Jones S E, Grozea P N, Metz E N, Haut A, Stephens R L, Morrison F S, Talley R, Butler J J, Byrne G E, Hartsock R, Dixon D, Salmon S E
Cancer. 1983 Mar 15;51(6):1083-90. doi: 10.1002/1097-0142(19830315)51:6<1083::aid-cncr2820510619>3.0.co;2-m.
Between 1974 and 1977, 652 patients with non-Hodgkin's lymphoma without prior chemotherapy were randomized to 1 of 3 combination chemotherapy programs designed to induce complete remission (CR): COP-bleomycin (180 patients), CHOP-bleomycin (232 patients) or CHOP plus immunotherapy with Bacillus Calmette Guerin (BCG) (240 patients). With mature follow-up, the major effect of BCG immunotherapy was observed in patients with large cell lymphomas (diffuse or nodular "histiocytic") and not in other common lymphoma subtypes. CR rate for 65 patients with large cell lymphoma treated with CHOP-BCG was 68% compared to 48% in 61 patients treated with CHOP-bleomycin (P = 0.02) (two-tailed test) or 44% for 45 patients treated with COP-bleomycin (P = 0.02). CR duration for both CHOP-based regimens was similar and superior to that produced by COP-bleomycin (P = 0.03). Survival of patients with large cell lymphoma treated with CHOP-BCG was better than that observed with CHOP-bleomycin (P = 0.02) or COP-Bleomycin (P = 0.002). Although the explanation for the favorable effect of BCG remains unclear, further clinical trials to evaluate the combination of chemotherapy and other "biologic response modifiers" is warranted for patients with lymphoma.
1974年至1977年间，652例未经化疗的非霍奇金淋巴瘤患者被随机分为3种联合化疗方案中的一种，这些方案旨在诱导完全缓解（CR）：COP-博来霉素方案（180例患者）、CHOP-博来霉素方案（232例患者）或CHOP加卡介苗（BCG）免疫疗法（240例患者）。随着随访的成熟，观察到BCG免疫疗法的主要疗效出现在大细胞淋巴瘤（弥漫性或结节性“组织细胞性”）患者中，而在其他常见淋巴瘤亚型中未观察到。接受CHOP-BCG治疗的65例大细胞淋巴瘤患者的CR率为68%，相比之下，接受CHOP-博来霉素治疗的61例患者的CR率为48%（P = 0.02）（双侧检验），接受COP-博来霉素治疗的45例患者的CR率为44%（P = 0.02）。两种基于CHOP的方案的CR持续时间相似，且优于COP-博来霉素方案（P = 0.03）。接受CHOP-BCG治疗的大细胞淋巴瘤患者的生存率优于接受CHOP-博来霉素治疗的患者（P = 0.02）或COP-博来霉素治疗的患者（P = 0.002）。尽管BCG产生有利作用的原因尚不清楚，但对于淋巴瘤患者，有必要进行进一步的临床试验以评估化疗与其他“生物反应调节剂”的联合应用。
