Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Eur J Cancer. 2012 Nov;48(17):3223-31. doi: 10.1016/j.ejca.2012.06.003. Epub 2012 Jul 4.
We performed a phase II study to evaluate the efficacy of bortezomib in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) as first-line treatment for patients with stage III/IV peripheral T-cell lymphomas (PTCLs) based on our phase I study results.
Patients received bortezomib on days 1 and 8 at a dose of 1.6 mg/m(2) in addition to CHOP every 3 weeks for a total of six cycles.
Forty-six patients were enrolled: PTCL, not otherwise specified (PTCL-NOS, n=16), extranodal NK/T-cell lymphoma, nasal type (ENKTL, n=10), angioimmunoblastic T-cell lymphoma (AITL, n=8), ALK-negative anaplastic large-cell lymphoma (ALCL, n=6), cutaneous T-cell lymphoma (CTCL, n=5) and hepatosplenic T-cell lymphoma (n=1). Thirty patients achieved complete response (CR, 65%) and the overall response rate was 76% (35/46). Although the CR rate of ENKTL was only 30% (3/10), three subtypes of PTCLs (PTCL-NOS, AITL and ALCL) showed 87% of overall response rate (ORR) (26/30) and 73% of CR rate (22/30). However, the 3-year overall survival and progression-free survival were 47% and 35%, respectively due to frequent relapse after remission. Grade 3/4 leucopenia was the most frequent toxicity whereas neurotoxicity was tolerable: grade 1 or 2 of peripheral neuropathy.
The combined treatment of bortezomib and CHOP is an effective and feasible regimen for advanced-stage PTCLs other than ENKTL, with acceptable toxicity. However, future studies exploring new drug combinations are warranted to overcome relapse after remission.
我们进行了一项 II 期研究，根据我们的 I 期研究结果，评估硼替佐米联合 CHOP（环磷酰胺、多柔比星、长春新碱和泼尼松）作为 III/IV 期外周 T 细胞淋巴瘤（PTCLs）患者一线治疗的疗效。
患者每 3 周接受一次 CHOP 治疗，同时在第 1 和第 8 天接受 1.6mg/m²的硼替佐米治疗，共进行 6 个周期。
共纳入 46 例患者：未特指的外周 T 细胞淋巴瘤（PTCL-NOS，n=16）、结外 NK/T 细胞淋巴瘤，鼻型（ENKTL，n=10）、血管免疫母细胞性 T 细胞淋巴瘤（AITL，n=8）、ALK 阴性间变大细胞淋巴瘤（ALCL，n=6）、皮肤 T 细胞淋巴瘤（CTCL，n=5）和肝脾 T 细胞淋巴瘤（n=1）。30 例患者达到完全缓解（CR，65%），总缓解率为 76%（35/46）。尽管 ENKTL 的 CR 率仅为 30%（3/10），但 3 种 PTCL 亚型（PTCL-NOS、AITL 和 ALCL）的总缓解率（ORR）为 87%（26/30），CR 率为 73%（22/30）。然而，由于缓解后频繁复发，3 年总生存率和无进展生存率分别为 47%和 35%。最常见的毒性是 3/4 级白细胞减少症，而神经毒性可耐受：周围神经病变 1 或 2 级。
硼替佐米联合 CHOP 的治疗方案对于除 ENKTL 以外的晚期 PTCL 是一种有效且可行的方案，毒性可接受。然而，需要进一步研究新的药物联合方案以克服缓解后的复发。
