Comparison of 5-fluorouracil/leucovorin and capecitabine in preoperative chemoradiotherapy for locally advanced rectal cancer

Kim, Dae Yong; Jung, Kyung Hae; Kim, Tae Hyun; Kim, Duck-Woo; Chang, Hee Jin; Jeong, Jin-Yeon; Kim, Young Hoon; Son, Seok-Hyun; Yun, Tak; Hong, Chang Won; Sohn, Dae Kyung; Lim, Seok‐Byung; Choi, Hyo Seong; Jeong, Seung‐Yong; Park, Jae-Gahb

doi:10.1016/j.ijrobp.2006.08.063

Cited by 89 publications

(74 citation statements)

References 27 publications

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“…In the current trial, even though we performed meticulous pathologic examination described previously, 11 our ypCR rate or other histologic parameters were comparable with other studies that used capecitabine, [16][17][18][23][24][25][26] and our ypCR rate was higher than that of the German trial (17% vs 8%) in spite of more adverse factors (Table 7). 2 The exact reason for these differences is not clear, but we propose the following 2 explanations.…”

Section: Pathologic Responsesupporting

confidence: 84%

“…15 However, previous retrospective studies comparing capecitabine and 5-FU indicated that capecitabine was at least as effective as 5-FU in preoperative CRT regimen. [16][17][18][19] The NSABP R-04 trial is expected to provide important information about the efficacy of oral capecitabine versus 5-FU chemotherapy. 20 This trial has completed accrual and the results are pending.…”

Section: Compliance and Toxicitymentioning

confidence: 99%

“…The first explanation seems to be reasonable but not conclusive because pathologic complete response rate has been reported to be slightly higher in the capecitabine-based regimen than 5-FU. 2,3,[16][17][18]20,27 The second explanations are difficult to prove but commonly used.…”

Section: Pathologic Responsementioning

confidence: 99%

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Randomized phase 3 trial comparing preoperative and postoperative chemoradiotherapy with capecitabine for locally advanced rectal cancer

Park

Yoon

et al. 2011

Cancer

137

111

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BACKGROUND: Although many trials have shown the efficacy of preoperative chemoradiotherapy (CRT) or postoperative CRT compared with surgery alone, the optimal sequence of radiotherapy and surgery is unclear. The authors reported the final results of this single institution prospective randomized phase 3 trial comparing preoperative CRT with postoperative CRT using capecitabine in survival, local control, sphincter preservation, and toxicity for the treatment of locally advanced rectal cancer. METHODS: Patients with locally advanced rectal cancer (cT3, potentially resectable cT4 or Nþ) were randomly assigned to receive preoperative or postoperative CRT. CRT consisted of 50 Gy/ 25 fractions and concurrent capecitabine (1,650 mg/m

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Section: Pathologic Responsesupporting

confidence: 84%

Section: Compliance and Toxicitymentioning

confidence: 99%

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Randomized phase 3 trial comparing preoperative and postoperative chemoradiotherapy with capecitabine for locally advanced rectal cancer

Park

Yoon

et al. 2011

Cancer

137

111

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“…At the time of writing, there were two published phase II trials of capecitabine CRT (De Paoli, 2006;Krishnan et al, 2006) and a further study comparing capecitabine CRT to 5FU/LV (Kim et al, 2007), and all three used the 825 mg m À2 continuous daily schedule. In these studies, the number of patients receiving the full dose of capecitabine was much lower compared to our 5-day schedule.…”

Section: Discussionmentioning

confidence: 99%

“…The study by De Paoli showed that 72% of patients received the full dose, whereas in the study by Krishnan, 11 out of the 54 (20%) patients received a dose reduction, and 11 out of the 54 (20%) patients had treatment stopped before completion (it is not clear whether or not these were the same 11 patients). The study by Kim et al (2007) published no data on the number of patients receiving dose reductions but quoted a 99.3% chemotherapy completion rate. Without detailed toxicity data, it is difficult to compare compliance between the 5-and 7-day regimes, but the available evidence suggests that more dose modifications are required using a 7-day schedule.…”

Section: Discussionmentioning

confidence: 99%

Preoperative radiotherapy combined with 5 days per week capecitabine chemotherapy in locally advanced rectal cancer

et al. 2007

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There is increasing evidence supporting the use of preoperative chemoradiotherapy in patients with locally advanced rectal cancer in an attempt to facilitate complete surgical resection with clear margins. We describe our experience of using a 5-day per week regime of preoperative capecitabine chemoradiotherapy. Between November 2004 and September 2006, 70 patients with MRI-defined locally advanced rectal cancer were selected for treatment. Capecitabine was given at a dose of 900 mg m À2 for 5 days per week combined with 45 Gy of radiotherapy in 25 doses. This regime was well tolerated with 89% of our patients receiving the full dose of chemotherapy and 96% receiving the full dose of radiotherapy. Ninety-three per cent proceeded to macroscopically complete surgical resection. The pathological complete response rate was 9.2% with a node-negative rate of 66%. A negative circumferential margin was achieved by 79% of the patients who underwent resection. Compared to studies using a 7-day per week capecitabine schedule, our results show increased compliance and less dose reductions with comparable pathological outcome. There is clear evidence from two systematic reviews that adjuvant radiotherapy reduces the risk of local recurrence in patients with resectable rectal cancer (Camma et al, 2000; Colorectal Cancer Collaborative, 2001). The greatest benefit is seen when preoperative radiotherapy is used with a biologically equivalent dose of 430 Gy. Further clinical trials were required to assess the benefit of adding concurrent chemotherapy to preoperative radiotherapy.The recent publication of two phase III trials confirms that preoperative concurrent chemoradiation (CRT) is superior to long-course radiotherapy alone in patients with T3/4 or nodepositive resectable rectal cancer. The EORTC 22921 (Bosset et al, 2005) and FFCD 9203 (Gerard et al, 2006) trials compared intravenous 5-fluorouracil (5FU) and leucovorin (LV) given during the first and fifth weeks of radiotherapy with radiotherapy alone (dose of RT was 45 Gy in 25 fractions in both arms of the studies). Both trials demonstrated a reduction in the rates of local recurrence at 5 years from 17% with radiotherapy alone to 8 -9% with preoperative CRT, but neither trial showed any difference in overall survival. A further recent phase III trial has demonstrated that preoperative 5FU CRT is superior to post-operative CRT with a significant reduction in local recurrence from 12 to 6% as well as a significant reduction in both acute and long-term toxicity (Sauer et al, 2004). This evidence will clearly result in an increasing use of fluoropyrimidine-based CRT.Intravenous 5FU-based chemoradiation presents many logistical challenges. Continuous infusion of 5FU requires the insertion of a central venous line with its attendant risks of thrombosis and infection as well as the inconvenience of a portable infusion pump. The use of the bolus 5FU/LV regimen used in the EORTC and FFCD trials requires 10 daily visits to the chemotherapy day unit, with associated waiting time, t...

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Toxicity and complications of preoperative chemoradiotherapy for locally advanced rectal cancer

Swellengrebel

Marijnen

Verwaal

et al. 2011

Journal of British Surgery

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Comparison of 5-fluorouracil/leucovorin and capecitabine in preoperative chemoradiotherapy for locally advanced rectal cancer

Cited by 89 publications

References 27 publications

Randomized phase 3 trial comparing preoperative and postoperative chemoradiotherapy with capecitabine for locally advanced rectal cancer

Randomized phase 3 trial comparing preoperative and postoperative chemoradiotherapy with capecitabine for locally advanced rectal cancer

Preoperative radiotherapy combined with 5 days per week capecitabine chemotherapy in locally advanced rectal cancer

Toxicity and complications of preoperative chemoradiotherapy for locally advanced rectal cancer

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