Skip to main content
. 2016 Nov 22;2016(11):CD005342. doi: 10.1002/14651858.CD005342.pub4

Peters 2000.

Study characteristics
Methods RCT
Participants Country: USA
Enrolled 268 patients, stage IA2, IB or IIA
Underwent radical hysterectomy and pelvic lymphadenectomy.
Ineligible 15
Assessed 243 (91%)
Interventions Chemotherapy plus radiotherapy versus radiotherapy
Arm 1: chemotherapy began on day 1 of radiotherapy and consisted of cisplatin 70 mg/m2 by 2‐hour intravenous infusion given on day 1 and 5‐FU 1000 mg/m2 per day given as a 96‐hour continuous infusion on days 1 to 4. The second cycle of chemotherapy began on day 22, and the third and fourth cycles of chemotherapy were scheduled after completion of radiotherapy, to begin on days 43 and 64.
Arm 2: consisted of 1.7 Gy per day on days 1 to 5 each week, for a total of 29 fractions (49.3 Gy); pelvic radiotherapy was given to a standard four‐field box. Patients with positive high common iliac lymph nodes also received treatment to a para‐aortic field with a dose of 1.5 Gy per day on days 1 to 5 of each week, for a total of 30 fractions. The radiation source of treatment was 4MeV or more. Brachytherapy was not permitted.
Outcomes Overall survival
Progression‐free survival
Grade 3/4 toxicity
Notes Statistics on survival:
Cox HR and P value.
Kaplan‐Meier survival plots; minimum follow‐up estimated from dates of accrual and date of interim analysis.
No. of deaths and disease recurrences by treatment arm.
The estimated 4‐year survival was 81% for chemotherapy plus radiotherapy and 71% for radiotherapy only.
The estimated 4‐year progression‐free survival for patients receiving chemotherapy plus radiotherapy was 80%, versus 63% for patients receiving radiotherapy alone.
Median follow‐up: 42 months.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported, "Patients were randomised to either pelvic radiotherapy or pelvic radiotherapy with four cycles of chemotherapy".
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding (performance bias and detection bias)
All outcomes Unclear risk Not reported.
Incomplete outcome data (attrition bias)
All outcomes Low risk For all survival outcomes:
% analysed: 243/243 (100%)
For toxicity:
% analysed: 234/243 (96%)
Chemotherapy + radiotherapy group: 122/127 (96%)
Radiotherapy group: 112/116 (97%)
"122 patients assessable for toxicity in the chemotherapy+ radiotherapy arm ... 112 patients randomised to RT alone and assessable for toxicity".
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement.
Other bias High risk Based on an interim analysis of the data which rejected the null hypothesis of no benefit of chemotherapy.