Jacobs P, King H S, Cassidy F, Dent D M, Harrison T
Cancer Treat Rep. 1981 Nov-Dec;65(11-12):987-93.
A pilot study has previously demonstrated antitumor activity for the epipodophyllotoxin VP-16-213 in patients with diffuse lymphocytic lymphoma of the large cell (histiocytic) variety. To define this observation further, a prospective randomized trial was undertaken in patients with stage III and IV disease, comparing this agent used alone (group 1, 41 patients) to the response obtained when the same schedule of VP-16-213 was combined with either cyclophosphamide (group 2, 36 patients) or doxorubicin (group 3, 41 patients). The quantity of VP-16-213 given to patients in the three groups was equivalent. Of these 118 patients, three were lost to followup and thus were excluded from further study. Specifically included were 12 patients who died within 1 month of diagnosis while still receiving induction chemotherapy. For the three groups, complete remission rates were 39%, 26%, and 54%, and additional partial remissions were obtained in 20%, 11%, and 10% of the patients, respectively. The lower remission rates obtained in patients receiving cyclophosphamide combined with VP-16-213 are statistically significant (P less than 0.05), but no explanation for this is evident since the distribution of poor prognostic factors among the three groups was uniform. The higher percent of complete remission and the greater number of patients remaining free from disease in group 3 demonstrate the superiority of the combination of VP-16-213 with the anthracycline antibiotic doxorubicin.
一项前期试验先前已证明，表鬼臼毒素VP - 16 - 213对大细胞（组织细胞）型弥漫性淋巴细胞淋巴瘤患者具有抗肿瘤活性。为进一步明确这一观察结果，对Ⅲ期和Ⅳ期疾病患者进行了一项前瞻性随机试验，将单独使用该药物的患者（第1组，41例）与相同方案的VP - 16 - 213联合环磷酰胺（第2组，36例）或阿霉素（第3组，41例）时所获得的反应进行比较。三组患者接受的VP - 16 - 213剂量相当。在这118例患者中，3例失访，因此被排除在进一步研究之外。特别纳入的患者包括12例在诊断后1个月内死亡但仍在接受诱导化疗的患者。三组的完全缓解率分别为39%、26%和54%，另有20%、11%和10%的患者分别获得部分缓解。接受环磷酰胺联合VP - 16 - 213治疗的患者缓解率较低，具有统计学意义（P小于0.05），但对此尚无明显解释，因为三组中预后不良因素的分布是均匀的。第3组较高的完全缓解率和更多无病生存的患者表明，VP - 16 - 213与蒽环类抗生素阿霉素联合使用具有优越性。
