Freeman A I, Boyett J M, Glicksman A S, Brecher M L, Leventhal B G, Sinks L F, Holland J F
Department of Hematology/Oncology, Children's Mercy Hospital, Kansas City, Missouri, USA.
Med Pediatr Oncol. 1997 Feb;28(2):98-107. doi: 10.1002/(sici)1096-911x(199702)28:2<98::aid-mpo3>3.0.co;2-n.
The cure rate of childhood acute lymphoblastic leukemia (ALL) has improved dramatically. Still there is a paucity of long-term data. With the improving cure rate, the quality of life and avoidance of second cancers have become important concerns. We evaluated 596 children and adolescents with ALL on Cancer and Leukemia Group B 7611 (CALGB 7611) who were randomized between 1976 and 1979 to receive intermediate-dose methotrexate (IDM) plus intrathecal methotrexate (IT MTX) or cranial radiation (CRT) plus IT MTX. After 10 additional years of follow-up, the pattern and significance of the results reported in 1983 are confirmed. IDM offered better hematologic protection (P < 0.0006), better testicular protection (P = 0.002), but CRT offered better central nervous system (CNS) protection (P < 0.0001). The retrieval rate for the 231 patients who relapsed while on therapy or within 6 months of elective cessation of therapy is 20 +/- 5%. For the 33 patients who relapsed more than 6 months after cessation of therapy, the retrieval rate is 49 +/- 10%. For all patients, the 12-year event-free survival was 37 +/- 3.6% and the overall survival was 49 +/- 3.5%. There were two cases of second malignancies reported in 3,502 person-years of survival. Both occurred following salvage therapy. There was no evidence of an excessive number of second primaries over the general population of children. There were no reported instances of clinical cardiopathy. After a median follow-up of 11 years, there have been no reports of cardiopathy and no evidence of an increased risk of second cancers in children treated on CALGB 7611. While the overall outcome is not what would be expected with modern therapy, one can conclude that CRT offered better CNS protection, but IDM offered better systemic and testicular protection. A small risk of second cancers or cardiac dys-function may be acceptable with therapies which produce long-term documented survival benefits.
儿童急性淋巴细胞白血病（ALL）的治愈率有了显著提高。然而，长期数据仍然匮乏。随着治愈率的提高，生活质量和避免二次癌症已成为重要关注点。我们评估了参加癌症与白血病B组7611（CALGB 7611）研究的596例儿童和青少年ALL患者，他们在1976年至1979年间被随机分组，分别接受中剂量甲氨蝶呤（IDM）加鞘内注射甲氨蝶呤（IT MTX）或颅脑放疗（CRT）加IT MTX。经过额外10年的随访，1983年报告结果的模式和意义得到了证实。IDM提供了更好的血液学保护（P < 0.0006）、更好的睾丸保护（P = 0.002），但CRT提供了更好的中枢神经系统（CNS）保护（P < 0.0001）。在治疗期间或选择性停止治疗后6个月内复发的231例患者的挽救率为20±5%。对于在停止治疗6个月后复发的33例患者，挽救率为49±10%。所有患者的12年无事件生存率为37±3.6%，总生存率为49±3.5%。在3502人年的生存时间里报告了2例二次恶性肿瘤。两者均发生在挽救治疗之后。没有证据表明二次原发性肿瘤的数量超过儿童总体人群。没有临床心脏病的报告。在中位随访11年后，没有心脏病的报告，也没有证据表明接受CALGB 7611治疗的儿童患二次癌症的风险增加。虽然总体结果不如现代治疗预期的那样，但可以得出结论，CRT提供了更好的CNS保护，但IDM提供了更好的全身和睾丸保护。对于产生长期有记录生存益处的治疗方法，二次癌症或心脏功能障碍的小风险可能是可以接受的。
