Multimodality approach in extra cervical locally advanced cervical cancer: chemoradiation, surgery and intra-operative radiation therapy. A phase II trial

Eur J Surg Oncol. 2011 May;37(5):442-7. doi: 10.1016/j.ejso.2011.02.011.

Abstract

Background: The goal of this study was to determine the rational of radical surgery with intra-operative high-dose radiotherapy after chemoradiation (RT-CT) in extra cervical locally advanced cervical cancer (LACC) patients.

Methods: Between 2000 and 2007, 42 LACC (stage IIA bulky-IVA) patients were treated at the Gynecologic Oncology Unit of the C.R.O. of Aviano in a Phase II Clinical Trial. Radiotherapy was administered to the whole pelvic region (50.4 Gy in 28 fractions) in combination with cisplatin (60 mg/mq) plus 5FU (750 mg/mq for 4 days) on first and fifth week of RT. Radical surgery with Intra-Operative Radiation Therapy (IORT) was performed 6-8 weeks after the end of RT-CT treatment.

Results: After RT-CT, 35/42 patients (83%) underwent radical surgery and IORT treatment. At pathologic examination 8/35 (23%) patients showed complete response, while the rest (27/35) had residual disease either microscopic (17/27) or gross (10/27). The 5-year disease free survival (DFS) and the 5-year overall survival (OS) were 46% and 49% respectively. There were significant better DFS and OS when residual tumor was absent or limited to the cervix, respectively 78% versus 16% and 81% versus 20% (p < 0.001). All recurrences occurred within 24 months from treatment.

Conclusions: RT-CT followed by surgery and IORT in LACC patients seems to be active in a subgroup of patients with pathological complete response to treatment or partial response with residual tumor limited to the cervix.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemotherapy, Adjuvant / adverse effects
  • Chemotherapy, Adjuvant / methods
  • Chi-Square Distribution
  • Cisplatin / administration & dosage
  • Disease-Free Survival
  • Dose Fractionation, Radiation
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Intraoperative Period
  • Kaplan-Meier Estimate
  • Middle Aged
  • Neoadjuvant Therapy / methods*
  • Neoplasm Recurrence, Local / therapy
  • Neoplasm Staging
  • Neoplasm, Residual / pathology*
  • Neoplasm, Residual / therapy*
  • Prognosis
  • Radiotherapy, Adjuvant / adverse effects
  • Radiotherapy, Adjuvant / methods
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Uterine Cervical Neoplasms / drug therapy
  • Uterine Cervical Neoplasms / mortality
  • Uterine Cervical Neoplasms / pathology*
  • Uterine Cervical Neoplasms / radiotherapy
  • Uterine Cervical Neoplasms / surgery
  • Uterine Cervical Neoplasms / therapy*

Substances

  • Cisplatin
  • Fluorouracil