Phase II study of perioperative combination chemotherapy with triweekly carboplatin and weekly dose dense paclitaxel and radical hysterectomy for locally advanced cervical cancer (SGSG-016 study).

Abstract

e17022 Background: The primary objective of this study was to assess efficacy and safety of triweekly carboplatin plus weekly dose dense paclitaxel (ddTC therapy) before and after radical hysterectomy without radiotherapy (RH) for women with locally advanced cervical cancer. Methods: Patients with FIGO stage IB2, IIA2, or IIB cervical cancer received 3 cycles of carboplatin at an area under the curve of 6 on day 1 and paclitaxel at 80mg/m2on day 1, 8, and 15 every 21 days followed by RH. Patients with one or more high-risk factors for recurrence including lymph vascular invasion, parametrial invasion, lymph node matastasis, or positive margin received additional 3 cycles of ddTC therapy after RH. Results: Between September 2014 and July 2016, 50 women including 13 with FIGO stage Ib2, 5 with stage IIa2, and 32 with stage IIb were enrolled in this study. There were 37 squamous cell carcinoma, 10 adenocarcinoma, 2 adenosquamous carcinoma, and 1 large cell neuroendocrine carcinoma. Median age was 46 years (range 30-78). Forty-three women (86%) completed planed 3 cycled of chemotherapy before surgery. The overall response rate was 92% (18 complete response, 28 partial response, 3 stable disease, 1 progressive disease). Forty-nine patients (98%) completed planed radical hystsrectomy, but a patient with invasion to bladder musculature received concurrent radiation therapy instead of surgery. Eleven patients (22%; 10 with SCC, 1 with large cell neuroendocrine carcinoma) achieved pathological complete response. Eleven other patients with one or more high-risk factors received 3 cycles of ddTC therapy after surgery. Grade 3/4 hematological toxicities included neutrocytopenia (58%), thrombocytopenia (2%) and anemia (24%). One patients experienced neutropenic fever. Grade 3/4 non-hematological toxicities were observed in 4 patients (1, grade 3 nausea; 1, grade3 carboplatin allergy; 1, grade 3 paclitaxel allergy; 1 grade 3 elevetaed liver enzyme). Conclusions: Administration of ddTC therapy before and after RH has good efficacy and acceptable toxicity in women with locally advanced cervical cancer. Clinical trial information: UMIN000024136.