食管癌新辅助治疗与辅助治疗试验（QUINTETT）的生活质量：随机平行临床优势试验。
The quality of life in neoadjuvant versus adjuvant therapy of esophageal cancer treatment trial (QUINTETT): Randomized parallel clinical superiority trial.
机构信息
Department of Oncology, Divisions of Thoracic Surgery and Surgical Oncology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
Radiation Oncology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
出版信息
Thorac Cancer. 2022 Jul;13(13):1898-1915. doi: 10.1111/1759-7714.14433. Epub 2022 May 24.
BACKGROUND
We compared the health-related quality of life (HRQOL) in patients undergoing trimodality therapy for resectable stage I-III esophageal cancer.
METHODS
A total of 96 patients were randomized to standard neoadjuvant cisplatin and 5-fluorouracil chemotherapy plus radiotherapy (neoadjuvant) followed by surgical resection or adjuvant cisplatin, 5-fluorouracil, and epirubicin chemotherapy with concurrent extended volume radiotherapy (adjuvant) following surgical resection.
RESULTS
There was no significant difference in the functional assessment of cancer therapy-esophageal (FACT-E) total scores between arms at 1 year (p = 0.759) with 36% versus 41% (neoadjuvant vs. adjuvant), respectively, showing an increase of ≥15 points compared to pre-treatment (p = 0.638). The HRQOL was significantly inferior at 2 months in the neoadjuvant arm for FACT-E, European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-OG25), and EuroQol 5-D-3 L in the dysphagia, reflux, pain, taste, and coughing domains (p < 0.05). Half of patients were able to complete the prescribed neoadjuvant arm chemotherapy without modification compared to only 14% in the adjuvant arm (p < 0.001). Chemotherapy related adverse events of grade ≥2 occurred significantly more frequently in the neoadjuvant arm (100% vs. 69%, p < 0.001). Surgery related adverse events of grade ≥2 were similar in both arms (72% vs. 86%, p = 0.107). There were no 30-day mortalities and 2% vs. 10% 90-day mortalities (p = 0.204). There were no significant differences in either overall survival (OS) (5-year: 35% vs. 32%, p = 0.409) or disease-free survival (DFS) (5-year: 31% vs. 30%, p = 0.710).
CONCLUSION
Trimodality therapy is challenging for patients with resectable esophageal cancer regardless of whether it is given before or after surgery. Newer and less toxic protocols are needed.
背景
我们比较了可切除 I-III 期食管癌患者接受三联疗法的健康相关生活质量（HRQOL）。
方法
共有 96 例患者被随机分为标准新辅助顺铂和 5-氟尿嘧啶化疗联合放疗（新辅助）后手术切除或辅助顺铂、5-氟尿嘧啶和表柔比星化疗联合手术切除后扩展容积放疗（辅助）。
结果
1 年时，各组间癌症治疗食管功能评估量表（FACT-E）总分无显著差异（p=0.759），分别为 36%和 41%（新辅助组和辅助组），与治疗前相比增加≥15 分（p=0.638）。新辅助组在 2 个月时 FACT-E、欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ-OG25）和欧洲五维健康量表 3 级（EuroQol 5-D-3L）的吞咽困难、反流、疼痛、味觉和咳嗽领域的 HRQOL 明显较差（p<0.05）。与辅助组相比，一半的患者能够完成规定的新辅助组化疗，而无需修改（p<0.001）。新辅助组化疗相关≥2 级不良事件发生率明显高于辅助组（100%比 69%，p<0.001）。两组手术相关≥2 级不良事件发生率相似（72%比 86%，p=0.107）。无 30 天死亡率，2%比 10%（p=0.204）的 90 天死亡率。总生存率（OS）（5 年：35%比 32%，p=0.409）或无病生存率（DFS）（5 年：31%比 30%，p=0.710）均无显著差异。
结论
无论在手术前还是手术后，三联疗法对可切除食管癌患者都是一种挑战。需要新的、毒性更小的方案。
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