Panettiere F J, Haas C, McDonald B, Costanzi J J, Talley R W, Athens J, Oishi N, Heilbrun L K, Chen T T
J Clin Oncol. 1984 May;2(5):420-4. doi: 10.1200/JCO.1984.2.5.420.
The FAM combination with the simultaneous administration of 5-fluorouracil, doxorubicin, and mitomycin C is considered standard chemotherapy for gastric adenocarcinoma. This study was initiated to determine whether a kinetically designed sequential administration of these three drugs would be superior and whether the presence or absence of easily measurable tumor would imply differences in survival. To do so, the Southwest Oncology Group tested two schedules in a randomized study of 239 patients. Independent judgments of response were made by two authors with the same results. Equivalent response rates (23% of all eligible sequential and 30% simultaneous) and median survival durations (22 and 23 weeks, respectively) were seen. Patients with and without readily measurable tumors each lived a median of 22 weeks. Higher degrees of hematologic toxicity were associated with prolonged survival (median 27 weeks versus 20 weeks, p = 0.04). Patients treated by community oncologists were described as having higher response rates than those treated in major medical centers (64% versus 31%, p = 0.03). The meaning of this is questionable in that there were no statistical differences in survival or toxicity. Those with prior exposure to 5-fluorouracil had only a tendency, without statistical significance, for a slightly inferior response and survival.
FAM方案联合同时使用5-氟尿嘧啶、阿霉素和丝裂霉素C被认为是胃腺癌的标准化疗方案。开展这项研究是为了确定这三种药物按动力学设计的序贯给药是否更优,以及是否存在易于测量的肿瘤是否意味着生存存在差异。为此,西南肿瘤协作组在一项对239例患者的随机研究中测试了两种给药方案。由两位作者对反应进行独立判断,结果相同。观察到等效的缓解率(所有符合条件的序贯给药患者中为23%,同时给药患者中为30%)和中位生存期(分别为22周和23周)。有和没有易于测量肿瘤的患者中位生存期均为22周。更高程度的血液学毒性与生存期延长相关(中位生存期27周对20周,p = 0.04)。社区肿瘤学家治疗的患者被描述为缓解率高于在主要医疗中心治疗的患者(64%对31%,p = 0.03)。鉴于生存或毒性方面没有统计学差异,这一结果的意义值得怀疑。先前接触过5-氟尿嘧啶的患者仅有一种趋势,即反应和生存略差,但无统计学意义。