Concomitant chemoradiotherapy with Cisplatin plus 5-Fluorouracil for anal squamous cell carcinoma.

Objective: The objective of this study was to evaluate the results of combined chemoradiotherapy using 5-fluorouracil and cisplatin with radiation in treatment of anal squamous cell carcinoma in terms of local control, survival, and toxicity.

Patients And Methods: This study included 32 patients with histologically confirmed locally advanced anal squamous cell carcinoma (T1-4 with any N). They received chemotherapy consisted of 5-fluorouracil 1000 mg/m(2)/day on the first 5 and last 5 days of RT, cisplatin 75 mg/m(2) on days 2 and 30. External beam RT consisted of 45Gy/f/25 sessions/5 sessions per week. A boost of 9Gy/5 sessions was given to those who developed complete or partial response.

Results: Median age was 55 years with female to male ratio 2.2:1. Fifty-six percent of them had ECOGPS of 1; moderately differentiated pathology was the most common one (53 %). Thirteen patients (40.6 %) presented with N0 and 56 % presented with T2. None of the patients died of acute complications and none developed grade 4 toxicity. Non-hematological complications were more common than hematological ones. Dermatitis was the most common toxicity (59.3 %) than diarrhea and neurologic one (40.7 %). Anemia was the most frequent hematological adverse event (37.5 %). Complete response was reported in 81.2 %. After median follow-up of 25 months, local recurrence was observed in five patients (15.6 %) as the following: three in the anal canal and two in the inguinal lymph nodes. Three patients (9.4 %) developed distant metastasis (two in the liver and one in the lung), while one patient (3 %) had both local and distant metastases. Three-year overall survival rate (OS) was 81.3 %, while 3-year progression-free survival (PFS) rate was 72 %, and colostomy-free survival was 90 %.

Conclusion: Concomitant chemoradiotherapy of 5-fluorouracil and cisplatin with radiotherapy is a highly effective and well-tolerated treatment of anal cancer. But further studies with larger number of patients are needed to support the indication to treat anal cancer using this regimen.