Tables--Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 1. Table 2

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Table 2. First-line Treatment With EGFR-TK Inhibitors Combined With Cytotoxic Agents for Patients With Advanced NSCLC

Study ID	EGFR-TK Inhibitor Dose [length of followup]	Chemo-therapy	No. of Patients, Age (median [range]), Sex^a	Histology	Stage	PS	Smoking Status	Outcomes Sought
Phase III
Herbst, et al., 2006⁶	Gefitinib 250-500 mg/day [12 months]	Carboplatin AUC 6 mg/ml-min & paclitaxel 225 mg/m² x 6 cycles	1037 pts 62 (26-86) 40% F	Squamous 19.4% Adeno 51.9% Adenosquamous 1.7% BAC 3.2% NSCLC NOS 11.3% Large cell 11.0	IIIA 3.8% IIIB 17.1% IIIB no pl eff 5.2% IIIB pl eff 11.9% IV 78.3%	0: 38.8% 1: 51.9% 2: 9.3%	NR	1. Overall survival 2. TTP Others: response rate, disease-related symptoms and QoL, toxicity
Giaccone, et al., 2004⁷	Gefitinib 250-500 mg/day [16 months]	Cisplatin 80 mg/m2 & gemcitabine 1250 mg/m² x 6 cycles	1093 pts 60 (31-85) 26% F	Squamous 29.2% Adeno 46.6% Adenosquamous 1.4% BAC 0.3% NSCLC NOS 11.8% Large cell 8.8%	IIIA 1.9% IIIB 28.4% IIIB no pl eff 6.6% IIIB pl eff 21.8% IV 68.6%	0: 33.9% 1: 55.6% 2: 9.6%	NR	1. Survival 2. TTP, response, toxicity
Miller, et al., 2004⁸	Erlotinib 150 mg/day [22 months]	Carboplatin/ paclitaxel (6 cycles)	1059 pts 62.6 (24-84) 38% F	Squamous 16% Adeno 61% Large cell 10% NSCLC NOS 12%	IV 82%	0: 36.2% 1: 63.6% 2: 0.2%	Never: 8%	1. Overall survival; Others: TTP, response rate, duration of response
Gatzemeier, et al., 2004⁹	Erlotinib 150 mg/day [NR]	Cisplatin 80 mg/m² and gemcitabine 1250 mg/m² x 6 cycles	~1150 NR NR	NR	NR	0/1: 100%	NR	1. Survival Others: TTP, toxicity
Phase II
Williams, et al., 2004¹⁰	Gefitinib 250 mg/day [NR]	Docetaxel 75 mg/m² every 3 weeks	12 pts 74 (70-82) 25% F	NR	NR	NR	NR	Response, survival

^a Patient characteristics based on placebo group when not reported for all patients in randomized controlled trial.

Abbreviations: Adeno = adenocarcinoma; AUC = area under the curve; BAC = bronchoalveolar carcinoma; EGFR-TK = epidermal growth factor receptor tyrosine kinase; F = female; No. = number; NR = not reported; NSCLC NOS = non-small cell lung cancer not otherwise specified; pl eff = pleural effusion; PS = performance status; pts = patients; TTP = time to progression.

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