Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations

Some subgroups of patients with advanced/metastatic non-small-cell lung cancer (NSCLC) are frequently considered ineligible for the aggressive, platinum-based combination chemotherapy that is the recommended treatment. Elderly patients may have a poorer tolerance of chemotherapy due to impaired orga...

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Main Authors: Stahel, R, Rossi, A, Petruzelka, L, Kosimidis, P, de Braud, F, Bernardo, M M, Souquet, P-J, Parra, H Soto, Gridelli, C
Formato: Artigo
Idioma:English
Publicado em: Nature Publishing Group 2003
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Original Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2750243/
https://ncbi.nlm.nih.gov/pubmed/14661049
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/sj.bjc.6601479
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spelling pubmed-27502432009-09-28 Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations Stahel, R Rossi, A Petruzelka, L Kosimidis, P de Braud, F Bernardo, M M Souquet, P-J Parra, H Soto Gridelli, C Br J Cancer Original Article Some subgroups of patients with advanced/metastatic non-small-cell lung cancer (NSCLC) are frequently considered ineligible for the aggressive, platinum-based combination chemotherapy that is the recommended treatment. Elderly patients may have a poorer tolerance of chemotherapy due to impaired organ function and frequent comorbidities; patients with poor performance status (PS; ⩾2 due to NSCLC and/or coexisting illnesses) are often considered unfit for chemotherapy; other patients may be unable or unwilling to endure the toxicity or inconvenience of chemotherapy. These patient groups may benefit from novel, relatively nontoxic treatment modalities. Gefitinib (‘Iressa’, ZD1839) 250 mg day(−1) is well tolerated and has proven antitumour and symptom improvement activity in patients with previously treated NSCLC. Phase II trials (IDEAL 1 and 2) of gefitinib in advanced/metastatic NSCLC included 70 out of 425 (16.5%) patients with PS ⩾2, and their response rate, clinical benefit rate and rates of adverse events were similar to those of the overall trial population. In addition, many patients with advanced/metastatic NSCLC with poor PS or advanced age have received gefitinib 250 mg day(−1) in an Expanded Access Programme (EAP). Observations from the EAP support those of IDEAL 1 and 2, and indicate that gefitinib 250 mg day(−1) warrants further investigation in these patient groups. Nature Publishing Group 2003-12 2003-12-10 /pmc/articles/PMC2750243/ /pubmed/14661049 http://dx.doi.org/10.1038/sj.bjc.6601479 Text en Copyright © 2003 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
institution US National Library of Medicine
collection PubMed Central
language English
format Article
topic Original Article
spellingShingle Original Article
Stahel, R
Rossi, A
Petruzelka, L
Kosimidis, P
de Braud, F
Bernardo, M M
Souquet, P-J
Parra, H Soto
Gridelli, C
Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations
description Some subgroups of patients with advanced/metastatic non-small-cell lung cancer (NSCLC) are frequently considered ineligible for the aggressive, platinum-based combination chemotherapy that is the recommended treatment. Elderly patients may have a poorer tolerance of chemotherapy due to impaired organ function and frequent comorbidities; patients with poor performance status (PS; ⩾2 due to NSCLC and/or coexisting illnesses) are often considered unfit for chemotherapy; other patients may be unable or unwilling to endure the toxicity or inconvenience of chemotherapy. These patient groups may benefit from novel, relatively nontoxic treatment modalities. Gefitinib (‘Iressa’, ZD1839) 250 mg day(−1) is well tolerated and has proven antitumour and symptom improvement activity in patients with previously treated NSCLC. Phase II trials (IDEAL 1 and 2) of gefitinib in advanced/metastatic NSCLC included 70 out of 425 (16.5%) patients with PS ⩾2, and their response rate, clinical benefit rate and rates of adverse events were similar to those of the overall trial population. In addition, many patients with advanced/metastatic NSCLC with poor PS or advanced age have received gefitinib 250 mg day(−1) in an Expanded Access Programme (EAP). Observations from the EAP support those of IDEAL 1 and 2, and indicate that gefitinib 250 mg day(−1) warrants further investigation in these patient groups.
author Stahel, R
Rossi, A
Petruzelka, L
Kosimidis, P
de Braud, F
Bernardo, M M
Souquet, P-J
Parra, H Soto
Gridelli, C
author_facet Stahel, R
Rossi, A
Petruzelka, L
Kosimidis, P
de Braud, F
Bernardo, M M
Souquet, P-J
Parra, H Soto
Gridelli, C
author_sort Stahel, R
title Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations
title_short Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations
title_full Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations
title_fullStr Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations
title_full_unstemmed Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations
title_sort lessons from the ‘iressa’ expanded access programme: gefitinib in special non-small-cell lung cancer patient populations
publisher Nature Publishing Group
publisher_facet Nature Publishing Group
publishDate 2003
url https://ncbi.nlm.nih.gov/pmc/articles/PMC2750243/
https://ncbi.nlm.nih.gov/pubmed/14661049
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/sj.bjc.6601479
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