Phase II study of consolidation chemotherapy after concurrent chemoradiation in cervical cancer: preliminary results

Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):817-22. doi: 10.1016/j.ijrobp.2006.12.038. Epub 2007 Mar 26.

Abstract

Purpose: Our aim was to determine the efficacy of consolidation chemotherapy after concurrent chemoradiation (CCRT) using high-dose-rate brachytherapy in patients with locally advanced cervical carcinoma.

Methods and materials: Patients with cervical carcinoma (FIGO stage IB2-IVA) were treated with external beam radiation therapy to the whole pelvis (50.4 Gy) and high-dose-rate brachytherapy (24 Gy to point A). Cisplatin 60 mg/m(2) (Day 1) and 5-fluorouracil 1000 mg/m(2) (Days 1-5) were given every 3 weeks starting concurrently with the radiation and followed by 3 more cycles of consolidation for a total of 6 cycles.

Results: Thirty patients (94%) received 3 more cycles of post-CCRT consolidation chemotherapy and were evaluable for the toxicity and efficacy of consolidation. The most common toxicities of Grade 2 or higher were nausea or vomiting (47%) and anemia (33%). Late complications of the rectum and bladder occurred in 13% and 6% of the patients, respectively. The clinical complete response rate was 87% (95% CI, 75%-99%). During a median follow-up of 27 months (range, 6-58 months), 5 patients (17%) had recurrence; the sites of failure were 3 (10%) inside the radiation field and 2 (7%) outside the radiation field. The estimated 3-year progression-free survival rate was 83% (95% CI, 67%-99%) and overall survival rate was 91% (95% CI, 79%-100%).

Conclusions: Consolidation chemotherapy after CCRT is well tolerated and effective in patients with locally advanced cervical carcinoma. A prospective randomized trial to compare this treatment strategy with standard CCRT seems to be worthwhile.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Cisplatin / administration & dosage
  • Comorbidity
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Dose-Response Relationship, Drug
  • Female
  • Fluorouracil / administration & dosage
  • Gastrointestinal Diseases / epidemiology
  • Gemcitabine
  • Humans
  • Incidence
  • Korea / epidemiology
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / mortality*
  • Neoplasm Recurrence, Local / prevention & control
  • Prognosis
  • Radiation Injuries / epidemiology*
  • Radiation-Sensitizing Agents / administration & dosage
  • Radiotherapy, Adjuvant / mortality*
  • Risk Assessment / methods
  • Risk Factors
  • Survival Analysis
  • Survival Rate
  • Treatment Outcome
  • Uterine Cervical Neoplasms / mortality*
  • Uterine Cervical Neoplasms / therapy*

Substances

  • Antimetabolites, Antineoplastic
  • Radiation-Sensitizing Agents
  • Deoxycytidine
  • Cisplatin
  • Fluorouracil
  • Gemcitabine