First-line Treatment Patterns Research Articles

Treatment Pathways in Patients With Crohn's Disease and Ulcerative Colitis: Understanding the Road to Advanced Therapy.

Patients with Crohn's disease (CD) or ulcerative colitis (UC) often cycle through conventional therapies (CT) with different mechanisms of action (MOA) before initiating advanced therapy (AT). We describe treatment patterns among patients with CD/UC. Using Merative MarketScan Research databases, adult patients with CD/UC were identified from medical/pharmacy claims (2017-2021). Patients had ≥1 hospitalization or ≥2 outpatient visits (≥30 days apart within 1 year) for CD/UC. Two cohorts were established; cohort 1: Newly diagnosed patients (index date is the date of first diagnosis) and cohort 2: Patients initiating AT (index date is the date of first AT). First-line treatment patterns (cohort 1) and CT pathways before AT initiation (cohort 2) by the number of episodes (ie, adding a new therapy, switching to another therapy, or restarting the same therapy after ≥60 days) and MOA are reported. Among newly diagnosed patients in cohort 1 (CD: n = 1739; UC: n = 2740), 14.4% (CD) and 5.9% (UC) of patients had any AT use during the follow-up period (mean: 2.3 years; ≥ 77% initiated corticosteroids). Among patients in cohort 2 (CD: n = 2594; UC: n = 2431), the mean number of CT episodes before AT initiation was 4.0 ± 4.3 (CD) and 5.9 ± 5.0 (UC). Among those with ≥1 corticosteroid episode (CD: 82.2%; UC: 91.5%), the mean number of episodes was 4.6 ± 4.3 (CD) and 6.3 ± 5.0 (UC). Overall, 13.3% (CD) and 23.7% (UC) of patients cycled through 3 MOAs before AT initiation. Despite treatment recommendations, few newly diagnosed CD/UC patients initiated AT as their first treatment. Moreover, patients cycled through multiple CTs before initiating AT.

PP01.05 First-Line Treatment Patterns and Healthcare Resource Utilization among Non-Small Cell Lung Cancer Patients in Puerto Rico: The TREATLINES-ONCOLUNG Study

PP01.05 First-Line Treatment Patterns and Healthcare Resource Utilization among Non-Small Cell Lung Cancer Patients in Puerto Rico: The TREATLINES-ONCOLUNG Study

First-line treatment patterns among patients with metastatic pancreatic ductal adenocarcinoma in the real-world setting.

e16320 Background: Treatment options for patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) have historically been limited. FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GnP) are both recommended first line (1L) treatments that have shown efficacy vs. gemcitabine monotherapy in clinical trials. More recently, small subgroups of pts have benefitted from regimens that include irinotecan liposome injection, targeted therapies, and checkpoint inhibitors (CPIs). To better understand treatment patterns in current practice, we examined the distribution of 1L therapies in a RW cohort of mPDAC pts diagnosed between 2015 and 2022. Methods: This retrospective observational study utilized the Ontada Clinical Data View: Pancreatic Cancer database. Adult pts diagnosed with mPDAC between November 2018 and November 2022 who initiated 1L treatment within 90 days of their diagnosis for metastatic disease were included in the study. Regimens were grouped into the following categories: FFX, GnP, gemcitabine monotherapy, FOLFOX, FOLFIRI, capecitabine/5-FU monotherapy, irinotecan liposome injection-containing regimens, CPI monotherapy, PARP inhibitors and other targeted therapy-containing regimens, no 1L, and other regimens (comprised of combinations of FFX and GnP components as well as other chemotherapeutic agents). Results: Of the 5,358 pts eligible for inclusion in the study, the majority received GnP (33%, 1,785 pts) or FFX (23%, 1,254 pts) in 1L. The next largest segment of pts did not receive 1L therapy (23%, 1,229 pts). Just 6% (345 pts) received gemcitabine monotherapy. The remaining 14% of pts received therapies other than the three primary 1L mPDAC treatments: 4% (207 pts) received FOLFOX, 2% (109 pts) received capecitabine/5-FU monotherapy, 2% (96 pts) received an irinotecan liposome injection-containing regimen, 0.7% (39 pts) received FOLFIRI, 0.5% (28 pts) received CPI monotherapy, and 0.5% (26 pts) received PARP inhibitors or other targeted therapies. 4% (240 pts) received various other chemotherapy combinations (comprised of combinations of FFX and GnP components and a small number of other chemotherapeutic agents, with ≤40 pts per combination). FFX pts were the youngest, with a mean age of 64yrs, compared to 70yrs for gemcitabine + nab-paclitaxel (p < .001). Gemcitabine monotherapy pts were the oldest (mean = 73yrs, p < .001 vs. GnP) and were more likely to have metastatic disease and an ECOG ≥2 (p < .001 vs. GnP). Conclusions: There are limited 1L treatment options for mPDAC. Since the and PRODIGE and MPACT trials, FFX, GnP, or gemcitabine monotherapy have been the primary recommended 1L treatments for most pts with mPDAC. While recent years have seen an increase in the availability of targeted and CPI therapies appropriate for small subgroups of mPDAC pts, in a RW sample, almost all pts received one of the three standard therapies.

Real-world first-line treatment patterns and outcomes in patients with locally advanced or metastatic urothelial carcinoma in the United States.

e23287 Background: Historically, cisplatin-containing chemotherapy has been the recommended first-line (1L) treatment for locally advanced or metastatic urothelial carcinoma (la/mUC). For those ineligible for cisplatin due to poor performance status, impaired renal function, or comorbidities, alternative choices include carboplatin-based chemotherapy and PD-1/L1 inhibitors. This study aimed to describe real-world treatment patterns and overall survival (OS) among US Medicare patients with la/mUC receiving 1L therapy. Methods: This retrospective study used Medicare fee-for-service claims data from 2015 through 2022 to identify patients diagnosed with la/mUC who received systemic treatment. Initiation of 1L therapy was the index date for study inclusion; treatment patterns and OS were assessed until end of data availability, discontinuation of health plan enrollment, or death. OS was estimated using the Kaplan–Meier approach, and a log-rank test was used to compare OS across the following 1L treatment groups: platinum-based chemotherapy (PBC; cisplatin- and carboplatin-based), non-PBC monotherapy, and PD-1/L1 inhibitor monotherapy. Hazard ratios (HRs) were estimated across groups using Cox proportional hazards models adjusting for baseline characteristics. Results: Of 13,104 patients included in this analysis, 77.5% were male, and mean (SD) age was 76.2 (7.5) years. The most commonly observed 1L treatment categories were PBC (cisplatin-based, 19.7%; carboplatin-based, 28.4%), PD-1/L1 inhibitors (34.8%), non-PBC (13.7%), and other combination therapies (2.9%). Common comorbidities included renal disease (39.9%), chronic obstructive pulmonary disease (36.1%), and diabetes (32.2%). Compared with patients in the cisplatin cohort, patients in other cohorts had higher NCI Comorbidity Index scores. Median duration of 1L treatment was 3.5 months for PD-1/L1 inhibitors, 3.2 months for carboplatin, 3.0 months for cisplatin, and 2.0 months for non-PBC. Median OS was longest with cisplatin (17.0 months; IQR: 7.8–51.9), followed by non-PBC (14.7; 5.5–39.7), carboplatin (10.5; 4.9–25.1), and PD-1/L1 inhibitors (9.4; 2.8–27.9). In the adjusted Cox model, all treatment groups had statistically significantly higher hazards of death compared with cisplatin, with an HR (95% CI) of 1.50 (1.41, 1.59; P< 0.001) for PD-1/L1 inhibitors, 1.38 (1.30, 1.46; P< 0.001) for carboplatin, and 1.11 (1.03, 1.19; P= 0.007) for non-PBC. Conclusions: In this large retrospective study of US Medicare patients from 2015–2022 with la/mUC, PBC was the most common 1L treatment, followed by PD-1/L1 inhibitors and non-PBC. While cisplatin-treated patients had longer OS than patients in other groups, treatment durations were short, and OS was generally poor across regimens. These findings highlight an unmet need for more effective 1L therapies in la/mUC.

Abstract PO3-05-03: Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil (BRAVE study - LACOG 0221)

Abstract Introduction: Endocrine therapy (ET) plus CDK 4/6 inhibitors is considered the standard of care as first-line therapy in hormone receptor positive (HR+)/HER2 negative (HER2-) metastatic breast cancer (mBC). Nonetheless, the use of chemotherapy (CT) is frequent in clinical practice, and access to CDK 4/6 inhibitors is limited in some countries. We used real-world data to describe treatment patterns, the impact of health insurance type, and outcomes among Brazilian patients with HR+/HER2- mBC treated in the first-line setting. Methods: In this observational retrospective study, female patients ≥ 18 years old diagnosed with de novo or recurrent HR+/HER2- mBC between January 2018 and December 2020 were included. Patients' data were extracted from medical charts or electronic health records (EHR). The primary endpoint was first-line treatment patterns in public and private health system cohorts. Key secondary endpoints were progression-free survival (PFS), defined as time from 1L treatment to progression or death, and overall survival (OS), defined as time from diagnosis of mBC until death or censoring. No formal statistical assumption was performed for sample size, the study recruited 2 cohorts of 150 patients from the public and 150 patients from the private health insurance system. Results: A total of 307 patients were included, 156 from public and 151 from private health insurance system, from 13 sites in Brazil. Median age was 56.8 (range 19.9-94.1), and 32.2% (N=99) had de novo MBC. Treatment patterns are described in Table 1. The most frequent treatment received in 1L was ET alone 42.4%, followed by CT (alone or CT followed by ET +- CDK4/6i) 31.6% and ET + CDK4/6i 25.1%. There was a significant difference between the 1L treatment with ET + CDK4/6i in the private and public systems, 48.3% vs 2.6%, p < .0001, respectively. The most frequently used CDK4/6i in 1L setting was Ribociclib (65.0%), followed by Palbociclib (36.9%) and Abemaciclib (7.1%). There was an increase in the use of CDK4/6i over time, 17% in 2018, 30.0% in 2019, and 27.9% in 2020. With a median follow-up of 32.2 months (95% CI: 29.4 - 34.4), the median 1L PFS was 22.9 months (95% CI: 16.9 - 25.2) in the public and 21.8 months (95% CI: 17.7 - 31.1) in the private health system, p=0.92. Median 1L PFS by treatment received was 13.6 months (95% CI: 6.1-39.0) with CT, 18.4 months (95% CI: 12.1-22.1) with CT followed by ET +-CDK4/6i, 21.9 months (95% CI: 17.3-25.5) with ET and 31.1 months with ET plus CDK 4/6i (95% CI: 15.8-42.8). Overall, median OS was 52.8 months (95%CI 49.4-NR). The 4-year OS rate per 1L treatment received were 50.3% (95% CI: 28.7-68.5) with CT, 39.0% (95% CI: 13.9-63.8) CT followed by ET +- CDK4/6i, 74.4% (95% CI: 58.0-85.1) with ET alone, 71.3% (95% CI: 49.6-85.0) ET + CDK4/6i, 50.3% (95% CI: 28.7-68.5) with CT and 39.0% (95% CI: 13.9-63.8) CT followed by ET +- CDK4/6i. Conclusion: ET is the most commonly used 1L treatment in clinical practice in Brazil, followed by ET + CDK4/6i and CT. A large difference in CDK4/6i use was observed between private and public health systems, reflecting the current limited access to CDK4/6i in Brazil. This study highlights treatment disparities within a nation with a fragmented health insurance system. Table 1. Treatment Patterns in Public and Private Healthcare Systems Citation Format: Gustavo Werutsky, Daniela Rosa, Tomás Reinert, Romualdo Barroso-Sousa, Heloísa Resende, Poliana Signorini, Eduardo Cronenberger, Juliana Góes Martins Fagundes, Jorge Henrique Santos Leal, Marina Dutra Giffoni, Aline Vieira, Luiza Nardin Weis, Jose Marcio Figueiredo, Tatiana Correa, Fernando Castilho Venero, Luisa Mostardeiro Tabajara Franche, Marina Musse Bernardes, Rafaela Jesus, Gustavo Gössling, José Bines. Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil (BRAVE study - LACOG 0221) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-05-03.

First-line Treatment Patterns and Outcomes in Advanced Non-Small Cell Lung Cancer in Sweden: A Population-based Real-world Study with Focus on Immunotherapy.

The treatment landscape for patients with advanced non-small cell lung cancer (NSCLC) has evolved significantly since the introduction of immunotherapies. We here describe PD-L1 testing rates, treatment patterns, and real-world outcomes for PD-(L)1 inhibitors in Sweden. Data were obtained from the Swedish National Lung Cancer Registry for patients with advanced NSCLC and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 who initiated first-line -systemic treatment from 01 April 2017 to 30 June 2020. PD-L1 testing was available in the registry from 01 January 2018. Kaplan-Meier was used for overall survival (OS) by type treatment and histology. A total of 2,204 patients with pathologically confirmed unresectable stage IIIB/C or IV NSCLC initiated first-line treatment, 1,807 (82%) with nonsquamous (NSQ) and 397 (18%) with SQ. Eighty-six per cent (NSQ) or 85% (SQ) had been tested for PD-L1 expression, a proportion that increased over time. The use of platinum-based therapy as first-line treatment decreased substantially over time while there was an upward trend for PD-(L)1-based therapy. Among patients with PS 0-1 initiating a first-line PD-(L)1 inhibitor monotherapy, the median OS was 18.6 and 13.3 months for NSQ and SQ NSCLC patients, respectively, while for the PD-(L)1 inhibitor and chemotherapy combination regimen, the median OS was 24.0 months for NSQ and not evaluable for SQ patients. The majority of advanced NSCLCs in Sweden were tested for PD-L1 expression. Real-world OS in patients with PS 0-1 receiving first-line PD-(L)1 inhibitor-based regimens was similar to what has been reported in pivotal clinical trials on PD-(L)1 inhibitors.

Real-life clinical management patterns in extensive-stage small cell lung cancer across France: a multi-method study

BackgroundWe designed this study based on both a physician practice survey and real-world patient data to: (1) evaluate clinical management practices in extensive-stage small cell lung cancer (ES-SCLC) among medical centers located across France; and (2) describe first-line treatment patterns among patients with ES-SCLC following the introduction of immunotherapy into clinical practice.MethodsA 50-item questionnaire was completed by physicians from 45 medical centers specialized in SCLC management. Responses were collected from June 2022 to January 2023. The survey questions addressed diagnostic workup of ES-SCLC, chemoimmunotherapy in first-line and second-line settings, and use of prophylactic cranial irradiation (PCI) and radiotherapy. In parallel, using a chart review approach, we retrospectively analyzed aggregated information from 548 adults with confirmed ES-SCLC receiving first-line treatment in the same centers.ResultsIn ES-SCLC, treatment planning is based on chest computed tomography (CT) (as declared by 100% of surveyed centers). Mean time between diagnosis and treatment initiation was 2–7 days, as declared by 82% of centers. For detection of brain metastases, the most common imaging test was brain CT (84%). The main exclusion criteria for first-line immunotherapy in the centers were autoimmune disease (87%), corticosteroid therapy (69%), interstitial lung disease (69%), and performance status ≥ 2 (69%). Overall, 53% and 36% of centers considered that patients are chemotherapy-sensitive if they relapse within ≥ 3 months or ≥ 6 months after first-line chemoimmunotherapy, respectively. Among the 548 analyzed patients, 409 (75%) received chemoimmunotherapy as a first-line treatment, 374 (91%) of whom received carboplatin plus etoposide and 35 (9%) cisplatin plus etoposide. Overall, 340/548 patients (62%) received maintenance immunotherapy. Most patients (68%) did not receive radiotherapy or PCI.ConclusionsThere is an overall alignment of practices reflecting recent clinical guidelines among medical centers managing ES-SCLC across France, and a high prescription rate of immunotherapy in the first-line setting.

First-line Treatment Patterns and Associated Survival Among Older Patients with Advanced Cancer

First-line Treatment Patterns and Associated Survival Among Older Patients with Advanced Cancer

Patterns of immunotherapy utilization for non-small cell lung cancer in Texas pre- and post-regulatory approval.

Immunotherapy has shown remarkable benefits for non-small cell lung cancer (NSCLC) since approved by the US Food and Drug Administration (FDA). Texas, however, ranks below the national average in access to treatment for NSCLC. This retrospective cohort study assessed first-line immunotherapy treatment patterns and associated factors pre- and post-FDA approval in Texas. Patients ≥18years diagnosed with NSCLC from the Texas Cancer Registry database (2011-2018) and were stratified into pre- and post-FDA approval era. The rates of immunotherapy utilization were examined, and the average annual percent change (AAPC) in immunotherapy utilization across patient subgroups was compared. Multivariable logistic regression was used to identify associations of patient characteristics with immunotherapy utilization for patients with metastatic- and all-stage NSCLC. A total of 13,501 and 9509 patients with NSCLC were identified in pre-post-approval periods, respectively. Post-approval, immunotherapy utilization increased from 1.7 to 13.0%, and AAPC from 54.8 to 82.7%. Pre-approval, patients living in a county with ≥20% of households below the poverty level were less likely to receive immunotherapy (OR=0.73, 95% CI=0.61-0.94) while patients with private insurance were more likely to receive immunotherapy (OR=1.56, 95% CI=1.10-2.23). Post-approval, socioeconomic disparities were more prominent (10-19.9 and ≥20% of households below the poverty level: OR=0.77, 95% CI=0.66-0.90 and OR=0.71, 95% CI=0.60-0.86, respectively). Patients with metastatic NSCLC showed similar patterns of socioeconomic disparities pre- and post-approval. Our findings suggest that patients' socioeconomic status hinders immunotherapy utilization for NSCLC in Texas. This emphasizes the need for state health policy reforms such as Medicaid expansion and tailored cancer care strategies.

Real-World Overall Survival and Treatment Patterns by PTEN Status in Metastatic Castration-Resistant Prostate Cancer.

It is estimated that the PTEN tumor suppressor gene is functionally lost in 40%-50% of patients with metastatic castration-resistant prostate cancer (mCRPC). There is limited information on the prognostic significance of PTEN status identified with genomic testing. This real-world cohort study assessed PTEN as a genetic biomarker using data from US-based oncology practices. This retrospective real-world cohort study used a deidentified US-based metastatic prostate cancer clinicogenomic database linked to longitudinal clinical data derived from electronic health records. Patients were aged 18 years and older and diagnosed with mCRPC between January 1, 2018, and June 30, 2021. Comprehensive genomic profiling (CGP) of tumor specimens was performed using next-generation sequencing. First-line (1L) and second-line (2L) treatment patterns were assessed and stratified by PTEN status. Kaplan-Meier methods and a multivariable Cox model were used to compare the real-world overall survival by PTEN status among patients who received 1L novel hormone therapy or taxanes. In patients with mCRPC who underwent CGP, PTEN loss of function (LOF) was associated with decreased survival compared with intact PTEN (hazard ratio, 1.61 [95% CI, 1.07 to 2.42]; P = .024). The results were not influenced by 1L treatment type. 1L treatment patterns were similar between intact PTEN and PTEN LOF subgroups, with abiraterone and enzalutamide being the two most common treatments in both groups. Patients with PTEN LOF were less likely to receive 2L treatments than patients with intact PTEN. PTEN LOF, identified with genomic testing, was associated with decreased survival and negative prognoses in patients with mCRPC.

Treatment patterns of gemcitabine-based chemotherapy in patients with de novo and recurrent advanced biliary tract cancer.

454 Background: Biliary tract cancers (BTC) are often diagnosed at advanced stages (aBTC) when prognosis is poor. In the Phase 3 TOPAZ-1 study (NCT03875235), durvalumab plus gemcitabine and cisplatin (GemCis) significantly improved overall survival versus placebo plus GemCis. To better understand the context of the TOPAZ-1 trial results in the US, we looked at first-line (1L) treatment patterns in participants with aBTC treated with GemCis and other gemcitabine (Gem)-based chemotherapy (CT) regimens. Methods: This retrospective observational cohort study used linked electronic health records and medical and pharmacy claims data from the Optum Market Clarity Database. Adults diagnosed with de novo or recurrent aBTC, who initiated 1L Gem-based CT between January 2016 and March 2022, were identified and followed from the index date (defined as the first administration of Gem-based CT on or after initial BTC diagnosis date) until death, end of continuous enrollment, or end of study period, whichever occurred first. Variables including patient demographics, clinical characteristics, and treatment patterns were described. Results: A total of 580 patients were included in the analysis with either de novo aBTC (n=481, 82.9%) or recurrent aBTC (n=99, 17.1%) with median follow-up time of 10.4 (interquartile range: 6.4, 17.5) and 12.0 (interquartile range: 6.3, 21.9) months, respectively. Mean (SD) age was 64.6 (11.2) and 66.8 (10.4) years, with 45.7% and 54.5% male in the de novo and recurrent aBTC groups, respectively. Most patients were white (77.6%). The most frequent site of primary tumor diagnosis was single-site intrahepatic (overall 62.8%, de novo 66.7%, recurrent 43.4%). In the 12 months prior to index date, 38.5% of patients had biliary obstruction, 30.2% had biliary stents, 29.3% had jaundice, and 17.1% had nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Common comorbidities included cardiovascular disease (50.9%), obesity (46.8%), and diabetes (35.2%). The most common 1L CT was GemCis followed by Gem for both the de novo (n=355, 73.8% and n=36, 7.5%) and recurrent groups (n=58, 58.6% and n=26, 26.3%), respectively. Approximately half of participants (50.9%) switched to a new line of treatment, 33.3% discontinued 1L CT, and 15.9% remained on 1L CT at last follow-up. Most frequent 2L treatments included fluorouracil/oxaliplatin (36.9%) and capecitabine (14.2%). Further analysis will characterize outcomes and regimen duration. Conclusions: Findings from this retrospective study showed that the most common 1L therapies were GemCis and Gem among both de novo and recurrent patients with aBTC. These results provide insight into aBTC treatment practices and may help inform treatment decisions.

Real-World Treatment Patterns and Overall Survival Among Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients: A Retrospective Cohort Study Using Claims Data

Introduction: Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow, characterized by abnormal clonal proliferation and differentiation arrest of myeloid progenitor cells. Prognosis is generally poor and worsens with age. While curative therapies are available, they are often unavailable to older patients and those with significant comorbidities due to high morbidity and mortality associated with intensive therapy. Since 2017, seven new systemic therapies have been approved for various AML patient populations, including those unfit for intensive therapy. This study aims to characterize first-line (1L) and second-line (2L) treatment patterns and outcomes in newly diagnosed (ND) and relapsed/refractory (R/R) AML patients, in the context of these newly available therapies. Methods: A large US administrative claims database (Optum) was used to identify ND AML patients between January 1, 2016, and August 31, 2022. The “ND index date” was defined as the first date a non-R/R AML diagnosis code was observed. To confirm that the initial AML diagnosis represented a true case of AML, ≥2 subsequent AML diagnoses within 60 days post-index were required. A washout period of 12 months was used to confirm no previous AML diagnosis. ND patients were required to have continuous enrollment from 1 year prior to the index until ≥30 days after the index date or death, whichever was earlier. A subgroup of R/R patients was then identified: all ND cohort members who 1) had an R/R AML diagnosis code, 2) had continuous enrollment between ND index date and ≥30 days after the RR index date, and 3) did not receive 1L hematopoietic stem cell transplant (HSCT) after the ND index date were eligible for inclusion. In this subgroup, the “RR index date” was defined as the first date an R/R AML diagnosis code was observed. Demographic characteristics, clinical characteristics, and treatment patterns over time were reported descriptively. Treatment regimens over time were described using the following classification: HSCT, intensive chemotherapy without targeted agents, intensive chemotherapy with targeted agents, hypomethylating agent (HMA) therapy only, other targeted therapy, Venetoclax-based therapy, unspecified/other treatment, no treatment/supportive care only. Overall survival (OS) was described using the Kaplan-Meier estimator. All analyses were stratified by line of therapy and transplant status. Results: We identified 5,135 ND AML patients and 934 R/R AML patients (ND cohort: mean age at initial AML diagnosis 73.5 years, mean follow-up time 6.1 months). ND patients receiving transplant in 1L tended to be younger and had fewer comorbidities than those not receiving transplant ( Table 1). Over the entire study period, 61% of ND patients and 69% of R/R patients received some treatment for AML; older patients were more likely to receive supportive care only. In 1L, Venetoclax-based and intensive chemotherapy without targeted agents were the most common treatment regimens (21% and 17% of all ND patients). In 2L, Venetoclax-based and HMA-only therapies were most common (17% and 16% of all R/R patients). Increases in the use of novel therapies (Venetoclax, intensive chemotherapy with targeted agents, or other targeted therapies) were observed in both 1L and 2L over the study period ( Figure 1). 1-year OS among ND patients was 32% in non-transplant recipients, and 84% in transplant recipients; among R/R patients, 1-year OS from RR index date was 21% in non-transplant recipients and 81% in transplant recipients. Conclusions: The findings from the present study indicate substantial disease burden and ongoing unmet need among ND and R/R AML patients in the USA. While treatment patterns for AML have changed significantly following the advent of novel therapies (with 41% of 1L patients and 31% of 2L patients being treated with novel therapies in 2022), OS remained low. Notably, around 1/3 of patients with RR AML did not receive active treatment; these patients tended to be older and were more frail. Increasing off-label use of Venetoclax in 2L further underscores high unmet need for patients who require more effective treatment options.

First-line real-world treatment patterns and survival outcomes in women younger or older than 40 years with metastatic breast cancer in the real-life multicenter French ESME cohort

AimTo describe first-line treatment patterns, overall survival (OS) and real-world progression-free survival (rwPFS) in young women (<40) with metastatic breast cancer (mBC), as compared to women aged 40–69. Materials and MethodsData on adult women diagnosed with mBC (2008–2017) were extracted from the ESME mBC database (NCT03275311) which includes consecutive patients starting first-line metastatic treatment in one of the 18 French Comprehensive cancer centers. We reported first-line therapeutic strategy and prognostic factors of OS and rwPFS for women aged < 40 and 40–69. ResultsIn total, 14,897 mBC women were included (1512 aged <40). HR+ /HER2- mBC was the most frequent subtype. First-line treatment differed between young patients and older ones for HR+ /HER2- and Triple Negative (TN) mBC. Median OS for women aged < 40 and 40–69, respectively, was 46.9 and 46.2 months for HR+ /HER2- mBC; 13.5 and 15.2 for TN mBC; and, 60.7 and 55.1 for HER2 + mBC. Median rwPFS under first line treatment was 11.6 and 11.9 months for HR+ /HER2- in women aged < 40 and 40–69, respectively; 5.5 and 5.9 for TN, and, 13.3 and 12.9 for HER2 + . Factors associated with shorter OS and rwPFS were similar for both women aged < 40 and 40–69 and included ≥ 3 metastatic sites, visceral metastases, and longer MFI, with time-varying effects observed for several prognostic factors. ConclusionYoung women presented more frequently with TN and HER2 + subtypes and aggressive mBC than women aged 40–69 did. Prognostic factors of OS and rwPFS were quite similar between age groups and mBC subtypes.

1147P First-line treatment (tx) patterns and overall survival (OS) of patients (pts) with advanced Merkel cell carcinoma (aMCC) in England from 2013-2022: Results of a nationwide observational cohort study

1147P First-line treatment (tx) patterns and overall survival (OS) of patients (pts) with advanced Merkel cell carcinoma (aMCC) in England from 2013-2022: Results of a nationwide observational cohort study

MDS-067 First-Line (1L) Treatment Patterns and Outcomes Among Patients With Newly Diagnosed Myelodysplastic Syndromes (MDS): A Global, Retrospective Observational Cohort Study

MDS-067 First-Line (1L) Treatment Patterns and Outcomes Among Patients With Newly Diagnosed Myelodysplastic Syndromes (MDS): A Global, Retrospective Observational Cohort Study

POSTER: MDS-067 First-Line (1L) Treatment Patterns and Outcomes Among Patients With Newly Diagnosed Myelodysplastic Syndromes (MDS): A Global, Retrospective Observational Cohort Study

POSTER: MDS-067 First-Line (1L) Treatment Patterns and Outcomes Among Patients With Newly Diagnosed Myelodysplastic Syndromes (MDS): A Global, Retrospective Observational Cohort Study

Real-World Treatment Patterns Among Patients With Metastatic Castration-Resistant Prostate Cancer: Results From an International Study.

There is limited real-world evidence on how increasing use of treatment intensification in metastatic castration-sensitive prostate cancer (mCSPC) has influenced treatment decisions in metastatic castration-resistant prostate cancer (mCRPC). The study objective was to evaluate the impact of novel hormonal therapy (NHT) and docetaxel use in mCSPC on first-line treatment patterns among patients with mCRPC in 5 European countries and the United States (US). Physician-reported data on patients with mCRPC from the Adelphi Prostate Cancer Disease Specific Program were descriptively analyzed. A total of 215 physicians provided data on 722 patients with mCRPC. Across 5 European countries and the US, 65% and 75% of patients, respectively, received NHT, and 28% and 9% of patients, respectively, received taxane chemotherapy as first-line mCRPC treatment. In Europe, patients who had received NHT in mCSPC (n = 76) mostly received taxane chemotherapy in mCRPC (55%). Patients who had received taxane chemotherapy, or who did not receive taxane chemotherapy or NHT in mCSPC (n = 98 and 434, respectively) mostly received NHT in mCRPC (62% and 73%, respectively). In the US, patients who had received NHT, taxane chemotherapy, or neither in mCSPC (n = 32, 12, and 72, respectively) mostly received NHT in mCRPC (53%, 83%, and 83%, respectively). Two patients in Europe were rechallenged with the same NHT. These findings suggest that physicians consider mCSPC treatment history when making first-line treatment decisions in mCRPC. Further studies are needed to better understand optimal treatment sequencing, especially as new treatments emerge.

BPI23-011: Real-World Study of First-Line Treatment Patterns in HR+/HER2– Metastatic Breast Cancer (MBC) at a Tertiary Care Cancer Institute

"BPI23-011: Real-World Study of First-Line Treatment Patterns in HR+/HER2– Metastatic Breast Cancer (MBC) at a Tertiary Care Cancer Institute" published on 31 Mar 2023 by National Comprehensive Cancer Network.

Clinicopathological Features and First-Line Treatment Outcomes of Geriatric Patients With Extensive-Stage Small Cell Lung Cancer: A Multicenter Study.

Introduction The geriatric patient population diagnosed with extensive stage small cell lung cancer (SCLC) is underrepresented in clinical studies. We aimed to evaluate the clinicopathological characteristics, first-line treatment patterns and treatment outcomes of patients aged 65 years or older with extensive stage SCLC. Material and methods In this multicenter, retrospective cohort study, patients aged 65 years or older, diagnosed with extensive-stage SCLC, between January 2009 and December 2021 were included. Patients who were under 65 years of age at the time of diagnosis and did not develop progression after curative treatment and patients with a second malignancy were excluded from the study. The clinicopathological characteristics, first-line treatment patterns and treatment outcomes were analyzed. Results A total of 132 patients were included in the study. The median age was 70 years (range:65-91), and 118 (89.4%) patients were male. There were 77 (58.3%) patients with eastern cooperative oncology group (ECOG) performance status (PS) of 0-1. There were 26 (19.7%) patients in the limited stage disease and 106 (80.3%) patients in the extensive stage disease at the time of diagnosis. First-line chemotherapy was given to 86 (65.2%) patients. Of the patients who could not receive treatment, 18 patients (13.6%) due to patient refusal, and 28 patients (21.2%) due to comorbid diseases and poor performance status with organ dysfunctions. The most common treatment regimen used as first-line treatment was cisplatin+etoposide (n=47, 54.7%), and followed by carboplatin+etoposide (n=39, 45.3%). First-line chemotherapy responses were complete response in 4 (4.7%) patients, partial response in 35 (40.7%) patients, stable disease in 13 (15.1%) patients, and progressive disease in 34 (39.5%) patients. The most common grade 3-4 adverse events was neutropenia in 33 (38.4%) patients. Forty nine patients (57.0%) completed the planned first-line treatment. The mPFS was 6.1 months and the mOS was 8.2 months with first-line treatment. We found that ECOG PS status was the most important negative prognostic factor for both PFS and OS. There was no difference between carboplatin+etoposide and cisplatin+etoposide regimens in terms of PFS, OS, adverse events and treatment compliance. Conclusion Thus, it may be an appropriate approach not to give up chemotherapy treatment easily in elderly patients with a diagnosis of extensive stage SCLC. It should be kept in mind that finding factors that might affect the prognosis and tailoring the tretment precisely on case-by-case basis in geriatric cancer patients have an impact on survival.

US real-world first-line (1L) treatment patterns and outcomes for patients with metastatic urothelial carcinoma (mUC) following maintenance avelumab approval.

483 Background: The introduction of the immune checkpoint inhibitors (ICI) pembrolizumab and atezolizumab has dramatically changed the 1L mUC treatment paradigm. These agents are currently recommended by the National Comprehensive Cancer Network for platinum-ineligible patients (irrespective of programmed death-ligand 1 (PD-L1) status) and, in the case of atezolizumab, for cisplatin-ineligible patients whose tumors express PD-L1. More recently, avelumab, received approval as the first ICI for the maintenance treatment of patients who have not progressed on 1L platinum-containing chemotherapy. In this study, we described real-world 1L treatment patterns and outcomes for mUC patients following avelumab maintenance approval. Methods: We used electronic medical record data from The US Oncology Network, which includes 1,400 affiliated physicians operating in over 500 sites of care across states and treats approximately 1.2 million cancer patients annually. mUC patients diagnosed between 30 April 2020 (i.e., ~3 months before avelumab maintenance approval) and 30 June 2021 were included, with follow-up until 31 December 2021, last patient record or death, whichever occurred first. Chart review was conducted to verify mUC diagnosis, baseline characteristics, treatment patterns, and clinical outcomes. Avelumab maintenance was defined as receiving avelumab after 1L platinum-containing chemotherapy, with no documented progressive disease prior to avelumab start or as maintenance therapy indicated by physician notes. Results: A total of 249 eligible mUC patients initiated 1L treatment. Of these, 132 (53%) received ICI monotherapy, 99 (40%) received platinum-containing chemotherapy, and 18 (7%) received other treatments. Almost one-third (n=32) of those who received 1L platinum-containing chemotherapy received avelumab maintenance therapy. ICI monotherapy use increased with age, ranging from 36% among &lt;65-year-olds to 67% among ≥75-year-olds. During a median follow-up of 14.5 months, 68 (27%) patients received second-line treatment. Median (95% confidence interval) overall survival (OS) for 1L ICI monotherapy and 1L platinum-containing chemotherapy was 10.9 (7.2, 13.0) and 16.8 (13.5, not reached) months, respectively. Conclusions: During the 18-month period following maintenance avelumab approval, in this US community oncology setting, ICI monotherapy was the most utilized 1L treatment for mUC patients, especially among older patients. The uptake of maintenance avelumab was modest. Longer follow-up is needed to further characterize OS, especially for those who received platinum therapy followed by avelumab maintenance.