Purpose/Objectives To evaluate the feasibility, usability, and satisfaction of a survivorship care plan (SCP) and identify the optimum time for its delivery during the first 12 months after diagnosis. Design Prospective, descriptive, single-arm study. Setting A National Cancer Institute–designated cancer center in the southeastern United States. Sample 28 nonmetastatic colon cancer survivors within the first year of diagnosis and their primary care physicians (PCPs). Methods Regular screening identified potential participants who were followed until treatment ended. An oncology certified nurse developed the JourneyForward™ SCP, which then was delivered to the patient by the oncology nurse practitioner (NP) during a routine follow-up visit and mailed to the PCP. Main Research Variables Time to complete, time to deliver, usability, and satisfaction with the SCP. Findings During one year, 75 patients were screened for eligibility, 34 SCPs were delivered, and 28 survivors and 15 PCPs participated in the study. It took an average of 49 minutes to complete a surgery SCP and 90 minutes to complete a surgery plus chemotherapy SCP. Most survivors identified that before treatment ended or within the first three months was the preferred time to receive an SCP. Conclusions The SCPs were well received by the survivors and their PCPs, but were too time and labor intensive to track and complete. Implications for Nursing More work needs to be done to streamline processes that identify eligible patients and to develop and implement SCPs. Measuring outcomes will be needed to demonstrate whether SCPs are useful or not.

Purpose Cancer patients have many medical and psychosocial needs, which may increase during the COVID-19 pandemic. We sought to (1) risk-stratify hematology/oncology patients using general medicine and cancer-specific methods to identify those at high risk for acute care utilization, (2) measure the correlation between two risk stratification methods, and (3) perform a telephone-based needs assessment with intervention for high-risk patients. Methods Patients were risk-stratified using a general medical health composite score (HCS) and a cancer-specific risk (CSR) stratification based on disease and treatment characteristics. The correlation between HCS and CSR was measured using Spearman's correlation. A multidisciplinary team developed a focused needs assessment script with recommended interventions for patients categorized as high-risk by either method. The number of patient needs identified and referrals for services made in the first month of outreach are reported. Results A total of 1697 patients were risk-stratified, with 17% high-risk using HCS and 22% high-risk using CSR. Correlation between HCS and CSR was modest (ρ = 0.41). During the first month of the pilot, 286 patients were called for outreach with 245 contacted (86%). Commonly identified needs were financial difficulties (17%), uncontrolled symptoms (15%), and interest in advance care planning (13%), resulting in referral for supportive services for 33% of patients. Conclusion There is a high burden of unmet medical and psychosocial needs in hematology/oncology patients during the COVID-19 pandemic. A telephone-based outreach program results in the identification of and intervention for these needs; however, additional cancer-specific risk models are needed to improve targeting to high-risk patients.

No abstract

88 Background: Cetuximab is a monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR) and is given alone or in combination with chemotherapy in the 60% of mCRC that are KRAS WT. Unfortunately, resistance inevitably develops, which may be related to downstream upregulation of the extracellular-signal-regulated kinase (ERK) pathway. Rechallenge with anti-EGFR mAb may be effective in patients previously benefiting from anti-EGFR therapy, but median progression-free survival is < 4 months, indicating need for novel more effective combinations for rechallenge. Co-inhibition of EGFR and downstream cyclin-dependent kinases 4/6 (CDK4/6) may overcome ERK pathway reactivation. We hypothesized that the addition of the CDK4/6 inhibitor palbociclib to cetuximab would be effective for anti-EGFR rechallenge in KRAS-WT mCRC. Methods: LCCC1717 was a multicenter, single-arm, Simon’s two stage phase II study of cetuximab and palbociclib in KRAS WT mCRC treated with ≥2 prior regimens (NCT03446157). Eligible pts were enrolled to one of two cohorts depending on previous anti-EGFR mAb therapy; we report here on cohort B, which enrolled pts who had disease control for at least 4 months with anti-EGFR therapy. Cohort B was designed to initially enroll 10 evaluable pts; if ≥ 4 pts had disease control at least 4 months, then 11 more pts would be enrolled. Treatment included cetuximab 400 mg/m2 followed by 250 mg/m2 weekly, plus palbociclib 125 mg daily on days 1-21 of a 28-day cycle until progression, toxicity, or withdrawal. Primary endpoint was disease control rate (DCR) at 4 months by RECIST 1.1. Secondary endpoints were overall response rate (ORR), progression free survival (PFS), and overall survival (OS). Results: In cohort B, 10 evaluable pts were enrolled from 2/2018-8/2020 (1 additional pt withdrew after an infusion reaction with first dose of cetuximab). Median age 59, 70% male, 90% left-sided primary. The 4-mo DCR was 2/10 (20%; 95% CI 5-52%). Given this, enrollment in this cohort was halted after first stage. Median PFS was 1.8 mo (95% CI: 1.7, NE) and median OS was 6.6 mo (95% CI: 3.6, NE). No pts had a complete or partial response; 3 pts (30%) had stable disease (SD), including 1 patient with SD for 24.7 months. The regimen was well tolerated; most common treatment-related grade 3-4 adverse events were lymphopenia (27%) and leukopenia (18%). While 55% of pts had acneiform rash, none were grade 3-4. Conclusions: Selection of patients for anti-EGFR rechallenge using clinical criteria alone was insufficient to identify pts likely to respond to palbociclib + cetuximab rechallenge. This emphasizes the need for screening using circulating tumor (ct) DNA of known resistance mutations to select pts for anti-EGFR rechallenge approaches. Translational work assessing ctDNA in this study is planned. Cohort A with anti-EGFR naïve patients continues enrollment. Clinical trial information: NCT03446157.

512 Background: mTOR is a controller of cellular growth and other processes that is activated by several oncogenic pathways in cancer. Everolimus is an oral inhibitor of mTOR activation. The mTOR inhibitor, temsirolimus, when combined with high dose 5FU, was limited by significant mucosal toxicity. Purpose: Phase I study to determine the maximum tolerated doses (MTD) and the safety of everolimus combined with 5FU/LV in patients with refractory solid tumors. Methods: Using a standard 3+3 design, starting doses were everolimus 15mg weekly, and q2 weekly 5FU 400mg/m2 bolus and 1800mg/m2 infusion (over 46 hours) and LV 400mg/m2. Daily dosing of everolimus was instituted during level 3 as data emerged about improved target inhibition and adverse event profile with daily dosing. Dose escalation to the maximum planned levels was achieved: everolimus 10mg daily, 5FU 400mg/m2 bolus and 2400mg/m2 infusion, and LV 400mg/m2. Dose limiting toxicities (DLT) were assessed in cycle 1 (4 weeks), defined as any grade 3/4 non-hematologic toxicity (except grade 3 skin rash, nausea and diarrhea), or complicated grade 3-4 heme toxicity. Tumors were measured every 8 weeks. Results: From 03/2008 and 11/2009, 21 patients were treated. Median age 58 (range 35-77), male/female 13/8, PS 0/1 10/11. One DLT was seen at dose level 1 (grade 3 hypersensitivity/angioedema); two at dose level 6 (grade 3 diarrhea, grade 3 hypophosphatemia). As such, dose level 5 is the MTD. Dose reductions were required in 4 patients for mouth sores (2), nasal sores (1), and grade 3 transaminitis (1). Responses are as follows: 11 stable disease and 8 progressive disease; 2 patients were not evaluable. Conclusions: MTD is everolimus 5mg daily, with q2 weekly 5FU 400mg/m2 bolus and 2400mg/m2 infusion and LV 400mg/m2. We are currently expanding the study to evaluate the addition of oxaliplatin and panitumumab to the 5-FU/LV and everolimus base. [Table: see text] [Table: see text]