Safety and Quality of Life in the Treatment of Non-metastasic Colorectal Cancer Patients: 5-fluorouracil Versus Capecitabine

Julia Sánchez-Gundín 1, Cristina Martín-Sabroso 2, Ana M. Fernández-Carballido 2, D. Barreda-Hernández 1, Ana I. Torres-Suárez 2*


1 Hospital Pharmacy Department. Virgen de la Luz Hospital, Hermandad de Donantes de Sangre, 16002, Cuenca, Spain
2 Department of Pharmaceutics and Food Technology, Complutense University, 28040 Madrid, Spain



Colorectal cancer (CRC) is the most frequent neoplasm of the digestive system and the third most frequent tumour worldwide. In stages I and II the treatment is only surgical and, in high-risk stages II and stages III surgery is complemented with adjuvant chemotherapy. Traditional adjuvant therapy consists of 5-fluorouracil, in combination with leucovorin, and oxaliplatin (FOLFOX regimen, all for iv administration). Alternatively 5-fluorouracil can be substituted by capecitabine, precursor of 5-fluorouracil, which has the advantage that it is administered orally (XELOX regimen). Both regimes are considered interchangeable.

The aim of this study is to compare these regimens (FOLFOX and XELOX) in terms of safety and quality of life (QoL) in patients diagnosed with stage II and III non-metastatic CRC.

For this purpose, a descriptive prospective study with patients diagnosed with stage II and III non-metastatic CRC in adjuvant treatment with FOLFOX and XELOX schemes was carried out. The appearance of symptomatic, haematological and hepatic adverse events (AE) during the treatment was established by evaluating their clinical and pharmacotherapeutic history. The severity of the AE was established following the Common Terminology Criteria for Adverse Events (CTCAE v.4.03). To evaluate the QoL, the QoL EORTC QLQ-C30 version 3.0 questionnaire was given to patients at the beginning and the middle of the adjuvant treatment. The statistical analysis of the data was carried out with the SPSS®15.0 program.

33 patients were finally included in the study. All the patients treated with FOLFOX and with XELOX presented some of the AE studied. The most frequent AE for both groups were neurotoxicity, diarrhoea, constipation and thrombocytopenia, but only statistically significant difference was found in case of palmar-plantar erythrodysesthesia síndrome (PPE), and more frequent in patients treated with XELOX. According to QoL, patients with FOLFOX presented a worsening in terms of daily activities, constipation and insomnia while in those treated with XELOX a worsening in daily activities, constipation, fatigue, nausea, vomiting, anorexia and diarrhoea was observed. Only statistically significant difference was found in the emotional role item at the middle of the treatment, at which point, patients treated with FOLFOX were better emotionally than those treated with XELOX.

As conclusion, both schemes seem to be safe, although differences in PPE (more frequent with XELOX) and emotional role (better with FOLFOX) were found. However, it should be taken into account that patients treated with FOLFOX presented higher frequency of haematological AE, which are difficult to perceive. In contrast, patients treated with XELOX had higher frequency of symptomatic AE, which probably leads to this slightly worse QoL

Keywords: Colorectal Cancer, Safety, Quality of Life, 5-fluorouracil, Capecitabine

Doi: 10.28991/ICCR-2019-006


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