Fujimoto S, Takahashi M, Minami T, Ishigami H, Miyazaki M, Itoh K
Jpn J Surg. 1979 Sep;9(3):190-6. doi: 10.1007/BF02469420.
A prospective clinical trial was undertaken in 121 patients with stomach cancer to compare immunochemotherapy with 5-fluorouracil and FT-207 combined with OK-432 or PS-K, immunostimulators, and plain chemotherapy with 5-fluororacil and FT-207. Of the 121 patients who received immunochemotherapy, 67 patients (group A) had undergone curative removal of the tumor. The other 54 patients had undergone noncurative tumor removal or had recurrence after non-curative tumor removal and they were divided into two groups (groups B and C) on the basis of lymphocyte reactivity induced with PHA. Although group A exhibited a significant increase in PHA-induced lymphocyte transformation and a trifling increase in lymphocyte counts, its survival rate within a 36 month period did not differ from that of the peer controls. Group B, composed of 21 patients showing improvement of PHA-induced lymphocyte transformation, significantly prolonged its survival compared to the peer controls. The survival of group C, composed of 33 patients showing a gradual drop in PHA-induced lymphocyte transformation, was not prolonged compared to the peer control patients; and they showed significant decreases in lymphocyte counts. The overall survival of group B and group C was not superior to that of the 48 peer controls.
对121例胃癌患者进行了一项前瞻性临床试验，以比较免疫化疗（5-氟尿嘧啶和FT-207联合OK-432或PS-K，即免疫刺激剂）与单纯化疗（5-氟尿嘧啶和FT-207）的疗效。在接受免疫化疗的121例患者中，67例患者（A组）进行了肿瘤根治性切除。另外54例患者进行了非根治性肿瘤切除或在非根治性肿瘤切除后复发，根据PHA诱导的淋巴细胞反应性将他们分为两组（B组和C组）。虽然A组PHA诱导的淋巴细胞转化显著增加，淋巴细胞计数略有增加，但其36个月内的生存率与对照组无差异。B组由21例PHA诱导的淋巴细胞转化改善的患者组成，与对照组相比，其生存期显著延长。C组由33例PHA诱导的淋巴细胞转化逐渐下降的患者组成，与对照患者相比，生存期未延长；且他们的淋巴细胞计数显著下降。B组和C组总的生存率并不优于48例对照患者。
