Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study

Beachler, Daniel C.; de Luise, Cynthia; Jamal-Allial, Aziza; Yin, Ruihua; Taylor, Devon H.; Suzuki, Ayako; Lewis, James H.; Freston, James W.; Lanes, Stephan

doi:10.1186/s12885-021-07790-z

BMC Cancer

Table 2 Select characteristics of new users of palbociclib-fulvestrant and new users of fulvestrant monotherapy (historical comparator group) before and after propensity score matching

From: Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study

Characteristics^a	Before Propensity Score Matching					After Propensity Score Matching^b
	New users of palbociclib-fulvestrant		New users of fulvestrant monotherapy (pre-2015)		Std. difference	New users of palbociclib-fulvestrant		New users of fulvestrant monotherapy (pre-2015)		Std. difference
	N/Mean	%/SD	N/Mean	%/SD		N/Mean	%/SD	N/Mean	%/SD
Overall	566	100%	2316	100%		561	100%	561	100%
Total duration of follow-up (in years)	324		1686			322		373
Demographics
Age at index date (in years)	59.3	11.0	64.1	12.9	0.4	59.5	11.0	59.9	13.3	0.04
Sex
Male	≤10	n/a	30	1.30	0.0	≤10	n/a	≤10	n/a	0.10
Female	557	98.4	2286	98.7	0.0	552	98.4	558	99.5	0.10
Geographic region of residence
Midwest	95	16.8	422	18.2	0.04	95	16.9	93	16.6	0.01
South	159	28.1	690	29.8	0.04	157	28.0	165	29.4	0.03
Northeast	166	29.3	580	25.0	0.10	164	29.2	158	28.2	0.02
West	146	25.8	624	26.9	0.03	145	25.8	145	25.8	0.00
Medical History
Other primary cancer prior to first breast cancer diagnosis code	223	39.4	1026	44.3	0.1	222	39.6	271	48.3	0.18
Secondary malignancy (metastasis)	496	87.6	1823	78.7	0.2	491	87.5	488	87.0	0.02
Lymph nodes of head, face, and neck	154	27.2	476	20.6	0.2	151	26.9	150	26.7	0.00
Respiratory and digestive systems	257	45.4	781	33.7	0.2	254	45.3	252	44.9	0.01
Other specified sites	463	81.8	1710	73.8	0.2	458	81.6	458	81.6	0.00
Deyo-Charlson comorbidity index (DCI) without cancer codes	8.5	1.8	7.85	2.3	0.3	8.5	1.8	8.56	1.6	0.03
Cancer Therapy History
Radiation therapy	112	19.8	386	16.7	0.1	112	20.0	117	20.9	0.02
Surgery	11	1.9	68	2.9	0.1	11	2.0	13	2.3	0.02
Chemotherapy	100	17.7	429	18.5	0.0	99	17.6	98	17.5	0.00
Imaging
CT related imaging in the last 6 months	139	24.6	501	21.6	0.1	138	24.6	146	26.0	0.03
Diagnostic imaging in the last 6 months	72	12.7	461	19.9	0.2	72	12.8	79	14.1	0.04
MRI related imaging	25	4.4	91	3.9	0.0	25	4.5	26	4.6	0.01
Healthcare Utilization (6 months prior to index date)
Number of outpatient visits	37.6	21.7	36.5	24.6	0.0	37.7	21.8	39.3	24.2	0.07
Number of inpatient hospitalizations	0.3	0.7	0.3	0.7	0.0	0.3	0.7	0.4	0.8	0.14
Number of emergency department visits	0.3	0.8	0.2	0.6	0.1	0.3	0.8	0.3	0.7	0.03
Medication Use (breast cancer related)
Palbociclib	0	0.00	0	0.00	n/a	0	0.00	0	0.00	n/a
Aromatase inhibitor	326	57.6	1285	55.5	0.04	321	57.2	303	54.0	0.06
Letrozole	116	20.5	429	18.5	0.05	113	20.1	116	20.7	0.01
Anastrazole	136	24.0	611	26.4	0.05	135	24.1	138	24.6	0.01
Exemestane	86	15.2	358	15.5	0.01	85	15.2	76	13.5	0.05
HER2 positive therapy	15	2.7	127	5.5	0.14	15	2.7	14	2.5	0.01
Trastuzumab	25	4.4	159	6.9	0.11	24	4.3	27	4.8	0.03
Lapatinib	≤10	n/a	16	0.7	0.05	≤10	n/a	≤10	n/a	0.03
Ado-trastuzumab	0	0.0	0	0.0	n/a	0	0.0	0	0.0	n/a
Pertuzumab	0	0.0	0	0.0	n/a	0	0.0	0	0.0	n/a
Tamoxifen	140	24.7	379	16.4	0.21	140	25.0	135	24.1	0.02
Fulvestrant	238	42.0	0	0.0	n/a	236	42.1	0	0.0	n/a
Denosumab or Pamidronate	206	36.4	424	18.3	0.41	201	35.8	197	35.1	0.01
Everolimus	40	7.1	84	3.6	0.15	39	7.0	37	6.6	0.01
Medication Use (not breast cancer related)
Anticonvulsants	126	22.3	347	15.0	0.19	122	21.7	123	21.9	0.00
Antidepressants	178	31.4	631	27.2	0.09	175	31.2	184	32.8	0.03
Antihypertensives	173	30.6	623	26.9	0.08	171	30.5	135	24.1	0.14
Antimycobacterials	109	19.3	446	19.3	0.00	107	19.1	117	20.9	0.04
Antivirals	32	5.7	112	4.8	0.04	32	5.7	30	5.3	0.02
Corticosteroids	148	26.1	416	18.0	0.20	146	26.0	146	26.0	0.00
Lipid lowering agent	132	23.3	556	24.0	0.02	130	23.2	121	21.6	0.04
Sedatives/hypnotics	57	10.1	291	12.6	0.08	57	10.2	63	11.2	0.03
Co-morbidities (6 months prior to index date)
Pathologic fracture	46	8.1	173	7.5	0.02	46	8.2	51	9.1	0.03
Major adverse cardiac events (MACE)	20	3.5	83	3.6	0.00	20	3.6	23	4.1	0.03
Cerebrovascular disease	301	53.2	1148	49.6	0.07	296	52.8	277	49.4	0.07
Hyperglycemia	27	4.8	55	2.4	0.13	23	4.1	29	5.2	0.05
Deyo-Charlson Index (DCI)
0–3	19	3.4	259	11.2	0.30	19	3.4	17	3.0	0.02
4–7	12	2.1	57	2.5	0.02	12	2.1	4	0.7	0.12
8–11	512	90.5	1937	83.6	0.20	508	90.6	517	92.2	0.06
12 or more	23	4.1	63	2.7	0.07	22	3.9	23	4.1	0.01
Risk factors associated with ALI
Chronic liver disease or Alcoholism^c	74	13.1	246	10.6	0.09	74	13.1	69	12.2	0.03
Chronic or acute disease of gallbladder or pancreas^c	36	6.4	145	6.3	0.01	36	6.4	34	6.0	0.01
Hepatic, Biliary or pancreatic cancer^c	160	28.3	458	19.8	0.18	160	28.3	143	25.3	0.07
Congestive heart failure^c	29	5.1	159	6.9	0.07	29	5.1	29	5.1	0.00
Any medication associated with liver failure^c	467	82.51	1749	75.52	0.17	466	82.48	466	82.48	0.00
Acetaminophen (prescription) ^c	204	36.04	899	38.82	0.06	204	36.11	202	35.75	0.01

Abbreviations: ER estrogen receptor, HER2 human epidermal growth factor receptor 2, N number, SD standard deviation, Std standardized, CT computed tomography, MRI magnetic resonance imaging
^aAll characteristics are measured as presence within 6 months prior to the index date, unless otherwise specified
^bThe following variables were included in the propensity score for all safety event analyses: age, region, Deyo-Charlson Index, number of outpatient visits, number of emergency room visits, secondary malignancy to lymph nodes of head, face, and neck, secondary malignancy to other specified sites, secondary malignancy to respiratory sites, tamoxifen, everolimus, anastrazole, denosumab or pamidronate, exemestane, chemotherapy, corticosteroids, diagnostic imaging, breast cancer surgery, letrozole, HER2 positive therapy, radiation therapy, CT imaging, mammography, MRI imaging, anticonvulsants, antidepressants, sedatives/hypnotics, secondary malignancy to breast, breast cancer diagnosis code, in situ breast cancer diagnosis, hyperglycemia, and cerebrovascular disease
^cThe following variables were included in the propensity score specific for subsequent ALI analyses (conducted after observing an association with ALI in initial analyses): age, region, Deyo-Charlson Index, number of outpatient visits, number of emergency room visits, secondary malignancy to lymph nodes of head, face, and neck, secondary malignancy to other specified sites, secondary malignancy to respiratory sites, tamoxifen, everolimus, anastrazole, denosumab or pamidronate, exemestane, chemotherapy, corticosteroids, diagnostic imaging, breast cancer surgery, letrozole, HER2 positive therapy, radiation therapy, CT imaging, mammography, MRI imaging, anticonvulsants, antidepressants, sedatives/hypnotics, secondary malignancy to breast, breast cancer diagnosis code, in situ breast cancer diagnosis, hyperglycemia, cerebrovascular disease, Chronic liver disease or Alcoholism, Chronic or acute disease of gallbladder or pancreas, Hepatic, Biliary or pancreatic cancer, Congestive heart failure, any medication associated with ALI- Acetaminophen, Allopurinol, Amiodarone, Amitriptyline, + clavulanic acid, Aripiprazole, Baclofen, Ciprofloxacin, Clindamycin, Clopidogrel, Duloxetine, Estrogens, Fluoxetine, Ketoconazole, Lisinopril, Losartan, Mirtazapine, Nitrofurantoin, NSAIDs, Omeprazole, Paroxetine, Phenothiazine, Sertraline, Statins, Tetracycline, Trazodone, and Trimethoprim

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