Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel in patients with locally advanced uterine cervical cancer: The JACCRO GY-01 trial

- Uterine cervical cancer patients received concurrent radiotherapy.
- The cumulative linear quadratic equivalent irradiation dose was 62-65 Gy.
- In 68 patients, the complete response rate was 76.5% at the 27-month follow-up.
- The 2-year progression-free and overall survival was 83.8% and 92.7%, respectively.
- Treatment was efficacious and well tolerated, but phase III trials are warranted.

ObjectiveA multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer.MethodsPatients with FIGO stage III-IVA uterine cervical cancer without para-aortic lymphadenopathy were enrolled. Patients received definitive radiotherapy (RT) consisting of external beam whole-pelvic RT and high-dose-rate intracavitary brachytherapy. The cumulative linear quadratic equivalent dose was 62-65 Gy prescribed at point A. weekly CDDP at 30 mg/m2 and PTX at 50 mg/m2 were administered concurrently with RT for ≥ 5 courses.ResultsSixty-eight of the 70 registered patients were eligible. The complete response rate was 76.5% (95% confidence interval [CI], 66.4-86.6%). With a median follow-up of 27 months (range, 7.9-33.5), the 2-year cumulative progression-free survival and the 2-year cumulative overall survival rates were 83.8% (95% CI, 75.1-92.6%) and 92.7% (95% CI, 86.4-98.9%), respectively. The pelvic cumulative disease progression-free and the 2-year cumulative distant metastasis rates were 89.6% (95% CI, 82.3-96.9%) and 13.2% (95% CI, 5.2-21.3%), respectively. The 2-year cumulative late complication rates were 25% for all grades, 13.2% for grade 1, 5.9% for grade 2, 2.9% for grade 3, and 2.9% for grade 4.ConclusionsFor locally advanced cervical cancer, CCRT with weekly CDDP 30 mg/m2 and PTX at 50 mg/m2 demonstrated favorable antitumor activity, and was feasible and safe with respect to the protocol-specified serious adverse reactions and events. Evaluation of this regimen in phase III trials is warranted.