Table 1.

Summary of Patients used in this Analysis

	Radiation Therapy Oncology Group Study
Characteristic	91-11 (Arm 1)	97-03 (Arms 1 & 3)	99-14 (Arm 1)	Total
Original No. of eligible patients	166	155	16	397
Reason for exclusion
Pretreatment swallowing disability1	20	42	18	80
Acute death2	10	8	3	21
Missing data/inevaluable for RT review	21	6	2	29
Dead NED3 (known cause and not RX related)	9	4	1	14
Cancer progression4	45	43	11	99
Total excluded	105	103	35	243
Total analyzable for this study	61	52	41	154
Late Toxicity Events 5
Feeding tube dependence ≥ 2 years post-RT	--6	16	7	23
RTOG late toxicity criteria, grade 3+
Pharyngeal Dysfunction (dysphagia)	12	11	9	32
Laryngeal dysfunction	16	3	0	19
Mucositis	1	0	5	6
Other (e.g. infection, fistula, wt. loss)	4	0	3	7
Dead NED [unknown cause and could be RX Related] ≤ 3 years after study entry	3	2	2	7
Any late toxicity events (cases)	28	24	19	71
No late toxicity events (controls)	33	28	22	83

Abbreviation: NED, no evidence of disease; RX, treatment; RT, radiation therapy

¹Pretreatment swallowing disability: airway obstruction, dysphagia, odynophagia, feeding tube, or gastrostomy

²Acute: 180 days from the start of RT for grade 5 toxicity or 180 days from the date of randomization for non-toxicity death

³Patients are NED if they do not have any of the following events/failures: persistence, local/regional recurrence, distant mets, second primary, death by study cancer, or death by second primary

⁴Cancer progression is having at least one of the previous events/failures.

⁵Numbers do not add up along columns due to some patients having more than one toxicity event.

⁶Feeding tube data were not collected in RTOG 91-11