Interstitial pneumonitis associated with combined regimen of immunotherapy and conventional therapies—pharmacovigilance database analysis with real-world data validation

Table 2 A synergistic interaction between ICI and RT associated with an increased risk of IP in patients with non-small cell lung cancer

Variables	Cases, N = 46,127	IP, N = 3830	Proportion (%), 95% CI	Crude ROR, 95% CI	Adjusted^a ROR, 95% CI	P-value
Age (mean/SD)			65.6 (11.1)	1.02 (1.02–1.03)	1.02 (1.02–1.03)	< 0.0001
Sex
Female	17,517	1022	5.83 (5.49–6.19)	1 [reference]	1 [reference]
Male	23,255	2,387	10.26 (9.88–10.66)	1.85 (1.71–1.99)	1.54 (1.41–1.68)	< 0.0001
Not reported	5355	421	7.86 (7.16–8.62)	1.38 (1.22–1.55)	0.95 (0.67–1.32)	0.773
Treatment options
ICI	19,083	2345	12.29 (11.83–12.76)	2.41 (2.25–2.58)	1.77 (1.64–1.92)	< 0.0001
CHEMO	9530	610	6.4 (5.92–6.92)	0.71 (0.65–0.77)	0.71 (0.61–0.83)	< 0.0001
TARGET	11,023	621	5.63 (5.21–16.08)	0.59 (0.54–0.65)	1.18 (1.04–1.33)	0.008
RT	519	459	88.44 (85.30–91.00)	95.85 (73.71–126.95)	9.15 (4.07–19.25)	< 0.0001
ICI^aCHEMO^b	3110	290	9.32 (8.34–10.41)		0.97 (0.79–1.19)	0.771
ICI^aTARGET^b	227	30	13.22 (9.23–18.49)		1.02 (0.65–1.55)	0.929
ICI^aRT^b	483	446	92.34 (89.50–94.48)		13.44 (5.81–33.07)	< 0.0001

IP Interstitial pneumonitis, ROR Reporting odds ratio, SD Standard deviation, RT Radiation therapy, ICI Immune checkpoint inhibitor therapy, CHEMO Chemotherapy, TARGET Molecular targeted therapy
^aAge increment was per year for reporting the odds ratio of multivariable logistic regression
^bThis row shows the result of the interaction between interstitial pneumonitis and 2 therapies. The P-value for adjusted ROR was calculated using a multivariable logistic regression model. P < 0.05 indicates a significant difference

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