Long-term results of a phase II trial of high-dose radiotherapy (60 Gy) and UFT/l-leucovorin in patients with non-resectable locally advanced rectal cancer (LARC)
Long-term results of a phase II trial of high-dose radiotherapy (60 Gy) and UFT/l-leucovorin in patients with non-resectable locally advanced rectal cancer (LARC)
复制标题
高剂量放疗（60 Gy）和 UFT/l-亚叶酸治疗不可切除局部晚期直肠癌 (LARC) 患者的 II 期试验的长期结果
作者：
L. Vestermark;A. Jacobsen;C. Qvortrup;F. Hansen;C. Bisgaard;G. Baatrup;P. Rasmussen;P. Pfeiffer
背景。术前放化疗是不可切除的局部晚期直肠癌（LARC）患者的基石。为了改善结果（R0 切除次数和生存率），高剂量放疗 (RT) 与口服 UFT/l-亚叶酸相结合，以便在根治性手术前使肿瘤消退。方法。使用 5 场技术用兆伏光子进行骨盆 RT。放疗以 CT 为基础，每周 5 天，通过一个后野和两个侧野（48.6 Gy/27 次）进行，以涵盖原发肿瘤和区域淋巴结。此外，瘤床还接受了同时加强（5.4 Gy/27 次）和最终加强（6 Gy/3 次）；因此，GTV 接受了 60 Gy/30 部分。与 RT 同时进行的患者每天接受口服 UFT 300 mg/m2 加上 L-亚叶酸 22.5 mg 5/7 天（分为三个剂量）。结果。从2000年9月到2004年11月，这项II期研究纳入了52名LARC患者（中位年龄60岁（32-83）；中位PS 0（0-2））（36名原发性，16名复发性）。除 3 名患者外，所有患者均接受了计划的 60 Gy 治疗，中位放疗持续时间为 42 天 (25-49)。毒性非常小；只有 4 名患者的 UFT 剂量减少。未发现有临床意义的血液学毒性。经常观察到 1 级非血液学毒性（胃肠道毒性、疲劳和/或排尿困难），但只有 4 名患者出现 3 级毒性（腹泻和/或恶心/呕吐）。 40 名患者 (77%) 在 RT 完成后中位 55 天 (27-112) 进行了手术 (30 R0、5 R1、5 R2)。七名 (13%) 患者出现病理完全缓解 (pCR)。 31 名患者 (60%) 在中位 25.4 个月（1.6-45.2 个月）后死亡。 2007 年 6 月，21 名患者 (40%) 仍然活着。 结论。术前高剂量放疗和伴随的 UFT 可使大多数不可切除的 LARC 患者出现重大消退，因此治愈的机会很大。
Background. Preoperative radiochemotherapy is a cornerstone in patients with non- resectable locally advanced rectal cancer (LARC). To improve outcome (number of R0 resections and survival) high-dose radiotherapy (RT) was combined with oral UFT/l-leucovorin to allow tumour regression before radical intended surgery. Methods. Pelvic RT was delivered with megavoltage photons using a 5 field technique. RT was CT-based, given 5 days a week through one posterior field and two lateral fields (48.6 Gy/27 fractions) to encompass the primary tumour and the regional lymph nodes. In addition, the tumour bed received a concurrent boost (5.4 Gy/27 fractions) and a final boost (6 Gy/3 fractions); thus GTV received 60 Gy/30 fractions. Concurrent with RT patients received a daily dose of oral UFT 300 mg/m2 plus l-leucovorin 22.5 mg 5/7days (divided in three doses). Results. From September 2000 to November 2004, 52 patients (median age 60 years (32–83); median PS 0 (0–2)) with LARC (36 primary, 16 recurrent) were included in this phase II study. All but three patients received the planned 60 Gy, median duration of RT was 42 days (25–49). Toxicity was very modest; only four patients had a dose reduction of UFT. No hematological toxicity of clinical significance was seen. Non-hematological toxicity grade 1 (GI-toxicity, fatigue and/or dysuria) was frequently observed but only four patients experienced grade 3 toxicity (diarrhoea and/or nausea/vomiting). Forty patients (77%) were operated (30 R0, 5 R1, 5 R2) median 55 days (27–112) after completion of RT. Seven (13%) patients had a pathological complete response (pCR). Thirty-one patients (60%) died after median 25.4 months (1.6–45.2 months). Twenty-one patients (40%) are still alive June 2007. Conclusions. Preoperative high-dose RT and concomitant UFT produces major regression in most patients with non-resectable LARC and thus a good chance of cure.
影响因子：
158.5
作者：
OCONNELL, M;MARTENSON, JA;RICH, TA
通讯作者：
RICH, TA
DOI：
10.1016/s0360-3016(02)02829-8
发表时间：
2002-08-01
影响因子：
7
作者：
Pollack, A;Zagars, GK;Rosen, I
通讯作者：
Rosen, I