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

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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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Authors and Affiliations

  1. Department of Radiation Oncology, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey

    Zuleyha Akgun & Zeynep Gural

  2. Department of Medical Oncology, Medical Faculty, Avrupa Florence Nightingale Oncology Hospital, Istanbul Bilim University, 34440, Sishane, Istanbul, Turkey

    Sezer Saglam

  3. Department of Radiation Oncology, Faculty of Medicine, Acibadem University, Istanbul, Turkey

    Serap Yucel

  4. Department of General Surgery, Koc University School of Medicine, Istanbul, Turkey

    Emre Balik

  5. Department of General Surgery, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey

    Gokhan Cipe

  6. Department of Radiology, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey

    Seyma Yildiz

  7. Department of Medical Oncology, Medical Faculty, Hacettepe University, Ankara, Turkey

    Sadettin Kilickap

  8. Department of Pharmacology, Faculty of Pharmacy, Istanbul University, Istanbul, Turkey

    Alper Okyar

  9. Department of Radiation Oncology, Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey

    Esra Kaytan-Saglam

Authors
  1. Zuleyha Akgun
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  2. Sezer Saglam
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Correspondence to Sezer Saglam.

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Akgun, Z., Saglam, S., Yucel, S. et al. Neoadjuvant chronomodulated capecitabine with radiotherapy in rectal cancer: a phase II brunch regimen study. Cancer Chemother Pharmacol 74, 751–756 (2014). https://doi.org/10.1007/s00280-014-2558-x

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  • DOI: https://doi.org/10.1007/s00280-014-2558-x

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