Figures
- FIGURE 1
a) Progression-free survival and b) overall survival in months by treatment arm. Data are presented with 95% CI. CPE: cisplatin-pemetrexed-erlotinib; E: erlotinib; HR: hazard ratio; cor: corrected.
Tables
- TABLE 1
Baseline patient characteristics
CPE Erlotinib monotherapy All Patients 11 11 22 Age, years 60 (58–64) 67 (62–68) 64 (59–68) Males 5 (45) 5 (45) 10 (45) Performance score 0 8 (73) 7 (64) 15 (68) 1 3 (27) 4 (36) 7 (32) Smoking Never-smoker 6 (55) 2 (18) 8 (36) Former smoker 5 (45) 5 (45) 10 (45) Current smoker 0 (0) 4 (36) 4 (18) Pack-years 14 (9–15) 14 (6–19) 14 (7–18) Stage IV 11 (100) 11 (100) 22 (100) Nonsquamous 11 (100) 11 (100) 22 (100) Type of EGFR mutation Exon 19 deletion 7 (64) 7 (64) 14 (64) L858R 2 (18) 3 (27) 5 (23) Other 2 (18) 1 (9) 3 (13) Data are presented as n, median (interquartile range) or n (%). CPE: cisplatin-pemetrexed-erlotinib; EGFR: epidermal growth factor receptor.
- TABLE 2
Outcome measures by treatment arm
CPE Erlotinib monotherapy HR (95% CI) Patients randomised 11 11 PFS months, median (95% CI) 13.7 (5.2–18.8) 10.3 (7.1–15.5) 0.62 (0.25–1.57)# Overall survival, median (95% CI) 31.7 (21.8–61.9) 17.2 (11.5–45.5) 0.55 (0.22–1.41) 1-year overall survival, % (95% CI) 100 (72–100) ORR, % (95% CI) 64 (31–89) 55 (23–83) Complete response 1 (9) 1 (9) Partial response 6 (54) 5 (46) Stable disease 4 (36) 5 (46) Duration of response in months, median (95% CI) 10.8 (7.3–31.2) 8.0 (5.5–8.7) 0.43 (0.12–1.47) Data are presented as n or n (%), unless otherwise stated. CPE: cisplatin-pemetrexed-erlotinib; HR: hazard ratio; PFS: progression-free survival; ORR: overall response rate. #: after compensating for numbers of days receiving erlotinib HR 0.24, 95% CI 0.07–0.83; p=0.02.
- TABLE 3
Number of treatment-related adverse events with incidence ≥10% or grade ≥3
All grades Grade ≥3# CPE E monotherapy p-value CPE E Abdominal pain 1 1 0 0 Alopecia 2 0 0.48 0 0 Anaemia 1 0 0 0 Anorexia 6 0 0.01 1 0 Diarrhoea 3 1 0.59 1 0 Dry eyes 0 1 0 0 Dry skin 5 4 1.00 0 0 Fatigue 5 2 0.36 1 0 Hypocalcaemia 1 0 1 0 Hypomagnesaemia 1 0 1 0 Mucositis 1 0 1 0 Nail infection 1 6 0.06 0 0 Nausea 2 1 1 0 Neutropenia 1 0 1 0 Pruritus 1 1 0 1 Rash 6 8 0.66 1 0 Renal toxicity 3 0 0.21 2 0 Weight loss 2 0 0.48 0 0 CPE: cisplatin-pemetrexed-erlotinib; E: erlotinib. #: due to limited sample size, no statistical analysis was performed for events grade ≥3.
Supplementary Material
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Supplementary material 00239-2022.SUPPLEMENT
