老药瘤可燃治疗malt疗效可观

期待康复

IELSG-19临床实验的最后结果提示便宜的老药瘤可燃治疗malt疗效相当不错
Results of the IELSG-19 Randomized Trial of Mucosa-Associated Lymphoid Tissue Lymphoma: Improved Event-Free and Progression-Free Survival With Rituximab Plus Chlorambucil Versus Either Chlorambucil or Rituximab Monotherapy.

Zucca E, et al. J Clin Oncol. 2017.

Purpose There is no consensus on the optimal systemic treatment of patients with extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue. The IELSG-19 phase III study, to our knowledge, was the first such study to address the question of first-line treatment in a randomized trial. Patients and Methods Eligible patients were initially randomly assigned (1:1 ratio) to receive either chlorambucil monotherapy (6 mg/m(2)/d orally on weeks 1 to 6, 9 to 10, 13 to 14, 17 to 18, and 21 to 22) or a combination of chlorambucil (same schedule as above) and rituximab (375 mg/m(2) intravenously on day 1 of weeks 1, 2, 3, 4, 9, 13, 17, and 21). After the planned enrollment of 252 patients, the protocol was amended to continue with a three-arm design (1:1:6 ratio), with a new arm that included rituximab alone (same schedule as the combination arm) and with a final sample size of 454 patients. The main end point was event-free survival (EFS). Analysis of chlorambucil versus the combination arm was performed and reported separately before any analysis of the third arm. Results At a median follow-up of 7.4 years, addition of rituximab to chlorambucil led to significantly better EFS (hazard ratio, 0.54; 95% CI, 0.38 to 0.77). EFS at 5 years was 51% (95% CI, 42 to 60) with chlorambucil alone, 50% (95% CI, 42 to 59) with rituximab alone, and 68% (95% CI, 60 to 76) with the combination ( P = .0009). Progression-free survival was also significantly better with the combination ( P = .0119). Five-year overall survival was approximately 90% in each arm. All treatments were well tolerated. No unexpected toxicities were recorded. Conclusion Rituximab in combination with chlorambucil demonstrated superior efficacy in mucosa-associated lymphoid tissue lymphoma; however, improvements in EFS and progression-free survival did not translate into longer overall survival.
the ORR rate was 87% for chlorambucil and 94% for the combination (p = .069). The CRR was significantly higher with the combination (78% vs. 65%, p = .025)
,。chlorambucil or cyclophosphamide in 24 patients with MALT lymphoma (17 stage I, 7 stage IV). The complete remission rate (CRR) was 75% after a median treatment duration of 12 month。
2013年IELSG-19   252个病例临床实验结果；瘤可燃单药Orr 87%.联用美罗华达94%
瘤可燃或环璘酰胺治疗12月后完crr可达75%。
454病例，中位随访7.4年，瘤可燃单药五年efs 51%.美罗华单药50%.瘤可燃加美罗华68%.三组五年os 90%.瘤可燃+美罗华efs明显提高，但没有转变成os的提升。三组治疗药物耐受性不错，未出现意外的毒性。

期待康复

根据近期发表的该三期临床实验，在治疗malt 方面，口服又老又便宜的瘤可燃或环璘酰胺的单药临床疗效数据超过又贵概念又新的口服药来那度胺，甚至依鲁替尼。加用美罗华的数据也超过R2。但这些药似乎临床应用并不多，文献报道国内不多，欧洲相对比较多。记得2008法国有一报道治疗肺malt 瘤可燃最优。
不知道便宜临床实验数据好的老口服药为什么用得少？耐药增加？实验数据与临床不符？第二肿瘤发生率高？有报道瘤可燃第二肿瘤发生率高的报道，但也有发生不增高的报道。就是高的报道也与苯达莫斯汀差不多，似乎也不是少用点原因。长期口服毒副作用大？来那度胺也不少啊。
敬请大家讨论
@范医生
@橙色雨丝
@爱心医生

橙色雨丝

1）局限期的MALT最好放疗；2）放疗不适用的情况下，考虑化疗，瘤可燃和环磷酰胺一样都属于烷化剂，口服化疗药也是化疗；3）根据这个试验，瘤可燃单药和美罗华单药相比，五年的EFS一个是51%，一个是50%，考虑到各自的副作用以及对未来病程的影响，美罗华完胜，瘤可燃单药几乎没有存在的必要；4）作为MALT的初治方案，美罗华+瘤可燃的完全缓解率75%，而美罗华+CHOP的完全缓解率根据有关临床试验高于90%，R-CHOP完胜，而且不能排除有一部分人经R-CHOP治疗后得以治愈；5）来那度胺和依鲁替尼因为价格贵和不具备治愈潜力等原因，基本上没有可能成为MALT的一线药物。

期待康复

橙色雨丝 发表于 2017-9-6 12:25
1）局限期的MALT最好放疗；2）放疗不适用的情况下，考虑化疗，瘤可燃和环磷酰胺一样都属于烷化剂，口服化疗 ...

分析太到位，受教了！

ttyiyu

橙色雨丝 发表于 2017-9-6 12:25
1）局限期的MALT最好放疗；2）放疗不适用的情况下，考虑化疗，瘤可燃和环磷酰胺一样都属于烷化剂，口服化疗 ...

谢谢大神分析，我们刚确定malt二期，正在纠结治疗方案。