Phase II study of panitumumab and paclitaxel as first-line treatment in recurrent or metastatic head and neck cancer. TTCC-2009-03/VECTITAX study

Oral Oncol. 2016 Nov:62:54-59. doi: 10.1016/j.oraloncology.2016.09.009. Epub 2016 Oct 8.

Abstract

Objective: To evaluate the activity and safety profile of panitumumab in combination with paclitaxel in patients with recurrent or metastatic SCCHN.

Materials and methods: The VECTITAX phase II, open-label, multicenter study included patients with confirmed metastatic and/or recurrent SCCHN deemed to be untreatable by surgery or radiotherapy and ECOG PS=0-1. All patients received paclitaxel (80mg/m2/week) and panitumumab (6mg/kg/2weeks) until disease progression or unacceptable toxicity. EQ-5D-3L andvisual analogic scale (VAS) were used to evaluate impact on quality of life (QoL).

Results: The study included 40 patients (ITT population): (median age: 61 years; 87% male). Previous treatment: 29 patients (73%) had undergone surgery, 34 (85%) had received prior radiotherapy and 23 (58%) prior systemic treatment for locally advanced disease. Confirmed response was observed in 19 patients (48%) which was a complete response in 15% of patients. Stable disease was observed in 11 patients (28%). Disease control rate was 75%. Median progression-free survival was 7.5 months (95%CI: 4.9-8.3) and median overall survival 9.9 months (95%CI: 7.9-16.3). Most frequent grade 3-4 adverse events were skin rash (25%); asthenia (17%); neurotoxicity (15%); hypomagnesemia (10%); neutropenia (10%). Permanent discontinuation of panitumumab or paclitaxel due to adverse events was required in 10 (25%) and 13 patients (33%), respectively. There was one toxic death due to febrile neutropenia. Patient-reported QoL was preserved with no decline of median VAS scores.

Conclusion: Panitumumab and paclitaxel is an active combination, providing promising outcomes with preservation of the QoL and a favorable safety profile. (EudraCT: 2010-018898-37; NCT01264328).

Keywords: Head and neck cancer; Metastatic; Paclitaxel; Panitumumab; Recurrent; Squamous cell carcinoma.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / pathology
  • Female
  • Head and Neck Neoplasms / drug therapy*
  • Head and Neck Neoplasms / pathology
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Paclitaxel
  • Panitumumab
  • Squamous Cell Carcinoma of Head and Neck

Substances

  • Antibodies, Monoclonal
  • Panitumumab
  • Paclitaxel

Associated data

  • ClinicalTrials.gov/NCT01264328