scholarly journals OA05.04 Real-World Progression-Free Survival in Oncogenic Driver-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated With Single-Agent Immunotherapy

2021 ◽  
Vol 16 (1) ◽  
pp. S6
Author(s):  
J. Bodor ◽  
J. Bauman ◽  
E. Handorf ◽  
C. Zawislak ◽  
E. Ross ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Single Agent ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Oncogenic Driver

Real-world effectiveness of nivolumab in patients with non-small-cell lung cancer: a systematic review and meta-analysis

2020 ◽  
Vol 16 (27) ◽  
pp. 2045-2058 ◽  
Author(s):  
Yong-Jin Kim ◽  
Mark Oremus ◽  
Helen H Chen ◽  
Thomas McFarlane ◽  
Devanshi Shah ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival

Background: The effectiveness of immunotherapies for non-small-cell lung cancer under real-world clinical settings remains uncertain. Materials & methods: Systematic searches of PubMed, EMBASE and Web of Science were conducted. Random-effects models were used to estimate pooled median overall survival and progression-free survival estimates. Results: 36 studies of nivolumab were included for narrative synthesis and 11 of these studies were included for meta-analysis. Age, sex, histology and prior lines of treatment did not affect survival outcomes, while Eastern Cooperative Oncology Group Performance Status and brain metastasis were inversely associated with survival. In the meta-analysis, nivolumab was associated with 9.6 months (95% CI: 8.4–10.9) of overall survival and 2.6 months (95% CI: 1.6–3.6) of progression-free survival. Conclusion: Very-low-certainty evidence suggested the real-world effectiveness of nivolumab was consistent with those observed in the clinical trials.

Progression-free survival estimates in non-small cell lung cancer when RECIST is unavailable: Project GENIE’s integration of genomic, therapeutic and phenomic data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9622-9622
Author(s):  
Jessica A. Lavery ◽  
Katherine Panageas ◽  
Michele LeNoue-Newton ◽  
Shawn Sweeney ◽  
Seth Sheffler-Collins ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Cancer Centers ◽  
Tumor Profiling

9622 Background: Molecular tumor profiling has become an integral component of oncology practice but linked genomic-phenomic data remain scarce. Recurrence, treatment response and progression are not structured consistently in medical records and this deficit has been a roadblock to discovery of biomarkers that are associated with favorable outcomes. Methods: The Genomics Evidence Neoplasia Information Exchange (GENIE) consortium is an AACR sponsored project to link and share genomic and phenomic data to promote discovery in precision medicine. 3 cancer centers that routinely perform somatic tumor profiling for advanced cancers agreed to curate anti-neoplastic treatment exposures and outcomes including recurrence, progression, response and survival using a standard method. 6 cancer types (lung, colorectal, breast, prostate, pancreas and bladder) were selected and a REDCAP database captures anti-neoplastic treatments, and specific elements from pathology, radiology and oncology reports. Curators abstract data using data fields that rely on the PRISSMM standard. “Real world” progression free survival (PFS) was identified based on curation of: 1) the text of radiologists’ reports for CT, PET/CT, PET and MRI scans (PFSI) and 2) medical oncologists’ notes (PFSM). PFSI and PFSM were estimated from the start of 1st line anti-neoplastic systemic therapy until progression or death for all patients with molecularly characterized non-small cell lung cancer (NSCLC). Results: Genomic sequencing was performed between 2015 and 2017 for 748 patients with NSCLC treated at three major cancer centers. Median age at diagnosis was 66 years (interquartile range 58, 73) and 43% were male. As shown in the table, when RECIST assessments are unavailable, estimates of PFS vary based on whether they are derived from radiologists’ or oncologists’ interpretations. Conclusions: Radiologists’ reports and oncologists’ reports provide different PFS estimates. Cohort studies should specify the method used to define “real world” endpoints. Project GENIE will have 1800 NSCLC patients with curated endpoints by the ASCO meeting. [Table: see text]

Clinical effectiveness outcomes and healthcare resource utilization of patients diagnosed with small-cell lung cancer

2020 ◽  
Author(s):  
Junji Lin ◽  
Santosh Gautam ◽  
Nan Hu ◽  
Gboyega Adeboyeje ◽  
Sumesh Kachroo
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Study Results

Background: Real-world data are lacking on patients with small-cell lung cancer (SCLC) with extensive-stage SCLC (eSCLC) and poor performance status (PS). Patients & methods: Eligible patients diagnosed with eSCLC between 1 January 2008 and 31 December 2017 were included in this retrospective, observational study. Results: The study included 406 patients, with 14.3% impaired PS. Progression-free survival and overall survival were not significantly different between impaired (Eastern Cooperative Oncology Group ≥2) and not impaired patients (median, 4.5 vs 5.3 months, and 7.2 vs 8.4 months, respectively). Impaired patients used more supportive care drugs (mean, 3.0 vs 2.0; p = 0.033). Conclusion: Effectiveness outcomes among patients with and without impaired PS did not differ in the real-world setting. Progression-free survival and overall survival were similar to data from clinical trials.

Association of circulating tumor DNA clearance during treatment with improved progression-free survival in advanced non-small cell lung cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 11528-11528
Author(s):  
Shun Lu ◽  
Yong Song ◽  
Zhanhong Xie ◽  
Min Li ◽  
Zhengfei Zhu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Circulating Tumor Dna ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Tumor Dna

11528 Background: Currently, response assessment of patients with non-small cell lung cancer (NSCLC) primarily relies on imaging scans, which do not reflect biological processes at the molecular level. We utilized circulating tumor DNA (ctDNA) coupled with capture-based ultra deep next generation sequencing to conduct dynamic monitoring of treatment response, thus evaluating the ability of ctDNA as a tumor clonal response biomarker. Methods: We performed capture-based sequencing on longitudinal plasma samples, including baseline and a minimum of 2 evaluation points, obtained from 88 patients with advanced NSCLC using a ctDNA panel, spanning 160KB of human genome and consisting of critical exons and introns from 168 genes. This real world study comprises a highly heterogeneous cohort with a mixture of prior treatment exposure. Results: At baseline, treatment-naïve patients often harbor solo driver mutation; in contrast, patients with prior treatments are more likely to harbor concurrent driver mutations. Patients who received molecular targeted therapy according to the baseline sequencing results have a longer progression-free survival (PFS) (p = 0.0001), demonstrating the value of ctDNA in directing treatment. During subsequent evaluations, we observed 74% concordance rate between molecular and radiographic responses. Furthermore, our data revealed that during follow-up, patients with at least one time of undetectable ctDNA are associated with a longer PFS (p = 5.52e-6), regardless the type of treatment commenced. Among 44 patients who had at least one time of undetectable ctDNA, 39 achieved partial response or stable disease as their best response. Collectively, this phenomenon reflects clonal response, thus demonstrating the biological nature underlying the clinical response assessed by imaging modalities. Conclusions: This real world study demonstrates that patients with at least one time of ctDNA clearance during subsequent evaluation are associated with a longer PFS. Our study warrants further investigations to explore the value of ctDNA clearance as a surrogate endpoint of efficacy and as a risk stratification factor.

scholarly journals Selpercatinib in RET fusion-positive non-small-cell lung cancer (SIREN): a retrospective analysis of patients treated through an access program

2021 ◽  
Vol 13 ◽  
pp. 175883592110196
Author(s):  
Oliver Illini ◽  
Maximilian Johannes Hochmair ◽  
Hannah Fabikan ◽  
Christoph Weinlinger ◽  
Amanda Tufman ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Objective Response ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Real World Setting ◽  
Access Program

Introduction: Rearranged during transfection (RET) gene fusions are rare genetic drivers in non-small cell lung cancer (NSCLC). Selective RET-inhibitors such as selpercatinib have shown therapeutic activity in early clinical trials; however, their efficacy in the real-world setting is unknown. Methods: A retrospective efficacy and safety analysis was performed on data from RET fusion-positive NSCLC patients who participated in a selpercatinib access program (named patient protocol) between August 2019 and January 2021. Results: Data from 50 patients with RET fusion-positive advanced NSCLC treated with selpercatinib at 27 centers in 12 countries was analyzed. Most patients were Non-Asian (90%), female (60%), never-smokers (74%), with a median age of 65 years (range, 38–89). 32% of the patients had known brain metastasis at the time of selpercatinib treatment. Overall, 13 patients were treatment-naïve, while 37 were pretreated with a median of three lines of therapy (range, 1–8). The objective response rate (ORR) was 68% [95% confidence interval (CI), 53–81] in the overall population. The disease control rate was 92%. The median progression-free survival was 15.6 months (95% CI, 8.8–22.4) after a median follow-up of 9 months. In patients with measurable brain metastases ( n = 8) intracranial ORR reached 100%. In total, 88% of patients experienced treatment-related adverse events (TRAEs), a large majority of them being grade 1 or 2. The most common grade ⩾ 3 TRAEs were increased liver enzyme levels (in 10% of patients), prolonged QTc time (4%), abdominal pain (4%), hypertension (4%), and fatigue/asthenia (4%). None of patients discontinued selpercatinib treatment for safety reasons. No new safety concerns were observed, nor where there any treatment-related death. Conclusions: In this real-world setting, the selective RET-inhibitor selpercatinib demonstrated durable systemic and intracranial antitumor activity in RET fusion-positive NSCLC and was well tolerated.

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