Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: a phase 2 trial.
Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: a phase 2 trial.
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DOI：
10.1038/bjc.2013.140
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发表时间：
2013-04-30
影响因子：
8.8
通讯作者：
Iaffaioli RV
中科院分区：
文献类型：
--
作者：
Nasti G;Piccirillo MC;Izzo F;Ottaiano A;Albino V;Delrio P;Romano C;Giordano P;Lastoria S;Caracò C;de Lutio di Castelguidone E;Palaia R;Daniele G;Aloj L;Romano G;Iaffaioli RV
结直肠癌（CRC）可切除肝转移的术前治疗是一个有争议的问题。本研究的目的是评估贝伐单抗联合FOLFIRI在这种情况下的可行性和活性。年龄18-75岁，PS 0-1，伴有可切除的肝局限性CRC转移的患者符合条件。患者接受贝伐单抗5 mg kg - 1，随后伊立替康180 mg m - 2，亚叶酸素200 mg m - 2, 5-氟尿嘧啶400 mg m - 2, 5-氟尿嘧啶2400 mg m - 2，每两周输注46小时，共7个周期。贝伐单抗在第6周期停止。采用单阶段，单臂2期研究设计，以1年无进展率为主要终点，需要39例患者。2007年10月至2009年12月，39例患者入组于同一机构。客观有效率为66.7%（95%精确CI: 49.8 ~ 80.9）。其中手术37例（94.9%），R0率为84.6%。5例患者病理性完全缓解（14%）。在37例患者中，16例（43.2%）至少有一种手术并发症（最常见的是胆囊瘤）。随访1年时，24例患者存活且无疾病进展（61.6%,95% CI: 44.6-76.6）。中位PFS和OS分别为14个月（95% CI: 11-24）和38个月（95% CI: 28-NA）。术前贝伐单抗联合FOLFIRI治疗可切除的结直肠癌肝转移患者是可行的，但需要进一步的研究来确定其临床相关性。
Preoperative treatment of resectable liver metastases from colorectal cancer (CRC) is a matter of debate. The aim of this study was to assess the feasibility and activity of bevacizumab plus FOLFIRI in this setting. Patients aged 18–75 years, PS 0–1, with resectable liver-confined metastases from CRC were eligible. They received bevacizumab 5 mg kg−1 followed by irinotecan 180 mg m−2, leucovorin 200 mg m−2, 5-fluorouracil 400 mg m−2 bolus and 5-fluorouracil 2400 mg m−2 46-h infusion, biweekly, for 7 cycles. Bevacizumab was stopped at cycle 6. A single-stage, single-arm phase 2 study design was applied with 1-year progression-free rate as the primary end point, and 39 patients required. From October 2007 to December 2009, 39 patients were enrolled in a single institution. Objective response rate was 66.7% (95% exact CI: 49.8–80.9). Of these, 37 patients (94.9%) underwent surgery, with a R0 rate of 84.6%. Five patients had a pathological complete remission (14%). Out of 37 patients, 16 (43.2%) had at least one surgical complication (most frequently biloma). At 1 year of follow-up, 24 patients were alive and free from disease progression (61.6%, 95% CI: 44.6–76.6). Median PFS and OS were 14 (95% CI: 11–24) and 38 (95% CI: 28–NA) months, respectively. Preoperative treatment of patients with resectable liver metastases from CRC with bevacizumab plus FOLFIRI is feasible, but further studies are needed to define its clinical relevance.
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影响因子：
8.8
作者：
Bertolini, F.;Malavasi, N.;Scarabelli, L.;Fiocchi, F.;Bagni, B.;Del Giovane, C.;Colucci, G.;Gerunda, G. E.;Depenni, R.;Zironi, S.;Fontana, A.;Pettorelli, E.;Luppi, G.;Conte, P. F.
通讯作者：
Conte, P. F.
对结直肠癌的可切除肝转移的FOLFOX4和手术的围手术性化疗（EORTC组间试验40983）：一项随机对照试验。
影响因子：
168.9
作者：
Nordlinger, Bernard;Sorbye, Halfdan;Glimelius, Bengt;Poston, Graeme J.;Schlag, Peter M.;Rougier, Philippe;Bechstein, Wolf O.;Primrose, John N.;Euan, T. Walpole;Finch-Jones, Meg;Jaeck, Daniel;Mirza, Darius;Parks, Rowan W.;Collette, Laurence;Praet, Michel;Bethe, Ullrich;Van Cutsem, Eric;Scheithauer, Werner;Gruenberger, Thomas
通讯作者：
Gruenberger, Thomas
影响因子：
254.7
作者：
Jemal, A;Tiwari, RC;Thun, MJ
通讯作者：
Thun, MJ
影响因子：
50.5
作者：
Van Cutsem, E.;Rivera, F.;Cunningham, D.
通讯作者：
Cunningham, D.
影响因子：
9
作者：
Adam, R;Pascal, G;Bismuth, H
通讯作者：
Bismuth, H