背景:外周T细胞淋巴瘤(PTCL)是典型的表观遗传恶性肿瘤,预后总是较差。需要新的和有效的治疗策略来改善临床结果。特别是复发/难治性患者。
方法:我们进行了一项多中心2期研究,以评估阿扎胞苷和西达胺的治疗效果,单独或与吉西他滨和奥沙利铂(GemOx)联合使用,复发/难治性PTCL患者(注册号:ChiCTR2000037232)。主要终点是最佳的总体反应率。
结果:截至5月1日,2024年,30例患者的疗效和毒性可评估。最佳总有效率为53.3%,满足其主端点。在血管免疫母细胞性T细胞淋巴瘤患者中(AITL;N=19),观察到数字上更高的反应率,不管是否联合化疗,与非AITL患者相比。经过36.6个月的中位随访,中位无进展生存期和总生存期分别为7.1和8.7个月,分别。接受联合化疗的AITL患者(N=12)获得了最有希望的缓解率(总体缓解率,91.7%;完全缓解率,66.7%)和生存结果(中位无进展生存期,17.2个月;中位总生存期,38.8个月)。最常见的3-4级毒性是中性粒细胞减少症(40.0%)和血小板减少症(30.0%)。
结论:表观遗传疗法与GemOx联合治疗在复发/难治性PTCL患者中具有良好的耐受性和高度有效性。AITL患者,特别是,可能会从这种联合治疗中获益更多,应该成为未来研究的重点。
背景:这项工作由江苏省自然科学基金(BK20232039)资助。
BACKGROUND: Peripheral T cell lymphomas (PTCLs) are prototypical epigenetic malignancies with invariably poor prognoses. Novel and effective therapeutic strategies are needed to improve clinical outcomes, particularly in relapsed/refractory patients.
METHODS: We conducted a multicenter phase 2 study to evaluate the therapeutic efficacy of azacitidine and chidamide, alone or in combination with gemcitabine and oxaliplatin (GemOx), in patients with relapsed/refractory PTCLs (registration number: ChiCTR2000037232). The primary endpoint was the best overall response rate.
RESULTS: As of May 1st, 2024, thirty patients were evaluable for efficacy and toxicity. The best overall response rate was 53.3%, meeting its primary endpoint. Among the patients with angioimmunoblastic T cell lymphoma (AITL; N = 19), a numerically higher response rate was observed, regardless of whether chemotherapy was combined, compared to patients with non-AITL. After a median follow-up of 36.6 months, median progression-free survival and overall survival were 7.1 and 8.7 months, respectively. Patients with AITL who received combination chemotherapy (N = 12) achieved the most promising response rates (overall response rate, 91.7%; complete remission rate, 66.7%) and survival outcomes (median progression-free survival, 17.2 months; median overall survival, 38.8 months). The most common grade 3-4 toxicities were neutropenia (40.0%) and thrombocytopenia (30.0%).
CONCLUSIONS: The combination of epigenetic therapy with GemOx was well tolerated and highly effective in patients with relapsed/refractory PTCLs. Patients with AITL, in particular, may benefit more from this combination treatment and should be the focus of future studies.
BACKGROUND: This work was funded by the Natural Science Foundation of Jiangsu Province (BK20232039).