Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study

被引:96
|
作者
Guigay, J. [1 ,2 ]
Fayette, J. [3 ,4 ]
Dillies, A. F. [5 ]
Sire, C. [6 ]
Kerger, J. N. [7 ]
Tennevet, I. [8 ]
Machiels, J. P. [9 ,10 ]
Zanetta, S. [11 ]
Pointreau, Y. [12 ]
Bozec Le Moal, L. [13 ]
Henry, S. [14 ]
Schilf, A. [15 ]
Bourhis, J. [16 ]
机构
[1] Ctr Antoine Lacassagne, Dept Med Oncol, F-06189 Nice 2, France
[2] CNRS, Gustave Roussy, UMR 8126, Villejuif, France
[3] Univ Lyon, Ctr Leon Berard, Dept Med Oncol, Lyon, France
[4] Hosp Civils Lyon, Lyon, France
[5] Ctr Jean Perrin, Dept Med Oncol, Clermont Ferrand, France
[6] Hop Bretagne Sud, Dept Med Oncol, Lorient, France
[7] CHU Dinant Godinne UCL, Dept Med Oncol, Namur, Belgium
[8] Ctr Henri Becquerel, Dept Med Oncol, F-76038 Rouen, France
[9] Univ St Luc, Inst Roi Albert 2, Dept Med Oncol, Brussels, Belgium
[10] Catholic Univ Louvain, Inst Rech Clin & Expt, Pole Miro, B-1200 Brussels, Belgium
[11] Ctr Georges Francois Leclerc, Dept Med Oncol, Dijon, France
[12] CHRU Tours, Dept Med Oncol, Tours, France
[13] Inst Curie Hop Rene Huguenin, Dept Med Oncol, St Cloud, France
[14] Clin St Elizabeth, Dept Med Oncol, Namur, Belgium
[15] Gustave Roussy, Dept Head & Neck Oncol, Villejuif, France
[16] GORTEC, Lausanne, Switzerland
关键词
head and neck cancer; docetaxel; cetuximab; chemotherapy; maintenance; first line; COOPERATIVE-ONCOLOGY-GROUP; CHEMOTHERAPY PLUS; RANDOMIZED-TRIAL; CANCER; COMBINATION; FLUOROURACIL; PACLITAXEL;
D O I
10.1093/annonc/mdv268
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Cetuximab in combination with platinum and 5-fluorouracil is the standard of care in the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Cetuximab and taxane combinations have shown promising activity. This study evaluated the efficacy and safety of four cycles of docetaxel associated with cisplatin and cetuximab (TPEx), followed by maintenance with cetuximab every 2 weeks. Patients with a histologically confirmed HNSCC with metastasis or recurrence unsuitable for locoregional curative treatment received docetaxel and cisplatin (75 mg/m(2) both) at day 1 and weekly cetuximab 250 mg/m(2) (loading dose of 400 mg/m(2)), repeated every 21 days for four cycles, followed by maintenance cetuximab 500 mg/m(2) every 2 weeks until progression or unacceptable toxicity. Prophylactic administration of granulocyte colony-stimulating factor was done systematically after each chemotherapy cycle. Patients had a good general status (performance status a parts per thousand currency sign1) and were under 71 years. Prior total doses of cisplatin exceeding 300 mg/m(2) were not allowed. The primary end point was objective response rate (ORR) after four cycles. Fifty-four patients were enrolled. The primary end point was met with an ORR of 44.4% (95% CI 30.9-58.6). Median overall and progression-free survivals were, respectively, 14 months (95% CI 11.3-17.3) and 6.2 months (95% CI 5.4-7.2). The most common grade 3/4 adverse events were skin rash (16.6%) and non-febrile neutropenia (20.4%). There were one pulmonary embolism and two infectious events leading to death. The TPEx regimen showed promising activity as first-line treatment in fit patients with recurrent/metastatic HNSCC. Further studies are needed to compare the TPEx versus EXTREME regimen in this population.
引用
收藏
页码:1941 / 1947
页数:7
相关论文
共 50 条
  • [31] Phase II study of figitumumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: GORTEC 2008-02
    Schmitz, S.
    Kaminsky-Forrett, M.
    Henry, S.
    Zanetta, S.
    Geoffrois, L.
    Bompas, E.
    Moxhon, A.
    Guigay, J.
    Machiels, J. H.
    JOURNAL OF CLINICAL ONCOLOGY, 2010, 28 (15)
  • [32] 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
    Wirth, Lori J.
    Dakhil, Shaker
    Kornek, Gabriela
    Axelrod, Rita
    Adkins, Douglas
    Pant, Shubham
    O'Brien, Paul
    Debruyne, Philip R.
    Oliner, Kelly S.
    Dong, Jun
    Murugappan, Swami
    ORAL ONCOLOGY, 2016, 61 : 31 - 40
  • [33] DOCETAXEL PLUS CISPLATIN AS FIRST-LINE CHEMOTHERAPY IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER
    Ohhara, Y.
    Nishimura, N.
    Nara, E.
    Nakano, K.
    Ueda, K.
    Sakajiri, S.
    Mishima, Y.
    Yokoyama, M.
    Terui, Y.
    Takahashi, S.
    Hatake, K.
    ANNALS OF ONCOLOGY, 2012, 23 : 125 - 125
  • [34] Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck
    Trieu, Vanessa
    Pinto, Harlan
    Riess, Jonathan W.
    Lira, Ruth
    Luciano, Richard
    Coty, Jessie
    Boothroyd, Derek
    Colevas, A. Dimitrios
    ONCOLOGIST, 2018, 23 (07): : 764 - +
  • [35] Cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Greenhalgh, J.
    Bagust, A.
    Boland, A.
    Fleeman, N.
    McLeod, C.
    Dundar, Y.
    Proudlove, C.
    Shaw, R.
    HEALTH TECHNOLOGY ASSESSMENT, 2009, 13 : 49 - 54
  • [36] Phase II study of dasatinib in combination with cetuximab in recurrent/metastatic head and neck squamous cell carcinoma
    Stabile, Laura P.
    Egloff, Ann Marie
    Zhou, Pei
    Gooding, William E.
    Grandis, Jennifer R.
    Bauman, Julie E.
    CANCER RESEARCH, 2016, 76
  • [37] Phase II study of cetuximab and lenalidomide in recurrent/metastatic squamous cell carcinoma of the head and neck.
    Taylor, Rodney J.
    Saloura, Vassiliki
    Wong, Richard
    Goloubeva, Olga
    Silpino, Lorna
    de Souza, Jonas
    Seiwert, Tanguy
    Vokes, Everett
    Cohen, Ezra
    Villaflor, Victoria
    MOLECULAR CANCER THERAPEUTICS, 2013, 12 (11)
  • [38] A phase II study of docetaxel and cisplatin in patients with squamous cell carcinoma of the head and neck (SCCN)
    Forastiere, A
    Glisson, B
    Murphy, B
    Frenette, G
    O'Connell, B
    ANNALS OF ONCOLOGY, 1998, 9 : 75 - 75
  • [39] Pembrolizumab plus nabpaclitaxe and platinum as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma: A prospective phase II study
    Gui, L.
    He, X.
    Yang, J.
    Liu, P.
    Yan, Q.
    Shi, Y-K.
    ANNALS OF ONCOLOGY, 2022, 33 (07) : S855 - S856
  • [40] Docetaxel, cisplatin, and fluorouracil for patients with inoperable recurrent or metastatic head and neck squamous cell carcinoma
    Cho, Hironori
    Nishiike, Suetaka
    Yamamoto, Yoshifumi
    Takenaka, Yukinori
    Nakahara, Susumu
    Yasui, Toshimichi
    Hanamoto, Atsushi
    Inohara, Hidenori
    AURIS NASUS LARYNX, 2015, 42 (05) : 396 - 400