A phase II study of bosentan, a dual endothelin receptor antagonist, as monotherapy in patients with stage IV metastatic melanoma

Richard Kefford, Jane Beith, Guy A. Van Hazel, Michael Millward, James Trotter, David Wyld, Rada Kusic, Jim Coward, Revati Shreeniwas, Adele Morganti

Research output: Contribution to journalMeeting abstractpeer-review


Thirty-five patients with stage IV metastatic melanoma were enrolled in this open-label, single-arm, prospective, multicentre trial. The objective was to assess the effects of bosentan monotherapy (500 mg oral tablets, twice daily) given as first- or second-line therapy on tumour response. Patients were followed up until disease progression, death or drug toxicity occurred. Tumour response was assessed at 6-weekly intervals using the Response Evaluation Criteria in Solid Tumours (RECIST). Results: The study population (n = 35) had a median age of 61.0 years (32–79) and an American Joint Committee on Cancer (AJCC) class of M1C (n = 21, 60.0%), M1B (n = 10, 28.6%) and M1A (n = 4, 11.4%). Nine patients (25.7%) had prior therapy for stage IV melanoma. Stable disease (SD) was observed in 6/35 patients at week 12, 5 of whom (M1A = 2, M1C = 2, M1B = 1) were stable at >_24 weeks. Five of the 6 patients with SD received bosentan as first-line therapy. Bosentan was well tolerated; it was discontinued due to adverse events in only 7/35 patients, one of whom had progressive disease at the same time. The most frequent adverse events were headache (n = 15, 42.9%), fatigue (n = 12, 34.3%), nausea (n = 11, 31.4%), back pain and abnormal hepatic function (both n = 8, 22.9%). Conclusions: Bosentan is well tolerated and may have benefit in disease stabilization in patients with metastatic melanoma. Further studies to evaluate bosentan as first-line treatment may be warranted.
Original languageEnglish
Article number153P
Pages (from-to)ii312
Number of pages1
JournalAnnals of Oncology
Issue numberSupplement 2
Publication statusPublished - 1 Jun 2005
Externally publishedYes
EventESMO Scientific and Educational Conference (ESEC) - Budapest, Hungary
Duration: 2 Jun 20055 Jun 2005

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