Concurrent chemo-radiotherapy for locally advanced cervical cancer: A prospective randomized trial comparing cis-platinum vs paclitaxel

5163 Introduction: This study prospectively compares weekly Cis-platinum to weekly Paclitaxel as concurrent chemotherapy with radiotherapy in patients with locally advanced cervical cancer. Methods: 33 women (Stage IB2-IVA) were randomized to receive, on a weekly basis, either 40mg/m2 Cis-platinum or 50 mg/m2 Paclitaxel (TAXOLR) during radiotherapy. Response rate, progression free survival, Kaplan Meier survival, and toxicity were compared. p < 00.5 was considered significant. Results: 16 patients received Cis-platinum (group 1) and 17 patients Taxol (group 2). The age (54.4 ± 13.6 and 52.8 ± 13.3 yrs respectively), stage, mean diameter of the lesion (5.0 ± 1.4 Vs 5.5 ± 2.2 cm respectively), and performance status were similar. The mean number of chemotherapy cycles was also comparable [4.6 ± 0.9, (range: 3–6) Vs 4.3 ± 1.3 (range:1–6)] with 87.5 % and 80% of patient receiving ≥ 4 doses respectively. Two patients in group 1 had grade II transient peripheral neuropathy. In group 2, two patients had an allergic reaction. 36.6% Vs 54.0% in groups 1 and 2 respectively had grade 3 and 4 diarrhea. The mean dose of radiotherapy to point A was comparable in both groups (74.0 ± 11.3 and 71 ± 18.2 Gy respectively). The mean duration of treament was also similar (53.1 ± 9.9 Vs 55.8 ± 9.0 days respectively, p=0.56). In the Cis-platinum group, five patients (31.3%) recurred, four outside the pelvis (local control:75.0%)]. In the Taxol group eight patients had either progressive disease or recurrred (total 8/17 or 47%), two distally (local control:.11/17: 64.7%), with no signifcant differrence in the local control between the two groups (p= 0.52). The mean time to progression was comparable (31.0 Vs 26.1 months (p=0.64) respectively. The 2 and 3 years survival for Cisplatinum were 63% and 33.86% respectively while for the Taxol they were 71.50% and 53.63% respectively. The projected mean survival was also similar (41 and 36 months respectively, p=0.36). Conclusions: Both chemotherapy regimen provided a good local control with different toxicity profiles. Failure due to distant metastasis is still high. Consideration should be given to systemic adjuvant chemotherapy post concurrent chemoradiotherapy. No significant financial relationships to disclose.