不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel:ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Outcomes of subsequent antilymphoma therapies after second-line axicabtagene ciloleucel or standard of care in ZUMA-7.
Outcomes of subsequent antilymphoma therapies after second-line axicabtagene ciloleucel or standard of care in ZUMA-7.
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对于复发/难治性大B细胞淋巴瘤(LBCL)患者,在疾病进展或对二线(2L)治疗无反应后的最佳管理仍不明确。在此,我们报告了ZUMA-7中按随机2L分组(即axicabtagene ciloleucel(axi-cel)vs标准治疗(SOC))分别接受研究者酌情决定的后续抗淋巴瘤治疗的患者结局。无进展生存期(PFS)和总生存期(OS)从3L治疗开始计算。在SOC组中,179例随机患者中有127例(71%)接受了3L治疗。接受3L细胞免疫治疗者(n = 68)与未接受者(n = 59)的中位PFS分别为6.3个月与1.9个月;中位OS分别为16.3个月与9.5个月。在axi-cel组中,180例随机患者中有84例(47%)接受了3L治疗。
接受3L化疗者(n = 60)与细胞免疫治疗者(n = 8)的中位PFS分别为1.7个月与3.5个月;中位OS分别为8.1个月与未达到。在接受3L化疗的60例患者中,10例在挽救性化疗后接受了干细胞移植(SCT)。达到SCT者与未达到SCT者的中位PFS分别为11.5个月与1.6个月,中位OS分别为17.5个月与7.2个月。8例患者在2L axi-cel后接受了3L细胞免疫治疗。其中,6例患者在任何线接受了后续SCT;截至数据截止时,6例均存活。这些发现有助于为复发/难治性LBCL在2L治疗失败后的后续治疗选择提供信息。该试验注册于www.ClinicalTrials.gov,编号为#NCT03391466。
The optimal management of patients with relapsed/refractory large B-cell lymphoma (LBCL) after disease progression or lack of response to second-line (2L) therapy remains unclear.
Here, we report outcomes among patients who received subsequent antilymphoma therapy per investigator discretion separately by their randomized 2L arm in ZUMA-7, namely axicabtagene ciloleucel (axi-cel) vs standard of care (SOC). Progression-free survival (PFS) and overall survival (OS) were calculated from 3L therapy initiation. In the SOC arm, 127 of 179 randomized patients (71%) received 3L therapy. Median PFS among those who received 3L cellular immunotherapy (n = 68) vs those who did not (n = 59) was 6. 3 vs 1. 9 months, respectively; median OS was 16. 3 vs 9. 5 months, respectively. In the axi-cel arm, 84 of 180 randomized patients (47%) received 3L therapy.
Median PFS among those who received 3L chemotherapy (n = 60) vs cellular immunotherapy (n = 8) was 1. 7 vs 3. 5 months, respectively; median OS was 8. 1 months vs not reached, respectively. Of the 60 patients who received 3L chemotherapy, 10 underwent stem cell transplantation (SCT) after salvage chemotherapy.
Median PFS was 11. 5 vs 1. 6 months, and median OS was 17. 5 vs 7. 2 months for those who did vs did not reach SCT, respectively. Eight patients received 3L cellular immunotherapy after 2L axi-cel. Of these, 6 patients received subsequent SCT in any line; all 6 were alive at data cutoff.
These findings help inform subsequent treatment choices after 2L therapy failure for relapsed/refractory LBCL. The trial was registered at www. clinicaltrials. gov as #NCT03391466.
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