Li En-Xiao, Zhang Ya-Ting, Shang Jin-Tang, Xu Zhen, Geng Yi, Li Shu-Ming, Shi Fan, Wu Yin-Ying
Department of Medical Oncology, First Affiliated Hospital, Medical College of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, P. R. China.
Ai Zheng. 2006 Aug;25(8):1048-51.
BACKGROUND & OBJECTIVES: Clinical study suggests that 72-hour continuous infusion (CIV) of MAID regimen is more effective and achieves longer time of no progression than ADR-based two-drug regimen in advanced soft tissue sarcoma (ASTS) treatment, but has no improvement on the long-term survival. Because of the severe grade 3/4 toxicities as well as treatment-related deaths, the regimen has not been widely applied in ASTS. This study was to investigate the efficacy and toxicity of the modified MAID regimen in ASTS treatment.
In the modified regimen, adriamycin (ADR) was substituted with tetrahydropyranyl adriamycin (THP-ADR) and the application of ifosfamide (IFO) was modified. All enrolled patients received chemotherapy (IFO 2,000 mg . m(-2), 4h, day 1-3; mesna 1,200 mg . m(-2) at 0, 4 and 8 hours of IFO infusion, day 1-3; THP-ADR 20 mg . m-2 and dacarbazine (DTIC) 333.3 mg . m(-2) were mixed in the same bag or pump, CIV for 3 days). The therapy was repeated every 3 weeks for at least 2 cycles before evaluating the effects and toxicities. The patients received follow-up every 2 months after completing 2 cycles until the study was finished. Life table was used to calculate long-term survival rates and time to progression.
Fifty-four cases of evaluable patients had completed at least 2 cycles of modified MAID chemotherapy. The overall response rate was 42.59%. The toxicities were mild. Grade 3/4 neutropenia and thrombocytopenia were 25.93% and 16.17%, respectively. Neutropenia fever was 11.11%. There were no other toxicities, such as hepatic and renal toxicities; no central nervous system toxicity and treatment-related deaths. During 2 year follow-up, time to progression was 7 months, 1- and 2- year survival rates were 61.11% and 36.36%, respectively.
Modified MAID regimen simplifies the application of treatment procedure compared with original regimen, which three drugs have to be CIV simultaneously. Moreover the modified MAID regimen has better survival rates in ASTS, with milder toxicity and better tolerance.
临床研究表明,在晚期软组织肉瘤(ASTS)治疗中,MAID方案72小时持续静脉输注(CIV)比基于阿霉素(ADR)的两药方案更有效,无进展时间更长,但对长期生存无改善。由于3/4级严重毒性以及与治疗相关的死亡,该方案尚未在ASTS中广泛应用。本研究旨在探讨改良MAID方案治疗ASTS的疗效和毒性。
在改良方案中,阿霉素(ADR)被四氢吡喃阿霉素(THP-ADR)替代,并对异环磷酰胺(IFO)的应用进行了改良。所有入组患者均接受化疗(IFO 2000 mg·m⁻²,静脉滴注4小时,第1 - 3天;美司钠1200 mg·m⁻²,在IFO静脉滴注的0、4和8小时给药,第1 - 3天;THP-ADR 20 mg·m⁻²和达卡巴嗪(DTIC)333.3 mg·m⁻²混合于同一袋或泵中,持续静脉输注3天)。每3周重复治疗至少2个周期,然后评估疗效和毒性。患者在完成2个周期后每2个月随访一次,直至研究结束。采用生命表计算长期生存率和无进展时间。
54例可评估患者至少完成了2个周期的改良MAID化疗。总缓解率为42.59%。毒性较轻。3/4级中性粒细胞减少和血小板减少分别为25.93%和16.17%。中性粒细胞减少性发热为11.11%。无其他毒性,如肝毒性和肾毒性;无中枢神经系统毒性及与治疗相关的死亡。在2年随访期间,无进展时间为7个月,1年和2年生存率分别为61.11%和36.36%。
与原方案相比,改良MAID方案简化了治疗程序的应用,原方案三种药物必须同时持续静脉输注。此外,改良MAID方案在ASTS中具有更好的生存率,毒性较轻,耐受性更好。