Phase II Study of Capecitabine in Substitution of 5-FU in the Chemoradiotherapy Regimen for Patients with Localized Squamous Cell Carcinoma of the Anal Canal

Oliveira, Suilane Coelho Ribeiro; Moniz, Camila Motta Venchiarutti; Riechelmann, Rachel P.; Alex, Alexandra Kichfy; Braghirolli, Maria Ignez; Bariani, Giovanni M.; Nahas, Caio Sérgio Rizkallah; Hoff, Paulo M.

doi:10.1007/s12029-015-9790-4

Cited by 53 publications

(37 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…From the remaining 158 studies, 152 were excluded as shown in Figure 1. Six trials met the predefined criteria [19, 24–28]; however, patients from the phase-I trial by Deenen et al [24] were also included in the analysis of Meulendijks’s retrospective trial [28], and for this reason, the former was excluded. Five trials were included in the pooled analysis, totalling 218 patients [19, 25–28].…”

Section: Resultsmentioning

confidence: 99%

“…There were two phase-II trials [19, 25], both open-label prospective single-arm studies, and three retrospective studies, with one of them being a comparative study [28]. The number of patients per study ranged from 24 to 62, and the median follow-up periods ranged from 14 to 23 months.…”

Section: Resultsmentioning

confidence: 99%

“…All trials reported CRR, although response evaluations differed across them: one trial [28] evaluated response only based on anal clinical examination, while the others three studies [19, 25, 26] included abdominal and pelvis imaging tests and one trial did not describe methods of response assessment [27]. Only three trials described CRR at 6 months [19, 25, 28].…”

Section: Resultsmentioning

confidence: 99%

“…Only three trials described CRR at 6 months [19, 25, 28]. The pooled analysis of these trials, with a total of 132 patients, reported a CRR at 6 months of 88% [83%–94%], considering all clinical stages (Figure 2).…”

Section: Resultsmentioning

confidence: 99%

“…Capecitabine has been assessed as a replacement for 5-FU in retrospective studies and phase-II trials in the treatment of SCCAC, including a phase II conducted by our group [19]. However, there is insufficient evidence to recommend this substitution to date.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Replacing 5-fluorouracil by capecitabine in localised squamous cell carcinoma of the anal canal: systematic review and meta-analysis

Souza¹,

Pereira²,

Araújo³

et al. 2016

ecancer

View full text Add to dashboard Cite

BackgroundThe standard treatment for localised squamous cell carcinoma of the anal canal (SCCAC) is chemoradiotherapy (CRT) with infusional 5-fluorouracil (5-FU) and mitomycin. Because 5-FU and capecitabine have offered similar efficacy in many phase-III trials of solid tumours, studies have tested capecitabine in this setting of SCCAC. However, these studies are small and have reported variable results. Therefore, a systematic review and meta-analysis was performed.MethodsMedline, Scopus and Embase were searched for studies that evaluated the efficacy outcomes of capecitabine used as a substitute of 5-FU in the CRT of localised SCCAC. The primary endpoint was complete response rate (CRR) at 6 months. Metaprop analysis of reported CRR-based on pooled estimates of proportions with corresponding 95% confidence intervals (95%CI) were calculated on the base of the Freeman-Tukey double arcsine transformation.ResultsWe retrieved 300 studies, of which six met our eligibility criteria. The capecitabine dose ranged from 500 mg/m2 to 825 mg/m2 BID for 5 days per week during radiation. With a total of 218 patients, the median follow-up was 21.5 months (14–23). The pooled analysis of three trials (N = 132 patients) reported a CRR at 6 months of 88% (83%–94%), considering all clinical stages. The pooled analysis of overall CRR (N = 218 patients), evaluated at different intervals, showed an overall CRR of 91% (87%–95%). Rates of locoregional relapse varied from 3.2% to 21%. The majority of patients completed the planned radiotherapy dose (93.5%–100%) and any chemotherapy interruption was reported in up to 55.8% of patients.ConclusionsCapecitabine is an acceptable and more convenient alternative to infusional 5-FU in the CRT for localised SCCAC, offering similar clinical CRR to those reported by phase-III trials.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Replacing 5-fluorouracil by capecitabine in localised squamous cell carcinoma of the anal canal: systematic review and meta-analysis

Souza¹,

Pereira²,

Araújo³

et al. 2016

ecancer

View full text Add to dashboard Cite

show abstract

Brazilian Society of Surgical Oncology: Guidelines for the management of anal canal cancer

Valadão

Riechelmann

Silva

et al. 2023

Journal of Surgical Oncology

View full text Add to dashboard Cite

BackgroundAnal canal squamous cell carcinoma (SCC) is a relatively uncommon neoplasia, and it is mostly a local‐regional cancer, of low metastatic potential (only 15%), resulting in cure in most cases treated with definitive chemoradiation. On the other hand, its incidence has been steadily increasing over the last decades, which makes it an important public health problem. In an effort to provide surgeons and oncologists who treat patients with anal cancer with the most updated information based on the best scientific evidence, the Brazilian Society of Surgical Oncology (SBCO) has produced the present guideline for the management of anal canal SCC, focused on the main topics related to daily clinical practice.ObjectivesThe SBCO developed the present guidelines to provide recommendations on the main topics related to the management of anal canal squamous cell carcinoma (SCC) based on current scientific evidence.MethodsBetween October 2022 and January 2023, 14 experts met to develop the guidelines for the management of anal canal cancer. A total of 30 relevant topics were distributed among the participants. The methodological quality of a final list with 121 sources was evaluated, all the evidence was examined and revised, and the management guidelines were formulated by the 14‐expert committee. To reach a final consensus, all the topics were reviewed in a meeting that was attended by all the experts.ResultsThe proposed guidelines contained 30 topics considered to be highly relevant in the management of anal canal cancer, covering subjects related to screening recommendations, preventive measures, tests required for diagnosing and staging, treatment strategies, response assessment after chemoradiotherapy, surgical technique‐related aspects, and follow‐up recommendations. In addition, screening and response assessment algorithms, and a checklist were proposed to summarize the important information and offer an updated tool to assist surgeons and oncologists who treat anal canal cancer and in providing the best care to their patients.ConclusionThese guidelines summarize recommendations based on the most current scientific evidence on relevant aspects of anal canal cancer management and are a practical guide to help surgeons and oncologists who treat anal canal cancer make the best therapeutic decisions.

show abstract

HPV-Associated Anal Cancer in the HIV/AIDS Patient

Wang

Palefsky

2018

Cancer Treatment and Research

View full text Add to dashboard Cite

Phase II Study of Capecitabine in Substitution of 5-FU in the Chemoradiotherapy Regimen for Patients with Localized Squamous Cell Carcinoma of the Anal Canal

Abstract: Capecitabine can safely substitute infusional 5-FU in the standard chemoradiation regimen for SCC of the anal cancer, with a locoregional control of 86% in 6 months (CI 95% 0.72-0.94).

Cited by 53 publications

References 22 publications

Replacing 5-fluorouracil by capecitabine in localised squamous cell carcinoma of the anal canal: systematic review and meta-analysis

Replacing 5-fluorouracil by capecitabine in localised squamous cell carcinoma of the anal canal: systematic review and meta-analysis

Brazilian Society of Surgical Oncology: Guidelines for the management of anal canal cancer

HPV-Associated Anal Cancer in the HIV/AIDS Patient

Contact Info

Product

Resources

About