Long-term safety and survival with gefitinib in select patients with advanced non–small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP)

Fred R. Hirsch; Lecia V. Sequist; Ira Gore; Meghan Mooradian; George Simon; Elisabeth F. Croft; Diana DeVincenzo; Jiefen Munley; Dara Stein; Klaus Freivogel; Frangiscos Sifakis; Paul A. Bunn

doi:10.1002/cncr.31313

Long-term safety and survival with gefitinib in select patients with advanced non–small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP)

Fred R. Hirsch, Lecia V. Sequist, Ira Gore, Meghan Mooradian, George Simon, Elisabeth F. Croft, Diana DeVincenzo, Jiefen Munley, Dara Stein, Klaus Freivogel, Frangiscos Sifakis, Paul A. Bunn

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17 Scopus citations

Abstract

BACKGROUND: This is the first report of long-term (>10 years) safety, tolerability, and survival data on patients with non–small cell lung cancer (NSCLC) who received treatment with gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. METHODS: Patients with advanced NSCLC (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to January 2013) and had previously obtained a clinical benefit from gefitinib therapy (including patients who had received gefitinib since 2001) were analyzed for adverse events (AEs). A subset of patients (n = 79) underwent retrospective chart review to capture demographic, safety, and survival data. RESULTS: Seventy-five of 191 patients (39%) remained on long-term gefitinib therapy as of September 2016. Overall, serious AEs (SAEs) were reported in 64 patients (34%), the majority of which were attributed to underlying disease or comorbidities; only 3 patients (1.6%) had SAEs that were considered as possibly gefitinib-related. In the retrospective chart review cohort, 70% of patients were women; 58% were former smokers, and 30% were never-smokers; 56% were diagnosed with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Although EGFR mutational status was tested in only 17 patients (22%), it was assumed that most tumors were EGFR-mutation-positive. The median duration of gefitinib therapy was 11.1 years (7.8 years before and 3.5 years during ICAP), with 10-year and 15-year survival rates of 86% and 59%, respectively, from the initiation of therapy. CONCLUSIONS: A subset of long-term NSCLC survivors who were receiving gefitinib had an excellent long-term safety profile. Although it is assumed that most of these patients' tumors harbor EGFR mutations, molecular studies of available tumor specimens are planned to uncover the features that predict long-term survival. Cancer 2018;124:2407-14.

Original language	English
Pages (from-to)	2407-2414
Number of pages	8
Journal	Cancer
Volume	124
Issue number	11
DOIs	https://doi.org/10.1002/cncr.31313
State	Published - 1 Jun 2018
Externally published	Yes

Keywords

epidermal growth factor receptor
gefitinib
non–small cell lung cancer
progression-free survival
safety
tyrosine kinase inhibitor

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10.1002/cncr.31313

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Hirsch, F. R., Sequist, L. V., Gore, I., Mooradian, M., Simon, G., Croft, E. F., DeVincenzo, D., Munley, J., Stein, D., Freivogel, K., Sifakis, F., & Bunn, P. A. (2018). Long-term safety and survival with gefitinib in select patients with advanced non–small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP). Cancer, 124(11), 2407-2414. https://doi.org/10.1002/cncr.31313

@article{0441975d7efd4cf986e11b36a1c19057,

title = "Long-term safety and survival with gefitinib in select patients with advanced non–small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP)",

abstract = "BACKGROUND: This is the first report of long-term (>10 years) safety, tolerability, and survival data on patients with non–small cell lung cancer (NSCLC) who received treatment with gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. METHODS: Patients with advanced NSCLC (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to January 2013) and had previously obtained a clinical benefit from gefitinib therapy (including patients who had received gefitinib since 2001) were analyzed for adverse events (AEs). A subset of patients (n = 79) underwent retrospective chart review to capture demographic, safety, and survival data. RESULTS: Seventy-five of 191 patients (39%) remained on long-term gefitinib therapy as of September 2016. Overall, serious AEs (SAEs) were reported in 64 patients (34%), the majority of which were attributed to underlying disease or comorbidities; only 3 patients (1.6%) had SAEs that were considered as possibly gefitinib-related. In the retrospective chart review cohort, 70% of patients were women; 58% were former smokers, and 30% were never-smokers; 56% were diagnosed with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Although EGFR mutational status was tested in only 17 patients (22%), it was assumed that most tumors were EGFR-mutation-positive. The median duration of gefitinib therapy was 11.1 years (7.8 years before and 3.5 years during ICAP), with 10-year and 15-year survival rates of 86% and 59%, respectively, from the initiation of therapy. CONCLUSIONS: A subset of long-term NSCLC survivors who were receiving gefitinib had an excellent long-term safety profile. Although it is assumed that most of these patients' tumors harbor EGFR mutations, molecular studies of available tumor specimens are planned to uncover the features that predict long-term survival. Cancer 2018;124:2407-14.",

keywords = "epidermal growth factor receptor, gefitinib, non–small cell lung cancer, progression-free survival, safety, tyrosine kinase inhibitor",

author = "Hirsch, {Fred R.} and Sequist, {Lecia V.} and Ira Gore and Meghan Mooradian and George Simon and Croft, {Elisabeth F.} and Diana DeVincenzo and Jiefen Munley and Dara Stein and Klaus Freivogel and Frangiscos Sifakis and Bunn, {Paul A.}",

note = "Publisher Copyright: {\textcopyright} 2018 American Cancer Society",

year = "2018",

month = jun,

day = "1",

doi = "10.1002/cncr.31313",

language = "English",

volume = "124",

pages = "2407--2414",

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Hirsch, FR, Sequist, LV, Gore, I, Mooradian, M, Simon, G, Croft, EF, DeVincenzo, D, Munley, J, Stein, D, Freivogel, K, Sifakis, F & Bunn, PA 2018, 'Long-term safety and survival with gefitinib in select patients with advanced non–small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP)', Cancer, vol. 124, no. 11, pp. 2407-2414. https://doi.org/10.1002/cncr.31313

TY - JOUR

T1 - Long-term safety and survival with gefitinib in select patients with advanced non–small cell lung cancer

T2 - Results from the US IRESSA Clinical Access Program (ICAP)

AU - Hirsch, Fred R.

AU - Sequist, Lecia V.

AU - Gore, Ira

AU - Mooradian, Meghan

AU - Simon, George

AU - Croft, Elisabeth F.

AU - DeVincenzo, Diana

AU - Munley, Jiefen

AU - Stein, Dara

AU - Freivogel, Klaus

AU - Sifakis, Frangiscos

AU - Bunn, Paul A.

PY - 2018/6/1

Y1 - 2018/6/1

N2 - BACKGROUND: This is the first report of long-term (>10 years) safety, tolerability, and survival data on patients with non–small cell lung cancer (NSCLC) who received treatment with gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. METHODS: Patients with advanced NSCLC (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to January 2013) and had previously obtained a clinical benefit from gefitinib therapy (including patients who had received gefitinib since 2001) were analyzed for adverse events (AEs). A subset of patients (n = 79) underwent retrospective chart review to capture demographic, safety, and survival data. RESULTS: Seventy-five of 191 patients (39%) remained on long-term gefitinib therapy as of September 2016. Overall, serious AEs (SAEs) were reported in 64 patients (34%), the majority of which were attributed to underlying disease or comorbidities; only 3 patients (1.6%) had SAEs that were considered as possibly gefitinib-related. In the retrospective chart review cohort, 70% of patients were women; 58% were former smokers, and 30% were never-smokers; 56% were diagnosed with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Although EGFR mutational status was tested in only 17 patients (22%), it was assumed that most tumors were EGFR-mutation-positive. The median duration of gefitinib therapy was 11.1 years (7.8 years before and 3.5 years during ICAP), with 10-year and 15-year survival rates of 86% and 59%, respectively, from the initiation of therapy. CONCLUSIONS: A subset of long-term NSCLC survivors who were receiving gefitinib had an excellent long-term safety profile. Although it is assumed that most of these patients' tumors harbor EGFR mutations, molecular studies of available tumor specimens are planned to uncover the features that predict long-term survival. Cancer 2018;124:2407-14.

AB - BACKGROUND: This is the first report of long-term (>10 years) safety, tolerability, and survival data on patients with non–small cell lung cancer (NSCLC) who received treatment with gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. METHODS: Patients with advanced NSCLC (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to January 2013) and had previously obtained a clinical benefit from gefitinib therapy (including patients who had received gefitinib since 2001) were analyzed for adverse events (AEs). A subset of patients (n = 79) underwent retrospective chart review to capture demographic, safety, and survival data. RESULTS: Seventy-five of 191 patients (39%) remained on long-term gefitinib therapy as of September 2016. Overall, serious AEs (SAEs) were reported in 64 patients (34%), the majority of which were attributed to underlying disease or comorbidities; only 3 patients (1.6%) had SAEs that were considered as possibly gefitinib-related. In the retrospective chart review cohort, 70% of patients were women; 58% were former smokers, and 30% were never-smokers; 56% were diagnosed with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Although EGFR mutational status was tested in only 17 patients (22%), it was assumed that most tumors were EGFR-mutation-positive. The median duration of gefitinib therapy was 11.1 years (7.8 years before and 3.5 years during ICAP), with 10-year and 15-year survival rates of 86% and 59%, respectively, from the initiation of therapy. CONCLUSIONS: A subset of long-term NSCLC survivors who were receiving gefitinib had an excellent long-term safety profile. Although it is assumed that most of these patients' tumors harbor EGFR mutations, molecular studies of available tumor specimens are planned to uncover the features that predict long-term survival. Cancer 2018;124:2407-14.

KW - epidermal growth factor receptor

KW - gefitinib

KW - non–small cell lung cancer

KW - progression-free survival

KW - safety

KW - tyrosine kinase inhibitor

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U2 - 10.1002/cncr.31313

DO - 10.1002/cncr.31313

M3 - Article

C2 - 29579334

AN - SCOPUS:85044423553

SN - 0008-543X

VL - 124

SP - 2407

EP - 2414

JO - Cancer

JF - Cancer

IS - 11

ER -

Long-term safety and survival with gefitinib in select patients with advanced non–small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP)

Abstract

Keywords

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