1843P - Safety of immunotherapy in cancer patients with comorbidities: Results of the phase IV Italian immuno-special trial

Background

Limited prospective data exist about the safety of immune checkpoint inhibitors (ICIs) use in patients (pts) who are at greater risk of immune-related adverse events (irAEs) due to comorbidities.

Methods

We conducted a prospective, phase IV, multicentre trial in pts affected by solid cancers treated with ICIs alone or combined (other ICI, chemo, or targeted therapies) and considered at higher risk of irAEs due to the following comorbidities: previous solid organ transplant (SOT), indolent haematological neoplasms, chronic viral (HIV, HBV, or HCV) infection, chronic severe organ dysfunction (renal, cardiac, pulmonary, or hepatic), or previous autoimmunity. Primary aim was to assess the incidence of CTCAE v5.0 grade (G)≥3 irAEs. Secondary objectives were: incidence of all-G irAEs, median treatment intensity, and analysis of irAEs according to cancer site, type of treatment, and comorbidity.

Results

From May 2020 to September 2023, 206 pts were enrolled. Median age was 72 years (range 25-96; IQR 65-77), while ECOG performance status was 0, 1, 2, or not available in 87 (42%), 92 (45%), 25 (12%), and 2 (1%) pts, respectively. Most frequent primary sites were lung (127, 62%) and skin (41, 20%). Comorbidities leading to enrolment were previous SOT, haematological neoplasms, chronic viral infection, severe chronic organ dysfunction, previous autoimmunity in 2 (1%), 24 (12%), 103 (50%), 51 (25%), and 69 (33%) pts, respectively; 49 pts (24%) had > 1 comorbidity. Most pts were treated with single-agent ICI (151, 73%). 42 G≥3 irAEs were reported (18% of all irAEs). All-G and G≥3 irAEs were observed in 39 (19%) and 132 (64%) pts, respectively. Median treatment intensity was 100% (3-100%), with 36 pts (17.6%) prematurely discontinuing ICI due to toxicities. On multivariate logistic regression, previous autoimmunity predicted all-G irAEs (OR 1.94, IC 95% 1.00-3.78; p 0.05) but not G≥3 irAE; no predictive factor of irAEs was found among clinical or laboratory factors.

Conclusions

ICI administration in pts with comorbidities in a real-world setting showed manageable toxicities with maintenance of treatment intensity, even if with relatively high ICI discontinuation due to irAEs. Special attention should be paid to pts with previous autoimmunity.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

NICSO - Italian Network for Supportive Care in Oncology.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.