Table 3.
Adverse events (NCI-CTCAE version 4.0) reported during treatment with nab-paclitaxel and cisplatin (safety population)
| AE | Patients with grade 1–2 AEs, n (%) | P a | Patients with grade ≥ 3 AEs, n (%) | P a | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| All (N = 67) | Cohort 1 (n = 23) | Cohort 2 (n = 21) | Cohort 3 (n = 23) | All (N = 67) | Cohort 1 (n = 23) | Cohort 2 (n = 21) | Cohort 3 (n = 23) | |||
| Any type | 67 (100) | 23 (100) | 21 (100) | 23 (100) | NA | 51 (76) | 17 (74) | 17 (81) | 17 (74) | 0.82 |
| Hematologicb | ||||||||||
| Leucopenia | 64 (96) | 21 (91) | 21 (100) | 22 (96) | 0.38 | 36 (54) | 10 (43) | 13 (62) | 13 (57) | 0.45 |
| Neutropenia | 58 (87) | 20 (87) | 18 (86) | 20 (87) | 0.99 | 43 (64) | 15 (65) | 14 (67) | 14 (61) | 0.92 |
| Anemia | 55 (82) | 16 (70) | 19 (90) | 20 (87) | 0.15 | 6 (9) | 3 (13) | 1 (5) | 2 (9) | 0.63 |
| Thrombocytopenia | 18 (27) | 8 (35) | 5 (24) | 5 (22) | 0.57 | 0 | 0 | 0 | 0 | NA |
| Non-hematologicc | N = 64 | n = 23 | n = 18 | n = 23 | N = 64 | n = 23 | n = 18 | n = 23 | ||
| Alopecia | 62 (97) | 21 (91) | 21 (91) | 23 (100) | 0.16 | 0 | 0 | 0 | 0 | NA |
| Fatigue | 57 (89) | 21 (91) | 17 (94) | 19 (83) | 0.44 | 3 (5) | 1 (4) | 0 | 2 (9) | 0.42 |
| Anorexia | 53 (83) | 21 (91) | 16 (89) | 16 (70) | 0.11 | 0 | 0 | 0 | 0 | NA |
| Myasthenia | 52 (81) | 18 (78) | 17 (94) | 17 (74) | 0.22 | 2 (3) | 0 | 0 | 2 (9) | 0.16 |
| Neuropathy | 46 (72) | 17 (74) | 15 (83) | 14 (61) | 0.27 | 0 | 0 | 0 | 0 | NA |
| Constipation | 42 (66) | 14 (61) | 15 (83) | 13 (57) | 0.17 | 0 | 0 | 0 | 0 | NA |
| Nausea | 40 (63) | 15 (65) | 13 (72) | 12 (52) | 0.40 | 0 | 0 | 0 | 0 | NA |
| Arthralgia | 39 (61) | 16 (70) | 12 (67) | 11 (48) | 0.27 | 1 (2) | 1 (4) | 0 | 0 | 0.40 |
| Vomiting | 38 (59) | 11 (48) | 14 (78) | 13 (57) | 0.14 | 4 (6) | 1 (4) | 3 (17) | 0 | 0.08 |
| Skin rash | 35 (55) | 14 (61) | 8 (44) | 13 (57) | 0.56 | 3 (5) | 2 (9) | 1 (6) | 0 | 0.37 |
| Myalgia | 34 (53) | 10 (43) | 10 (56) | 14 (61) | 0.48 | 1 (2) | 1 (4) | 0 | 0 | 0.40 |
| Pruritus | 32 (50) | 15 (65) | 5 (28) | 12 (52) | 0.06 | 0 | 0 | 0 | 0 | NA |
| Diarrhea | 21 (33) | 8 (35) | 6 (33) | 7 (30) | 0.95 | 1 (2) | 0 | 1 (6) | 0 | 0.27 |
| Edema | 20 (31) | 5 (22) | 2 (11) | 13 (57) | 0.004 | 0 | 0 | 0 | 0 | NA |
Cohort 1, cisplatin 75 mg/m2 day 1 + nab-paclitaxel 260 mg/m2 day 1 Q3W; Cohort 2, cisplatin 75 mg/m2 day 1 + nab-paclitaxel 140 mg/m2 day 1, 8 Q3W; Cohort 3, cisplatin 75 mg/m2 day 1 + nab-paclitaxel 100 mg/m2 day 1, 8, 15 Q3W
a P value for the inter-cohort difference
bBlood samples for hematologic AE assessment were available for 67 patients
cNon-hematologic AEs were assessed in the 64 patients who completed 4–6 cycles