416 Background: Patients with cancer can experience disease- and treatment-related symptoms that are underreported and underestimated by physicians. This observational, non-interventional study evaluated the use of ePROs and their impact on duration of treatment (DoT) in patients with solid tumors receiving IO therapy in community practice. Methods: Patients initiating index IO therapy immediately prior to (Jan-2017 to Dec-2018) and after (Sep-2019 to Dec-2020) implementation of Noona, the ePRO platform at Tennessee Oncology clinics, were included in a retrospective historical control (HC) and ePRO cohort, respectively, and followed for up to 6 months. The ePRO cohort was further divided into ePRO users (platform enrollment ≤45 days from index) and non-users. ePRO questionnaires, based on Common Terminology Criteria for Adverse Events (CTCAE), were sent within a week after each IO infusion and could be completed using an internet browser or smartphone app. Patient characteristics and DoT were described and compared between the HC and ePRO cohorts and between the HC cohort and ePRO users subgroup. Use of ePROs was evaluated within the ePRO cohort. Differences in baseline characteristics between cohorts were adjusted using Cox proportional hazards models. Results: Data were collected for 538 HC and 1014 ePRO patients (319 ePRO users and 695 non-users). Patient characteristics were generally similar between cohorts, but more HC patients were diagnosed with Stage IV disease (54% vs 47%; p < 0.01) and initiated IO as monotherapy (82% vs 52%), while more ePRO patients initiated IO as combination therapy (48% vs 18%). ePRO users were more likely than non-users to be female, white, married, living with a spouse, and have higher education (college or graduate degree) (all p < 0.05). Use of ePROs was durable over follow-up, with a consistent number of questionnaires sent over Months 1-3 and Months 4-6 (median: 6 questionnaires in each period) and a slight decrease in the number answered (median: 4 vs 3 questionnaires). ePRO patients had a longer DoT than HC patients (median time to end of first IO regimen: not estimable vs 5.1 months). Significantly more ePRO than HC patients remained on their first IO regimen at 6 months (54% vs 46%; p < 0.05). Multivariate Cox regression showed the risk of ending first IO therapy was lower for ePRO versus HC patients (p < 0.05). Conclusions: The increased DoT observed in the ePRO versus HC cohort in this study suggests that use of ePROs may facilitate improved care coordination and enable patients to remain on IO therapy longer. However, ePRO uptake was only 31% in the ePRO cohort, with several social determinants appearing to influence use. Overcoming barriers in ePRO uptake is an area for future study.

Introduction: The evolving treatment landscape for non-small-cell lung cancer (NSCLC) and complexities of regulations and reimbursement present challenges to community oncologists. Clinical pathways are tools to optimize care, but information on their value in the real world is limited. This retrospective study assessed treatment patterns and clinical outcomes in patients with Stage I–III NSCLC pre- and post-pathways implementation at Tennessee Oncology, a large, community-based oncology practice in the USA. Methods & Materials: Chart data were abstracted for adults diagnosed with Stage I–III NSCLC who received systemic treatment. Patients were divided into pre-pathways (treatment initiation 2014–2015) and post-pathways (treatment initiation 2016–2018) cohorts. Patient characteristics, treatment patterns and outcomes were summarized descriptively. Kaplan–Meier curves were used to assess time-dependent outcomes, and log-rank test was used to compare the cohorts. Results: 291 patients were included (Stage I–II: 38 pre-pathways, 55 post-pathways; Stage III: 105 pre-pathways, 93 post-pathways). Duration on first-line (1L) therapy was similar for Stage I–II patients pre- and post-pathways (median 1.9 months vs 2.1 months; p = 0.75), but increased for Stage III patients post-pathways (2.1 months vs 1.4 months pre-pathways; p < 0.01). Achievement of a complete or partial response with 1L therapy was similar post-pathways among Stage I–Stage –IIII patients (60.0% vs 55.2% pre-pathways), but increased for Stage III patients (56.0% vs 35.2% pre-pathways). Conclusion: Given that improvements in rates of treatment response post-pathways occurred only for patients diagnosed with Stage III NSCLC, among whom immunotherapy uptake increased post-pathways, such improvements may be attributable to evolving practices in cancer care, including advances in treatment and care delivery, rather than clinical pathways implementation. Further research is warranted to assess the impact of clinical pathways in the current treatment era, given that immunotherapy has now become the standard of care in NSCLC.

The compatibility and stability at room temperature for up to 7 days of a three-drug admixture of cyclophosphamide, methotrexate, and 5-fluorouracil (5-FU) (CMF) was established permitting the practical delivery of the combination as an infusion in an ambulatory setting. Fourteen patients received 20 courses of CMF administered on a continuous infusion schedule for 14 days of a 28-day cycle. The dose rates were fixed for 5-FU (300 mg/M2/day) and methotrexate (0.75 mg/M2/day). The cyclophosphamide dose was escalated from 25 to 50, 75, and 100 mg/M2/d. Leukopenia and thrombocytopenia were observed in two of five patients receiving the maximal dose of cyclophosphamide. No other toxicities were observed including alopecia, stomatitis or liver function abnormalities. This Phase I trial suggests that the cumulative doses of cyclophosphamide, methotrexate, and 5-FU are comparable to the maximum doses delivered as single agent infusions. Furthermore, when the infusion CMF is compared to the "standard" bolus schedule for CMF, the infusion schedule delivers 116%, 8%, and 350% of the respective three component drugs (cyclophosphamide, methotrexate, and 5-FU).

263 Background: IO-based combination therapies have improved clinical outcomes in aRCC; several are approved for first-line use. AEs can significantly impact quality of life, and IO therapy is associated with AEs that differ from prior standard treatment toxicities. PROMs capture health status directly from patients and often include the symptoms and severity of AEs. Our aim was to assess the extent to which the PROMs used in pivotal trials covered the most common AEs associated with IO combinations. Methods: This was a review of data from four phase 3, randomized, open-label studies of IO-based combinations in previously untreated advanced/metastatic clear-cell RCC (CheckMate 214, CheckMate 9ER, KEYNOTE-426, CLEAR [KEYNOTE-581]). The 10 most common all-grade, all-cause AEs (%) and the PROMs used in each trial were identified. The inclusion of the most common AEs in the PROMs was explored descriptively. Results: The most common AEs and their frequencies varied among the different combination regimens. There was also variation across trials in the PROMs used. Capture of the most common AEs by the PROMs used in each study is summarized in the Table. Conclusions: Current PROMs used in clinical trials of IO combinations for aRCC tend to capture more of the common AEs for IO-IO vs IO-tyrosine kinase inhibitor regimens. PROMs that reflect the unique AE profiles of IO therapies, especially from the patient perspective, may be needed for future trials.[Table: see text]

e18719 Background: Clinical pathways have been introduced as tools to optimize cancer care delivery, but evidence of their value in the real world is limited. This retrospective study was performed to assess treatment patterns and clinical outcomes in patients with non-small cell lung cancer (NSCLC) before and after pathway implementation at Tennessee Oncology (TO). Methods: Chart data were abstracted for patients (≥18 years) diagnosed with Stage I-IV NSCLC who initiated first-line (1L) systemic treatment at a TO clinic and had follow-up for ³6 months or until death. Patients were divided into two cohorts: pre-pathways (treatment initiation 2014–2015) and post-pathways (treatment initiation 2016–2018). Patient characteristics, treatment patterns, and outcomes were described and compared across cohorts. An exploratory study endpoint was the evaluation of outcomes based on disease stage at diagnosis. Results: Among 501 patients (251 pre-pathways and 250 post-pathways), most had advanced or metastatic NSCLC at diagnosis (Stage III: 40%; Stage IV: 42%). Chemotherapy comprised almost all 1L systemic therapy used pre-pathways (Stage I/II: 100%; Stage III: 96%; Stage IV: 83%). Post-pathways, chemotherapy remained the most common 1L therapy in patients with Stage I/II (89%) and Stage III (72%) disease, but among patients with Stage IV disease, use of chemotherapy decreased (47%) and immuno-oncology (IO) therapy alone or in combination became common (45%). Median duration of 1L therapy was longer post-pathways in patients with Stage III (2.1 months vs 1.4 months pre-pathways; P < 0.01) and Stage IV disease (3.3 months vs 2.3 months pre-pathways; P < 0.01) but did not differ among Stage I/II patients. Median progression-free survival was significantly longer post-pathways in patients with Stage IV disease (7.0 months vs 4.2 months pre-pathways; P < 0.05), but not in other disease-stage subgroups. Median overall survival increased non-significantly post-pathways for all disease stage subgroups (Stage I/II: 26 months vs 20 months pre-pathways; Stage III: 26 months vs 20 months; Stage IV: 10 months vs 9 months). For each disease stage, rates of severe adverse events were similar between cohorts. Conclusions: While outcomes for patients diagnosed with Stage III/IV NSCLC were generally improved following the implementation of clinical pathways, this change coincided with a dramatic shift in available treatment options. Improvements post-pathways were mainly observed in patients diagnosed with advanced disease. Thus, differences in outcomes between pre-pathways and post-pathways cohorts in our study are more likely attributable to other evolving practices in cancer care, particularly the availability of newer, more effective treatments such as IO therapy as part of standard practice, than implementation of the clinical pathways.