title: Phase II study of sunitinib in recurrent or metastatic squamous cell carcinoma of the head and neck: GORTEC 2006-01.
abstract: PURPOSE To assess the efficacy and toxicity of sunitinib monotherapy in palliative squamous cell carcinoma of the head and neck (SCCHN). PATIENTS AND METHODS Thirty-eight patients with SCCHN having evidence of progressive disease (PD) were treated with sunitinib 37.5 mg/d given continuously until PD or unacceptable toxicity. The primary end point was the rate of disease control, defined as stable disease (SD) or partial response (PR) at 6 to 8 weeks after treatment initiation (two-stage design, Simon). Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) was performed in a subset of patients before and 6 to 8 weeks after treatment. The volume transfer constant of the contrast agent (K(trans)) was used to measure changes in the microcirculation blood flow and endothelial permeability of the tumor. Results A PR was observed in one patient, SD in 18, and PD in 19 (Response Evaluation Criteria in Solid Tumors [RECIST]), resulting in a disease control rate of 50%. Among the 18 patients with SD, there were five unconfirmed PRs and six additional minor responses. A significant decrease in K(trans) was seen in three of the four patients who received DCE-MRI monitoring. Grade 5 head and neck bleeds occurred in four patients. Local complications, including the appearance or worsening of tumor skin ulceration or tumor fistula, were recorded in 15 patients. CONCLUSION Sunitinib demonstrated modest activity in palliative SSCHN. The severity of some of the complications highlights the importance of improved patient selection for future studies with sunitinib in head and neck cancer. Sunitinib should not be used outside clinical trials in SSCHN.
authors.affiliation: Medical Oncology Unit, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, 10 Avenue Hippocrate, 1200 Brussels, Belgium. jean-pascal.machiels@uclouvain.be
authors.forename: Jean-Pascal H
authors.initials: JP
authors.lastname: Machiels
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Henry
authors.forename: Sylvie
authors.initials: S
authors.lastname: Zanetta
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Kaminsky
authors.forename: Nicolas
authors.initials: N
authors.lastname: Michoux
authors.forename: Denis
authors.initials: D
authors.lastname: Rommel
authors.forename: Sandra
authors.initials: S
authors.lastname: Schmitz
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Bompas
authors.forename: Anne-Françoise
authors.initials: AF
authors.lastname: Dillies
authors.forename: Sandrine
authors.initials: S
authors.lastname: Faivre
authors.forename: Anne
authors.initials: A
authors.lastname: Moxhon
authors.forename: Thierry
authors.initials: T
authors.lastname: Duprez
authors.forename: Joel
authors.initials: J
authors.lastname: Guigay
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib