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Miguel Caballero, MD, PhD; Juan José Grau, MD, PhD; Jose Luís Blanch, MD, PhD; Jose Domingo-Domenech, MD, PhD; Jose Maria Auge, MD, PhD; Wladimiro Jimenez, MD, PhD; Manuel Bernal-Sprekelsen, MD, PhD

Arch Otolaryngol Head Neck Surg. 2007;133(11):1143-1148.

Objective  To evaluate serum vascular endothelial growth factor (VEGF) as a prognostic factor in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with metronomic (weekly) paclitaxel.

Design  Before-and-after trial.

Patients  A total of 33 consecutive patients were enrolled. Patients with recurrent and/or metastatic cancer of the head and neck refractory to platinum-based chemotherapy met inclusion criteria.

Setting  Tertiary referral center.

Intervention  Patients were treated weekly with 80 mg/m² of paclitaxel for 6 weeks.

Main Outcome Measures  Blood samples were collected after each dose and analyzed for serum VEGF using enzyme-linked immunosorbent assay kits. Nonparametric tests were used to analyze serum VEGF levels.

Results  In 33 patients, complete response was achieved in 1 (3%) and partial response in 20 (61%). No differences were found between responders and nonresponders with different levels of serum VEGF at any of the measurement times (baseline, after the first dose, and after the sixth dose). In responders, the median level of serum VEGF decreased after the first dose compared with baseline, but by the sixth dose, the median serum VEGF level had returned to baseline levels in all groups. The intensity of the serum VEGF level decrease (simple decrease, a decrease of at least 30%, or a decrease of at least 70%) was not related to response. The progression-to-disease time increased in the patients with a serum VEGF level reduction of at least 30% (P = .01) after 6 doses and decreased in patients with initially high levels, which remained high after the sixth dose (P = .03).

Conclusions  Serum VEGF levels after the first dose of paclitaxel may predict response to weekly paclitaxel in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Initially high serum VEGF levels that persist after the sixth dose predict a shorter period until tumor progression.

Author Affiliations: Departments of Otorhinolaryngology (Drs Caballero, Blanch, and Bernal-Sprekelsen), Oncology, ICMHO (Institut Clinic de Malalties Hemato-Oncologiques) and IDIBAPS (Instituto de Investigaciones Biomédicas Augusto Pi Sunyer) (Drs Grau and Domingo-Domenech), and Biochemistry and Molecular Genetics (Drs Auge and Jimenez), Hospital Clínic, University of Barcelona, Barcelona, Spain.

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