BACKGROUND There is a need for culturally-relevant nutrition programs targeted to underserved cancer survivors. OBJECTIVE To examine the effect of a culturally-based approach to dietary change on increasing fruit/vegetable intake and decreasing fat intake among Hispanic breast cancer (BC) survivors. DESIGN Participants were randomized to intervention (IG) and control (CG) groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3-, 6- and 12-months. PARTICIPANTS/SETTING Hispanic women (n=70) with stage 0-III BC who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012. INTERVENTION The IG (n=34) participated in ¡Cocinar Para Su Salud! (¡CPSS!), a culturally-based 9-session (24-hours over 12 weeks) intervention including nutrition education, cooking classes and food shopping field trips. The CG (n=36) received written dietary recommendations for BC survivors. MAIN OUTCOME MEASURES Change at 6 months in daily fruit/vegetable servings and % calories from total fat. STATISTICAL ANALYSES Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3- and 6-months. RESULTS Baseline characteristics: mean age 56.6 years (SD 9.7), mean time since diagnosis 3.4 years (SD 2.7), mean BMI 30.9 kg/m2 (SD 6.0), 62.9% with annual household income ≤$15,000, average daily servings of all fruits/vegetables 5.3 (targeted fruits/vegetables 3.7 servings excluding legumes/juices/starchy vegetables/fried foods) and 27.7% of daily calories from fat. Over 60% in the IG attended ≥7/9 classes with overall study retention of 87% retention at 6 months. At month 6, the IG compared to CG reported an increase in mean servings of fruits/vegetables from baseline (all fruits/vegetables: +2.0 vs. −0.1, P=0.005; targeted fruits/vegetables: +2.7 vs. +0.5, P=0.002) and a non-significant decrease in % calories from fat (−7.5% vs. −4.4%, P=0.23) and weight (−2.5kg vs. +3.8kg, P=0.22). CONCLUSIONS ¡CPSS! was effective at increasing short-term fruit/vegetable intake in a diverse population of Hispanic BC survivors.
BACKGROUND Patients with hepatocellular carcinoma (HCC) have a poor prognosis if their tumors are not diagnosed early. The authors investigated factors associated with the receipt of liver transplant among patients with HCC and evaluated the effects of these differences on survival. METHODS The authors reviewed records from consecutive patients diagnosed with HCC at Columbia University Medical Center from January 1, 2002 to September 1, 2008. We compared patient clinical and demographic characteristics, developed a multivariable logistic regression model of predictors of transplant, and used a Cox model to analyze predictors of mortality. RESULTS Of 462 HCC patients, 175 (38%) received a transplant. Black patients were much less likely than whites to receive a transplant (odds ratio [OR], 0.03; 95% confidence interval [CI], 0.0–0.37). Hispanics and Asians were also less likely to undergo transplantation, but the differences were not statistically significant. Patients with private insurance were more likely to receive a transplant than those with Medicaid (odds ratio [OR], 22.07; 95% confidence interval [CI], 2.67–182.34). Black and Hispanic patients, and Medicaid recipients, presented with more advanced disease than whites and privately insured patients, and had poorer survival. In a Cox model, those who did not receive a transplant were 3 times as likely as transplant recipients to die, but race and insurance were not independently predictive of mortality. CONCLUSIONS Race and insurance status were strongly associated with receipt of transplantation and with more advanced disease at diagnosis, but transplantation was the most important determinant of survival. Improved access to care for non-white and Medicaid patients may allow more patients to benefit from transplant.
Introduction For many cancers, features of the metabolic syndrome, such as diabetes and obesity, have been associated with both increased risk of cancer development and poor outcomes. Materials and Methods We examined a large retrospective cohort of 342 consecutive patients who underwent liver transplantation for hepatocellular carcinoma between January, 1999 and July, 2010 at our institution. We evaluated the relationship between diabetes, obesity, HCC recurrence, and overall survival. Results We found that a body mass index (BMI)>30 was an independent predictor of poor overall survival in a multivariable Cox model, approximately doubling the risk of death after transplant. BMI>30 was also a predictor of recurrent HCC, although this was of borderline statistical significance (HR for recurrence 1.9, 95% CI 0.9–4.1). We also found increased BMI to be an independent predictor of microvascular invasion (MVI) within HCC tumors, lending a possible explanation to these results. Those with diabetes had worsened overall survival compared to those without diabetes in univariate, but not multivariable analysis, possibly related to longer wait times. Conclusions Our findings suggest a relationship between higher BMI, tumor vascular invasion, increased recurrence, and worsened overall survival. These findings may help explain why those with high BMI have worse outcomes from their cancers. A better understanding of the role of obesity and diabetes in patients with cancer should help develop better predictors of outcome and improved treatment options for patients with HCC.
354 Background: Patients (pts) with mUC who progress after platinum (PLT)-based chemotherapy and immune checkpoint inhibitor (CPI) therapy have poor outcomes and limited treatment options. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate. It consists of a monoclonal antibody targeting Trop-2, an epithelial cell surface antigen overexpressed in UC, conjugated to the active metabolite of irinotecan (SN38). Methods: We performed a phase I/II basket study in pts with advanced solid tumors receiving intravenous SG administered on day 1 and 8 of 21-day cycles, until progression or unacceptable toxicity. CT/MRI scans were obtained at 8-week intervals for response assessment. We evaluated pts with mUC who progressed after ≥1 prior systemic therapy and were treated with SG at the 10 mg/kg dose level. Endpoints included safety, objective response rate (ORR) by RECIST 1.1, clinical benefit rate (CBR; complete response [CR], partial response [PR], or else SD ≥6-mo), and Kaplan-Meier estimated duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results: 45 pts (41M/4F; median age 67, range 49-90; ECOG 0/1: 31%/69%) received a median of 2 (range: 1-6) prior treatment lines, including PLT-based chemotherapy (95%) and CPI (38%). 33 had visceral metastases involving liver (n=15), lung (n=27), and other organs (n=5). The ORR was 31% (14/45), with 2 CR and 12 PR. In pts with visceral involvement, the ORR was 27% (9/33). The ORR in CPI-treated pts was 23% (4/17). The median DOR was 12.6 mo (2 pts continuing >2 y), and the CBR was 47% (21/45). Median PFS and OS were 7.3 mo and 18.9 mo, respectively. The AE profile was consistent with prior reports. Grade ≥3 AEs in ≥5% of pts were neutropenia/neutrophil count decreased (38%), anemia (11%), hypophosphatemia (11%), diarrhea (9%), fatigue (9%), and febrile neutropenia (7%). Conclusions: SG demonstrated clinical activity in pts with relapsed/refractory mUC, including CPI-treated pts and pts with visceral disease. A single-arm, open-label, global phase 2 trial is underway to evaluate antitumor activity and safety of SG in advanced UC.(TROPHY-U-01; NCT03547973). Clinical trial information: NCT03547973.
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