Abstract 286P
Background
Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer specific comprehensive archive of PROMs and to identify their main characteristics and target outcome domains.
Methods
As part of the PRO4All project, we identified available PROMs in oncology by searching facit.org, eortc.org, eprovide.mapi-trust.org, ema.europa.eu (European Public Assessment Reports) and published reviews. For this analysis, only breast cancer specific tools were extracted. We described information about PROM name, type of questionnaire (self-reported, proxy-reported or caregiver’s report), questionnaire variant(s), recall period, number of items, and presence of minimum clinically important difference (MCID) reference in literature. In addition, we assigned each item to a specific domain according to a predefined taxonomy of 38 items for outcome classification.
Results
We identified and analysed 376 PROMs. Of these, 29 were breast cancer specific, but 2 were excluded because the full-text questionnaires were not available. So, we fully examined a total of 27 breast cancer specific PROMS. 6 (22.2%) were variants of another questionnaire. All questionnaires (100%) were self-reported. In 6 cases (22.2%) the recall period to consider was the “last week”. The mean number of items per questionnaire was 25.81 (range 6-71). In total, 602 items were assigned an outcome domain: emotional functioning/wellbeing in 26.6% of cases, physical functioning in 14.1%, delivery of care in 10.8%, and general outcomes in 10.5%. MCID reference was found only in 4 (14.8%) cases.
Conclusions
Similar to the findings obtained from a general search for PROMs, this research highlighted the availability of many instruments specifically developed for breast cancer. The newly developed archive could represent a useful tool to optimize the use of PROMs in the evaluation of treatments in patients with cancer, promoting a patient-centered approach both in clinical research and practice.
Legal entity responsible for the study
PRO4All, CERGAS (SDA Bocconi).
Funding
This study was supported by a research grant (PRO4All) from Roche Italy to CERGAS (SDA Bocconi).
Disclosure
A. Servetto: Financial Interests, Institutional, Funding, funding for research: AIRC; Financial Interests, Personal, Other, Travel support: Bristol Myers Squibb, Roche and AstraZeneca; Financial Interests, Personal, Other, Honoraria: Eli Lilly, MSD, AstraZeneca and Janssen. F. Giovanardi: Financial Interests, Personal, Other, Honoraria: Eli Lilly, MSD, AstraZeneca, Novartis, Pfizer, Roche, Tesaro/ GSK. C. Pinto: Financial Interests, Personal, Advisory Board, honoraria for consultancy or participation to advisory boards: Amgen, Astellas, AstraZeneca, Bayer, Bristol Meyer Squibb, Celgene, Clovis Oncology, Eisai, Ipsen, Janssen, Incyte, Merck-Serono, Merck Sharp and Dohme, Novartis, Roche, Sandoz, Sanofi, and Servier . M. Di Maio: Financial Interests, Personal, Advisory Board, Consultancy about clinical trial methodology and clinical trial results interpretation: Novartis; Financial Interests, Personal, Advisory Board, Consultancy about immunotherapy in SCLC: Roche; Financial Interests, Personal, Advisory Board, Consultancy about role and interpretation of patient-reported outcomes and quality of life in clinical trials: Takeda; Financial Interests, Personal, Advisory Board, Advisory board about the role of chemotherapy and hormonal treatment in hormone-sensitive prostate cancer: Janssen; Financial Interests, Personal, Advisory Board, Consultancy about the results obtained with lorlatinib and dacomitinib in advanced non-small cell lung cancer: Pfizer; Financial Interests, Personal, Advisory Board, Consultancy about role of osimertinib as adjuvant treatment of NSCLC: AstraZeneca; Financial Interests, Personal, Invited Speaker, Compensation for a talk and a document about role of patient-reported outcomes in clinical trials and in clinical practice, with a specific focus on lung cancer: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board, Participation in advisory boards about olaparib in pancreatic cancer, about olaparib in prostate cancer, and about immunotherapy in lung cancer: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board, Consultant for the new indication of avelumab in urothelial cancer: Merck Serono; Financial Interests, Personal, Advisory Board, Advisory board about treatment of gastric cancer: Amgen; Financial Interests, Personal, Advisory Board, Lesson for the personnel of the drug company about quality of life, patient-reported outcomes and methodological aspects of clinical trials: GSK; Financial Interests, Institutional, Research Grant, Financial support and drug supply for the Meet-URO12 trial (niraparib as maintenance treatment of urothelial carcinoma after first-line treatment with platinum-based chemotherapy): Tesaro - GSK; Financial Interests, Institutional, Invited Speaker, Local PI of trial with tislelizumab in hepatocellular carcinoma: BeiGene; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with cabozantinib and atezolizumab in advanced HCC: Exelixis; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with atezolizumab and bevacizumab in advanced HCC: Roche; Financial Interests, Institutional, Invited Speaker, Local PI of trials with pembrolizumab in hepatocellular carcinoma: Merck Sharp & Dohme; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with sasanlimab in NMI bladder cancer: Pfizer. O. Ciani: Financial Interests, Personal, Advisory Board: MSD. All other authors have declared no conflicts of interest.