Abstract
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 language | English |
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Article number | 153P |
Pages (from-to) | ii312 |
Number of pages | 1 |
Journal | Annals of Oncology |
Volume | 16 |
Issue number | Supplement 2 |
Publication status | Published - 1 Jun 2005 |
Externally published | Yes |
Event | ESMO Scientific and Educational Conference (ESEC) - Budapest, Hungary Duration: 2 Jun 2005 → 5 Jun 2005 |