197 Background: Cancer survivors have physical, psychosocial, emotional and financial needs that vary in prevalence and may differ from needs of patients on active cancer treatment. Distress screening is mandated for cancer program accreditation and identifies, addresses and monitors the needs of patients. There is a paucity of data on the clinical application of distress screening among survivors. We used a validated distress screening tool to conduct a needs assessment of cancer survivors in the solid oncology clinic. Methods: The Cancer Support Source Distress Screening tool is an 18-item questionnaire given to patients on their 2nd and every 3 month medical oncology clinic visit to assess depression and distress. We merged patient survey data (patients completing ≥ 2) with the cancer registry to identify cancer survivors from July 2015 to October 2018. We performed bivariate and multivariate analysis evaluating change in depression and distress scores over time. Results: 92 patients were identified. The table indicates changes in depression and distress scores by cancer. Depression scores improved for most cancer types with an improvement in distress scores across all cancers. Emotional/mental health, communication, provider relationship, system of care, body image and social support were associated with significant changes in survivorship concern. We are completing a multivariate analysis controlling for sociodemographic factors to evaluate change in depression and distress scores across the survivorship trajectory. Conclusions: A distress screening survey may be a useful tool in assessing the unmet needs of cancer survivors. Identifying prevalent domains of survivorship issues can highlight areas of greatest perceived need and can guide quality improvement initiatives within a cancer program. [Table: see text]
e15016 Background: Neratinib (N) is a potent irreversible inhibitor of HER1, HER2, and HER4. Capecitabine (X) at optimal dose of 7 days on and 7 days off schedule (7/7) is well-tolerated with low rates of ≥ grade (G3) diarrhea. Methods: We conducted phase Ib/II study of N with X (7/7) with loperamide and colestipol prophylaxis in patients (pts) with pretreated HER2+ MBC (NCT03377387). Eligible pts had normal left ventricular ejection fraction (≥ 50%), any and < 4 prior chemotherapy-based treatments in phase Ib and II, respectively. Primary endpoint of phase Ib is maximum tolerated dose (MTD) and phase II is response rate. Secondary endpoints are safety, tolerability, and progression-free survival. Exploratory endpoint is to quantify cell-free DNA (cfDNA), correlating with response. Phase Ib follows traditional 3+3 design with 4 dose levels. In phase II, if > 3/9 respond, study is expanded to 24. If > 10/24 respond, study is deemed successful. Results: As of 2-4-2021, 10 pts were enrolled in phase Ib. 4 pts were treated at dose level 1 (X at 1500 mg BID at 7/7 and N at 240 mg daily); 2/4 pts experienced with G3 diarrhea during cycle 1. Six pts were treated at dose level -1 (X at 1000 mg BID 7/7 and N at 240 mg daily); 1 (17%) developed G3 diarrhea. The MTD is X at 1000 mg BID 7/7 and N at 240 mg daily. Twenty-two of 24 pts have been enrolled in phase II. Of 22 pts, data show 6 with partial response, 8 with stable disease, 3 with progressive disease, and 5 have not been assessed radiographically. Overall, 6/22 (27.3%) and 1/22 (4.5%) had all G and G3 diarrhea, respectively. Other significant toxicities at MTD included G2 hand foot syndrome (n = 1, 4.5%), G1 fatigue (n = 1, 4.5%) and G1 nausea (n = 4, 18%). Conclusions: The MTD is X at 1000 mg BID at 7/7 and N at 240 mg daily. This combination is safe and well tolerated with G3 diarrhea rate of 4.5%, which is significantly lower than the X 14/7 schedule in NALA study. The phase II portion of the study is near completion and updated result will be presented. Analysis of cfDNA, to correlate with response for phase II portion, is ongoing. Clinical trial information: NCT03377387.
138 Background: Cancer survivors have varied physical, psychosocial, emotional and financial needs that may differ from needs of active cancer treatment patients. Distress screening identifies and monitors the needs of patients and is mandated for certain accreditations. There is a paucity of data on the application of distress screening among survivors. We used a validated distress screening tool to conduct a needs assessment of cancer survivors in solid oncology. Methods: The Cancer Support Source Distress Screening tool is an 18-item survey given on the 2nd and every 3-month clinic visit to assess depression and distress. The first analysis, merged patient data (patients completing ≥ 2) with cancer registry to identify solid cancer survivors from July 2015 to October 2018. A descriptive analysis of these patients was performed. The second analysis was cross-sectional with a larger data set of all solid tumor patients completing a survey at any time pre, during, or post treatment. We compared distress and depression scores using analysis of variance. A bivariate and multivariate analysis evaluating change in depression and distress scores over time is ongoing. Results: In analysis one, 92 patients were identified. Depression scores improved for most cancer types; distress scores improved for all cancers. Emotional, communication, provider relationship, system of care, body image and social support were associated with significant changes in survivorship concern. In the expanded dataset, 908 patients were identified. The distribution of depression and distress scores are shown in the table. There was a significant decrease for depression scores (p<.001) and distress scores (p<.001). Multivariate analysis to evaluate change in depression and distress scores across the survivorship trajectory is ongoing. Conclusions: A distress screening survey may be a useful tool in assessing the unmet needs of cancer survivors. Identifying prevalent domains of survivorship issues can highlight areas of greatest perceived need and can guide quality improvement initiatives within a cancer program. [Table: see text]
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