Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

Summary: To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using computed tomography (CT) or magnetic resonance imaging (MRI) scan
  -  Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
  -  Karnofsky Performance Status (KPS) score ≥ 60% at screening
  -  Men or women age ≥18 years
  -  Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test
  Exclusion Criteria:
  -  Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
  -  Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
  -  Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
  -  History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
  -  Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
  -  Known allergy or hypersensitivity to any component of panitumumab
  -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions:
  -  Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed > 24 weeks prior to randomization
  -  Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
  -  Significant thromboembolic event ≤ 8 weeks prior to enrollment
  -  Subjects not recovered from all previous acute radiotherapy-related toxicities
  -  History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
  -  History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
  -  Subject is currently in a clinical trial ≤ 30 days prior to enrollment
  -  Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
  -  Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
  -  Female subject who is pregnant or breast-feeding
  -  Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.

Relevance to patient case: not relevant