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01-10-2014 | Original Article

Neoadjuvant chronomodulated capecitabine with radiotherapy in rectal cancer: a phase II brunch regimen study

Authors: Zuleyha Akgun, Sezer Saglam, Serap Yucel, Zeynep Gural, Emre Balik, Gokhan Cipe, Seyma Yildiz, Sadettin Kilickap, Alper Okyar, Esra Kaytan-Saglam

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2014

Abstract

Purpose

The aim of this study was to evaluate efficacy and safety of chronomodulated capecitabine administered according to a specific time schedule (Brunch Regimen: Breakfast and Lunch) as a part of neoadjuvant chemoradiation therapy in patients with locally advanced rectal cancer.

Methods

Eighty-five patients with stage II and III rectal cancer were included. Patients received capecitabine (1,650 mg/m² per day; 60 % dose at 8:00 AM and 40 % dose at 12:00 noon) administered during pelvic radiation (total 50.4 Gy in 28 fractions, 1.8 Gy daily dose between 2:00 p.m. and 4:00 p.m.). After chemoradiotherapy, patients underwent surgery. The primary endpoints were pathological complete response (pCR) rate and toxicity.

Results

In 17 patients (20 %), total tumor regression was achieved according to Dworak pathological grading system. Grade III diarrhea occurred in nine patients (10.5 %), while only one patient had grade 3 thrombocytopenia. Grade II or III proctitis were seen in nine (10.5 %) subjects, and grade I or II cystitis in six (6.9 %). Only three patients (3.3 %) developed hand and foot syndrome (both grade I–II). There were no grade IV toxicities.

Conclusions

Brunch Regimen for locally advanced rectal cancer consisting of neoadjuvant chronomodulated capecitabine and concurrent radiation therapy is effective and well tolerated with good safety profile, particularly with regard to the occurrence of hand and foot syndrome, in patients with locally advanced rectal cancer.

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Title: Neoadjuvant chronomodulated capecitabine with radiotherapy in rectal cancer: a phase II brunch regimen study
Authors: Zuleyha Akgun
Sezer Saglam
Serap Yucel
Zeynep Gural
Emre Balik
Gokhan Cipe
Seyma Yildiz
Sadettin Kilickap
Alper Okyar
Esra Kaytan-Saglam
Publication date: 01-10-2014
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 4/2014
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-014-2558-x

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