A phase II trial of concurrent chemoradiaiton with paclitaxel/carboplatin in high-risk cervical cancer patients after radical hysterectomy: A multicenter prospective Korean study

Abstract

5598 Background: In 1999, five randomized studies demonstrated that cisplatin based chemoradiation had a benefit over radiotherapy in cervical cancer. However, paclitaxel has been known to be safe and effective as a radiosensitizer, and carboplatin to be less toxic than cisplatin with simpler administration. Therefore, the object of this study was to evaluate the 2 year disease free survival and toxicity of high risk cervical cancer patients who received chemoradiation with paclitaxel/carboplatin. Methods: Seventy-one patients with at least one high risk factor after radical hysterectomy (metastasis to pelvic lymph nodes (LNs), invasion of parametrial tissue (PMs), positive vaginal resection margin) were administered 135 mg/m2 of paclitaxel, carboplatin (AUC = 5) every 3 weeks for 3 cycles as an adjuvant treatment. Radiotherapy was concomitantly administered to the whole pelvic region in 28 fractions totaling 4.5∼5.4Gy. Results: Median age was 49 (range: 26–80). Seven women were dropped from the study due to noncompliance and two patients did not complete treatment due to anaphylactic shock and prolonged infection. In total, sixty-two patients completed the protocol treatment. Of 211 chemotherapy cycles administered, grade 3 or 4 neutropenia occurred in 85 (40.3%) and the majority were transient. Dose reductions were in 7 cycles due to prolonged (over 4 days) neutropenia (6), and elevated liver enzyme (1). Febrile neutropenia occurred in only two patients. 14 patients experienced grade 3 or 4 non-hematologic toxicities: 1 sensory neurotoxicity, 2 fatigue, 4 diarrhea, 3 allergic reaction, 2 genitourinary, 2 hepatic, with no treatment related deaths. With a median follow-up of 20.1 (16–28) months, 8 patients experienced recurrences, 2 distant lung metastasis and 6 pelvic side wall or paraaortic recurrences (DFS: 87.1%, 95CI:78.8∼95.4). Conclusions: Concurrent chemoradiation with paclitaxel/carboplatin is well tolerated and appears effective in early stage high risk cervical cancer patients. Considering the advantages of lower toxicity and shorter treatment schedule, this regimen shows promise and should be further tested on a larger number of patients with a prolonged follow-up. No significant financial relationships to disclose.