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Randomized Phase 3 Trial Comparing 2 Cisplatin Dose Schedules in 326 Patients With Locally Advanced Squamous Cell Cervical Carcinoma: Long-Term Follow-Up
  1. Viorica Magdalena Nagy, PhD, MD*,,
  2. Claudia Ordeanu, PhD, MD*,
  3. Ovidiu Coza, PhD, MD*,,
  4. Cristian Rancea Alin, PhD, MD*,,
  5. Alexandru Traila, PhD, MD* and
  6. Nicolae Todor, PhD*
  1. *Oncology Institute“Prof. Dr. Ion Chiricuţâ”, Cluj-Napoca, Romania, and
  2. University of Medicine and Pharmacy“Iuliu Haţieganu”, Cluj-Napoca, Romania.
  1. Address correspondence and reprint requests to Nicolae Todor, PhD, Oncology Institute “Prof. Dr. Ion Chiricuţâ”, Cluj-Napoca, Romania. E-mail: todor@iocn.ro.

Abstract

Objective The evaluation of 5-year results obtained through 2 radiochemotherapy (RCT) regimens: cisplatin (CDDP), 20 mg/m2 × 5 days every 21 days; and CDDP, 40 mg/m2 per week in locally advanced cervical carcinoma.

Methods/Materials In this single-institution prospective randomized phase 3 study, 326 patients with stage IIB to IIIB squamous cell cervical carcinoma treated from March 2003 to March 2005 were included. One hundred sixty patients (49%) had stage IIB cervical carcinoma, 103 patients (31.5%) had stage IIIA cervical carcinoma, and 63 patients (19.5%) had stage IIIB cervical carcinoma. The patients were randomly assigned to 2 therapeutic arms: 164 patients in arm A (5 days) concurrent RCT with CDDP, 20 mg/m2 per day, days 1 to 5 every 21 days; and 162 patients in arm B (weekly), concurrent RCT with CDDP, 40 mg/m2 per day weekly. All patients were treated with external beam radiotherapy on the abdominopelvic region using 15-MV x-rays and a cervical boost using the x-rays arch technique or medium-dose-rate intracavitary brachytherapy.

Results The 5-year survival rate obtained through the 2 RCT regimens are not statistically different, even if a tendency of superiority can be observed in the 5-day arm as far as overall survival (78% in arm A vs 72% in arm B; p = 0.14) and disease-free survival (73% in arm A and 69% in arm B; p = 0.09) are concerned. Five-year local relapse-free survival was significantly superior in the 5-day CDDP arm (87%) in comparison with the weekly CDDP arm (77%); p < 0.01. In the 5-day arm, local relapse rate was twice lower, 21/164 (13%), compared with the weekly arm, 40/162 (25%); p < 0.01). Distance failures were identical in the 2 therapeutic groups: 22/164 (13%) and 21/162 (13%), respectively, which shows the superiority of arm A regarding local control.

Conclusions The results of our study demonstrate that RCT with cisplatin, 20 mg/m2 × 5 days every 21 days, is superior regarding local efficacy and is less toxic compared with the weekly chemotherapy regimen.

  • Cervical cancer
  • Concomitant radio-chemotherapy
  • Cisplatin

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Footnotes

  • The authors declare no conflicts of interest.

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