Concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy for women with locally advanced carcinoma of the uterine cervix--final results of a prospective phase II-study

Gynecol Oncol. 2006 Nov;103(2):494-9. doi: 10.1016/j.ygyno.2006.03.060. Epub 2006 Jun 30.

Abstract

Objectives: To evaluate the efficacy and toxicity of ifosfamide and cisplatin administered concomitantly with low-dose rate brachyradiotherapy followed by consolidation chemotherapy in the treatment of locally advanced squamous cell carcinoma (LASCC) or adeno/adenosquamous carcinoma of the uterine cervix.

Methods: Sixty-two patients with primary uterine cervical cancer were enrolled between August 1999 and November 2004. The patients had to have FIGO-stage IB2 bulky to IVA disease, biopsy-proven squamous cell or adeno/adenosquamous carcinoma of the uterine cervix. The patients were to receive external radiotherapy (50 Gy in 25 fractions); ifosfamide 2 g/m2 plus cisplatin 75 mg/m2 was applied concomitantly during two low-dose rate brachyradiotherapy applications; the planned dose to point A was 85 Gy in total. After the completion of radiotherapy, i.e. external and concomitant chemobrachyradiotherapy, four cycles of consolidation chemotherapy with the same drug combination were to be administered.

Results: The clinical complete response rate according to WHO-classification (assessed after the completion of the whole treatment procedures by gynecologic and radiologic evaluation and cervical biopsy) was 100%. After a median follow-up of 49 months (range 11-74 months), the recurrence-free and overall survival rates were 88.7%, respectively. The most frequent early toxicities were grade 3 and 4 leukopenias occurring in 25% and 11% of the cycles, respectively. Major delayed local complications occurred in 10 patients (16.1%).

Conclusion: These results indicate that concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy with the same drug combination is a highly efficacious and very promising treatment protocol for patients with locally advanced LASCC or adeno/adenosquamous carcinoma of the uterine cervix.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Brachytherapy / adverse effects
  • Brachytherapy / methods*
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Combined Modality Therapy
  • Disease-Free Survival
  • Dose Fractionation, Radiation
  • Drug Administration Schedule
  • Female
  • Humans
  • Ifosfamide / administration & dosage
  • Ifosfamide / adverse effects
  • Middle Aged
  • Neoplasm Staging
  • Prospective Studies
  • Uterine Cervical Neoplasms / drug therapy*
  • Uterine Cervical Neoplasms / pathology
  • Uterine Cervical Neoplasms / radiotherapy*

Substances

  • Cisplatin
  • Ifosfamide