A phase II study of neoadjuvant radiochemotherapy followed by Surgery for locally advanced cervical cancer

Objective: We investigate the feasibility of chemoradiotherapy with paclitaxel and carboplatin before surgery and assess the response rate of the treatment regimen. Methods: This is a single-arm phase II trial of 52 patients, with locally advanced cervical cancer (stage Ib2-IIIB). Patients received radiotherapy (20Gy/10 fractions during Weeks 2) using a three-dimensional conformal radiation therapy or intensity-modulated radiation therapy technique plus brachytherapy (7Gy/fraction during Weeks 2) together with docetaxel: 20 mg/m(2)i.v., cisplatin: 40 mg/m2i.v. on Days 1, 8 and 15. The primary end point was response rate 12 weeks post-chemoradiotherapy. Results: Baseline characteristics were: median age at diagnosis 43 years old; 86.5% squamous, 13.5% adenocarcinoma; FIGO stage I-II (63.5%), III (36.15%). Complete or partial response rate was 69.2%, CRT showed potential benefit for CR+PR rate enhancement rate in all 52 cases (22/28, 78.6% vs 14/24, 58.3%; P=0.115). The median follow-up was 24 months. Overall and progression-free survivals at 3 years were 84.6% (44/52, 95% CI: 44-52) and 90.4% (47/52, 95% CI: 56-63), respectively. Survival status showed obvious differences in the positive of postoperative lymph-node group in comparison with negative of postoperative lymph-node group (66.7% vs 94.7%; P= 0.039 for 3-year OS; P= 0.049, 75.0% vs 92.8% for 3-year PFS) and showed obvious differences in the tumor diameters >= 5 cm group in comparison with tumor diameters <= 5 cm group(80.0% vs 96.9%; P= 0.045 for 3-year OS; P= 0.021, 70.0% vs 93.8% for 3-year PFS). The complications were observed without significant differences between the CRT and RT-alone groups (21.4% vs 20.8%, P= 0.782). Conclusion: This study confirms good response rate in locally advanced cervical cancer patients after chemoradiotherapy with paclitaxel and carboplatin. Our results indicate that this treatment regimen is feasible as evidenced by the acceptable toxicity of chemoradiotherapy and by the high compliance to radiotherapy.