6635 Background: The Oncology Care Model (OCM) is intended to incentivize physicians to improve the quality and reduce the cost of cancer care. In OCM, providers are accountable for all costs during six month episodes of care relative to target costs (TC) derived from a baseline spending period (BSP; 2013-2015). This accountability is intended to foster care coordination to reduce preventable emergency department visits and hospitalizations (EDH). Benefits of reducing EDH may be diluted when new treatment indications for costly immunotherapies (IO) are introduced into clinical practice after BSP. Methods: We identified all non-small cell lung cancer (NSCLC) and bladder cancer (BC) OCM episodes attributed to Tennessee Oncology (TO), a large community oncology network of over 90 oncologists, during performance period 2 (PP2; the most recent PP with available data). We selected NSCLC and BC because both diseases have IO indications that became standard of care after BSP. Using claims data analytics software, we identified all NSCLC and BC episodes with spending above TC, and found a subset of these above target episodes (ATEs) without any EDH that remained above TC due to IO use. Two medical oncologists reviewed these cases in duplicate to assess guideline concordance of IO. Results: During PP2 there were 2,623 OCM episodes attributed to TO, including 240 NSCLC and 31 BC episodes. Spending was above TC in 118 (49%) and 13 (42%) of NSCLC and BC episodes, respectively. For these NSCLC and BC ATEs, EDH was prevented in 62 (53%) and 5 (38%) of cases, respectively. In NSCLC and BC ATEs without EDH, 43 (69%) and 5 (100%) of episodes included IO, respectively. Clinician review in duplicate (S.M.S.; C.A.W.) found that the use of IO was NCCN guideline concordant in 33 (77%) and 4 (80%) of these NSCLC and BC cases, respectively (K = 0.87). Conclusions: Guideline-concordant use of expensive IO as its treatment indications expand poses substantial challenges to meeting cost targets in OCM, even when practices prevent EDH. [Table: see text]
Background: Fulvestrant is used to treat women with metastatic ER-positive breast cancer after AI failure, but has a short duration of benefit. Pi3K/mTOR signaling has been implicated in preclinical models of fulvestrant resistance and recent trials suggest that everolimus, an oral inhibitor of mTOR, can overcome resistance to other forms of endocrine therapy. We hypothesized that everolimus may delay resistance to fulvestrant and prolong time to progression (TTP). Methods: We designed a phase II clinical trial of combined fulvestrant and everolimus in postmenopausal women with ER-positive breast cancer who relapsed or experienced metastatic disease progression within 6 months of AI use. Fulvestrant was given at 500 mg IM on day1, 250 mg d14, 250 mg d28, and monthly thereafter. Everolimus was given at 10 mg po daily. Patients were required to have measurable or evaluable disease with preserved performance status and adequate organ function. Primary endpoint is TTP, and secondary endpoints are safety, response rate, clinical benefit rate, and biomarker analysis. A sample size of 40 patients was calculated to meet a median TTP of 7.0 vs. 3.7 months for fulvestrant alone as reported in the EFECT trial. Patients were followed monthly for clinical and toxicity assessment and imaging was obtained every 2 months. Tumor blocks were collected when available and biopsies were offered if disease was accessible. Results: To date, 30 patients enrolled on study with a median age of 56 years (range 39–85). Most common metastatic disease sites were bone in 26 patients (87%), liver in 19 (63%), and lung in 16 (53%). Prior therapy included tamoxifen in 21 patients (70%), and chemotherapy in 20 (67%), of those 17 were in the adjuvant/neoadjuvant setting. 6 patients (20%) received more than one AI. 2 patients were ruled ineligible immediately after enrollment and starting study treatment, one because of a creatinine level outside the reference range and one because of the need for palliative radiation. Of the remaining 28 patients, 18 discontinued therapy because of disease progression, 3 because of toxicity, 2 upon patient request, and 1 because of unrelated intercurrent illness, with 4 patients currently on therapy. Most common adverse events reported were mucositis in 13 patients (43%) and rash in 11 (36%). Most common laboratory abnormalities were elevated ALT/AST in 18 patients (60%), elevated cholesterol in 13 (43%), and hypokalemia in 13 (43%). The majority of toxicities were grade I/II. Most common grade III toxicities, regardless of attribution, were infection requiring hospitalization in 3 patients (10%), hypokalemia in 3 (10%) and mucositis in 2 (7.4%). There was one grade 4 toxicity reported-hypokalemia. Overall, treatment was reasonably tolerated and toxicities manageable. Efficacy findings, including the primary endpoint of TTP, will be analyzed and presented at the meeting. Conclusions: Combined everolimus with fulvestrant is feasible and has manageable toxicities in this cohort of women with metastatic ER-positive breast cancer. Detailed efficacy analysis along with updated toxicity data will be presented at the meeting. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-14-05.
22 Background: End-of-life anti-neoplastic treatment does not improve quality of life nor prolong survival of advanced cancer patients. It is also not cost-effective. To-date, there has been little data examining real-world patterns of chemotherapy and immunotherapy treatment at end of life. We investigated use of chemotherapy and/or immunotherapy in the last 14 days of life across a community oncology network of 5 practices, 100 sites of care, and 160 oncology providers. Methods: Using a real-time, network-wide database, we identified patients with solid tumor malignancies who died during an episode of active treatment, defined as having received intravenous (IV) chemotherapy and/or immunotherapy within 90 days of death. We then identified patients in this cohort who received IV chemotherapy and/or IV immunotherapy within 14 days of death (TxEoL). We studied TxEoL patterns by cancer type, treatment type, line of therapy, patient age, patient race, and oncology provider years in practice. Statistical significance was assessed using Pearson’s Chi-squared test. Results: 2,858 qualifying solid tumor cancer patients with dates of death between 1/1/2019 and 5/31/2020 were identified. Observed rates of TxEoL were 16.7% for immunotherapy alone vs. 19.6% for chemotherapy +/- immunotherapy (p = 0.09). We found high variation in TxEoL across 132 oncologists that had 5 or more deceased patients (range: 0% to 50%, mean: 19.2%, median: 19.6%). We found no association of TxEOL with physician years in practice, patient age or race. Rates of TxEoL in the first-line setting were significantly higher than in second-line setting or later (23.3% versus 16.4%, p < 0.01). Patients with head and neck, pancreatic, and hepatobiliary malignancies were the most likely to receive TxEoL, while patients with prostate, brain, and ovarian malignancies were the least likely to receive TxEoL. Conclusions: Our data and method identified wide variation in TxEoL patterns across a large community oncology network, suggesting room for provider-level interventions to improve treatment decisions in patients at high risk of death. Studies within our group, such as examining the impact of palliative care referrals on IV anti-cancer treatment in patients potentially facing end of life, are ongoing.
281 Background: Early advanced care planning and palliative care improves outcomes during the end-of-life phase of care (EOL) for metastatic cancer patients. Identifying patients who are likely to transition to EOL is a necessary step to prioritize limited palliative care resources and is integral to success in value-based payment models. We analyzed whether physician documentation of prognosis in a clinical pathways system (CPS) could reliably predict when patients are nearing EOL for a large community oncology practice of more than 70 medical oncologists. Methods: Tennessee Oncology (TO) requires physicians to use CPS for all Medicare patients. CPS prompts physicians to answer the “prognostic question” “would you be surprised if this patient died in the next year?” for all OCM patients with advanced solid tumors at the beginning of treatment or at the time of a change in treatment plan. Prognostic question responses were compared to actual dates of death documented in the practice management system. Results: A total of 5,266 distinct patients were expected to trigger an OCM episode during 2017. The CPS prompted a response to the prognostic question for 1,228 (23%) of these OCM patients. There were 665 (54%) positive prognoses (expect patient to live more than 1 year) and 563 (46%) negative prognoses (expect patient to die within 1 year). Physicians documented accurate prognoses in 712 (58%) of cases. For patients with positive prognosis 557 (84%) were accurate. For patients with negative prognosis 155 (21.8%) were accurate. Conclusions: We found that for patients with terminal cancer, it is difficult for physicians to accurately predict prognosis. These findings support the importance of ASCO guidelines pertaining to patient access to palliative care during the entirety of cancer treatment for all patients with metastatic cancer. [Table: see text]
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