CAPECITABINE INITIALLY CONCOMITANT TO RADIOTHERAPY THEN PERIOPERATIVELY ADMINISTERED IN LOCALLY ADVANCED RECTAL CANCER

被引:33
|
作者
Zampino, Maria Giulia [1 ]
Magni, Elena [1 ]
Leonardi, Maria Cristina [2 ]
Petazzi, Elena [2 ]
Santoro, Luigi [3 ]
Luca, Fabrizio [4 ]
Chiappa, Antonio [4 ]
Petralia, Giuseppe [5 ]
Trovato, Cristina [6 ]
Fazio, Nicola [1 ]
Orecchia, Roberto [2 ,7 ]
Nole, Franco [1 ]
de Braud, Filippo [1 ]
机构
[1] European Inst Oncol, Med Care Unit, Dept Med, I-20141 Milan, Italy
[2] European Inst Oncol, Div Radiotherapy, I-20141 Milan, Italy
[3] European Inst Oncol, Epidemiol & Biostat Div, I-20141 Milan, Italy
[4] European Inst Oncol, Dept Gen Surg, I-20141 Milan, Italy
[5] European Inst Oncol, Div Radiol, I-20141 Milan, Italy
[6] European Inst Oncol, Endoscopy Div, I-20141 Milan, Italy
[7] Univ Milan, I-20122 Milan, Italy
关键词
Capecitabine; Radiotherapy; Locally advanced rectal cancer; Regression; Toxicity; PREOPERATIVE RADIATION-THERAPY; PHASE-I TRIAL; TOTAL MESORECTAL EXCISION; RANDOMIZED-TRIAL; ORAL CAPECITABINE; SPHINCTER PRESERVATION; CONTINUOUS-INFUSION; CHEMORADIOTHERAPY; 5-FLUOROURACIL; LEUCOVORIN;
D O I
10.1016/j.ijrobp.2008.11.002
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To evaluate the impact of neoadjuvant capecitabine, concomitant to radiotherapy, followed by capecitabine monotherapy, in operable locally advanced rectal cancer (LARC) by measuring pathologic response and conservative surgery rate, toxicity profile, and disease-free survival (DFS). Methods and Materials: From October 2002 to July 2006, a total of 51 patients affected by LARC (T3-T4 or any node positive tumor), received capecitabine (825 mg/m(2), orally, twice daily continuously) concomitant to radio therapy on the pelvis (50.4 Gy/ 28 fractions), followed by two cycles of capecitabine (1,250 mg/m(2), orally, twice daily, 14 days on 7 days off) up until 2 weeks before surgery. Tailored adjuvant systemic treatment was discussed according to pathologic stage. Results: Of 51 patients, (median age 61 years, range 38-82 years; 19 women and 32 men; ECOG performance status 0/1/2: 46/4/1), 50 were evaluable for response: 18% complete pathologic remission; 12% T-downstaging, and 30% N-downstaging. One patient died before surgery from mesenteric stroke. Grade 3 acute toxicities were 2% diarrhea, 8% dermatitis, 2% liver function test elevation, and 2% hand-foot syndrome. Sphincter preservation rates for tumors <= 56 cm from the anal verge were 62% and 80% for the whole population. Median follow up was 43.0 months (range 0.8-68.6 months). Five-years DFS was 85.4% (95% CI = 75.3-95.4%). Conclusions: Based on our study results, we conclude that this regimen is well tolerated and active and compares favorably with existing capecitabine-based approaches. (C) 2009 Elsevier Inc.
引用
收藏
页码:421 / 427
页数:7
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