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Effect of Neoadjuvant Chemoradiotherapy on Health-Related Quality of Life in Esophageal or Junctional Cancer: Results From the Randomized CROSS Trial
Journal of Clinical Oncology ( IF 45.3 ) Pub Date : 2018-01-20 , DOI: 10.1200/jco.2017.73.7718 Bo Jan Noordman 1 , Mathilde G.E. Verdam 1 , Sjoerd M. Lagarde 1 , Maarten C.C.M. Hulshof 1 , Pieter van Hagen 1 , Mark I. van Berge Henegouwen 1 , Bas P.L. Wijnhoven 1 , Hanneke W.M. van Laarhoven 1 , Grard A.P. Nieuwenhuijzen 1 , Geke A.P. Hospers 1 , Johannes J. Bonenkamp 1 , Miguel A. Cuesta 1 , Reinoud J.B. Blaisse 1 , Olivier R. Busch 1 , Fiebo J.W. ten Kate 1 , Geert-Jan M. Creemers 1 , Cornelis J.A. Punt 1 , John Th.M. Plukker 1 , Henk M.W. Verheul 1 , Ernst J. Spillenaar Bilgen 1 , Herman van Dekken 1 , Maurice J.C. van der Sangen 1 , Tom Rozema 1 , Katharina Biermann 1 , Jannet C. Beukema 1 , Anna H.M. Piet 1 , Caroline M. van Rij 1 , Janny G. Reinders 1 , Hugo W. Tilanus 1 , Ewout W. Steyerberg 1 , Ate van der Gaast 1 , Mirjam A.G. Sprangers 1 , J. Jan B. van Lanschot 1
Journal of Clinical Oncology ( IF 45.3 ) Pub Date : 2018-01-20 , DOI: 10.1200/jco.2017.73.7718 Bo Jan Noordman 1 , Mathilde G.E. Verdam 1 , Sjoerd M. Lagarde 1 , Maarten C.C.M. Hulshof 1 , Pieter van Hagen 1 , Mark I. van Berge Henegouwen 1 , Bas P.L. Wijnhoven 1 , Hanneke W.M. van Laarhoven 1 , Grard A.P. Nieuwenhuijzen 1 , Geke A.P. Hospers 1 , Johannes J. Bonenkamp 1 , Miguel A. Cuesta 1 , Reinoud J.B. Blaisse 1 , Olivier R. Busch 1 , Fiebo J.W. ten Kate 1 , Geert-Jan M. Creemers 1 , Cornelis J.A. Punt 1 , John Th.M. Plukker 1 , Henk M.W. Verheul 1 , Ernst J. Spillenaar Bilgen 1 , Herman van Dekken 1 , Maurice J.C. van der Sangen 1 , Tom Rozema 1 , Katharina Biermann 1 , Jannet C. Beukema 1 , Anna H.M. Piet 1 , Caroline M. van Rij 1 , Janny G. Reinders 1 , Hugo W. Tilanus 1 , Ewout W. Steyerberg 1 , Ate van der Gaast 1 , Mirjam A.G. Sprangers 1 , J. Jan B. van Lanschot 1
Affiliation
Purpose To compare pre-agreed health-related quality of life (HRQOL) domains in patients with esophageal or junctional cancer who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery or surgery alone. Secondary aims were to examine the effect of nCRT on HRQOL before surgery and the effect of surgery on HRQOL. Patients and Methods Patients were randomly assigned to nCRT (carboplatin plus paclitaxel with concurrent 41.4-Gy radiotherapy) followed by surgery or surgery alone. HRQOL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and -Oesophageal Cancer Module (QLQ-OES24) questionnaires pretreatment and at 3, 6, 9, and 12 months postoperatively. The nCRT group also received preoperative questionnaires. Physical functioning (PF; QLQ-C30) and eating problems (EA; QLQ-OES24) were chosen as predefined primary end points. Predefined secondary end points were global QOL (GQOL; QLQ-C30), fatigue (FA; QLQ-C30), and emotional problems (EM; QLQ-OES24). Results A total of 363 patients were analyzed. No statistically significant differences in postoperative HRQOL were found between treatment groups. In the nCRT group, PF, EA, GQOL, FA, and EM scores deteriorated 1 week after nCRT (Cohen's d: -0.93, P < .001; 0.47, P < .001; -0.84, P < .001; 1.45, P < .001; and 0.32, P = .001, respectively). In both treatment groups, all end points declined 3 months postoperatively compared with baseline (Cohen's d: -1.00, 0.33, -0.47, -0.34, and 0.33, respectively; all P < .001), followed by a continuous gradual improvement. EA, GQOL, and EM were restored to baseline levels during follow-up, whereas PF and FA remained impaired 1 year postoperatively (Cohen's d: 0.52 and -0.53, respectively; both P < .001). Conclusion Although HRQOL declined during nCRT, no effect of nCRT was apparent on postoperative HRQOL compared with surgery alone. In addition to the improvement in survival, these findings support the view that nCRT according to the Chemoradiotherapy for Esophageal Cancer Followed by Surgery Study-regimen can be regarded as a standard of care.
中文翻译：
新辅助放化疗对食管癌或交界癌患者健康相关生活质量的影响：随机 CROSS 试验的结果
目的 比较接受新辅助放化疗 (nCRT) 后接受手术或单独手术的食管癌或交界癌患者预先约定的健康相关生活质量 (HRQOL) 域。次要目的是检查术前 nCRT 对 HRQOL 的影响以及手术对 HRQOL 的影响。患者和方法 患者被随机分配接受 nCRT（卡铂加紫杉醇同时进行 41.4-Gy 放疗），然后进行手术或单独手术。HRQOL 是在治疗前和术后 3、6、9 和 12 个月使用欧洲癌症研究和治疗组织生活质量问卷核心 30 (QLQ-C30) 和食管癌模块 (QLQ-OES24) 问卷测量的。nCRT 组也收到了术前问卷。身体机能（PF; QLQ-C30）和饮食问题（EA；QLQ-OES24）被选为预定义的主要终点。预先定义的次要终点是总体生活质量（GQOL；QLQ-C30）、疲劳（FA；QLQ-C30）和情绪问题（EM；QLQ-OES24）。结果共分析了363例患者。在治疗组之间没有发现术后 HRQOL 的统计学显着差异。在 nCRT 组中，nCRT 后 1 周 PF、EA、GQOL、FA 和 EM 评分恶化（Cohen's d：-0.93，P < .001；0.47，P < .001；-0.84，P < .001；1.45， P < .001；和 0.32，分别为 P = .001）。在两个治疗组中，与基线相比，所有终点在术后 3 个月均有所下降（Cohen's d：分别为 -1.00、0.33、-0.47、-0.34 和 0.33；所有 P < .001），随后持续逐渐改善。EA、GQOL、和 EM 在随访期间恢复到基线水平，而 PF 和 FA 在术后 1 年仍然受损（Cohen's d：分别为 0.52 和 -0.53；P < .001）。结论 尽管 nCRT 期间 HRQOL 下降，但与单独手术相比，nCRT 对术后 HRQOL 没有明显影响。除了提高生存率之外，这些发现还支持以下观点，即根据食管癌放化疗后手术研究方案的 nCRT 可被视为护理标准。
更新日期：2018-01-20
中文翻译：
新辅助放化疗对食管癌或交界癌患者健康相关生活质量的影响：随机 CROSS 试验的结果
目的 比较接受新辅助放化疗 (nCRT) 后接受手术或单独手术的食管癌或交界癌患者预先约定的健康相关生活质量 (HRQOL) 域。次要目的是检查术前 nCRT 对 HRQOL 的影响以及手术对 HRQOL 的影响。患者和方法 患者被随机分配接受 nCRT（卡铂加紫杉醇同时进行 41.4-Gy 放疗），然后进行手术或单独手术。HRQOL 是在治疗前和术后 3、6、9 和 12 个月使用欧洲癌症研究和治疗组织生活质量问卷核心 30 (QLQ-C30) 和食管癌模块 (QLQ-OES24) 问卷测量的。nCRT 组也收到了术前问卷。身体机能（PF; QLQ-C30）和饮食问题（EA；QLQ-OES24）被选为预定义的主要终点。预先定义的次要终点是总体生活质量（GQOL；QLQ-C30）、疲劳（FA；QLQ-C30）和情绪问题（EM；QLQ-OES24）。结果共分析了363例患者。在治疗组之间没有发现术后 HRQOL 的统计学显着差异。在 nCRT 组中，nCRT 后 1 周 PF、EA、GQOL、FA 和 EM 评分恶化（Cohen's d：-0.93，P < .001；0.47，P < .001；-0.84，P < .001；1.45， P < .001；和 0.32，分别为 P = .001）。在两个治疗组中，与基线相比，所有终点在术后 3 个月均有所下降（Cohen's d：分别为 -1.00、0.33、-0.47、-0.34 和 0.33；所有 P < .001），随后持续逐渐改善。EA、GQOL、和 EM 在随访期间恢复到基线水平，而 PF 和 FA 在术后 1 年仍然受损（Cohen's d：分别为 0.52 和 -0.53；P < .001）。结论 尽管 nCRT 期间 HRQOL 下降，但与单独手术相比，nCRT 对术后 HRQOL 没有明显影响。除了提高生存率之外，这些发现还支持以下观点，即根据食管癌放化疗后手术研究方案的 nCRT 可被视为护理标准。
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