TY - JOUR
T1 - Sorafenib and dacarbazine as first-line therapy for advanced melanoma
T2 - Phase i and open-label phase II studies
AU - Eisen, T.
AU - Marais, R.
AU - Affolter, A.
AU - Lorigan, P.
AU - Robert, C.
AU - Corrie, P.
AU - Ottensmeier, C.
AU - Chevreau, C.
AU - Chao, D.
AU - Nathan, P. D.
AU - Jouary, T.
AU - Harries, M.
AU - Negrier, S.
AU - Montegriffo, E.
AU - Ahmad, T.
AU - Gibbens, I.
AU - James, M. G.
AU - Strauss, U. P.
AU - Prendergast, S.
AU - Gore, M. E.
N1 - Funding Information:
E Montegriffo, UP Strauss, and S Prendergast are employees of Bayer Pharmaceuticals. T Eisen receives research support from Bayer and has received honoraria for advisory boards and speaking engagements. R Marais has received honoraria and research support from Bayer Healthcare Pharmaceuticals. PD Nathan has received honoraria for advisory boards and speaking engagements for Bayer Healthcare. T Jouary has received honoraria for consulting from Bristol Myer Squibb. I Coombes received financial support from Bayer Healthcare to attend meetings (2004). ME Gore is funded by the National Institute for Health Research, UK. A Affolter, P Lorigan, C Robert, P Corrie, C Ottensmeier, M Harries, MG James, C Chevreau, D Chao, S Negrier, and T Ahmad declare no conflict of interest.
PY - 2011/7/26
Y1 - 2011/7/26
N2 - Method:The safety of oral sorafenib up to a maximum protocol-specified dose combined with dacarbazine in patients with metastatic, histologically confirmed melanoma was investigated in a phase I dose-escalation study and the activity of the combination was explored in an open-label phase II study.Results:In the phase I study, three patients were treated with sorafenib 200 mg twice daily (b.i.d.) plus 1000 mg m2 dacarbazine on day 1 of a 21-day cycle and 15 patients had the sorafenib dose escalated to 400 mg b.i.d. without reaching the maximum tolerated dose of the combination. In the phase II study (n83), the overall response rate was 12% (95% CI: 6, 21): one complete and nine partial, with median response duration of 46.7 weeks. Stable disease was the best response in 37%; median duration was 13.3 weeks. Median overall survival (OS) was 37.0 weeks (95% CI: 33.9, 46.0). Conclusion: Oral sorafenib combined with dacarbazine had acceptable toxicity and some antineoplastic activity against metastatic melanoma.
AB - Method:The safety of oral sorafenib up to a maximum protocol-specified dose combined with dacarbazine in patients with metastatic, histologically confirmed melanoma was investigated in a phase I dose-escalation study and the activity of the combination was explored in an open-label phase II study.Results:In the phase I study, three patients were treated with sorafenib 200 mg twice daily (b.i.d.) plus 1000 mg m2 dacarbazine on day 1 of a 21-day cycle and 15 patients had the sorafenib dose escalated to 400 mg b.i.d. without reaching the maximum tolerated dose of the combination. In the phase II study (n83), the overall response rate was 12% (95% CI: 6, 21): one complete and nine partial, with median response duration of 46.7 weeks. Stable disease was the best response in 37%; median duration was 13.3 weeks. Median overall survival (OS) was 37.0 weeks (95% CI: 33.9, 46.0). Conclusion: Oral sorafenib combined with dacarbazine had acceptable toxicity and some antineoplastic activity against metastatic melanoma.
UR - http://www.scopus.com/inward/record.url?scp=79960848073&partnerID=8YFLogxK
U2 - 10.1038/bjc.2011.257
DO - 10.1038/bjc.2011.257
M3 - Article
C2 - 21750549
AN - SCOPUS:79960848073
SN - 0007-0920
VL - 105
SP - 353
EP - 359
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 3
ER -