Multicenter phase IV study of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphomas undergoing repeated cycles of moderately emetogenic chemotherapy

Figures & data

Table I. Patient characteristics.

Characteristic	Patients (N = 88)
Age (years)
Median (range)	61.5 (29–89)
Age group, n (%)
< 65 years	53 (60.2)
≥ 65 years	35 (39.8)
Gender, n (%)
Male	53 (60.2)
Female	35 (39.8)
Karnofsky performance status^†
Median (range)	90.0 (50–100)
Race, n (%)
White	87 (98.9)
Hispanic	1 (1.1)
Diagnosis of non-Hodgkin lymphoma	88 (100)
Chemotherapy regimen
CHOP	41 (46.6)
R-CHOP (after)*	32 (36.4)
R-CHOP (before)^†	14 (15.9)
ProMACE-CytaBOM	1 (1.1)

n, number of patients in specified treatment group; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; ProMACE-CytaBOM, prednisone, doxorubicin, cyclophosphamide, etoposide, cytarabine, bleomycin, vincristine, methotrexate plus leucovorin; R-CHOP, rituximab–CHOP; MEC, moderately emetogenic chemotherapy.

*R-CHOP (after): regimen with rituximab after study drug administration and MEC, day 1.

^†R-CHOP (before): regimen with rituximab before study drug administration and MEC, day 1.

Table II. Number and percentage of patients with a complete response, by study cycle and overall.

Day(s)/interval, h	Cycle 1 (N = 88)		Cycle 2 (N = 82)		Cycle 3 (N = 78)		Cycle 4 (N = 69)		Total (N = 317)
	n	(%)	n	(%)	n	(%)	n	(%)	n	(%)
Overall, 0–120	60	(68.2)	66	(80.5)	61	(78.2)	56	(81.2)	243	(76.7)
Delayed phase, > 24–120	73	(83.0)	77	(93.9)	72	(92.3)	65	(94.2)	287	(90.5)
Day 1, 0–24	68	(77.3)	69	(84.1)	64	(82.1)	58	(84.1)	259	(81.7)
Day 2, > 24–48	77	(87.5)	79	(96.3)	75	(96.2)	67	(97.1)	298	(94.0)
Day 3, > 48–72	80	(90.9)	80	(97.6)	76	(97.4)	66	(95.7)	302	(95.3)
Day 4, > 72–96	84	(95.5)	80	(97.6)	76	(97.4)	67	(97.1)	307	(96.8)
Day 5, > 96–120	82	(93.2)	78	(95.1)	74	(94.9)	67	(97.1)	301	(95.0)

Table III. Nausea scores by category and cycle.

Phase/interval, h	Nausea, mm^†	Cycle 1 (N = 88)		Cycle 2 (N = 82)		Cycle 3 (N = 78)		Cycle 4 (N = 69)		Total (N = 317)
		n	(%)	n	(%)	n	(%)	n	(%)	n	(%)
Acute, 0–24	< 5	69	(78.4)	63	(76.8)	61	(78.2)	61	(88.4)	254	(80.1)
	5 ≤ 25	14	(15.9)	14	(17.1)	14	(17.9)	4	(5.8)	46	(14.5)
	≥ 25	5	(5.7)	5	(6.1)	3	(3.8)	4	(5.8)	17	(5.4)
Delayed, > 24–120 (max)*	< 5	54	(61.4)	62	(75.6)	62	(79.5)	55	(79.7)	233	(73.5)
	5 ≤ 25	21	(23.9)	16	(19.5)	13	(16.7)	9	(13.0)	59	(18.6)
	≥ 25	13	(14.8)	4	(4.9)	3	(3.8)	5	(7.2)	25	(7.9)
Overall, 0–120 (max)*	< 5	49	(55.7)	59	(72.0)	56	(71.8)	54	(78.3)	218	(68.8)
	5 ≤ 25	24	(27.3)	16	(19.5)	17	(21.8)	9	(13.0)	66	(20.8)
	≥ 25	15	(17.0)	7	(8.5)	5	(6.4)	6	(8.7)	33	(10.4)

VAS, visual analog scale.

*Patients’ maximum values during given time interval.

^†VAS scores (in mm) were categorized as: < 5: no nausea, 5 ≤ 25: no significant nausea, ≥ 25: nausea.

Table IV. Complete protection, emesis-free and no rescue medication rates by cycle.

Phase/interval, h	Cycle 1 (N* = 88)		Cycle 2 (N = 82)		Cycle 3 (N = 78)		Cycle 4 (N = 69)		Total (N = 317)
	n*	(%)	n	(%)	n	(%)	n	(%)	n	(%)
Complete protection
Acute, 0–24	67	(76.1)	66	(80.5)	62	(79.5)	56	(81.2)	251	(79.2)
Delayed, > 24–120	67	(76.1)	75	(91.5)	70	(89.7)	62	(89.9)	274	(86.4)
Overall, 0–120	55	(62.5)	64	(78.0)	57	(73.1)	53	(76.8)	229	(72.2)
No emesis
Acute, 0–24	80	(90.9)	77	(93.9)	75	(96.2)	65	(94.2)	297	(93.7)
Delayed, > 24–120	78	(88.6)	78	(95.1)	73	(93.6)	66	(95.7)	295	(93.1)
Overall, 0–120	76	(86.4)	75	(91.5)	72	(92.3)	64	(92.8)	287	(90.5)
No rescue medication
Acute, 0–24	73	(83.0)	72	(87.8)	67	(85.9)	59	(85.5)	271	(85.5)
Delayed, > 24–120	79	(89.8)	79	(96.3)	76	(97.4)	67	(97.1)	301	(95.0)
Overall, 0–120	67	(76.1)	69	(84.1)	66	(84.6)	57	(82.6)	259	(81.7)

*N, number of cycles; n, number of cycles with data available. Percentages are based on N. It should be noted that for each cycle (1, 2, 3 and 4), N and n are also equal to the number of patients in that cycle and to the number of patients with data available in that cycle, respectively.

Table V. Summary of TEAEs by cycle.

Category	Cycle 1 (N* = 88)			Cycle 2 (N = 81)			Cycle 3 (N = 77)			Cycle 4 (N = 68)
	n*	(%)	n′*	n	(%)	n′	n	(%)	n′	n	(%)	n′
Cycles with at least one
TEAE	51	(58.0)	125	44	(54.3)	74	29	(37.7)	58	22	(32.4)	44
Non-related TEAE	48	(54.5)	116	42	(51.9)	72	29	(37.7)	58	22	(32.4)	41
Drug-related TEAE^†	5	(5.7)	9	2	(2.5)	2	0	(0.0)	0	3	(4.4)	3
Patients who died in the cycle	1	(1.1)		0	(0.0)		1	(1.3)		0	(0.0)
Cycles with at least one
Severe TEAE	8	(9.1)	16	6	(7.4)	7	4	(5.2)	6	1	(1.5)	2
Severe drug-related TEAE^†	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0
Non-serious TEAE	50	(56.8)	111	43	(53.1)	71	29	(37.7)	51	22	(32.4)	42
Serious TEAE	9	(10.2)	14	2	(2.5)	3	5	(6.5)	7	2	(2.9)	2
Serious drug-related TEAE^†	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0
TEAE leading to study discontinuation	2	(2.3)	4	0	(0.0)	0	3	(3.9)	5	0	(0.0)	0
Drug-related TEAE leading to study discontinuation^†	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0
Serious TEAE leading to study discontinuation	2	(2.3)	2	0	(0.0)	0	2	(2.6)	2	0	(0.0)	0

TEAE, treatment-emergent adverse event.

*N, number of cycles; n, number of cycles with at least one event in the category; n′, number of events in the category. It should be noted that a patient could have had findings in more than one category, in a given cycle, and that for each cycle (1, 2, 3 and 4), N and n are also equal to the number of patients in that cycle and to the number of patients with data available in that cycle, respectively.

^†TEAEs which the investigator considered to have a possible, probable, definite, unassessable or missing (if any) relationship to study medication.

Table VI. Study drug-related TEAEs* by system organ class and preferred term for the overall study period occurring in ≥ 2% of patients.

SOC and PT (MedDRA, version 12.0)	N = 88
	n	(%)	n′
Patients with at least one drug-related TEAE	7	(8.0)	14
Gastrointestinal disorders	2	(2.3)	2
Constipation	2	(2.3)	2
General disorders and administration site conditions	3	(3.4)	4
Chills	1	(1.1)	1
Fatigue	2	(2.3)	3
Nervous system disorders	2	(2.3)	2
Headache	1	(1.1)	1
Peripheral sensory neuropathy	1	(1.1)	1

TEAE, treatment-emergent adverse event; SOC, system organ class; PT, preferred term; MedDRA, Medical Dictionary for Regulatory Activities; N, number of patients; n, number of patients with at least one event in the category; n′, number of events.

*It should be noted that drug-related TEAEs were TEAEs which the investigator considered to a have a possible, probable, definite, unassessable or missing (if any) relationship to study medication.