Table 2.

Event-time distribution by KRAS-variant genotype and first-line recurrent/metastatic HNSCC treatment regimen in HN0501 (phase II docetaxel and bortezomib) and E5397 (phase III cisplatin with/without cetuximab)

Survival outcome	Treatment regimens	KRAS genotype	# of events/N	Median survival (95% CI)	Log-rank P	Univariate	Wald P	Multivariablea	Wald P
						HR (TG/GG versus TT) (95% CI)		HR (TG/GG versus TT) (95% CI)
Progression-free survival	HN0501: docetaxel + bortezomib	TG/GG	8/8	1.6 (1.1–4.7)	0.89	0.93 (0.33–2.62	0.90	–	–
		TT	8/11	1.7 (1.4–4.1)
	E5397: overall cisplatin + placebo or cetuximab	TG/GG	12/12	2.2 (1.0–4.5)	0.002	2.82 (1.40–5.67)	0.004	3.68 (1.50–9.03)	0.004
		TT	40/42	4.7 (3.7–5.9)
	E5397: cisplatin + placebo	TG/GG	5/5	1.9 (0.0–3.4)	0.002	4.94 (1.58–15.40)	0.006	3.75 (0.78–18.12)	0.10
		TT	22/23	3.9 (2.3–5.5)
	E5397: cisplatin + cetuximab	TG/GG	7/7	3.9 (1.8–4.6)	0.04	2.65 (1.01–6.98)	0.049	3.59 (0.96–13.41)	0.057
		TT	18/19	5.8 (3.7–6.3)
Overall survival	HN0501: docetaxel + bortezomib	TG/GG	8/8	6.7 (1.6–9.8)	0.60	1.30 (0.49–3.50)	0.60	–	–
		TT	11/11	5.1 (1.3–12.6)
	E5397: overall cisplatin + placebo or cetuximab	TG/GG	12/12	7.3 (1.0–12.1)	0.11	1.71 (0.89–3.31)	0.11	–	–
		TT	38/42	8.2 (7.0–12.2)
	E5397: cisplatin + placebo	TG/GG	5/5	5.4 (0.0–12.1)	0.09	2.38 (0.85–6.62)	0.10	–	–
		TT	21/23	8.1 (6.1–13.5)
	E5397: cisplatin + cetuximab	TG/GG	7/7	8.0 (1.8–12.2)	0.52	1.34 (0.55–3.25)	0.52	–	–
		TT	17/19	8.2 (6.3–12.3)

P-values in bold indicate P-values which are statistically significant.

^aCovariates included PS (0 versus 1), disease status (previously untreated versus recurrent), cell differentiation (well/moderate versus poorly differentiation), primary site (oropharynx versus non-oropharynx), smoking history (≤40 versus >40 packs-years), alcohol consumption (<10 oz whiskey/week versus ≥10 oz whiskey/week) and treatment (when appropriate). N = 21 in the cisplatin + placebo arm and in the cisplatin + cetuximab arm.