质子笔形束扫描与被动散射/均匀扫描治疗局限性前列腺癌后的患者报告结局：PCG 001-09的二次分析
Patient reported outcomes following proton pencil beam scanning vs. passive scatter/uniform scanning for localized prostate cancer: Secondary analysis of PCG 001-09.
作者信息
Mishra Mark V, Khairnar Rahul, Bentzen Søren M, Larson Gary, Tsai Henry, Sinesi Christopher, Vargas Carlos, Laramore George, Rossi Carl, Rosen Lane, Sun Kai, Hartsell William
机构信息
Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, United States.
Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, United States.
出版信息
Clin Transl Radiat Oncol. 2020 Mar 7;22:50-54. doi: 10.1016/j.ctro.2020.03.003. eCollection 2020 May.
BACKGROUND
Although pencil beam scanning (PBS) is the most conformal method for proton beam therapy (PBT) delivery, it is unknown if outcomes differ compared to treatment with passive scatter/uniform scanning (PS/US). This analysis compares patient reported outcomes (PRO) changes following PBS and PS/US for prostate cancer (PC) in a prospective multicenter registry study.
METHODS
We evaluated PROs with the Expanded Prostate Cancer Index Composite (EPIC) instrument for men with localized PC enrolled in PCG 001-09 (NCT01255748). PROs were assessed at baseline and through 12 months of follow-up. We compared mean changes in EPIC scores, as well as the proportions of men experiencing a one- and two-fold minimally important difference (MID) in domain scores, between PBS and PS/US. Multivariate analyses (MVAs) were performed to further evaluate the association between proton modality and PRO changes.
RESULTS
Three-hundred-and-four men completed EPIC at baseline; 72 received PBS and 232 received PS/US. The average quality-of-life (QOL) declines from baseline through 12 months did not significantly differ between the two groups. The proportion of men reporting a 1-MID decline at 12 months for PBS and PS/US was 34.3% and 27.4%, respectively, for urinary QOL ( = 0.27); 40. 1% and 40.9% for bowel QOL ( = 0.36); and 30. 1% and 36.6% for sexual QOL ( = 0.94). Corresponding 2-MID declines for PBS and PS/US were observed in 26.9% and 13.2% of men for urinary QOL ( = 0.01), 35.3% and 29.1% for bowel QOL ( = 0.33); and 16.4% and 18.1% for sexual QOL ( = 0.76). The association between proton modality and 2-MID changes in urinary QOL at 12-months remained significant on MVA (P = 0.007).
CONCLUSIONS
The results of this analysis show differences between PBS and PS/US with regards to two-fold MID changes in urinary function at 12 months, but no differences for average score declines over time. Future studies evaluating PRO measures between the two PBT modalities are warranted.
背景
尽管笔形束扫描（PBS）是质子束治疗（PBT）中最适形的方法，但与被动散射/均匀扫描（PS/US）治疗相比，其疗效是否存在差异尚不清楚。本分析在前瞻性多中心注册研究中比较了前列腺癌（PC）患者接受PBS和PS/US治疗后患者报告结局（PRO）的变化。
方法
我们使用扩展前列腺癌指数综合量表（EPIC）评估了纳入PCG 001 - 09（NCT01255748）的局限性PC男性患者的PRO。在基线和随访12个月期间对PRO进行评估。我们比较了PBS和PS/US之间EPIC评分的平均变化，以及各领域评分出现1倍和2倍最小重要差异（MID）的男性比例。进行多变量分析（MVA）以进一步评估质子治疗方式与PRO变化之间的关联。
结果
304名男性在基线时完成了EPIC评估；72人接受了PBS，232人接受了PS/US。两组从基线到12个月的平均生活质量（QOL）下降无显著差异。在12个月时，PBS和PS/US组报告尿QOL下降1倍MID的男性比例分别为34.3%和27.4%（P = 0.27）；肠道QOL分别为40.1%和40.9%（P = 0.36）；性QOL分别为30.1%和36.6%（P = 0.94）。PBS和PS/US组尿QOL相应的2倍MID下降在男性中的比例分别为26.9%和13.2%（P = 0.01），肠道QOL分别为35.3%和29.1%（P = 0.33）；性QOL分别为16.4%和18.1%（P = 0.76）。在MVA中，质子治疗方式与12个月时尿QOL的2倍MID变化之间的关联仍然显著（P = 0.007）。
结论
本分析结果显示，PBS和PS/US在12个月时尿功能2倍MID变化方面存在差异，但随时间的平均评分下降无差异。有必要开展未来研究评估两种PBT方式之间的PRO指标。
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