Table 3:
Risk Factors for dose reductions interruptions and discontinuations in the Trastuzumab and Trastuzumab + Lapatinib arms in older patients (≥ 65)
| Tested Risk Factor | Trastuzumab Arm (N= 216) | Trastuzumab + Lapatinib Arm (N=214) | |||
|---|---|---|---|---|---|
| Temporary Treatment Interruptions | Permanent Treatment Discontinuations | Temporary Treatment Interruptions | Permanent Treatment Discontinuations | Lapatinib Dose Reductions | |
| Any Grade 2/3/4 vs No AEI | |||||
| Events (%)* | 41 (47.67) vs 34 (26.15) | 17 (19.77) vs 27 (20.77) | 141 (84.43) vs 21 (44.68) | 91 (54.49) vs 24 (51.06) | 46 (27.54) vs 1 (2.13) |
| Univariate OR (95%CI) | 2.57 (1.45 to 4.58) p= 0.001 | 0.94 (0.48 to 1.85) p=0.858 | 6.71 (3.30 to 13.67) p <0.001 | 1.15 (0.60 to 2.19) p=0.677 | 17.49 (2.34 to 130.5) p=0.005 |
| Multivariate OR (95%CI) | 2.25 (1.18 to 4.30) p= 0.014 | 0.86 (0.41 to 1.79) p=0.685 | 5.18 (2.40 to 11.19) p <0.001 | 0.95 (0.47 to 1.93) p=0.897 | 17.84 (2.33 to 136.5) p=0.006 |
| Any Grade 2 vs No AEI | |||||
| Events (% of N) | 24 (42.11) vs 51 (32.08) | 13 (22.81) vs 31 (19.50) | 56 (73.68) vs 106 (76.81) | 31 (40.79) vs 84 (60.87) | 14 (18.42) vs 33 (23.91) |
| Univariate OR (95%CI) | 1.54 (0.83 to 2.87) p= 0.174 | 1.22 (0.59 to 2.54) p=0.595 | 0.85 (0.44 to 1.61) p=0.610 | 0.44 (0.25 to 0.78) p=0.005 | 0.72 (0.36 to 1.45) p=0.354 |
| Multivariate OR (95%CI) | 1.56 (0.79 to 3.06) p=0.199 | 1.15 (0.54 to 2.44) p=0.721 | 0.92 (0.47 to 1.81) p=0.814 | 0.47 (0.26 to 0.83) p=0.010 | 0.71 (0.35 to 1.45) p=0.351 |
| Any Grade 3 vs no AEI | |||||
| Events (% of N) | 12 (57.14) vs 63 (32.31) | 4 (19.05) vs 40 (20.51) | 76 (92.68) vs 86 (65.15) | 52 (63.41) vs 63 (47.73) | 28 (34.15) vs 19 (14.39) |
| Univariate OR (95%CI) | 2.79 (1.12 to 6.97) p=0.028 | 0.91 (0.29 to 2.86) p= 0.874 | 6.78 (2.74 to 16.75) p<0.001 | 1.90 (1.08 to 3.34) p=0.026 | 3.08 (1.58 to 6.01) p<0.001 |
| Multivariate OR (95%CI) | 1.97 (0.74 to 5.23) p=0.173 | 0.82 (0.25 to 2.67) p=0.741 | 5.25 (2.06 to 13.36) p<0.001 | 1.71 (0.94 to 3.12) p=0.080 | 3.08 (1.51 to 6.29) p=0.002 |
| Any Grade 4 vs No AEI | |||||
| Events (% of N) | 5 (62.50) vs 70 (33.65) | 0 (0.0) | 9 (100.0) vs 153 (74.63) | 8 (88.89) vs 107 (52.20) | 4 (44.44) vs 43 (20.98) |
| Univariate OR (95%CI) | 3.29 (0.76 to 14.15) p= 0.110 | NA | NA | 7.33 (0.90 to 59.65) p=0.063 | 3.01 (0.78 to 11.71) p=0.111 |
| Multivariate OR (95%CI) | 1.98 (0.40 to 9.92) p=0.405 | NA | NA | 6.33 (0.77 to 52.08) p=0.086 | 2.99 (0.75 to 11.97) p=0.121 |
| Comorbidity vs no Comorbidity | |||||
| Events (% of N) | 53 (35.57) vs 22 (32.84) | 32 (21.48) vs 12 (17.91) | 120 (77.92) vs 42 (70.00) | 85 (55.19) vs 30 (50.00) | 32 (20.78) vs 15 (25.00) |
| Univariate OR (95%CI) | 1.13 (0.61 to 2.08) p=0.696 | 1.25 (0.60 to 2.62) p=0.548 | 1.51 (0.77 to 2.96) p=0.226 | 1.23 (0.68 to 2.24) p=0.494 | 0.79 (0.39 to 1.59) p=0.503 |
| Multivariate OR (95%CI) | 0.83 (0.42 to 1.65) p= 0.591 | 1.41 (0.65 to 3.09) p=0.383 | 1.42 (0.69 to 2.91) p= 0.340 | 1.11 (0.60 to 2.06) p=0.742 | 0.78 (0.38 to 1.63) p=0.512 |
| Polypharmacy vs no Polypharmacy | |||||
| Events (% of N) | 31 (51.67) vs 44 (28.21) | 11 (18.33) vs 33 (21.15) | 42 (82.35) vs 120 (73.62) | 32 (62.75) vs 83 (50.92) | 11 (21.57) vs 36 (22.09) |
| Univariate OR (95%CI) | 2.72 (1.47 to 5.03) p=0.001 | 0.84 (0.39 to 1.79) 0.645 | 1.67 (0.75 to 3.72) p=0.208 | 1.62 (0.85 to 3.10) p=0.141 | 0.97 (0.45 to 2.08) p=0.938 |
| Multivariate OR (95%CI) | 2.27 (1.13 to 4.55) p=0.021 | 0.72 (0.31 to 1.66) 0.445 | 1.32 (0.56 to 3.15) p=0.526 | 1.48 (0.75 to 2.95) p=0.261 | 1.00 (0.44 to 2.27) p=0.999 |
| Concomitant vs Sequential | |||||
| Events (% of N) | 52 (46.43) vs 23 (22.12) | 24 (21.43) vs 20 (19.23) | 87 (87.00) vs 75 (65.79) | 59 (59.00) vs 56 (49.12) | 26 (26.00) vs 21 (18.42) |
| Univariate OR (95%CI) | 3.05 (1.69 to 5.53) <0.001 | 1.15 (0.59 to 2.23) p=0.689 | 3.48 (1.73 to 7.00) p<0.001 | 1.49 (0.87 to 2.56) p=0.149 | 1.56 (0.81 to 2.98) p=0.183 |
| Multivariate OR (95%CI) | 2.52 (1.34 to 4.74) 0.004 | 1.28 (0.63 to 2.61) p=0.490 | 3.40 (1.66 to 6.96) p<0.001 | 1.42 (0.81 to 2.47) p=0.219 | 1.59 (0.82 to 3.10) p=0.171 |
| Anthracycline vs Non-Anthracycline | |||||
| Events (% of N) | 66 (33.17) vs 9 (52.94) | 41 (20.60) vs 3 (17.65) | 150 (75.00) vs 12 (85.71) | 106 (53.00) vs 9 (64.29) | 44 (22.00) vs 3 (21.43) |
| Univariate OR (95%CI) | 0.44 (0.16 to 1.20) p=0.108 | 1.21 (0.33 to 4.41) p=0.772 | 0.50 (0.11 to 2.31) p= 0.375 | 0.63 (0.20 to 1.94) p=0.416 | 1.03 (0.28 to 3.87) p=0.961 |
| Multivariate OR (95%CI) | 0.88 (0.30 to 2.60) p=0.824 | 1.33 (0.34 to 5.20) p=0.685 | 0.99 (0.19 to 5.09) p= 0.986 | 0.87 (0.26 to 2.85) p=0.815 | 1.20 (0.30 to 4.78) p=0.799 |
AEI: Adverse event of interest. Patients considered as no AEI include those with AEs not of interest and no AEs
Analysis presented in the format OR (95%IC) and P-value
*
% of patient with risk factor