Nakajima T, Inokuchi K, Hattori T, Inoue K, Taguchi T, Kondou T, Abe O, Kikuchi K, Tanabe T, Ogawa N
Division of Surgery, Cancer Institute Hospital.
Gan To Kagaku Ryoho. 1989 Apr;16(4 Pt 1):799-806.
The Gastric Cancer Immunochemotherapy Study Group, constituted of 412 institutions, carried out six independent trials simultaneously from 1978 to 1981. A total of 4,456 cases were subjected to the study, from which 826 cases (18.5%) were excluded due to the violence of entry criteria. Curative gastrectomy, followed by a combination of mitomycin C (MMC), Ftorafur (FT)and Krestin (PSK) produced better postoperative survivals than either combination of MMC and FT, or MMC and PSK (5-year survival rate: 71.7% in MMC + FT + PSK, 64.1% in MMC + PSK, and 58.5% in MMC + FT). In the subset of patients with negative nodes (n(-)), and with involved serosa by histological examination (ps(+)), a combination of FT and PSK after gastrectomy seemed to be more favorable for the post-operative survivals than the single use of either drug. Four drug combinations of MMC, FT, PSK and Picibanil (OK-432) also had a clinical benefit in the group of patients with poorly differentiated adenocarcinoma, compared with chemotherapy alone. These results, though there are biases due to excluding 18.5% of cases, suggest some clinical benefits in the control of cancer relapse after surgery. The conclusion should be confirmed by a further elaborate trial.
由412个机构组成的胃癌免疫化疗研究小组,在1978年至1981年期间同时开展了六项独立试验。共有4456例患者参与了该研究,其中826例(18.5%)因入组标准严格而被排除。根治性胃切除术后,联合使用丝裂霉素C(MMC)、替加氟(FT)和云芝多糖K(PSK)的患者术后生存率高于单独使用MMC和FT或MMC和PSK的患者(5年生存率:MMC + FT + PSK组为71.7%,MMC + PSK组为64.1%,MMC + FT组为58.5%)。在淋巴结阴性(n(-))且组织学检查显示浆膜受累(ps(+))的患者亚组中,胃切除术后联合使用FT和PSK似乎比单独使用任何一种药物更有利于术后生存。与单纯化疗相比,MMC、FT、PSK和匹鲁卡品(OK-432)的四种药物联合方案对低分化腺癌患者组也有临床益处。尽管由于排除了18.5%的病例存在偏差,但这些结果表明在控制术后癌症复发方面有一定的临床益处。这一结论应通过进一步精心设计的试验来证实。