P-612 Gefitinib (Iressa, ZD1839) is active as first-line, compassionate use therapy in patients with advanced non-small cell lung cancer (NSCLC)

Efficacy and tolerability of gefitinib in pretreated elderly patients with advanced non-small-cell lung cancer (NSCLC)

“…No patient experienced lung toxicity, and, in the three patients in whom there was worsening dyspnea, this was mainly due to disease progression. The side effects reported in our study are similar to those reported in other trials in which diarrhoea and skin toxicity occurred in about 40 and 50% of cases (Janne et al, 2002;Ruckdeschel et al, 2002;Argiris et al, 2003;Copin et al, 2003;Fukuoka et al, 2003;Kommareddy et al, 2003;Pallis et al, 2003). Symptom assessment was not the main end point of our study, and for that reason no questionnaire has been used.…”

“…Although elderly patients were also enrolled in all these trials, the activity of gefitinib in this subgroup has not been addressed. The response rate (CR þ PR) observed in our trial was only 5%, lesser than that reported in the IDEAL 1 and 2 trials, but not different from that reported in other compassionate use studies (Janne et al, 2002;Ruckdeschel et al, 2002;Argiris et al, 2003;Copin et al, 2003;Kommareddy et al, 2003;Pallis et al, 2003). Moreover, in our study, disease stabilisation has been documented in 45% of patients, and, importantly, 15% had disease stabilisation lasting at least 6 months.…”

“…Although elderly patients have not been excluded from second-line chemotherapy trials (Shepherd et al, 2000;Hanna et al, 2003), in clinical practice, a second option is generally offered only to well-selected cases, with good . The activity and tolerability of gefitinib as a single agent has been evaluated in two large phase II studies Fukuoka et al, 2003), and also in smaller studies with unselected pretreated NSCLC patients enrolled in the ZD1839 Expanded Access Programme (Janne et al, 2002;Ruckdeschel et al, 2002;Argiris et al, 2003;Kommareddy et al, 2003;Pallis et al, 2003). All these trials showed that gefitinib is a valid option for pretreated NSCLC patients, with response rates ranging from 5 to 18%, and with a consistent portion of patients experiencing disease stabilisation.…”

‘Classical’ but not ‘other’ mutations of EGFR kinase domain are associated with clinical outcome in gefitinib-treated patients with non-small cell lung cancer

“…However, this observation should be considered with caution given the small number of patients analysed. On the other hand, tumour growth control was significantly higher (P ¼ 0.013) in patients who presented the classical EGFR mutations compared to that of patients with wildtype EGFR, as already has been reported (Argiris et al, 2003;Miller et al, 2004;Han et al, 2005;Kim et al, 2005;Thatcher et al, 2005;Tsao et al, 2005). Similarly, although patients with 'other' EGFR mutations had a numerically longer survival as compared with patients of the 'wild-type' group, this difference failed to reach statistical significance.…”

Gefitinib as first-line, compassionate use therapy in patients with advanced non-small-cell lung cancer

“…The data were analyzed with SPSS software (version 11.5; SPSS Inc., Chicago, IL). A preliminary report of our results that included patients from Evanston Northwestern Healthcare has been previously reported [16].…”