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Concomitant Chemobrachyradiotherapy with Ifosfamide and Cisplatin Followed by Consolidation Chemotherapy in Locally Advanced Squamous Cell Carcinoma (LASCC) of the Cervix Uteri: Results of a Phase II Study

Objective: Cisplatin-based concomitant chemoradiation is nowadays the standard treatment for LASCC of the cervix, but the optimal chemotherapy regimen, the optimal chemotherapy scheduling and the impact of the addition of adjuvant chemotherapy have yet to be determined. Ifosfamide exerts synergistic-additive effects when given concurrently with LDR-brachytherapy. Thus, we evaluated the efficacy and toxicity of ifosfamide and cisplatin administered concomitantly with low dose rate (LDR) brachytherapy followed by consolidation chemotherapy in the treatment of LASCC. Methods: Ifosfamide 2g/m2 (24 hr infusion) + cisplatin 75mg/m2 (1 hr infusion) were applied during two LDR brachytherapy applications, and four cycles of consolidation chemotherapy with ifosfamide 2g/m2 (3 hr infusion) (days 1-3) + cisplatin 75mg/m2 were given after completion of radiotherapy. The planned dose to point A was 85Gy. Results: 41 patients (median age: 49 years) with biopsy proven LASCC of the cervix uteri were enrolled. FIGO stage was IB2 in 7 (17%), IIA in 6 (15%), IIB in 18 (44%), IIIB in 9 (22%), and IVA in 1 patient (2%). All patients received both courses of concomitant chemobrachytherapy and at least one cycle of consolidation chemotherapy. The average duration of radiation was 45.3 days. The clinical complete response rate, determined by cervical biopsies, CT scans and clinical examination, was 100%. Leukopenia Grade III/IV occurred in 25% and 11% of the cycles, respectively. After a median follow-up of 19 (4-34) months the recurrence-free and the overall survival rates were 95% and 98%, respectively. Major delayed local complications, i.e. postradiation proctitis, cystitis or fistulae, occurred in five cases (12%). Conclusions: These results indicate that concomitant chemobrachyradiotherapy with ifosfamide and cisplatin is an extremely effective treatment for patients with LASCC of the cervix uteri. A prospective, randomized phase III trial comparing this regimen vs. the standard treatment with weekly cisplatin during external radiation is strongly warranted.

cisplatin; ifosfamide; concomitant chemoradiation; cervix cancer

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