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794 Background: Tumor genomic testing (GT) has increased diagnostic accuracy and treatment options for patients (pts) with cancer. Dana-Farber Cancer Institute (DFCI) has made GT accessible as an institute-supported research effort for >10 yrs. We estimate 50% standard therapies and 15-35% clinical trials in Gastrointestinal Cancer Clinic (GCC) require GT to determine eligibility. Pts in GCC with certain cancers are eligible for GT as a clinical test – these include metastatic/locally advanced colorectal, gastric, pancreatic, or biliary cancers. Clinical testing requires CLIA lab certification and insurance reimbursement; research does not. Herein we ID gaps in our GT database. Methods: We reviewed data on GT uptake in GCC between 4/2015 - 6/2022. 20,096 pts were captured by the GT tracking system. Data included: testing ordered and completed (proportion, type, time to receiving tissue for testing [TR], time to testing completion [TC]). Demographic data is not captured in the tracking system; matching unique patient identifiers with electronic health record is pending. Results: Most pts received GT (57.6%); 12% were not eligible; 30.4% declined consent. Most testing was completed (67.6%), but 21.3% of tests failed (45.5% of these from insufficient tissue). Research testing (71%) comprised most tests, but clinical tests were completed faster (median 34 days research vs 20 days clinical). Ampullary (91%), anal (90%), colon (90%) had highest completion rates; pancreatic (59%), hepatocellular carcinoma (56%) had lowest (from insufficient viable tumor in submitted specimens). Conclusions: GCC has a robust recruitment program that has yielded high GT uptake. Given the frequency that GT is used for treatment and trials, building a demographically representative dataset is crucial, especially for pts with largest burden of morbidity and mortality from cancer. We ID'd data gaps in the GT tracking system, which lacks demographics and reason for not testing. Demographic data is available in the electronic health record but does not speak with the GT tracking system so this analysis is not routinely done. Ability to visualize this data is important to ensure equitable GT uptake. Future efforts will focus on improving rates of consent in genomics databases and cancer clinical trials. Genomic testing at Dana-Farber Cancer Institute Gastrointestinal Cancer Center, 4/2015 – 6/2022.[Table: see text]

Background: Lack of representation in genomic databases limits the generalizability of study findings, predictive models, and therapeutics. In cancer, the development of nearly 75% of cancer drugs have been informed by genomic data,1 yet there is persistent lack of diversity of genomic testing databases that inform clinical trials and lead to drug approval.2,3 The PROFILE project at Dana-Farber Cancer Institute (DFCI) is available to all adult cancer patients, offering free genomic testing for inclusion in their genomic database. Herein, we describe the enrollment ratios in PROFILE delineated by demographic group and cancer type. Methods: We conducted a cross-sectional analysis of the prevalence of PROFILE enrollment 7/8/2011 – 1/1/2022. Over this time period 177,788. Enrollment processes vary in each DFCI disease center, but all solid tumor patients are meant to be approached for enrollment around the time of their first visit. The electronic health record was queried to identify demographics, which are collected by registration staff at intake. Queried demographics included gender, age ( Citation Format: Nadine Jackson McCleary, Ellana K. Haakenstad, Bridget Neville, Arrien A. Bertram, Wendy Loeser, Joseph Grider, Andea Kruse, Alissa Gentile, Olga Kozyreva, Pedro Sanz-Altamira, Christopher Lathan, Michael J. Hassett, Ethan Cerami, Annette S. Kim, Marios Giannakis, R. Coleman Lindsley, Neal I. Lindeman, William C. Hahn, Janina Longtine, Barrett Rollins, Levi Garraway, Bruce E. Johnson. REAL variance in genomic testing by sex, age, race, ethnicity, and language: PROFILE database 7/2011 - 1/2022 [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr C070.

This study evaluated the efficacy and tolerability of aprepitant, dexamethasone, and palonosetron in the prevention of nausea and vomiting in breast cancer patients receiving their initial cycle of doxorubicin and cyclophosphamide (AC).Patients with breast cancer, ≥ age 18, with a performance status of ≤ 2, receiving doxorubicin (≥ 60 mg/m(2)) and cyclophosphamide (≥ 500 mg/m(2)) for the first time were eligible. Prior to chemotherapy patients received aprepitant 125 mg orally (PO), dexamethasone 8-10 mg PO/intravenously (IV), and palonosetron 0.25 mg IV. On days 2-3, dexamethasone 4 mg PO and aprepitant 80 mg PO were given. Outcomes were recorded in patient diaries for the 120-h study period following chemotherapy. Primary endpoint was the proportion of patients achieving complete response (no emesis or rescue) for the 120-h study period.Thirty-six patients were enrolled and all are evaluable. The median age was 53 (33-75) and 36 are females. Eighteen patients (50%) achieved a complete response during the 120-h study period. Acute (≤ 24 h) and delayed (24-120 h) complete response rates were 81% (27/36) and 61% (22/36), respectively. No emesis rates for the acute, delayed, and overall study periods were 97% (35/36), 94% (34/36), and 92% (33/36), respectively. Treatment was well tolerated.The combination of aprepitant, dexamethasone, and palonosetron prevented emesis in more than 90% of breast cancer patients receiving their initial cycle of AC chemotherapy. Nausea was less well controlled. Overall complete response was achieved in one half of the study patients. Further improvement in the prevention of AC-induced chemotherapy-induced nausea and vomiting will require more effective antinausea treatments.

This study sought to prospectively determine the frequency of delayed nausea and vomiting with oxaliplatin-based chemotherapy following day 1 prophylaxis with a 5-HT-(3) receptor antagonist and dexamethasone.Patients with colon cancer, ≥ age 18, with a performance status ≤ 2, receiving oxaliplatin (85-100 mg/m(2)) as part of a standard folinic acid, 5-fluorouracil, oxaliplatin regimen for the first time were eligible. All patients received a 5-HT(3) receptor antagonist and dexamethasone 20 mg on day 1 prior to oxaliplatin. No routine prophylaxis for delayed emesis was given. Antiemetic outcome was recorded in patient-completed diaries for the 120-h study period following oxaliplatin administration. Primary endpoint was frequency of delayed (24-120 h) emesis (vomiting/retching).Forty-one patients were enrolled and 39 are evaluable. Median age was 70 (34-85) and the female/male ratio was 20:19. Four patients (10%) experienced vomiting or retching during the delayed period. One patient vomited during the first 24 h after oxaliplatin. The overall (120 h) no emesis rate was 87% (34/39). Twenty-one patients (54%) developed delayed nausea. Nine patients had moderate or severe nausea. Eighteen patients (46%) took rescue antiemetics during the delayed period. Delayed and overall complete response (no emesis or use of rescue antiemetics) rates were 54% and 49%, respectively.The use of a 5-HT(3) antagonist and dexamethasone prior to oxaliplatin results in excellent control of nausea and vomiting (CR-90%) during the 24 h after chemotherapy. However, without further antiemetic treatment, complete response in the delayed period decreased to 54%. This study supports the need for routine antiemetic prophylaxis for delayed nausea and vomiting following oxaliplatin-based chemotherapy.

To assess the efficacy of adding aprepitant to a 5-HT(3) antagonist and dexamethasone as salvage antiemetic therapy for breast cancer patients receiving their initial cycle of an anthracycline and cyclophosphamide (AC) and failing to achieve complete control of emesis.Eligibility: breast cancer patients receiving their first cycle of AC.standard dose of a 5-HT(3) antagonist and dexamethasone 8-10 mg IV/PO on day 1 prior to cycle 1 of AC and dexamethasone 4 mg bid on days 2 and 3. Patients without complete control (no emesis, no nausea, or rescue antiemetics) during cycle 1 could proceed to cycle 2. During cycle 2, patients received AC and identical antiemetics (except dexamethasone 4 mg qd on days 2 and 3) plus aprepitant 125 mg PO day 1 and 80 mg PO days 2 and 3. Primary endpoint: complete control, 0-120 h after chemotherapy.Sixty-two patients received cycle 1 of AC. Complete control cycle 1: 13 patients (21%; 95%CI, 12-33%). Of the 49 patients eligible for cycle 2, four elected not to continue on study. Of the 45 patients receiving cycle 2, 44 were evaluable. Complete control and complete response (no emesis, no rescue) for the 5-day study period improved from 0% to 18% (p = 0.14) and 7% to 36% (p = 0.02) on cycles 1 and 2, respectively.In breast cancer patients receiving AC, the addition of aprepitant to a 5-HT(3) antagonist and dexamethasone during cycle 2 of treatment improved antiemetic outcome. Although the improvement in the primary endpoint of complete control during cycle 2 was not significant, all secondary endpoints such as complete response and no emesis rates were significantly better during cycle 2. The extent of antiemetic control during cycle 2 was numerically inferior to the results achieved in a phase III trial employing aprepitant with cycle 1 of AC chemotherapy, suggesting that the preferred approach is to include aprepitant with the initial cycle of AC chemotherapy.

568 Background: The androgen receptor (AR) is the most highly expressed steroid receptor in breast cancer (BC) with 75-95% of estrogen receptor positive (ER+) and 50% of ER negative BCs expressing ...

9645 Background: Oxaliplatin (OX) is a platinum compound commonly used in colorectal cancer. The emetogenic potential of OX has not been well characterized despite reports of frequent nausea (N) an...

8618 Background: Aprepitant (APR), a neurokinin-1 receptor antagonist, has efficacy in the prevention of nausea and vomiting (NV) in breast cancer (BC) patients (pts) receiving doxorubicin (A) and cyclophosphamide (C) (JCO 2005, 23:2822). Nevertheless, many pts continue to receive only 5-hydroxytryptamine antagonists and dexamethasone (doublet therapy) during cycle 1 of AC. APR is often used as a salvage treatment, with anecdotal reports of improved outcome. We sought to prospectively evaluate this issue in a phase II trial. Methods: Design: multicenter study funded by an unrestricted grant from Merck. Eligibility: BC pts receiving their first cycle of A (≤ 60 mg/m2) and C (≥ 500 mg/m2) on day (d) 1. Antiemetics: ondansetron 8mg IV/PO, or dolasetron 100 mg IV/PO, or granisetron 1 mg IV or 2 mg PO on d 1; and dexamethasone (dex) 8–10 mg IV/PO d 1 and 4 mg PO bid d 2–3. Pts without complete control (no emesis, nausea, or rescue antiemetics) during cycle 1 could continue to cycle 2.During cycle 2, pts again received AC and identical antiemetics (except dex only 4 mg qd d 2–3) plus APR 125 mg PO d 1 and 80 mg PO d 2–3. Data on nausea (4-point scale), emesis and rescue was collected with a pt-report diary. Primary end point: proportion of pts with complete control (CC) during the 120-hours after chemotherapy. Secondary endpoints included acute (< 24 hrs), delayed (24–120 hrs) CC and complete response (no emesis or rescue) Results: Pts: total (47), female (47), eligible (46), analyzed (42), still on study (4). Median age: 49 yrs. CC during cycle 1: 8 pts (19%). Thirty-four pts continued to cycle 2. During cycle 2, 7 pts (21%)(95% CI 9–38%) achieved CC and 13 pts (38 %) complete response (CR) for the 120-hour study period. Acute CR and delayed CR rates for cycles 1 and 2 were 32%(11 pts) vs 68% (23 pts) (p=0.01) and 12%(4 pts) vs 44% (15 pts) (p=0.02) respectively. No emesis rates were 38 vs 79 % during cycles 1 and 2 respectively(p=0.02). The proportion of pts with no nausea or severe nausea for cycles 1 and 2 were 0 vs 21% and 12 vs 3 % respectively. Conclusions: The addition of APR to standard doublet therapy improves antiemetic outcome in BC pts receiving AC who failed to achieve CC during cycle 1 with standard doublet therapy alone. Improvement is seen in the control of emesis and nausea. APR was well tolerated. [Table: see text]