Hughes Brett G M, Yip Desmond, Chao Michael, Gibbs Peter, Carroll Susan, Goldstein David, Burmeister Bryan, Karapetis Christos
Medical Oncology Unit, The Canberra Hospital, Canberra, ACT, Australia.
ANZ J Surg. 2004 Nov;74(11):951-6. doi: 10.1111/j.1445-1433.2004.03218.x.
Improved disease free and overall survivals were seen in curatively resected patients with gastric and gastroesophageal adenocarcinoma treated with the Intergroup 0116 (INT 0116) protocol of postoperative adjuvant chemoradiotherapy compared to surgery alone. This protocol has not been widely adopted in Australian centres because of perceived risks of toxicity.
We reviewed the case records from 45 consecutive patients treated between May 1998 and August 2003 with the INT 0116 protocol and variations at five Australian institutions. The median age was 61.5 years (range 38-79). Twenty-nine patients had gastric and 12 had gastroesophageal junction primaries. All patients had attempted curative resection, however, seven had involved microscopic margins (R1 resection). Thirty-five had regional node involvement and none had evidence of distant metastasis.
The overall National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 grade 3 and grade 4 toxicity rates for all patients were 37.8% and 4.4%, respectively. There were no treatment related deaths. Gastrointestinal grade 3 toxicity was observed in 20% of patients, while haematologic grade 3 and 4 toxicity was observed in 17.8%. Toxicities experienced led to chemotherapy dose reductions in 22 patients and dose delay in 11 patients. Seven patients had a delay in radiotherapy and two did not proceed with radiotherapy. At a median follow up of 16 months (range 5-35) from surgery, 28 patients have relapsed (six with local recurrence alone) with 22 deaths occurring, all but one caused by cancer.
The INT 0116 protocol is a safe and feasible schedule in a multicentre setting with an acceptable rate of toxicity and is an appropriate adjuvant treatment option for high-risk resected gastroesophageal adenocarcinoma.
与单纯手术相比,采用0116组(INT 0116)术后辅助放化疗方案治疗的胃及胃食管腺癌根治性切除患者的无病生存期和总生存期得到改善。由于存在毒性风险,该方案在澳大利亚各中心尚未得到广泛采用。
我们回顾了1998年5月至2003年8月期间在澳大利亚五家机构接受INT 0116方案及相关变体治疗的45例连续患者的病例记录。中位年龄为61.5岁(范围38 - 79岁)。29例患者为胃癌,12例为胃食管交界癌。所有患者均尝试进行根治性切除,但7例患者切缘有镜下肿瘤残留(R1切除)。35例患者有区域淋巴结转移,无远处转移证据。
所有患者的总体美国国立癌症研究所通用毒性标准(NCI - CTC)2.0版3级和4级毒性发生率分别为37.8%和4.4%。无治疗相关死亡。20%的患者出现3级胃肠道毒性,17.8%的患者出现3级和4级血液学毒性。毒性反应导致22例患者化疗剂量减少,11例患者化疗剂量延迟。7例患者放疗延迟,2例患者未进行放疗。术后中位随访16个月(范围5 - 35个月),28例患者复发(6例仅局部复发),22例患者死亡,除1例外均由癌症引起。
INT 0116方案在多中心环境中是一种安全可行的方案,毒性发生率可接受,是高危胃食管腺癌根治性切除术后合适的辅助治疗选择。