Abstract 1355P
Background
One of the major need in the oncology field is to include patients into clinical trials and, more specifically, enroll cancer patients truly reflecting the real world population. However, several issues can limit enrollment.
Methods
From April to October 2021 we prospectively collected data of lung cancer patients receiving new treatment indication in four Italian Oncological Institutions, in order to evaluate study inclusion rates and factors limiting trials participation.
Results
397 patients were included in the analysis. Median age was 70 years (range 31-91). Patients were predominately males (250, 63%), former/active smokers (302, 76%), affected by NSCLC (349, 88%), with locally advanced/metastatic disease (373, 94%). ECOG Performance Status (PS) ≥2 patients were 13% (52) of the entire population and 72% (286) presented with at least one major comorbidity. 374 (94%) were candidate to active anticancer therapy, in particular for adjuvant/neoadjuvant (6%), first (64%), second (19%) or third (11%) treatment line. Among them, 309 (83%) received standard treatment as per clinical practice, 15 (4%) targeted agents within expanded access programs and 58 (15%) were included in clinical trials. Median age of patients enrolled in clinical studies was 62 years (range 45-83). Trials were mainly phase II (27, 47%) and III (22, 38%), profit (38, 66%) and with a superiority (37, 64%), open-label (39, 67%) design, not requiring re-biopsy (39, 6%) nor placebo-containing (41, 71%). Targeted therapy + other drugs (19, 33%), immunotherapy + other drugs (17, 29%) and antibody-drug conjugate therapy (9, 16%) were the most common experimental treatments. Main obstacles to recruitment were: unavailability of studies at home/near institutions (167, 54%), disease/molecular characteristics not satisfying inclusion criteria (37, 12%), poor PS (22, 7%), presence of relevant comorbidities/non-permissive medical history (10, 3%), patient's refusal (5, 2%) for studies requiring re-biopsy or placebo-containing.
Conclusions
Enrolling patients in clinical trials remains an important goal in thoracic oncology. Efforts to recognize and face inclusion limitations are paramount in order to provide high-quality patients ‘care.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M.L. Reale: Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Advisory Board: MSD. P. Bironzo: Financial Interests, Personal, Invited Speaker: Roche, Bristol-Myers Squibb, AstraZeneca, Takeda, Merck Sharp and Dohme, BeiGene. M. Tiseo: Financial Interests, Personal, Invited Speaker: AstraZeneca, Pfizer, Eli-Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Otsuka, Takeda and Pierre Fabre. S. Pilotto: Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, BMS, Roche, MSD, AstraZeneca. F. Passiglia: Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, BMS, Pfizer. S. Novello: Financial Interests, Personal, Invited Speaker: Eli Lilly, MSD, Roche, BMS, Takeda, Pfizer, AstraZeneca. All other authors have declared no conflicts of interest.