ABSTRACT
PURPOSE: Concomitant chemoradiotherapy (CT/RT) is the gold standard for advanced cervical carcinoma, but with frequent debates over treatment schedules and toxicity. This study compared 2 concomitant CT/RT regimens in terms of quality of life (QoL) and acute toxicity. PATIENTS AND METHODS: Between March 2003 and March 2005, 335 patients with stage IIB-IIIB cervical carcinoma were evaluated in a randomized single-center phase III trial at the Oncology Institute Cluj-Napoca. Patients received concurrent CT/RT with cisplatin 20 mg/m(2), days 1-5, every 21 days (arm A, n=171) or 40 mg/m(2)/weekly (arm B, n=164). QoL was estimated using the EORTC QLQ-30, v.3.0 questionnaire and acute toxicity using the common toxicity criteria (CTC) v.2.0. RESULTS: Significant improvement of global health status (p <0.01) and a decrease in pain (p <0.01) was observed in arm A. In arm B fatigue increased (p=0.01) and role functioning diminished (p=0.05). In both arms depression, nausea, vomiting and diarrhea increased (p <0.05). Gastrointestinal toxicity was similar in both arms (76% vs. 77.5%). Hemoglobin drop was higher in arm B: 75% vs. 63% (p=0.02), while no differences were seen in leukocyte and platelet toxicity. CONCLUSION: Concomitant CT/RT with cisplatin 20 mg/m(2) x 5 days every 21 days has better impact on patients' QoL and lower toxicity compared with the weekly chemotherapy regimen.
Subject(s)
Carcinoma/therapy , Quality of Life , Uterine Cervical Neoplasms/therapy , Adult , Aged , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma/drug therapy , Carcinoma/radiotherapy , Cisplatin/adverse effects , Cisplatin/therapeutic use , Combined Modality Therapy/adverse effects , Female , Humans , Middle Aged , Radiation-Sensitizing Agents/adverse effects , Radiation-Sensitizing Agents/therapeutic use , Treatment Outcome , Uterine Cervical Neoplasms/drug therapy , Uterine Cervical Neoplasms/radiotherapyABSTRACT
PURPOSE: To evaluate the overall and disease-free survival of patients with advanced cervical carcinoma (FIGO stages IIB-IIIB) treated with external beam radiotherapy (EBRT) and medium dose rate brachytherapy (MDR-BT) plus/minus surgery. PATIENTS AND METHODS: One hundred and seven patients received preoperative RT (group A) and 154 were treated with definitive RT (group B); 73 patients in both groups also received cisplatin as radiosensitizer. EBRT delivered as preoperative reached a total dose of 44-46 Gy/pelvis, whereas the definitive RT reached a total dose of 62-64 Gy with standard fractionation. MDR-BT was performed with a LDR/MDR Cs-137 Selectron machine; 10 Gy/point A were delivered in the preoperative group A and 14 Gy/point A/, 1-2 fractions in group B. Cisplatin as radiosensitizer was administered during EBRT at a dose of 20 mg/m(2)/day for 5 days with 21 days interval between cycles. RESULTS: With a median follow-up of 44.4 months (range 3.4-61.6) the overall survival at 3 years in group A was 92% vs. 68% for group B (p<0.01). According to FIGO stages 3-year overall survival was 88% in stage IIB, 79% in IIIA and 60% in IIIB (p<0.01). Three-year local control was 73.5% (192 patients). Thirty-three (13%) patients developed locoregional recurrences, and another 8 (3.07%) locoregional recurrences plus distant metastases. CONCLUSION: The association of EBRT with MDR-BT represents an effective treatment in advanced cervical carcinoma. A significant difference in 3-year overall survival was found, favoring preoperative RT, with a very good rate of local control.
