Phase 2 trial of rituximab with either pentostatin or bendamustine for multiply relapsed or refractory hairy cell leukemia.

Prospective data were unreported for either regimen.

这两种方案的前瞻性数据均未报道。

Fifty-six patients received 6 28-day cycles of rituximab (375 mg/m2, days 1 and 15) with either bendamustine (90 mg/m2, days 1 and 2) or pentostatin (4 mg/m2, days 1 and 15).

56名患者接受了6个28天周期的利妥昔单抗（第1天和第15天各375 mg/m2）联合苯达莫司汀（第1天和第2天各90 mg/m2）或喷司他汀（第1天和第15天各4 mg/m2）。

Eligibility required ≥2 purine analogs, or 1 purine analog plus rituximab for response of <1 year to the initial purine analog.

纳入标准要求患者至少使用过2种嘌呤类似物，或者在初始嘌呤类似物治疗后使用过1种嘌呤类似物加利妥昔单抗且反应时间少于1年。

Although patients were assigned to either regimen through randomization to increase homogeneity of the 2 treatment groups, the DCFR arm had fewer previous purine analogs (P = .021) and lower baseline marrow HCL/HCLv infiltration (P = .013).

尽管通过随机分组将患者分配到任一治疗方案以增加两组治疗的同质性，但DCF方案组的患者之前接受的嘌呤类似物较少（P = .021），且基线骨髓HCL/HCLv浸润较低（P = .013）。

ORRs for DCFR and BR were 93% (95% confidence intervals [CI], 83-102) and 86%, (95% CI, 73-99), respectively, exceeding 40% (P< .0001) for each group.

DCF方案和BR方案的总缓解率(ORR)分别为93%（95%置信区间[CI]，83-102）和86%，（95% CI，73-99），每组均超过40%（P< .0001）。

Rates for complete remission (CR) and minimal residual disease-free CR and median progression-free survival(141 vs 50 months; HR, 0.63; 95% CI, 0.32-1.25) numerically favored DCFR, but that arm was significantly enriched with less previous purine analogs and marrow infiltration, each of which was associated post hoc with better response.

完全缓解(CR)率和无最小残留病灶的CR率以及中位无进展生存期（141个月对比50个月；风险比，0.63；95%置信区间，0.32-1.25）在数值上更倾向于DCFR治疗组，但该治疗组显著地包含了更少的既往嘌呤类似物治疗和骨髓浸润患者，这些因素事后分析与更好的反应相关。

Post hoc subgroup analysis, particularly for 41 patients with classic HCL, suggested any superiority of DCFR vs BR might apply to patients with more favorable disease.

事后亚组分析，特别是针对41名经典毛细胞白血病患者，提示DCFR与BR相比的任何优势可能适用于疾病预后较好的患者。

DCFR and BR were highly effective in multiply relapsed HCL/HCLv.

DCFR和BR在多次复发的毛细胞白血病（HCL/HCLv）中效果显著。

Possible DCFR superiority was hypothesis-generating, given uneven baseline risks and trial design.

考虑到基线风险不均和试验设计的差异，DCFR可能具有优越性的假设是具有启发性的。

This trial was registered at www.clinicaltrials.gov as #NCT01059786.

该试验已在www.clinicaltrials.gov上注册，注册号为#NCT01059786。