A patient-reported outcome (PRO) is a measurement of the patient’s condition, reported directly by the patient, without the interpretation by a clinician or anyone else [1] Recently, there has been a growing interest in the integration of PROs as part of data collection about toxicity and symptoms experienced by patients with cancer This integration could have relevant implications not only for a more accurate reporting of adverse events and definition of quality of life (QoL) within clinical trials [2], but also for a better patients’ management in routine clinical practice [3] Many tools and questionnaires have been validated to properly measure QoL and symptoms in patients with lung cancer The inclusion of these measures in clinical trials has several important advantages It allows providing a patient-focused assessment of the burden and the impact of disease Moreover, it allows completely assessing the clinical benefit of a therapy, by complementing the information provided by commonly used efficacy endpoints, including overall survival, and the traditional description of safety based on physicians’ assessment Furthermore, the availability of QoL data from trials could allow a more accurate patient-physician communication about the treatment strategies offered in clinical practice However, a systematic review that we performed in order to evaluate the adoption of QoL among endpoints in randomized phase III trials conducted in lung cancer, published between 2012 and 2018 in 11 major journals, showed quite disappointing findings [4] Beyond the importance in clinical trials, PROs can play an important role in clinical practice Several studies have demonstrated a clear benefit in terms of patients’ QoL [5,6] Our experience, focused on the adoption of PROs in patients receiving active anticancer treatment at Mauriziano Hospital in Turin, showed that the introduction of PROs, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement compared to the traditional modality of visit [6] In details, we compared 2 groups: patients in the control group underwent “usual” visits, while patients in the “PRO” group received a paper questionnaire by a dedicated nurse before each visit, in order to provide information about symptoms and toxicities After 1 month, mean change from baseline of global QoL was significantly better in the PRO group, and significantly higher proportion of patients obtained a clinically significant improvement in global QoL score In addition to QoL benefit, several studies have shown a significant improvement in overall survival with the adoption of electronic PROs in patients with lung cancer [7-9] In a pivotal randomized trial involving US patients with different solid tumors (including lung cancer) undergoing chemotherapy, patients assigned to the control arm received usual care, while subjects assigned to experimental arm could report their symptoms remotely from home, using tablet computers or computer kiosks [5,7] Doctors received a report of symptoms referred by patients during visits, and nurses received email alerts when patients reported severe or worsening symptoms Beyond the QoL improvement (the primary endpoint of the trial), a significantly longer life expectancy in the experimental arm (median 31 2 months) compared to the usual care arm (26 0 months) was reported [7] A French randomized trial, conducted in lung cancer patients without evidence of disease progression after or during initial treatment, compared a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every 3-6 months according to the disease stage (control arm) [8] In the experimental arm, the oncologist received automatically an alert email when self-scored symptoms matched predefined criteria Notably, a significant improvement in overall survival was found in patients assigned to experimental arm [9] The adoption of electronic PROs in clinical practice could have many advantages [10] Regular discussion of PROs questionnaires, filled out electronically by patients and received by nurses or doctors, could allow a systematic check of the clinical trend of symptoms and side-effects The early, proactive identification of worsening symptoms and toxicities could help prevent the occurrence of severe adverse events needing ER access and hospitalization Adoption and discussion of PROs would reasonably have a positive psychological impact on patients, increasing their satisfaction with healthcare services While the adoption of electronic PROs could initially appear as a challenging organizational effort, we believe that their benefits will definitely be evident in the long-term The use of PROs may allow a significant benefit in terms of patients’ QoL, and this should be more than enough to consider its adoption in clinical practice, which - overall survival benefit or not – is worth the trouble References: 1 Di Maio M, et al Patient-reported outcomes in the evaluation of toxicity of anticancer treatments Nat Rev Clin Oncol 2016;13(5):319-25 2 Marandino L, et al Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016 Ann Oncol 2018;29:2288-2295 3 Sperti E, Di Maio M Outcomes research: Integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble Nat Rev Clin Oncol 2017;14(9):529-530 4 Reale ML, et al Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018 Lung Cancer 2020 Jan;139:47-54 5 Basch E, et al Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial J Clin Oncol 2016;34(6):557-65 6 Baratelli C, et al The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients' quality of life Support Care Cancer 2019;27(12):4697-4704 7 Basch E, et al Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment JAMA 2017;318(2):197-198 8 Denis F, et al Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients J Natl Cancer Inst 2017 Sep 1;109(9) 9 Denis F, et al Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer JAMA 2019;321(3):306-307 10 Marandino L, et al COVID-19 Emergency and the Need to Speed Up the Adoption of Electronic Patient-Reported Outcomes in Cancer Clinical Practice JCO Oncol Pract 2020;16(6):295-298 Keywords: patient-reported outcomes, health-related quality of life, ePROs
ES19.04 Improving Lung Cancer Survival Through Tracking of Patient Reported Outcomes