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:Phase 2 Clinical Trial of Simultaneous Boost Intensity Modulated Radiation Therapy With 3 Dose Gradients in Patients With Stage I-II Nasal Type Natural Killer/T-Cell Lymphoma: Long-Term Outcomes of Survival and Quality of Life.
Phase 2 Clinical Trial of Simultaneous Boost Intensity Modulated Radiation Therapy With 3 Dose Gradients in Patients With Stage I-II Nasal Type Natural Killer/T-Cell Lymphoma: Long-Term Outcomes of Survival and Quality of Life.
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我们设计的靶区勾画和剂量设定方案在治疗 I-II 期鼻腔 NKTCL 和 Waldeyer 环 NKTCL 患者中具有较好的临床疗效,且副作用轻微。
本研究旨在探讨早期结外自然杀伤/T细胞淋巴瘤患者接受3个剂量梯度的同步加量调强放疗(SIB-IMRT)前瞻性治疗后的治疗结果和长期生活质量。
2011年8月至2015年4月,60例I-II期鼻腔自然杀伤/T细胞淋巴瘤(NKTCL)及Waldeyer环NKTCL患者被纳入一项单臂、前瞻性、2期临床试验。所有患者均接受根治性放疗联合短程诱导化疗。统一采用新设计的SIB-IMRT方案,原发肿瘤大体肿瘤体积(GTV)及阳性淋巴结GTV为54.6 Gy,高危临床靶体积(CTV)为50.7 Gy,低危CTV为45.5 Gy,均分26次每日照射。在SIB-IMRT前,95.0%(57/60)的患者接受了以L-天冬酰胺酶为基础的诱导化疗。
中位随访时间为95.8个月,5年局部区域无复发生存率、无进展生存率和总生存率分别为83.3%、81.7%和88.3%。前21例患者的剂量学分析显示,GTV计划靶区、高危CTV和低危CTV的适形性令人满意,同时危及器官得到了良好保护。无进展患者的长期生活质量调查结果良好,鼻部不适是最常见的症状。未观察到3级或4级急性或晚期毒性。
The aim of this study was to investigate the treatment results and long-term quality of life in patients with early-stage extranodal natural killer/T-cell lymphoma who were prospectively treated with simultaneous boost intensity modulated radiation therapy (SIB-IMRT) with 3 dose gradients. METHODS AND MATERIALS: Sixty patients with stage I-II nasal cavity natural killer/T-cell lymphoma (NKTCL) and Waldeyer's ring NKTCL were enrolled in a single-arm, prospective, phase 2 clinical trial from August 2011 to April 2015. All patients were treated with definitive radiation therapy combined with short-course induction chemotherapy. A newly designed SIB-IMRT scheme was uniformly adopted, with 54.6 Gy for the gross tumor volume (GTV) of the primary tumor and GTV of the positive lymph nodes, 50.7 Gy for the high-risk clinical target volume (CTV), and 45.5 Gy for the low-risk CTV, all delivered in 26 daily fractions. Before SIB-IMRT, L-asparaginase-based induction chemotherapy was used in 95.0% (57/60) of patients.
With a median follow-up time of 95.8 months, the 5-year locoregional recurrence-free survival, progression-free survival, and overall survival rates were 83.3%, 81.7%, and 88.3%, respectively. Dosimetric analysis in the first 21 patients showed satisfying conformality for planning target volume of GTV, high-risk CTV, and low-risk CTV, while the organs at risk were well protected. The results of long-term quality-of-life investigations in patients without progression were favorable, and nasal discomfort was the most common symptom. No grade 3 or 4 acute or late toxicities were observed.
The scheme of target volume delineation and dose setting that we designed has favorable clinical effects with mild side effects in treating patients with stage I-II nasal cavity NKTCL and Waldeyer's ring NKTCL.
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