Table 2.

Characteristics of Patients with Severe Late Toxicities (Cases) and Controls

	Cases (n = 71)		Controls (n = 83)
Characteristic	No.	%	No.	%	P-value
Age, years
Median	59		54
Min-Max	33–77		26–78
≤ 70	63	89	77	93	0.38
> 70	8	11	6	7
Sex
Male	53	75	63	76	0.86
Female	18	25	20	24
Race
Non-Black	63	89	78	94	0.24
Black	8	11	5	6
KPS
70–80	16	23	9	11	0.049
90–100	55	77	74	89
Hemoglobin, g/dL
Median	14.3		14.1
Min-Max	10.1–17.2		9.9–18.2
≤ 13.5	18	25	31	37	0.11
> 13.5	53	75	52	63
Weight loss in previous 6 months, kg
≤ 5	54	76	69	83
> 5	17	24	14	17
T stage
T1/T2	16	23	28	34	0.28
T3/T4	55	77	55	66
N stage
NX/N0/N1	32	45	35	42	0.71
N2	34	48	39	47
N3	5	7	9	11
Tumor site
Oral cavity/oropharynx	31	44	43	52	0.31
Oral Cavity	5	7	1	1
Oropharynx	26	37	42	51
Larynx/hypopharynx	40	56	40	48
Larynx	30	42	35	42
Hypopharynx	10	14	5	6
Radiotherapy dose-intensity delivered, BED1 Gy
Mean	115.7		115.6		0.74
Median	116.7		116.7
Min-Max	108.7–116.7		108.6–120.0
Neck dissection after RT
Yes	19	27	21	25	0.84
No	52	73	62	75
Chemotherapy dose delivered2 %
< 85	10	14	10	12	0.71
≥ 85	61	86	73	88

Abbreviations: No., number; KPS, Karnofsky performance status; BED, biologically equivalent dose; RT, radiation therapy.

¹BED for toxicity = Total dose × (1 + Actual dose/Fx /3)

²Chemotherapy dose delivered = (total dose patient [pt] received) / (BSA × total dose specified in the study protocol). If the pt refused chemo, received the wrong chemo agent(s), or there was no chemo documentation than these pts were treated as receiving none of their specified chemo dose(= 0%).