Low- versus high-dose interferon alfa-2a in relapsed indolent non-Hodgkin's lymphoma.

Low- versus high-dose interferon alfa-2a in relapsed indolent non-Hodgkin's lymphoma.
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低剂量与高剂量干扰素α-2a治疗复发性惰性非霍奇金淋巴瘤的比较。

DOI:
10.1093/jnci/82.3.235
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发表时间:
1990
期刊:
Journal of the National Cancer Institute
影响因子:
--
通讯作者:
Hartmann,LC
Hartmann,LC
中科院分区:
--
文献类型:
--
作者:
VanderMolen,LA;Steis,RG;Duffey,PL;Foon,KA;Smith2nd,JW;Clark,JW;Conlon,K;Stevenson,HC;Urba,WJ;Hartmann,LC

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II期临床试验报道,干扰素α(IFN-α)治疗非霍奇金淋巴瘤的应答率高达55%[综述见(/)],但最佳治疗剂量或方案尚未确定。我们在40例晚期惰性非霍奇金淋巴瘤患者中比较了两种不同的rIFN-a2 a给药方案和剂量,这些患者在化疗诱导缓解后复发或在化疗期间进展。此外,我们评估了在疾病稳定(SD)或低剂量rIFN-a2 a进展后对高剂量治疗的反应。比较低剂量组和高剂量组的总体毒性和剂量限制性毒性,要求患者有可测量的疾病,并诊断为以下亚型之一的恶性淋巴瘤:滤泡小裂细胞(NPDL)、滤泡混合型(NML)、弥漫性中分化淋巴细胞(DIDL)、小淋巴细胞(DWDL)或弥漫性小裂细胞(DPDL)淋巴瘤。根据美国国家癌症研究所的临床模式,这五种组织学类型被归类为惰性淋巴瘤(2)。所有40例患者均能走动,Karnofsky体力状态为60%或更高。所有患者之前均接受过联合化疗。大多数患者对既往化疗有初始反应,但对化疗产生耐药性或在化疗诱导缓解后进展(表1)。11例患者在联合化疗后3个月内复发,9例患者在接受联合化疗时发生疾病进展(PD)。其余患者在既往治疗后进展超过3个月。末次治疗与入组试验之间至少间隔4周。
Phase II trials have reported response rates with interferon alfa (IFN-a) up to 55%[reviewed in (/)] in non-Hodgkin's lymphoma, but the optimal therapeutic dose or schedule has not been determined. We compared two different schedules and doses of rIFN-a2a in 40 patients with advanced-stage indolent non-Hodgkin's lymphoma who had either relapsed from a chemotherapyinduced remission or had progressed while on chemotherapy. Additionally, we evaluated the response to high-dose therapy after stable disease (SD) or progression on low-dose rIFN-a2a. Overall toxicity and dose-limiting toxicity between the low-and high-dose groups were also compared.Patients were required to have measurable disease and a diagnosis of malignant lymphoma of one of the following subtypes: follicular small cleaved cell (NPDL), follicular mixed (NML), diffuse intermediately differentiated lymphocytic (DIDL), small lymphocytic (DWDL), or diffuse small cleaved cell (DPDL) lymphoma. These five histologic types are classified as indolent lymphomas according to the National Cancer Institute clinical schema (2). All 40 patients were ambulatory with a Karnofsky performance status of 60% or higher. All had been treated previously with combination chemotherapy. Most patients had had an initial response to previous chemotherapy but had become resistant to chemotherapy or had progressed after a chemotherapy-induced remission (table 1). Eleven patients had relapsed within 3 months of achieving a response to combination chemotherapy, and nine patients had progressive disease (PD) while receiving combination chemotherapy. The remainder had progressed more than 3 months after previous therapy. A minimum of 4 weeks had elapsed between the time of the last treatment and entry in the trial.