Sullivan M P, Boyett J, Pullen J, Crist W, Doering E J, Trueworthy R, Hvizdala E, Ruymann F, Steuber C P
Cancer. 1985 Jan 15;55(2):323-36. doi: 10.1002/1097-0142(19850115)55:2<323::aid-cncr2820550204>3.0.co;2-9.
From September 1976 to August 1979 the Pediatric Oncology Group accessed 145 children to study the effectiveness of modified LSA2-L2 therapy for the treatment of non-Hodgkin's lymphoma (NHL). Burkitt's lymphoma patients were ineligible; E-rosette-positive patients with greater than or equal to 25% blasts in the marrow entered after February 1977 were reported separately. Radiotherapy could be used to treat patients with compressive mediastinal disease at diagnosis and was prescribed for those with residual abdominal disease as demonstrated by second-look surgery on completion of induction chemotherapy. Confirmation of diagnosis by the Pathology Panel and Repository Center for Lymphoma Clinical Trials was mandatory. Diagnostic tissues of 131 patients were reviewed. Among 107 evaluable patients, 91 (85%) achieved complete remission. Differences in response rates among the three major histologic groups (lymphoblastic, undifferentiated, and large cell) were of statistical significance, with response being poorest for diffuse undifferentiated lymphoma (P = 0.03). Failure-free survival did not differ significantly for the three major histologic diagnoses. While response rate was lowest for Murphy Stage III patients (79%), the differences among the stages were not significant. Stage was not a significant prognostic factor for failure-free survival (P = 0.08). The number of patients still at risk and the Kaplan-Meier estimate of percentage of patients remaining at risk after 3 years is: Stage I, 8 (100%); Stage II, 10 (67%); Stage III, 28 (57%); Stage IV, 6 (39%); and greater than 25% blasts, 1 (13%). Stage III failure curves for lymphoblastic disease show continuing stepwise failure through 3 years. Among patients with diffuse large cell and undifferentiated disease, most failures occurred by 8 months. M1 and M2 levels of marrow involvement were not prognostic among children with lymphoblastic disease. The presence of a mediastinal mass was a significant factor contributing to failure in children with lymphoblastic disease without marrow involvement. Leucocytosis greater than 10,000/1, was a significant (P = less than 0.001) factor predicting failure-free survival for patients with large cell lymphoma. The delivery of radiotherapy was not a significant factor in achieving remission. No consistent benefit resulted from using radiotherapy to treat postinduction residual disease demonstrated on second-look exploration. The LSA2-L2 regimen was associated with considerable toxicity, severe or worse in 77% and life-threatening to 40% of these patients. Four died of toxicity. However, therapy was given more easily and safely as investigator experience increased.(ABSTRACT TRUNCATED AT 400 WORDS)
1976年9月至1979年8月,儿科肿瘤学组对145名儿童进行了研究,以评估改良LSA2-L2疗法治疗非霍奇金淋巴瘤(NHL)的有效性。伯基特淋巴瘤患者不符合条件;1977年2月以后入组的骨髓中E玫瑰花结阳性且原始细胞大于或等于25%的患者已单独报告。放疗可用于治疗诊断时患有纵隔压迫性疾病的患者,对于诱导化疗结束后经二次探查手术证实有腹部残留病灶的患者也可进行放疗。淋巴瘤临床试验病理小组和标本库中心对诊断进行确认是强制性的。对131例患者的诊断组织进行了复查。在107例可评估患者中,91例(85%)实现了完全缓解。三个主要组织学组(淋巴细胞母细胞型、未分化型和大细胞型)的缓解率差异具有统计学意义,弥漫性未分化淋巴瘤的缓解情况最差(P = 0.03)。三种主要组织学诊断的无失败生存率无显著差异。虽然墨菲III期患者的缓解率最低(79%),但各期之间的差异不显著。分期不是无失败生存的显著预后因素(P = 0.08)。仍有风险的患者数量以及3年后无风险患者百分比的Kaplan-Meier估计值为:I期,8例(100%);II期,10例(67%);III期,28例(57%);IV期,6例(39%);原始细胞大于25%,1例(13%)。淋巴细胞母细胞型疾病的III期失败曲线显示3年内持续逐步失败。在弥漫性大细胞和未分化疾病患者中,大多数失败发生在8个月内。淋巴细胞母细胞型疾病患儿中,骨髓受累的M1和M2水平不是预后因素。纵隔肿块的存在是无骨髓受累的淋巴细胞母细胞型疾病患儿失败的一个重要因素。白细胞增多大于10,000/μl是大细胞淋巴瘤患者无失败生存的一个显著(P < 0.001)预测因素。放疗的实施不是实现缓解的显著因素。对二次探查发现的诱导后残留病灶进行放疗未产生一致的益处。LSA2-L2方案有相当大的毒性,77%的患者为严重或更严重毒性,40%的患者有生命危险。4例死于毒性反应。然而,随着研究者经验的增加,治疗实施起来更轻松、安全。(摘要截短至400字)