The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria
Ryan D. Gentzler*, Sarah E. Yentz, Melissa L. Johnson, Alfred W. Rademaker, Jyoti D. Patel
Medicine, Hematology Oncology Division
Over the last decade, new cytotoxic treatments and targeted therapies have altered treatment paradigms for patients with metastatic non-small cell lung cancer (NSCLC).We sought to analyze the impact of histology and biomarker selection criteria on outcomes of clinical trials in metastatic NSCLC reported over the last decade at the American Society of Clinical Oncology (ASCO) Annual Meeting. Data were collected from ASCO abstracts of Phase II-IV clinical trials for patients with metastatic NSCLC from 2004-2014. 770 of 2, 989 identified metastatic NSCLC category abstracts met selection criteria. Despite a decline in the number of abstracts from 107 to 46 abstracts annually over this period, the proportion of trials with positive progression free survival (PFS) and overall survival (OS) outcomes has increased significantly. Trials with histology selection (6%) or molecular biomarker (15%) criteria were more likely to result in an improvement in PFS than those without selection criteria (21% vs. 8%, p50.0001 and 31% vs. 10%, p<0.0001, respectively). These data demonstrate profound changes in the clinical trial landscape over the last 10 years with significantly increasing proportion of trials with positive outcomes. These changes are likely attributed to the use of histology and biomarker selection criteria in clinical trial design.
https://doi.org/10.1002/cncr.28956
Individualized medicine
Non-small cell lung carcinoma
10.1002/cncr.28956
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Non Small Cell Lung Cancer Medicine and Dentistry 41%
Gentzler, R. D., Yentz, S. E., Johnson, M. L., Rademaker, A. W., & Patel, J. D. (2014). The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria. Cancer, 120(24), 3853-3858. https://doi.org/10.1002/cncr.28956
Gentzler, Ryan D. ; Yentz, Sarah E. ; Johnson, Melissa L. et al. / The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria. In: Cancer. 2014 ; Vol. 120, No. 24. pp. 3853-3858.
@article{4261b798fd3c473091aedbefe8179cc7,
title = "The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria",
abstract = "Over the last decade, new cytotoxic treatments and targeted therapies have altered treatment paradigms for patients with metastatic non-small cell lung cancer (NSCLC).We sought to analyze the impact of histology and biomarker selection criteria on outcomes of clinical trials in metastatic NSCLC reported over the last decade at the American Society of Clinical Oncology (ASCO) Annual Meeting. Data were collected from ASCO abstracts of Phase II-IV clinical trials for patients with metastatic NSCLC from 2004-2014. 770 of 2, 989 identified metastatic NSCLC category abstracts met selection criteria. Despite a decline in the number of abstracts from 107 to 46 abstracts annually over this period, the proportion of trials with positive progression free survival (PFS) and overall survival (OS) outcomes has increased significantly. Trials with histology selection (6%) or molecular biomarker (15%) criteria were more likely to result in an improvement in PFS than those without selection criteria (21% vs. 8%, p50.0001 and 31% vs. 10%, p<0.0001, respectively). These data demonstrate profound changes in the clinical trial landscape over the last 10 years with significantly increasing proportion of trials with positive outcomes. These changes are likely attributed to the use of histology and biomarker selection criteria in clinical trial design.",
keywords = "Biomarkers, Individualized medicine, Metastasis, Non-small cell lung carcinoma",
author = "Gentzler, {Ryan D.} and Yentz, {Sarah E.} and Johnson, {Melissa L.} and Rademaker, {Alfred W.} and Patel, {Jyoti D.}",
note = "Publisher Copyright: {\textcopyright} 2014 American Cancer Society.",
doi = "10.1002/cncr.28956",
journal = "Cancer",
Gentzler, RD, Yentz, SE, Johnson, ML, Rademaker, AW & Patel, JD 2014, 'The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria', Cancer, vol. 120, no. 24, pp. 3853-3858. https://doi.org/10.1002/cncr.28956
The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria. / Gentzler, Ryan D.; Yentz, Sarah E.; Johnson, Melissa L. et al.
In: Cancer, Vol. 120, No. 24, 01.12.2014, p. 3853-3858.
T1 - The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria
AU - Gentzler, Ryan D.
AU - Yentz, Sarah E.
AU - Johnson, Melissa L.
AU - Rademaker, Alfred W.
AU - Patel, Jyoti D.
N1 - Publisher Copyright: © 2014 American Cancer Society.
N2 - Over the last decade, new cytotoxic treatments and targeted therapies have altered treatment paradigms for patients with metastatic non-small cell lung cancer (NSCLC).We sought to analyze the impact of histology and biomarker selection criteria on outcomes of clinical trials in metastatic NSCLC reported over the last decade at the American Society of Clinical Oncology (ASCO) Annual Meeting. Data were collected from ASCO abstracts of Phase II-IV clinical trials for patients with metastatic NSCLC from 2004-2014. 770 of 2, 989 identified metastatic NSCLC category abstracts met selection criteria. Despite a decline in the number of abstracts from 107 to 46 abstracts annually over this period, the proportion of trials with positive progression free survival (PFS) and overall survival (OS) outcomes has increased significantly. Trials with histology selection (6%) or molecular biomarker (15%) criteria were more likely to result in an improvement in PFS than those without selection criteria (21% vs. 8%, p50.0001 and 31% vs. 10%, p<0.0001, respectively). These data demonstrate profound changes in the clinical trial landscape over the last 10 years with significantly increasing proportion of trials with positive outcomes. These changes are likely attributed to the use of histology and biomarker selection criteria in clinical trial design.
AB - Over the last decade, new cytotoxic treatments and targeted therapies have altered treatment paradigms for patients with metastatic non-small cell lung cancer (NSCLC).We sought to analyze the impact of histology and biomarker selection criteria on outcomes of clinical trials in metastatic NSCLC reported over the last decade at the American Society of Clinical Oncology (ASCO) Annual Meeting. Data were collected from ASCO abstracts of Phase II-IV clinical trials for patients with metastatic NSCLC from 2004-2014. 770 of 2, 989 identified metastatic NSCLC category abstracts met selection criteria. Despite a decline in the number of abstracts from 107 to 46 abstracts annually over this period, the proportion of trials with positive progression free survival (PFS) and overall survival (OS) outcomes has increased significantly. Trials with histology selection (6%) or molecular biomarker (15%) criteria were more likely to result in an improvement in PFS than those without selection criteria (21% vs. 8%, p50.0001 and 31% vs. 10%, p<0.0001, respectively). These data demonstrate profound changes in the clinical trial landscape over the last 10 years with significantly increasing proportion of trials with positive outcomes. These changes are likely attributed to the use of histology and biomarker selection criteria in clinical trial design.
KW - Individualized medicine
KW - Metastasis
KW - Non-small cell lung carcinoma
U2 - 10.1002/cncr.28956
DO - 10.1002/cncr.28956
JO - Cancer
JF - Cancer
Gentzler RD, Yentz SE, Johnson ML, Rademaker AW, Patel JD. The changing landscape of phase II/III metastatic NSCLC clinical trials and the importance of biomarker selection criteria. Cancer. 2014 Dec 1;120(24):3853-3858. doi: 10.1002/cncr.28956