
Tianjin Medical Journal ›› 2025, Vol. 53 ›› Issue (3): 321-325.doi: 10.11958/20241942
• Drug Clinical Evaluations • Previous Articles Next Articles
WANG Wei1(
), XIA Haishui2, MA Shang3
Received:2024-11-26
Revised:2024-12-25
Published:2025-03-15
Online:2025-03-31
WANG Wei, XIA Haishui, MA Shang. Efficacy of trastuzumab combined with neratinib in the treatment of HER-2 positive metastatic breast cancer[J]. Tianjin Medical Journal, 2025, 53(3): 321-325.
CLC Number:
| 组别 | n | 年龄/岁 | 肿瘤直径/cm | 转移部位 | 发病部位 | BMI/(kg/m2) | |||
|---|---|---|---|---|---|---|---|---|---|
| 肝 | 肺 | 其他部位 | 单侧 | 双侧 | |||||
| 奈拉替尼组 | 41 | 54.27±10.23 | 3.63±0.49 | 15(36.58) | 14(34.15) | 12(29.27) | 31(75.61) | 10(24.39) | 22.47±6.72 |
| 联合组 | 41 | 53.85±9.46 | 3.59±0.50 | 17(41.46) | 13(31.71) | 11(26.83) | 28(68.29) | 13(31.71) | 22.61±7.23 |
| t或χ2 | 0.191 | 0.448 | 0.206 | 0.544 | 0.084 | ||||
Tab.1 Comparison of general data between the two groups of patients
| 组别 | n | 年龄/岁 | 肿瘤直径/cm | 转移部位 | 发病部位 | BMI/(kg/m2) | |||
|---|---|---|---|---|---|---|---|---|---|
| 肝 | 肺 | 其他部位 | 单侧 | 双侧 | |||||
| 奈拉替尼组 | 41 | 54.27±10.23 | 3.63±0.49 | 15(36.58) | 14(34.15) | 12(29.27) | 31(75.61) | 10(24.39) | 22.47±6.72 |
| 联合组 | 41 | 53.85±9.46 | 3.59±0.50 | 17(41.46) | 13(31.71) | 11(26.83) | 28(68.29) | 13(31.71) | 22.61±7.23 |
| t或χ2 | 0.191 | 0.448 | 0.206 | 0.544 | 0.084 | ||||
| 组别 | n | 明显缓解 | 部分缓解 | 病情加重 | 总缓解 |
|---|---|---|---|---|---|
| 奈拉替尼组 | 41 | 7(17.07) | 24(58.54) | 10(24.39) | 31(75.61) |
| 联合组 | 41 | 10(24.39) | 28(68.29) | 3(7.32) | 38(92.68) |
Tab.2 Comparison of clinical efficacy between the two groups
| 组别 | n | 明显缓解 | 部分缓解 | 病情加重 | 总缓解 |
|---|---|---|---|---|---|
| 奈拉替尼组 | 41 | 7(17.07) | 24(58.54) | 10(24.39) | 31(75.61) |
| 联合组 | 41 | 10(24.39) | 28(68.29) | 3(7.32) | 38(92.68) |
| 组别 | n | FACT-B | ||
|---|---|---|---|---|
| 治疗前 | 治疗后 | t | ||
| 奈拉替尼组 | 41 | 50.63±14.59 | 82.78±16.74 | 9.375* |
| 联合组 | 41 | 52.17±15.32 | 91.66±18.43 | 10.985* |
| t | 0.465 | 2.283* | ||
Tab.3 Comparison of quality of life scores before and after treatment between the two groups of patients
| 组别 | n | FACT-B | ||
|---|---|---|---|---|
| 治疗前 | 治疗后 | t | ||
| 奈拉替尼组 | 41 | 50.63±14.59 | 82.78±16.74 | 9.375* |
| 联合组 | 41 | 52.17±15.32 | 91.66±18.43 | 10.985* |
| t | 0.465 | 2.283* | ||
| 组别 | n | CD4+/% | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 41 | 32.71±9.82 | 37.08±9.58 | 2.167* | ||||||
| 联合组 | 41 | 32.43±8.20 | 41.94±10.36 | 4.626* | ||||||
| t | 0.140 | 2.209* | ||||||||
| 组别 | CD8+/% | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 30.56±9.01 | 23.89±6.43 | 3.902* | |||||||
| 联合组 | 30.77±9.14 | 19.67±5.98 | 5.753* | |||||||
| t | 0.110 | 3.080* | ||||||||
| 组别 | CD4+/CD8+ | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 1.07±0.35 | 1.55±0.41 | 5.461* | |||||||
| 联合组 | 1.05±0.39 | 2.13±0.53 | 10.462* | |||||||
| t | 0.364 | 5.626* | ||||||||
Tab.4 Comparison of relevant indicators of immune function before and after treatment between the two groups of patients
| 组别 | n | CD4+/% | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 41 | 32.71±9.82 | 37.08±9.58 | 2.167* | ||||||
| 联合组 | 41 | 32.43±8.20 | 41.94±10.36 | 4.626* | ||||||
| t | 0.140 | 2.209* | ||||||||
| 组别 | CD8+/% | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 30.56±9.01 | 23.89±6.43 | 3.902* | |||||||
| 联合组 | 30.77±9.14 | 19.67±5.98 | 5.753* | |||||||
| t | 0.110 | 3.080* | ||||||||
| 组别 | CD4+/CD8+ | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 1.07±0.35 | 1.55±0.41 | 5.461* | |||||||
| 联合组 | 1.05±0.39 | 2.13±0.53 | 10.462* | |||||||
| t | 0.364 | 5.626* | ||||||||
| 组别 | n | CA125/(U/mL) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 41 | 75.47±9.17 | 45.36±12.36 | 12.257* | ||||||
| 联合组 | 41 | 75.19±9.24 | 26.79±9.67 | 22.975* | ||||||
| t | 0.143 | 7.580* | ||||||||
| 组别 | CA153/(U/mL) | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 154.34±15.76 | 52.49±9.45 | 37.745* | |||||||
| 联合组 | 152.73±16.28 | 33.41±6.68 | 48.832* | |||||||
| t | 0.452 | 10.563* | ||||||||
| 组别 | CEA/(μg/L) | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 15.85±1.69 | 9.43±1.08 | 19.636* | |||||||
| 联合组 | 15.74±1.56 | 6.52±0.71 | 34.075* | |||||||
| t | 0.279 | 14.440* | ||||||||
Tab.5 Comparison of tumor markers before and after treatment between the two groups of patients
| 组别 | n | CA125/(U/mL) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 41 | 75.47±9.17 | 45.36±12.36 | 12.257* | ||||||
| 联合组 | 41 | 75.19±9.24 | 26.79±9.67 | 22.975* | ||||||
| t | 0.143 | 7.580* | ||||||||
| 组别 | CA153/(U/mL) | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 154.34±15.76 | 52.49±9.45 | 37.745* | |||||||
| 联合组 | 152.73±16.28 | 33.41±6.68 | 48.832* | |||||||
| t | 0.452 | 10.563* | ||||||||
| 组别 | CEA/(μg/L) | |||||||||
| 治疗前 | 治疗后 | t | ||||||||
| 奈拉替尼组 | 15.85±1.69 | 9.43±1.08 | 19.636* | |||||||
| 联合组 | 15.74±1.56 | 6.52±0.71 | 34.075* | |||||||
| t | 0.279 | 14.440* | ||||||||
| 组别 | 恶心 | 呕吐 | 便秘 | 腹泻 | 皮疹 | 总发生 |
|---|---|---|---|---|---|---|
| 奈拉替尼组 | 5(12.20) | 3(7.32) | 2(4.88) | 20(48.78) | 4(9.76) | 34(82.93) |
| 联合组 | 3(7.32) | 3(7.32) | 1(2.44) | 6(14.63) | 2(4.88) | 15(36.59) |
Tab.6 Comparison of adverse reactions between the two groups of patients
| 组别 | 恶心 | 呕吐 | 便秘 | 腹泻 | 皮疹 | 总发生 |
|---|---|---|---|---|---|---|
| 奈拉替尼组 | 5(12.20) | 3(7.32) | 2(4.88) | 20(48.78) | 4(9.76) | 34(82.93) |
| 联合组 | 3(7.32) | 3(7.32) | 1(2.44) | 6(14.63) | 2(4.88) | 15(36.59) |
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