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每两周一次的CHOP或THP-COP方案治疗新诊断的侵袭性非霍奇金淋巴瘤:阿霉素与吡柔比星的比较:一项随机II期研究

Biweekly CHOP or THP-COP regimens in the treatment of newly diagnosed aggressive non-Hodgkin's lymphoma. A comparison of doxorubicin and pirarubicin: a randomized phase II study.

作者信息

Tsurumi Hisashi, Yamada Toshiki, Sawada Michio, Kasahara Senji, Kanemura Nobuhiro, Kojima Yasushi, Fukuno Kenji, Hara Takeshi, Saio Masanao, Takahashi Takeshi, Oyama Masami, Ozawa Keiya, Takami Tsuyoshi, Moriwaki Hisataka

机构信息

First Department of Internal Medicine, Gifu University School of Medicine, 40 Tsukasa-machi, 500-8705, Japan.

出版信息

J Cancer Res Clin Oncol. 2004 Feb;130(2):107-13. doi: 10.1007/s00432-003-0508-9. Epub 2003 Nov 27.

DOI:10.1007/s00432-003-0508-9
PMID:14648210
Abstract

PURPOSE

To compare the efficacy and safety of a biweekly CHOP regimen consisting of cyclophosphamide (CPA), doxorubicin (DOX), vincristine (VCR), and prednisolone (PSL) and those of a biweekly THP-COP regimen containing pirarubicin (THP), an anthracyclin with less cardiotoxicity than DOX.

METHODS

A prospective, randomized phase II study with 80 patients (40 receiving CHOP or THP-COP) less than 70 years of age with previously untreated aggressive non-Hodgkin's lymphoma (NHL). The regimens consisted of DOX or THP 50 mg/m2, CPA 750 mg/m2, VCR 1.4 mg/m2, and PSL 100 mg/body administered for 5 days every 2 weeks for eight cycles.

RESULTS

No significant differences in known prognostic factors were found between the two groups. Complete remission rate was 72.5% (72.5% for CHOP, 72.5% for THP-COP). The 5-year overall survival rate was 49.2% (43.7% for CHOP, 54.0% for THP-COP). When the patients were divided into groups with favorable or poor prognostic factors according to the International Prognostic Index, survival of the former group (L/LI) was superior to that of the later group (HI/H), regardless of chemotherapy regimen ( P < 0.001). Although grade 3 cardiotoxicity occurred in one patient in the CHOP group, no fatal toxic reactions occurred in either group. The THP-COP produced results equivalent to those of CHOP regarding efficacy and safety in aggressive NHL patients less than 70 years of age.

CONCLUSIONS

Although both regimens effectively treated those patients with favorable prognostic factors, neither was satisfactory for treating those with poor prognostic factors.

摘要

目的

比较由环磷酰胺(CPA)、阿霉素(DOX)、长春新碱(VCR)和泼尼松龙(PSL)组成的每两周一次的CHOP方案与包含吡柔比星(THP)的每两周一次的THP - COP方案的疗效和安全性,THP是一种心脏毒性比DOX小的蒽环类抗生素。

方法

一项前瞻性、随机II期研究,纳入80例年龄小于70岁、先前未接受过治疗的侵袭性非霍奇金淋巴瘤(NHL)患者(40例接受CHOP或THP - COP治疗)。方案包括每2周给药5天,共8个周期,DOX或THP 50mg/m²、CPA 750mg/m²、VCR 1.4mg/m²、PSL 100mg/体。

结果

两组之间已知的预后因素无显著差异。完全缓解率为72.5%(CHOP组为72.5%,THP - COP组为72.5%)。5年总生存率为49.2%(CHOP组为43.7%,THP - COP组为54.0%)。根据国际预后指数将患者分为预后因素良好或不良组,无论化疗方案如何,前一组(L/LI)的生存率均优于后一组(HI/H)(P<0.001)。虽然CHOP组有1例患者发生3级心脏毒性,但两组均未发生致命毒性反应。在年龄小于70岁的侵袭性NHL患者中,THP - COP在疗效和安全性方面产生的结果与CHOP相当。

结论

虽然两种方案都有效地治疗了预后因素良好的患者,但对于治疗预后因素不良的患者均不令人满意。

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