Department of Hematology, The Affiliated Hospital of Inner Mongolia Medical University, 1 TongDao Avenue North, Hohhot, 010059, People's Republic of China,
J Cancer Res Clin Oncol. 2014 Feb;140(2):303-9. doi: 10.1007/s00432-013-1570-6. Epub 2013 Dec 15.
This was an open-label, observational, prospective assessment. We conducted an analysis of the impact of bortezomib-based therapy (PAD: bortezomib, doxorubicin, high-dose dexamethasone vs. CBd: cyclophosphamide bortezomib, low-dose dexamethasone) on the survival rates and adverse events in elderly patients with newly diagnosed multiple myeloma (MM).
Out of 303 patients, 128 received the PAD regimen and the other 175 patients received the CBd induction therapy (age 65-89 years). Baseline patient characteristics between the two cohorts were balanced in age (P = 0.69), international staging system (ISS) prognostic stages (P = 0.90), serum calcium (P = 0.70), and serum creatinine (P = 0.52).
Overall response (OS) after the induction chemotherapy was achieved in 214 of 303 patients (70.6 %), with no significant differences observed between the two treatment groups (71.9 vs. 69.7 %, P = 0.68). Patients with ISS stage 2 reached the same 5-year OS advantages compared to patients with ISS stage 1, because they received bortezomib-based PAD or CBd treatments. Patients receiving CBd protocol gained similar satisfactory progression-free survival (PFS) results when compared to the PAD regimen group: PFS at 5 years reached 58.2 versus 58.9 % (P = 0.85). Five-year OS in the CBd arm had significant advantages compared to the PAD group, 79.9 versus 49.9 % (P < 0.05). The overall safety profiles showed that 26 of 128 (20.3 %) patients died in the PAD arm, while 13 of 175 patients died (7.4 %) in the CBd group (P < 0.01). Similarly, the PAD arm had a higher serious infection rate than that of the CBd arm (39.2 vs. 13.1 %, P < 0.01).
Bortezomib benefits elderly patients with newly diagnosed MM; they achieve satisfactory treatment responses and survival advantages. Further, patients treated with CBd have superior treatment advantages, with a predictable safety profile, when compared to the PAD regimen.
这是一项开放标签、观察性、前瞻性评估。我们分析了硼替佐米为基础的治疗(PAD:硼替佐米、多柔比星、高剂量地塞米松与 CBd:环磷酰胺硼替佐米、低剂量地塞米松)对新诊断多发性骨髓瘤(MM)老年患者生存率和不良事件的影响。
在 303 例患者中,128 例接受 PAD 方案,175 例接受 CBd 诱导治疗(年龄 65-89 岁)。两组患者的基线特征在年龄(P=0.69)、国际分期系统(ISS)预后分期(P=0.90)、血清钙(P=0.70)和血清肌酐(P=0.52)方面无显著差异。
303 例患者中,214 例(70.6%)在诱导化疗后获得总体缓解(OS),两组间无显著差异(71.9%比 69.7%,P=0.68)。ISS 分期 2 期患者与 ISS 分期 1 期患者一样,因接受硼替佐米为基础的 PAD 或 CBd 治疗,获得了 5 年 OS 优势。与 PAD 方案组相比,接受 CBd 方案的患者获得了相似的无进展生存期(PFS)结果:5 年 PFS 达到 58.2%比 58.9%(P=0.85)。与 PAD 组相比,CBd 组的 5 年 OS 有显著优势,分别为 79.9%和 49.9%(P<0.05)。总体安全性谱显示,PAD 组 26 例(20.3%)患者死亡,而 CBd 组 13 例(7.4%)患者死亡(P<0.01)。同样,PAD 组严重感染发生率高于 CBd 组(39.2%比 13.1%,P<0.01)。
硼替佐米有益于新诊断的 MM 老年患者;他们获得了令人满意的治疗反应和生存优势。此外,与 PAD 方案相比,接受 CBd 治疗的患者具有更好的治疗优势,且安全性可预测。