Crump Michael, Baetz Tara, Couban Stephen, Belch Andrew, Marcellus Deborah, Howson-Jan Kang, Imrie Kevin, Myers Robert, Adams Grenfell, Ding Keyue, Paul Nancy, Shepherd Lois, Iglesias Jose, Meyer Ralph
National Cancer Institute of Canada-Clinical Trials Group, Kingston, Ontario, Canada.
Cancer. 2004 Oct 15;101(8):1835-42. doi: 10.1002/cncr.20587.
Gemcitabine has been shown to have activity as a single agent in lymphoma and, when combined with cisplatin, is effective therapy for a number of solid tumors. The authors wished to determine the response rate and toxicity of gemcitabine, dexamethasone, and cisplatin for recurrent or refractory non-Hodgkin lymphoma (NHL).
Patients with recurrent or refractory diffuse large B-cell NHL or variants (REAL classification), measurable disease, and one previous chemotherapy regimen were eligible. Treatment consisted of gemcitabine 1000 mg/m(2) intravenously (i.v.) on Days 1 and 8, dexamethasone 40 mg orally on Days 1-4, and cisplatin 75 mg/m(2) i.v. on Day 1 (GDP), every 21 days as an outpatient. The primary end point was a response after two cycles. Patients could then proceed to stem cell transplantation (SCT) or receive up to six treatment cycles.
Fifty-one eligible patients were evaluable for toxicity and response. The median age of the patients was 57 years (range, 18-84 years) and most had diffuse large-cell lymphoma. After 2 cycles, there were 8 complete responses (CR; 16%) and 17 partial responses (PR; 33%). There was an overall response rate (RR) of 49% (95% confidence interval = 37-63%). The RR afer completion of all protocol chemotherapy (including those who received > 2 cycles of GDP) was 53% (11 CR, 16 PR). Grade 3 and 4 neutropenia occurred in 33% and 39% of patients, respectively. Grade 3 and 4 thrombocytopenia occurred in 24% and 4% of patients, respectively. Seven patients (14%) experienced febrile neutropenia. Of the 35 patients < 66 years, 22 (63%) proceeded to SCT.
GDP is an active regimen in B-cell NHL and can be administered with acceptable toxicity to outpatients. A Phase III trial comparing GDP with standard cisplatin-based chemotherapy is now ongoing through the National Cancer Institute of Canada Clinical Trials Group.
吉西他滨已被证明作为单一药物在淋巴瘤治疗中具有活性，并且与顺铂联合使用时，对多种实体瘤是有效的治疗方法。作者希望确定吉西他滨、地塞米松和顺铂治疗复发或难治性非霍奇金淋巴瘤（NHL）的缓解率和毒性。
复发或难治性弥漫性大B细胞NHL或变异型（REAL分类）、可测量疾病且既往接受过一种化疗方案的患者符合条件。治疗方案为第1天和第8天静脉注射（i.v.）吉西他滨1000mg/m²，第1 - 4天口服地塞米松40mg，第1天静脉注射顺铂75mg/m²（GDP方案），每21天进行一次门诊治疗。主要终点是两个周期后的缓解情况。患者随后可进行干细胞移植（SCT）或接受最多六个治疗周期。
51名符合条件的患者可评估毒性和缓解情况。患者的中位年龄为57岁（范围18 - 84岁），大多数患有弥漫性大细胞淋巴瘤。两个周期后，有8例完全缓解（CR；16%）和17例部分缓解（PR；33%）。总缓解率（RR）为49%（95%置信区间 = 37 - 63%）。所有方案化疗完成后（包括接受>2个周期GDP方案的患者）的RR为53%（11例CR，16例PR）。3级和4级中性粒细胞减少分别发生在33%和39%的患者中。3级和4级血小板减少分别发生在24%和4%的患者中。7名患者（14%）发生发热性中性粒细胞减少。在35名年龄<66岁的患者中，22名（63%）进行了SCT。
GDP方案在B细胞NHL中是一种有效的治疗方案，并且对门诊患者的毒性可接受。一项将GDP方案与基于顺铂的标准化疗进行比较的III期试验正在通过加拿大国家癌症研究所临床试验组进行。
