TABLE 4.

Additional Patient and Tumor Characteristics, With Response Assessments^a

Dose Level	Age, y	Sex	Cigarette History, Pack-Years	HPV ISH Status	Mutational Profiling Result	Primary Tumor, Site, and Stage	Best Response or Reason for I nevaluable Status
1	56	Woman	30	Not done	WTb	Hypopharynx, T3N2bM0	−21%
1	54	Man	Never	Positive	WT	BOT, T2N2cM0	−47%
1	44	Man	11	Not done	WT	Nasal Cavity, T3N2cM0	−22%
2	70	Woman	50	Not done	WT	BOT, T2N3M0	Removed from study in cycle 1 because of noncompliance with oral regimen and cisplatin-related toxicities
2	60	Man	11	Not done	WT	Soft palate, T2N2bM0	Off study because of AE in cycle 2
2	48	Woman	10	Not done	WT	BOT/tonsil, T2N3M0	−11%
2	56	Man	35	Positive	WT	BOT, T1N2bM0	Off study because of DLT in cycle 1
2	52	Man	Never	Not done	WT	BOT, T3N2cM0	−64%
2	46	Man	Never	Negative	WT	BOT, T1N2bM0	−32%
2	50	Man	Never	Not done	WT	Tonsil, T1N2bM0	Noncompliance with oral regimen
2	56	Man	Never	Negative	WT	Nasopharynx, T1N2M0	−27%
3	68	Man	23	Positive	WT	Tonsil, T2N2cM0	−53%
3	60	M	30	Positive	WT	BOT, T3N3M0	Off study because of DLT in cycle 1
3	57	Man	30	Positive	WT	Tonsil, T4aN2cM0	−39%
3	59	Man	18	Positive	PIK3CA E545Q	BOT, T2N2bM0	−58%
3	55	Man	Never	Positive	PIK3CA E545Q	BOT, T2N2aM0	Off study because of AE in cycle 1 (not DLT)
3	59	Man	30	Negative	KRAS A146T	Oral cavity, T4aN2bM0	Off study because of DLT in cycle 1

Abbreviations: AE, adverse event; BOT, base of tongue; DLT, dose-limiting toxicity; HPV, human papillomavirus; ISH, immunohistochemistry; KRAS, A146T, alanine to threonine substitution at codon 146; PIK3CA, E545Q, glutamic acid to glutamine substitution at codon 545.

^aThis does not include 1 patient who was enrolled but never treated (tonsil primary, never smoker).

^bWT indicates that no mutations were detected in the assay panel for the study.