Machiels Jean-Pascal, Van Maanen Aline, Vandenbulcke Jean-Marie, Filleul Bertrand, Seront Emmanuel, Henry Stéphanie, D'Hondt Lionel, Lonchay Christophe, Holbrechts Stéphane, Boegner Petra, Brohee Dany, Dequanter Didier, Louviaux Ingrid, Sautois Brieuc, Whenham Nicolas, Berchem Guy, Vanderschueren Brigitte, Fontaine Christel, Schmitz Sandra, Gillain Aline, Schoonjans Joelle, Rottey Sylvie
Institut Roi Albert II, Department of Medical Oncology, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Brussels, Belgium
Statistical Support Unit, Institut Roi Albert II, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
Oncologist. 2016 Dec;21(12):1416-e17. doi: 10.1634/theoncologist.2016-0296. Epub 2016 Nov 30.
Cabazitaxel has activity in squamous cell carcinoma of the head and neck (SCCHN) and taxane-resistant cell lines. For the first time, cabazitaxel was investigated in incurable patients with recurrent SCCHN. Patients were randomly assigned to cabazitaxel every 3 weeks or weekly methotrexate.This phase II study did not meet its primary endpoint.Cabazitaxel has low activity in SCCHN.The toxicity profile in this population also was not favorable owing to the high rate of febrile neutropenia observed (17%).
Cabazitaxel is a second-generation taxane that improves the survival of patients with metastatic castrate-resistant prostate cancer following docetaxel therapy. Cabazitaxel has activity in squamous cell carcinoma of the head and neck (SCCHN) and taxane-resistant cell lines. In this randomized phase II trial, we investigated cabazitaxel in patients with recurrent SCCHN.
Patients with incurable SCCHN with progression after platinum-based therapy were randomly assigned to cabazitaxel every 3 weeks (cycle 1, 20 mg/m, increased to 25 mg/m for subsequent cycles in the absence of nonhematological adverse events [AEs] greater than grade 2 and hematological AEs greater than grade 3) or methotrexate (40 mg/m/week). The patients were stratified according to their performance status and previous platinum-based chemotherapy for palliation versus curative intent. The primary endpoint was the progression-free survival rate (PFSR) at 18 weeks.
Of the 101 patients, 53 and 48, with a median age of 58.0 years (range, 41-80), were randomly assigned to cabazitaxel or methotrexate, respectively. The PFSR at 18 weeks was 13.2% (95% confidence interval [CI], 5%-25%) for cabazitaxel and 8.3% (95% CI, 2%-20%) for methotrexate. The median progression-free survival was 1.9 months in both arms. The median overall survival was 5.0 and 3.6 months for cabazitaxel and methotrexate, respectively. More patients experienced serious adverse events with cabazitaxel than with methotrexate (54% vs. 36%). The most common drug-related grade 3-4 AE in the cabazitaxel arm was febrile neutropenia (17.3%).
This study did not meet its primary endpoint. Cabazitaxel has low activity in recurrent SCCHN.
卡巴他赛对头颈部鳞状细胞癌（SCCHN）和紫杉烷耐药细胞系具有活性。首次对复发性SCCHN的不可治愈患者进行了卡巴他赛的研究。患者被随机分配接受每3周一次的卡巴他赛治疗或每周一次的甲氨蝶呤治疗。这项II期研究未达到其主要终点。卡巴他赛在SCCHN中的活性较低。由于观察到的发热性中性粒细胞减少率较高（17%），该人群的毒性特征也不理想。
卡巴他赛是一种第二代紫杉烷类药物，可改善多西他赛治疗后转移性去势抵抗性前列腺癌患者的生存率。卡巴他赛对头颈部鳞状细胞癌（SCCHN）和紫杉烷耐药细胞系具有活性。在这项随机II期试验中，我们对复发性SCCHN患者进行了卡巴他赛的研究。
铂类治疗后病情进展的不可治愈的SCCHN患者被随机分配接受每3周一次的卡巴他赛治疗（第1周期，20mg/m²，在无大于2级的非血液学不良事件[AEs]和大于3级的血液学AEs的情况下，后续周期增加至25mg/m²）或甲氨蝶呤（40mg/m²/周）。患者根据其体能状态和既往铂类化疗的姑息性与根治性意图进行分层。主要终点是18周时的无进展生存率（PFSR）。
101例患者中，53例和48例，中位年龄58.0岁（范围41 - 80岁），分别被随机分配接受卡巴他赛或甲氨蝶呤治疗。卡巴他赛组18周时的PFSR为13.2%（95%置信区间[CI]，5% - 25%），甲氨蝶呤组为8.3%（95%CI，2% - 20%）。两组的中位无进展生存期均为1.9个月。卡巴他赛组和甲氨蝶呤组的中位总生存期分别为5.0个月和3.6个月。与甲氨蝶呤相比更多接受卡巴他赛治疗的患者出现严重不良事件（54%对36%）。卡巴他赛组最常见的3 - 4级药物相关AE是发热性中性粒细胞减少（17.3%）。
本研究未达到其主要终点。卡巴他赛在复发性SCCHN中的活性较低。
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