Abstract
6069 Background: P, a multi-targeted antifolate, is well tolerated and has single-agent activity in HNSCC. B is a humanized monoclonal antibody against the vascular endothelial growth factor. In other cancers, various chemotherapies combined with B have produced survival benefits. We are conducting a phase II trial of P and B in recurrent or metastatic (R/M) HNSCC (ASCO 2006;A6049). Methods: Eligible pts have R/M HNSCC with no prior systemic therapy (chemotherapy as part of initial potentially curative therapy without P or B is allowed, if completed >6 months earlier), ECOG performance status 0–1, and measurable disease. Pts with history of gross hemoptysis, unequivocal invasion of major vessels by tumor or receiving therapeutic anticoagulation are excluded. Treatment consists of P 500 mg/m2 and B 15 mg/kg, given intravenously every 21 days, until disease progression or intolerable toxicity. All pts receive folic acid, vitamin B12, and corticosteroid prophylaxis. The primary endpoint is the time to progression (TTP) with a sample size of 40 pts (one stage design). Results: 25 pts have been enrolled. Median age 62 years (36–85); male/female 22/3; PS 0/1: 9/16; prior chemotherapy: 19; primary site: oropharynx (14), oral cavity (4), unknown primary (3), larynx (3), hypopharynx (1). A median 6 cycles of therapy were delivered (1- 11). With a median follow up of 8 months, the median TTP was 7 months (95% CI, 3.7–10.3). Best response in 22 evaluable pts: CR: 3, PR: 5, SD: 13, PD: 1, with overall response rate of 36%. There were two grade (G) 5 toxicities; 1 pt died after 8 cycles from sepsis presumably related to aspiration, with G 3 neutropenia; 1 pt died after 5 cycles from tracheal bleeding (a previously re-irradiated area) triggered by suctioning. 3 additional pts had G 3 hemorrhage (2 tumor-related and 1 due to gastric ulcer post gastrostomy tube placement). Other G 3 toxicities were dysphagia (3), fatigue (2), infection (2), hypokalemia (2), hyponatremia (2), neutropenia (2), anorexia (1), mucositis (1). There were no G 4 toxicities. Conclusions: Updated results show that P plus B is associated with bleeding complications but very encouraging efficacy in R/M HNSCC. Study accrual continues. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genentech™ BioOncology, Lilly Oncology
Published Version
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