Heiblig Maël, Elhamri Mohamed, Tigaud Isabelle, Plesa Adriana, Barraco Fiorenza, Labussière Hélène, Ducastelle Sophie, Michallet Mauricette, Nicolini Franck, Plesa Claudiu, Wattel Eric, Salles Gilles, Thomas Xavier
Department of Hematology, Lyon-Sud Hospital, Hospices Civils de Lyon, Pierre Bénite, France.
Laboratory of Cytogenetics, Lyon-Sud Hospital, Hospices Civils de Lyon, Pierre Bénite, France.
Mediterr J Hematol Infect Dis. 2016 Jan 1;8(1):e2016009. doi: 10.4084/MJHID.2016.009. eCollection 2016.
Low-dose cytarabine (LD-AraC) is still regarded as the standard of care in elderly patients with acute myeloid leukemia (AML) 'unfit' for intensive chemotherapy. In this study, we reported our experience with LD-AraC in patients ≥ 70 years old and compared the results to those of intensive chemotherapy, best supportive care (BSC), or hypomethylating agents in the same age population.
Between 2000 and 2014, 60 patients received LD-AraC at 20 mg once or twice daily by subcutaneous injection for 10 consecutive days every 4-6 weeks.
Complete remission rate with LD-AraC was 7% versus 56% with intensive chemotherapy and 21% with hypomethylating agents. Median overall survival (OS) of patients treated with LD-AraC was 9.6 months with 3-year OS of 12%. Survival with LD-AraC was better than with BSC only (P = 0.001). Although not statistically significant, intensive chemotherapy and hypomethylating agents tended to be better than LD-AraC in terms of OS (median: 12.4 months and 16.1 months, respectively). There was no clear evidence that a beneficial effect of LD-AraC was restricted to any particular subtype of patients, except for cytogenetics. There was a trend for a better OS in LD-AraC treated patients in the setting of clinical trials as compared with those treated outside of a clinical trial.
Despite a trend in favor of intensive chemotherapy and hypomethylating agents over LD-AraC, no real significant advantage could be demonstrated, while LD-AraC showed a significant advantage comparatively to BSC. All this tends to confirm that LD-AraC can still represent a baseline against which new promising agents may be compared either alone or in combination.
低剂量阿糖胞苷(LD - AraC)仍被视为不适于强化化疗的老年急性髓系白血病(AML)患者的标准治疗方案。在本研究中,我们报告了我们在70岁及以上患者中使用LD - AraC的经验,并将结果与同年龄人群中强化化疗、最佳支持治疗(BSC)或去甲基化药物的结果进行了比较。
2000年至2014年期间,60例患者接受皮下注射LD - AraC,剂量为20 mg,每日一次或两次,每4 - 6周连续注射10天。
LD - AraC的完全缓解率为7%,强化化疗为56%,去甲基化药物为21%。接受LD - AraC治疗的患者中位总生存期(OS)为9.6个月,3年总生存率为12%。LD - AraC治疗的生存率仅优于最佳支持治疗(P = 0.001)。尽管无统计学意义,但在总生存期方面,强化化疗和去甲基化药物倾向于比LD - AraC更好(中位生存期分别为:12.4个月和16.1个月)。除细胞遗传学外,没有明确证据表明LD - AraC的有益作用仅限于任何特定亚型的患者。与非临床试验环境中治疗的患者相比,在临床试验环境中接受LD - AraC治疗的患者有更好总生存期的趋势。
尽管与LD - AraC相比,强化化疗和去甲基化药物有一定优势趋势,但未显示出真正显著的优势,而LD - AraC与最佳支持治疗相比显示出显著优势。所有这些都倾向于证实,LD - AraC仍然可以作为一个基线,用于单独或联合比较新的有前景的药物。