Douglass H O
Roswell Park Cancer Institute, State University of New York at Buffalo.
Ann Oncol. 1994;5 Suppl 3:49-57. doi: 10.1093/annonc/5.suppl_3.s49.
Up to now, the majority of adjuvant chemotherapy trials in gastric cancer have failed to show a clear survival benefit as compared to surgical controls, and this is especially true for trials conducted in western countries. But this does not necessarily mean, that adjuvant chemotherapy of gastric cancer is in general ineffective. There are several common threads that appear repeatedly in adjuvant therapy trials which might help to explain the current situation. In most trials stratification was done according to stage and not to the TNM category leading to important stratification bias. A homogeneous surgical approach and a surgical and pathological quality control was not mandatory. There are sufficient data, that in comparison to 'limited' surgery, extended surgery with systematic lymphadenectomy of the N2 compartment markedly improves the prognosis of patients with stage II and IIIa tumors. The kind of chemotherapy, its timing and scheduling, and route of administration might also have been inappropriate to demonstrate a possible benefit of adjuvant therapy. All these things have to be considered seriously in future well designed trials, if an assumed therapeutic gain is to be demonstrated by adjuvant treatment of gastric cancer.
到目前为止，与手术对照组相比，大多数胃癌辅助化疗试验未能显示出明显的生存获益，在西方国家进行的试验尤其如此。但这并不一定意味着胃癌辅助化疗总体无效。在辅助治疗试验中反复出现了几个共同因素，这可能有助于解释当前的情况。在大多数试验中，分层是根据分期而不是TNM分类进行的，这导致了重要的分层偏差。统一的手术方法以及手术和病理质量控制并非强制性要求。有充分的数据表明，与“有限”手术相比，对N2区域进行系统性淋巴结清扫的扩大手术可显著改善II期和IIIa期肿瘤患者的预后。化疗的种类、时机、疗程安排以及给药途径可能也不适合证明辅助治疗的潜在益处。如果要通过胃癌辅助治疗证明假定的治疗效果，那么在未来精心设计的试验中必须认真考虑所有这些因素。
