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Chronomodulated oxaliplatin plus Capecitabine (XELOX) as a first line chemotherapy in metastatic colorectal cancer: A Phase II Brunch regimen study

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Abstract

Purpose

The aim of this study was to evaluate safety and toxicity of chronomodulated capecitabine administered in the morning and at noon according to a specific time schedule (Brunch Regimen: Breakfast and Lunch) as a part of first-line XELOX chemotherapy in patients with metastatic colorectal cancer.

Methods

A total of 30 treatment-naïve colorectal cancer patients with metastatic disease were included. Oxaliplatin 130 mg/m2 on day 1 plus chronomodulated oral capecitabine 2000 mg/m2 per day were administered (50 % dose at 8:00 a.m. and 50 % dose at 12:00 noon on days 1–14, every 21 days). All adverse events, treatment responses and survival were evaluated. In addition, pharmacokinetic profile of capecitabine was examined in a subset of 5 patients.

Results

Median age was 57.1 years (range 32–77 years). Median follow-up was 19 months (range 3–36 months). Three patients (10 %) had complete response, 13 patients (43.3 %) had partial response and 4 patients (13.3 %) had stabile disease. Ten patients had progressive disease at their first evaluation (33.3 %). The median progression-free survival (PFS) was 10 months (range 2–36 months). There were no grade 4 toxicities. One patient (3.3 %) had grade 3 neutropenia. Hand-foot syndrome developed in three patients (10 %): 6.6 %, grade 1 and 3.3 %, grade 2.

Conclusions

Chronomodulated XELOX seems to represent a promising therapeutic option in the first-line treatment of metastatic colorectal carcinoma due to good tumor control and favorable toxicity profile. Phase III randomized trials are required to assess the actual clinical efficacy and side effect profile of this regimen.

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Acknowledgments

We deeply express our gratitude to A. Nur Sozudogru M.D. for his grammar and spelling revision of the text.

Funding

This work was supported by Scientific Research Projects Coordination Unit of Istanbul University. Project number is ONAP-25139.

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Authors and Affiliations

  1. Department of Medical Oncology, Haseki Education and Research Hospital, Istanbul, Turkey

    Kezban Nur Pilancı

  2. Department of Medical Oncology, Istanbul Bilim University, Istanbul, Turkey

    Sezer Saglam, Cetin Ordu, Esat Namal & Ulkuhan Iner-Koksal

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

    Alper Okyar & Zeliha Pala-Kara

  4. Department of Radiation Oncology, Acıbadem University, Istanbul, Turkey

    Serap Yucel

  5. Medical Oncology Department, Bakirkoy Dr Sadi Konuk Education and Research Hospital, Istanbul, Turkey

    Rumeysa Ciftci

  6. Institute of Oncology, Department of Radiation Oncology, Istanbul University, Istanbul, Turkey

    Esra Kaytan-Saglam

  7. Gayrettepe Florence Nigtingale Hastanesi, Cemil Arslan Guder Sok. No: 8, Besiktas, 34349, Istanbul, Turkey

    Sezer Saglam

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  1. Kezban Nur Pilancı
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Pilancı, K.N., Saglam, S., Okyar, A. et al. Chronomodulated oxaliplatin plus Capecitabine (XELOX) as a first line chemotherapy in metastatic colorectal cancer: A Phase II Brunch regimen study. Cancer Chemother Pharmacol 78, 143–150 (2016). https://doi.org/10.1007/s00280-016-3067-x

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