Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, FC, Italy.
Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.
Support Care Cancer. 2019 Jul;27(7):2425-2434. doi: 10.1007/s00520-018-4517-2. Epub 2018 Oct 24.
Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.
In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.
The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.
Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.
ClinicalTrials.gov (NCT01996540).
早期姑息治疗（EPC）已显示出对生活质量（QoL）、护理质量和医疗保健成本的积极影响。我们评估了晚期胃癌患者的这种影响。
在这项前瞻性、多中心研究中，186 名晚期胃癌患者按 1:1 随机分为接受标准癌症护理（SCC）加按需 EPC（标准组）或 SCC 加系统 EPC（干预组）。主要结局是通过功能评估癌症治疗-胃癌问卷评估的试验结果指数（TOI）评分在随机分组（T0）和 T1（T0 后 12 周）之间的 QoL 变化。次要结局是患者情绪、总生存期以及家庭对医疗保健和护理积极性的满意度。
标准组患者从 T0 到 T1 的 TOI 评分平均变化为-1.30（标准差 20.01），干预组为 1.65（标准差 22.38），差异为 2.95（95%置信区间-4.43 至 10.32）（p=0.430）。标准组的胃癌亚量表平均变化值为 0.91（标准差 14.14），干预组为 3.19（标准差 15.25），差异为 2.29（95%置信区间-2.80 至 7.38）（p=0.375）。标准组 43%的患者接受了 EPC。
我们的结果表明 EPC 略有获益，但无统计学意义。如果姑息治疗管理不当，姑息治疗研究的结果可能会被低估：干预类型、肿瘤学家和姑息治疗医生之间的共同决策过程、标准组污染的风险、研究持续时间、主要结局评估的及时性、队列开始的及时性以及招募有明显症状负担的患者。
ClinicalTrials.gov（NCT01996540）。
