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.

Autor: Wirth LJ; Massachusetts General Hospital, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: lwirth@mgh.harvard.edu., Dakhil S; Cancer Center of Kansas, Wichita, KS, USA., Kornek G; Medizinische Universitaet Wien, Wien, Austria., Axelrod R; Thomas Jefferson University Hospital, Philadelphia, PA, USA., Adkins D; Washington University School of Medicine, St. Louis, MO, USA., Pant S; University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA., O'Brien P; Medical University of South Carolina, Charleston, SC, USA., Debruyne PR; Kortrijk Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium; Faculty of Health, Social Care and Education, Anglia Ruskin University, Chelmsford, UK., Oliner KS; Amgen Inc., Thousand Oaks, CA, USA., Dong J; Amgen Inc., Thousand Oaks, CA, USA., Murugappan S; Amgen Inc., Thousand Oaks, CA, USA.
Jazyk: angličtina
Zdroj: Oral oncology [Oral Oncol] 2016 Oct; Vol. 61, pp. 31-40. Date of Electronic Publication: 2016 Aug 20.
DOI: 10.1016/j.oraloncology.2016.07.005
Abstrakt: 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 (75mg/m(2) each) with/without panitumumab (9mg/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 <70years 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 6.9weeks versus 11.0weeks 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.
(Copyright © 2016 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: