Taguchi T, Ohta K, Hotta T, Shirakawa S, Masaoka T, Kimura I
Osaka University.
Gan To Kagaku Ryoho. 1997 Aug;24(10):1263-71.
A late Phase II multicenter study with menogaril was conducted nationwide in patients with malignant lymphoma [non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD)], and ATLL, menogaril was orally administered at 100 mg daily after breakfast, for seven consecutive days with two- or three-week drug withdrawal, then menogaril administration was repeated. For malignant lymphoma, in 81 patients with NHL and 5 patients with HD registered, 70 and 5 patients were evaluable for efficacy, respectively. The efficacy rates were 32.9% (6 CRs + 17 PRs/70) for NHL and 20.0% (1 PR/5) for HD, respectively; that for the NHL patients with prior anthracycline antibiotic chemotherapy was 30.5% (5 CRs and 13 PRs/59). For ATLL, among the 16 patients registered, 15 were evaluable for efficacy, and the efficacy rate was 40.0% (2 CRs and 4 PRs/15). Adverse drug reactions frequently observed in the patients with malignant lymphoma and ATLL included bone-marrow suppression and gastrointestinal symptoms such as anorexia, and nausea/vomiting. With these results, menogaril was considered to be effective for the treatment of non-Hodgkin's lymphoma and ATLL.
一项关于美诺立尔的多中心II期晚期研究在全国范围内针对恶性淋巴瘤患者(非霍奇金淋巴瘤(NHL)、霍奇金病(HD))以及成人T细胞白血病/淋巴瘤(ATLL)开展。美诺立尔早餐后口服,每日100毫克,连续服用7天,停药2至3周后重复给药。对于恶性淋巴瘤,在登记的81例NHL患者和5例HD患者中,分别有70例和5例可评估疗效。NHL的有效率分别为32.9%(6例完全缓解 + 17例部分缓解/70例),HD为20.0%(1例部分缓解/5例);既往接受过蒽环类抗生素化疗的NHL患者有效率为30.5%(5例完全缓解和13例部分缓解/59例)。对于ATLL,在登记的16例患者中,15例可评估疗效,有效率为40.0%(2例完全缓解和4例部分缓解/15例)。恶性淋巴瘤和ATLL患者中经常观察到的药物不良反应包括骨髓抑制以及胃肠道症状,如厌食、恶心/呕吐。基于这些结果,美诺立尔被认为对非霍奇金淋巴瘤和ATLL的治疗有效。