An analysis of safety in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) receiving chemotherapy (CT) with or without panitumumab (pmab) in a phase III clinical trial (SPECTRUM)
Authors: Vermorken J. B. , Stöhlmacher J. , Davidenko I. , Winquist E. , Licitra L. , Pai V. R. , Skladowski K. , Blajman C. R. , Faivre S. , Gansert J. 
Published: August 2020

6050^

Background: The epidermal growth factor receptor (EGFR) is an important target for treatment of patients with SCCHN. Pmab is a fully human monoclonal antibody against EGFR. This study is planned to assess the safety and efficacy of pmab in combination with a standard platinum-based CT regimen for patients with R/M disease. Methods: This ongoing, global, phase III, open-label, randomized (1:1) study is enrolling pts with R/M SCCHN. Pts receive cisplatin 100 mg/m2 IV on day 1 plus 5-FU (1,000 mg/m2) continuous IV daily on days 1–4 ± pmab (9 mg/kg on day 1) every 21 days for up to 6 cycles. Changes to carboplatin (AUC 5) are allowed for specific cisplatin-related toxicities. Pts in the pmab arm without disease progression after 6 cycles may remain on pmab monotherapy until disease progression or intolerability. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, response rate, duration of response, and safety. This study includes multiple planned safety interim analyses conducted by an independent Data Monitoring Committee (DMC). The latest analysis included the first 300 of approximately 650 planned patients. Results: Of 300 pts enrolled, 88% are male; median age is 59 years (range 31–82); ECOG PS 0: 32%, PS 1: 68%. Of the 300 patients, 99% received any study treatment and 76% had ended all CT. Median follow-up time is 13.9 weeks. The rate of any grade 5 treatment-related AE was 3.4%. Adverse events of interest are shown in the Table. Conclusions: After the interim safety analysis of the first 300 pts conducted by the independent DMC, SPECTRUM continues per protocol. Enrollment is estimated to be completed in Feb 2009.

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