Table 3.

Treatment-Related Toxicity (> 20% of patients)

Toxicity	Course One (n = 38)*				Courses Two to Four (n = 24)
	Grade 1 or 2		Grade 3 or 4		Grade 1 or 2		Grade 3 or 4
	No.	%	No.	%	No.	%	No.	%
Nonhematologic
Pain	11	29	26	68	10	42	12	50
Sinus tachycardia	27	71			16	67
Fever without neutropenia	25	66	8	21	14	58
Weight loss	22	58			8	33
Hypoalbuminemia	20	53			9	38
Anorexia	19	50	1	3	8	33
Alanine aminotransferase	20	53			15	63	1	4
Aspartate aminotransferase	19	50			12	50	2	8
Nausea	19	50			15	63
Hyponatremia	17	45	4	11	12	50
Hypertension	16	42	1	3	12	50
Vomiting	16	42			9	38
Ocular/visual	16	42			13†	54
Fatigue (asthenia, lethargy, malaise)	15	39	1	3	8	33
Cough	15	39	1	3	13	54
Hyperglycemia	11	29			11	46	1	4
Pruritis/itching	9	24			5	21
Hypokalemia	7	18	4	11	10	42
Hypophosphatemia	7	18			5	21
Rash/desquamation	5	13			6	25
Hypotension					4	17
Elevated alkaline phosphatase	5	13			5	21
Hematologic
Hemoglobin	11	29	3	8	9	38
Leukopenia	7	18	1	3	8	33	1	4
Platelets	6	16	1	3	6	25	2	8
Lymphopenia	5	13	5	13	6	25	2	8
Neutrophils	5	13			6	25	3	13

NOTE. Grades according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Each adverse event was counted once (any course, highest grade) for each patient during course one and also once for each patient during courses two to four.

^*Thirty-nine patients enrolled; one patient excluded because of withdrawal of consent before administration of any study drug.

^†No. includes nine patients who had visual/ocular abnormalities in course one that persisted during courses two to four.