Prognostic value of patient-reported outcomes from international randomised clinical trials on cancer: a systematic review

Mierzynska, Justyna; Piccinin, Claire; Pe, Madeline; Martinelli, Francesca; Gotay, Carolyn; Coens, Corneel; Mauer, Murielle; Eggermont, Alexander M.M.; Grøenvold, Mogens; Bjordal, Kristin; Reijneveld, Jaap C.; Velikova, Galina; Bottomley, Andrew

doi:10.1016/s1470-2045(19)30656-4

Cited by 94 publications

(113 citation statements)

References 78 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…[2][3][4] Patient-reported outcomes (PROs) are commonly used as a secondary outcome in clinical trials, and evidence indicates they are prognostic for a wide range of conventional anticancer treatments. [5][6][7][8][9] There is also emerging evidence that routine collection of PROs, a relatively inexpensive intervention, can enhance quality of life, patient satisfaction and survival. 5,6 To date, however, there has been minimal research on the prognostic significance of PROs for ICI therapy.…”

mentioning

confidence: 99%

Patient‐reported outcomes as a prognostic marker of survival in patients with advanced nonsmall cell lung cancer treated with immunotherapy

Hopkins

Wagner

Kichenadasse

et al. 2020

Intl Journal of Cancer

View full text Add to dashboard Cite

There has been minimal research on the prognostic value of patient-reported outcomes (PROs) for immune checkpoint inhibitors (ICIs). The relative performance of PROs compared to established markers such as Eastern Cooperative Oncology Group Performance Status (ECOG-PS) and the Lung Immune Prognostic Index (LIPI) is unknown. In our study, data from the advanced nonsmall cell lung cancer (NSCLC) single-arm atezolizumab trials BIRCH, FIR and randomised-trials OAK, POPLAR (atezolizumab vs docetaxel) were pooled. The study included 1548 participants who initiated atezolizumab. The associations between pretreatment PROs and overall survival (OS) and progression-free survival (PFS) were modelled using Cox proportional hazards regression. Prediction performance was assessed using the C-statistic (c). PROs were recorded via the EORTC QLQ-C30 and QLQ-LC13. Patient-reported physical function, fatigue, global health, appetite, role function, pain, dyspnoea, social function, constipation, nausea-vomiting, emotional function and coughing were significantly associated with OS and PFS on univariable and adjusted analysis (P < .05). Physical function (c = 0.654), fatigue (c = 0.653) and global health (c = 0.650) were the most predictive variables for OS. Comparatively, the OS prediction performance of physical function (c = 0.65) was superior to ECOG-PS (c = .59) and LIPI (c = 0.63). On multivariable analysis physical function, ECOG-PS and LIPI were all significant (P < .001). In conclusion, PROs were identified as independent prognostic factors for OS and PFS in advanced NSCLC patients receiving ICI therapy. Further, patient-reported physical function was more predictive of OS than ECOG-PS and LIPI and contained independent information. This highlights the value of PROs as prognostic and stratification factors for clinical use and research trials of ICIs.

show abstract

mentioning

confidence: 99%

Patient‐reported outcomes as a prognostic marker of survival in patients with advanced nonsmall cell lung cancer treated with immunotherapy

Hopkins

Wagner

Kichenadasse

et al. 2020

Intl Journal of Cancer

View full text Add to dashboard Cite

show abstract

“…Multiple prior analyses have demonstrated a relationship between PROs and survival outcomes in several different cancer populations. 2,9,[30][31][32] In the baseline setting, these findings may be attributed to a higher symptom burden at the initiation of systemic chemotherapy correlating with a lower performance status, a metric also previously shown to correlate with overall survival. 33,34 Patients with reduced performance status and/or higher symptom burden may be less able to tolerate therapy, thus attenuating the ability of cancer treatment to offer survival benefits.…”

Section: Discussionmentioning

confidence: 88%

Associations of baseline patient‐reported outcomes with treatment outcomes in advanced gastrointestinal cancer

Seventer

Fish

Fosbenner

et al. 2020

Cancer

View full text Add to dashboard Cite

Background Patient‐reported outcomes (PROs) assessing quality of life (QOL) and symptom burden correlate with clinical outcomes in patients with cancer. However, to the authors' knowledge, data regarding associations between PROs and treatment response are lacking. Methods The authors prospectively approached consecutive patients with advanced gastrointestinal cancer who were initiating a new treatment. Prior to treatment, patients reported their QOL (Functional Assessment of Cancer Therapy‐General [FACT‐G], 4 subscales: Functional, Physical, Emotional, Social; higher scores indicate better QOL) and symptom burden (Edmonton Symptom Assessment System [ESAS], Patient Health Questionnaire‐4 [PHQ‐4]; higher scores represent greater symptoms). Regression models were used to examine associations of baseline PROs with treatment response (clinical benefit or progressive disease [PD] at time of first scan), healthcare utilization, and survival. Results From May 2019 to April 2020, a total of 112 patients with advanced gastrointestinal cancer were enrolled. For treatment response, 64.3% had CB and 35.7% had PD. Higher baseline ESAS‐Physical (odds ratio, 1.04; P = .027) and lower FACT‐G Functional (odds ratio, 0.92; P = .038) scores were associated with PD. Higher ESAS‐Physical (hazard ratio [HR], 1.03; P = .044) and lower FACT‐G Total (HR, 0.96; P = .005), FACT‐G Physical (HR, 0.89; P < .001), and FACT‐G Functional (HR, 0.87; P < .001) scores were associated with a greater hospitalization risk. Lower FACT‐G Total (HR, 0.96; P = .009) and FACT‐G Emotional (HR, 0.86; P = .012) scores as well as higher ESAS‐Total (HR, 1.03; P = .014) and ESAS‐Physical (HR, 1.04; P = .032) scores were associated with worse survival. Conclusions Baseline PROs are associated with treatment response in patients with advanced gastrointestinal cancer, namely physical symptoms and functional QOL, in addition to health care use and survival. The findings of the current study support the association between PROs and important clinical outcomes, including the novel finding of treatment response.

show abstract

“…Many previous studies have identi ed PROs as prognostic factors for survival of patients with cancer [7][8][9][10][11], but few have examined the cut-off values for PRO measurements to predict survival. Therefore, we examined the cut-off values of dyspnea and fatigue in the QLQ-C15-PAL for detecting the risk of a short-term prognosis of < 3 weeks (21 days).…”

Section: Discussionmentioning

confidence: 99%

“…A patient-reported outcome (PRO) is a measurement based on a report from a patient without amendment or interpretation by a clinician or anyone else [6]. Some of the scales in PRO have been signi cantly associated with survival and identi ed as independent prognostic factors in uencing survival in patients with advanced cancer [7][8][9][10][11][12]. However, despite previous studies supporting the added prognostic value of PROs, their systematic use during the cancer treatment and palliative care process remains unknown [11].…”

Section: Introductionmentioning

confidence: 99%

The Role of EORTC QLQ-C15-PAL Scores and Inflammatory Biomarkers in Predicting Survival in Terminally Ill Patients with Cancer

Koyama

Matsumura

Shitashimizu

et al. 2020

Preprint

View full text Add to dashboard Cite

Background The clinical use of patient-reported outcomes as compared to inflammatory biomarkers for predicting cancer survival remains a challenge in palliative care settings. We evaluated the accuracy of survival prediction in both indicators of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative scores (EORTC QLQ-C15-PAL) and the inflammatory biomarkers C-reactive protein (CRP), albumin (Alb), and neutrophil-lymphocyte ratio (NLR) in patients with advanced cancer. Methods This was an observational study in terminally ill patients with cancer hospitalized in a palliative care unit between June 2018 and December 2019. Patients’ data collected at the time of hospitalization were analyzed. Cox regression was performed to examine significant factors influencing survival. A receiver operating characteristic (ROC) analysis was performed to estimate cut-off values for predicting survival within 3 weeks, and a log-rank test was performed to compare survival curves between groups divided by the cut-off values. Results Totally, 130 patients participated in the study. Cox regression suggested that the QLQ-C15-PAL dyspnea and fatigue scores and levels of CRP, Alb, and NLR were significantly associated with survival time, and cut-off values were 66.67, 66.67, 3.0 mg/dL, 2.5 g/dL, and 8.2, respectively. The areas under ROC curves of these variables were 0.6–0.7. There were statistically significant differences in the survival curves between groups categorized using each of these cut-off values (p < .05 for all cases). Conclusion Our findings suggest that the assessment of not only objective indicators for the systemic inflammatory response but also patient-reported outcomes using EORTC QLQ-C15-PAL is beneficial for the prediction of short-term survival in terminally ill patients with cancer.

show abstract

Prognostic value of patient-reported outcomes from international randomised clinical trials on cancer: a systematic review

Abstract: This is a repository copy of Prognostic value of patient-reported outcomes from international randomised clinical trials on cancer: a systematic review.

Cited by 94 publications

References 78 publications

Patient‐reported outcomes as a prognostic marker of survival in patients with advanced nonsmall cell lung cancer treated with immunotherapy

Patient‐reported outcomes as a prognostic marker of survival in patients with advanced nonsmall cell lung cancer treated with immunotherapy

Associations of baseline patient‐reported outcomes with treatment outcomes in advanced gastrointestinal cancer

The Role of EORTC QLQ-C15-PAL Scores and Inflammatory Biomarkers in Predicting Survival in Terminally Ill Patients with Cancer

Contact Info

Product

Resources

About