Real-world outcomes for metastatic non-small cell lung cancer patients treated with checkpoint inhibitor immunotherapy in Canada.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 54-54
Author(s):  
Dimas Yusuf ◽  
Jenny J. Ko ◽  
Hyokeun Cho ◽  
Corey Sheremeto ◽  
Ying Wang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Small Cell ◽  
Small Cell Lung ◽  
Term Survival ◽  
The Real ◽  
Metastatic Nsclc

54 Background: The majority of patients with non-small cell lung cancer (NSCLC) are diagnosed with incurable, metastatic disease. Immunotherapy (IO) agents have improved overall, long term survival. There is a need to better understand how these drugs are utilized and perform in the real world to further inform physicians and policymakers. Methods: In this retrospective study, we analyzed characteristics, treatment patterns, and outcomes of patients with metastatic NSCLC treated with checkpoint inhibitors nivolumab or pembrolizumab at five Canadian cancer centres, with a focus on patients who received these treatments in the 2nd (2L) or 3rd line (3L) setting. We excluded patients who were in blinded clinical trials, exposed to multiple IO drugs, or who had tumors with EGFR or ALK mutations. Primary endpoints were overall survival (OS) and progression free survival (PFS) from start of IO. Secondary endpoints included immune-related toxicities. Results: Across all sites, we screened 322 patients and included 230 who met criteria: 49 (21%) from Alberta; 60 (26%) from British Columbia; and 121 (53%) from Ontario. Patients were diagnosed with metastatic NSCLC from 2009 to 2018, but the majority were diagnosed after 2015. Median age at diagnosis was 66.6 years, 54% were female, and 86% were either current or former smokers and 67% had stage IV disease. About 88% received nivolumab; 87% (n=200) received IO in 2L (n=111) or 3L (n=89). The median OS from start of IO was 10.9 (8.7–15.6) months, and were similar for 2L vs 3L (9.3 vs 12.0 months, p = 0.2). Median PFS was 5.7 (4.4–8.1) months. Pneumonitis was the most frequently reported toxicity affecting 7% of patients. Thyroiditis was reported in 4%; colitis, while dermatitis and hepatitis were each reported in 3%, and nephritis in 1%. Conclusions: In the real world, IO for advanced NSCLC was well-tolerated and had outcomes that were comparable to landmark clinical trials.

scholarly journals Nivolumab for Previously Treated Patients with Non-Small-Cell Lung Cancer—Daily Practice versus Clinical Trials

2020 ◽  
Vol 9 (7) ◽  
pp. 2273
Author(s):  
Magdalena Knetki-Wróblewska ◽  
Dariusz M. Kowalski ◽  
Maciej Krzakowski
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Prognostic Factors ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Small Cell ◽  
Small Cell Lung ◽  
The Real ◽  
Response To Chemotherapy

Based on the results of the CheckMate 017 and CheckMate 057 studies, nivolumab therapy has become a new standard treatment for both squamous and non-squamous non-small-cell lung cancer (NSCLC). However, due to the specific inclusion criteria of these clinical trials, the efficacy and safety of nivolumab in real-world practice were not certain. In general, the real-world results of nivolumab treatment have been consistent with those obtained in clinical trials. Additional analyses of the real-world data have made the identification of prognostic factors possible. Good performance status is the most significant predictor of clinical benefit. Brain metastases, liver metastases, EGFR mutation, malignant pleural effusion, and a high number of metastatic sites were identified as negative prognostic factors. By contrast, a longer time to disease progression (>6 months) from the beginning of prior chemotherapy and an objective response to chemotherapy seem to have positive prognostic value in the case of nivolumab treatment. In terms of patient age, the data are inconclusive. Some blood biomarkers can also be considered significant prognostic factors.

scholarly journals A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Alessio Bruni ◽  
Vieri Scotti ◽  
Paolo Borghetti ◽  
Stefano Vagge ◽  
Salvatore Cozzi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Term Survival ◽  
Unresectable Stage

IntroductionFor unresectable stage III non-small cell lung cancer (NSCLC), the standard therapy consists of chemoradiotherapy (CRT) followed by durvalumab maintenance for responding patients. The present study reports on the safety and outcome of durvalumab use after CRT in a real-world, multicenter, retrospective cohort.MethodsTwo hundred thirty-eight patients have been included. We collected data on systemic therapy, radiation therapy, the timing between CRT and durvalumab, number of durvalumab cycles, reasons for non-starting or discontinuation, incidence and grade of adverse events (AEs), and progression-free survival (PFS) and overall survival (OS).ResultsOne hundred fifty-five patients out of 238 (65.1%) received at least one durvalumab dose: 91 (58.7%) after concomitant CRT (cCRT) and 64 (41.3%) after sequential CRT (sCRT). Programmed-death ligand 1 (PD-L1) status was unknown in 7/155 (4.5%), negative in 14 (9.1%), and positive ≥1% in 134/155 (86.4%). The main reasons for non-starting durvalumab were progression (10.1%), PD-L1 negativity (7.5%), and lung toxicity (4.6%). Median follow-up time was 14 months (range 2–29); 1-year PFS and OS were 83.5% (95%CI: 77.6–89.7) and 97.2% (95%CI: 94.6–99.9), respectively. No significant differences in PFS or OS were detected for cCRT vs. sCRT, but the median PFS was 13.5 months for sCRT vs. 23 months for cCRT. Potentially immune-related AEs were recorded in 76/155 patients (49.0%). Pneumonitis was the most frequent, leading to discontinuation in 11/155 patients (7.1%).ConclusionsDurvalumab maintenenace after concurrent or sequential chemoradiation for unresectable, stage III NSCLC showed very promising short-term survival results in a large, multicenter, restrospective, real-world study. Durvalumab was the first drug obtaining a survival benefit over CRT within the past two decades, and the present study contributes to validating its use in clinical practice.

Phenotyping clinical trial treatment regimens in cancer: An integrative ontology, artificial intelligence and knowledge engineering approach.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14054-e14054
Author(s):  
Yun Mai ◽  
Kyeryoung Lee ◽  
Zongzhi Liu ◽  
Zhiqiang Li ◽  
Scott Jones ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Small Cell ◽  
Small Cell Lung ◽  
Treatment Regimens

e14054 Background: Matching clinical attributes (i.e. indications, lab tests, treatment regimens) of clinical trial eligibility criteria with real world patient data is extremely challenging. Attribute phenotyping is one of the key components of Trial2Patient, a customized system developed by Sema4 to find patients for clinical trials. Transforming treatment regimens to a standard ontology and encoding drugs with standard nomenclatures will facilitate the semantic retrieval of treatments mentioned in clinical trial criteria. This will also enable the interoperation between different data sources that is often required for fast-learning and scalable healthcare information system. Methods: Free text containing treatment regimen/medication terms were extracted and preprocessed from three sources: 1) clinical trials listed in a commercial database citeline.com, 2) clinical trials listed in clinicaltrials.gov, and 3) National Comprehensive Cancer Network (NCCN) Guidelines. The regimen terms such as neoadjuvant therapy for non-small cell lung cancer, checkpoint inhibitor, EGFR inhibitor, androgen deprivation therapy (ADT), among many others, were profiled by AI methods (i.e. pattern reorganization and rule-based) and knowledge engineering via Sema4’s in-house knowledge base (CAV), Pharmaprojects in citline.com and NCCN Guidelines. The drugs related to each regimen were identified and mapped to RxCUI via RxNorm ontology. Results: We identified 76 regimen terms for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and prostate cancer (e.g. PD-L1 ≥1% nonsquamous NSCLC, bone antiresorptive therapy for M1 castration resistant prostate cancer), and 14,476 drug-category pair (e.g. pembrolizumab is a PD-1 inhibitor, pembrolizumab is used as the third line and beyond systemic therapy for M1 CRPC). All drugs identified were mapped to RxCUI for real world patient matching. Conclusions: This approach systematically extracted and normalized regimens and medications mentioned in clinical trials in NSCLC, SCLC and prostate cancer to standard codes. These standardized data can be used in mapping treatment histories of a patient to the eligibility criteria for clinical studies or for identifying studies relevant to a patient. The outcome of profiling cancer treatment regimens through standard ontology RxNorm may be particularly valuable in cancer studies based on real-world evidence.

scholarly journals Biomarker testing strategies in non-small cell lung cancer in the real-world setting: analysis of methods in the Prospective Central Lung Cancer Biomarker Registry (LungPath) from the Spanish Society of Pathology (SEAP)

2021 ◽  
pp. jclinpath-2021-208034
Author(s):  
Javier Martín-López ◽  
Federico Rojo ◽  
Antonio Martínez-Pozo ◽  
Teresa Hernández-Iglesias ◽  
David Carcedo ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Small Cell ◽  
Small Cell Lung ◽  
The Real ◽  
Biomarker Testing ◽  
Lung Cancer Biomarker

AimsThe aim of this study is to extend the analysis of the Lung Cancer Biomarker Testing Registry (LungPath), by analysing the techniques used in the determination of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1) and programmed death ligand-1 (PD-L1) for the diagnostic of patients with advanced non-small-cell lung cancer (NSCLC).MethodsInformation of the technique used for the determination of EGFR, ALK, ROS1 and PD-L1 was recorded from March 2018 to January 2019 from 44 centres, but only 34 centres matched with the 38 centres previously analysed, allowing to analyse the techniques used in 8970 matched determinations of EGFR, ALK, ROS1 and PD-L1. Therefore, a by-centre analysis studied the level of implementation of the techniques in the 44 centres, while a by-determination analysis made it possible to assess the overall frequency of the techniques used on the 9134 matched samples.ResultsBy-centre analysis showed that only 46.5% and 25.6% of the centres used reflex strategies for ALK and ROS1 determination, respectively. By-determination analysis showed that 94.4% of EGFR determinations were performed by PCR, 80.7% of ALK determinations were performed by IHC with clone D5F3, while 55.7% of ROS1 determinations were performed by IHC with clone D4D6. 22C3 were the PD-L1 clone more used (43.5%) followed by SP263 clone (31.1%).ConclusionsThe real-world evidence obtained from LungPath shows the effort of Spanish hospitals in performing biomarker determination in NSCLC with different methodologies despite that next-generation sequencing (NGS) utilisation in the year of the analysis was low. Biomarker determination results could be optimised with the incorporation of sequencing methods such as NGS in pathology departments.

50 Systemic therapy in the management of non small cell lung cancer (NSCLC): The real world experience

Lung Cancer ◽  
2013 ◽  
Vol 79 ◽  
pp. S17
Author(s):  
A. Lewis ◽  
N. Hough ◽  
D.K. Woolf ◽  
R. Trehy ◽  
B. Kolotia ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Systemic Therapy ◽  
Small Cell ◽  
Small Cell Lung ◽  
The Real
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