ASCO 2013：中山大学林桐榆教授发现CHOP-B/IMVD/DHAP-三联循环方案治疗鼻型结外NK/T细胞淋巴瘤效果积极

背景：与B-NHL相比，鼻型结外NK/T细胞淋巴瘤(ENKL) 在亚洲更为普遍。目前尚未发现针对ENKL的治疗策略。本临床II/III期研究目的为，对CHOP-B/IMVD/DHAP-三联循环治疗方案(CID-ATT)与常规CHOP一线治疗方案进行前瞻性对比。
方法：自2006年1月至2012年1月期间，共有109例(pts)初步确诊的I至II期ENKL患者接受了CID-ATT或 CHOP随机治疗方案。在CID-ATT方案中，按照循环顺序进行CHOP-B、IMVD及DHAP治疗，共进行6个疗程(两个周期)。在6个疗程(两个周期)的CID-ATT治疗或6个周期的CHOP治疗后，对受累部位进行放疗。在进行每个DHAP疗程时，所有患者均接受粒细胞集落刺激因子、白介素-11及促血小板生成素预防性治疗。
结果：共有109例(54例CID-ATT; 55例 CHOP)患者可进行评价。经过中位时间为40.3个月的随访后发现，CID-ATT组患者在OS及PFS方面均显著长于CHOP。CID-ATT组在完全缓解率方面远高于CHOP组。对于在一个治疗周期(3个疗程)后取得CR的患者，其生存情况显著优于非CR组患者。尽管在CID-ATT方案中曾发现III/IV级中性粒细胞减少(30/54,55.6%)及血小板减少事件发生，但并未发现与治疗相关的死亡病例。
结论：本研究表明，CID-ATT方案为一种理想的一线治疗方案，该方案具有较佳的临床活性，并具有(在密切监视前提下)良好的安全性和可耐受的毒性，对于初治的早期ENKL患者，还可作为一种较好的支持性治疗方法。在放疗后进行的诱导化疗CR对于ENKL患者的生存至为重要。本研究临床试验信息：CSWOG0002。
Phase II/III randomized trial of CID-ATT with radiotherapy compared with CHOP with radiotherapy as first-line treatment for previously untreated early staging extranodal NK/T-cell lymphoma, nasal type (ENKL).
Abstract
Background: Extranodal NK/T cell lymphoma, nasal type (ENKL) is more prevalent in Asia and has worse prognosis than B-NHL. No therapeutic strategy is currently identified for ENKL. This phase II/III study was undertaken to compare CHOP-B/IMVD/DHAP-Alternating Triple Therapy (CID-ATT) and standard CHOP regimen as first-line treatment prospectively. Methods:109 patients (pts) initially diagnosed as ENKL (16-70 ys old) with Ann Abor Stage I to II were randomized to receive CID-ATT or CHOP regimen from Jan 2006 to Jan 2012. CID-ATT alternated among CHOP-B, IMVD, and DHAP, given in alternating sequence for a total of 6 courses (2 circle). Involved field radiation was administered after 6 courses(2 circle) of CID-ATT regimen or 6 cycles of CHOP regimen. All pts received prophylactic granulocyte colony-stimulating factor, interleukin-11and thrombopoietin for each DHAP cycle. Results: 109 pts were evaluable (54CID-ATT; 55 CHOP). With a median follow-up of 40.3months,OS and PFS was significantly prolonged with CID-ATT compared with CHOP (1yOS :80.2% vs 78.6%, 3yOS:68.0% vs 42.3%, 5yOS: 64.2% vs 34.5%,P=0.023; 1yPFS: 74.9% vs 59.6%, 3yPFS:60.5% vs 32.0%, 5yPFS: 60.5% vs 32.0% ; P=0.016). Compared to CHOP group, CID-ATT group has a much higher complete remission rate (CID-ATT:47/54,87.0 % vs CHOP:29/55,52.7%, P<0.001). The survivals for pts who achieved CR after One circle (3 courses) were significantly better than those who were in non-CR group.(5yOS: CR group in ATT:75.3%, non-CR group in ATT:51.5%, CR group in CHOP:39.3%, non-CR group in CHOP:31.0%; P=0.003). No treatment related death was observed, although Grade III/IV neutropenia (30/54,55.6%) and thrombocytopenia (33/54,61.1%) were observed in CID-ATT regimen, especially in DHAP cycle. Conclusions: Our study has demonstrated that the CID-ATT regimen as an optimal first-line therapy achieved promising clinical activity with safe and tolerated toxicity under close monitoring and good supportive care of untreated early staging ENKL pts. CR of induce chemotherapy following radiotherapy is very important for ENKL survival. Clinical trial information: CSWOG0002.