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

Gynecol Oncol. 2013 Apr;129(1):129-34. doi: 10.1016/j.ygyno.2013.01.007. Epub 2013 Jan 17.

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 >4 cm were eligible. The neoadjuvant regimen comprised paclitaxel (60 mg/m(2) intravenously on days 1, 8, and 15) and cisplatin (70 mg/m(2) TUAC followed by transcatheter embolization with gelatin sponge particles on day 2) repeated every 3 weeks for 3 cycles. The primary endpoints were clinical and pathological responses.

Results: Twenty-two patients (median age, 51 years; range, 33-75 years) 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 84 months after enrollment.

Conclusions: TUAC showed high clinical and pathological response rates. TUAC is promising for stage IB2-IIB and IVA bulky AC.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / mortality
  • Adenocarcinoma / pathology
  • Adenocarcinoma / therapy
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Cisplatin / administration & dosage
  • Disease-Free Survival
  • Embolization, Therapeutic
  • Female
  • Humans
  • Middle Aged
  • Neoadjuvant Therapy*
  • Neoplasm Staging
  • Paclitaxel / administration & dosage
  • Retrospective Studies
  • Uterine Cervical Neoplasms / drug therapy*
  • Uterine Cervical Neoplasms / mortality
  • Uterine Cervical Neoplasms / pathology
  • Uterine Cervical Neoplasms / therapy

Substances

  • Paclitaxel
  • Cisplatin