Adapted Treatment Guided by Interim PET-CT Scan in Advanced Hodgkin's Lymphoma.
Adapted Treatment Guided by Interim PET-CT Scan in Advanced Hodgkin's Lymphoma.
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在晚期霍奇金淋巴瘤中以临时PET-CT扫描为指导的改编治疗。
DOI：
10.1056/nejmoa1510093
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发表时间：
2016-06-23
期刊：
影响因子：
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通讯作者：
Barrington S
中科院分区：
文献类型：
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作者：
Johnson P;Federico M;Kirkwood A;Fosså A;Berkahn L;Carella A;d'Amore F;Enblad G;Franceschetto A;Fulham M;Luminari S;O'Doherty M;Patrick P;Roberts T;Sidra G;Stevens L;Smith P;Trotman J;Viney Z;Radford J;Barrington S
为了指导晚期霍奇金淋巴瘤患者的治疗，我们测试了中期正电子发射断层扫描-计算机断层扫描(PET-CT)作为化疗早期反应的指标。新诊断的晚期经典霍奇金淋巴瘤患者接受了基线的PET-CT扫描，接受了两个周期的ABVD(阿霉素、博莱霉素、长春新碱和达卡巴津)化疗，然后接受了临时的PET-CT扫描。使用5分的正电子发射计算机断层扫描结果对图像进行集中复查。2个周期后PET检查阴性的患者随机分为ABVD组(ABVD组)和未用博莱霉素组(AVD组)，治疗周期3~6个周期。2个周期后PET阳性的患者接受BEACOPP(博莱霉素、依托泊苷、阿霉素、环磷酰胺、长春新碱、丙卡巴肼和强的松)治疗。对于中期扫描结果为阴性的患者，不建议进行放射治疗。主要结果是随机组之间的3年无进展存活率的差异，排除差异5个或更多个百分点的非劣势比较。总共登记了1214名患者；根据协议接受临时PET-CT扫描的1119名患者中，有937名(83.7%)的结果为阴性。中位随访41个月，ABVD组的3年无进展生存率和总生存率分别为85.7%(95%可信区间，82.1~88.6)和97.2%(95%CI，95.1~98.4)，AVD组的3年无进展生存率和总生存率分别为84.4%(95%CI，80.7~87.5)和97.6%(95%CI，95.6~98.7)。3年无进展生存率的绝对差值为1.6个百分点(95%可信区间，−为3.2%~5.3%)。ABVD组的呼吸道不良事件比AVD组严重。172例中期扫描阳性的患者接受了BEACOPP治疗，第三次PET-CT检查阴性者占74.4%，3年无进展生存率为67.5%，总生存率为87.8%。共有62名患者在试验期间死亡(24名死于霍奇金淋巴瘤)，3年无进展存活率为82.6%，总存活率为95.8%。虽然结果略低于指定的非劣质边界，但在中期PET结果为阴性后，ABVD方案中省略博莱霉素会导致肺部毒性反应的发生率低于继续使用ABVD的患者，但疗效并未显著降低。(由英国癌症研究和其他机构资助；ClinicalTrials.gov编号，NCT00678327。)
We tested interim positron-emission tomography–computed tomography (PET-CT) as a measure of early response to chemotherapy in order to guide treatment for patients with advanced Hodgkin’s lymphoma. Patients with newly diagnosed advanced classic Hodgkin’s lymphoma underwent a baseline PET-CT scan, received two cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy, and then underwent an interim PET-CT scan. Images were centrally reviewed with the use of a 5-point scale for PET findings. Patients with negative PET findings after two cycles were randomly assigned to continue ABVD (ABVD group) or omit bleomycin (AVD group) in cycles 3 through 6. Those with positive PET findings after two cycles received BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone). Radiotherapy was not recommended for patients with negative findings on interim scans. The primary outcome was the difference in the 3-year progression-free survival rate between randomized groups, a noninferiority comparison to exclude a difference of 5 or more percentage points. A total of 1214 patients were registered; 937 of the 1119 patients (83.7%) who underwent an interim PET-CT scan according to protocol had negative findings. With a median follow-up of 41 months, the 3-year progression-free survival rate and overall survival rate in the ABVD group were 85.7% (95% confidence interval [CI], 82.1 to 88.6) and 97.2% (95% CI, 95.1 to 98.4), respectively; the corresponding rates in the AVD group were 84.4% (95% CI, 80.7 to 87.5) and 97.6% (95% CI, 95.6 to 98.7). The absolute difference in the 3-year progression-free survival rate (ABVD minus AVD) was 1.6 percentage points (95% CI, −3.2 to 5.3). Respiratory adverse events were more severe in the ABVD group than in the AVD group. BEACOPP was given to the 172 patients with positive findings on the interim scan, and 74.4% had negative findings on a third PET-CT scan; the 3-year progression-free survival rate was 67.5% and the overall survival rate 87.8%. A total of 62 patients died during the trial (24 from Hodgkin’s lymphoma), for a 3-year progression-free survival rate of 82.6% and an overall survival rate of 95.8%. Although the results fall just short of the specified noninferiority margin, the omission of bleomycin from the ABVD regimen after negative findings on interim PET resulted in a lower incidence of pulmonary toxic effects than with continued ABVD but not significantly lower efficacy. (Funded by Cancer Research UK and Others; ClinicalTrials.gov number, NCT00678327.)