{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T06:40:21Z","timestamp":1791009621901,"version":"4.1.0"},"reference-count":42,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2002,11,1]]},"abstract":"<jats:p>PURPOSE: To establish the safety and tolerability of ZD1839 (Iressa), a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, and to explore its pharmacokinetic and pharmacodynamic effects in patients with selected solid tumor types.<\/jats:p>\n                  <jats:p>PATIENTS AND METHODS: This was a phase I dose-escalating trial of oral ZD1839 150 mg\/d to a maximum of 1,000 mg\/d given once daily for at least 28 days. Patients with either advanced non\u2013small-cell lung, ovarian, head and neck, prostate, or colorectal cancer were recruited.<\/jats:p>\n                  <jats:p>RESULTS: Eighty-eight patients received ZD1839 (150 to 1,000 mg\/d). At 1,000 mg\/d, five of 12 patients experienced dose-limiting toxicity (grade 3 diarrhea [four patients] and grade 3 somnolence [one patient]). The most frequent drug-related adverse events (AEs) were acne-like rash (64%) and diarrhea (47%), which were generally mild (grade 1\/2) and reversible on cessation of treatment. No change in ZD1839 safety profile was observed with prolonged administration. Pharmacokinetic analysis showed steady-state exposure to ZD1839 in 98% of patients by day 7. Nineteen patients had stable disease and received ZD1839 for \u2265 3 months; seven of these patients remained on study drug for \u2265 6 months. Serial skin biopsies taken before treatment and at approximately day 28 revealed changes indicative of inhibition of the EGFR signaling pathway.<\/jats:p>\n                  <jats:p>CONCLUSION: ZD1839 was generally well tolerated, with manageable and reversible AEs at doses up to 600 mg\/d and dose-limiting toxicity observed at 1,000 mg\/d. ZD1839 treatment resulted in clinically meaningful disease stabilization across a range of tumor types and doses. Pharmacodynamic changes in skin confirmed inhibition of EGFR signaling, which was predicted from the mode of action of ZD1839.<\/jats:p>","DOI":"10.1200\/jco.2002.03.100","type":"journal-article","created":{"date-parts":[[2002,10,30]],"date-time":"2002-10-30T13:22:42Z","timestamp":1035984162000},"page":"4292-4302","source":"Crossref","is-referenced-by-count":684,"title":["Phase I Safety, Pharmacokinetic, and Pharmacodynamic Trial of ZD1839, a Selective Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, in Patients With Five Selected Solid Tumor Types"],"prefix":"10.1200","volume":"20","author":[{"given":"J.","family":"Baselga","sequence":"first","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Rischin","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Ranson","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Calvert","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Raymond","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.G.","family":"Kieback","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.B.","family":"Kaye","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Gianni","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Harris","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Bjork","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.D.","family":"Averbuch","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Feyereislova","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; Istituto Nazionale Tumori, Milan, Italy;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Swaisland","sequence":"additional","affiliation":[{"name":"From Vall d\u2019Hebron University Hospital, Barcelona, Spain; Peter MacCallum Institute, Melbourne, Australia; Christie Hospital National Health Service Trust, Manchester, Northern Centre for Cancer Treatment, Newcastle-upon-Tyne, The Royal Marsden Hospital, Sutton, Churchill Hospital, Oxford, and AstraZeneca, Alderley Park, United Kingdom; Institut Gustave Roussy, Villejuif, France; Maastricht University Medical Center, Maastricht, the Netherlands; 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