Cervix: Oral Abstract: Chemoradiation for the management of locally advanced carcinoma uterine cervix: Comparative evaluation of concomitant weekly versus three weekly cisplatin
This article was originally published by Wolters Kluwer - Medknow and was migrated to Scientific Scholar after the change of Publisher.
Aims and Objectives:
To determine and evaluate the difference/s, in terms of tumor control and side effects, between weekly and three weekly cisplatin concomitant with external beam radiotherapyfor locally advanced carcinoma of cervix.
Materials and Methods:
The study was conducted in Radiotherapy Department, University of Health Sciences, Rohtak (India), on sixty previously untreated, histopathologically proven patients of locally advanced carcinoma of uterine cervix. The patients were treated with External Beam Radiotherapy (EBRT) 50 Gy/25 fractions over 5 weeks and concomitant cisplatin, followed by intra-cavitary HDR brachytherapy (ICBT) 700 cGy to point A; three times, once in a week. The patients were assigned randomly either of two groups of 30 patients each. In Group I (Study Group) the patients received three weekly cisplatin 75 mg/m2 for 2 cycles whilein Group II (Control Group) the patients received weekly cisplatin 40 mg/m2 for 5 cycles. Evaluation of response and toxicity was done weekly during treatment and monthly thereafter up to six months. The data thus obtained was assessed and analysed using La Morte statistical tool. The study was approved by Ethical committee of the institute and quality was periodically monitored by senior consultant and guide.
Stage wise disease response in study and control respectively at the end of treatment was as follows: Stage IIA-CR (80% vs 100%), PR (20% vs 0%); Stage IIB-CR (80% vs 76.47%), PR (20% vs 23.53%); Stage IIIA-CR (60% vs 100%), PR (40% vs 0%); Stage IIIB-CR (60% vs 60%), PR (40% vs 20%), NR (0% vs 20%). Stage wise disease status at the end of sixth month follow up was as follows: Stage IIA – NED (80% vs 100%), RD (20% vs 0%); Stage IIB – NED (80% vs 76.67%), RD (20% vs 23.53%); Stage IIIA – NED (60% vs 100%), RD (40% vs 0%); Stage IIIB - NED (60% vs 60%), RD (40% vs 40%). Tumor response was not significantly different in the two groups with respect to age distribution, rural/urban distribution, histopathological distribution and treatment interruption. Maximum level of hematological toxicity (WHO criteria) observed in study and control group respectively at the end of treatment was as follows: Anaemia; Grade II - 4 (13.33%) in both the groups, Leukopenia; Grade II - 1 (3.33%) vs 0 (0%). The worst acute skin reactions observed by the end of treatment in Group I and II respectively were grade II - 2 (6.67%) vs 0 (0%). The worst acute mucosal reactions were grade II - 5 (16.66%) vs 0 (0%). Upper Gastrointestinal toxicity (Grade II & III) was 16.7% versus 13.3% respectively. Lower gastrointestinal toxicity (Grade II & III) was 30.0% versus 36.7%. No significant weight loss was observed in either of the groups. Though, all the patients completed the intended treatment, treatment interruption for more than a week was observed in 10 (33.33%) vs 8 (26.67%) patients respectively, due to acute toxicities.
Three weekly cisplatin, concomitant with radiation seems to be the potential, effective and acceptable alternate as standard of treatment for locally advanced carcinoma cervix; especially for increased work load and limited resource setups.