Identification of optimal contemporary antiemetic prophylaxis for doxorubicin-cyclophosphamide chemotherapy in Chinese cancer patients: post-hoc analysis of 3 prospective studies

Winnie Yeo; Leung Li; Thomas KH Lau; Kwai T Lai; Vicky TC Chan; Kwan H Wong; Christopher CH Yip; Elizabeth Pang; Maggie Cheung; Vivian Chan; Carol CH Kwok; Joyce JS Suen; Frankie KF Mo

doi:10.20892/j.issn.2095-3941.2020.0241

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Table 1

Treatment arms of the 3 prospective studies of Chinese breast cancer patients undergoing doxorubicin-cyclophosphamide chemotherapy

Studies	Treatment arms	Patient No.	Day 1	Day 2	Day 3	Day 4	Day 5
Study A*	Group 1	62	Ondansetron 8 mg twice + Dexamethasone 20 mg	Ondansetron 8 mg twice	Ondansetron 8 mg twice	–	–
	Group 2	62	Aprepitant 125 mg + Ondansetron 8 mg twice + Dexamethasone 12 mg	Aprepitant 80 mg	Aprepitant 80 mg	–	–
Study B	Group 3	60	Aprepitant 125 mg + Ondansetron 8 mg twice + Dexamethasone 12 mg	Aprepitant 80 mg + Dexamethasone 8 mg	Aprepitant 80 mg + Dexamethasone 8 mg	–	–
	Group 4	60	Aprepitant 125 mg + Ondansetron 8 mg twice + Dexamethasone 12 mg + olanzapine 10 mg	Aprepitant 80 mg + olanzapine 10 mg	Aprepitant 80 mg + olanzapine 10 mg	Olanzapine 10 mg	Olanzapine 10 mg
Study C	Group 5	60	Netupitant 300 mg + Palonosetron 0.5 mg + Dexamethasone 12 mg	Dexamethasone 8 mg	Dexamethasone 8 mg	–	–

*Placebo controlled study.

**These were combined in a capsule, NEPA.

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Table 2

Antiemetic efficacies during cycle 1 of the AC emesis endpoint of Groups 3, 4, and 5 individually compared with Group 1

	Group 1	Group 2*		Group 3		Group 4		Group 5
	Outcomes	Outcomes	P	Outcomes	P	Outcomes	P	Outcomes	P
Acute (0–24 h), n (%)
NV	46 (74.2)	44 (72.1)	0.7963	31 (51.7)	0.0099	44 (73.3)	0.9140	43 (71.7)	0.7534
NSN	52 (83.9)	54 (88.5)	0.4546	45 (75.0)	0.2249	57 (95.0)	0.0464	52 (86.7)	0.6633
NN	37 (59.7)	38 (62.3)	0.7660	32 (53.3)	0.4797	46 (76.7)	0.0443	42 (70.0)	0.2328
CR	45 (72.6)	44 (72.1)	0.9556	31 (51.7)	0.0172	42 (70.0)	0.7527	42 (70.0)	0.7527
Delayed (24–120 h), n (%)
NV	31 (67.4)	34 (75.6)	0.3887	24 (77.4)	0.3394	41 (93.2)	0.0018	37 (86.0)	0.0383
NSN	39 (75.0)	40 (74.1)	0.9129	38 (84.4)	0.2515	55 (96.5)	0.0010	47 (90.4)	0.0381
NN	22 (59.5)	18 (47.3)	0.2940	20 (62.5)	0.7963	35 (76.1)	0.1045	32 (76.2)	0.1106
CR	26 (57.8)	29 (64.4)	0.5165	23 (74.2)	0.1417	39 (92.9)	0.0001	36 (85.7)	0.0040
Overall time frame (0–120 h), n (%)
NV	31 (50.0)	34 (54.8)	0.5896	24 (40.0)	0.2671	41 (68.3)	0.0395	37 (61.7)	0.1946
NSN	39 (62.9)	41 (66.1)	0.7074	38 (63.3)	0.9607	55 (91.7)	0.0002	47 (78.3)	0.0617
NN	22 (35.5)	19 (30.6)	0.5669	20 (33.3)	0.8026	35 (58.3)	0.0114	32 (53.3)	0.0472
CR	26 (41.9)	29 (46.8)	0.5876	23 (38.3)	0.6849	39 (65.0)	0.0107	36 (60.0)	0.0460
FLIE scores, mean (standard deviation)**
Nausea domain	32.46 (32.32)	27.44 (25.70)	0.8059	27.71 (28.33)	0.5246	8.39 (17.02)	<0.0001	17.55 (28.03)	0.0040
Vomiting domain	24.03 (30.77)	3.49 (13.14)	<0.0001	10.69 (19.99)	0.1280	3.63 (11.45)	0.0045	6.74 (22.40)	0.0016
Total score	28.2 (30.48)	15.5 (16.03)	0.2509	19.2 (20.78)	0.3116	6.01 (13.31)	<0.0001	12.14 (23.26)	0.0012

*Comparisons between Group 1 and 2 were previously reported⁴.

**Scorings of each item ranged from a 1 to 7 point scale that was based on a 100 mm visual analogue scale. For most items, the higher the score, the worse the impact was on the patient’s quality of life; for some items, the opposite stands and these scores were transformed back to having the same direction as the majority of the items.

NV, no vomiting; NSN, no significant nausea; NN, no nausea; CR, complete response.

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Table 3A

Comparison of antiemetic efficacy in terms of complete response over multiple cycles: Group 3 vs. Group 5

	Acute (0–24 h), %			Delay (24–120 h), %			Overall (0–120 h), %
	Group 3 n (%)	Group 5 n (%)	P	Group 3 n (%)	Group 5 n (%)	P	Group 3 n (%)	Group 5 n (%)	P
Cycle 1	31 (51.7)	42 (70.0)	0.0397	23 (74.2)	36 (85.7)	0.2165	23 (38.3)	36 (60.0)	0.0176
Cycle 2	39 (66.1)	51 (85.0)	0.0164	34 (87.2)	47 (92.2)	0.4354	34 (57.6)	47 (78.3)	0.0154
Cycle 3	39 (66.1)	53 (88.3)	0.0038	34 (87.2)	52 (98.1)	0.0428	34 (57.6)	52 (86.7)	0.0004
Cycle 4	42 (71.2)	53 (88.3)	0.0198	34 (81.0)	52 (98.1)	0.0053	34 (57.6)	52 (86.7)	0.0004

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Table 3B

Comparison of antiemetic efficacies in terms of complete response over multiple cycles: Group 2 vs. Group 3

	Acute (0–24 h), %			Delay (24–120 h), %			Overall (0–120 h), %
	Group 2 n (%)	Group 3 n (%)	P	Group 2 n (%)	Group 3 n (%)	P	Group 2 n (%)	Group 3 n (%)	P
Cycle 1	44 (72.1)	31 (51.7)	0.0204	29 (64.4)	23 (74.2)	0.3689	29 (46.8)	23 (38.3)	0.3459
Cycle 2	55 (91.7)	39 (66.1)	0.0006	36 (65.5)	34 (87.2)	0.0173	40 (66.7)	34 (57.6)	0.3093
Cycle 3	54 (90.0)	39 (66.1)	0.0016	37 (68.5)	34 (87.2)	0.0367	41 (68.3)	34 (57.6)	0.2264
Cycle 4	53 (89.8)	42 (71.2)	0.0106	35 (66.0)	34 (81.0)	0.1054	42 (71.2)	34 (57.6)	0.1240