Real-World Patient Characteristics and Treatment Outcomes Among Newly Diagnosed Multiple Myeloma Patients Initiating Daratumumab, Lenalidomide, and Dexamethasone As First-Line Therapy

Abstract Introduction: Daratumumab, a CD38 monoclonal antibody, was approved for the treatment of heavily pretreated relapsed or refractory multiple myeloma (MM) in 2015 and for newly diagnosed MM (NDMM) in 2018. The phase 3 MAIA study demonstrated that daratumumab plus lenalidomide/dexamethasone (D-Rd) improved clinical outcomes, including overall survival, versus lenalidomide/dexamethasone (Rd) in transplant-ineligible NDMM (Facon T, et al. EHA Library. 2021). However, limited real-world data are available regarding patients with MM treated with daratumumab in the US. We evaluated patient characteristics and treatment outcomes among transplant-ineligible NDMM patients who received D-Rd as first-line therapy in US oncology practices. Methods: This retrospective, observational cohort study evaluated patients from the Flatiron MM Core Registry who received first-line D-Rd between November 1, 2015 and February 28, 2021. The Flatiron Health electronic health record (EHR)-derived deidentified database has longitudinal patient-level records for patients treated at community oncology practices and academic medical centers across the US. The index date was the date of the first observed record of the D-Rd regimen. Patients aged <18 years on the index date, enrolled in a clinical trial on the index date, with other malignancies prior to the index date, with a diagnosis of amyloid light-chain amyloidosis prior to the index date, or with hematopoietic stem cell transplant from the diagnosis date to the index date were excluded. Patient characteristics analyzed included age at time of D-Rd initiation, race, Eastern Cooperative Oncology Group performance status (ECOG PS) score, International Staging System (ISS) stage, frailty, and presence of comorbidities such as diabetes and acute renal impairment. Time-to-next-treatment and progression-free survival (PFS) were analyzed using the Kaplan-Meier method. Results: From November 1, 2015 to February 28, 2021, 1,721 patients were identified from the Flatiron MM Core Registry as patients treated with a daratumumab-based regimen; 120 (7.0%) of the 1,721 patients were treated with a daratumumab-based regimen as first-line therapy, and 35 (29.2%) of the 120 patients were identified as eligible patients treated with D-Rd as first-line therapy. For patients treated with first-line D-Rd (n=35), the mean age as of the index date was 73.5 years (SD: 7.9). Most patients were White (72.4%), had an ECOG PS score of 1 (51.9%), and had an ISS stage of II (38.1%) or III (42.9%). Of these patients, 15 (42.9%) patients were ≥75 years of age, 4 (11.4%) were Black or African American, 4 (11.4%) had high-risk cytogenetics, 21 (60.0%) were frail, 6 (17.1%) had diabetes, and 6 (17.1%) had acute renal impairment. The median time from the initial diagnosis date to the index date was 1.2 months and the median follow-up was 8.0 months. The median PFS was not reached in this study. The estimated 6-month PFS rate was 91.6%, 9-month PFS rate was 81.0%, and 12-month PFS rate was 73.6% (Figure). After 15 months of follow-up, an estimated 80.5% of patients had not received their next treatment. Conclusions: The real-world population of patients who received D-Rd as first-line therapy is similar to the population studied in MAIA. The early trend of PFS is also similar to that in MAIA, with the majority of patients progression free at 6, 9, and 12 months. Greater understanding of long-term outcomes among transplant-ineligible NDMM patients who received D-Rd as first-line therapy at US oncology practices is needed to further facilitate the safe and effective use of daratumumab. Figure 1 Figure 1. Disclosures Tai: Janssen Scientific Affairs, LLC: Current Employment. Cai: Janssen: Current Employment. Fu: Janssen: Current Employment. Khare: Janssen: Current Employment. Kaila: Janssen Scientific Affairs, LLC: Current Employment.

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Real-World Treatment Patterns and Outcomes Among Patients with Hairy Cell Leukemia

Blood ◽

10.1182/blood.v126.23.2125.2125 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2125-2125

Author(s):

Sudeep Karve ◽

Victoria Divino ◽

Andrew Gaughan ◽

Mitch DeKoven ◽

Guozhi Gao ◽

...

Keyword(s):

Health Plan ◽

Real World ◽

Index Date ◽

Treatment Patterns ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

First Line Therapy ◽

Line Therapy

Abstract Background and Objective : Hairy cell leukemia (HCL) is a rare condition and accounts for ~2% of all leukemia cases in the US. NCCN guidelines recommend first-line agents including pentostatin and cladribine among patients with HCL. However, a paucity of data exists with regard to real-world treatment patterns among patients with HCL. Current study evaluates treatment patterns and associated clinical outcomes among patients with HCL using a large US administrative claims database. Methods : This retrospective observational study was conducted using the IMS Health PharMetrics Plus Health Plan Claims Database (2006-2014), which includes over 150 million unique health plan members across the US and is nationally representative of the commercially-insured US population. Data includes date stamped medical and pharmacy records along with information on health plan enrollment. Individuals with at least 2 medical claims with a diagnosis for HCL (identified using ICD-9-CM cod: 202.4x) were selected and the first observed claim defined the "index date." Patients <18 years of age at index date or with other malignancies during 6 months (the "pre-index period") prior to index date were excluded. Patients were required at least 90 days of continuous enrollment (the variable "follow-up period") in the health plan post index date with exception of patients who died within 3 months of diagnosis. Patients were followed until death (recorded on inpatient discharge disposition), end of enrollment or end of database, whichever occurred earlier. Study measures including patient demographic and baseline clinical characteristics, line of therapy (LOT), treatment patterns, relapse (receipt of same or new regimen in subsequent LOT following a gap of 365 days) and refractory disease (receipt of same or new regimen where the gap of two adjacent LOTs was <365 days) and post-treatment complications were assessed during the follow-up period. All analyses were descriptive in nature. Results : The study cohort included 749 patients after applying the selection criteria (mean follow-up from diagnosis 32 months). At diagnosis, the mean age (standard deviation) of the study cohort was 56 (10) years and majority of patients were male (77%). Mean baseline comorbidity burden (assessed using Charlson Comorbidity Index score) was 0.8 (1.1) with hypertension (24%) and aplastic anemia (22%) being the two most common co-morbidities. Only 38% (n=282) of patients received first-line chemotherapy post diagnosis. Majority initiated first-line cladribine (76%) as a single agent, while 9% had evidence of single agent pentostatin. Mean time to initiation of first-line therapy from diagnosis was 132 (294) days and average time on first-line therapy was 34 (104) days. Among patients with first-line therapy 14% received second-line therapy and rituximab (53%) and cladribine (21%) were frequently observed second-line agents. Post first-line therapy, mean time to initiation of second-line therapy was 303 (406) days. Among second-line initiators, 76% had refractory disease and 24% had relapsed following first-line. Neutropenia and fever were frequently reported complications while on chemotherapy. Conclusion : The real-world chemotherapy utilization patterns observed in this study are consistent with the NCCN guidelines with cladribine and pentostatin being the agents of choice for first-line therapy. Following diagnosis, more than one-third of patients initiated chemotherapy and only a small proportion of these received second-line chemotherapy suggesting durable response with first-line therapy. Limited follow-up post first-line therapy may have impacted the proportion of patients initiating second-line therapy as well as categorization of refractory and relapse disease. Disclosures Karve: AstraZeneca: Employment. Divino:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gaughan:AstraZeneca: Employment. DeKoven:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gao:MedImmune: Employment. Lanasa:MedImmune: Employment.

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Phase 2 study of pembrolizumab as first-line therapy for PD-L1–positive metastatic triple-negative breast cancer (mTNBC): Preliminary data from KEYNOTE-086 cohort B.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.1088 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 1088-1088 ◽

Cited By ~ 42

Author(s):

Sylvia Adams ◽

Sherene Loi ◽

Deborah Toppmeyer ◽

David W. Cescon ◽

Michele De Laurentiis ◽

...

Keyword(s):

Antitumor Activity ◽

Tumor Imaging ◽

Treatment Options ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

New Treatment ◽

Combined Positive Score ◽

Ecog Ps

1088 Background: Standard first-line treatment for mTNBC is chemotherapy. However, outcomes are poor, and new treatment options are needed. Cohort B of KEYNOTE-086 (NCT02447003) assessed the safety and antitumor activity of pembrolizumab as first-line therapy for patients (pts) with PD-L1–positive mTNBC. Methods: Men and women with centrally confirmed mTNBC, no prior systemic anticancer therapy for metastatic disease, ECOG PS 0-1, and a tumor PD-L1 combined positive score (CPS) ≥1% received pembrolizumab 200 mg Q3W for 24 mo or until disease progression, intolerable toxicity, or investigator or pt decision. Tumor imaging was performed Q9W for 12 mo and Q12W thereafter. Clinically stable pts with PD could remain on pembrolizumab until PD was confirmed on subsequent assessment. Primary end point was safety. Secondary end points included ORR, DOR, and PFS (RECIST v1.1, central review). Planned enrollment was 80 pts. This analysis included all pts who had ≥18 wk of follow-up as of Nov 10, 2016. Results: 79 of the first 137 pts with PD-L1–evaluable tumors (58%) had PD-L1 CPS ≥1%. Of the first 52 pts enrolled, 100% were women, median age was 53 y, 40% had elevated LDH, 69% had visceral metastases, and 87% received prior (neo)adjuvant therapy. After a median follow-up of 7.0 mo (range 4.4-12.5), 15 (29%) pts remained on pembrolizumab. Treatment-related AEs occurred in 37 (71%) pts, most commonly fatigue (31%), nausea (15%), and diarrhea (13%). 4 (8%) pts experienced 5 grade 3-4 treatment-related AEs: back pain, fatigue, hyponatremia, hypotension, and migraine (n = 1 each). No pts died or discontinued pembrolizumab due to an AE. ORR was 23% (95% CI 14%-36%). Best overall response was CR in 4%, PR in 19%, SD in 17%, PD in 58%, and not assessed in 2%. Median time to response was 8.7 wk (range 8.1-17.7). Median DOR was 8.4 mo (range, 2.1+ to 8.4), with 8 (67%) responses ongoing at cutoff. Median PFS was 2.1 mo (95% CI, 2.0-3.9); estimated 6-mo PFS rate was 29%. Conclusions: Data from the first 52 pts enrolled in KEYNOTE-086 cohort B suggest that pembrolizumab monotherapy has a manageable safety profile and promising antitumor activity as first-line therapy for PD-L1–positive mTNBC. Clinical trial information: NCT02447003.

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KEYNOTE-604: Pembrolizumab (pembro) or placebo plus etoposide and platinum (EP) as first-line therapy for extensive-stage (ES) small-cell lung cancer (SCLC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.9001 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 9001-9001 ◽

Cited By ~ 1

Author(s):

Charles M. Rudin ◽

Mark M. Awad ◽

Alejandro Navarro ◽

Maya Gottfried ◽

Solange Peters ◽

...

Keyword(s):

Standard Dose ◽

Rank Test ◽

P Value ◽

First Line ◽

Double Blind ◽

First Line Therapy ◽

Significance Threshold ◽

Line Therapy ◽

Ecog Ps

9001 Background: Pembro monotherapy showed durable antitumor activity as third-line or later therapy for metastatic SCLC, leading to FDA approval in that setting. KEYNOTE-604 was a double-blind, phase 3 study of pembro + EP vs placebo + EP as first-line therapy for ES-SCLC (NCT03066778). Methods: Eligible patients (pts) with previously untreated ES-SCLC and no untreated CNS metastases were randomized 1:1 to pembro 200 mg Q3W or saline placebo for up to 35 cycles plus 4 cycles of standard-dose EP. Pts with CR or PR after cycle 4 could receive PCI at investigator discretion. Randomization was stratified by platinum choice (carboplatin vs cisplatin), ECOG PS (0 vs 1), and LDH (≤ULN vs > ULN). Primary endpoints were OS and PFS (RECIST v1.1, blinded central review) in the ITT population. ORR, DOR, and safety were secondary endpoints. OS and PFS treatment differences were assessed by the stratified log-rank test. The protocol specified 2 interim analyses (IAs) and a final analysis (FA). Prespecified efficacy boundaries were one-sided P = 0.0048 for PFS at IA2 (prespecified final PFS analysis) and 0.0128 for OS at FA. Results: 453 pts were randomized. 223/228 pts assigned to pembro + EP and 222/225 assigned to placebo + EP received ≥1 dose of assigned treatment; 1 pt assigned to pembro + EP received placebo + EP in error. Median age was 65 y, 74% had ECOG PS 1, and 57% had LDH > ULN; more pts in the pembro + EP arm had baseline brain metastases (14% vs 10%). At FA (median follow-up, 21.6 mo), 9% of pts in the pembro + EP arm and 1% in the placebo + EP arm remained on study treatment; 12% and 14% received PCI. At IA2 (median follow-up, 13.5 mo), pembro + EP significantly improved PFS in the ITT population (HR 0.75 [95% CI 0.61-0.91], P = 0.0023; median 4.5 vs 4.3 mo). At FA, pembro + EP prolonged OS in the ITT population, but the significance threshold was not met (HR 0.80 [95% CI 0.64-0.98], P = 0.0164; median 10.8 vs 9.7 mo). In a post hoc analysis of OS in the as-treated population, the nominal P value was smaller than the significance threshold (HR 0.78 [95% CI 0.63-0.97], P = 0.0124). ORR at FA was 71% for pembro + EP vs 62% for placebo + EP; median DOR was 4.2 vs 3.7 mo. Observed AEs were as expected; any-cause AEs were grade 3-4 in 77% vs 75%, grade 5 in 6% vs 5%, and led to discontinuation in 15% vs 6%. Conclusions: Pembro + EP significantly improved PFS and prolonged OS compared with placebo + EP as first-line therapy for pts with ES-SCLC. No unexpected toxicities were seen with pembro + EP. These data support the benefit of pembro-containing regimens for ES-SCLC. Clinical trial information: NCT03066778.

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Progression of Follicular Lymphoma within 24 Months of First Treatment (POD -24) As a Predictor of Overall Survival - a Single Center Retrospective Analysis

Blood ◽

10.1182/blood-2019-125218 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1534-1534

Author(s):

Guy Bitansky ◽

Elena Vasilev ◽

Maya Zlotnick ◽

Elena Ribakovsky ◽

Ohad Benjamini ◽

...

Keyword(s):

Overall Survival ◽

Multivariate Analysis ◽

Real World ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Early Progression ◽

Progression Of Disease ◽

Routine Imaging

Background: Follicular lymphoma (FL) is the most common indolent lymphoma in the western world with a median survival approaching 20 years. However, the course of the disease is extremely heterogeneous and therefore, at diagnosis it is difficult to predict survival. Roughly 20% of patients experience rapid progression of disease post first line treatment. Progression of disease within 24 months of first treatment (POD24) was previously identified a robust predictor of reduced overall survival (OS) (Casulo et al., JCO, 2015). Aims: We aimed to validate POD24 as a predictor of poor OS in a real-world cohort of patients, which was not uniformly treated, including patients that were initially treated with radiation or observed at least 6 months prior to first line therapy. Methods: We thoroughly reviewed 635 patient's records that were diagnosed between 1987 and 2018. Patients with FL grade 3B or de-novo transformation, as well as those that were never treated, treated prior to the rituximab era or had missing relevant clinical data were excluded. POD24 was defined as time from first therapy (systemic or radiation therapy) to first documented progression (either clinical or by imaging). Overall Survival was defined as time from diagnosis to either last follow-up or death. Progression Free Survival (PFS) was defined as the time from first treatment to first documented progression, death or last follow-up. Survival was analyzed with Kaplan-Meier method and comparison of survivals was done with Log-Rank test. Multivariate analysis was conducted with Cox regression. Results: A total of 317 patients met the study inclusion criteria and were included in our analysis. Median age was 57 (23-87), 162 (51%) were male and 155(49%) female .Median follow-up was 7.5 years (0.24-24.4). FLIPI (available in n=149) was high in 41 (27%) patients, intermediate in 37 (25%) and low in 71 (48%). Eighty seven patients (27.4%) received radiation as their first treatment and 86 (27%) were initially observed. Systemic therapy regimens included alkylator based regimens (n=152, RCHOP-88), bendamustine based (45), fludarabine Based (32), and Rituximab alone (2). Maintenance therapy administration was documented in 119 patients. Progression was documented in 133 (42%) patients, and transformation in 34 (11%). Thirty four patients (11%) deceased. Median OS was not reached in our study cohort, and median PFS was 109 months (CI:68-150). Early progression (POD24) was captured in 68 (21.5%) patients. The OS of those patients was significantly lower than those whom did not progress within 24 months of first therapy (figure 1A, p<0.0001). High FLIPI score also predicted lower OS (p=0.001). In multivariate analysis both factors remained significant (POD24 p=0.013, FLIPI p=0.023). In the group of patients that were initially observed (86), 18 had early progression after first treatment. In this group, OS did not differ between the patients that had POD24 vs those who did not (p=0.095). The same was true for patients that had radiation as their first line therapy (p=0.36). The impact of POD24 on OS was observed in patients that were treated with alkylator based regimens (p=0.02) as well as with bendamustine based regimens (p=0.028). In the Fludarabine treated patients no significant difference in OS was observed in the different POD24 groups, probably due to small sample size. Interestingly, POD24 did not predict inferior OS in 69 patients in whom progression was diagnosed by routine imaging (PET/CT or CT) (Figure 1B). However, it was borderline predictive (p=0.1) when progression was clinically diagnosed (n=38). Conclusions: Our real-world analysis validated the importance of POD24 as predictor of OS in patients who were treated at diagnosis with alkylator or bendamustine based regimens. POD24 did not predict survival in patients treated with radiation or in those initially observed, a result that may reflect their superior outcome. Notably, POD24 did not predict OS in patients that were diagnosed with progression by routine imaging. As we, and others use imaging studies frequently in the follow-up of FL patients, especially in first two years after therapy, the scenario of positive findings in imaging is relatively frequent. Our data suggest that random findings in imaging that do not have clinical expression may not predict inferior outcome which is of major clinical implications. Disclosures No relevant conflicts of interest to declare.

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Clinical Experience Of Lenalidomide Plus Low Dose Dexamethasone As First-Line Therapy For Multiple Myeloma At a Large County Hospital Caring For An Indigent Population

Blood ◽

10.1182/blood.v122.21.5399.5399 ◽

2013 ◽

Vol 122 (21) ◽

pp. 5399-5399

Author(s):

Yehuda E. Deutsch ◽

Daniel J Dammrich ◽

Jesus C Fabregas ◽

Agustin Pimentel ◽

Alexandra Stefanovic ◽

...

Keyword(s):

Multiple Myeloma ◽

Clinical Trials ◽

Real World ◽

Patient Population ◽

County Hospital ◽

Published Data ◽

First Line ◽

First Line Therapy ◽

Line Therapy

Abstract Background There is ample data for the response rates and clinical outcomes for patients with newly diagnosed multiple myeloma (MM) treated with first-line lenalidomide and dexamethasone (LEN/DEX). Phase II and III studies have reported objective response rates (ORR) in the range of 70-90%. However, extrapolating from clinical trials to ‘real world' clinical practice is sometimes difficult. This is particularly so when it comes to large city hospital systems such as Jackson Memorial Hospital (JMH) in Miami, Florida. JMH is the third-largest public hospital and third-largest teaching hospital in the United States. Patients are primarily uninsured or insured through Medicaid. Additionally, one might surmise, that for a medication like LEN- with a relatively narrow therapeutic index, high cost, and cumbersome prescribing/dispensing requirements- outcomes in the ‘real world' might be inferior to those cited in clinical study. We endeavored to explore such outcomes in JMH to determine whether the benefits of this high cost drug in this setting are concordant with published data. Methods We conducted a retrospective analysis of all patients enrolled into the Celgene patient assistance program and prescribed LEN from January 1, 2010 through July 30, 2013 at JMH. We identified 96 patients enrolled into this program, 35 patients received LEN/DEX as first-line therapy for MM and are evaluable for this analysis. The primary end-point for analysis was response at 4 months. Results Medical records of 35 patients were reviewed. The mean age was 59 (46-75), majority of patients were female (60%), and 29% were black. Consistent with our patient population, 71.4% of patients were Hispanic, 44% were uninsured, and 64% had Medicaid. IgG (60%) was the most common heavy chain involved while 3 patients had light chain disease only. The majority of patients (88.6%) had stage III disease by the Durie-Salmon criteria, and 37.1% had ISS stage III disease. Cytogenetic studies were evaluable in 30 patients: 66.7% were standard-risk, 30% intermediate-risk and 3.3 % high-risk according to mSMART risk classification. At 4-month follow-up, 26 (74.3%) patients had an OR: 6 (17.1%) patients had CR, 7 (20%) had VGPR, and 13 (37.1%) had PR. 6 (17.1%) patients had progressive disease, change in therapy, or were lost to follow-up. There were no documented deep venous thromboses, a known risk of LEN therapy. Only 8 patients (23%) underwent autologous stem cell transplant following primary therapy. Conclusion Responses with upfront LEN/DEX in MM at JMH, were relatively similar to published data in large clinical studies. This provides support for the extrapolation of data from well supported clinical trials at fully-resourced medical institutions, for an oral chemotherapy drug with significant potential toxicities and logistical barriers, to a primarily Medicaid patient population in a county hospital. Disclosures: No relevant conflicts of interest to declare.

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Real-world aromatase inhibitor use and failure in women with metastatic ER+/HER2- breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.593 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 593-593

Author(s):

Pamela Landsman-Blumberg ◽

Madhav Namjoshi ◽

Erin Thomson ◽

William Johnson

Keyword(s):

Breast Cancer ◽

Postmenopausal Women ◽

Real World ◽

Newly Diagnosed ◽

First Line ◽

First Line Therapy ◽

Her2 Breast Cancer ◽

Line Therapy ◽

Thomson Reuters

593 Background: Aromatase Inhibitors (AIs) have replaced tamoxifen as first-line therapy for postmenopausal women with metastatic, ER+ breast cancer (BC). However, little information is available on the real-world use of AIs. The objectives of this retrospective claims study were to compare demographic, clinical and treatment characteristics of postmenopausal women with metastatic ER+/HER2- BC treated with AIs and experiencing 0, 1, 2 or ≥ 3 AI failures (AIF). Methods: Women ≥ 55 years old, newly diagnosed with metastatic BC (index) were identified in the 2006-2010 Thomson Reuters MarketScan databases and followed until chemotherapy or 03/31/2011. ER+/HER2- disease was defined as any endocrine therapy (ET: tamoxifen, fulvestrant) or AI (anastrozole, letrozole, or exemestane) use and no trastuzumab or lapatinib use in the 6-month pre-or variable post-index periods. Those with any post-index AI use were retained for study. AIF post-index was defined as a switch to an alternative AI, ET or chemotherapy, or AI discontinuation with no further BC treatment. Patients were stratified by number of post-index AIF: 0, 1, 2 or ≥ 3. Results: Among 4,274 patients identified, 61% had ≥ 1 AIF (1: 80%, 2: 15%, ≥3: 5%). There was no difference in pre-index AI use across AIF cohorts: 0, 1, 2, and ≥3 (54%, 52%, 48%, 56%; p=0.073). AIFs increased with Medicare-eligibility (51%, 56%, 60%, 61%) and bone metastases at index (48%, 53%, 62%, 63%). Among those with ≥1 AIF, median follow-up (FU) increased with each failure but there was no notable pattern to reason for FU end. Median FU of the 0 AIF cohort (408 days) fell between those of the 1 and 2 AIF cohorts, 335 and 517 days. Anastrozole was the most common first line treatment for all cohorts except ≥ 3 AIFs where letrozole was most common. Pre-index and first line fulvestrant use both increased with the number of post-index AIFs: 0.3%, 1.9%, 2.0%, 5.0% and 0.7%, 2.5%, 4.0%, 14.9% respectively. There was no association between number of AIFs and chemotherapy use (36%, 29%, 38%). Conclusions: Over 60% of women with ER+/HER2- metastatic BC treated with AIs failed at least 1 and 20% of those failed ≥ 2. Surprisingly, increased rates of prior fulvestrant treatment appear associated with increasing numbers of AIF.

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Overall survival and treatment patterns among real-world patients with locally advanced or metastatic urothelial carcinoma treated with first-line therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.6_suppl.464 ◽

2018 ◽

Vol 36 (6_suppl) ◽

pp. 464-464

Author(s):

Jason C Simeone ◽

Beth L Nordstrom ◽

Ketan Patel ◽

Alyssa B Klein ◽

Laura Horne

Keyword(s):

Overall Survival ◽

Real World ◽

Locally Advanced ◽

First Line ◽

First Line Therapy ◽

Real World Setting ◽

Line Therapy ◽

Platinum Based Chemotherapy ◽

Metastatic Urothelial Carcinoma

464 Background: Although platinum-based chemotherapy has been the standard of care for the treatment of locally advanced or metastatic urothelial carcinoma (UC), overall survival (OS) remains poor. Real world data on the treatment patterns for UC and effectiveness of these treatments are limited. Methods: Patients with locally advanced or metastatic UC who received first line therapy were identified from the Flatiron Oncology electronic medical record database from 2011–2016; patients who previously received immunotherapy treatment were excluded. Treatment characteristics included the most frequently administered first-line regimens in the study cohort and the time from advanced/metastatic diagnosis to start of first-line therapy. Median OS from the start of first-line therapy was calculated using Kaplan-Meier curves and 95% confidence intervals (CI) are presented. Results: Of 1,811 included patients who met study inclusion and exclusion criteria, the mean age was 70.4 ± 9.5 years, and 73.2% were male. Fewer than 3% of patients were tested for PD-L1 during follow-up. Platinum-based chemotherapy was the most commonly prescribed first-line treatment and immunotherapy was used in 1.3% of first-line regimens (Table 1); patients received a median of one treatment line during follow-up. The median OS was 12.7 months (95% CI: 11.8–13.5) from initiation of first-line therapy. Conclusions: Overall survival among locally advanced/metastatic UC patients who received first-line therapy in a real-world setting was approximately one year. As immunotherapy treatment for UC becomes more common, the impact on OS in the real world setting remains to be seen. [Table: see text]

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Real-world effectiveness of palbociclib in combination with an aromatase inhibitor as first-line therapy in metastatic breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e12541 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e12541-e12541

Author(s):

Xianchen Liu ◽

Jack Mardekian ◽

Lynn McRoy

Keyword(s):

Breast Cancer ◽

Clinical Practice ◽

Aromatase Inhibitor ◽

Real World ◽

Metastatic Breast ◽

Small Sample ◽

First Line ◽

First Line Therapy ◽

Line Therapy

e12541 Background: Palbociclib in combination with an aromatase inhibitor (AI) was approved as initial endocrine therapy for patients with HR+/HER2– metastatic/advanced breast cancer (mBC) in February 2015. Evidence of real world outcomes for the combination to date has been limited by small sample size and short follow-up. This study describes patient characteristics and effectiveness of palbociclib + AI as first-line therapy in a large cohort of mBC patients in US clinical practice. Methods: Utilizing Flatiron Health’s longitudinal database, a retrospective cohort study was conducted to evaluate patients with HR+/HER2– mBC who started palbociclib + AI as first-line therapy between February 3, 2015 and August, 31, 2018. Patients were evaluated retrospectively from start of palbociclib + AI therapy on or after February 3, 2015 to November 30, 2018, death, or last visit in the database, whichever came first. Real-world progression free survival (rwPFS) was defined as months from start of palbociclib + AI therapy to death or disease progression based on clinical assessment or evidence by radiographic scan/tissue biopsy. Kaplan-Meier methods were used to estimate survival proportions in overall survival (OS) and rwPFS. Results: Of 878 who met the criteria, 66.9% were white, mean age was 65.2 years, 50.8% had visceral disease (liver and/or lung involvement), and 94% were treated in community practice. Patients were followed up to 46 months. Median rwPFS was 21.9 months (95% CI = 20.1 – 28.2). At 3 years of follow-up, OS rate was 91.9%. For additional outcomes, see Table. Conclusions: These findings from the largest cohort yet evaluated for real world effectiveness confirm the effectiveness of palbociclib + AI in routine clinical practice as a standard of care for first line treatment of HR+/HER2- mBC. [Table: see text]

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Real-World Multiple Myeloma Treatment Patterns By Patient Characteristics and Outcomes in the United States

Blood ◽

10.1182/blood-2021-147523 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4114-4114

Author(s):

Joshua Richter ◽

Erin Singh ◽

Megan S. Rice

Keyword(s):

Real World ◽

Patient Characteristics ◽

The United States ◽

Treatment Patterns ◽

First Line ◽

Treatment Regimens ◽

First Line Therapy ◽

Line Therapy ◽

Line Of Therapy ◽

To Receive

Abstract Introduction: Despite numerous therapies approved for multiple myeloma (MM) in the past decade, the disease remains largely incurable. As a result, patients (pts) typically require successive lines of therapy, comprised of various combinations of drugs, to treat relapsed disease. As the treatment landscape evolves, continued real-world (RW) studies provide additional understanding of the treatment patterns of MM pts outside of clinical trials, particularly for those with unmet medical need and/or high-risk disease. In this retrospective, observational cohort study, we examined RW treatment patterns among MM pts overall and within patient subgroups classified by age, race/ethnicity, renal impairment (RI), cytogenetic risk, and 1q21 amplification, as well as patient outcomes. Methods: This study used the nationwide Flatiron Health electronic health record-derived de-identified database of MM pts treated in the United States. During the study period, January 1, 2016 to April 30, 2021, pts who had ≥1 line of therapy or whose first-line treatment was initiated after the study start were included. Treatment class regimens (lines 1-4) were classified as: proteasome inhibitor (PI)-based, immunomodulatory drug (IMiD)-based, PI + IMiD-based, chemotherapy-based, antibody-based, or other treatments. We examined patient characteristics as well as treatment patterns overall and in patient subgroups. We also assessed real-world progression-free survival (rwPFS), defined as the time from start of line therapy to the date of progression or death, by treatment regimen received. Results: At the time of data cutoff, 5465 pts received ≥1 line of therapy; 45.3% of pts were female, 57.4% were white, median age at the start of first-line therapy was 70 years (interquartile range 62-77), and 88.7% received care at community practices. A total of 14.6% had high-risk cytogenetic abnormalities, 21.0% had 1q21 amplification, 20.7% had International Staging System stage III at diagnosis and 33.2% had RI (eGFR <60 mL/min/1.73 m 2) at the start of first-line therapy. The most common first-line regimens were PI + IMiD-based (53.4%), whereas 12.8% received PI-based, 11.5% IMiD-based, 13.4% chemotherapy-based, 2.8% antibody-based, and 6.1% had other treatments (Figure 1). Although uncommon in first-line therapy, antibody-based treatments were more commonly used in later lines of therapy (second-line: 21.0%; third-line: 33.7%; fourth-line: 40.0%). In first-line, pts aged ≥75 years were less likely to receive PI + IMiD-based regimens than those aged <75 years (40.4% vs 60.1%) (Figure 2). Similarly, RI pts received PI + IMiD-based regimens less frequently in first-line than those without impairment (47.8% vs 65.0%). In first-line, 18.9% of pts had evidence of undergoing a transplant. Both older pts and those with RI were also less likely to receive a transplant as part of their first-line treatment (1.7% vs 27.7% and 13.9% vs 24.2% respectively). Treatment differences were less pronounced in later lines as well as by race/ethnicity, cytogenetic risk, and 1q21 amplification. In first-line therapy, rwPFS was longer for pts treated with PI + IMiD-based regimens (median [95% confidence interval], 29.5 months [27.3-31.9]). In later lines of therapy, pts treated with IMiD-based regimens had longer median rwPFS (second-line: 22.7 months [18.5-30.4]; third-line: 19.7 months [14.2-37.0]; fourth-line: 16.1 months [6.4-26.7]). Additional analyses examining newer treatment regimens will be presented. Conclusions: PI + IMiD combination therapy was the most common first-line therapy. Although not commonly used in first-line therapy, antibody-based regimens are increasingly used in later lines of therapy. Older pts as well as pts with RI were less likely to receive PI + IMiD regimens or transplant in first-line therapy. Pts receiving PI + IMiD regimens in first-line therapy had longer rwPFS. Pts receiving IMiD-based regimens had longer rwPFS in later lines. Analyses of newer treatment regimens to be presented within this dataset will provide additional insight into changes in RW treatment patterns in the era of novel agents. Figure 1 Figure 1. Disclosures Richter: BMS, Karyopharm, Antengene: Membership on an entity's Board of Directors or advisory committees; Adaptive biotechnologies: Speakers Bureau; Janssen, Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Tisch Cancer Institute: Icahn School of Medicine at Mount Sinai: Current Employment. Singh: Sanofi: Current Employment. Rice: Sanofi: Current Employment, Current holder of individual stocks in a privately-held company.

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GCT-28. RECURRENCE PATTERN AND SURVIVAL FOR RELAPSED INTRACRANIAL NON-GERMINOMATOUS GERM CELL TUMORS: A SINGLE-INSTITUTION EXPERIENCE

Neuro-Oncology ◽

10.1093/neuonc/noaa222.248 ◽

2020 ◽

Vol 22 (Supplement_3) ◽

pp. iii333-iii333

Author(s):

Lei Wen ◽

Zhaoming Zhou ◽

Qingjun Hu ◽

Juan Li ◽

Mingyao Lai ◽

...

Keyword(s):

Germ Cell ◽

Germ Cell Tumors ◽

Late Recurrence ◽

Salvage Chemotherapy ◽

Recurrence Time ◽

First Line ◽

Primary Tumor Site ◽

First Line Therapy ◽

Line Therapy

Abstract PURPOSE Intracranial non-germinomatous germ cell tumors (NGGCTs) have lower overall survival than germinoma because relatively higher recurrence usually occurs after first line therapy. METHODS Between January 2003 and December 2018, 111 consecutive patients diagnosed with NGGCTs reviewed. Those who progressed after first line therapy were included in this study. Data of first line treatment, salvage treatment, clinicopathological features and survival were collected and analyzed. RESULTS Totally, thirty patients (30/111, 27.0%) relapsed in our cohort, including 19 patients with accurate relapse information detail, and 11 patients who died of disease progression during follow up but without exact time and site of relapse. The median OS from diagnosis of the disease was 49.2 months (95% CI: 14.1 to 84.3 months) and 3-year OS was 54.3%. Patients who received both CSI and chemotherapy relapsed less than those who received reduced volume of radiotherapy or only CSI or only chemotherapy (22.5% vs. 45.5%, p=0.034). Of 19 patients who had detail information of recurrence time and site, the median time from diagnosis of disease to relapse was 9.5 months (2.2 to 72.1 months). Regarding to recurrence site, most patients relapsed in primary site (10/19, 52.6%) or distant intracranial (6/19, 31.6%). The recurrence site of other 3 patients were spinal (n=1), ventricular (n=1) and peritoneal (n=1). CONCLUSION Protracted follow-up is recommended because late recurrence is not uncommon. Primary tumor site and distant intracranial are the most prevalent relapsed location. Patients who relapsed could benefited from both CSI and salvage chemotherapy.

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