Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung

Figures & data

Table 1 Patient demographics and baseline characteristics in the Chinese subgroup and the overall LUX-Lung 8 population

Characteristic	Chinese patients (N=67)		Overall population (N=795)a
	Afatinib (n=36)	Erlotinib (n=31)	Afatinib (n=398)	Erlotinib (n=397)
Sex, n (%)
Female	5 (13.9)	2 (6.5)	63 (15.8)	66 (16.6)
Male	31 (86.1)	29 (93.5)	335 (84.2)	331 (83.4)
Median age, years (range)	62.0 (36–74)	60.0 (43–78)	65.0 (36–84)	64.0 (35–88)
≥65 years, n (%)	13 (36.1)	7 (22.6)	209 (52.5)	187 (47.1)
ECOG PS, n (%)
0	9 (25.0)	8 (25.8)	126 (31.7)	134 (33.8)
1	27 (75.0)	23 (74.2)	269 (67.6)	262 (66.0)
2b	0	0	3 (0.8)	1 (0.3)
Ethnic origin, n (%)
Non-eastern Asian	0	0	312 (78.4)	311 (78.3)
Eastern Asian	36 (100.0)	31 (100.0)	86 (21.6)	86 (21.7)
Smoking status, n (%)
Never smoked	5 (13.9)	5 (16.1)	26 (6.5)	18 (4.5)
Light ex-smokerc	0	2 (6.5)	11 (2.8)	12 (3.0)
Other current or ex-smokerd	31 (86.1)	24 (77.4)	361 (90.7)	367 (92.4)
Median time since diagnosis, years (range)	0.7 (0.3–6.6)	0.6 (0.2–6.2)	0.8 (0.2–9.3)	0.7 (0.2–13.5)
Tumor histology, n (%)
Squamous	33 (91.7)	28 (90.3)	381 (95.7)	382 (96.2)
Mixede	3 (8.3)	2 (6.5)	17 (4.3)	11 (2.8)
Undifferentiatede	0	1 (3.2)	0	4 (1.0)
Clinical stage at screening, n (%)
IIIA	1 (2.8)	0	1 (0.3)	4 (1.0)
IIIB	7 (19.4)	5 (16.1)	48 (12.1)	48 (12.1)
IV	28 (77.8)	26 (83.9)	349 (87.7)	345 (86.9)

Notes:

a Reprinted from Lancet Oncol. 2015;16(8). Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. 897–907, Copyright (2015), with permission from Elsevier;¹⁹

b Protocol violations;

c <15 pack-years and stopped >1 year before diagnosis;

d in the overall population, 71 (17.8%) patients treated with afatinib vs 85 (21.4%) treated with erlotinib were current smokers; in the Chinese population, four (11.1%) vs three (9.7%) patients were current smokers;

e originally classed as squamous by the treating investigator.

Abbreviation: ECOG PS, Eastern Cooperative Oncology Group performance status.

Table 2 PFS by independent review, OS, and best overall tumor response by independent review, in the Chinese subgroup and the overall LUX-Lung 8 population

Parameter	Chinese subgroup (N=67)				Overall population (N=795)a
	Afatinib (n=36)	Erlotinib (n=31)	HR (95% CI)	P-value	Afatinib (n=398)	Erlotinib (n=397)	HR (95% CI)	P-value
Median PFS, months	2.8	2.8	0.70 (0.38–1.27)	0.2250	2.4	1.9	0.82 (0.68–1.00)	0.0427
Median OS, months	10.8	8.2	0.69 (0.39–1.21)	0.1957	7.9	6.8	0.81 (0.69–0.95)	0.0077
Disease control, n (%)	20 (55.6)	13 (41.9)		0.2713	201 (50.5)	157 (39.5)		0.0020
Objective response, n (%)	3 (8.3)	2 (6.5)		0.7723	22 (5.5)	11 (2.8)		0.0551
Complete response, n (%)	0	0		NA	1 (0.3)	0 (0)		NA
Partial response, n (%)	3 (8.3)	2 (6.5)		NA	21 (5.3)	11 (2.8)		NA
Stable disease, n (%)	9 (25.0)	7 (22.6)		NA	124 (31.2)	103 (25.9)		NA
Non-complete response/non-progressive disease,b n (%)	8 (22.2)	4 (12.9)		NA	55 (13.8)	43 (10.8)		NA
Progressive disease, n (%)	16 (44.4)	8 (25.8)		NA	133 (33.4)	169 (42.6)		NA
Not evaluable, n (%)	0	10 (32.3)		NA	64 (16.1)	71 (17.9)		NA

Notes:

a Reprinted from Lancet Oncol. 2015;16(8). Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. 897–907, Copyright (2015), with permission from Elsevier;¹⁹

b Stable non-target disease in the absence of baseline target disease.

Abbreviations: NA, not applicable; OS, overall survival; PFS, progression-free survival.

Figure 1 (A) PFS (independent review) and (B) OS for the Chinese subgroup.

Abbreviations: OS, overall survival; PFS, progression-free survival.

Figure 2 Long-term benefit of afatinib in LTRs (Chinese patients).

Notes: ^aPatients ordered by treatment duration. Values are duration of treatment at the doses indicated.
Abbreviations: LTRs, long-term responders; OS, overall survival.

Figure 3 Time to deterioration in coughing in the Chinese subgroup.

Abbreviation: NE, not evaluable.

Table 3 AEas in the Chinese subgroup and the overall safety population

Patients with AEas, n (%)	Chinese subgroup (N=67)				Overall safety population (N=787)b
	Afatinib (n=36)		Erlotinib (n=31)		Afatinib (n=392)		Erlotinib (n=395)
	All	Grade 3	All	Grade 3	All	Grade 3	All	Grade 3
Any AE	36 (100.0)	8 (22.2)	28 (90.3)	6 (19.4)	390 (99.5)	124 (31.6)	385 (97.5)	138 (34.9)
Diarrhea	27 (75.0)	0	4 (12.9)	0	293 (74.7)	39 (9.9)	163 (41.3)	12 (3.0)
Rash/acnec	23 (63.9)	1 (2.8)	16 (51.6)	0	273 (69.6)	26 (6.6)	276 (69.9)	42 (10.6)
Stomatitisc	14 (38.9)	2 (5.6)	2 (6.5)	0	118 (30.1)	16 (4.1)	42 (10.6)	2 (0.5)
Fatiguec	7 (19.4)	0	6 (19.4)	1 (3.2)	132 (33.7)	19 (4.8)	119 (30.1)	23 (5.8)
Hemoptysis	7 (19.4)	0	3 (9.7)	0	49 (12.5)	2 (0.5)	49 (12.4)	2 (0.5)
Dyspnea	6 (16.7)	1 (2.8)	1 (3.2)	0	79 (20.2)	12 (3.1)	94 (23.8)	18 (4.6)
Hypokalemia	6 (16.7)	1 (2.8)	1 (3.2)	0	20 (5.1)	9 (2.3)	12 (3.0)	3 (0.8)
Cough	4 (11.1)	0	3 (9.7)	1 (3.2)	65 (16.6)	2 (0.5)	69 (17.5)	2 (0.5)
Paronychiac	4 (11.1)	0	0	0	43 (11.0)	2 (0.5)	20 (5.1)	1 (0.3)
Decreased appetite	2 (5.6)	1 (2.8)	3 (9.7)	1 (3.2)	97 (24.7)	12 (3.1)	103 (26.1)	8 (2.0)
Nausea	3 (8.3)	0	2 (6.5)	1 (3.2)	81 (20.7)	6 (1.5)	64 (16.2)	4 (1.0)
Vomiting	0	0	2 (6.5)	0	51 (13.0)	3 (0.8)	40 (10.1)	4 (1.0)
Constipation	2 (5.6)	0	1 (3.2)	0	43 (11.0)	0	43 (10.9)	1 (0.3)

Notes:

a The data shown are for AEs that occurred (at any grade) in >10% of patients in the afatinib arm, in either the overall population or the Chinese subgroup. AEs were coded using MedDRA version 17.1. Of the AEs listed, the following also occurred at grade 4/5 in the afatinib arm (overall safety population): grade 4 diarrhea (n=3); grade 4 fatigue (n=1); grade 5 fatigue (n=1); grade 4 dyspnea (n=3); grade 5 dyspnea (n=3); grade 5 hemoptysis (n=2).

b Data on file;

c grouped term.

Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities.

SoriaJCFelipECoboMAfatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trialLancet Oncol201516889790726156651

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