<div>PD-1 抑制剂联合化疗在复发性宫颈癌患者中有效性及安全性的临床研究</div>

郝俊宽; 李立安; 王政; 王楠; 孟元光

doi:10.12435/j.issn.2095-5227.24093002

PD-1 抑制剂联合化疗在复发性宫颈癌患者中有效性及安全性的临床研究

Clinical outcomes and safety of PD-1 inhibitors in combination with chemotherapy in patients with recurrent cervical cancer

摘要

摘要:
背景　临床试验表明PD-1抑制剂与化疗联合使用在治疗复发性宫颈癌(recurrent cervical cancer，rCC)中效果良好，但针对PD-1抑制剂联合化疗治疗rCC的真实世界研究相对较少。目的　探讨PD-1抑制剂联合化疗在rCC患者的实际临床效果。方法　选取解放军总医院第一医学中心2014年7月至2022年7月收治的接受PD-1抑制剂联合化疗的rCC患者作为观察组，选取同期只接受同样方案化疗的rCC患者作为对照组。比较两组客观缓解率(objective response rate，ORR)、疾病控制率(disease control rate，DCR)、中位总生存期(median overall survival，mOS)、1年生存率、2年生存率、病理类型为鳞癌患者的鳞状细胞癌抗原(squamous cell carcinoma antigen，SCCAg)下降程度及不良反应。结果　共计88例患者纳入该研究，其中观察组39例，对照组49例，两组一般资料及临床基线资料均可比(P＞0.05)。观察组的ORR高于对照组(59.0% vs 32.7%，P=0.014)，但DCR两组差异无统计学意义(89.7% vs 83.7%，P=0.410)。观察组mOS为16.0(95% CI：13.66 ~ 39.70)个月，高于对照组mOS15.0(95% CI：12.70 ~ 18.58)个月，差异无统计学意义(P=0.176)；观察组的1年生存率高于对照组(84.6% vs 67.3%，P=0.047)，2年生存率高于对照组(69.2% vs 46.9%，P=0.011)；病理类型为鳞癌的患者与治疗前比较，观察组治疗后血清SCCAg水平降低(P＜0.001)，且治疗后观察组SCCAg低于对照组(P=0.046)。两组不良反应中，主要不良反应组间差异无统计学意义(P＞0.05)，观察组的骨髓抑制发生率较对照组高(92.3% vs 71.4%，P=0.014)，但较严重的III-IV度骨髓抑制两组差异无统计学意义(20.5% vs 16.3%，P=0.613)。结论 PD-1 抑制剂联合化疗与单纯化疗相比更加有效控制rCC进展，虽然骨髓抑制发生率较高，但未增加重度骨髓抑制发生率，安全性可控。

Abstract: Background Clinical trials have shown that the combination of PD-1 inhibitors and chemotherapy is effective in treating recurrent cervical cancer (rCC), but there are relatively few real-world studies on the combination of PD-1 inhibitors and chemotherapy for rCC. Objective To explore the actual clinical effects of PD-1 inhibitors combined with chemotherapy in rCC patients. Methods Patients with rCC who received PD-1 inhibitors with chemotherapy in the First Medical Center of Chinese PLA General Hospital from July 2014 to July 2022 were served as the observation group, and rCC patients who received the same chemotherapy regimen during the same period as the control group. The objective response rate (ORR), disease control rate (DCR), median overall survival (mOS), 1-year survival rate, 2-year survival rate, and the degree of decline in squamous cell carcinoma antigen (SCCAg) in patients with squamous cell carcinoma and adverse reactions were compared between the two groups. Results A total of 88 patients were enrolled in the study, with 39 in the observation group and 49 in the control group. The general information and clinical baseline data of the two groups were comparable (P>0.05). The ORR of the observation group was higher than that of the control group (59.0% vs 32.7%, P=0.014), while the DCR showed no significant difference between the two groups (89.7% vs 83.7%, P=0.410). The mOS in the observation group was 16.0 months (95% CI: 13.66-39.70), which was higher than the 15.0 months (95% CI: 12.70-18.58) in the control group, but the difference was not statistically significant (P=0.176). The 1-year survival rate of the observation group was higher than that of the control group (84.6% vs 67.3%, P=0.047), and the 2-year survival rate was also higher than that of the control group (69.2 % vs 46.9 %, P = 0.024). For patients with squamous cell carcinoma, compared with before treatment, the sera SCCAg level decreased after treatment in the observation group (P<0.001), and the SCCAg level in the observation group was lower than that in the control group after treatment (P=0.046). There was no significant difference in the main adverse reactions between the two groups (P>0.05). The incidence of myelosuppression in the observation group was higher than that in the control group (92.3% vs 71.4%, P=0.014), but there was no difference in severe III-IV degree myelosuppression (20.5% vs 16.3%, P=0.613).Conclusion PD-1 inhibitors combined with chemotherapy are more effective in controlling the progression of rCC than chemotherapy alone. Although the incidence of myelosuppression is higher, it does not increase the incidence of severe myelosuppression, and the safety is controllable.

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