A phase II study of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed or refractory non-Hodgkin lymphoma

IF 3.3 4区 医学 Q2 HEMATOLOGY
Yoshikazu Ikoma, Nobuhiko Nakamura, Junichi Kitagawa, Takao Miwa, Eri Takada, Takuro Matsumoto, Yuhei Shibata, Hiroshi Nakamura, Nobuhiro Kanemura, Senji Kasahara, Takeshi Hara, Michio Sawada, Hisashi Tsurumi, Masahito Shimizu
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引用次数: 0

Abstract

This study evaluated the efficacy and safety of salvage chemotherapy with gemcitabine, carboplatin, dexamethasone, and rituximab (GCD ± R) for Japanese patients with relapsed or refractory non-Hodgkin lymphoma (NHL). A multicenter, phase II trial of GCD ± R administered every 3 weeks for up to 6 cycles was conducted. Rituximab was administered as a therapeutic strategy for CD20-positive lymphoma. The primary endpoint was the complete response (CR) rate. Secondary endpoints included the overall response (OR) rate, overall survival (OS), progression-free survival (PFS), toxicity, and success rate of peripheral blood stem cell collection for eligible transplant patients. A total of 25 patients (median age 66 years) were evaluated, with a median follow-up period of 66.7 months. CR and OR rates were 28% and 52%, respectively. Median PFS and OS were 8.7 and 32.2 months, respectively. The major toxicity was myelosuppression, but the regimen was generally well-tolerated, with a low incidence of febrile neutropenia (20%) and no treatment-related deaths. Of the 6 patients who were eligible for autologous stem cell transplantation and underwent peripheral blood stem cell mobilization, the required number of CD34-positive cells was collected in 5 (83%). All 6 proceeded to transplantation and achieved successful engraftment without recurrence. The present results suggest that GCD ± R may be effective and well-tolerated in Japanese patients with relapsed or refractory NHL. However, further investigation is needed to confirm these results.

吉西他滨、卡铂、地塞米松和利妥昔单抗治疗复发或难治性非霍奇金淋巴瘤的II期研究。
本研究评估了吉西他滨、卡铂、地塞米松和利妥昔单抗(GCD±R)联合挽救性化疗治疗日本复发或难治性非霍奇金淋巴瘤(NHL)患者的疗效和安全性。进行了一项GCD±R的多中心II期试验,每3周给药一次,最多6个周期。利妥昔单抗作为CD20阳性淋巴瘤的治疗策略。主要终点是完全缓解率。次要终点包括符合条件的移植患者的总有效率(OR)、总生存率(OS)、无进展生存率(PFS)、毒性和外周血干细胞采集成功率。共评估了25名患者(中位年龄66岁),中位随访期为66.7个月。CR率和OR率分别为28%和52%。中位PFS和OS分别为8.7个月和32.2个月。主要毒性是骨髓抑制,但该方案总体耐受性良好,发热性中性粒细胞减少症发生率较低(20%),无治疗相关死亡。在6名符合自体干细胞移植条件并接受外周血干细胞动员的患者中,5名(83%)采集到所需数量的CD34阳性细胞。所有6例均进行了移植,并成功植入,无复发。目前的结果表明,GCD±R可能对日本复发或难治性NHL患者有效且耐受性良好。然而,还需要进一步的调查来证实这些结果。
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来源期刊
Hematological Oncology
Hematological Oncology 医学-血液学
CiteScore
4.20
自引率
6.10%
发文量
147
审稿时长
>12 weeks
期刊介绍: Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged: -Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders -Diagnostic investigations, including imaging and laboratory assays -Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases -Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies -Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems. Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.
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