Background: The development of distant metastases of squamous cell carcinoma of the anal canal (SCCA) is rare but has a poor prognosis. A combination of carboplatin and paclitaxel is commonly used for treating squamous cell cancer in different organs, but its efficacy in advanced SCCA is unclear. The objective of this study is to determine the tolerability and outcome of patients with advanced SCCA on carboplatin plus paclitaxel treatment at the Moffitt Cancer Center. Methods: Retrospective analysis was conducted by looking at records from the Moffitt Cancer Center Tumor Registry from January 2007 to January 2012. Eligible patients had to have a diagnosis of SCCA and have received carboplatin plus paclitaxel every 3 weeks as part of the treatment plan. Results: Eighteen patients fulfilled the criteria; 14 were initially diagnosed with early-stage disease and received concurrent chemoradiation, but then relapsed. Median age was 56 years. Upon diagnosis of metastatic disease, 12 patients received carboplatin plus paclitaxel as a first-line treatment. Five patients had received prior systemic chemotherapy regimens and 1 had received prior local regional therapy. The response rate was high at 53% including 3 patients who achieved a complete response. Median overall survival was 12.19 months. Conclusions: Carboplatin and paclitaxel treatment shows encouraging activity in advanced SCCA.

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Background: Although squamous cell anal carcinomas are relatively rare, their incidence has been increasing steadily. Because of the limited data, treatment of metastatic disease is a major therapeutic challenge. In this study, we report the safety and efficacy of epidermal growth factor receptor (EGFR) inhibitors in patients with advanced squamous cell anal carcinomas. Method: A retrospective analysis was conducted using the Moffitt Cancer Tumor Registry from January 2009 to January 2014. Eligible patients had diagnosis of advanced squamous cell anal carcinomas and received an EGFR inhibitor as part of their treatment. Result: A total of 13 patients were identified for analysis. All of them received concurrent chemoradiation as initial treatment and subsequently had recurrence. Five patients received single agent cetuximab or panitumumab, and the others received cetuximab or panitumumab with irinotecan or FOLFIRI. The objective response rate was 30.8% including 1 complete response, and the disease control rate was 46.2%. With a median follow-up of 9.6 months, the median progression-free survival and median overall survival were 4.4 months and 11.4 months, respectively. Conclusion: Our analysis suggests that EGFR inhibitors have potential efficacy and are reasonably well tolerated in patients with squamous cell anal carcinomas. These findings warrant further evaluation in a large prospective trial.

e14519 Background: FOLFIRINOX resulted in significant improvement in survival in a recent phase III trial. However, the toxicity associated with its use may be significant. Theobjectives of this study were to determine the tolerability and outcome in patients with advanced PCA treated with FOLFIRINOX in 3 cancer centers in the USA. Methods: This was a retrospective analysis in pts with PCA treated with FOLFIRINOX at Karmanos Cancer Center (Detroit, MI), University of Michigan (Ann Arbor, MI) and Moffitt Cancer Center (Tampa, FL) from 2010 to 2012. Results: 54 patients with advanced PCA (61%males, median age 57.5 years [range 34-73], 72 % Caucasians) were evaluable. 67% of the primary tumors were in the head of the pancreas and 48% of patients had biliary stents prior to treatment. ECOG performance status (PS) was 0-1 in 91%. 91% of the patients had stage IV disease mostly with liver metastases. The median number of cycles received per patient was 5 (1-24). At the outset of treatment, bolus 5FU was omitted in 15% of pts and granulocyte growth factor was given in 89% of the cases. 80% of patients experienced at least one grade 1 or 2 toxicity (fatigue in 44%). Grade 3 toxicities occurred in 26 (48%) pts (fatigue [9]; neutropenia [7]; vomiting [7]; diarrhea [5]; neuropathy [4]; anemia [4]; thrombocytopenia [2] and infection [2]). 13% of patients (7) experienced grade 4 toxicities (vomiting [3]; febrile neutropenia [2] and neutropenia [2]). There was no grade 5 toxicity. Dose reduction was necessary in 87% of pts. 17% of pts required hospitalization during treatment. Partial responses were documented in 39% and stable disease in 29%. Side effects were the reason for treatment discontinuation in 35% of this population. Median PFS and OS were 3.8 (0.9 – 13.6) and 7.2 (0.5 – 17.8) months, respectively. Conclusions: In this multi-institutional experience in pts with PCA, significant grade 3 and 4 toxicities were associated with the FOLFIRINOX regimen leading to treatment discontinuation in a third of the population. PFS and OS represented a modest improvement over what would be expected from using single agent gemcitabine despite the relatively high objective response rate.