Background Hypovitaminosis D can have a negative impact in patients (pts) with cancer. We hypothesized that systematic vitamin D repletion could improve outcomes in pts receiving immune-checkpoint inhibitors (ICIs). Methods We planned a prospective observational study (PROVIDENCE) to investigate vitamin D levels in pts with advanced cancer receiving ICIs (cohort 1 at treatment initiation, cohort 2 during treatment) and the impact of systematic repletion in the case of hypovitaminosis on survival and toxicity outcomes. In an exploratory analysis, we compared clinical outcomes of cohort 1 with a control cohort of pts followed at the participating centers who did not receive systematic vitamin D repletion. Results Overall, 164 pts were prospectively recruited. In cohort 1, consisting of 101 pts with 94.1% hypovitaminosis (≤30 ng/ml) at baseline, adequate repletion with cholecalciferol was obtained in 70.1% at the three months re-assessment. Cohort 2 consisted of 63 pts assessed for vitamin D at a median time of 3.7 months since immunotherapy initiation, with no pts having adequate levels (>30 ng/ml). Even in cohort 2, systematic supplementation led to adequate levels in 77.8% of pts at the three months re-assessment. Compared to a retrospective control group of 238 pts without systematic vitamin D repletion, PROVIDENCE cohort 1 showed longer OS and time to treatment failure (TTF), p=0.013 and p=0.017. The IPTW-fitted multivariable Cox regression confirmed the significantly decreased risk of death (HR 0.55, 95%CI: 0.34-0.90) and treatment discontinuation (HR 0.61, 95%CI: 0.40-0.91) for pts from PROVIDENCE cohort 1 in comparison to the control cohort. In the context of longer treatment exposure, the cumulative incidence of any grade irAEs was higher in the PROVIDENCE cohort 1 compared to the control cohort. Nevertheless, pts from cohort 1 experienced a significantly decreased risk of all grade thyroid irAEs than the control cohort (OR 0.16, 95%CI: 0.03-0.85). Conclusions The PROVIDENCE study suggests the potential positive impact of early systematic vitamin D supplementation on outcome of pts with advanced cancer receiving ICIs and support adequate repletion as a possible prophylaxis for thyroid irAEs.
2125P Potential ROle of hypoVItaminosis D in patiENts with cancer treated with immune ChEckpoint inhibitors (PROVIDENCE): A prospective observational study / Cortellini, A.; Leonetti, A.; Parisi, A.; Tiseo, M.; Bordi, P.; Michiara, M.; Bui, S.; Cosenza, A.; Ferri, L.; Giudice, G. C.; Testi, I.; Vincenzi, B.; Santo, V.; Ricozzi, V.; Sgargi, P.; Zustovich, F.; Stucci, L. S.; Santini, D.; Buti, S.; Bersanelli, M.. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 34:S2(2023), pp. S1110-S1110. [10.1016/j.annonc.2023.09.907]
2125P Potential ROle of hypoVItaminosis D in patiENts with cancer treated with immune ChEckpoint inhibitors (PROVIDENCE): A prospective observational study
Leonetti, A.;Tiseo, M.Investigation
;Bordi, P.Investigation
;bui, S.Investigation
;Giudice, G. C.Investigation
;Testi, I.Investigation
;Buti, S.Conceptualization
;
2023-01-01
Abstract
Background Hypovitaminosis D can have a negative impact in patients (pts) with cancer. We hypothesized that systematic vitamin D repletion could improve outcomes in pts receiving immune-checkpoint inhibitors (ICIs). Methods We planned a prospective observational study (PROVIDENCE) to investigate vitamin D levels in pts with advanced cancer receiving ICIs (cohort 1 at treatment initiation, cohort 2 during treatment) and the impact of systematic repletion in the case of hypovitaminosis on survival and toxicity outcomes. In an exploratory analysis, we compared clinical outcomes of cohort 1 with a control cohort of pts followed at the participating centers who did not receive systematic vitamin D repletion. Results Overall, 164 pts were prospectively recruited. In cohort 1, consisting of 101 pts with 94.1% hypovitaminosis (≤30 ng/ml) at baseline, adequate repletion with cholecalciferol was obtained in 70.1% at the three months re-assessment. Cohort 2 consisted of 63 pts assessed for vitamin D at a median time of 3.7 months since immunotherapy initiation, with no pts having adequate levels (>30 ng/ml). Even in cohort 2, systematic supplementation led to adequate levels in 77.8% of pts at the three months re-assessment. Compared to a retrospective control group of 238 pts without systematic vitamin D repletion, PROVIDENCE cohort 1 showed longer OS and time to treatment failure (TTF), p=0.013 and p=0.017. The IPTW-fitted multivariable Cox regression confirmed the significantly decreased risk of death (HR 0.55, 95%CI: 0.34-0.90) and treatment discontinuation (HR 0.61, 95%CI: 0.40-0.91) for pts from PROVIDENCE cohort 1 in comparison to the control cohort. In the context of longer treatment exposure, the cumulative incidence of any grade irAEs was higher in the PROVIDENCE cohort 1 compared to the control cohort. Nevertheless, pts from cohort 1 experienced a significantly decreased risk of all grade thyroid irAEs than the control cohort (OR 0.16, 95%CI: 0.03-0.85). Conclusions The PROVIDENCE study suggests the potential positive impact of early systematic vitamin D supplementation on outcome of pts with advanced cancer receiving ICIs and support adequate repletion as a possible prophylaxis for thyroid irAEs.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
