Wang W S, Chiou T J, Liu J H, Fan F S, Yen C C, Tung S L, Chen P M
Department of Medicine, Veterans General Hospital-Taipei, Taiwan.
Jpn J Clin Oncol. 1999 Jan;29(1):33-7. doi: 10.1093/jjco/29.1.33.
The ESHAP regimen, a combination of the chemotherapeutic drugs etoposide, methylprednisolone (solumedrol), high-dose cytarabine (ara-C) and cisplatin, has been shown to be active against refractory non-Hodgkin's lymphoma in therapeutic trials. We were interested in determining whether this regimen would be effective and tolerable for Chinese patients.
Thirty-two patients with refractory/relapsed non-Hodgkins lymphoma (23 intermediate-grade and nine high-grade) were enrolled in this study. Etoposide was administered at a dose of 40 mg/m2/day as a 1 h intravenous infusion from day 1 to day 4, solumedrol 500 mg/day was given as a 15 min intravenous infusion from day 1 to day 5, ara-C 2 g/m2 was given as a 2 h intravenous infusion on day 5 and cisplatin was given at a dose of 25 mg/m2/day as a continuous infusion from day 1 to day 4. Clinical efficacy and toxicity were assessed on the basis of the WHO criteria.
Ten patients (31.3%, 95% Cl 15.2-47.4%) attained complete remission (CR) and seven had partial remission (PR). The overall response rate was 53.1% (95% Cl 35.8-70.4%). In eight of the 10 CR patients, the remission lasted for more than 8 months. The remaining two patients had CR of 5 and 6 months. The median duration of CR was 12.2 months (range 5-22 months). Myelosuppression with subsequent infections was the major toxicity. Severe leukopenia (WBC < 1000/microliter) lasted for an average of 12 days and thrombocytopenia (< 25,000/microliter) 18 days. One patient (3.1%) died of neutropenia-associated sepsis within 4 weeks after treatment. Non-myeloid toxicities included alopecia in 66% (28% grade 2, 22% grade 3), stomatitis in 72% (25% grade 2, 28% grade 3, 13% grade 4), hepatotoxicity in 9% (3% grade 2), renal toxicity in 13% (6% grade 2, 3% grade 3) and infection in 56% (18% grade 2, 25% grade 3, 13% grade 4). The majority of the responders relapsed within 2 years after ESHAP treatment. Median survival for all patients was 8.6 months.
ESHAP is an active and tolerable regimen in Chinese patients with relapsed/refractory lymphoma, but the duration of remission is brief and without significant impact on survival.
ESHAP方案是一种联合使用化疗药物依托泊苷、甲泼尼龙（甲强龙）、大剂量阿糖胞苷（阿糖胞嘧啶）和顺铂的方案，在治疗试验中已显示出对难治性非霍奇金淋巴瘤有效。我们感兴趣的是确定该方案对中国患者是否有效且可耐受。
32例难治性/复发性非霍奇金淋巴瘤患者（23例中度恶性和9例高度恶性）纳入本研究。依托泊苷剂量为40mg/m²/天，于第1天至第4天静脉输注1小时；甲强龙500mg/天，于第1天至第5天静脉输注15分钟；阿糖胞苷2g/m²于第5天静脉输注2小时；顺铂剂量为25mg/m²/天，于第1天至第4天持续静脉输注。根据世界卫生组织标准评估临床疗效和毒性。
10例患者（31.3%，95%可信区间15.2 - 47.4%）达到完全缓解（CR），7例部分缓解（PR）。总缓解率为53.1%（95%可信区间35.8 - 70.4%）。10例CR患者中有8例缓解持续超过8个月。其余2例患者CR分别为5个月和6个月。CR的中位持续时间为12.2个月（范围5 - 22个月）。骨髓抑制及随后的感染是主要毒性。严重白细胞减少（白细胞计数<1000/微升）平均持续12天，血小板减少（<25,000/微升）持续18天。1例患者（3.1%）在治疗后4周内死于中性粒细胞减少相关的败血症。非骨髓毒性包括脱发66%（28%为2级，22%为3级）、口腔炎72%（25%为2级，28%为3级，13%为4级）、肝毒性9%（3%为2级）、肾毒性13%（6%为2级，3%为3级）和感染56%（18%为2级，25%为3级，13%为4级）。大多数缓解者在ESHAP治疗后2年内复发。所有患者的中位生存期为8.6个月。
ESHAP方案对中国复发/难治性淋巴瘤患者是一种有效且可耐受的方案，但缓解期短暂，对生存期无显著影响。
