Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.

2.50
Hdl Handle:
http://hdl.handle.net/10541/78894
Title:
Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.
Authors:
LoRusso, Patricia M; Herbst, Roy S; Rischin, Danny; Ranson, Malcolm R; Calvert, A Hilary; Raymond, Eric; Kieback, Dirk; Kaye, Stan B; Gianni, Luca; Harris, Adrian L; Björk-Eriksson, Thomas; Maddox, Anne-Marie; Rothenberg, Mace L; Small, Eric J; Rubin, Eric H; Feyereislova, Andrea; Heyes, Anne; Averbuch, Steven D; Ochs, Judith; Baselga, Jose
Abstract:
PURPOSE: The feasibility and utility of assessing quality of life (QoL) and disease-related symptoms in patients with advanced cancer have been evaluated in two Phase I clinical trials of p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced cancer. EXPERIMENTAL DESIGN: Functional Assessment of Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head and neck, colorectal, prostate, and ovarian cancer, were completed by patients in two open-label, Phase I, escalating multiple-dose safety and tolerability trials. RESULTS: In 157 patients, 92% of whom had received prior therapy, compliance in returning FACT questionnaires was 87% (European/Australian trial) and 57% (United States trial). This did not appear to be influenced by dose level or tumor type. For patients with colorectal, prostate, or ovarian cancer, median QoL [FACT and Trial Outcome Index (TOI)] scores deteriorated over time. In contrast, for patients with non-small cell lung cancer (NSCLC) or head and neck cancer, median FACT and TOI scores did not deteriorate significantly, and in the United States trial, head and neck cancer scores improved significantly over time. In patients with NSCLC, symptom-related scores measured by the Lung Cancer Subscale of FACT-L appeared sensitive to clinical change. CONCLUSIONS: QoL (FACT-L) questionnaires were used successfully in the Phase I clinical trials of ZD1839. They appeared to be a sensitive tool to monitor clinical changes for the five tumor types in these trials and showed that ZD1839 has the potential to improve patients' QoL.
Affiliation:
Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.
Citation:
Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors. 2003, 9 (6):2040-8 Clin. Cancer Res.
Journal:
Clinical Cancer Research
Issue Date:
Jun-2003
URI:
http://hdl.handle.net/10541/78894
PubMed ID:
12796366
Type:
Article
Language:
en
ISSN:
1078-0432
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorLoRusso, Patricia M-
dc.contributor.authorHerbst, Roy S-
dc.contributor.authorRischin, Danny-
dc.contributor.authorRanson, Malcolm R-
dc.contributor.authorCalvert, A Hilary-
dc.contributor.authorRaymond, Eric-
dc.contributor.authorKieback, Dirk-
dc.contributor.authorKaye, Stan B-
dc.contributor.authorGianni, Luca-
dc.contributor.authorHarris, Adrian L-
dc.contributor.authorBjörk-Eriksson, Thomas-
dc.contributor.authorMaddox, Anne-Marie-
dc.contributor.authorRothenberg, Mace L-
dc.contributor.authorSmall, Eric J-
dc.contributor.authorRubin, Eric H-
dc.contributor.authorFeyereislova, Andrea-
dc.contributor.authorHeyes, Anne-
dc.contributor.authorAverbuch, Steven D-
dc.contributor.authorOchs, Judith-
dc.contributor.authorBaselga, Jose-
dc.date.accessioned2009-08-27T13:31:40Z-
dc.date.available2009-08-27T13:31:40Z-
dc.date.issued2003-06-
dc.identifier.citationImprovements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors. 2003, 9 (6):2040-8 Clin. Cancer Res.en
dc.identifier.issn1078-0432-
dc.identifier.pmid12796366-
dc.identifier.urihttp://hdl.handle.net/10541/78894-
dc.description.abstractPURPOSE: The feasibility and utility of assessing quality of life (QoL) and disease-related symptoms in patients with advanced cancer have been evaluated in two Phase I clinical trials of p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced cancer. EXPERIMENTAL DESIGN: Functional Assessment of Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head and neck, colorectal, prostate, and ovarian cancer, were completed by patients in two open-label, Phase I, escalating multiple-dose safety and tolerability trials. RESULTS: In 157 patients, 92% of whom had received prior therapy, compliance in returning FACT questionnaires was 87% (European/Australian trial) and 57% (United States trial). This did not appear to be influenced by dose level or tumor type. For patients with colorectal, prostate, or ovarian cancer, median QoL [FACT and Trial Outcome Index (TOI)] scores deteriorated over time. In contrast, for patients with non-small cell lung cancer (NSCLC) or head and neck cancer, median FACT and TOI scores did not deteriorate significantly, and in the United States trial, head and neck cancer scores improved significantly over time. In patients with NSCLC, symptom-related scores measured by the Lung Cancer Subscale of FACT-L appeared sensitive to clinical change. CONCLUSIONS: QoL (FACT-L) questionnaires were used successfully in the Phase I clinical trials of ZD1839. They appeared to be a sensitive tool to monitor clinical changes for the five tumor types in these trials and showed that ZD1839 has the potential to improve patients' QoL.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshPatient Compliance-
dc.subject.meshQuality of Life-
dc.subject.meshQuinazolines-
dc.subject.meshReceptor, Epidermal Growth Factor-
dc.titleImprovements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.en
dc.typeArticleen
dc.contributor.departmentKarmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.en
dc.identifier.journalClinical Cancer Researchen
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