Phase II Study of Single Agent Capecitabine in the Treatment of Metastatic Neuroendocrine Tumours


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Felicity Murphy (1), Louise Medley (1), Armand Morel (1), David Farrugia (2), Nicholas Reed (3), Joanne Davies (1), Oksana Kirichek (1), Rajesh Thakker (4), Denis Talbot (1)

Department of Medical Oncology, University of Oxford, Oxford, United Kingdom (1), Gloucestershire Hospital NHS Foundation Trust, Cheltenham General Hospital, Cheltenham, United Kingdom (2), Beatson Oncology Centre, Western Infirmary, Glasgow, United Kingdom (3), Oxford Centre for Diabetes, Endocrinology & Metabolism, Oxford, United Kingdom (4)

Background

Neuroendocrine tumours (NETs) are a heterogeneous group of rare tumours with variable clinical course. In patients with metastatic disease, particularly liver metastases, the prognosis is less favorable, and effective systemic therapy is needed. Although there is no standard treatment, available chemotherapy regimens often incorporate 5-fluorouracil (5FU), an inhibitor of thymidylate synthase. Capecitabine is an orally administered pro-drug of 5-fluorouracil. It has demonstrated higher response rates and better tolerability than 5FU in colorectal cancer. This UK multicentre phase II study sought to evaluate the tolerability and efficacy of single agent capecitabine in patients with metastatic non-pancreatic NET to provide the rationale for potential inclusion in combination regimens.

Method

This was an open-label single arm phase II study. Patients had histologically proven and previously untreated locally advanced or metastatic non-pancreatic NET. Oral capecitabine 2000 mg/m2/day was administered in two divided doses on days 1-14 of every 3-week cycle until disease progression or intolerable toxicity. The primary endpoint was toxicity (NCIC-CTC v2); secondary endpoints were response rate (RECIST), progression-free (PFS) and overall survival (OS).

Results

  • Twenty patients were recruited from three centres (Oxford, Cheltenham and Glasgow).
  • Nineteen patients received at least one cycle of treatment and were therefore evaluable for safety, radiological and biochemical response.
  • Five episodes of grade 4 toxicity occurred: 3 haematological, 1 biochemical (abnormal liver function), and 1 episode of infection.
  • Grade 3 toxicities were diarrhoea (26%), fatigue (21%) and abnormal liver function (21%).
  • The disease control rate was 68%. There were no complete or partial responders. Thirteen patients (68%) achieved stable disease, including 2 (11%) with biochemical partial responses.
  • The median PFS and OS were 9.9 and 36.5 months, respectively.
  • Conclusion

    Capecitabine is safe and well tolerated in patients with metastatic non-pancreatic NET. It should be considered for inclusion in combination therapeutic regimens.

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