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)

Abstract

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. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .