NEW YORK (Reuters Health) Feb 24 - The addition of bevacizumab to pemetrexed improves outcomes in patients with recurrent or metastatic head and neck cancer, according to findings published in the February 22nd online Journal of Clinical Oncology.
"Novel regimens are highly warranted for the treatment of patients with head and neck cancer," Dr. Athanassios Argiris from University of Pittsburgh School of Medicine told Reuters Health by email.
"Although cisplatin is widely accepted as the backbone of chemotherapy for head and neck cancer, this phase II study shows that a non-platinum doublet that contains bevacizumab can be at least as efficacious in recurrent or metastatic head and neck cancer."
Dr. Argiris and colleagues tested the hypothesis that bevacizumab can potentiate pemetrexed in a study of 40 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The primary end point was time to progression. Secondary efficacy end points included objective response rate and overall survival.
The median time to progression was 5 months, which was significantly greater than the 3.9 months reported in a recent phase II trial of pemetrexed.
The median overall survival was 11.3 months. In 37 evaluable patients, the objective response rate was 30% (including 9 partial and 2 complete responses). The disease control rate was 86%.
Grade 3 to 5 toxicities included bleeding events in 6 patients, infection in 5 patients, neutropenia in 4 patients, and anemia, fatigue, hypokalemia, and hyponatremia in 2 patients each. One patient died from tracheal bleeding.
Overall survival was superior in patients with the AC/CC genotype of MTHFR A1298C single nucleotide polymorphism (32 months) compared with the AA genotype (11 months), and one patient with VEGF G634C GG genotype had significantly better survival than patients with the GC and CC genotypes.
"Patient selection on the basis of gene polymorphisms appears promising and should be explored in future clinical trials in head and neck cancer," Dr. Argiris said.
"The Eastern Cooperative Oncology Group is currently conducting a phase III study of cisplatin-based chemotherapy with or without bevacizumab in patients with recurrent or metastatic head and neck cancer (E1305)," Dr. Argiris noted.
"At the University of Pittsburgh, we have moved the combination of pemetrexed and bevacizumab to the combined modality treatment of locally advanced disease. In an ongoing phase II randomized trial, we evaluate the combination of radiotherapy, pemetrexed and cetuximab with or without bevacizumab in patients with locally advanced head and neck cancer. This is a promising multi-agent regimen that does not contain platinum. Study results are eagerly anticipated."
The study was supported in part by Lilly Oncology and Genentech, which also provided honoraria and/or research funding to 3 of the 8 authors.
J Clin Oncol. Posted February 2011. Abstract
"Novel regimens are highly warranted for the treatment of patients with head and neck cancer," Dr. Athanassios Argiris from University of Pittsburgh School of Medicine told Reuters Health by email.
"Although cisplatin is widely accepted as the backbone of chemotherapy for head and neck cancer, this phase II study shows that a non-platinum doublet that contains bevacizumab can be at least as efficacious in recurrent or metastatic head and neck cancer."
Dr. Argiris and colleagues tested the hypothesis that bevacizumab can potentiate pemetrexed in a study of 40 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The primary end point was time to progression. Secondary efficacy end points included objective response rate and overall survival.
The median time to progression was 5 months, which was significantly greater than the 3.9 months reported in a recent phase II trial of pemetrexed.
The median overall survival was 11.3 months. In 37 evaluable patients, the objective response rate was 30% (including 9 partial and 2 complete responses). The disease control rate was 86%.
Grade 3 to 5 toxicities included bleeding events in 6 patients, infection in 5 patients, neutropenia in 4 patients, and anemia, fatigue, hypokalemia, and hyponatremia in 2 patients each. One patient died from tracheal bleeding.
Overall survival was superior in patients with the AC/CC genotype of MTHFR A1298C single nucleotide polymorphism (32 months) compared with the AA genotype (11 months), and one patient with VEGF G634C GG genotype had significantly better survival than patients with the GC and CC genotypes.
"Patient selection on the basis of gene polymorphisms appears promising and should be explored in future clinical trials in head and neck cancer," Dr. Argiris said.
"The Eastern Cooperative Oncology Group is currently conducting a phase III study of cisplatin-based chemotherapy with or without bevacizumab in patients with recurrent or metastatic head and neck cancer (E1305)," Dr. Argiris noted.
"At the University of Pittsburgh, we have moved the combination of pemetrexed and bevacizumab to the combined modality treatment of locally advanced disease. In an ongoing phase II randomized trial, we evaluate the combination of radiotherapy, pemetrexed and cetuximab with or without bevacizumab in patients with locally advanced head and neck cancer. This is a promising multi-agent regimen that does not contain platinum. Study results are eagerly anticipated."
The study was supported in part by Lilly Oncology and Genentech, which also provided honoraria and/or research funding to 3 of the 8 authors.
J Clin Oncol. Posted February 2011. Abstract
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