PurposeA proportion of patients with metastatic colorectal cancer (mCRC) are still able to continue with active therapy after their progression to fluoropyrimidines, oxaliplatin, and irinotecan regimens. Studies suggest that gemcitabine and fluoropyrimidines are synergic antimetabolites. The purpose was to evaluate gemcitabine–capecitabine (Gem–Cape) in heavily pretreated mCRC and to thus assess possible predictive factors for progression-free survival (PFS) and overall survival (OS). Patients and methodsThis analysis was performed on 119 evaluable patients pretreated with fluoropyrimidines, oxaliplatin, irinotecan, and biological agents between June 2001 and July 2011. Patients received gemcitabine 1,000 mg/m2 day 1 and capecitabine 1,000 mg/m2bid for 7 days every 2 weeks.ResultsThe general characteristics were ECOG 0–1, 89 %; male, 68 %, and median age 63 years. In total, 61 % had received two chemotherapy lines, while 39 % had received three or more. Objective response rates and stable disease rates at 3 months were 6.72 and 37.81 %, equalling a clinical benefit of 44.53 %. The median PFS and OS were 2.87 months [95 % confidence interval (CI) 2.53–3.17 months] and 6.53 months (95 % CI 5.33–8.77), respectively. The most frequent toxicities were grades 1–2, anemia (22 %), thrombocytopenia (10 %), and hand–foot syndrome (9 %); grade ≥3, diarrhea (2 %), with no treatment-related discontinuations. No treatment-related deaths were reported. Statistical significance was obtained by subgroups, assessing clinical benefits and objective responses for PFS and OS. Moreover, patients under 65 tended to have a better PFS.ConclusionThese data suggest that Gem–Cape is a tolerable and feasible regimen, associated with clinical benefit in non-selected, heavily pretreated, mCRC patients.

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10598 Background: GEICAM 9906 interim analysis showed FECP improved disease-free survival (DFS) compared to FEC (SABCS 2005, abstract #39). As a secondary objective, predictive markers were centrally determined and DFS of subgroups analyzed. A prior report from CALGB 9344 trial suggested that patients (pt) with HER2+ tumors get the maximum benefit with adjuvant P (ASCO 2006, abstract #510). We aimed to confirm this finding in our dataset. Methods: 1248 node + pt received 6 q3wk cycles (cy) of FEC (600/90/600 mg/m2) or 4 cy of same FEC followed by 8 wk cy of P (100 mg/m2). Tumor paraffin-embedded blocks were prospectively collected from 889 pt (71%) for Tissue Microarrays. Statistical analysis used Kaplan-Meier estimates for DFS by treatment group at a median follow-up (FU) of 65 months (m). HER2 status was evaluated by FISH. HR status was determined by IHC, following Allred criteria. Results: At a median of 65 m FU, DFS for FECP remains better than FEC (79% vs. 72%; p=0.0042; HR= 0.71). HER2: DFS for HER2+ and HER2- pt were 66% vs. 78% (p=0.0008; HR= 0.60). HER2+ subgroup (n=177): DFS with FECP and FEC were 63% vs. 70% [p=0.5187, HR=1.18 (0.71–1.98)]. HER2- subgroup (n=712): FECP was significantly better than FEC [82% vs. 74%, p=0.0075; HR=0.65 (0.48–0.89)]. HR: DFS for HR+ and HR- pt were 80% vs. 68% (p<0.0001; HR= 0.52). HR+ subgroup (n=561): DFS with FECP and FEC were 82% vs. 79%, [p=0.2162; HR=0.79 (0.54–1.15)]. HR- subgroup (n=311): DFS was 72% vs. 65% [p=0.1633, HR=0.76 (0.51–1.12)]. DFS data in the four HER2/HR subgroups is summarized in the table . Conclusions: FECP is superior to FEC mostly in HER2-HR- (triple negative) tumors. Our subgroup analysis does not support the superiority of the paclitaxel-containing arm (FECP) in pt with HER2 positive tumors. [Table: see text] [Table: see text]

Purpose. Kaposi's sarcoma (KS) is a rare low-grade vascular tumor associated with the human herpes virus 8. By analyzing the epidemiology, staging, and treatment of KS, we hoped to improve the quality of care at our institution. Methods. Review of the Mount Sinai Medical Center tumor registry database in Miami Beach, FL, USA, identified 143 cases of KS between January 1, 1987 and December 31, 2007. Results. The majority of patients were non-Hispanic whites, non smoking males diagnosed between 1987 and 1996. Most of the patients were HIV positive, with an equal percentage diagnosed with local or distant disease. Most patients received no chemotherapy or radiation. There were no significant differences in patient survival based on sex, HIV status, or radiation received. There was a trend toward improved survival among older patients who smoked, received no chemotherapy, and had localized stage at diagnosis. Multivariate analysis revealed that non-Hispanic whites had a significant worse survival than Hispanic whites (HR = 0.55, 95% CI (0.33, 0.90), P = 0.02). Patients diagnosed between 1987 and 1996 had a worse survival than those between 1997 and 2007 (HR = 0.33 (95% CI 0.19, 0.55), P < 0.0001). Conclusion. This large retrospective study provides further insight into KS. Ethnicity and date of diagnosis are important predictors of long-term survival.

4830 Introduction Kaposi's sarcoma (KS) is a rare low-grade vascular tumor associated with the human herpes virus 8 (HHV-8). The demographics, epidemiology, diagnosis, and treatment for Kaposi's sarcoma changed significantly over the past 30 years with the spread of the HIV/AIDS epidemic in the early 1980s, the widespread introduction of combination highly active anti-retroviral treatment (HAART) in the mid 1990s, and finally the advanced aging of the United States population seen in the 2000s. Our Miami Beach community had a very unique position during this time span: It served an extensive elderly population while also serving a population that was one of the epicenters for the HIV/AIDS epidemic in the United States. Materials and Methods Upon review of the Mount Sinai Medical Center tumor registry database in Miami Beach, FL, 143 cases of KS were identified between January 1st 1987 and December 31st 2007. Descriptive statistics were used to characterize the demographic and background variables. The Kaplan-Meier and Cox proportional hazard statistical methods were used to estimate overall survival and clinical variables. A chart review was performed for confirmation of CD4 counts. Results Of the 143 KS patients identified in the database, the majority were non-Hispanic white (60.1%) non-smoking (42.7%) males (90.2%) diagnosed between 1987–1996 (57.3%). More than half of our study population was HIV positive (52.4%), with an equal percentage of patients diagnosed with local or distant disease (40.6%), and most of the patients receiving no chemotherapy (80.4%) or radiation (65%). The overall survival at 5 years was 27% with a median survival time of 24 months. No significant differences in survival were observed among patients based on sex, age at diagnosis, or treatment received. There was a trend towards improved survival among current smokers and patients presenting with local versus distant disease stage. Multivariate analysis and analysis of maximum likelihood estimates revealed that among patients with KS, Hispanic whites were significantly less likely to die than non-Hispanic whites (HR=0.47, 95% CI=(0.29, 0.78), p=0.003). Patients diagnosed between 1997–2007 had a significantly longer survival than those diagnosed between 1987–1996 (HR=0.38 (95% CI 0.24, 0.60), p<0.0001). Conclusion The majority of KS patients identified through our database were young, non-smoking, HIV positive, non-Hispanic white males diagnosed during the peak of the HIV epidemic between 1987 and 1996. Hispanic patients diagnosed with KS during this time period had superior outcomes when compared to non-Hispanic whites. Patients diagnosed from 1997–2007 had superior outcomes when compared to those diagnosed from 1987–1996. There was a trend toward a significance difference in survival among patients based on smoking status and tumor stage at diagnosis. There were no significant differences in survival among patients based on sex, age, or treatment received. Disclosures: No relevant conflicts of interest to declare.