Gutterman J U, Cardenas J O, Blumenschein G R, Hortobagyi G, Burgess M A, Livingston R B, Mavligit G M, Freireich E J, Gottlieb J A, Hersh E M
Br Med J. 1976 Nov 20;2(6046):1222-5. doi: 10.1136/bmj.2.6046.1222.
Forty-five patients with disseminated breast cancer were given a trial of combination chemotherapy consisting of fluorouracil, adriamycin, and cyclophosphamide (FAC) and immunotherapy with BCG given by scarification. The results were compared with those in a comparable group of 44 patients treated with FAC alone immediately before the chemoimmunotherapy study. The remission rates (73% and 76% for FAC and FAC-BCG respectively) were similar in both studies. The durations of remission for patients on FAC-BCG (medium 12 months) were longer than remissions achieved for patients given FAC alone (median 8 months) (P = 0.068). The most notable effect of BCG was on survival. Thus 21 out of 34 patients achieving remission on FAC-BCG were alive at the time of the last follow-up examination (median over 22 months) compared with 11 out of 32 patients achieving remission on FAC (median 15 months) (P = 0.01). Twenty-six of the 45 patients given FAC-BCG were alive at the time of the last follow-up examination (median over 22 months) compared with 12 of the 44 patients given FAC (median 15 months) (P = 0.005). Although the apparent benefit of BCG could be explained by a maldistribution of some prognostic factors, the data suggest that further trial of chemoimmunotherapy of breast cancer should be carried out.
45例播散性乳腺癌患者接受了由氟尿嘧啶、阿霉素和环磷酰胺（FAC）组成的联合化疗试验，并通过划痕接种卡介苗进行免疫治疗。将结果与在化疗免疫治疗研究之前立即接受单纯FAC治疗的44例可比患者组的结果进行比较。两项研究中的缓解率相似（FAC组和FAC - BCG组分别为73%和76%）。接受FAC - BCG治疗的患者缓解期（中位12个月）比单纯接受FAC治疗的患者缓解期（中位8个月）更长（P = 0.068）。卡介苗最显著的作用是对生存的影响。因此，在最后一次随访检查时，34例接受FAC - BCG治疗获得缓解的患者中有21例存活（中位超过22个月），而32例接受FAC治疗获得缓解的患者中有11例存活（中位15个月）（P = 0.01）。45例接受FAC - BCG治疗的患者中有26例在最后一次随访检查时存活（中位超过22个月），而44例接受FAC治疗的患者中有12例存活（中位15个月）（P = 0.005）。虽然卡介苗的明显益处可能是由于一些预后因素分布不均所致，但数据表明应进一步开展乳腺癌化疗免疫治疗试验。
