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 -
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.
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

주제명(Target field)
연구참여(Sample size)
질병특성(Condition Category)
연구설계(Study Design)
중재방법(Intervention Type)
중재명칭(Intervention Name)
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)
ICD 03