Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy.
Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy,
Oncology. 2020;98(11):763-770. doi: 10.1159/000507733. Epub 2020 Jul 6.
Induction chemotherapy followed by cetuximab and RT (IBRT) (Arm A) was compared to cisplatin/RT (CRT) (Arm B) in a randomized phase III study.
Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible. Arm A (IBRT): 3 TPF induction followed by cetuximab-RT (equivalent daily dose 2 Gy up to 70 Gy); Arm B: 3 cisplatin concurrent with the same RT scheduling. Due to slow accrual and incomplete data collection a futility analysis was performed.
236/282 patients were evaluable. Therefore, no formal analyses can be made between the two arms. OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms. Neutropenia and skin toxicity were significantly worse in Arm A and body weight loss was significantly worse in Arm B. Compliance with the planned drug administration was higher in Arm B (p = 0.0008).
The study suggests that IBRT and CRT have similar efficacy, activity and toxicity.
在一项随机 III 期研究中，比较了诱导化疗后联合西妥昔单抗和放疗（IBRT）（A 组）与顺铂/放疗（CRT）（B 组）。
患有 III-IVa 期、组织学证实的局部晚期头颈部癌症（LASCCHN）的初治患者符合条件。A 组（IBRT）：3 个 TPF 诱导后联合西妥昔单抗放疗（等效日剂量 2 Gy，直至 70 Gy）；B 组：3 个顺铂与相同的 RT 方案同时使用。由于入组速度缓慢和数据收集不完整，进行了无效性分析。
236/282 名患者可评估。因此，无法在两组之间进行正式分析。A 组/B 组的 OS 分别为 45.2/53.6 个月。两组患者的完全缓解率均为 64%。A 组的中性粒细胞减少和皮肤毒性明显更严重，B 组的体重减轻明显更严重。B 组的计划药物给药依从性更高（p = 0.0008）。
该研究表明 IBRT 和 CRT 具有相似的疗效、活性和毒性。
