Ringash Jolie, Waldron John N, Siu Lillian L, Martino Rosemary, Winquist Eric, Wright Jim R, Nabid Abdenour, Hay John H, Hammond Alex, Sultanem Khalil, Hotte Sebastien, Leong Carson, El-Gayed Ali Abdel Halim, Naz Farah, Ramchandar Kevin, Owen Timothy E, Montenegro Alexander, O'Sullivan Brian, Chen Bingshu E, Parulekar Wendy R
Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Eur J Cancer. 2017 Feb;72:192-199. doi: 10.1016/j.ejca.2016.11.008. Epub 2016 Dec 29.
To compare quality of life (QOL) between standard (SFX) chemoradiotherapy (arm A) and altered fractionation radiotherapy (AFX) with panitumumab (PMab; arm B).
Patients with T any N + M0 or T3-4N0M0 squamous cell head-neck carcinoma were randomised to SFX (70 Gy/35/7 wks) plus cisplatin (100 mg/m IV × 3) versus AFX (70 Gy/35/6 wks) plus PMab (9 mg/kg IV × 3). QOL was collected at baseline, end of radiation therapy (RT) and 2, 4, 6, 12, 24 and 36 months post-RT using the Functional Assessment of Cancer Therapy Head and Neck (FACT-H&N), MD Anderson Dysphagia Index (MDADI) and SWAL-QOL. We hypothesised a 6-point more favourable change in FACT-H&N score from baseline to 1 year in arm B over arm A.
Among 320 patients, median follow-up was 46 (range: 0.1-64.3) months, median age 56, 84% male, Eastern Cooperative Oncology Group PS 0 (71%), 1 (29%). Primary site was oropharynx in 81% (p16+ 68%, p16- 16%, missing 16%). Baseline scores did not differ by arm (A/B): FACT-H&N 116.5/115, MDADI Global 83/77, SWAL-QOL General 67/68. At 1 year, no difference was seen between arms in FACT-H&N change from baseline: A -1.70, B -4.81, p = 0.194. Subscale change scores by arm were (A/B): last week RT, FACT-Physical (-11.6, -10, p = 0.049), MDADI Physical (-40.4, -33.9, p = 0.045), and SWAL-QOL Eating Duration (-61.2, -51.2, p = 0.02), Eating Desire (-53.3, -43.9, p = 0.031) and Mental Health (-42, -32.6, p = 0.009); 4 months, HN subscale (-7.7, -10, p = 0.014). No clinically important differences by arm were seen post-treatment.
PMab with AFX did not durably improve QOL or swallowing as compared with SFX with cisplatin.
ClinicalTrials.gov: NCT00820248.
比较标准（SFX）放化疗（A组）与联合帕尼单抗（PMab）的分割放疗（AFX，B组）的生活质量（QOL）。
将T任何N + M0或T3 - 4N0M0的头颈部鳞状细胞癌患者随机分为SFX（70 Gy/35次/7周）联合顺铂（100 mg/m²静脉注射×3次）组与AFX（70 Gy/35次/6周）联合PMab（9 mg/kg静脉注射×3次）组。在基线、放疗结束时以及放疗后2、4、6、12、24和36个月，使用癌症治疗功能评估头颈量表（FACT - H&N）、MD安德森吞咽指数（MDADI）和吞咽生活质量量表（SWAL - QOL）收集生活质量数据。我们假设B组从基线到1年FACT - H&N评分比A组有更有利的6分变化。
在320例患者中，中位随访时间为46（范围：0.1 - 64.3）个月，中位年龄56岁，84%为男性，东部肿瘤协作组体能状态0（71%），1（29%）。81%的原发部位为口咽（p16 + 68%，p16 - 16%，缺失16%）。两组基线评分无差异（A/B）：FACT - H&N 116.5/115，MDADI总体评分83/77，SWAL - QOL一般评分67/68。1年时，两组从基线开始的FACT - H&N变化无差异：A组 - 1.70，B组 - 4.81，p = 0.194。两组各分量表变化得分（A/B）为：放疗最后一周，FACT - 身体分量表（-11.6，-10，p = 0.049），MDADI身体分量表（-40.4，-33.9，p = 0.045），以及SWAL - QOL进食持续时间（-61.2，-51.2，p = 0.02）、进食欲望（-53.3，-43.9，p = 0.031）和心理健康（-42，-32.6，p = 0.009）；4个月时，头颈分量表（-7.7，-10，p = 0.014）。治疗后两组未见具有临床意义的差异。
与联合顺铂的SFX相比，联合PMab的AFX并不能持久改善生活质量或吞咽功能。
ClinicalTrials.gov：NCT00820248。
