Article Figures & Data
Tables
- 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.
- 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.
- 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 - 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