Postoperative chemotherapy for node-positive cervical cancer: Results of a multicenter phase II trial (JGOG1067).
Gynecol Oncol
; 149(3): 513-519, 2018 06.
Article
in En
| MEDLINE
| ID: mdl-29661497
ABSTRACT
OBJECTIVE:
This multicenter phase II Japanese Gynecologic Oncology Group study (JGOG1067) was designed to evaluate the efficacy and safety of postoperative chemotherapy in patients with node-positive cervical cancer.METHODS:
Patients with stage IB-IIA squamous cervical cancer who underwent radical hysterectomy and were confirmed to have pelvic lymph node metastasis were eligible for this study. The patients postoperatively received irinotecan (CPT-11; 60mg/m2 intravenously on days 1 and 8) and nedaplatin (NDP; 80mg/m2 intravenously on day 1). Chemotherapy administration commenced within 6weeks after surgery and was repeated every 28days for up to 5cycles. The primary endpoint of this study was the 2-year recurrence-free survival (RFS) rate. The secondary endpoints were the 5-year overall survival (OS) rate, 5-year RFS rate, and adverse events such as complications of chemotherapy and lower-limb edema.RESULTS:
Sixty-two patients were analyzed according to our protocol, among whom 55 (88.7%) completed 5cycles of scheduled treatment. The median follow-up period was 66.1months (range, 16.8-96.6months). The 2-year and 5-year RFS rates were 87.1% (95% confidence interval [CI] 75.9-99.3) and 77.2% (95% CI 64.5-85.8), respectively. Fourteen patients (22.5%) experienced recurrence during the follow-up period, 8 of whom died of the disease. The 5-year OS rate in this study was 86.5% (95% CI 74.8-93.0). Only 9.7% of the patients experienced lymphedema in their legs.CONCLUSION:
Postoperative chemotherapy without radiotherapy was found to be very effective in high-risk patients with node-positive cervical cancer.
Full text:
1
Database:
MEDLINE
Main subject:
Antineoplastic Combined Chemotherapy Protocols
/
Uterine Cervical Neoplasms
Type of study:
Clinical_trials
/
Guideline
Limits:
Adult
/
Aged
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Female
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Humans
/
Middle aged
Language:
En
Journal:
Gynecol Oncol
Year:
2018
Type:
Article