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一项针对侵袭性非霍奇金淋巴瘤患者的随机EPOCH与CHOP一线治疗对比研究:长期结果

A randomized EPOCH vs. CHOP front-line therapy for aggressive non-Hodgkin's lymphoma patients: long-term results.

作者信息

Khaled H M, Zekri Z K, Mokhtar N, Ali N M, Darwish T, Elattar I, Gaafar R, Moawad M S

机构信息

Department of Medical Oncology, National Cancer Institute, Cairo, Egypt.

出版信息

Ann Oncol. 1999 Dec;10(12):1489-92. doi: 10.1023/a:1008395014398.

Abstract

BACKGROUND

The value of continuous-infusion chemotherapy (EPOCH) vs. the standard CHOP combination was evaluated in 78 patients with previously untreated aggressive non-Hodgkin's lymphoma in a randomized phase III clinical trial.

PATIENTS AND METHODS

The EPOCH regimen given to 38 patients consisted of the drugs etoposide (50 mg/m2), vincristine (0.4 mg/m2), and doxorubicin (10 mg/m2), all given in a continuous infusion on days 1-4. Cyclophosphamide (750 mg/m2) was administered on day 6 as i.v. bolus, while prednisone was given orally 60 mg/m2 on days 1-6. Courses were repeated every three weeks. CHOP was given to 40 patients as routinely prescribed.

RESULTS

Forty-eight patients were males and thirty were females. Their ages ranged from 19-75 years (median 45 years). Forty-three (55%) had grade 2 and thirty-five (45%) had grade 3 pathologic subtype. Nine patients (12%) presented with stage I, fourteen (18%) with stage II, forty (51%) with stage III, and fifteen (19%) with stage IV disease. The different clinico-pathologic characteristics, including international index categories, were comparable in the two groups. The number of courses given ranged between 3 and 9 (median 6) for both the EPOCH and CHOP regimens. Complete remission (CR) was achieved in 19 (50%), and 27 (67%) of the 38 and 40 patients for both the EPOCH and CHOP combinations, respectively. After a median observation time of 27 months, the four-year overall and failure-free survival rates were 42% and 30% for the EPOCH and 71% and 54% for the CHOP regimen (P = 0.006 and 0.1 for the overall and FFS rates, respectively). Toxicities were comparable and were mostly of grades 1 and 2, except for hair loss, hematologic toxicities, and infectious episodes which were more common in the EPOCH group. In the EPOCH group, overall survival rates were 55% vs. 22% (P < 0.04) at four years for the low-risk (2 prognostic factors) and high-risk (> 2 factors) groups, respectively.

CONCLUSIONS

Thus, it may be concluded that continuous-infusion (EPOCH) chemotherapy did not improve treatment outcome over that of the CHOP regimen for aggressive non-Hodgkin's lymphoma patients.

摘要

背景

在一项随机III期临床试验中,对78例先前未经治疗的侵袭性非霍奇金淋巴瘤患者评估了持续静脉输注化疗(EPOCH)与标准CHOP方案的价值。

患者与方法

38例患者接受的EPOCH方案包括依托泊苷(50mg/m²)、长春新碱(0.4mg/m²)和多柔比星(10mg/m²),均在第1 - 4天持续静脉输注。环磷酰胺(750mg/m²)在第6天静脉推注,而泼尼松在第1 - 6天口服,剂量为60mg/m²。每三周重复疗程。40例患者按常规处方接受CHOP方案治疗。

结果

48例为男性,30例为女性。年龄范围为19 - 75岁(中位年龄45岁)。43例(55%)为2级病理亚型,35例(45%)为3级病理亚型。9例(12%)为I期,14例(18%)为II期,40例(51%)为III期,15例(19%)为IV期疾病。两组的不同临床病理特征,包括国际预后指数类别,具有可比性。EPOCH和CHOP方案的疗程数在3至9之间(中位6个疗程)。EPOCH和CHOP方案分别使38例和40例患者中的19例(50%)和27例(67%)达到完全缓解(CR)。中位观察时间27个月后,EPOCH方案的4年总生存率和无进展生存率分别为42%和30%,CHOP方案为71%和54%(总生存率和无进展生存率的P值分别为0.006和0.1)。毒性反应具有可比性,大多为1级和2级,但脱发、血液学毒性和感染性发作在EPOCH组更常见。在EPOCH组,低风险(2个预后因素)和高风险(>2个因素)组的4年总生存率分别为55%和22%(P<0.04)。

结论

因此,可以得出结论,对于侵袭性非霍奇金淋巴瘤患者,持续静脉输注(EPOCH)化疗的治疗效果并不优于CHOP方案。

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