`
`Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
`Vol 23, No 16S (June 1 Supplement), 2005: 7098
`© 2005 American Society of Clinical Oncology
`Abstract
`An openlabel, multi centre, phase II, noncomparative trial of
`ZD1839 monotherapy in chemotherapynaive patients with
`stage IV or stage III nonoperable nonsmall cell lung cancer
`(NSCLC)
`M. Reck, U. Gatzemeier, E. Bucholz, C. G. Gahlemann and C. Manegold
`
`Hosp Grosshansdorf, Grosshansdorf, Germany; Thoraxklinik Heidelberg Rohrbach,
`Heidelberg, Germany; AstraZeneca, Wedel, Germany
`
`7098
`
`Background: Second or thirdline gefitinib (IRESSA) monotherapy is active and well
`tolerated in patients with advanced nonsmallcell lung cancer (NSCLC). The aim of this
`study was to determine the efficacy and safety of gefitinib as monotherapy in
`chemotherapynaïve patients with good performance status (PS). Methods:
`Chemotherapynaïve patients who had PS 0–2 with histologically confirmed, nonoperable,
`stage III/IV NSCLC were enrolled. Patients received gefitinib 250 mg/day until disease
`progression. To ensure that the best available treatment was not withheld for an undue
`length of time, tumors were assessed by Xray at weeks 3 and 9, and by computed
`tomography every 6 weeks following start of treatment. Results: 58 out of 59 patients
`were evaluable: Histology: Adeno carcinoma (CA) (32); bronchioalveolar CA (10);
`squamous cell CA (8); large cell CA (4); other (4). Median age: 67 years (range 41–84).
`Smoking history: current 33%, former 48%, never 19%. PS 0/1/2: 10%;66%,24%.
`Response: complete response (CR; n=1; 2%), partial response (PR; n=2; 3%), stable
`disease (SD; n=23; 40%); progressive disease (PD; n=28; 48%). Median progression free
`survival to date: 52 days. 14 patients are still undergoing treatment. There were no
`therapyrelated serious adverse events. Grade 3 toxicities were rash 1,7%, nausea 1,7%,
`fatigue 6,9%, cough 3,4%, pain 1,7%. Conclusions: Gefitinib as firstline monotherapy
`has activity in patients with advanced NSCLC, with clinical benefit (CR+PR+SD) observed
`in 45% (26/58) of patients. Due to the favorable tolerability profile, gefitinib should be
`investigated further in controlled, randomized studies in those patients who are unable to
`tolerate, or who refuse, chemotherapy. IRESSA is a trademark of the AstraZeneca group
`of companies
`
`Author Disclosure
`
`Employment or
`Leadership
`
`Consultant or
`Advisory Role
`
`Stock
`Ownership Honoraria
`
`Research
`Funding
`
`Expert
`Testimony
`
`Other
`Remuneration
`
`AstraZeneca
`
`Abstract presentation from the 2005 ASCO Annual Meeting
`
`CYRAMZA as a single agent,
`or in combination with
`paclitaxel, is indicated for the
`treatment of patients with
`advanced or metastatic
`gastric or gastroesophageal
`junction (GEJ) adenocarcinoma
`with disease progression on or
`after prior fluoropyrimidine
`or platinumcontaining
`chemotherapy.
`
`Safety and Boxed Warning
`SAFETY AND BOXED WARNING
`Hemorrhage: CYRAMZA increased the risk of
`hemorrhage and gastrointestinal hemorrhage,
`including severe and sometimes fatal hemorrhagic
`events. Permanently discontinue CYRAMZA in
`patients who experience severe bleeding.
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