Profile of toxicities and quality of life in long-term survivors treated with immunotherapy: A prospective cross sectional trial.

Paolo Bossi Medical Oncology Unit, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy info_outline Paolo Bossi, Maria Baronchelli, Luigi Lorini, Consiglia Paduano, Davide Smussi, Erika Stucchi, Fiorella Manfredi, Maritini Kalogerini, Giorgos Giotis, Thanos Kalligeris, Spyros Papafragkos, Kostantina Liagkou, Simona Carnio, Silvia Stragliotto, Fausto Roila, Giulia De Feo, Laura Velutti, Andrea Caglio, Marco Gunnellini, Alfredo Berruti

Authors Paolo Bossi Medical Oncology Unit, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy info_outline Paolo Bossi, Maria Baronchelli, Luigi Lorini, Consiglia Paduano, Davide Smussi, Erika Stucchi, Fiorella Manfredi, Maritini Kalogerini, Giorgos Giotis, Thanos Kalligeris, Spyros Papafragkos, Kostantina Liagkou, Simona Carnio, Silvia Stragliotto, Fausto Roila, Giulia De Feo, Laura Velutti, Andrea Caglio, Marco Gunnellini, Alfredo Berruti Organizations Medical Oncology Unit, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy, Medical Oncology Unit, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili; University Hospital of Parma, Parma, Italy, University of Pisa, Pisa, Italy, ATC Innovation Lab, Athens, Greece, Division of Thoracic Oncology, Department of Oncology, University of Torino at San Luigi Gonzaga University Hospital, Orbassano, Italy, Oncology Unit 3, Istituto Oncologico Veneto (IOV-IRCCS), Padova, Italy, Santa Maria della Misericordia University Hospital, Perugia, Italy, Supportive Care in Cancer Unit, Fondazione IRCCS, Istituto Nazionale Dei Tumori, Onco-Haematology, Milan, Italy, Medical Oncology Unit, Cancer Center, Humanitas Research Hospital, Rozzano, Italy, Department of Oncology , University of Turin, A.O.Ordine Mauriziano, Turin, Italy, Medical Oncology Unit, Department of Oncology, Gubbio-Gualdo Tadino Hospital, Gubbio, Italy Abstract Disclosures Research Funding Other ASCAPE Grant Background: Long-term cancer survivors (LTS) patients (pts) treated with immunotherapy (IT) represent a relatively new population whose characteristics, such as long-term toxicities, quality of life (QoL), and financial toxicities, need to be elucidated in a real-world setting. The aim of this study is to evaluate long-term toxicities in patients free of disease progression and treated with IT. Methods: This is a cross-sectional, multicentric study, involving ten Italian centres. Pts should have started IT (as monotherapy or combination, either in curative or adjuvant setting) more than 2 years before accrual and they needed to be progression free at last follow up (fup). Subjects who discontinued IT for disease progression or who started any subsequent line of systemic treatment were excluded. We retrieved baseline demographic and clinical characteristics of the pts, as well as haematological and biochemical exams at the start of IT (baseline) and at the last fup. We also assessed the patient's toxicities (according to CTCAE v5.0) at last fup and we submitted to each patient three questionnaires: PRO-CTCAE (selection of questions), EORTC QLQ C30, and FITALY (for financial toxicities), which were analysed according to subdomains. Results: We enrolled 141 LTS pts treated with IT from 2013 to 2022. Median age was 69 years (35-88), most were male (72%), and still receiving IT at time of last fup (72%). Primary tumour was in lung (43%), genito-urinary tract (26%), or melanoma (14%). IT included pembrolizumab and nivolumab in 40% and 32% of cases, respectively. The median global health status of QoL was 83 (IQR 25). Any toxicities > G2 negatively impacted on individual functional scales (physical, p=0.02; role, p= 0.06; and social p=0.08). A higher baseline Charlson Comorbidity Index was associated with worse global health status (p=0.02) at last fup. Most frequent low grade adverse events were fatigue, dyspnoea, and insomnia; younger age (< 65 years) was associated with higher pain (p=0.04). PRO-CTCAE questionnaires showed that the prevalent complained symptoms were rheumatological and cutaneous, regardless of tumor site. The most affected domain of financial toxicities was financial stress, including costs for out of pocket medications and transports. Pts with melanoma (p=0.01), with skin toxicities (p=0.04), and younger than 65 years (p=0.01) were at higher risk of financial toxicities (global score). Conclusions: Overall QoL is well preserved in LTS treated with IT. At long term fup, the pts complained mostly about rheumatological and skin adverse events. Financial stress due to out of pocket costs was the most affected financial toxicity domain. Baseline comorbidities predicted a worse long-term global health status, while young age, skin toxicities and melanoma predicted higher financial toxicities.