108P Real-world time on treatment (rwToT) analysis for first-line pembrolizumab combination therapy in advanced nonsquamous NSCLC

Abstract OBJECTIVES: The purpose of this study was to examine real-world differences in healthcare resource utilization of indolent non-Hodgkin's Lymphoma (iNHL) patients treated with first-line ibrutinib monotherapy (IM) or first-line bendamustine + rituximab (BR) combination therapy using U.S. administrative claims data. METHODS: The MarketScan® Research Databases were used to identify patients aged 18 years or older with commercial or Medicare supplemental insurance plans based on their first prescription (index date) of either IM or BR therapy between 02/01/2014 and 08/30/2017. Patients were required to be diagnosed with iNHL and be treatment naïve, as well as be continuously enrolled (CE) for 6 months prior to and at least 30 days following the index date. All-cause and iNHL-related healthcare resource utilization (e.g., inpatient admission (IP) and emergency room (ER) visits) were evaluated during a 12-month follow-up period from the index date among the subset of patients with 12 months of continuous enrollment and reported per-patient per-month (PPPM). Statistical differences in the distribution of IP and ER visits between the IM versus BR therapy groups were estimated using chi-squared test for categorical variables and t-test for continuous variables. RESULTS: A total of 1,544 iNHL patients were identified, with 207 patients in the IM cohort and 1,337 patients in the BR cohort. The IM cohort was significantly older (mean = 68.3 years; SD = 11.8) then the BR cohort (mean age = 62.1 years; SD = 11.1). The proportion of females was significantly (p<.05) lower in the IM cohort (36%) relative to the BR cohort (49%). The two cohorts did not differ in comorbidity as assessed by National Cancer Institute Comorbidity Index score (IM=0.7 vs. BR=0.8, p=0.40). The results of the comparisons between the two groups with 12 months of follow-up (IM = 110; BR = 745) are provided in Table 1. For all-cause healthcare utilization, the proportion of IM patients experiencing at least one IP admission was significantly higher than the BR cohort as were the PPPM number of admissions. The proportion of patients with at least one ER visit was similar in the IM and BR cohorts. However, the average PPPM number of ER visits was significantly higher in the IM cohort relative to the BR cohort. A similar pattern was found for the iNHL-related healthcare utilization variables with one exception. The proportion of patients with at least one iNHL-related ER visit was significantly higher in the IM relative to the BR cohort. Conclusions: The current study examined differences in healthcare utilization among iNHL-patients treated in a front-line setting with either ibrutinib or BR combination therapy. Results indicated that not only did more ibrutinib patients experience an IP admission and ER visits, including both all-cause and iNHL-related, but they also experienced more repeat admissions and ER visits. These real-world findings highlight the importance of considering the healthcare resource utilization of iNHL patients which may be associated with their first-line therapy. Disclosures Irwin: Teva: Consultancy. Zhang:Teva: Consultancy. Wilson:Teva: Consultancy. Hoehn:Teva: Employment. Szabo:Teva: Employment. Tang:Teva: Employment.

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A Real-World Analysis of Patients with Untreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Mutated Lung Adenocarcinoma Receiving First-Line Erlotinib and Bevacizumab Combination Therapy

Oncology and Therapy ◽

10.1007/s40487-021-00152-6 ◽

2021 ◽

Author(s):

Chin-Chou Wang ◽

Li-Chung Chiu ◽

Pi-Hung Tung ◽

Scott Chih-Hsi Kuo ◽

Chia-Hsun Chu ◽

...

Keyword(s):

Epidermal Growth Factor Receptor ◽

Growth Factor ◽

Epidermal Growth Factor ◽

Combination Therapy ◽

Lung Adenocarcinoma ◽

Real World ◽

Growth Factor Receptor ◽

First Line ◽

Epidermal Growth ◽

Egfr Mutated

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Efficacy and safety of lenvatinib monotreatment and lenvatinib-based combination therapy for patients with unresectable hepatocellular carcinoma: a retrospective, real-world study in China

Cancer Cell International ◽

10.1186/s12935-021-02200-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yun Zhu ◽

Penghui Sun ◽

Kunyuan Wang ◽

Shuzhe Xiao ◽

Yanling Cheng ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Combination Therapy ◽

Combination Treatment ◽

Real World ◽

Single Agent ◽

Line Treatment ◽

Efficacy And Safety ◽

First Line ◽

Curative Effect ◽

Single Agent Therapy

Abstract Background Lenvatinib and lenvatinib-based combination treatments are widely used in patients with unresectable hepatocellular carcinoma (uHCC) in clinical practice, but their curative effect and safety need further study in the real world. Methods This was a retrospective study involving patients with uHCC receiving lenvatinib monotherapy and lenvatinib-based combination treatment between Nov, 2018 and Sep, 2020 in Nanfang Hospital. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of monotherapy and combination therapy were compared. Stratified analysis was performed according to systemic line of treatment and medication regimen for combination therapy. Results For lenvatinib monotherapy (n = 39), OS and PFS were 80 weeks and 24.3 weeks, respectively. For combination treatment (n = 72), median OS and PFS were 99 weeks and 45.6 weeks, respectively. OS, PFS, and TTP for patients in the combination treatment cohort were significantly longer compared to those of patients in the monotreatment cohort (OS: P = 0.04, PFS: P = 0.003; TTP, P = 0.005). The incidence of TRAEs could be controlled both in the monotherapy cohort and the combination treatment cohort. In the monotherapy cohort, OS and PFS were significantly decreased in the second-line treatment group compared with the first-line treatment group, while no differences were observed in the combination cohort. The efficacy of triple therapy (lenvatinib plus PD-1 antibody plus TACE or HAIF) was similar to lenvatinib plus PD-1 antibody or lenvatinib plus TACE or HAIF. Conclusions Our real-world study showed that lenvatinib monotherapy and lenvatinib-based combination therapy were well tolerated, with encouraging efficacies in patients with uHCC. Lenvatinib-based combination therapy showed a better curative effect compared with lenvatinib single-agent therapy. In patients who have failed first-line TKI treatment, lenvatinib-based combination therapy may be a better choice than lenvatinib single-agent therapy. Lenvatinib-based triple therapy may not have an advantage over dual therapy.

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Real-world effectiveness of ribociclib + aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line treatment in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer: Baseline data from the RIBANNA study.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e12520 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e12520-e12520

Author(s):

Achim Wöckel ◽

Thomas Decker ◽

Peter A. Fasching ◽

Christian Jackisch ◽

Diana Luftner ◽

...

Keyword(s):

Breast Cancer ◽

Estrogen Receptor ◽

Clinical Practice ◽

Combination Therapy ◽

Aromatase Inhibitor ◽

Real World ◽

Locally Advanced ◽

Line Treatment ◽

First Line ◽

First Line Treatment

e12520 Background: Ribociclib, a selective CDK4/6 inhibitor, in combination with an aromatase inhibitor (AI) is approved for the treatment of HR+/HER2- advanced breast cancer (aBC) (locally advanced or metastatic). Real-world evidence for the effectiveness, safety and tolerability of ribociclib + AI in routine clinical practice is needed to support its use. Methods: RIBANNA (CLEE011ADE03) is a non-interventional study running in Germany since October 2017 involving up to 3020 postmenopausal patients receiving ribociclib + AI, endocrine monotherapy (ET), or chemotherapy (CT) as first-line treatment for HR+/HER2- aBC, prescribed in line with German guidelines. Data are collected from clinical practice in all three cohorts. Further lines of treatment are documented to examine outcomes of sequential therapy. Results: 461 patients enrolled to October 9, 2018 (Table). First-line mean daily ribociclib dose was 382 mg including and 540 mg excluding dose interruptions; mean duration of exposure to ribociclib: 128 days. Ribociclib was given in combination with anastrozole (8%), exemestane (7%), and letrozole (83%); ET comprised a selective estrogen receptor degrader (25%), nonsteroidal AI (64%), steroidal AI (5%), and a selective estrogen receptor modulator (7%); CT included taxane-based monotherapy (30%) or combination therapy (27%), anthracycline-based combination therapy (5%), other monotherapy (23%) or other combination therapy (13%). Conclusions: Population characteristics from the RIBANNA study show a diverse group of patients from a real-world setting of ribociclib treatment. Baseline demographics and characteristics. Clinical trial information: CLEE011ADE03. [Table: see text]

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Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC

Targeted Oncology ◽

10.1007/s11523-019-00686-w ◽

2019 ◽

Vol 14 (6) ◽

pp. 759-768 ◽

Cited By ~ 3

Author(s):

Sohita Dhillon ◽

Yahiya Y. Syed

Keyword(s):

Combination Therapy ◽

First Line ◽

Nonsquamous Nsclc

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Real-World Survival Outcomes Associated With First-Line Immunotherapy, Targeted Therapy, and Combination Therapy for Metastatic Clear Cell Renal Cell Carcinoma

JAMA Network Open ◽

10.1001/jamanetworkopen.2021.11329 ◽

2021 ◽

Vol 4 (5) ◽

pp. e2111329

Author(s):

Nicholas H. Chakiryan ◽

Da David Jiang ◽

Kyle A. Gillis ◽

Elizabeth Green ◽

Ali Hajiran ◽

...

Keyword(s):

Renal Cell Carcinoma ◽

Targeted Therapy ◽

Combination Therapy ◽

Cell Carcinoma ◽

Real World ◽

Renal Cell ◽

Clear Cell ◽

Survival Outcomes ◽

First Line ◽

Cell Renal Cell Carcinoma

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Outcomes with CDK4/6 inhibitors based on endocrine sensitivity in hormone receptor-positive metastatic breast cancer (HR+ MBC).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e12526 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e12526-e12526

Author(s):

Amit L Jain ◽

Janice Nhan Mullins ◽

Kelsey Anne Poorman ◽

Amina Chaudhry ◽

Harsha Avinash Ranganath ◽

...

Keyword(s):

Breast Cancer ◽

Combination Therapy ◽

Endocrine Therapy ◽

Real World ◽

Endocrine Resistance ◽

Second Line ◽

First Line ◽

Free Survival ◽

Potential Biomarker ◽

Esr1 Mutation

e12526 Background: PALOMA-3 results demonstrated that patients (pts) with sensitivity to previous endocrine therapy had a substantial benefit with Palbociclib compared to those with intrinsic endocrine resistance (Turner NC et al. NEJM 2018). ESR1 mutation has been associated with decreased response to endocrine therapy (Fribbens C et al. JCO 2016) and NSD3 amplification in breast cancer cells have been correlated with the overexpression of ESR1 (Irish JC et al. Mol Oncol 2016). Here we demonstrate a real-world response to CDK4/6i based on high-risk features and correlation to biomarkers of response. Methods: We retrospectively analyzed 115 HR+MBC pts at a single large community cancer center who received CDK4/6i + endocrine therapy and 40 matched controls treated with endocrine therapy and underwent NextGen Sequencing (NGS) profiling of 592 genes (Caris Life Sciences, Phoenix, AZ). The primary outcome was progression-free survival (PFS). Hazard ratios were calculated from Cox proportional hazards models built using the survival package[1] in R. Results: Among 115 pts in the CDK4/6i cohort, the median PFS for pts treated in the first-line (N=77) versus (vs.) second-line (N=38) was 9.7 and 4.6 months (mo) respectively (HR 2.04, p=0.001). Further, the median PFS in first-line cases who had a Disease-Free Survival (DFS) of >2 years (endocrine sensitive) (N=27) was 11.9 mo, and in pts with DFS < 2years (endocrine resistant) (N=24), it was 7.7 mo (HR 0.71, p= 0.397). Six pts with ESR1 mutations had worse PFS compared to ESR1 wild-type (N=40) when treated with CDK4/6i in 1st line, 6.4 vs. 18 mo (HR: 2.25, p=0.052) and 2nd line 2.5 (N=9) vs. 5.6 mo (N=17) HR: 2.09, p=0.1). NSD3 amplification was the only other genomic alteration showing significance as a negative predictor of PFS (first-line: 6.1 vs. 14.7 mo, HR: 2.40, p=0.04; second-line: 2.8 vs. 6.5 mo, HR: 3.61, p=0.06). NSD3 amplification appeared to have no significant effect in the control cohort 6.5 vs. 4.4 mo, (HR 1.29, p=0.63). Conclusions: In this real-world cohort, CDK 4/6 combination therapy benefits HR+ MBC patients in the first and second-line setting. ESR1 mutation is a predictor of worse outcome. NSD3 gene amplification is a potential biomarker of resistance to CDK4/6i combination therapy. (Therneau T (2015). A Package for Survival Analysis in S version 2.38, https://CRAN.R-project.org/package=survival).

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Real-world outcomes of first-line pembrolizumab plus pemetrexed-carboplatin for metastatic nonsquamous NSCLC at US oncology practices

Scientific Reports ◽

10.1038/s41598-021-88453-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Vamsidhar Velcheti ◽

Xiaohan Hu ◽

Bilal Piperdi ◽

Thomas Burke

Keyword(s):

Real World ◽

Performance Status ◽

Clinical Settings ◽

First Line ◽

Ecog Performance Status ◽

Kaplan Meier ◽

Outcome Information ◽

Genomic Aberrations ◽

Line Setting ◽

Nonsquamous Nsclc

AbstractEvidence from real-world clinical settings is lacking with regard to first-line immunotherapy plus chemotherapy for the treatment of non-small cell lung cancer (NSCLC). Our aim was to describe outcomes for patients treated with first-line pembrolizumab-combination therapy for metastatic nonsquamous NSCLC in US oncology practices. Using an anonymized, nationwide electronic health record-derived database, we identified patients who initiated pembrolizumab plus pemetrexed-carboplatin in the first-line setting (May 2017 to August 2018) after diagnosis of metastatic nonsquamous NSCLC that tested negative for EGFR and ALK genomic aberrations. Eligible patients had ECOG performance status of 0–1. An enhanced manual chart review was used to collect outcome information. Time-to-event analyses were performed using the Kaplan–Meier method. Of 283 eligible patients, 168 (59%) were male; median age was 66 years (range 33–84); and the proportions of patients with PD-L1 tumor proportion score (TPS) of ≥ 50%, 1–49%, < 1%, and unknown were 28%, 27%, 28%, and 17%, respectively. At data cutoff on August 31, 2019, median patient follow-up was 20.3 months (range 12–28 months), and median real-world times on treatment (rwToT) with pembrolizumab and pemetrexed were 5.6 (95% CI 4.5–6.4) and 2.8 months (95% CI 2.2–3.5), respectively. Median overall survival (OS) was 16.5 months (95% CI 13.2–20.6); estimated 12-month survival was 59.5% (95% CI 53.3–65.0); rwProgression-free survival was 6.4 months (95% CI 5.4–7.8); and rwTumor response rate (complete or partial response) was 56.5% (95% CI 50.5–62.4). Median OS was 20.6, 16.3, 13.2, and 13.7 months for patient cohorts with PD-L1 TPS ≥ 50%, 1–49%, < 1%, and unknown, respectively. These findings demonstrate the effectiveness of pembrolizumab plus pemetrexed-carboplatin by describing clinical outcomes among patients with metastatic nonsquamous NSCLC who were treated at US oncology practices.

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