ABSTRACT
Background: Early phase clinical trials often represent a therapeutical opportunity for cancer patients (pts). However, high logistic commitment is demanded for participation. Here we explore the COVID-19 related risk during the pandemic for pts enrolled in clinical trials compared to pts receiving standard treatments. Methods: We retrospectively assessed the incidence of COVID-19 in pts treated in our Department from March 2020 to April 2021. Pts were divided into two groups;those enrolled in phase I/II clinical trials (A) and those being treated with standard therapies (B). Logistical (telemedicine and drug home-delivery), as well as clinical, characteristics of susceptibility to COVID-19 and number of events (SARS-CoV2 infections) were collected. The number of teleconsultations and COVID-19 events among the two groups were compared through Fisher’s exact test. Results: 115 pts were evaluated: 36 pts (31%) in A and 79 pts (69%) in B. Pts in A were younger, with a median age of 55 years (range 39-77) compared to 62 years (range 31-83) in B. Performance status (PS, ECOG) was similarly distributed: 0 (A 78%, B 83%), 1-2 (A 22%, B 17%). The median of previous treatment was 1 in A (range 0-9) and 2 (range 0-14) in B. The majority of the pts had at least one comorbidity in both groups (A: 72% and B: 83%). None of the pts had pulmonary comorbidity in A and 6% in B. Obesity was similarly distributed (A 11%, B 14%). The mean of monthly scheduled accesses was 1,5 in both groups. However, teleconsultation and delivery of oral cancer treatments at home were given, at least on one occasion, to only 6% of pts in A compared to 43% in B (p<0.01). A total of 15 COVID-19 cases were observed (13%): 8 (22%) in A and 7 (8%) in B. No statistically significant difference was observed (p = 0.068). Conclusions: Pts enrolled in early phase clinical trials had a significantly lower chance to perform teleconsultations compared to pts receiving standard therapy. Even if a trend was observed, they did not have a higher risk of contracting COVID-19. Future pts should then be encouraged to participate, if indicated. Considering the small numbers of pts in our cohorts, the foreseen trend toward a higher infection risk and the subsequent implications should be further explored in larger populations. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: G Curigliano: Financial Interests, Funding: Roche;Financial Interests, Funding: Novartis;Financial Interests, Funding: Lilly;Financial Interests, Funding: Pfizer;Financial Interests, Funding: Seattle Genetics. All other authors have declared no conflicts of interest.
ABSTRACT
Cancer vaccines (CVs) represent a long-sought therapeutic and prophylactic immunotherapy strategy to obtain antigen (Ag)-specific T-cell responses and potentially achieve long-term clinical benefit. However, historically, most CV clinical trials have resulted in disappointing outcomes, despite promising signs of immunogenicity across most formulations. In the past decade, technological advances regarding vaccine delivery platforms, tools for immunogenomic profiling, and Ag/epitope selection have occurred. Consequently, the ability of CVs to induce tumor-specific and, in some cases, remarkable clinical responses have been observed in early-phase clinical trials. It is notable that the record-breaking speed of vaccine development in response to the coronavirus disease-2019 pandemic mainly relied on manufacturing infrastructures and technological platforms already developed for CVs. In turn, research, clinical data, and infrastructures put in place for the severe acute respiratory syndrome coronavirus 2 pandemic can further speed CV development processes. This review outlines the main technological advancements as well as major issues to tackle in the development of CVs. Possible applications for unmet clinical needs will be described, putting into perspective the future of cancer vaccinology.