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.
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.
Kim
Young Seok
YS
Department of Radiation Oncology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
Shin
Seong Soo
SS
Nam
Joo-Hyun
JH
Kim
Young-Tak
YT
Kim
Yong-Man
YM
Kim
Jong Hoon
JH
Choi
Eun Kyung
EK
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010349:Patient Compliance; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
D002945:Cisplatin; D005472:Fluorouracil