1. 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.
- Author
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Vorgias G, Profitis E, Sarris G, Strigou S, Kosmas C, Katsoulis M, Karamoussa E, Kalinoglou N, Koliarakis N, Dertimas B, Bafaloukos D, and Akrivos T
- Subjects
- Adult, Aged, Aged, 80 and over, Amifostine administration & dosage, Camptothecin administration & dosage, Camptothecin analogs & derivatives, Carcinoma, Adenosquamous drug therapy, Carcinoma, Adenosquamous radiotherapy, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell radiotherapy, Combined Modality Therapy, Feasibility Studies, Female, Humans, Interferon alpha-2, Interferon-alpha administration & dosage, Irinotecan, Middle Aged, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local radiotherapy, Neoplasm Staging, Pilot Projects, Preoperative Care, Prognosis, Radiotherapy Dosage, Recombinant Proteins, Survival Rate, Treatment Outcome, Uterine Cervical Neoplasms drug therapy, Uterine Cervical Neoplasms radiotherapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Adenosquamous surgery, Carcinoma, Squamous Cell surgery, Neoplasm Recurrence, Local surgery, Uterine Cervical Neoplasms surgery
- Abstract
Purpose: 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., Patients and Methods: 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., Results: 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)., Conclusion: 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.
- Published
- 2009