Evaluation of the possible benefits of post-radiotherapy surgery after concomitant chemoradiotherapy with a new radio-sensitizing regimen (irinotecan / CPT-11, interferon A2b and amifostine) for advanced-stage cervical carcinoma. Preliminary results of a pilot phase-II study

• Published in: Journal of B.U. ON. Vol. 14; no. 2; p. 197
• Main Authors: Vorgias, G, Profitis, E, Sarris, G, Strigou, S, Kosmas, C, Katsoulis, M, Karamoussa, E, Kalinoglou, N, Koliarakis, N, Dertimas, B, Bafaloukos, D, Akrivos, T
• Format: Journal Article
• Language: English
• Published: Greece 01.04.2009
• Subjects: Adult; Aged; Aged, 80 and over; Amifostine - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Carcinoma, Adenosquamous - drug therapy; Carcinoma, Adenosquamous - radiotherapy; Carcinoma, Adenosquamous - surgery; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - radiotherapy; Carcinoma, Squamous Cell - surgery; Combined Modality Therapy; Feasibility Studies; Female; Humans; Interferon-alpha - administration & dosage; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - radiotherapy; Neoplasm Recurrence, Local - surgery; Neoplasm Staging; Pilot Projects; Preoperative Care; Prognosis; Radiotherapy Dosage; Recombinant Proteins; Survival Rate; Treatment Outcome; Uterine Cervical Neoplasms - drug therapy; Uterine Cervical Neoplasms - radiotherapy; Uterine Cervical Neoplasms - surgery
• ISSN: 1107-0625

This phase II pilot study was conducted to evaluate the results of a three-modality approach (which included post-chemoradiotherapy surgery) in advanced-stage cervical carcinomas. Thirty-six patients underwent either surgery or were put on follow-up after having received radical cervical radiotherapy (RT) combined with radiosensitizing chemoimmunotherapy with irinotecan (CPT-11), interferon (IFN) A2b, and amifostine. The last selection (surgery or follow-up) was based on clinical evaluation (downstaged or not). Feasibility, morbidity, surgical outcome and survival were evaluated. Twenty-six patients had stage IIb and 10 IIIb disease at diagnosis. Sixteen (44%) were clinically downstaged, thus becoming eligible for surgery. Twelve (33%) were operated and the others were put on follow-up. There was no significant increase in treatment-related morbidity of the group of patients receiving three-modality therapy, since only one intraoperative complication had occurred. In 58% of the operated patients, chemoradiotherapy-resistant tumor was found on pathology of the cervical specimens, while 29% of them had lymph nodes infiltrated by the tumor. After a median follow-up of 42.5 months, overall survival (OS) of operated vs. non-operated patients (88 vs. 56%, respectively) show only a trend toward significance (p=0.10). The overall recurrence/metastasis rate was 36.1% and the disease-free survival (DFS) 56% for operated vs. 76% for non-operated patients, respectively (p=0.63). These results indicate that post-chemoradiotherapy surgery is justified because of the high rate of residual disease found. Morbidity can be effectively limited with proper patient selection. A considerable survival benefit is expected, although this remains to be confirmed with phase III studies.