e15023 Background: CRC, the third most common cancer in the United States, carries racial/ethnic disparities in both incidence and mortality. With availability of effective systemic therapies, the life of CRC patients can be prolonged which thereby increases the risk of metastases at uncommon sites, such as the brain. We report our investigation into the impact of race/ethnicity on the incidence of BM in CRC patients using retrospective data (2010 – 2018) at a single institution. Methods: We retrospectively reviewed patients diagnosed with CRC and collected data on age, race/ethnicity, stage, treatment modalities, metastatic sites, and survival. Race and ethnicity were defined in accordance with federal standards set by the U.S. Census. Following this, race/ethnicity was self-declared and/or based on the primary language declared and categorized as non-Hispanic White, Hispanic White, non–Hispanic Black, Asian, or Unknown/Other. CRC location was classified as right-sided, left-sided or rectal. Results: We identified 264 CRC patients (median age: 61; range: 38 - 99). Among them 123 identified as non-Hispanic white, 28 non-Hispanic black, 26 Hispanic white, and 9 declared Other. There were 76 (29%) who identified as Asian. Of those 76 patients, 5 (7%) developed BM. All 5 patients were male and stage IV at initial diagnosis. BM was a late stage phenomenon with rectal primary and lung metastases seemly associated with an increased risk in the specific cohort. Molecular markers such as KRAS were available in 3 patients without clear association. Median time to development of BM was 29 months (range: 26 - 33). Median overall survival after BM diagnosis was 5.5 months (range: 4 - 11). Overall survival was longest for the patient who had both radiation and surgery. Conclusions: Our study showed an incidence of BM of 7% in the Asian sub-population compared to the historical control of 0.6 – 3.2% in the overall population. These results at the least warrant further investigation in a larger patient population of BM in CRC patients with emphasis on molecular markers. Recognition of BM in CRC patients is clinically relevant secondary to multiple lines of therapy as mentioned earlier and its grave impact on outcome.

TPS477 Background: In pts with LAPC, more effective systemic therapies may be associated with improved local control, delay of metastasis, and overall survival (OS). The phase III MPACT trial in pts with metastatic PC demonstrated longer OS (median, 8.7 vs 6.6 mos; HR, 0.72; P < 0.001) and an ≈ 3-fold greater shrinkage of primary tumors with nab-P + Gem vs Gem alone (−22.15% vs −7.02%), raising the possibility of improved local PC control with nab-P + Gem. LAPACT will assess the efficacy and safety of nab-P + Gem in LAPC. Methods: LAPACT will enroll treatment-naive pts (planned n ≈ 110) in the United States, Canada, and Europe with Eastern Cooperative Oncology Group performance status ≤ 1, confirmed unresectable LAPC, no distant metastases, and adequate organ function. Pts with mixed-origin tumors, any other malignancy within 5 years, peripheral neuropathy grade > 1, or clinically significant ascites are ineligible. Pts will receive nab-P 125 mg/m2 + Gem 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle. Pts without progressive disease (PD) or unacceptable toxicity after 6 cycles will receive investigator’s choice of surgery, chemoradiotherapy, or continued nab-P + Gem. If a major response is observed, surgery may occur prior to completing 6 cycles of nab-P + Gem. The primary endpoint is time to treatment failure (TTF; time from first therapy dose to discontinuation due to PD, start of a new non–protocol-defined anti-cancer therapy, or death). The study design allows for 80% power at a 1-sided α of 0.05 to detect a 30% increase over the 5.1-month median TTF observed for nab-P + Gem in the MPACT study. The secondary endpoints are disease control rate (DCR) after 6 cycles, overall response rate, progression-free survival, OS, safety, and quality of life. The exploratory endpoint is correlation of changes in circulating nucleic acids with PD and treatment response. An interim DCR analysis will occur after all pts have completed 6 cycles of nab-P + Gem, discontinued therapy due to PD, died, or started a new non–protocol-defined therapy before completing 6 cycles of therapy. Enrollment is ongoing (first pt enrolled in April 2015). Clinical trial information: NCT02301143.

No abstract

e16053 Background: Fluoropyrimidines such as 5-FU and capecitabine are known to be cardiotoxic drugs. TAS-102 (trifluridine-tipiracil) is a novel oral fluoropyrimidine that was recently FDA approved to treat gastric and colon cancer. However, the incidence of cardiac related events of TAS-102 is not fully ascertained. We performed a meta-analysis and systematic review to determine the incidence of cardiotoxic events associated with TAS-102. Methods: We performed a literature search through PubMed, Embase, and Web of Science to identify any publications in any language up to December 31st, 2019 where TAS-102 (and equivalent terms such as “trifluridine-tipiracil” and “Lonsurf”) was used. These were then manually reviewed to identify any publications reporting cardiac events. Randomized controlled trials (RCTs) were included for meta-analysis to determine the incidence of cardiotoxic events, which were summarized as pooled odds ratios (OR) when compared to placebo. Non-randomized, non-controlled clinical trials (phase I and phase II studies) were included in the systematic review but excluded from the pooled OR calculation. Results: 869 publications were identified in the initial literature search, of which 17 trials (3 Phase III studies, 6 Phase II studies, and 8 phase I studies) met inclusion criteria. A total of 1,877 patients among 4 RCTs were included in the meta-analysis. Compared with placebo, TAS-102 did not increase the risk of myocardial infarction (OR 1.97 95% CI [0.22-17.89]), hypertension (OR 0.73 95% CI [0.37, 1.44]), palpitations (OR 1.51 95% CI [0.30, 7.56]), cardio-pulmonary arrest (OR 0.83 95% CI [0.11-6.32]), or syncope (OR 1.50 95% CI [0.06-37.14]). Among the 1,252 patients receiving TAS-102, the overall incidence of cardiovascular events was low, with hypertension being the most common side effect (21 events), followed by palpitations (6 events), cardiopulmonary arrest (2 events), and myocardial infarction (3 events), though there was no statistically significant increased risk compared to placebo. No deaths were reported. Conclusions: Unlike other fluoropyrimidines, TAS-102 appears to be a cardiogentle drug, with no increased risk of cardiac events compared to placebo. Since fluoropyrimidines remain the backbone of treatment for gastrointestinal malignancies, TAS-102 can offer an alternative to patients who developed cardiotoxicities from other agents. Prospective studies with consideration of cardiac risk factors are required.

10112 Background: Pegfilgrastim is typically administered 24 hours after chemotherapy per package insert; however some pts are unable or unwilling to return for this additional visit due to work or transportation especially with regimens consisting of infusional 5-FU. Same-day dosing eliminates need for this additional visit. Results from prior studies in other tumor types are inconclusive as few support same-day dosing whereas others show inferiority. Purpose of our study was to determine safety and efficacy of administering pegfilgrastim on same day as chemotherapy in pts with GI malignancies. Methods: A single-institution retrospective review was conducted of pts with GI malignancies who received chemotherapy and same-day pegfilgrastim (6 mg) within 1 hour of completion of chemotherapy from Jan 2014 through Jan 2017. Decision to administer pegfilgrastim was based on NCCN or ASCO recommendations. As per institutional guidelines, pts were counseled on risks of same-day pegfilgrastim prior to its administration. Data was collected on demographics, clinic notes and complete blood counts. Analyses included neutropenia, febrile neutropenia, hospitalization, use of antibiotics or bone pain. Results: A total of 536 chemotherapy cycles in 69 pts were analyzed. Median age was 60 years (range 32-87) with 46% of pts ≥ 65. Pts had an average of 4 risk factors for febrile neutropenia: advanced disease, gender, age > 65 and chemotherapy regimen. Most common malignancy was colon (48%), pancreas (17%) and gastric (17%). Most commonly used regimens included mFOLFOX6 (42%), FOLFIRINOX (23%) and FOLFIRI (12%). Median absolute neutrophil count nadir for all cycles was 4538/uL (range: 1160-25168). Grade 1 and 2 neutropenia developed in 6 of 536 (1%) cycles. Bone pain reported in 3 pts (4%). There were no episodes of grade 3 or 4 neutropenia or febrile neutropenia. None had dose reductions, chemotherapy delays, hospitalizations, or antibiotic use due to neutropenia. Conclusions: We believe our study is the first in GI malignancies to report that same-day pegfilgrastim administration may be as effective and safe as next-day administration, benefiting pts and might reduce costs.