PARTNER: An open-label, randomized, phase 2 study of docetaxel/cisplatin chemotherapy with or without panitumumab as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck

Lori J. Wirth, Shaker Dakhil, Gabriela Kornek, Rita Axelrod, Douglas Adkins, Shubham Pant, Paul O'Brien, Philip R. Debruyne, Kelly S. Oliner, Jun Dong, Swami Murugappan

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

Objective This phase 2 estimation study evaluated docetaxel/cisplatin with/without panitumumab, an anti–epidermal growth factor receptor monoclonal antibody, as first-line therapy for recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). Patients and methods Randomized patients received docetaxel/cisplatin (75 mg/m2 each) with/without panitumumab (9 mg/kg) in 21-day cycles. Patients randomized to panitumumab + chemotherapy could continue panitumumab monotherapy after completing six chemotherapy cycles without progression; patients randomized to chemotherapy alone could receive second-line panitumumab after progression. Progression-free survival (PFS) was the primary endpoint. Secondary endpoints included overall survival (OS), overall response rate (ORR), time to response (TTR), duration of response (DOR), and safety. A protocol amendment limited enrollment to patients <70 years owing to excess toxicity in older patients and added mandatory pegfilgrastim/filgrastim support. Outcomes were also analyzed by human papillomavirus status. Results 103 of the 113 enrolled patients were evaluable and randomized to receive ⩾1 dose of first-line treatment. Median PFS for panitumumab + chemotherapy was 6.9 (95% CI = 4.7–8.3) months versus 5.5 (95% CI = 4.1–6.8) months for chemotherapy alone (hazard ratio [HR] = 0.629; 95% CI = 0.395–1.002; P = 0.048). ORR for panitumumab + chemotherapy was 44% (95% CI = 31–58%) versus 37% (95% CI = 24–51%) for chemotherapy alone (odds ratio [OR] = 1.37; 95% CI = 0.57–3.33). Median OS for panitumumab + chemotherapy was 12.9 (95% CI = 9.4–18.5) months versus 13.8 (95% CI = 11.8–22.9) months for chemotherapy alone (HR = 1.103; 95% CI = 0.709–1.717). Median TTR for panitumumab + chemotherapy treatment was 6.9 weeks versus 11.0 weeks for chemotherapy alone. Median DOR was 8.0 (95% CI = 5.7–11.1) months with panitumumab + chemotherapy versus 5.1 (95% CI = 4.4–7.2) months with chemotherapy alone. Grade 3/4 adverse event incidence was 73% with panitumumab + chemotherapy versus 56% with chemotherapy alone. 41% and 55% of patients in the panitumumab + chemotherapy and chemotherapy-alone arms, respectively, received panitumumab monotherapy. Conclusion The addition of panitumumab to docetaxel/cisplatin may improve PFS in recurrent/metastatic SCCHN and has the potential to improve outcomes in these fully, or mostly, active patients.

Original languageEnglish
Pages (from-to)31-40
Number of pages10
JournalOral Oncology
Volume61
DOIs
StatePublished - Oct 1 2016

Keywords

  • Anti-EGFR therapy
  • Docetaxel/cisplatin
  • Head and neck cancer
  • Human papillomavirus (limit 1–10)
  • Panitumumab
  • Squamous cell carcinoma

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