Publikation

First-line temozolomide combined with bevacizumab in metastatic melanoma: a multicentre phase II trial (SAKK 50/07)

Wissenschaftlicher Artikel/Review - 28.04.2011

PubMed
DOI

Zitation
von Moos R, Dummer R, Schönewolf N, Mamot C, Mjhic-Probst D, Schraml P, Moch H, Schläppi M, Cathomas R, Michielin O, Ochsenbein A, Gillessen S, Goldinger S, Simcock M, Seifert B, on behaalf of the Swiss Group for Clinical Cancer Research (SAKK). First-line temozolomide combined with bevacizumab in metastatic melanoma: a multicentre phase II trial (SAKK 50/07). Ann Oncol 2011; 23:531-6.
Art
Wissenschaftlicher Artikel/Review (Englisch)
Zeitschrift
Ann Oncol 2011; 23
Veröffentlichungsdatum
28.04.2011
eISSN (Online)
1569-8041
Seiten
531-6
Kurzbeschreibung/Zielsetzung

BACKGROUND
Oral temozolomide has shown similar efficacy to dacarbazine in phase III trials with median progression-free survival (PFS) of 2.1 months. Bevacizumab has an inhibitory effect on the proliferation of melanoma and sprouting endothelial cells. We evaluated the addition of bevacizumab to temozolomide to improve efficacy in stage IV melanoma.

PATIENTS AND METHODS
Previously untreated metastatic melanoma patients with Eastern Cooperative Oncology Group performance status of two or more were treated with temozolomide 150 mg/m(2) days 1-7 orally and bevacizumab 10 mg/kg body weight i.v. day 1 every 2 weeks until disease progression or unacceptable toxicity. The primary end point was disease stabilisation rate [complete response (CR), partial response (PR) or stable disease (SD)] at week 12 (DSR12); secondary end points were best overall response, PFS, overall survival (OS) and adverse events.

RESULTS
Sixty-two patients (median age 59 years) enrolled at nine Swiss centres. DSR12 was 52% (PR: 10 patients and SD: 22 patients). Confirmed overall response rate was 16.1% (CR: 1 patient and PR: 9 patients). Median PFS and OS were 4.2 and 9.6 months. OS (12.0 versus 9.2 months; P = 0.014) was higher in BRAF V600E wild-type patients.

CONCLUSIONS
The primary end point was surpassed showing promising activity of this bevacizumab/temozolomide combination with a favourable toxicity profile. Response and OS were significantly higher in BRAF wild-type patients.