Abstract

A STUDY OF COX-2 INHIBITOR CELECOXIB AND CHEMORADIATION IN PATIENTS WITH LOCALLY ADVANCED CERVICAL CANCER

Author(s): Kuppa Prakash1, M. Venkatesh2, M. Vijaya Kumar3

AIMS AND OBJECTIVES
To evaluate efficacy of concurrent oral Cox-2 Inhibitor (celecoxib) and chemoradiation in locoregional control, distant control, disease free survival and/or overall survival in patients with locally advanced cervical cancer. To determine treatment related toxicity rates in patients with locally advanced cervical cancer treated by oral celecoxib, intravenous cisplatin and concurrent pelvic radiation therapy.
MATERIALS AND METHODS
Study was done for a period of 2 years in a tertiary care cancer hospital which caters to the cancer patients. Advanced squamous, adenocarcinoma or adenosquamous carcinoma of uterine cervix, Patients with age <70 years, ECOG performance status 0-2, Normal haematological investigations, Normal renal function test, Normal liver function test, No disease outside of pelvis.
RESULTS
This prospective study consisted 30 patients, 15 patients on either arm. Overall pooled mean age for both study and comparison group was 50.3 years with a probability value P=0.91 for age. 14 patients (93.33%) in both the arms had a performance status of ECOG 0 or 1 and 1 patient in both arms had ECOG PS-2. Stage distribution of the patients in study arm was 3 in IB2, 2 in IIA, 5 in IIB, 4 in III and 1 in stage IVA. In control arm, out of the 15 patients 2 are in IB2, 2 in IIA, 5 in IIB, 5 in III and 1 in stage IVA. The mean probability value was P=0.65 for stage distribution. 15 patients in arm-A (study arm) received pelvic RT 50Gy 2Gy/Fr 5#/week followed by HDR –ICR 3 Fr. 700 cGy/Fr after pelvic RT on an average of 1 week along with weekly cisplatin 40 mg/m2 (50 mg) (D1, D8, D15, D22) and Cox-2 inhibitor oral celecoxib 400 mg twice daily (800 mg/d) starting from day 1 to throughout the duration of the chemoradiation. 15 patients in arm-B (Control arm) received pelvic RT 50Gy 2Gy/Fr 5#/week followed by HDR –ICR 3 Fr. 700 cGy/Fr on an average of 1 week after pelvic RT along with weekly cisplatin 40 mg/m2 (50 mg) (D1, D8, D15, D22). The probability value (86.67% vs. 73.33%) was P=0.37 for local control, which is not significant. 2 patients (13.33%) failed at local control in study arm and 4 patients (26.67%) failed locally in control arm. In both arms, 4 patients (26.67%) had local/distant relapse. The probability value P=1.00 for local /distant relapse, non-significant, but locoregional control is high in study arm compared to control arm with a probability value P=0.37 which is not significant. Most of the relapses were observed with stage III and stage IVA disease. The median time to response from the end of the radiation was 3 months.
CONCLUSION
Celecoxib is a safe drug to use along with chemoradiation without any serious cardiovascular side effects.