DeNardo G L, DeNardo S J, Lamborn K R, Goldstein D S, Levy N B, Lewis J P, O'Grady L F, Raventos A, Kroger L A, Macey D J, McGahan J P, Mills S L, Shen S
University of California Davis Medical Center, Sacramento 95816, USA.
Cancer Biother Radiopharm. 1998 Aug;13(4):239-54. doi: 10.1089/cbr.1998.13.239.
This trial was conducted to assess the toxicity and efficacy of 131I-Lym-1 in patients with either malignant B-cell non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) using low-dose, fractionated radioimmunotherapy (RIT).
Thirty adult patients who had advanced B-cell malignancies (25 NHL and 5 CLL) had progressed despite standard therapy; 12 patients entered the trial with Karnofsky performance status (KPS) of equal to or greater than 60. Patients were treated with a series of intravenous doses of 131I-Lym-1 with a goal of reaching a cumulative dose in each patient of at least 300 mCi. All patients were Lym-1 reactive. Clinical responses and immediate toxicity were evaluable in all 30 patients and delayed toxicity in 26.
Toxicity to Lym-1 antibody occurred with 28% of the 176 doses and was transient. Human antimouse antibodies (HAMA) were generated in 30% after a mean of 4 doses, but interrupted therapy in only 10% of the patients. Thrombocytopenia was dose-limiting; there were no deaths due to toxicity. Tumor regression occurred in 25 (83%) of the patients and was great enough, and durable enough, in 17 (57%) to qualify them as responders; 13 NHL patients and 4 CLL patients. Advanced disease often interrupted therapy prematurely. However, 18 patients received at least 180 mCi of 131I-Lym-1; 17 (94%) of these responded to the therapy.
Although advanced disease often interrupted therapy prematurely, the results from 131I-Lym-1 therapy are clearly promising and warrant additional trials.
本试验旨在通过低剂量、分次放射免疫疗法（RIT）评估131I-Lym-1对恶性B细胞非霍奇金淋巴瘤（NHL）或慢性淋巴细胞白血病（CLL）患者的毒性和疗效。
30例患有晚期B细胞恶性肿瘤（25例NHL和5例CLL）的成年患者尽管接受了标准治疗仍病情进展；12例患者以卡诺夫斯基功能状态（KPS）等于或大于60进入试验。患者接受一系列静脉注射剂量的131I-Lym-1，目标是使每位患者的累积剂量至少达到300毫居里。所有患者对Lym-1均有反应。所有30例患者均可评估临床反应和即时毒性，26例患者可评估延迟毒性。
176剂中有28%出现对Lym-1抗体的毒性，且为短暂性。平均4剂后，30%的患者产生了人抗鼠抗体（HAMA），但仅10%的患者中断治疗。血小板减少是剂量限制性的；无因毒性导致的死亡。25例（83%）患者出现肿瘤消退，其中17例（57%）消退程度足够大且持续时间足够长，符合反应者标准；13例NHL患者和4例CLL患者。晚期疾病常过早中断治疗。然而，18例患者接受了至少180毫居里的131I-Lym-1；其中17例（94%）对治疗有反应。
尽管晚期疾病常过早中断治疗，但131I-Lym-1治疗的结果显然很有前景，值得进一步试验。
