Analysis of treatment outcome
Patients were followed for disease related parameters and adverse side
effects every 3 months in the first 2 years, in 6 month intervals for
the next 3 years and then annually. MRI was done every 6 months in the
first 5 years. Complete response (CR) was defined as total resolution of
clinically visible and/or palpable tumor of the cervix and vagina.
Treatment failures were classified according to the site(s) of first
tumor relapse and were defined as primary (cervix, uterine corpus,
vagina, parametrium), pelvic node, or distant metastases. Time intervals
for disease free survival (DFS), local recurrence free survival (LRFS),
metastasis recurrence-free survival (MRFS) and cancer specific survival
(CSS) rates were calculated from the date of diagnosis to the date of
event or last follow-up appointment. Acute toxicities were defined as
those occurring within 90 days after the last treatment date, and late
toxicities were defined as those that occurred more than 90 days after
the last treatment date.
Late toxicity was graded according to site and severity using the
National Cancer Institute CTCAE v4.03 (Common Terminology Criteria for
Adverse Events version 4.03) guidelines. Cox regression models were used
to analyze the association between predictors and time-to-event
outcomes. The Kaplan–Meier test was used to calculate survival curves.
All analyses were performed using SPSS software, version 21 of the SPSS
System for Windows.