Reduction of Combined Modality Treatment Intensity in Early Stage Hodgkin’s Lymphoma: Interim Analysis of the HD 10 Trial of the GHSG.
Reduction of Combined Modality Treatment Intensity in Early Stage Hodgkin’s Lymphoma: Interim Analysis of the HD 10 Trial of the GHSG.
复制标题
降低早期霍奇金淋巴瘤的联合治疗强度：GHSG HD 10 试验的中期分析。
DOI：
10.1182/blood.v104.11.1307.1307
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发表时间：
2004
期刊：
影响因子：
20.3
通讯作者：
B. Pfistner
中科院分区：
文献类型：
--
作者：
V. Diehl;C. Brillant;A. Engert;J. Wolf;L. Nogova;R. Mueller;H. Eich;H. Mueller;R. Herrmann;B. Doerken;L. Kanz;R. Greil;B. Pfistner
背景资料：如今，在大多数研究组中，化疗（通常是ABVD）+受累野放疗（IF）的联合治疗是I-II期早期霍奇金淋巴瘤（HL）的标准治疗方案，没有危险因素。这种治疗策略的完全缓解率超过90%。然而，问题出现了，是否化疗，放疗或两者的治疗强度可能会进一步降低这些患者。目的：在GHSG的HD 10试验中，研究了ABVD周期的减少以及IF-RT剂量的减少。研究方法：患者随机分为4个周期ABVD +30戈伊IF放疗标准治疗组（A组）、4个周期ABVD + 20戈伊IF组（B组）、2个周期ABVD + 30戈伊IF组（C组）和2个周期ABVD + 20戈伊IF组（D组）。结果：1998年5月至2002年5月，1131例HL患者与早期疾病（CS I，II无危险因素）进行了随机化。847例患者（75%）可用于2003年8月进行的第二次中期分析。治疗组之间的患者特征平衡良好。总的来说，98.4%的患者达到完全缓解。0.9%的患者病情进展或无变化，复发率为2.5%。研究期间共有13名患者死亡（1.5%）。化疗期间，19%的白细胞减少症是最常见的WHO III/IV级毒性（4xABVD：22%，2xABVD：15%）。2.3%的患者对放射治疗耐受良好，伴有吞咽困难。共观察到10例继发性肿瘤：1例AML，4例NHL和5例实体瘤。在中位观察时间为2年后，总生存率（OS）和无治疗失败率（FRTF）分别为98.5%和96.6%。在4xABVD和2xABVD之间未检测到FRTF和OS的统计学差异。此外，不同剂量放射治疗（30 Gy vs. 20 Gy）之间无统计学差异。结论：由于仅观察到少数事件，因此该中期分析的结果可以解释为一种趋势，即早期综合治疗中的治疗强度可能在化疗周期数和放疗剂量方面进一步降低，即使在IF-RT设置中也是如此。
Background: Combined modality treatment of chemotherapy (usually ABVD) followed by involved field irradiation (IF) is today a standard treatment regimen for early stage Hodgkin′s lymphoma (HL)in stages I-II without risk factors in most study groups. The complete remission rates achieved with this treatment strategy are more than 90%. However, the question arises, whether treatment intensity of chemotherapy, radiotherapy or both may be further reduced in these patients. Aim: In the HD10 trial of the GHSG, reduction of ABVD cycles as well as reduction of IF- RT dose were investigated. Methods: Patients were randomized between 4 cycles of ABVD followed by 30 Gy IF radiotherapy as standard treatment (arm A), 4 cycles ABVD + 20 Gy IF (arm B), 2 cycles ABVD + 30 Gy IF (arm C) and 2 cycles ABVD + 20 Gy IF (arm D). Results: Between May 1998 and May 2002, 1131 HL patients with early stage disease (CS I,II without risk factors) were randomized. 847 patients (75%) were evaluable for this second interim analysis performed in August 2003. Patient characteristics were well balanced between the treatment arms. In total, 98.4% of the patients reached complete remission. Progressive disease or no change were observed in 0.9% of patients, relapse rate was 2.5%. In total, thirteen patients died during the study (1,5%). During chemotherapy there were 19% leukopenia as the most common WHO grade III/IV toxicity (4xABVD: 22 %, 2xABVD: 15%). Radiotherapy was well tolerated with dysphagia in 2.3%. Altogether ten secondary neoplasias were seen: 1AML, 4 NHL and 5 solid tumors. After a median observation time of two years, overall survival (OS) and freedom from treatment failure (FFTF) rates were 98.5% and 96.6%, respectively. No statistical differences in FFTF and OS were detected between 4xABVD and 2xABVD. In addition, there was no statistical difference between the different doses of radiotherapy (30Gy vs. 20Gy). Conclusions: Since only few events were observed, the results of this interim analysis can be interpreted as a trend that therapy intensity in combined modality treatment of early stage might be further reduced in terms of the number of chemotherapy cycles as well as the radiotherapy dose, even in IF-RT setting.