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Long-Term Results of a Phase II Trial of Concomitant Cisplatin-Paclitaxel Chemoradiation in Locally Advanced Cervical Cancer
  1. María Isabel Martínez-Fernández, MD,
  2. Jairo Legaspi Folgueira, MD,
  3. Germán Valtueña Peydró, MD,
  4. Mauricio Cambeiro, MD,
  5. Jaime Espinós, MD,
  6. José Manuel Aramendía, MD,
  7. José A. Minguez-Milio, MD and
  8. Rafael Martínez-Monge, MD
  1. * Departments of Oncology and
  2. Gynecology and Obstetrics, Clínica Universidad de Navarra, University of Navarra, Pamplona, Navarre, Spain.
  1. Address correspondence and reprint requests to Rafael Martínez-Monge, MD, Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Avda Pío XII s/n, Pamplona, Navarre, Spain. E-mail: rmartinezm{at}unav.es.

Abstract

Objectives The aim of this study was to determine the long-term results of a 7-week schedule of external beam radiation therapy, high dose rate brachytherapy, and weekly cisplatin and paclitaxel in patients with locally advanced carcinoma of the cervix.

Methods Thirty-seven patients with International Federation of Gynecology and Obstetrics stages IB2 to IVa cervical cancer were treated with 40 mg/m2 per week of intravenous cisplatin and 50 mg/m2 per week of intravenous paclitaxel combined with 45 Gy of pelvic external beam radiation therapy and 28 to 30 Gy of high dose rate brachytherapy.

Results Sixteen patients (43.2%) were able to complete the 6 scheduled cycles of chemotherapy. The median number of weekly chemotherapy cycles administered was 5. Thirty-six (16.2%) of 222 cycles of chemotherapy were not given because of toxicity. The mean dose intensity of cisplatin was 29.6 mg/m2 per week (95% confidence interval, 27.0–32.1); that of paclitaxel was 40.0 mg/m2 per week (95% confidence interval, 36.9–43.1). Thirty-four patients (91.8%) completed the planned radiation course in less than 7 weeks. Median radiation treatment length was 43 days. After a median follow-up of 6 years, 7 patients (18.9%) experienced severe (RTOG grade 3 or higher) late toxicity. No fatal events were observed. Ten patients have failed, 1 locally and 9 at distant sites. The 14-year locoregional control rate was 96.7%, and the 14-year freedom from systemic failure rate was 64.6%. Fourteen-year actuarial disease-free survival and overall survival rates were 44.8% and 50%, respectively.

Conclusions This study demonstrates excellent very long-term results and tolerable toxicity although the target weekly dosage of cisplatin and paclitaxel needs to be adjusted in the majority of the patients.

  • Cisplatin
  • Paclitaxel
  • Chemoradiation
  • Locally advanced cervical cancer

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Footnotes

  • The authors declare no conflicts of interest.

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