Table 3. Safety and tolerability observations from eight case series >45 patients with advanced NSCLC who received gefitinib compassionately through the gefitinib EAP.

Author	Patients treated (evaluable), n	Median age and/or range (years)	Histology/disease stage	Prior treatment experience	Overall assessment of gefitinib tolerability by author
Haringhuizen, ICE abs	92 (92)	33–76	62% Adenocarcinoma	92% ⩾first-line chemotherapy	Good tolerability. Most side effects were mild. Most frequent side effects were grade 1/2 skin rash, diarrhoea and desquamation/itching (34.0, 21.8 and 21.8% of patients, respectively). ILD without symptoms observed in one (1%) patient, which resolved during treatment
			14% Stage III
			86% Stage IV
Gridelli [a], ICE abs	59 (57)		46% Adenocarcinoma	97% ⩾first-line treatment	Good tolerability in both elderly and unfit patients. Elderly group: the most frequent adverse events were grade 1/2 skin changes in five (28%) patients and grade 1 diarrhoea in three (17%) patients. PS ⩾2 group: the most frequent adverse events were grade 1 diarrhoea in two (5%) patients and grade 2 hypertransaminasaemia in one (3%) patient
	18 (18) (Elderly)	73.5	46% Squamous-cell
	41 (39) (PS ⩾2)	60	2% Bronchioalveolar
			7% Other
			12% Stage IIIb
			88% Stage IV
Gridelli [b], ICE abs	83 (71)	33–80	47% Adenocarcinoma	98% ⩾first-line treatment	Good tolerability. The most frequent adverse events were grade 1/2 skin changes and grade 1 diarrhoea (11 and 10% of patients, respectively). Other reported adverse events: grade 2 hypertransaminasaemia in one (1%) patient and grade 1 epistaxis in one (1%) patient
			42% Squamous-cell
			2% Bronchioalveolar
			8% Other
			13% Stage IIIb
			87% Stage IV
Bianco, ICE abs	49 (49)	59 (29–80)	49% Adenocarcinoma	100% ⩾second-line chemotherapy	Tolerability was excellent, two (4%) patients experienced mild, drug-related skin rash
	PS ⩽2		47% Squamous-cell
			2% Bronchioalveolar
			2% Large-cell
			16% Stage IIIb
			84% Stage IV
Cortes-Funes, ICE abs	113 (113)	61 (36–83)	41% Adenocarcinoma	79% ⩾second-line chemotherapy	Well tolerated. Most side effects were mild/moderate. The most frequent adverse events were grade 1/2 skin toxicity 42.5% patients (3.5% grade 3/4), diarrhoea 21.2% patients (0.9% grade 3/4) and 20.4% asthenia (5.3% grade 3/4). Other adverse events included nausea and vomiting (grade 1/2 10.6%; grade 3/4 0.9%), anorexia (9.7%; 3.5%), neurological toxicity (9.7%; 1.8%) and pulmonary toxicity (0.9%; 0.9%)
			40% Squamous-cell
			15% large-cell
			4% Other
			30% Stage I-IIa
			70% Stage IIIb-IV
Chioni, ICE abs	74 (72)	65 (43–81)	24% Adenocarcinoma	53% second-line chemotherapy	Well tolerated. Most side effects were mild: grade 1 diarrhoea (5.4%) and cutaneous toxicity (8%). Two patients had grade 3 diarrhoea (3%) and one patient had grade 3 diarrhoea plus cutaneous toxicity (1%)
			36% Squamous-cell
			9% Bronchioalveolar
			14% Undifferentiated large-cell
			16% Other
			Disease stage not reported
de Braud , ICE abs	79 (67)	56 (31–77)	65% Adenocarcinoma	Median number of chemotherapy regimens=2 range (1–6)	Well tolerated. Most side effects were mild/moderate grade 1/2 skin reactions (30%), diarrhoea (9%) and nausea (4%). Grade 3/4 skin reactions occurred in 2% of patients
			18% Squamous-cell
			4% Bronchioalveolar
			5% Other
			Locally advanced or metastatic disease

^aCase series were discussed at the ‘Iressa’ Clinical Experience (ICE) meeting and provided information on safety and tolerability. ILD=interstitial lung disease; EHP=Expanded Access Programme; NSCLC=non-small-cell lung cancer.