Genomic testing and treatment landscape in patients with advanced non-small cell lung cancer (aNSCLC) using real-world data from community oncology practices.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1585-1585 ◽  
Author(s):  
Hinco Jasper Gierman ◽  
Seth Goldfarb ◽  
Monica Labrador ◽  
Caroline M. Weipert ◽  
Bill Getty ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Targeted Therapies ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
P Value ◽  
Genomic Testing ◽  
Tumor Type ◽  
Real World Data ◽  
Nccn Guidelines ◽  
Community Oncology

1585 Background: While aNSCLC is a leading cause of US cancer deaths, targeted therapies and immune checkpoint inhibitors (ICPi) have emerged as important new treatment options for these pts NCCN guidelines recommend testing of eight genes in aNSCLC patients at diagnosis. Targetable alterations (TA) in four genes, EGFR, ALK, ROS1, and BRAF, are associated with FDA-approved therapies. The labels for ICPis indicate that pts with TAs in EGFR and ALK are not candidates for first line treatment with ICPi. Methods: The Integra Connect database, which includes electronic medical record (EMR) and claims data on approximately 600,000 cancer patients, was queried across five community oncology practices (289 oncologists) to identify aNSCLC patients (stage 3B or 4) treated since January 2017. Manual review of charts was done to abstract tumor type/stage, drug regimens, and evidence of somatic genetic testing. A Wilcoxon rank sum test was used to test difference in time to results (TTR) for blood- vs tissue-based tests. Results: A total of 1,203 aNSCLC patients were identified. Testing rates varied from 54% for EGFR to 22% for all 4 genes (table). 163 patients had a TA in EGFR, ALK, ROS1 or BRAF, and 55% of these pts did not receive targeted therapy. 84 pts with TA’s in EGFR or ALK had no evidence of progression on targeted therapy, yet 31 (37%) received an ICPi; 24% had the TA test result prior to ICPi use and 13% received the TA result after starting ICPi. Median TTR for blood-based somatic tests was shorter than tissue-based tests (4 vs 14 days, p-value= 3.5-e07). Conclusions: Our analysis in the community oncology setting for aNSCLC pts finds evidence of underutilization of genomic testing, underutilization of targeted therapies, and ICPi use outside of label. Further research is needed to identify strategies to increase testing in aNSCLC pts to provide physicians with the information needed to make optimal treatment decisions. [Table: see text]

A retrospective three-year analysis using real-world data on uptake of broad-based NextGen sequencing panels in community oncology practices.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13668-e13668
Author(s):  
Hinco J. Gierman ◽  
Nikhil Pai ◽  
Casey Catasus ◽  
Alvin Tam ◽  
Monica Labrador ◽  
...  
Keyword(s):  
Targeted Therapies ◽  
Single Gene ◽  
Tumor Type ◽  
Real World Data ◽  
Chi Square ◽  
Large Panels ◽  
Nextgen Sequencing ◽  
Community Oncology ◽  
Improved Outcomes ◽  
Chi Square Test

e13668 Background: There are over 100 FDA approved targeted therapies across 15 cancer types, offering improved outcomes over existing therapies. However, many of these require genetic testing, for example, advanced non-small cell lung cancer (aNSCLC) patients have over 15 targeted therapies requiring a DNA-based test. Doing multiple tests can exhaust sample, while increasing cost and turn-around time. NGS panels, often with hundreds of genes, can address some of these issues. Here we asked across aNSCLC patients if the use of NGS panels has increased over the last 3 years in community oncology practices. Methods: The Integra Connect database, which includes electronic medical record (EMR) and claims data on over 1,000,000 US cancer patients, was queried across five community oncology practices to identify aNSCLC patients (stage IIIB or IV) treated between January 2017 and January 2020. Manual chart review abstracted tumor type, stage, treatment, and testing. Patients tested for all 7 NCCN recommended genes (EGFR, ALK, ROS1, BRAF, MET, RET, ERBB2) were grouped as “NGS Panel”, patients with less genes as “Single Gene/Small Panel”, and patients with no evidence of testing as “No Test”. A Chi-Square test was used to compare actionable results between patients with NGS panels versus small panels. Results: 1,007 aNSCLC patients were analyzed and showed a doubling of the use of broad-based NGS testing from 13% in 2017 to 26% in 2019 across over 100 oncologists (table). 23% of patients had actionable results when tested on broad-based panels versus 17% using single gene or small panels (p = .048). Targeted therapies were used in 17% of broad-based tested patients, versus 15% in patients tested for single genes or small panels. Conclusions: We see an uptake of broad-based NGS testing in community oncology, which can lead to more actionable results and better utilization of targeted therapies for those patients. However, this seems to be caused by providers shifting from small panels to large panels, rather than an overall increase in testing, as we do not see the percentage of untested patients decrease. [Table: see text]

Emerging Strategies in Systemic Therapy for the Treatment of Melanoma

2018 ◽  
pp. 751-758 ◽  
Author(s):  
Paolo A. Ascierto ◽  
Keith Flaherty ◽  
Stephanie Goff
Keyword(s):  
Targeted Therapy ◽  
Targeted Therapies ◽  
De Novo ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
Acquired Resistance ◽  
Interleukin 2 ◽  
Advanced Melanoma ◽  
Adoptive Cell Transfer ◽  
Mek Inhibition

Recent years have seen major improvements in survival of patients with advanced melanoma with the advent of various novel systemic immunotherapies and targeted therapies. As our understanding of these agents and their various mechanisms of action improves, even more impressive outcomes are being achieved through use of various combination strategies, including the combining of different immunotherapies with one another as well as with other modalities. However, despite the improved outcomes that have been achieved in advanced melanoma, responses to treatment are heterogeneous and may not always be durable. Additional advances in therapy are required, and several emerging strategies are a focus of interest. These include the investigation of several new immunotherapy and/or targeted therapy combinations, such as checkpoint inhibitors (anti–PD-1/anti–CTLA-4) with other immunotherapies (e.g., indoleamine 2,3 dioxygenase [IDO] inhibitors, antilymphocyte activation 3 [anti–LAG-3], histone deacetylase [HDAC] inhibitors, Toll-like receptor 9 [TLR-9] agonists, antiglucocorticoid-induced tumor necrosis factor receptor [anti-GITR], pegylated interleukin-2 [IL-2]), combined targeted therapies (e.g., MEK and CDK4/6 coinhibition), and combined immunotherapy and targeted therapy (e.g., the triplet combination of BRAF/MEK inhibition with anti–PD-1s). The identification of novel therapeutic targets in the MAP kinase pathway also offers opportunities to improve outcomes by overcoming de novo and acquired resistance to BRAF/MEK inhibition (e.g., the development of ERK inhibitors). In addition, adoptive cell transfer, the infusion of large numbers of activated autologous lymphocytes, may have a potential role in patients whose disease has progressed after immunotherapy. Taken together, these new approaches offer further potential to increase systemic treatment options and improve long-term outcomes for patients with advanced melanoma.

Identification and management of pathogenic mutations in BRCA1, BRCA2, and PALB2 in a tumor-only genomic testing program.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 10528-10528
Author(s):  
Brittany L. Bychkovsky ◽  
Tianyu Li ◽  
Jilliane Sotelo ◽  
Nabihah Tayob ◽  
Joanna Mercado ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Familial Cancer ◽  
Clinical Indication ◽  
Genomic Testing ◽  
Tumor Type ◽  
Nccn Guidelines ◽  
Somatic Alterations ◽  
Prostate Cancers ◽  
Brca1 Brca2 ◽  
Germline Testing

10528 Background: Tumor-genomic testing is increasingly used to guide treatment decisions in cancer patients. Although tumor-only testing cannot definitively distinguish between germline versus somatic alterations, the identification of pathogenic or likely pathogenic (P/LP) variants in certain genes should prompt consideration of germline testing. Germline P/LPs in BRCA1, BRCA2 and PALB2 ( B1B2PAL) are associated with hereditary cancer syndromes. Methods: We reviewed tumor-only genomic data (Dana-Farber Oncopanel) between 10/2016 and 6/2018 to examine the prevalence of P/LPs in BRCA1, BRCA2, PALB2 among adult cancer patients at Dana-Farber Cancer Institute/Brigham and Women’s Hospital. We characterized the frequency of P/LPs by primary tumor type, confirmation by germline testing before or within 12 months after Oncopanel testing or not, and factors associated with germline testing. Results: Among 7,575 patients, the median age was 62 (range 18-99); 53.9% were female. A total of 272 (3.6%) had P/LPs in BRCA1 (n = 90), BRCA2 (n = 162) and/or PALB2 (n = 29). P/LPs in B1B2PAL were detected in 5.3% (38/712) of breast, 11.9% (34/285) of ovarian, 6.6% (18/272) of pancreatic, and 5.1% (12/234) of prostate cancers. P/LPs in B1B2PAL were also detected in other neoplasms (12.9% (8/62) of non-melanoma skin, 5.0% (43/855) of colorectal, 7.6% (20/264) of endometrial, and 4.6% (10/216) of head and neck cancers). Of 169 patients who had not had prior germline testing, 29/169 (17.2%) completed germline testing within 12 months after Oncopanel; 13 (7.7%) referred for testing declined or did not complete testing within 12 months, 14 (8.3%) died before or within 3 months of the Oncopanel results, and 113 (66.9%) had no documented germline testing within 12 months. Among 132 patients who had germline testing, 117 (88.6%) had a clinical indication based on personal or family history compared to 66/140 (47.1%) who did not undergo germline testing. Among 132/272 (48.5%) germline-tested patients, 70.5% were positive for a germline mutation in B1B2PAL; the remainder had somatic B1B2PAL mutations only. Germline testing was more often performed in patients with B1B2PAL-associated tumors (breast, ovarian, pancreatic and prostate cancers) or other clinical indications for germline testing. Conclusions: A low but clinically meaningful rate of P/LPs in BRCA1, BRCA2 and PALB2 was detected by tumor-only genomic testing in diverse malignancies. Given the implications of B1B2PAL alterations on treatment and familial cancer risk, our data support current NCCN guidelines recommending germline testing among patients with cancer and P/LPs in B1B2PAL detected on tumor-genomic testing and highlights the need for systems to ensure germline testing when indicated.

scholarly journals New drug developments in metastatic gastric cancer

2018 ◽  
Vol 11 ◽  
pp. 175628481880807 ◽  
Author(s):  
Aaron C. Tan ◽  
David L. Chan ◽  
Wasek Faisal ◽  
Nick Pavlakis
Keyword(s):  
Gastric Cancer ◽  
Clinical Trials ◽  
Targeted Therapies ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
Predictive Biomarkers ◽  
Metastatic Gastric Cancer ◽  
New Era

Metastatic gastric cancer is associated with a poor prognosis and novel treatment options are desperately needed. The development of targeted therapies heralded a new era for the management of metastatic gastric cancer, however results from clinical trials of numerous targeted agents have been mixed. The advent of immune checkpoint inhibitors has yielded similar promise and results from early trials are encouraging. This review provides an overview of the systemic treatment options evaluated in metastatic gastric cancer, with a focus on recent evidence from clinical trials for targeted therapies and immune checkpoint inhibitors. The failure to identify appropriate predictive biomarkers has hampered the success of many targeted therapies in gastric cancer, and a deeper understanding of specific molecular subtypes and genomic alterations may allow for more precision in the application of novel therapies. Identifying appropriate biomarkers for patient selection is essential for future clinical trials, for the most effective use of novel agents and in combination approaches to account for growing complexity of treatment options.

scholarly journals CMET-23. IMPACT OF SYSTEMIC THERAPY IN MELANOMA BRAIN METASTASIS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi56-vi56
Author(s):  
Soumya Sagar ◽  
Adam Lauko ◽  
Addison Barnett ◽  
Wei (Auston) Wei ◽  
Samuel Chao ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Brain Metastasis ◽  
Brain Metastases ◽  
Systemic Therapy ◽  
Checkpoint Inhibitors ◽  
Care Center ◽  
Performance Status ◽  
Tertiary Care ◽  
P Value ◽  
Surgical Removal

Abstract BACKGROUND Melanoma is the third most common malignancy that results in brain metastasis and is associated with a median overall survival (OS) of approximately 9 months. In recent years, management of melanoma brain metastases (MBM) by surgery and radiation [stereotactic radiosurgery (SRS) and whole brain radiation therapy (WBRT)] has been bolstered by targeted therapy and immune checkpoint inhibitors (ICI). METHODS 351 patients, treated for MBM at our tertiary care center from 2000–2018, were grouped into: received chemotherapy, ICI, or targeted therapy. 34% of patients treated with ICI had received other systemic therapies as well as part of their management. OS was calculated from the date of diagnosis of the brain metastases. The Kaplan Meier analysis was utilized to determine median OS and difference in OS was determined by utilizing the Cox proportional hazard model. RESULTS The median survival after the diagnosis of brain metastasis was 10.4, 11.96, and 7.06 months in patients who received ICI, chemotherapy and targeted therapy respectively. A multivariate model was developed including the type of systemic therapy, presence of extracranial metastases, age, KPS and number of intracranial lesions. 114 patients underwent SRS alone, 56 underwent SRS and WBRT, 43 underwent SRS and surgical removal, 28 had surgical removal, SRS and WBRT, and 78 had no intracranial therapy. Compared to patients who received chemotherapy, patients who received immunotherapy had a hazard ratio, HR = 0.628 (confidence interval = 0.396 – 0.994, p-value = 0.047). Presence of EC metastases (HR= 1.25, p-value < .001), lower KPS (HR = .97, p-value < .0001) and multiple brain lesions (HR = 1.117, p-value < .0001) were associated with significantly worse OS. CONCLUSIONS Addition of ICI significantly improves the OS in MBM compared to chemotherapy. Lower performance status, multiple brain metastases, and EC metastases are associated with poor OS.

Analysis of real-world data (RWD) on treatment (tx) sequencing in patients with advanced non-small cell lung cancer (aNSCLC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20642-e20642
Author(s):  
Meng Ma ◽  
Xiang Zhou ◽  
Howard Goldsweig ◽  
Nicholas Hahner ◽  
Dianwei Han ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Kinase Inhibitors ◽  
Checkpoint Inhibitors ◽  
Rank Test ◽  
Real World Data ◽  
Therapeutic Modalities ◽  
Platinum Based Chemotherapy ◽  
Line Of Therapy ◽  
Line Setting

e20642 Background: While optimal sequencing of systemic therapy in aNSCLC is critical to achieve maximal clinical benefit, it is practically challenging to study tx sequencing through clinical trials. RWD allow retrospective, observational studies to examine tx patterns and associated clinical outcomes. Methods: 1,609 aNSCLC patients who received systemic therapies at Mount Sinai hospitals were analyzed for the number of line of therapy (LOT), therapeutic modalities (chemotherapy, targeted therapy and immunotherapy), and the sequence in which treatments were given when LOT > 1. Time to tx discontinuation (TTD) was used as a surrogate clinical endpoint for outcomes. Results: 578 of the 1,609 (36%) patients received more than one LOT. 356 (22%) received tyrosine kinase inhibitors (TKIs), and 297 (16%) received immune checkpoint inhibitors (CPIs). Kaplan-Meier analysis revealed that among 297 patients who received CPIs, median TTD was longer in the 1st line setting (295 days, 95% CI 169 to 523; n=132) than when LOT > 1 (169 days, 95% CI 113 to 269; n=165), although the difference was not statistically significant (P=0.092, log-rank test). No difference of TTD on TKIs was observed between LOT = 1 and LOT > 1 (P=0.51). With respect to tx sequencing, when patients (n=94) received TKIs as the 1st LOT, 60%, 35%, and 5% of them received another TKI, chemotherapy, or a CPI-containing regimen, respectively, as the 2nd LOT. Among patients (n=370) who progressed on 1st line platinum-based chemotherapy, 52%, 32%, and 16% received another chemo regimen, a CPI-containing regimen, or a targeted therapy, respectively, as the 2nd LOT; these percentages shifted significantly toward more CPIs (24%, 66%, 10% for chemo, CPI, targeted, respectively) when only 2016-2018 data were examined. In the 2nd line setting after platinum therapy, TTD was significantly longer in the CPI group (332 days, 95% CI 169-484) compared to the chemo group (88 days, 95% CI 65-100; P<0.0001), consistent with results from pivotal clinical trials. Conclusions: As the tx algorithm of aNSCLC has been evolving rapidly, we observed diverse tx patterns in RWD. Various tx sequences may impact patient outcomes, and therefore warrant further investigation.

Real-world data validation for differential expression of immunoregulatory molecules and targetable cancer genes may provide therapeutic insights into agnostic-driven trial designs.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 10-10 ◽  
Author(s):  
Jacob J. Adashek ◽  
Christopher W. Szeto ◽  
Sandeep K. Reddy ◽  
Philippe E. Spiess
Keyword(s):  
Differential Expression ◽  
Real World ◽  
Treatment Options ◽  
Expression Patterns ◽  
Gene Mutations ◽  
Tissue Type ◽  
Tumor Type ◽  
Cancer Genes ◽  
Real World Data ◽  
External Database

10 Background: Targeting actionable genes and using immunotherapy have increased treatment options. We previously reported that some immunoregulatory molecules are found differentially regulated in the presence of certain gene mutations regardless of cancer subtype. Here we validated a subset of these associations in an independent, real-world dataset with distinct clinicopathological characteristics. Methods: Previously, 2740 TCGA patients were identified to have at least one potentially oncogenic mutation (mt) within an established 50-gene hotspot panel. Differential expression of 10 immunoregulatory molecules (IRM) was analyzed between mutant (mt) vs. wild-type (wt). To ensure observed significant associations were not confounded by tumor-type, differential IRM expression within mt-enriched tumor-types was compared to that of mt vs. wt. Now, using the NantHealth external database of 2739 unselected clinical cases these associations were validated. Results: Within the TCGA cohort 19/50 gene mutations were found to be significantly associated with ≥1 IRM expression. In many, the mt effect-size was larger than that of tumor-type; e.g. head & neck carcinomas (HNSCC) are highly enriched for CDKN2A mt (OR = 4.9, p = 4.3e-9), yet CDKN2A mt are more associated with CTLA4 expression than HNSCC histology (t = 7.0 vs. 5.4). Of these 15 associations, 6 were validated within the independent later-stage NantHealth cohort. Most notably, CDKN2A mt was validated as associated with increased PD1 and CTLA4 expression while KRAS and APC mt were validated as associated with decreased PDL1/2 expression. Conclusions: The presented differential checkpoint expression patterns are strongly associated with mutation status and are not primarily driven by tissue-type, which have been further validated by an external database. Strategies combining genomic targets have been shown to yield success as well as using immunotherapies. Our data suggests there may be a role for combining NGS targets along with IRM expression patterns to better guide future design of clinical trials in combatting various cancers in a tissue-agnostic fashion.

scholarly journals Palliative care in the context of immune and targeted therapies: A qualitative study of bereaved carers’ experiences in metastatic melanoma

2020 ◽  
Vol 34 (10) ◽  
pp. 1351-1360 ◽  
Author(s):  
Jennifer A Fox ◽  
John Rosenberg ◽  
Stuart Ekberg ◽  
Danette Langbecker
Keyword(s):  
Palliative Care ◽  
Targeted Therapy ◽  
Qualitative Study ◽  
Metastatic Melanoma ◽  
End Of Life ◽  
Targeted Therapies ◽  
Treatment Options ◽  
Family Needs ◽  
Term Survival ◽  
Treatment Paradigm

Background: Immune and targeted therapies continue to transform treatment outcomes for those with metastatic melanoma. However, the role of palliative care within this treatment paradigm is not well understood. Aim: To explore bereaved carers’ experiences of immune and targeted therapy treatment options towards end of life for patients with metastatic melanoma. Design: An interpretive, qualitative study using a social constructivist framework was utilised. Interviews were recorded, transcribed and analysed using grounded theory methods. Setting/participants: Participants ( n = 20) were bereaved carers of patients who had received some form of immune and/or targeted therapy at one of three Australian metropolitan melanoma treatment centres. Results: Carers struggled to reconcile the positive discourse around the success of immune and targeted therapies in achieving long-term disease control, and the underlying uncertainty in predicting individual responses to therapy. Expectations that immune and targeted therapies necessarily provide longer-term survival were evident. Difficulty in prognostication due to clinical uncertainty and a desire to maintain hope resulted in lack of preparedness for treatment failure and end of life. Conclusion: Immune and targeted therapies have resulted in increased prognostic challenges. There is a need to engage, educate and support patients and carers to prepare and plan amid these challenges. Educational initiatives must focus on improving communication between patients, carers and clinicians; the differences between palliative and end-of-life care; and increased competency of clinicians in having goals-of-care discussions. Clinicians must recognise and communicate the benefit of collaborative palliative care to meet patient and family needs holistically and comprehensively.

Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (D.O.S.E.) Registry: Analysis of outcomes and costs of epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment in cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 16009-16009
Author(s):  
A. Memisoglu ◽  
C. Peake ◽  
E. Buscaino ◽  
R. S. McKenzie ◽  
J. B. Forlenza ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Drug Cost ◽  
Iron Supplementation ◽  
Treatment Guidelines ◽  
Ferritin Level ◽  
Treated Group ◽  
Tumor Type ◽  
Real World Data ◽  
Nccn Guidelines ◽  
Wholesale Acquisition Cost

16009 Background: NCCN anemia treatment guidelines recommend hemoglobin (Hb) levels be maintained between 11 and12 g/dL. To understand erythropoiesis-stimulating therapy (EST) dosing, outcomes and costs in cancer patients, data were analyzed from an ongoing prospective, observational registry (D.O.S.E. Registry) collecting real-world data on cancer patients treated for anemia in U.S. oncology clinics. Methods: Data were collected from participating hospital- and community-based outpatient oncology practices between 1/2004 and 11/2005. This analysis included adult patients who had received ≥2 doses of either EPO or DARB. Outcomes assessed included Hb values at weeks 4, 8, 12, and 16 following EST initiation. Drug cost was based on EST utilization and 2005 wholesale acquisition cost. Results: 652 patients (235 EPO, 417 DARB) from 32 sites were identified. Baseline characteristics of age, gender, Hb, tumor type and ferritin level were similar between treatment groups. The proportion of patients with iron supplementation at baseline was significantly higher in the DARB-treated group (EPO 18% v. DARB 31%, p < 0.001). EPO-treated patients were maintained between 11 and 12 g/dL throughout the therapeutic duration ( Table ). Mean cumulative administered dose of EPO was 393,047 Units and DARB 1205 mcg, corresponding to an overall drug cost of $4,783 for EPO and $5253 for DARB (p = 0.001). Conclusions: These results demonstrate that EPO-treated patients maintained target Hb levels consistent with NCCN guidelines, which was not observed in the DARB-treated patients. Drug cost was significantly higher in the DARB group compared to the EPO group without considering the costs of iron supplementation. [Table: see text] [Table: see text]

Treatment outcomes and healthcare resource utilization (HRU) among patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy in US community oncology setting.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19513-e19513
Author(s):  
Roger M. Lyons ◽  
Jalaja Potluri ◽  
Cat Bui ◽  
Michelle E Choi ◽  
Esprit Ma ◽  
...  
Keyword(s):  
Real World ◽  
Treatment Options ◽  
Unmet Need ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Median Number ◽  
Best Supportive Care ◽  
Intensive Chemotherapy ◽  
Nccn Guidelines ◽  
Community Oncology

e19513 Background: Treatment options for AML patients ineligible for intensive chemotherapy are limited. This study aims to describe demographic and clinical characteristics, outcomes, and HCRU in this patient population. Methods: This was a retrospective observational study of patients aged > 60 years who received first-line (1L) treatment within 60 days of AML diagnosis between 1/1/2011 – 1/1/2018 and had > 2 visits at US Oncology Network (USON) clinics. Patients were followed until 6/30/2018, last visit, or death, whichever came first. Data were sourced from structured fields of the USON database and chart reviews. Patient characteristics and HRU were assessed using descriptive statistics while overall survival (OS), time-to-treatment failure (TTF), and progression-free survival (PFS) from 1L treatment initiation were assessed using the Kaplan-Meier method. Results: 378 patients were included with median age of 79 years; 62.7% were male, 29.3% had an ECOG score > 2, and 38.4% had poor cytogenetic risk profile. Most patients received 1L hypomethylating agent (HMA) monotherapy: azacitidine (AZA, 57.9%) or decitabine (DEC, 25.9%). Few patients received best supportive care only (7.1%) or other AML treatment (9.1%). Median (range) durations of 1L treatment among patients receiving AZA and DEC were 2.9 (0.0, 46.9) and 2.5 (0.1, 26.4) months, respectively. Median (95% CI) OS, TTF, and PFS in the AZA and DEC cohorts were 7.5 (5.7, 9.6) and 7.3 (4.8, 8.8) months, 3.4 (2.8, 4.4) and 3.7 (2.4, 5.2) months, and 6.7 (5.0, 8.0) and 5.7 (3.4, 7.4) months, respectively. Among patients receiving HMAs, 84.5% received at least one transfusion. Median number of red blood cell and platelet transfusions was 4.0. Hospitalization rates in the AZA and DEC cohorts were 79.9% and 83.7%; proportions with hospitalization > 2 days duration were 64.4% and 66.3%, respectively, with median (range) durations of 6.5 (3.0, 34.0) and 7.0 (3.0, 26.0) days, respectively. Conclusions: The low TTF and OS and high HRU in this real-world community oncology study indicates an unmet need to improve outcomes among AML patients ineligible for intensive chemotherapy. NCCN guidelines were updated since this study and future real-world studies are warranted to evaluate impact of novel therapies on treatment patterns and outcomes.

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