一项多中心2期研究的患者报告结局，该研究调查吉西他滨和立体定向体部放射治疗在局部晚期胰腺癌中的应用。
Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer.
作者信息
Rao Avani D, Sugar Elizabeth A, Chang Daniel T, Goodman Karyn A, Hacker-Prietz Amy, Rosati Lauren M, Columbo Laurie, O'Reilly Eileen, Fisher George A, Zheng Lei, Pai Jonathan S, Griffith Mary E, Laheru Daniel A, Iacobuzio-Donahue Christine A, Wolfgang Christopher L, Koong Albert, Herman Joseph M
机构信息
Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Department of Biostatistics and Epidemiology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
出版信息
Pract Radiat Oncol. 2016 Nov-Dec;6(6):417-424. doi: 10.1016/j.prro.2016.05.005. Epub 2016 May 25.
PURPOSE
We previously reported clinical outcomes and physician-reported toxicity of gemcitabine and hypofractionated stereotactic body radiation therapy (SBRT) in locally advanced pancreatic cancer (LAPC). Here we prospectively investigate the impact of gemcitabine and SBRT on patient-reported quality of life (QoL).
METHODS AND MATERIALS
Forty-nine LAPC patients received 33 Gy SBRT (6.6 Gy daily fractions) upfront or after ≤3 doses of gemcitabine (1000 mg/m) followed by gemcitabine until progression. European Organization for Research and Treatment of Cancer QoL core cancer (QLQ-C30) and pancreatic cancer-specific (European Organization for Research and Treatment of Cancer QLQ-PAN26) questionnaires were administered to patients pre-SBRT and at 4 to 6 weeks (first follow-up [1FUP]) and 4 months (2FUP) post-SBRT. Changes in QoL scores were deemed clinically relevant if median changes were at least 5 points in magnitude.
RESULTS
Forty-three (88%) patients completed pre-SBRT questionnaires. Of these, 88% and 51% completed questionnaires at 1FUP and 2FUP, respectively. There was no change in global QoL from pre-SBRT to 1FUP (P = .17) or 2FUP (P > .99). Statistical and clinical improvements in pancreatic pain (P = .001) and body image (P = .007) were observed from pre-SBRT to 1FUP. Patients with 1FUP and 2FUP questionnaires reported statistically and clinically improved body image (P = .016) by 4 months. Although pancreatic pain initially demonstrated statistical and clinical improvement (P = .020), scores returned to enrollment levels by 2FUP (P = .486). A statistical and clinical decline in role functioning (P = .002) was observed in patients at 2FUP.
CONCLUSIONS
Global QoL scores are not reduced with gemcitabine and SBRT. In this exploratory analysis, patients experience clinically relevant short-term improvements in pancreatic cancer-specific symptoms. Previously demonstrated acceptable clinical outcomes combined with these favorable QoL data indicate that SBRT can be easily integrated with other systemic therapies and may be a potential standard of care option in patients with LAPC.
目的
我们之前报道了吉西他滨与低分割立体定向体部放射治疗（SBRT）用于局部晚期胰腺癌（LAPC）的临床结局及医生报告的毒性反应。在此，我们前瞻性地研究吉西他滨与SBRT对患者报告的生活质量（QoL）的影响。
方法与材料
49例LAPC患者接受33 Gy的SBRT（每日分次剂量为6.6 Gy），在≤3剂吉西他滨（1000 mg/m²）之前或之后进行，随后持续给予吉西他滨直至病情进展。在SBRT前、SBRT后4至6周（首次随访[1FUP]）和4个月（2FUP）时，对患者进行欧洲癌症研究与治疗组织生活质量核心癌症问卷（QLQ-C30）和胰腺癌特异性问卷（欧洲癌症研究与治疗组织QLQ-PAN26）调查。如果QoL评分的中位数变化幅度至少为5分，则认为QoL评分的变化具有临床相关性。
结果
43例（88%）患者完成了SBRT前问卷。其中，分别有88%和51%的患者在1FUP和2FUP时完成了问卷。从SBRT前到1FUP（P = 0.17）或2FUP（P > 0.99），总体生活质量没有变化。从SBRT前到1FUP，观察到胰腺疼痛（P = 0.001）和身体形象（P = 0.007）在统计学和临床上有所改善。完成1FUP和2FUP问卷的患者在4个月时报告身体形象在统计学和临床上均有改善（P = 0.016）。尽管胰腺疼痛最初在统计学和临床上有所改善（P = 0.020），但到2FUP时评分恢复到入组水平（P = 0.486）。在2FUP时观察到患者的角色功能在统计学和临床上出现下降（P = 0.002）。
结论
吉西他滨与SBRT不会降低总体生活质量评分。在这项探索性分析中，患者在胰腺癌特异性症状方面经历了具有临床相关性的短期改善。先前已证明的可接受的临床结局以及这些有利的生活质量数据表明，SBRT可以很容易地与其他全身治疗相结合，可能成为LAPC患者潜在的标准治疗选择。
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