Neoadjuvant treatment for unresectable rectal cancer: An interim analysis of a multicentre randomized study

被引:45
作者
Bujko, Krzysztof [1 ,7 ]
Nasierowska-Guttmejer, Anna [2 ]
Wyrwicz, Lucjan [3 ]
Malinowska, Malgorzata [4 ]
Krynski, Jacek [3 ]
Kosakowska, Ewa [3 ]
Rutkowski, Andrzej [3 ]
Pietrzak, Lucyna [1 ,7 ]
Kepka, Lucyna [1 ,7 ]
Radziszewski, Jakub [1 ,7 ]
Olszyna-Serementa, Marta [1 ,7 ]
Bujko, Magdalena [1 ,7 ]
Danek, Anna [5 ]
Kryj, Mariusz [6 ]
Wydmanski, Jerzy
Zegarski, Wojciech [8 ]
Markiewicz, Wlodzimierz [9 ]
Lesniak, Tadeusz [10 ]
Zygulski, Ireneusz [11 ]
Porzuczek-Zuziak, Dorota [12 ]
Bebenek, Marek [13 ]
Maciejczyk, Adam
Polkowski, Wojciech [15 ]
Czeremszynska, Beata [16 ]
Cieslak-Zeranska, Ewa [17 ]
Toczko, Zygmunt [18 ]
Radkowski, Andrzej [19 ]
Kolodziejski, Leszek [20 ]
Szczepkowski, Marek [21 ,22 ]
Majewski, Adam [14 ,23 ]
Jankowski, Michal [8 ]
机构
[1] M Sklodowska Curie Mem Canc Ctr, Dept Radiotherapy 2, Warsaw, Poland
[2] Minist Internal Affairs & Adm, Clin Hosp, Dept Pathol, Warsaw, Poland
[3] M Sklodowska Curie Mem Canc Ctr, Dept Colorectal Canc, Warsaw, Poland
[4] M Sklodowska Curie Mem Canc Ctr, Dept Pathol, Warsaw, Poland
[5] M Sklodowska Curie Mem Canc Ctr, Dept Radiotherapy 1, Warsaw, Poland
[6] M Sklodowska Curie Mem Canc Ctr, Dept Surg, Gliwice, Poland
[7] M Sklodowska Curie Mem Canc Ctr, Dept Radiotherapy, PL-02781 Warsaw, Poland
[8] Reg Ontol Ctr, Dept Surg, Bydgoszcz, Poland
[9] Bialystok Oncol Ctr, Dept Surg, Bialystok, Poland
[10] Beskid Ctr Oncol, Dept Surg, Bielsko Biala, Poland
[11] Beskid Ctr Oncol, Dept Radiotherapy, Bielsko Biala, Poland
[12] Beskid Ctr Oncol, Dept Med Oncol, Bielsko Biala, Poland
[13] Lower Silesian Oncol Ctr, Dept Surg, Wroclaw, Poland
[14] Lower Silesian Oncol Ctr, Dept Radiotherapy, Wroclaw, Poland
[15] Med Univ, Dept Surg, Lublin, Poland
[16] Warminsko Mazurskie Ctr Oncol, Dept Med Oncol, Olsztyn, Poland
[17] Warminsko Mazurskie Ctr Oncol, Dept Radiotherapy, Olsztyn, Poland
[18] Reg Hosp, Dept Surg, Elblag, Poland
[19] Reg Canc Ctr, Dept Radiotherapy, Tarnow, Poland
[20] Reg Canc Ctr, Dept Surg, Tarnow, Poland
[21] J Pilsudski Univ Phys Educ, Dept Rehabil, Inst Rehabil Gen, Warsaw, Poland
[22] J Pilsudski Univ Phys Educ, Colorectal Surg Dept Rehabil, Warsaw, Poland
[23] Int Ctr Oncol, Dept Surg, Walbrzych, Poland
关键词
Unresectable rectal cancer; Preoperative chemoradiation; SHORT-COURSE RADIOTHERAPY; PREOPERATIVE RADIOTHERAPY; DELAYED SURGERY; PHASE-III; PRIMARY TUMOR; TRIAL; CHEMORADIATION; CHEMORADIOTHERAPY; OXALIPLATIN; CHEMOTHERAPY;
D O I
10.1016/j.radonc.2013.03.001
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To present an interim analysis of the trial comparing two neoadjuvant therapies for unresectable rectal cancer. Methods: Patients with fixed cT3 or cT4 or locally' recurrent rectal cancer without distant metastases were randomized to either 5 x 5 Gy and 3 courses of FOLFOX4 (schedule I) or 50.4 Gy delivered in 28 fractions given simultaneously with 5-Fu, leucovorin and oxaliplatin (schedule II). Surgery in both groups was performed 12 weeks after the beginning of radiation and 6 weeks after neoadjuvant treatment. Results: 49 patients were treated according to schedule I and 48 according to schedule II. Grade III+ acute toxicity was observed in 26% of patients in group I and in 25% in group II. There were two toxic deaths, both in group II. The microscopically radical resection (primary endpoint) rate was 73% in group I and 71% in group II. Overall and severe postoperative complications were recorded in 27% and 9% of patients vs. 16% and 7%, respectively. Pathological complete response was observed in 21% of the patients in group I and in 9% in group II. Conclusions: The interim analysis revealed no major differences in acute toxicity and local efficacy between the two evaluated strategies. (C) 2013 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 107 (2013) 171-177
引用
收藏
页码:171 / 177
页数:7
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