Original Article Organ-preserving multimodality management of squamous cell carcinoma of anal canal S V S Deo, N K Shukla, V Raina,* B K Mohanti,** Rajeev Sharan, Madhabananda Kar, G K Rath* Departments of Surgical Oncology, **Medical Oncology and *Radiation Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110 029 Aim: To study the efficacy of an organ-preserving, sequential chemoradiation therapy for squamous cell carcinoma of the anal canal, and of salvage surgery in those in whom this treatment fails. Methods: Forty biopsy-proven untreated patients (28 men) with squamous cell carcinoma of the anal canal received two cycles of chemotherapy using cisplatin and methotrexate, followed by 45 to 60 (median 50) Gy external beam radiotherapy. Salvage surgery was offered to those in whom this treatment failed. Overall survival, disease-free survival and colostomy-free survival were analyzed. Results: Most patients (n=35; 87%) had T3 or T4 lesions and 5 (12.5%) had involvement of inguinal nodes. Thirty-one patients (77.5%) had complete response after chemoradiation. Only three patients (7.5%) developed chemotherapy-related grade 3 mucositis and myelosuppression. Radiotherapy- related toxicity included grade III cystitis in one patient and grade III proctitis in three patients. Three patients had post-treatment anal stenosis requiring repeated dilatation and two had chronic non-healing ulcers at the anal verge. Nine patients had failure of chemoradiation or disease recurrence; of these, only 5 could undergo salvage surgery. After a median follow up of 60 months, overall survival, disease-free survival and colostomy-free survival were 80%, 77.5% and 72.5%, respectively. Conclusion: Chemoradiation is effective in the treatment of squamous cell anal cancer and has acceptable toxicity. Surgical salvage may be useful in those with failure of this treatment. [Indian J Gastroenterol 2005;24:201-204] A nal cancer (AC) accounts for 1%-2% of all large bowel cancers. During the last three decades, the standard of care in this disease has shifted from radical surgery to organ-preserving chemoradiation- based protocols. 1 The 5-year survival rate in patients with AC after radical surgery like abdomino-perineal resection alone was only 40%-60%. 2 Combined- modality approach (CMT), which was initially propagated by Nigro et al 3 in 1974 as a pre-operative regimen, has now evolved into a stand-alone treatment Copyright © 2005 by Indian Society of Gastroenterology program. 4,5 Using this treatment, complete and sustained tumor eradication with sphincter preservation has been reported in 75%-90% of patients with AC. 5,6,7 Therefore, the role of surgery in patients with AC is now limited to salvaging those who fail CMT. 5,6,8 In this study, we looked at the results of combined chemoradiotherapy in patients with AC. Methods Between 1990 and 1997, 68 previously untreated patients with AC attended the Gastrointestinal Can- cer Clinic. Of these, 28 patients had metastatic dis- ease, significant co-morbid conditions, Kornofsky performance score below 70, or adenocarcinoma, and were excluded. The remaining 40 patients were included in the study and were followed up till 2004. All patients underwent clinical and proctoscopic examination of the anal canal and rectum. Computed tomography examination of the abdomen and pelvis, chest X-ray, hemogram, and renal and liver function tests were done. Punch biopsy of the primary growth and fine-needle aspiration cytology of suspicious lymph nodes in the groin was done. Ethical clearance was obtained from the institution and all patients gave informed consent for inclusion in this protocol be- fore start of treatment. A sequential chemoradiotherapy protocol using 2 cycles of chemotherapy followed by radiotherapy was followed. Patients with either no response or presence of residual disease were considered for salvage surgery. Chemotherapy protocol Chemotherapy consisted of two cycles of intrave- nous cisplatin 30 mg/m 2 for three days and intrave- nous methotrexate 200 mg/m 2 given as a bolus on day 1, with parenteral hydration of at least 1 liter. Sufficient hydration was done to ensure urinary output of 100 mL per hour during and 4 hours after the infusion of cisplatin. Anti-emetic drugs were admin- istered during chemotherapy. The cycle was repeated after three weeks.