Cabanillas F, Rodriguez-Diaz Pavón J, Hagemeister F B, McLaughlin P, Rodriguez M A, Romaguera J E, Dong K, Moon T
Department of Lymphoma-Myeloma, University of Texas M.D. Anderson Cancer Center, Houston, USA.
Ann Oncol. 1998 May;9(5):511-8. doi: 10.1023/a:1008214629544.
CHOP is currently considered the gold standard of treatment for intermediate grade lymphomas. We designed a new regimen known as 'ATT' (alternating triple therapy) which uses three non-cross resistant combinations in alternating sequence for nine cycles.
This is a phase II clinical trial with comparison to CHOP/CMED historical controls using prognostic factors. The tumor score system was used to evaluate the results of this trial. Two hundred sixty-eight eligible patients who had one or more of the following adverse features: bulky disease, elevated LDH or > 1 extranodal site were analyzed. Outcome measures consist of survival and failure free survival.
At a median follow-up of 32 months, there was no statistically significant difference in survival for those with favorable prognostic factors (tumor score < or = 2). However, there was a statistically significant difference in favor of ATT for those with unfavorable tumor scores. When we examined the failure-free survival of those with unfavorable tumor scores, we again observed a superiority for the ATT regimen over CHOP/CMED but the opposite was true for those with favorable tumor scores. We also found a statistically significant difference in favor of the ATT regimen when compared with CHOP/CMED for patients < or = 60 years old with a tumor score > or = 3, while no advantage was found for those > 60 years.
ATT appears more effective but only for patients < 60 years old with unfavorable tumor scores. In those older than 60 years with favorable tumor score, CHOP/CMED appears superior. ATT might be an adequate regimen for young patients with poor prognostic features while CHOP/CMED might be a better choice for those with good prognosis irrespective of age. For those > 60 years with unfavorable tumor scores neither ATT or CHOP/CMED were adequate treatment. Because of the phase II nature of this study, these conclusions should be considered as hypotheses which require prospective testing.
CHOP目前被认为是治疗中等级别淋巴瘤的金标准。我们设计了一种名为“ATT”(交替三联疗法)的新方案,该方案交替使用三种无交叉耐药的联合方案,共九个周期。
这是一项II期临床试验,与使用预后因素的CHOP/CMED历史对照进行比较。采用肿瘤评分系统评估该试验结果。对268例具有以下一项或多项不良特征的合格患者进行分析:肿块型病变、乳酸脱氢酶升高或结外部位>1个。观察指标包括生存率和无失败生存率。
在中位随访32个月时,预后良好(肿瘤评分≤2)的患者在生存率方面无统计学显著差异。然而,肿瘤评分不良的患者在ATT治疗组有统计学显著差异。当我们检查肿瘤评分不良患者的无失败生存率时,我们再次观察到ATT方案优于CHOP/CMED,但肿瘤评分良好的患者情况则相反。我们还发现,对于肿瘤评分≥3且年龄≤60岁的患者,与CHOP/CMED相比,ATT方案有统计学显著差异,而60岁以上患者则未发现优势。
ATT似乎更有效,但仅适用于肿瘤评分不良的60岁以下患者。对于肿瘤评分良好的60岁以上患者,CHOP/CMED似乎更优。ATT可能是预后不良年轻患者的合适方案,而CHOP/CMED可能是无论年龄预后良好患者的更好选择。对于肿瘤评分不良的60岁以上患者,ATT或CHOP/CMED都不是充分的治疗方案。由于本研究为II期性质,这些结论应被视为需要前瞻性验证的假设。