Yoshikawa Takaki, Tsuburaya Akira, Kobayashi Osamu, Sairenji Motonori, Motohashi Hisahiko, Noguchi Yoshikazu
Third Department of Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815, Japan.
Hepatogastroenterology. 2003 Nov-Dec;50(54):2259-63.
BACKGROUND/AIMS: Based on theories of biochemical modulation and immunotherapy, a novel regimen consisting of 5-fluorouracil, cisplatin, leucovorin, and OK-432 (FLPO therapy) was devised for the treatment of patients with advanced and recurrent gastric carcinoma.
The 14-day combination therapy consisted of continuous infusion of 5-fluorouracil (250 mg/m2/day), a bolus injection of 10 mg cisplatin and 30 mg leucovorin every other day, and a subcutaneous injection or per oral administration of OK-432 (3KE or 5KE) every other day. Thirty patients completed 59 courses of treatment consisting of 2 weeks of therapy followed by at least 2 weeks rest.
The overall response rate was 40%, with 1 complete response and 11 partial responses observed. All twelve patients responded after 1 course of treatment. The response rate differed depending upon tumor location, 22.2% at the primary site, 60.0% in the lymph nodes, 45.5% with peritoneal dissemination, 44.4% with liver metastases, 50.0% in the lung, and 100.0% with skin metastases. The most frequently observed toxicity was stomatitis (53.3%). The overall incidence of toxicities of grade 3 or greater was 6.6%, including diarrhea (3.3%) and stomatitis (3.3%). One patient required treatment interruption because of the grade 3 toxicity of diarrhea. The median survival time was 198 days overall, 242 days for responders and 125 days for non-responders.
FLPO therapy seemed to be an effective regimen for the treatment of advanced and recurrent gastric carcinoma.
背景/目的：基于生化调节和免疫治疗理论，设计了一种由5-氟尿嘧啶、顺铂、亚叶酸钙和OK-432组成的新方案（FLPO疗法），用于治疗晚期和复发性胃癌患者。
为期14天的联合治疗包括持续输注5-氟尿嘧啶（250mg/m²/天），每隔一天静脉推注10mg顺铂和30mg亚叶酸钙，以及每隔一天皮下注射或口服OK-432（3KE或5KE）。30例患者完成了59个疗程的治疗，包括2周的治疗，随后至少休息2周。
总缓解率为40%，观察到1例完全缓解和11例部分缓解。所有12例患者在1个疗程治疗后均有反应。缓解率因肿瘤部位而异，原发部位为22.2%，淋巴结为60.0%，腹膜播散为45.5%，肝转移为44.4%，肺为50.0%，皮肤转移为100.0%。最常观察到的毒性是口腔炎（53.3%）。3级或更高等级毒性的总发生率为6.6%，包括腹泻（3.3%）和口腔炎（3.3%）。1例患者因3级腹泻毒性需要中断治疗。总体中位生存时间为198天，缓解者为242天，未缓解者为125天。
FLPO疗法似乎是治疗晚期和复发性胃癌的有效方案。
