Table 4 Overview of studies with erlotinib in elderly patients (≥70 years) with advanced NSCLC

Jackman et al. (2007) [28]

First line

Open-label, phase 2

None

N = 80; 95% Caucasian

9/43 patients tested

• Median OS: 10.9 months (95% CI 7.8–14.6)

• 1-year survival rate 46%

• Well tolerated: most common AEs were rash (79%) and diarrhea (69%)

Chen et al. (2012) [27]

First line

Open-label, randomized, phase 2

Vino-relbine (V)

N = 113; 57 (E) vs. 56 (V); 100% Taiwanese

24/60 patients tested

• Median OS: 17.3 months (E) vs. 22.6 months (V)

• Mild toxicities: most frequent treatment-related AEs were rash (64.91%), diarrhea (29.82%), and mouth ulceration (14.04%)

TRUST elderly subgroup [29]

First line

Open-label, phase 4 (subgroup analysis)

None

N = 485; 82% Caucasian; 16% Asian

2/18 patients tested

• Median OS: 7.29 months (95% CI 6.27–8.67), non-Asian population: 7.19 months

• 1-year survival rate: 36.6%

• Disease control rate 79% (compared with 69% for the overall population; p < 0.0001)

• Good tolerability: only 4% had grade ≥ 3 treatment-related AEs, 7% had treatment-related SAEs (compared with 4% of the overall population)

Stinchcombe et al. (2011) [30]

Any

Open-label, randomized, phase 2

Gem, E + Gem

N = 146; 51 (E) vs. 44 (gem) vs. 51 E/gem; US study (included ethnicities not reported)

Unknown

• Median OS with E: 5.8 months (95% CI 3.0–8.3)

• Acneiform rash with E: 45%

• No significant difference in 6-month PFS, OS and toxicity rates among the groups

POLARSTAR [31]

Any

Open-label,phase 4

None

N = 9907^a; Age-stratified: 7848 (< 75 years), 1911 (75–84 years), 148 (≥85 years); 100% Japanese

Unknown

• Efficacy and incidence of non-hematologic and hematologic toxicities were comparable between age groups

BR.21 Study elderly subgroup [20]

≥Second line

Double-blind, randomized, phase 3 (retrospective subgroup analysis)

Placebo

Erlotinib: 112 (elderly) vs. 376 (young); 9.2% Asian, 90.8% other

15/115 patients tested

• Median OS (elderly vs. young): 7.6 months (elderly) vs. 6.4 months (young); HR 1.02 (95% CI 0.81–1.30)

• More overall and severe (grade 3–4) toxicity with erlotinib in elderly vs. younger patients (35% vs 18%; p < 0.001)

Keio Lung Oncology Group Study 001 [33]

≥Second line

Phase 2

None

N = 38; 100% Japanese

13/35 tested

• Median OS: 17.3 months (95% CI 13.3–21.3)

• Main AE was skin rash (76%)

Lung Oncology Group in Kyushu (LOGiK-0802) [32]

≥Second line

Phase 2

None

N = 40^b; 100% Japanese

10/29 tested

• Median OS: 12.2 months (95% CI 6,1–24,7)

• Major toxicities: skin disorders, fatigue, anorexia

• 32.5% required dose reduction

ElderTac (present study)

≥Second line

Prospective, non-interventional

None

N = 465^c; 99.2% Caucasian

18/119 patients tested

• Median OS: 7.1 months

• 1-year survival rate: 30.6%

• No new safety signals; most frequently reported AEs were rash (45.2%) and diarrhea (22.6%)