免疫联合靶向二线治疗转移性非透明细胞肾细胞癌的疗效及安全性
目的:评估程序性死亡蛋白1(PD－1)抑制剂联合酪氨酸激酶抑制剂(TKI)作为TKI一线治疗失败的转移性非透明细胞肾癌(nccRCC)二线治疗方案的临床疗效及安全性。方法:回顾性分析2011年10月至2020年9月在中山大学肿瘤防治中心接受TKI一线治疗后进展的67例转移性nccRCC患者的临床病理资料。根据二线治疗方案，将患者分为TKI单药治疗组(22例)和免疫联合靶向治疗组(45例)，TKI单药治疗组患者接受TKI单药二线治疗，免疫联合靶向治疗组患者接受TKI联合PD－1抑制剂的二线治疗。采用实体瘤的疗效评价标准(RECIST)1.0/1.1进行疗效评估，采用Kaplan－Meier法进行...
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| Published in | 中华肿瘤杂志 Vol. 45; no. 8; pp. 704 - 708 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | Chinese |
| Published |
中山大学肿瘤防治中心泌尿外科，广州 510060
01.08.2023
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 0253-3766 |
| DOI | 10.3760/cma.j.cn112152-20220330-00220 |
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| Abstract | 目的:评估程序性死亡蛋白1(PD－1)抑制剂联合酪氨酸激酶抑制剂(TKI)作为TKI一线治疗失败的转移性非透明细胞肾癌(nccRCC)二线治疗方案的临床疗效及安全性。方法:回顾性分析2011年10月至2020年9月在中山大学肿瘤防治中心接受TKI一线治疗后进展的67例转移性nccRCC患者的临床病理资料。根据二线治疗方案，将患者分为TKI单药治疗组(22例)和免疫联合靶向治疗组(45例)，TKI单药治疗组患者接受TKI单药二线治疗，免疫联合靶向治疗组患者接受TKI联合PD－1抑制剂的二线治疗。采用实体瘤的疗效评价标准(RECIST)1.0/1.1进行疗效评估，采用Kaplan－Meier法进行生存分析，并观察两组患者的治疗相关不良反应。结果:全部67例患者的客观缓解率(ORR)为37.3%(25/67)，疾病控制率(DCR)为56.7%(38/67)，二线治疗后的中位无进展生存时间(PFS)为7.7个月，中位总生存时间(OS)为25.2个月。免疫联合靶向治疗组患者的ORR为48.9%(22/45)，DCR为71.1%(32/45)，与TKI单药治疗组[分别为13.6%(3/22)和27.3%(6/22)]相比明显改善(
P值分别为0.007和0.001)。免疫联合靶向治疗组患者二线治疗的中位PFS为9.2个月，长于TKI单药治疗组(5.2个月，
P＝0.001)，但中位OS(28.2个月)与TKI单药治疗组(20.8个月)差异无统计学意义(
P＝0.068)。两组常见的治疗相关不良反应包括高血压、腹泻、乏力、口腔炎、手足综合征和甲状腺功能减退。免疫联合靶向治疗组甲状腺功能减退的发生率[40.0%(18/45)]高于TKI单药治疗组[22.7%(5/22)，
P＝0.044]，除此之外，两组间其他治疗相关不良反应的发生率差异均无统计学意义(均
P>0.05)。
结论:对TKI一线治疗失败的转移性nccRCC，免疫联合靶向治疗比单一靶向治疗更有效，且患者的耐受性良好。 |
|---|---|
| AbstractList | 目的:评估程序性死亡蛋白1(PD－1)抑制剂联合酪氨酸激酶抑制剂(TKI)作为TKI一线治疗失败的转移性非透明细胞肾癌(nccRCC)二线治疗方案的临床疗效及安全性。方法:回顾性分析2011年10月至2020年9月在中山大学肿瘤防治中心接受TKI一线治疗后进展的67例转移性nccRCC患者的临床病理资料。根据二线治疗方案，将患者分为TKI单药治疗组(22例)和免疫联合靶向治疗组(45例)，TKI单药治疗组患者接受TKI单药二线治疗，免疫联合靶向治疗组患者接受TKI联合PD－1抑制剂的二线治疗。采用实体瘤的疗效评价标准(RECIST)1.0/1.1进行疗效评估，采用Kaplan－Meier法进行生存分析，并观察两组患者的治疗相关不良反应。结果:全部67例患者的客观缓解率(ORR)为37.3%(25/67)，疾病控制率(DCR)为56.7%(38/67)，二线治疗后的中位无进展生存时间(PFS)为7.7个月，中位总生存时间(OS)为25.2个月。免疫联合靶向治疗组患者的ORR为48.9%(22/45)，DCR为71.1%(32/45)，与TKI单药治疗组[分别为13.6%(3/22)和27.3%(6/22)]相比明显改善(
P值分别为0.007和0.001)。免疫联合靶向治疗组患者二线治疗的中位PFS为9.2个月，长于TKI单药治疗组(5.2个月，
P＝0.001)，但中位OS(28.2个月)与TKI单药治疗组(20.8个月)差异无统计学意义(
P＝0.068)。两组常见的治疗相关不良反应包括高血压、腹泻、乏力、口腔炎、手足综合征和甲状腺功能减退。免疫联合靶向治疗组甲状腺功能减退的发生率[40.0%(18/45)]高于TKI单药治疗组[22.7%(5/22)，
P＝0.044]，除此之外，两组间其他治疗相关不良反应的发生率差异均无统计学意义(均
P>0.05)。
结论:对TKI一线治疗失败的转移性nccRCC，免疫联合靶向治疗比单一靶向治疗更有效，且患者的耐受性良好。 |
| Abstract_FL | Objective:This study aimed to evaluate the efficacy and safety of programmed death-1 (PD-1) inhibitor combined tyrosine kinase inhibitor (TKI) therapy versus TKI monotherapy as the second-line regimen for patients with metastatic non-clear cell renal carcinoma (nccRCC) who failed first-line TKI therapy.Methods:The clinicopathological data of 67 patients with metastatic nccRCC who failed first-line TKI therapy between October 2011 and September 2020 were retrospectively analyzed, including 22 patients who received TKI monotherapy and 45 patients who received TKI plus PD-1 inhibitor as the second-line therapy. The efficacy was assessed according to Response Evaluation Criteria in Solid Tumors version 1.0/1.1 (RECIST 1.0/1.1), the Kaplan-Meier method was used to plot the survival curves, and the Log rank test was used to analyze the differences in the survival between the two groups. Treatment-related adverse events (AEs) after treatment were observed in both groups.Results:The overall objective response rate (ORR) and disease control rate (DCR) were 37.3% (25/67) and 56.7% (38/67), respectively. The overall second-line progression-free survival (PFS) was 7.7 months and Overall Survival (OS) was 25.2 months. The ORR and DCR of patients in the combination therapy group were 48.9% (22/45) and 71.1% (32/45), respectively, which were significantly improved compared with the TKI monotherapy group [13.6% (3/22) and 27.3% (6/22), respectively] (
P=0.007 and
P=0.001, respectively). The median PFS of 9.2 months for second-line treatment was longer in patients in the combination therapy group than in the TKI monotherapy group (5.2 months,
P=0.001), but the median OS was not statistically different between the two groups (28.2 months vs 20.8 months,
P=0.068). Common treatment-related AEs included hypertension, diarrhea, fatigue, stomatitis, hand-foot syndrome, and hypothyroidism. The incidence of hypothyroidism was higher in the combination therapy group [40.0% (18/45)] than in the TKI monotherapy group [22.7% (5/22),
P=0.044]; the incidence of other treatment-related AEs between the two groups were not statistically significant (all
P>0.05).
Conclusion:Immune-targeted combination therapy was more effective than TKI monotherapy alone and was well tolerated in the treatment of metastatic nccRCC patients who failed first-line TKIs. |
| Author | 郭胜杰 韩辉 周芳坚 张志凌 蒋丽娟 董培 王骏 危文素 |
| AuthorAffiliation | 中山大学肿瘤防治中心泌尿外科，广州 510060 |
| AuthorAffiliation_xml | – name: 中山大学肿瘤防治中心泌尿外科，广州 510060 |
| Author_FL | Wang Jun Han Hui Wei Wensu Jiang Lijuan Zhou Fangjian Dong Pei Zhang Zhiling Guo Shengjie |
| Author_FL_xml | – sequence: 1 fullname: Wang Jun – sequence: 2 fullname: Wei Wensu – sequence: 3 fullname: Jiang Lijuan – sequence: 4 fullname: Zhang Zhiling – sequence: 5 fullname: Guo Shengjie – sequence: 6 fullname: Han Hui – sequence: 7 fullname: Zhou Fangjian – sequence: 8 fullname: Dong Pei |
| Author_xml | – sequence: 1 fullname: 王骏 – sequence: 2 fullname: 危文素 – sequence: 3 fullname: 蒋丽娟 – sequence: 4 fullname: 张志凌 – sequence: 5 fullname: 郭胜杰 – sequence: 6 fullname: 韩辉 – sequence: 7 fullname: 周芳坚 – sequence: 8 fullname: 董培 |
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| Keywords | 二线治疗 Programmed death-1 inhibitor Tyrosine kinase inhibitor 免疫治疗 Renal neoplasms, non-clear cell Immunotherapy Second-line therapy 程序性死亡蛋白1抑制剂 酪氨酸激酶抑制剂 肾肿瘤，非透明细胞 |
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| Publisher | 中山大学肿瘤防治中心泌尿外科，广州 510060 |
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