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小细胞肺癌中循环交替化疗与反应导向化疗的比较:一项针对321例患者的德国多中心随机试验

Cyclic-alternating versus response-oriented chemotherapy in small-cell lung cancer: a German multicenter randomized trial of 321 patients.

作者信息

Wolf M, Pritsch M, Drings P, Hans K, Schroeder M, Flechtner H, Heim M, Hruska D, Mende S, Becker H

机构信息

Department of Internal Medicine, Philipps-University Hospitals, Marburg, Germany.

出版信息

J Clin Oncol. 1991 Apr;9(4):614-24. doi: 10.1200/JCO.1991.9.4.614.

DOI:10.1200/JCO.1991.9.4.614
PMID:1648598
Abstract

To test whether alternating chemotherapy is a favorable treatment modality in small-cell lung cancer (SCLC), 334 patients were randomized to receive either fixed cyclic-alternating treatment with ifosfamide/etoposide (IE), cyclophosphamide, doxorubicin, and vincristine (CAV), or response-oriented treatment with IE therapy up to maximal response and subsequently an immediate switch to CAV. In both arms, six cycles were given in 3-week intervals. After chemotherapy, patients with limited-stage disease received chest irradiation with 45 Gy. Prophylactic cranial irradiation with 30 Gy was applied to all complete responders. No maintenance therapy was given to patients with complete response. Minimum follow-up was 2 years. Of 321 assessable patients, the overall response rate was 70% for cyclic alternating and 77% for response-oriented treatment. Complete remission (CR) rates were 26% versus 26%. The median survival times were 9.7 months for cyclic-alternating versus 10.7 months for response-oriented treatment; the 2-year survival rates were 11% versus 9%. In limited-stage disease (LD) patients, there was a median survival of 12.5 months versus 12.3 months and a 2-year survival rate of 21% versus 18%. In extensive-stage disease (ED) patients, median survival was 8.5 versus 9.1 months, and the 2-year survival rate 3% versus 4%. From these results, we conclude that the cyclic-alternating treatment according to the hypothesis of Goldie et al has no advantage in comparison to a sequential treatment strategy with an immediate switch to a second-line protocol at the time no further response to first-line therapy is seen. Our major aim in the treatment of SCLC is to administer an active regimen at any time during the course of treatment regardless of whether sequential or alternating therapy is used.

摘要

为了测试交替化疗是否是小细胞肺癌(SCLC)的一种有利治疗方式,334名患者被随机分组,分别接受异环磷酰胺/依托泊苷(IE)、环磷酰胺、多柔比星和长春新碱(CAV)的固定周期交替治疗,或接受以IE疗法进行的反应导向治疗直至达到最大反应,随后立即改用CAV。在两组中,均每3周进行6个周期的治疗。化疗后,局限期疾病患者接受45 Gy的胸部照射。所有完全缓解者均接受30 Gy的预防性颅脑照射。对完全缓解的患者不给予维持治疗。最短随访时间为2年。在321名可评估患者中,周期交替治疗的总缓解率为70%,反应导向治疗为77%。完全缓解(CR)率分别为26%和26%。周期交替治疗的中位生存时间为9.7个月,反应导向治疗为10.7个月;2年生存率分别为11%和9%。在局限期疾病(LD)患者中,中位生存时间分别为12.5个月和12.3个月,2年生存率分别为21%和18%。在广泛期疾病(ED)患者中,中位生存时间分别为8.5个月和9.1个月,2年生存率分别为3%和4%。从这些结果中,我们得出结论,与在一线治疗不再有反应时立即改用二线方案的序贯治疗策略相比,根据戈尔迪等人的假设进行的周期交替治疗没有优势。我们治疗SCLC的主要目标是在治疗过程中的任何时候给予积极的治疗方案,无论使用的是序贯治疗还是交替治疗。

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引用本文的文献

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Quality-of-life assessment in small cell lung cancer.小细胞肺癌的生活质量评估
Pharmacoeconomics. 1992 Sep;2(3):181-8. doi: 10.2165/00019053-199202030-00001.
2
Economic and quality-of-life aspects of treating small cell lung cancer.治疗小细胞肺癌的经济和生活质量方面
Pharmacoeconomics. 1993 Jun;3(6):446-53. doi: 10.2165/00019053-199303060-00004.
3
Initial prognostic factors in small-cell lung cancer patients predicting quality of life during chemotherapy. Swiss Group for Clinical Cancer Research (SAKK).预测小细胞肺癌患者化疗期间生活质量的初始预后因素。瑞士临床癌症研究组(SAKK)。
Br J Cancer. 1996 Nov;74(10):1660-7. doi: 10.1038/bjc.1996.606.
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Evaluation of quality of life for diverse patient populations.不同患者群体的生活质量评估。
Breast Cancer Res Treat. 1996;40(1):87-104. doi: 10.1007/BF01806005.
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CMF vs alternating CMF/EV in the adjuvant treatment of operable breast cancer. A single centre randomised clinical trial (Naples GUN-3 study).CMF方案与交替使用CMF/EV方案在可手术乳腺癌辅助治疗中的比较。一项单中心随机临床试验(那不勒斯GUN-3研究)。
Br J Cancer. 1995 Jun;71(6):1283-7. doi: 10.1038/bjc.1995.248.
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Ifosfamide/mesna. A review of its antineoplastic activity, pharmacokinetic properties and therapeutic efficacy in cancer.异环磷酰胺/美司钠。关于其抗肿瘤活性、药代动力学特性及在癌症治疗中疗效的综述。
Drugs. 1991 Sep;42(3):428-67. doi: 10.2165/00003495-199142030-00006.