Prospective study of alternating chemoradiotherapy consisting of extended-field dynamic conformational radiotherapy and systemic chemotherapy using 5-FU and nedaplatin for patients in high-risk group with cervical carcinoma.
OBJECTIVE
To assess the efficacy of alternating chemoradiotherapy combined with extended-field conformal radiotherapy for patients with high-risk cervical cancer.


METHODS
Patients with previously untreated cervical cancer, with Stage III/IVA disease, or Stage IB/II with high-risk factor (primary tumor diameter >/=50 mm or positive lymph node) were entered into this study. Three cycles of chemotherapy with 3,500 mg/m(2) of 5-fluorouracil (5-FU) and nedaplatin (NDP) were accompanied with pelvic irradiation of 45.6-51.3 Gy in 24-27 fractions over 6 weeks. Prophylactic (36 Gy/20 fractions) or definitive (45-56 Gy) irradiation for para-aortic region was followed by pelvic irradiation.


RESULTS
Between 1998 and 2004, 40 patients were recruited for this protocol study. Eighteen patients from Phase I setting were registered. Twenty-two patients were treated with NDP of 140 mg/m(2) (the recommended dose) in the Phase II segment. Twenty-five patients had T3 disease, and 25 patients had nodal disease including para-aortic involvement (n = 5). Overall/progression-free survival rates at 5 years were 78.8 and 66.5%, respectively. The median follow-up time was 61.8 months (25.5-106.7). Hematologic and gastrointestinal Grade 3 or more toxicities were relatively high rate (27.5-45%); however, they were well manageable. Two for bladder toxicity of Grade 3 were noted. Comparing the data from historical control group evaluated by magnetic resonance imaging, alternating chemoradiotherapy revealed a significant favorable factor for survival and disease recurrence in multivariate analysis (p < 0.05).


CONCLUSIONS
Acquired results from our unique protocol for cervical cancer with high-risk factor were thought to be promising, considering that the majority of our cohort consisted of high-risk population.
Kodaira
Takeshi
T
Department of Radiation Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
Fuwa
Nobukazu
N
Nakanishi
Toru
T
Tachibana
Hiroyuki
H
Nakamura
Tatsuya
T
Tomita
Natsuo
N
Nakahara
Rie
R
Inokuchi
Haruo
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D011446:Prospective Studies; D020266:Radiotherapy, Conformal; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000628:therapy*
D009944:Organoplatinum Compounds; C053989:nedaplatin; D005472:Fluorouracil