弥漫性大 B 细胞淋巴瘤患者采用 R-CHOP-14（SAKK 38/07）治疗中中期正电子发射断层扫描预测价值的前瞻性评估的最终结果。
Final Results of a Prospective Evaluation of the Predictive Value of Interim Positron Emission Tomography in Patients With Diffuse Large B-Cell Lymphoma Treated With R-CHOP-14 (SAKK 38/07).
机构信息
Christoph Mamot and Mario Bargetzi, Cantonal Hospital Aarau, Aarau; Dirk Klingbiel, Christine Biaggi, and Corinne Rusterholz, Swiss Group for Clinical Cancer Research Coordinating Center; Thomas Pabst, Inselspital Bern, Bern; Felicitas Hitz and Christoph Driessen, Cantonal Hospital St. Gallen, St. Gallen; Christoph Renner, Hirslanden Zürich; Thomas Hany, Magnetic Resonance Imaging Roentgen Zürich; Andrei Samarin, University Hospital Zürich, Zürich; Ulrich Mey, Cantonal Hospital Graubuenden, Chur; Miklos Pless, Cantonal Hospital Winterthur, Winterthur; Fatime Krasniqi and Stephan Dirnhofer, University Hospital of Basel, Basel; Emanuele Zucca, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland; and Federica Gigli and Giovanni Martinelli, European Institute of Oncology Milan, Milan, Italy.
出版信息
J Clin Oncol. 2015 Aug 10;33(23):2523-9. doi: 10.1200/JCO.2014.58.9846. Epub 2015 Jul 6.
PURPOSE
Our main objective was to prospectively determine the prognostic value of [(18)F]fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) after two cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone given every 14 days (R-CHOP-14) under standardized treatment and PET evaluation criteria.
PATIENTS AND METHODS
Patients with any stage of diffuse large B-cell lymphoma were treated with six cycles of R-CHOP-14 followed by two cycles of rituximab. PET/CT examinations were performed at baseline, after two cycles (and after four cycles if the patient was PET-positive after two cycles), and at the end of treatment. PET/CT examinations were evaluated locally and by central review. The primary end point was event-free survival at 2 years (2-year EFS).
RESULTS
Median age of the 138 evaluable patients was 58.5 years with a WHO performance status of 0, 1, or 2 in 56%, 36%, or 8% of the patients, respectively. By local assessment, 83 PET/CT scans (60%) were reported as positive and 55 (40%) as negative after two cycles of R-CHOP-14. Two-year EFS was significantly shorter for PET-positive compared with PET-negative patients (48% v 74%; P = .004). Overall survival at 2 years was not significantly different, with 88% for PET-positive versus 91% for PET-negative patients (P = .46). By using central review and the Deauville criteria, 2-year EFS was 41% versus 76% (P < .001) for patients who had interim PET/CT scans after two cycles of R-CHOP-14 and 24% versus 72% (P < .001) for patients who had PET/CT scans at the end of treatment.
CONCLUSION
Our results confirmed that an interim PET/CT scan has limited prognostic value in patients with diffuse large B-cell lymphoma homogeneously treated with six cycles of R-CHOP-14 in a large prospective trial. At this point, interim PET/CT scanning is not ready for clinical use to guide treatment decisions in individual patients.
目的
我们的主要目的是前瞻性地确定在标准治疗和 PET 评估标准下，每 14 天给予两次利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松（R-CHOP-14）后，[（18）F]氟脱氧葡萄糖正电子发射断层扫描/计算机断层扫描（PET/CT）的预后价值。
患者和方法
任何阶段的弥漫性大 B 细胞淋巴瘤患者均接受 6 周期 R-CHOP-14 治疗，然后接受 2 周期利妥昔单抗治疗。基线、2 周期后（如果患者在 2 周期后 PET 阳性，则在 4 周期后）和治疗结束时进行 PET/CT 检查。PET/CT 检查由当地和中心审查进行评估。主要终点是 2 年无事件生存（2 年 EFS）。
结果
中位年龄为 58.5 岁，根据世界卫生组织（WHO）的表现状态，分别有 56%、36%和 8%的患者为 0、1 或 2 级。根据当地评估，83 次（60%）R-CHOP-14 治疗后 2 周期的 PET/CT 扫描报告为阳性，55 次（40%）为阴性。与 PET 阴性患者相比，PET 阳性患者的 2 年 EFS 明显缩短（48%对 74%；P=0.004）。2 年总生存率无显著差异，PET 阳性患者为 88%，PET 阴性患者为 91%（P=0.46）。使用中心审查和 Deauville 标准，R-CHOP-14 治疗后 2 周期进行中期 PET/CT 扫描的患者 2 年 EFS 为 41%，而 PET/CT 扫描在治疗结束时进行的患者为 76%（P<0.001）。
结论
我们的结果证实，在一项大型前瞻性试验中，对 6 个周期的 R-CHOP-14 进行同质治疗的弥漫性大 B 细胞淋巴瘤患者中，中期 PET/CT 扫描具有有限的预后价值。目前，中期 PET/CT 扫描还没有准备好用于临床，以指导个别患者的治疗决策。
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