Aprepitant as add-on to standard antiemetic regimen for concurrent chemoradiotherapy induced nausea vomiting in head and neck cancer

Table 1 Details of antiemetic regimens in the two study groups

Group A (aprepitant + ondansetron + dexamethasone)	Group B (ondansetron + dexamethasone)
On day 1 (half hour before CCRT)
Inj. ondansetron 8 mg IV	Inj. ondansetron 8 mg IV
Inj. dexamethasone 12 mg IV	Inj. dexamethasone 12 mg IV
Cap aprepitant 125 mg OD	Cap placebo OD
After CCRT
Tab. ondansetron 8 mg	Tab. ondansetron 8 mg
On day 2, 3, 4, and 5
Cap Aprepitant 80 mg OD on day 2, 3	Cap placebo OD on day 2, 3
Tab ondansetron 8 mg BD on days 2, 3, 4, and 5	Tab ondansetron 8 mg BD on days 2, 3, 4, and 5

CCRT: Concurrent chemo-radiotherapy; OD: Once daily; BD: Twice daily; IV: Intravenous.

Table 2 Baseline demographic & disease characteristics of the two study groups, n (%)/mean ± SD/median (range)

Characteristics	Group A, n = 43	Group B, n = 43	P value
Age (years)	59.93 ± 9.18	55.12 ± 10.38	0.02
Males	39 (90.7)	38 (88.4)	0.73
BMI (kg/m2)	22.42 ± 1.11	22.84 ± 1.08	0.08
ECOG performance
0	5 (11.62)	6 (13.95)
1	38 (88.4)	37 (86)	0.75
Tumor stage
Stage III	19 (44.19)	17 (39.53)	0.67
Stage IV A	23 (53.49)	24 (55.81)	0.83
Stage IV B	1 (2.33)	2 (4.65)	0.56
Tumor location
Oral cavity	2 (4.65)	8 (18.60)	0.04
Oropharynx	34 (79.07)	26 (60.47)	0.06
Hypopharynx	0 (0.00)	2 (4.65)	0.16
Larynx	7 (16.28)	7 (16.28)	1.00
History of smoking
No. of smokers	42 (97.67)	39 (90.70)	0.17
No. of years of smoking	30 (1-55)	25 (0.5-40)	0.01
No. of bidis smoked	20 (5-40)	20 (2-50)	0.83
No. of hukka smokers	2 (4.65)	0 (0.00)
History of alcohol	34 (79.07)	27 (62.79)	0.1
Presence of comorbidities	9 (20.93)	4 (9.30)	0.1

ECOG: Eastern Cooperative Oncology Group; 0: Fully active, no restrictions; 1: Restricted in strenuous activity, ambulatory; BMI: Body mass index.

Table 3 Secondary efficacy outcomes, n/N (%)

Efficacy parameter	Acute-phase			Delayed-phase
	Group A	Group B	P value	Group A	Group B	P value
Complete protection	42/43 (97.7)	35/43 (81.4)	0.014	33/43 (76.7)	22/43 (51.2)	0.013
Degree of nausea as per CTCAE criteria1
Grade 1	5/43 (11.63)	4/43 (9.30)	0.72	9/43 (20.93)	17/43 (39.53)	0.06
Grade 2	0/43	12/43 (27.90)	0.0001	5/43 (11.63)	11/43 (25.58)	0.09
Degree of vomiting as per CTCAE criteria2
Grade 1	0/43	3/43 (6.8)	0.07	1/43 (2.3)	0/43	0.31
Grade 2	0/43	3/43 (6.8)	0.07	3/43 (6.8)	9/43 (20.9)	0.06

¹Grade 1: Loss of appetite without alteration in eating habits; Grade 2: Oral intake decreased without significant weight loss, dehydration, malnutrition; Grade 3: Inadequate oral caloric or fluid intake; tube feeding; total parenteral nutrition; hospitalization.

²Grade 1: Intervention not indicated; Grade 2: Outpatient IV hydration, medical intervention indicated; Grade 3: Tube feeding, total parenteral nutrition or hospitalization indicated; Grade 4: Life threatening consequences; Grade 5: Death.

Data analysed by Pearson χ² test. CTCAE: Common terminology criteria for adverse events.

Table 4 Degree (intensity) of nausea during acute and delayed-phases in both the groups as per MASSC Antiemesis Tool Scale, mean ± SD

Phase of emesis	Group A	Group B	P value
Acute- phase	0.65 ± 1.85	2.49 ± 3.37	0.004
Delayed-phase
Day 2	0.76 ± 1.97	1.90 ± 3.00	0.05
Day 3	0.53 ± 1.77	2.30 ± 3.09	0.002
Day 4	0.54 ± 1.75	2.18 ± 3.11	0.004
Day 5	0.90 ± 2.30	1.53 ± 2.74	0.210

Data analysed by the Mann Whitney U test.

Table 5 Adverse events reported in the two study groups, n (%)

Symptoms	Group A	Group B	P value
Reduced appetite	19 (44.1)	28 (65.1)	0.52
Abdominal discomfort	16 (37.2)	17 (39.5)	0.82
Generalized weakness	9 (20.9)	7 (16.2)	0.58
Constipation	8 (18.6)	12 (27.9)	0.31
Headache	6 (13.9)	5 (11.6)	0.75
Diarrhoea	4 (9.3)	7 (16.2)	0.33
Abdominal discomfort with flatulence	3 (6.9)	4 (9.3)	0.69
Dizziness	3 (6.9)	1 (2.3)	0.31
Ghabrahat	0 (0.0)	2 (4.6)	0.15