131I-tositumomab therapy as initial treatment for follicular lymphoma
131I-tositumomab therapy as initial treatment for follicular lymphoma
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DOI：
10.1056/nejmoa041511
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发表时间：
2005-02-03
影响因子：
158.5
通讯作者：
Wahl, RL
中科院分区：
文献类型：
--
作者：
Kaminski, MS;Tuck, M;Wahl, RL
背景：晚期滤泡性B细胞淋巴瘤被认为是不可治愈的。抗CD 20放射免疫治疗是有效的化疗后复发或谁有难治性滤泡性淋巴瘤的患者，但它还没有在以前未经治疗的patients.METHODS：76例III期或IV期滤泡性淋巴瘤患者作为初始治疗接受了一个疗程的治疗与I-131-托西莫单抗治疗（注册为托西莫单抗和碘I131托西莫单抗[Bexxar治疗方案]）。这包括剂量测定剂量的托西莫单抗和I-131标记的托西莫单抗，一周后给予治疗剂量，向全身提供75 cGy的辐射。结果：95%的患者有任何反应，75%有完全反应。使用聚合酶链反应（PCR）检测BCL 2基因重排，在80%具有临床完全缓解的可评估患者中显示分子缓解。在中位随访5.1年后，所有患者的5年无进展生存率为59%，中位无进展生存期为6.1年。随着时间的推移，年复发率逐渐下降：第一年、第二年和第三年分别为25%、13%和12%，三年后每年为4.4%。在57例完全缓解的患者中，40例持续缓解4.3至7.7年。血液学毒性为中度，没有患者需要输血或造血生长因子。没有骨髓增生异常综合征的情况下已经observed.CONCLUSIONS：一个单一的I-131-托西莫单抗治疗作为初始治疗的一个星期的课程可以诱导晚期滤泡性淋巴瘤患者的临床和分子缓解。
BACKGROUND:Advanced-stage follicular B-cell lymphoma is considered incurable. Anti-CD20 radioimmunotherapy is effective in patients who have had a relapse after chemotherapy or who have refractory follicular lymphoma, but it has not been tested in previously untreated patients.METHODS:Seventy-six patients with stage III or IV follicular lymphoma received as initial therapy a single course of treatment with I-131-tositumomab therapy (registered as Tositumomab and Iodine I 131 Tositumomab [the Bexxar therapeutic regimen]). This consisted of a dosimetric dose of tositumomab and I-131-labeled tositumomab followed one week later by a therapeutic dose, delivering 75 cGy of radiation to the total body.RESULTS:Ninety-five percent of the patients had any response, and 75 percent had a complete response. The use of polymerase chain reaction (PCR) to detect rearrangement of the BCL2 gene showed molecular responses in 80 percent of assessable patients who had a clinical complete response. After a median follow-up of 5.1 years, the actuarial 5-year progression-free survival for all patients was 59 percent, with a median progression-free survival of 6.1 years. The annualized rate of relapse progressively decreased over time: 25 percent, 13 percent, and 12 percent during the first, second, and third years, respectively, and 4.4 percent per year after three years. Of 57 patients who had a complete response, 40 remained in remission for 4.3 to 7.7 years. Hematologic toxicity was moderate, with no patient requiring transfusions or hematopoietic growth factors. No cases of myelodysplastic syndrome have been observed.CONCLUSIONS:A single one-week course of I-131-tositumomab therapy as initial treatment can induce prolonged clinical and molecular remissions in patients with advanced follicular lymphoma.