Strojan Primož, Grašič Kuhar Cvetka, Žumer Barbara, Kadivec Maksimilijan, Karner Katarina, Fajdiga Igor, Jančar Boris, Gale Nina, Poljak Mario, Kocjan Boštjan J, Zakotnik Branko
Department of Radiation Oncology, Institute of Oncology, Ljubljana, Slovenia.
Head Neck. 2014 Nov;36(11):1555-61. doi: 10.1002/hed.23506. Epub 2013 Dec 18.
The purpose of this study was to assess the efficacy and toxicity of docetaxel, cisplatin/5-fluorouracil (TPF) induction chemotherapy and concomitant immunochemoradiotherapy with cetuximab and cisplatin in unresectable head and neck carcinoma.
Treatment consisted of TPF induction chemotherapy (docetaxel 75 mg/m(2) day 2; cisplatin, 75 mg/m(2) day 2; and 5-fluorouracil 750 mg/m(2) days 1-4; 4 cycles), followed by radiotherapy (RT) and concomitant weekly cetuximab, (250 mg/m(2), after a loading dose of 400 mg/m(2)) and cisplatin (30 mg/m(2)).
Twenty-five of 30 patients completed 4 cycles of induction chemotherapy. Six or more concomitant infusions of cisplatin and cetuximab were administered in 13 of 25 and 18 of 25 patients, respectively. The 2-year locoregional control, disease-free survival (DFS), and overall survival (OS) were 47%, 47%, and 50%, respectively. Patients with grade ≥ 2 skin reaction to cetuximab had a superior outcome.
The tested regimen was effective; however, cetuximab and low-dose cisplatin after induction TPF increased the treatment toxicity. A grade ≥ 2 skin rash correlated with improved efficacy.
本研究旨在评估多西他赛、顺铂/5-氟尿嘧啶(TPF)诱导化疗以及西妥昔单抗和顺铂同步免疫化放疗用于不可切除头颈部癌的疗效和毒性。
治疗包括TPF诱导化疗(多西他赛75mg/m²,第2天;顺铂75mg/m²,第2天;5-氟尿嘧啶750mg/m²,第1 - 4天;共4个周期),随后进行放疗(RT),并同步每周给予西妥昔单抗(初始剂量400mg/m²后,250mg/m²)和顺铂(30mg/m²)。
30例患者中有25例完成了4个周期的诱导化疗。25例患者中分别有13例和18例接受了6次或更多次顺铂与西妥昔单抗的同步输注。2年局部区域控制率、无病生存率(DFS)和总生存率(OS)分别为47%、47%和50%。对西妥昔单抗有≥2级皮肤反应的患者预后较好。
所测试的方案有效;然而,诱导TPF后使用西妥昔单抗和低剂量顺铂增加了治疗毒性。≥2级皮疹与疗效改善相关。