Phase II trial on neoadjuvant intravenous and trans-uterine arterial chemotherapy for locally advanced bulky cervical adenocarcinoma

Abstract Objective A phase II trial on neoadjuvant trans-uterine arterial chemotherapy (TUAC) followed by type III radical hysterectomy (RH) was conducted for patients with bulky cervical adenocarcinoma (AC). Methods Tumors of >4cm were eligible. The neoadjuvant regimen comprised paclitaxel (60mg/m 2 intravenously on days 1, 8, and 15) and cisplatin (70mg/m 2 TUAC followed by transcatheter embolization with gelatin sponge particles on day 2) repeated every 3weeks for 3cycles. The primary endpoints were clinical and pathological responses. Results Twenty-two patients (median age, 51years; range, 33–75years) were enrolled. The International Federation of Gynecology and Obstetrics stages were IB2 (9 patients), IIA–IIB (8), IIIB (3), and IVA (2). The adeno/adenosquamous ratio was 16/6. The overall clinical response rate was 95.4% (95% confidence interval [CI], 86.7–100%). RH was completed in 19 patients (86%), including 2 stage IVA patients who underwent anterior or posterior pelvic exenteration. Of the 19 patients, no residual malignant cells were found pathologically in 4; thus, the pathological complete response rate was 18% (4/22). No patients experienced grade 4 thrombocytopenia or febrile neutropenia or required platelet transfusions. The 5-year progression-free survival and overall survival rates in stages IB2–IIB were 70.0% (95%CI, 48.1–92.1%) and 69.5% (95%CI, 47.0–92.0%), respectively. The 2 patients with stage IVA tumors were alive without recurrence for 72 and 84months after enrollment. Conclusions TUAC showed high clinical and pathological response rates. TUAC is promising for stage IB2–IIB and IVA bulky AC.