Division of Cancer Chemotherapy Center and Gastroenterology, Osaka Medical College Hospital, Osaka, Japan.
Digestion. 2013;87(1):59-64. doi: 10.1159/000343943. Epub 2013 Jan 21.
BACKGROUND/AIM: Combination chemotherapies of oxaliplatin or irinotecan with fluoropyrimidine and molecular target drug were reported to be active in several clinical studies and so regarded as a first-line standard therapy for unresectable or metastatic colorectal cancer. However, the incidence of adverse events is not so low. We investigated the efficacy and safety of chemotherapy combined bevacizumab with fluoropyrimidine as a first-line treatment for frail patients.
Twenty-six patients with unresectable or metastatic colorectal cancer who were treated with first-line chemotherapy combined bevacizumab with S-1 or 5FU/LV (modified Roswell Park Memorial Institute regimen) at our hospital between October 2007 and December 2010 were retrospectively investigated.
The median age was 72 years (range 66-84). Performance status was 0, 1 and 2 in 8, 17 and 1 patient, respectively. The primary lesion was located in the colon in 14 patients and in the rectum in 12. Twenty patients were with resection of the primary lesion and 6 were without, 8 were with postoperative adjuvant chemotherapy and 18 were without. The number of metastasized organs was 1, 2 and 3 in 17, 9 and 0 patients, respectively. The liver, lung, lymph node and peritoneum were metastasized in 9, 9, 11 and 5 patients, respectively. The KRAS gene was wild in 11, mutated in 7 and unknown in 8 patients. Bevacizumab with S-1 was used in 17 patients and bevacizumab with 5FU/LV was used in 9. Response and disease control rates were 50 and 100%, respectively. The median duration of progression-free survival was 9.1 months and the median time to treatment failure was 9.0 months. The incidences of all grades of neutropenia and hypertension were 31%, those of grade 3 or severer were 12%, and those of other adverse events were low. Grade 3 cerebral hemorrhage, grade 4 pulmonary embolism and grade 5 febrile neutropenia each occurred in 1 patient.
The first-line chemotherapy combined bevacizumab with fluoropyrimidine for frail patients with unresectable or metastatic colorectal cancer in Japan was comparable to the safety and efficacy of combination therapy reported previously in Western countries.
背景/目的:奥沙利铂或伊立替康联合氟嘧啶和分子靶向药物的联合化疗在几项临床研究中显示出活性,因此被认为是不可切除或转移性结直肠癌的一线标准治疗。然而,不良反应的发生率并不低。我们研究了贝伐单抗联合氟嘧啶化疗作为虚弱患者一线治疗的疗效和安全性。
我们回顾性分析了 2007 年 10 月至 2010 年 12 月在我院接受一线化疗联合贝伐单抗联合 S-1 或 5FU/LV(改良罗格斯帕克纪念研究所方案)治疗的 26 例不可切除或转移性结直肠癌患者。
中位年龄为 72 岁(范围 66-84 岁)。体能状态为 0、1 和 2 的患者分别为 8、17 和 1 例。原发性病变位于结肠 14 例,直肠 12 例。20 例患者行原发病灶切除术,6 例未行,8 例术后辅助化疗,18 例未行。转移器官数为 1、2 和 3 的患者分别为 17、9 和 0 例。肝、肺、淋巴结和腹膜转移患者分别为 9、9、11 和 5 例。KRAS 基因野生型 11 例,突变型 7 例,未知型 8 例。贝伐单抗联合 S-1 治疗 17 例,贝伐单抗联合 5FU/LV 治疗 9 例。有效率和疾病控制率分别为 50%和 100%。无进展生存期的中位时间为 9.1 个月,治疗失败时间的中位时间为 9.0 个月。所有级别中性粒细胞减少症和高血压的发生率为 31%,3 级或更严重的发生率为 12%,其他不良反应发生率较低。1 例患者分别发生 3 级脑出血、4 级肺栓塞和 5 级发热性中性粒细胞减少症。
日本不可切除或转移性结直肠癌虚弱患者的一线化疗联合贝伐单抗联合氟嘧啶与先前报道的西方国家联合治疗的安全性和疗效相当。