给beyond211战友译稿的建议

26.Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803) (Saltz et al: Abstract #3500)
http://www.asco.org/ac/1,1003,_12-002643-00_18-0026-00_19-001571,00.asp
原文部分:Background: Irinotecan prolongs survival in second line 5FU-refractory metastatic colorectal cancer (MCRC). First line irinotecan, weekly bolus 5FU, and leucovorin (IFL) was superior to daily x 5 bolus 5FU and leucovorin alone (FL) in a phase III trial in MCRC in terms of response rate, progression free survival and overall survival (OS). We conducted a phase III randomized study to evaluate whether IFL was also superior to weekly bolus FL after curative resection for stage III colon cancer. Methods: Eligible patients had TxN1-2M0 disease, Zubrod 0-2, and no prior chemotherapy. Patients (pts) received either IFL (irinotecan 125mg/m2 over 90 minutes followed by leucovorin 20 mg/m2 IV bolus and then 5FU 500mg/m2 IV bolus, given 4 weeks on, 2 weeks off, x 5 cycles (30 weeks total)) or the Roswell Park schedule of FL (leucovorin 500mg/m2 IV over 2 hours plus 5FU 500 mg/m2 at 1 hour after start of leucovorin, given 6 weeks on, two weeks off, x 4 cycles (32 weeks total)). Pts were stratified for N1 vs. N2 disease, high vs. low grade histology, and preoperative CEA of < 5 ng/ml, > 5ng/ml, or unknown. Results: 1264 pts were randomized between April, 1999 and April, 2001. Median follow up is 2.6 years, and 67% of total expected deaths and 85% of total expected failures have occurred. Median OS and failure-free survival (FFS) have not yet been reached. IFL shows no improvement over FL in terms of either OS (p=0.88) or FFS (p=0.84) Futility boundaries for both of these endpoints have been exceeded. Toxicities are shown in the table. 18 deaths occurred on the IFL arm during treatment vs. 6 deaths on the FL arm (p=0.008). Conclusions: In stage III colon cancer, IFL, as compared to FL, is associated with a greater degree of neutropenia, neutropenic fever, and death on treatment, with no associated clinical benefit. Weekly bolus IFL should not be used in the management of stage III colon cancer.

Gr 3-4 Diarrhea Gr 3-4 Neutropenia Febrile Neutropenia Gr 3-4 Nausea Deaths during Rx
IFL 31 % 42 % 4% 12 % 2.8 %
FL 35 % 5 % 1% 11 % 1.0 %
P value 0.11 <0.00001 0.0005 0.46 0.008

翻译部分:背景：对5Fu耐药的转移性结肠癌(MCRC)患者,依立替康作为二线用药可延长其生存期。在MCRC的一项III期试验中，一线用药以依立替康续予5Fu及甲酰四氢叶酸每周用药方案（IFL）在反应率、疾病无进展生存期以及总体生存期（OS)均优于单用5Fu和甲酰四氢叶酸每周5天（FL）的用药方案。我们进行了一项III期随机研究来评价对III期结肠癌根治性切除术后患者IFL方案是否亦优于的方案。
方法：入选患者为TxN1-2M0，Zubrod 评分在0－2，无化疗史。一组患者予IFL方案（依立替康125mg/m2，90分钟内滴完，然后依次予甲酰四氢叶酸20 mg/m2、5FU 500mg/m2静滴，给药4周、停药2周为一周期，共5周期（即时间共30周）），另一组患者予Roswell Park FL方案（甲酰四氢叶酸500mg/m2静滴2小时，于开始一小时后加用5FU 500 mg/m2，用药6周、停2周为一周期，共4周期（即时间共32周）。患者依疾病淋巴结侵犯情况( N1 vs N2)，组织学分期的高低及术前CEA的水平（< 5 ng/ml, > 5ng/ml, 或未知）分层比较。
结果：在1999年4月至2001年4月期间共有1264例患者入组。中位随访期为2.6年，有67％的总预期死亡及85％的总预期治疗失败出现。中位总体存活期及治疗有效存活期(FFS)还未达到。同FL方案相比IFL方案在OS(p＝0.84）和FFS(p＝0.88)均未见提高，这两个终点的无效边限已超出。表中列出其毒副作用。IFL组治疗过程中有18例患者死亡，而在FL组中有6例患者死亡（p＝0.008）。
结论：在III期结肠癌患者中，同FL方案相比，IFL方案易引起中性粒细胞减少、中性粒细胞减少性发烧及治疗引起的死亡，而无临床益处。IFL每周用药方案不应用于III期结肠癌患者。

整篇译稿比较通顺，但有几处关键之处有漏译和错译，需要改正：

1. bolus 一次注射，iv是注射不是静滴（Ivgtt）；

2.关于注射时间，文中有over，指不少于该时间；

3.We conducted a phase III randomized study to evaluate whether IFL was also superior to weekly bolus FL after curative resection for stage III colon cancer.
我们进行了一项III期随机研究来评价对III期结肠癌根治性切除术后患者IFL方案是否亦优于的方案。

应为：我们进行了一项III期随机研究来评价IFL方案治疗III期结肠癌根治性术后患者是否亦优于FL每周注射方案。









4. 最后一句觉得应为：IFL方案引起更多的中性粒细胞减少、中性粒细胞减少性发烧及治疗期间的死亡。