Ravaud A, Eghbali H, Trojani M, Hoerni-Simon G, Soubeyran P, Hoerni B
Fondation Bergonié, Cancer Center, Bordeaux, France.
J Clin Oncol. 1990 Apr;8(4):608-14. doi: 10.1200/JCO.1990.8.4.608.
Between 1973 and 1977, 48 patients less than 65 years old with non-Hodgkin's malignant lymphoma (NHML) of poor prognosis (+/- high grade malignancy, +/- clinical stages III or IV, +/- first or repeated relapse) were included in a prospective clinical trial. After complete remission (CR), obtained with chemotherapy and radiotherapy, patients were randomized to receive bacillus Calmette-Guérin (BCG) or no further therapy. BCG was administered in weekly scarifications up to 3 years. Forty-three patients are assessable. Twenty-four patients have relapsed: nine out of 21 in the BCG group, and 15 out of 22 in the control group. There is a significant difference in favor of the BCG group in disease-free survival (P = .03). Twenty-one patients have died, 18 from NHML: seven in the BCG group, and 11 in the control group. There is a significant difference in favor of the BCG group for overall survival at 10 years (P = .05). A multivariate analysis points out BCG as a significant prognostic factor. Adjuvant BCG may improve particularly disease-free survival and overall survival for patients with clinical stages I and II or intermediate- and high-grade malignancy. These results suggest that in patients less than 65 years old with NHML of poor prognosis, BCG may significantly increase disease-free survival and overall survival.
1973年至1977年间，48例年龄小于65岁、预后较差的非霍奇金恶性淋巴瘤（NHML）患者（±高分级恶性肿瘤，±临床分期III或IV期，±首次或复发）被纳入一项前瞻性临床试验。在通过化疗和放疗获得完全缓解（CR）后，患者被随机分组，分别接受卡介苗（BCG）治疗或不再接受进一步治疗。BCG通过每周划痕接种的方式给药，持续3年。43例患者可进行评估。24例患者出现复发：卡介苗组21例中有9例复发，对照组22例中有15例复发。在无病生存期方面，卡介苗组具有显著优势（P = 0.03）。21例患者死亡，18例死于NHML：卡介苗组7例，对照组11例。在10年总生存期方面，卡介苗组具有显著优势（P = 0.05）。多因素分析指出卡介苗是一个显著的预后因素。辅助性卡介苗可能特别有助于改善临床分期I和II期或中高分级恶性肿瘤患者的无病生存期和总生存期。这些结果表明，对于年龄小于65岁、预后较差的NHML患者，卡介苗可能显著提高无病生存期和总生存期。
