Department of Radiation Oncology, Tenon Hospital, AP-HP, Sorbonne Université, Paris, France.
Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, INSERM UMR 1098, Besançon, France.
Clin Oncol (R Coll Radiol). 2022 Dec;34(12):e473-e481. doi: 10.1016/j.clon.2022.09.046. Epub 2022 Oct 5.
The EXTREME regimen is the standard for recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). However, many patients have a poor performance status and/or comorbidities, making them unfit for this regimen. We have treated them with carboplatin and cetuximab (simplified EXTREME regimen) since 2007. Our aim was to assess the efficacy and tolerance of this regimen in this frail population.
A retrospective chart review of all patients treated with the simplified EXTREME regimen for recurrent and/or metastatic HNSCC in three academic hospitals between 2007 and 2017 was carried out. The primary end point was overall survival. Secondary end points were progression-free survival (PFS), overall response rate (ORR) and toxicity.
One hundred and three patients were included. The median age was 63 years, 40% had performance status 2-3. The median follow-up was 30.2 months. The median overall survival and PFS were 7.2 and 3.7 months, respectively. The median overall survival was 10.1 months in patients with performance status 0-1 versus 4.6 months in patients with performance status 2-3 (P = 0.01). ORR was 39%. Acute grade 3-4 haematological and non-haematological toxicity rates were 25.2% and 27.2%, respectively. Patients with grade 1 or more skin toxicity had a higher ORR (hazard ratio = 3.44; P = 0.03), a prolonged overall survival (hazard ratio = 0.37; P < 0.0001) and PFS (hazard ratio = 0.29; P < 0.0001). During treatment, 29% of patients had pain reduction, 13.5% had weight gain and 17.2% had an improvement in performance status.
This is the largest cohort of patients treated with simplified EXTREME for HNSCC. It was well tolerated, with a high ORR. Interestingly, skin toxicity correlated with treatment efficacy.
EXTREME 方案是复发性和/或转移性头颈部鳞状细胞癌（HNSCC）的标准治疗方案。然而，许多患者的身体状况较差，存在合并症，不适合使用该方案。自 2007 年以来，我们一直使用卡铂和西妥昔单抗（简化 EXTREME 方案）对这些患者进行治疗。我们的目的是评估该方案在这一脆弱人群中的疗效和耐受性。
对 2007 年至 2017 年间在三所学术医院接受简化 EXTREME 方案治疗复发性和/或转移性 HNSCC 的所有患者进行回顾性图表审查。主要终点是总生存期。次要终点是无进展生存期（PFS）、总缓解率（ORR）和毒性。
共纳入 103 例患者。中位年龄为 63 岁，40%的患者体力状况为 2-3 级。中位随访时间为 30.2 个月。中位总生存期和 PFS 分别为 7.2 个月和 3.7 个月。体力状况为 0-1 级的患者中位总生存期为 10.1 个月，而体力状况为 2-3 级的患者中位总生存期为 4.6 个月（P = 0.01）。ORR 为 39%。急性 3-4 级血液学和非血液学毒性发生率分别为 25.2%和 27.2%。出现 1 级或更高级别的皮肤毒性的患者 ORR 更高（风险比=3.44；P=0.03），总生存期更长（风险比=0.37；P<0.0001），PFS 也更长（风险比=0.29；P<0.0001）。在治疗期间，29%的患者疼痛减轻，13.5%的患者体重增加，17.2%的患者体力状况改善。
这是接受简化 EXTREME 方案治疗 HNSCC 的最大患者队列。该方案耐受性良好，ORR 较高。有趣的是，皮肤毒性与治疗效果相关。
