Mandelli F, Latagliata R, Avvisati G, Fazi P, Rodeghiero F, Leoni F, Gobbi M, Nobile F, Gallo E, Fanin R, Amadori S, Vignetti M, Fioritoni G, Ferrara F, Peta A, Giustolisi R, Broccia G, Petti M C, Lo-Coco F
Department of Cellular Biotechnology and Hematology, University of Rome La Sapienza, Via Benevento 6, Rome 00161, Italy.
Leukemia. 2003 Jun;17(6):1085-90. doi: 10.1038/sj.leu.2402932.
In all, 134 elderly patients (median age 66 years, range 60-75 years) with newly diagnosed acute promyelocytic leukemia (APL) were enrolled in two successive protocols of the Italian multicenter group GIMEMA. All patients received an identical induction with all-trans retinoic acid and idarubicin; 116 (86%) entered complete remission (CR), two (2%) were resistant and 16 (12%) died during induction. After CR, 106 patients received further therapy whereas 10 did not, because of refusal (n=5) or toxicity (n=5). Consolidation consisted of three chemotherapy courses in the AIDA protocol (AIDA, 67 patients) or, since 1997, of an amended protocol including only the first cycle (amended AIDA, aAIDA, 39 patients). In the AIDA group, 43 patients (64%) completed consolidation, while seven (11%) and 17 (25%) patients were withdrawn after first and second courses, respectively; nine patients (13%) died in CR and 12 (18%) relapsed. In the aAIDA group, all patients received the assigned treatment; two patients (5%) died in CR and six (15%) relapsed. In the AIDA and aAIDA series, the 3-year overall and discase-free survival rates were 81 and 83% (P=NS), 73 and 72% (P=NS), respectively. We highlight here the frequency and severity of complications linked to intensive chemotherapy in this clinical setting and suggest that, in APL of the elderly, less intensive postremission therapy allows significant reduction of severe treatment-related toxicity and may be equally effective.
共有134例新诊断的急性早幼粒细胞白血病（APL）老年患者（中位年龄66岁，范围60 - 75岁）纳入了意大利多中心研究组GIMEMA的两个连续方案。所有患者均接受了相同的全反式维甲酸和伊达比星诱导治疗；116例（86%）进入完全缓解（CR），2例（2%）耐药，16例（12%）在诱导治疗期间死亡。CR后，106例患者接受了进一步治疗，而10例未接受，原因是拒绝（n = 5）或毒性（n = 5）。巩固治疗在AIDA方案中包括三个化疗疗程（AIDA组，67例患者），或者自1997年起，采用仅包括第一个周期的修订方案（修订后的AIDA，aAIDA，39例患者）。在AIDA组中，43例患者（64%）完成了巩固治疗，而分别有7例（11%）和17例（25%）患者在第一个和第二个疗程后退出；9例患者（13%）在CR期死亡，12例（18%）复发。在aAIDA组中，所有患者均接受了指定的治疗；2例患者（5%）在CR期死亡，6例（15%）复发。在AIDA组和aAIDA组中，3年总生存率和无病生存率分别为81%和83%（P = 无显著性差异），73%和72%（P = 无显著性差异）。我们在此强调了这种临床情况下与强化化疗相关的并发症的发生率和严重程度，并建议，在老年APL患者中，强度较低的缓解后治疗可显著降低严重的治疗相关毒性，且可能同样有效。
