Preoperative Chemoradiotherapy for Rectal Cancer: Randomized Trial Comparing Oral Uracil and Tegafur and Oral Leucovorin Vs. Intravenous 5-Fluorouracil and Leucovorin

Torre, Alejandro de la; Garcia-Berrocal, M.I.; Arias, Fernando; Mariño, Alfonso; Valcárcel, Francisco; Magallón, Rosa; Regueiro, C.A.; Romero, Jesús; Zapata, I.; Fuente, Cristina De La; Fernández-Lizarbe, E.; Vergara, Gloria; Belinchón, Belén; Veiras, M.; Molerón, R.; Millán, Isabel

doi:10.1016/j.ijrobp.2007.05.068

Cited by 33 publications

(24 citation statements)

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“…Oral fluoropyrimidines mimic continuously infused FU and simplify chemoradiation. Nevertheless, randomized phase III studies revealed that the administration of oral fluoropyrimidines with preoperative radiotherapy achieved similar rates of ypCR and tumor downstaging compared to 5-FU [31,32]. …”

Section: Discussionmentioning

confidence: 99%

Clinical predictive factors of pathologic tumor response after preoperative chemoradiotherapy in rectal cancer

et al. 2012

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PurposeThe aim of this study was to identify clinical predictive factors for tumor response after preoperative chemoradiotherapy (CRT) in rectal cancer.Materials and MethodsThe study involved 51 patients who underwent preoperative CRT followed by surgery between January 2005 and February 2012. Radiotherapy was delivered to the whole pelvis at a dose of 45 Gy in 25 fractions, followed by a boost of 5.4 Gy in 3 fractions to the primary tumor with 5 fractions per week. Three different chemotherapy regimens were used (5-fluorouracil and leucovorin, capecitabine, or tegafur/uracil). Tumor responses to preoperative CRT were assessed in terms of tumor downstaging and pathologic complete response (ypCR). Statistical analyses were performed to identify clinical factors associated with pathologic tumor response.ResultsTumor downstaging was observed in 28 patients (54.9%), whereas ypCR was observed in 6 patients (11.8%). Multivariate analysis found that predictors of downstaging was pretreatment relative lymphocyte count (p = 0.023) and that none of clinical factors was significantly associated with ypCR.ConclusionPretreatment relative lymphocyte count (%) has a significant impact on the pathologic tumor response (tumor downstaging) after preoperative CRT for locally advanced rectal cancer. Enhancement of lymphocyte-mediated immune reactions may improve the effect of preoperative CRT for rectal cancer.

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Section: Discussionmentioning

confidence: 99%

Clinical predictive factors of pathologic tumor response after preoperative chemoradiotherapy in rectal cancer

et al. 2012

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“…In general, UFT 300–400 mg/m 2 /day plus leucovorin (LV) 25–75 mg/day for 5 days a week at 45 Gy radiation (RT) for locally advanced rectal cancer was efficacious and tolerable [4]. This combination produced comparable outcomes to 5-FU in terms of toxicity profile and pathologic complete response rate in a randomized trial, although the study was underpowered due to incomplete accrual [5]. …”

Section: Introductionmentioning

confidence: 99%

A phase II study of preoperative chemoradiation with tegafur-uracil plus leucovorin for locally advanced rectal cancer with pharmacogenetic analysis

Kim

Baek

et al. 2017

Radiat Oncol

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“…The pathological CR rate achieved in this study was a little lower (9% pathological CR), although 23% of patients had only residual microscopic foci and 54% of patients were downstaged. De la Torre et al [11] have recently published the results of a randomized phase III trial comparing 5FU/LV versus UFT/LV given concurrently with preoperative irradiation (45 -50.4 Gy) in patients with locally advanced rectal cancer. The authors reported a pathological CR rate of 13% in both arms.…”

Section: Discussionmentioning

confidence: 99%

“…Phase II studies have shown that the UFT/radiotherapy combination is effective and well tolerated in the preoperative treatment of rectal cancer [7][8][9][10][11]. On the other hand, CDHP (gimeracil), a component of S-1, has potent radiosensitizing property [12].…”

Section: Introductionmentioning

confidence: 99%

A Phase II Trial of Preoperative Chemoradiotherapy with Oral DPD-Inhibitory Fluoropyrimidines in Patients with Advanced Rectal Cancer

Hotchi¹,

Okitsu²,

Miura³

et al. 2012

JCT

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Background: Preoperative chemoradiotherapy (CRT) with 5-FU has been widely used to improve local control of disease and to preserve anal sphincter in the treatment of rectal cancer. UFT and S-1 as oral dihydropyrimidine dehydrogenase (DPD)-inhibitory fluoropyrimidines enhance the therapeutic effect of 5-FU by modulating its metabolic pathways. The purpose of this study was to evaluate the efficacy and toxicity of CRT using UFT versus S-1 in patients with locally advanced rectal cancer. Methods: Fifty-nine patients who received preoperative CRT (40 Gy radiotherapy) were randomly assigned to either UFT or S-1 groups. UFT and S-1 were administered during the radiotherapy course. Response to CRT was determined using a histopathologic examination and RECIST of surgically resected specimens and classified as responders (CR, PR and Grade 2, 3) or nonresponders (SD, PD and Grade 0, 1). Results: All patients were randomly allocated to S-1 group (n = 30) or UFT group (n = 29). Pathological response rate (Grade 2 and Grade 3) was 57% in the S-1 group and 45% in the UFT group (p = 0.36). Pathological complete response (CR) rate (Grade3) was 7% in the S-1 group and 4% in the UFT group (p = 0.98). There was no statistically significant difference between the two groups in regard to the response rate of RECIST (p = 0.52). There was no statistically significant difference between the groups based on the downstaging rate, resection of tumor, sphincter preservation and marginal invasion. The incidence of Grade 3 diarrhea was significantly more frequent in the S-1 group (7%) compared with the UFT group (0%) (p = 0.02). Conclusion: The results supported the conclusion that CRT using UFT or S-1 is effective and feasible for patients with locally advanced rectal cancer.

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Preoperative Chemoradiotherapy for Rectal Cancer: Randomized Trial Comparing Oral Uracil and Tegafur and Oral Leucovorin Vs. Intravenous 5-Fluorouracil and Leucovorin

Cited by 33 publications

References 45 publications

Clinical predictive factors of pathologic tumor response after preoperative chemoradiotherapy in rectal cancer

Clinical predictive factors of pathologic tumor response after preoperative chemoradiotherapy in rectal cancer

A phase II study of preoperative chemoradiation with tegafur-uracil plus leucovorin for locally advanced rectal cancer with pharmacogenetic analysis

A Phase II Trial of Preoperative Chemoradiotherapy with Oral DPD-Inhibitory Fluoropyrimidines in Patients with Advanced Rectal Cancer

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