OBJECTIVES: This study was an open-label multicenter phase II trial to investigate the efficacy and safety of nab-paclitaxel and bevacizumab as first-line therapy in patients with histologically confirmed unresectable metastatic melanoma. METHODS: The treatment regimen consisted of a 28-day cycle in which patients received nab-paclitaxel, 150 mg/m through intravenous (IV) infusion weekly for 3 weeks and bevacizumab, 10 mg/kg IV every 2 weeks without a rest period. The 28-day cycle was repeated until there was unacceptable toxicity or disease progression. If 1 drug had to be stopped because of toxicity, treatment was continued with the other drug until disease progression or unacceptable toxicity. The primary endpoint was the progression-free survival rate (PFS) at 4 months. RESULTS: Fifty patients were enrolled. The PFS rate at 4 months was 75%. The median PFS was 7.6 months and the median overall survival was 16.8 months with a median duration follow-up of 41.6 months. The overall survival rate was 64% at 1 year and 30% at 2 years. Ten patients (20%) remain alive. The objective response rate was 36%. Common adverse events associated with this regimen were peripheral neuropathy, fatigue, alopecia, and gastrointestinal disorders. CONCLUSIONS: In this phase II multicenter study, this doublet had significant activity in patients with metastatic melanoma, and was well tolerated. These results are promising and follow-up trials to further explore this regimen are warranted.
OBJECTIVES: This study was an open-label multicenter phase II trial to investigate the efficacy and safety of nab-paclitaxel and bevacizumab as first-line therapy in patients with histologically confirmed unresectable metastatic melanoma. METHODS: The treatment regimen consisted of a 28-day cycle in which patients received nab-paclitaxel, 150 mg/m through intravenous (IV) infusion weekly for 3 weeks and bevacizumab, 10 mg/kg IV every 2 weeks without a rest period. The 28-day cycle was repeated until there was unacceptable toxicity or disease progression. If 1 drug had to be stopped because of toxicity, treatment was continued with the other drug until disease progression or unacceptable toxicity. The primary endpoint was the progression-free survival rate (PFS) at 4 months. RESULTS: Fifty patients were enrolled. The PFS rate at 4 months was 75%. The median PFS was 7.6 months and the median overall survival was 16.8 months with a median duration follow-up of 41.6 months. The overall survival rate was 64% at 1 year and 30% at 2 years. Ten patients (20%) remain alive. The objective response rate was 36%. Common adverse events associated with this regimen were peripheral neuropathy, fatigue, alopecia, and gastrointestinal disorders. CONCLUSIONS: In this phase II multicenter study, this doublet had significant activity in patients with metastatic melanoma, and was well tolerated. These results are promising and follow-up trials to further explore this regimen are warranted.
Authors: Ozlen Saglam; Syeda M H Naqvi; Yonghong Zhang; Tania Mesa; Jamie K Teer; Sean Yoder; Jae Lee; Jane Messina Journal: Melanoma Res Date: 2018-12 Impact factor: 3.599
Authors: Francisco Rodríguez; Pablo Caruana; Noa De la Fuente; Pía Español; María Gámez; Josep Balart; Elisa Llurba; Ramón Rovira; Raúl Ruiz; Cristina Martín-Lorente; José Luis Corchero; María Virtudes Céspedes Journal: Biomolecules Date: 2022-06-04
Authors: E M Hersh; M Del Vecchio; M P Brown; R Kefford; C Loquai; A Testori; S Bhatia; R Gutzmer; R Conry; A Haydon; C Robert; S Ernst; J Homsi; J J Grob; K Kendra; S S Agarwala; M Li; A Clawson; C Brachmann; M Karnoub; I Elias; M F Renschler; A Hauschild Journal: Ann Oncol Date: 2015-09-26 Impact factor: 32.976
Authors: Julie M Roda; Yijie Wang; Laura A Sumner; Gary S Phillips; Clay B Marsh; Timothy D Eubank Journal: J Immunol Date: 2012-08-06 Impact factor: 5.422
Authors: A P Algazi; E Cha; S M Ortiz-Urda; T McCalmont; B C Bastian; J Hwang; M H Pampaloni; S Behr; K Chong; B Cortez; A Quiroz; F Coakley; S Liu; A I Daud Journal: Br J Cancer Date: 2015-03-31 Impact factor: 7.640