Recent developments in the clinical pharmacology of rolapitant: subanalyses in specific populations

Figures & data

Table 1 Complete response (%) in total population by phase and chemotherapy treatment following oral administration of rolapitant

	MEC or AC trial, %^Citation50	P-value	HEC1 and HEC2 trials; cisplatin-based, %^Citation49	P-value
	ROL (n=666) vs CON (n=666)		ROL (n=535) vs CON (n=535)
Acute phase (0–24 h)	83.5 vs 80.3	0.1425	83.6 vs 76.6	0.0045
Delayed phase (24–120 h)	71.3 vs 61.6	0.0002	71.4 vs 60.2	0.0001
Overall phase (0–120 h)	68.6 vs 57.8	<0.0001	68.8 vs 58.5	0.0005

Abbreviations: AC, anthracycline and cyclophosphamide; CON, control; h, hours; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; ROL, rolapitant.

Table 2 Complete response (%) by cancer population, phase, and chemotherapy treatment following oral administration of rolapitant

	Breast cancer population^Citation52				GI/colorectal cancer population^Citation53,*				Lung cancer population^Citation54
	MEC plus AC, %	P-value	AC only, %	P-value	MEC; non-AC, %	P-value	Cisplatin-baseda, %	P-value	Carboplatin or cisplatin-basedb, %	P-value
	ROL (n=417) vs CON (n=428)		ROL (n=333) vs CON (n=347)		ROL (n=47) vs CON (n=37)		ROL (n=54) vs CON (n=50)		ROL (n=337) vs CON (n=350)
Acute phase (0–24 h)	77.9 vs 77.8	0.963	76.0 vs 76.7	0.835	91.5 vs 73.0	0.025	88.9 vs 80.0	0.212	88.4 vs 81.7	0.014
Delayed phase (24–120 h)	66.7 vs 59.8	0.039	66.7 vs 58.8	0.034	74.5 vs 54.1	0.052	72.2 vs 48.0	0.012	77.4 vs 65.1	<0.001
Overall phase (0–120 h)	62.8 vs 55.1	0.023	62.5 vs 53.9	0.024	74.5 vs 48.6	0.016	72.2 vs 48.0	0.012	75.4 vs 63.1	<0.001

Notes:

a Pooled analysis of the two HEC phase 3 trials;

b pooled analysis of the two HEC and the MEC plus AC trials.

* (Tesaro, Inc., data on file, 2016).

Abbreviations: AC, anthracycline and cyclophosphamide; CON, control; GI, gastrointestinal; h, hours; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; ROL, rolapitant.

Table 3 Endpoint of no nausea (%) by cancer population, phase, and chemotherapy treatment following oral administration of rolapitant

	Breast cancer population^Citation52				GI/colorectal cancer population^Citation53,*				Lung cancer population^Citation54
	MEC plus AC, %	P-value	AC only, %	P-value	MEC; non-AC, %	P-value	Cisplatin-baseda, %	P-value	Carboplatin or cisplatin-basedb, %	P-value
	ROL (n=417) vs CON (n=428)		ROL (n=333) vs CON (n=347)		ROL (n=47) vs CON (n=37)		ROL (n=54) vs CON (n=50)		ROL (n=337) vs CON (n=350)
Acute phase (0–24 h)	56.8 vs 62.1	0.116	54.1 vs 59.1	0.187	74.5 vs 56.8	0.089	75.9 vs 58.0	0.053	75.7 vs 70.9	0.155
Delayed phase (24–120 h)	38.8 vs 40.4	0.641	36.9 vs 38.9	0.597	61.7 vs 35.1	0.016	48.1 vs 30.0	0.060	63.5 vs 51.1	0.001
Overall phase (0–120 h)	35.3 vs 37.4	0.520	33.6 vs 35.2	0.676	57.4 vs 35.1	0.043	48.1 vs 28.0	0.036	60.5 vs 48.6	0.002

Notes:

a Pooled analysis of the two HEC phase 3 trials;

b pooled analysis of the two HEC and the MEC plus AC trials.

* (Tesaro, Inc., data on file, 2016).

Abbreviations: AC, anthracycline and cyclophosphamide; CON, control; GI, gastrointestinal; h, hours; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; ROL, rolapitant.

Table 4 Complete response (%) by age, phase, and chemotherapy treatment following oral administration of rolapitant^55,56

	Patients <65 years old				Patients ≥65 years old
	MEC plus AC, %	P-value	Cisplatin-baseda, %	P-value	MEC- or AC-based, %	P-value	Cisplatin-baseda, %	P-value
	ROL (n=495) vs CON (n=470)		ROL (n=397) vs CON (n=393)		ROL (n=171) vs CON (n=196)		ROL (n=138) vs CON (n=142)
Acute phase (0–24 h)	81.8 vs 77.9	0.127	81.9 vs 76.8	0.082	88.3 vs 86.2	0.553	88.4 vs 76.1	0.007
Delayed phase (24–120 h)	70.3 vs 60.9	0.002	71.3 vs 59.8	<0.001	74.3 vs 63.3	0.024	71.7 vs 61.3	0.064
Overall phase (0–120 h)	67.5 vs 56.6	<0.001	68.0 vs 58.5	0.006	71.9 vs 60.7	0.024	71.0 vs 58.5	0.028

Note:

a Pooled analysis of the two HEC phase 3 trials.

Abbreviations: AC, anthracycline and cyclophosphamide; CON, control; h, hours; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; ROL, rolapitant.

Table 5 Endpoint of no nausea (%) by age, phase, and chemotherapy treatment following oral administration of rolapitant^55,56

	Patients <65 years old				Patients ≥65 years old
	MEC plus AC, %	P-value	Cisplatin-baseda, %	P-value	MEC plus AC, %	P-value	Cisplatin-baseda, %	P-value
	ROL (n=495) vs CON (n=470)		ROL (n=397) vs CON (n=393)		ROL (n=171) vs CON (n=196)		ROL (n=138) vs CON (n=142)
Acute phase (0–24 h)	60.4 vs 61.9	0.630	67.3 vs 62.8	0.194	78.4 vs 75.5	0.519	79.7 vs 68.3	0.030
Delayed phase (24–120 h)	44.6 vs 42.1	0.430	54.7 vs 42.5	<0.001	59.6 vs 51.5	0.119	58.7 vs 49.3	0.115
Overall phase (0–120 h)	41.2 vs 38.5	0.392	50.9 vs 39.9	0.002	57.9 vs 50.5	0.157	56.5 vs 46.5	0.093

Note:

a Pooled analysis of the two HEC phase 3 trials.

Abbreviations: AC, anthracycline and cyclophosphamide; CON, control; h, hours; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; ROL, rolapitant.

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