; Shin, Seong Soo; Nam, Joo-Hyun; Kim, Young-Tak; Kim, Yong-Man; Kim, Jong Hoon; Choi, Eun Kyung
Gynecologic oncology
2008Jan ; 108 ( 1 ) :195-200.
저자 상세정보
Kim, Young Seok -
Shin, Seong Soo -
Nam, Joo-Hyun -
Kim, Young-Tak -
Kim, Yong-Man -
Kim, Jong Hoon -
Choi, Eun Kyung -
ABSTRACT
OBJECTIVE: To compare monthly fluorouracil (FU) plus cisplatin and weekly cisplatin concurrent with radiotherapy for locally advanced cervical cancer.

METHODS: A total of 158 patients (stages IIB through IVA) without para-aortic lymph nodes were randomized to receive 3 monthly cycles of FU (1000 mg/m2/day i.v.) plus cisplatin (20 mg/m2/day i.v.) for 5 days (group I, n=79) or 6 cycles of weekly cisplatin (30 mg/m2 i.v.) (group II, n=79), concurrent with definitive radiotherapy. Radiotherapy consisted of external irradiation to the whole pelvis of 41.4-50.4 Gy in 23-28 fractions plus high-dose rate (HDR) intracavitary brachytherapy (30-35 Gy in 6-7 fractions) to point A, together with a parametrial boost. Compliance with treatment, toxicity, response, and survival was analyzed and compared.

RESULTS: Of the 158 women, 155 women were eligible for analysis; the median follow-up of surviving patients was 39 months. Full planned chemoradiotherapy was delivered to 47 (60%) and 55 (71%) patients in groups I and II, respectively. The incidence of acute grade 3/4 hematologic toxicity was 43% and 26% (p=0.037). The complete response rate of each group was 91%. Four-year overall and progression-free survival rates were 70% and 67%, respectively, in group I and 67% and 66%, respectively, in group II.

CONCLUSIONS: The regimen of chemoradiation using weekly cisplatin significantly improves compliance with treatment and reduces acute hematologic toxicity, while not affecting response and survival rates.
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MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse, Brachytherapy/adverse effects/methods, Cisplatin/*administration & dosage/adverse effects, Combined Modality Therapy, Disease-Free Survival, Drug Administration Schedule, Female, Fluorouracil/administration & dosage/adverse effects, Follow-Up Studies, Humans, Middle Aged, Neoplasm Staging, Patient Compliance, Treatment Outcome, Uterine Cervical Neoplasms/*drug therapy/pathology/*radiotherapy
링크

주제코드
주제명(Target field)
연구대상(Population)
연구참여(Sample size)
대상성별(Gender)
질병특성(Condition Category)
연구환경(Setting)
연구설계(Study Design)
연구기간(Period)
중재방법(Intervention Type)
중재명칭(Intervention Name)
키워드(Keyword)
유효성결과(Recomendation)
Although the two regimens had similar survival rates, the regimen of weekly cisplatin at a dose of 30 mg/m 2 is an efficacious regimen, and that the addition of FU to cisplatin in group 2 results in higher acute complication and poorer compliance without a clear improvement in treatment outcomes.
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
출판년도(Year)
참여저자수(Authors)
대표저자
DOI
10.1016/j.ygyno.2007.09.022
KCD코드
ICD 03
건강보험코드