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[大学生论坛]:白血病治疗

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3151204002 发表于 2019-1-4 12:04:16 来自手机 | 显示全部楼层 |阅读模式
本帖最后由 3151204002 于 2019-1-4 12:10 编辑

      BACKGROUND

  Ibrutinib has been approved by the Food and Drug Administration for the treatment of patients with untreated chronic lymphocytic leukemia (CLL) since 2016 but has not been compared with chemoimmunotherapy. We conducted a phase 3 trialto evaluate the efficacy of ibrutinib, either alone or in combination with rituximab,relative to chemoimmunotherapy.
自2016年以来,伊布替尼已被食品药品监督管理局批准用于治疗未经治疗的慢性淋巴细胞白血病(CLL),但尚未与化学免疫疗法进行比较。我们进行了第3阶段的试验,以评价伊布替尼单独或联合利妥昔单抗治疗的疗效。
METHODS

  Patients 65 years of age or older who had untreated CLL were randomly assigned to receive bendamustine plus rituximab, ibrutinib, or ibrutinib plus rituximab. The primary end point was progression-free survival. The Alliance Data and Safety Monitoring Board made the decision to release the data after the protocol-specified efficacy threshold had been met.
对65岁或65岁以上未经治疗的CLL患者随机分为苯达莫司汀联合利妥昔单抗、伊布替尼或伊布替尼联合利妥昔单抗。主要结果是无进展生存率。联盟数据和安全监测委员会决定在满足协议规定的疗效阈值后发布数据。
RESULTS

   A total of 183 patients were assigned to receive bendamustine plus rituximab, 182to receive ibrutinib, and 182 to receive ibrutinib plus rituximab. Median progression-free survival was reached only with bendamustine plus rituximab. The estimated percentage of patients with progression-free survival at 2 years was 74% with bendamustine plus rituximab and was higher with ibrutinib alone (87%; hazard ratio fordisease progression or death, 0.39; 95% confidence interval [CI], 0.26 to 0.58;P<0.001) and with ibrutinib plus rituximab (88%; hazard ratio, 0.38; 95% CI, 0.25to 0.59; P<0.001). There was no significant difference between the ibrutinib-plus-rituximab group and the ibrutinib group with regard to progression-free survival(hazard ratio, 1.00; 95% CI, 0.62 to 1.62; P=0.49). With a median follow-up of 38months, there was no significant difference among the three treatment groups with regard to overall survival. The rate of grade 3, 4, or 5 hematologic adverse eventswas higher with bendamustine plus rituximab (61%) than with ibrutinib or ibrutinibplus rituximab (41% and 39%, respectively), where as the rate of grade 3, 4, or 5 nonhematologic adverse events was lower with bendamustine plus rituximab (63%) thanwith the ibrutinib-containing regimens (74% with each regimen).
共有183名患者接受了苯达莫司汀加利妥昔单抗治疗,182名接受了伊布替尼治疗,182名接受了伊布替尼加利妥昔单抗治疗。只有苯达莫司汀联合利妥昔单抗才能达到中位无进展生存率。本达莫司汀联合利妥昔单抗治疗2年无进展生存率估计为74%,单用伊布替尼治疗2年无进展生存率更高(87%;疾病进展或死亡风险比为0.39;95%可信区间(CI)为0.26-0.58;P<0.001),伊布替尼联合利妥昔单抗治疗2年无进展生存率估计为88%;风险比为0.38;95%可信区间(CI)为0.25-0.59;P<0.001)。0.001)。ibrutinib加利妥昔单抗组与ibrutinib组在无进展生存率方面无显著差异(危险比1.00;95%可信区间0.62-1.62;p=0.49)。中位随访38个月,三个治疗组的总生存率没有显著差异。苯达莫司汀加利妥昔单抗组(61%)的3、4或5级血液学不良事件发生率高于伊布替尼组或伊布替尼加利妥昔单抗组(分别为41%和39%),其中苯达莫司汀加利妥昔单抗组(63%)的3、4或5级非血液学不良事件发生率低于伊布替尼组(74%)每个疗程)。
CONCLUSIONS

      Among older patients with untreated CLL, treatment with ibrutinib was superior to treatment with bendamustine plus rituximab with regard to progression-free survival. There was no significant difference between ibrutinib and ibrutinib plus ritux-imab with regard to progression-free survival. (Funded by the National Cancer Insti-tute and Pharmacyclics; ClinicalTrials.gov number, NCT01886872.)
在未治疗CLL的老年患者中,就无进展生存率而言,伊布替尼治疗优于苯达莫司汀联合利妥昔单抗治疗。伊布替尼与伊布替尼联合利妥昔在无进展生存率方面没有显著差异。

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