Time spent in hormone-sensitive and castration-resistant disease states in men with advanced prostate cancer, and its health economic impact: registry-based study in Sweden

Figures & data

Table 1. Definition of prostate cancer disease states.

Disease state	Definition
Non-metastatic hormone-sensitive prostate cancer	Start date for ADT
	No date for imaging with metastatic disease
Metastatic hormone-sensitive prostate cancer	Start date for ADT
	Date for imaging with metastatic disease
Non-metastatic castration-resistant prostate cancer	Date for CRPC based on clinical assessment^a or PSA progression^b
	No date for imaging with metastatic disease
Metastatic castration-resistant prostate cancer	Date for CRPC based on clinical assessment^a or PSA progression^b
	Confirmed by date for imaging with metastatic disease^c or initiation of treatment for mCRPC

ADT included monotherapy with bicalutamide, GnRH analogs or orchiectomy.

^aThe occurrence of one or more signs of progression (two consecutive PSA values of > 2 µg, local progression evaluated by digital rectal examination, or imaging with new or growing metastases during treatment with a GnRH analog or after orchiectomy).

^bIncrease of 5 ng/mL in serum PSA compared to preceding value.

^cAs waiting times for imaging can be long, a 1-month minimum time threshold was applied to changes in disease state due to imaging.

ADT, androgen deprivation therapy; CRPC, castration-resistant prostate cancer; GnRH, gonadotropin-releasing hormone; PSA, prostate-specific antigen.

Table 2. Patient characteristics by disease state at date of entry into disease state for men registered in PPC.

	nmHSPC	mHSPC	nmCRPC	mCRPC
Patients, n	1,034	884	356	1,172
Age, years, mean ± SD	72.2 ± 7.4	70.1 ± 8.2	74.8 ± 7.1	72.7 ± 7.9
Years since prostate cancer diagnosis
Mean ± SD	2.6 ± 3.4	1.2 ± 2.9	5.3 ± 3.8	4.5 ± 4.0
Median	0.7	0.1	4.7	3.3
Mean ALP at disease state entry,^a µkat/L	1.53	4.2	2.15	3.43
Prostate cancer risk category at diagnosis,^b n (%)
Low	80 (8)	30 (3)	12 (4)	54 (5)
Intermediate	289 (28)	56 (6)	85 (24)	188 (16)
High	399 (38)	93 (11)	139 (39)	258 (22)
Regionally metastatic	144 (14)	67 (8)	61 (17)	123 (10)
Distant metastases	113 (11)	635 (72)	55 (15)	541 (46)
Missing	9 (1)	3 (0)	4 (1)	8 (1)
Primary prostate cancer treatment at prostate cancer diagnosis,^c n (%)
GnRH analog	244 (24)	550 (62)	123 (35)	545 (47)
Antiandrogen^d	220 (21)	74 (8)	59 (17)	126 (11)
Other ADT, including orchiectomy	19 (2)	57 (6)	5 (1)	57 (5)
Radical prostatectomy	197 (19)	65 (7)	59 (17)	166 (14)
Radiotherapy	169 (16)	68 (8)	47 (13)	136 (12)
Watchful waiting	44 (4)	13 (1)	17 (5)	30 (3)
Active surveillance	45 (4)	13 (1)	9 (3)	21 (2)
Other/missing	96 (9)	44 (5)	37 (10)	91 (8)

A man can be included in more than one disease state due to transitioning between states.

^aLatest value captured in PPC, up to 6 months before state entry.

^bA modified version of the National Comprehensive Cancer Network risk categorization was used (localized low-risk: T1–2, Gleason score ≤ 6, and PSA < 10 ng/l; intermediate-risk: T1–2, Gleason score 7, and/or PSA > 10 to < 20 ng/l; high-risk and locally advanced: T1–3, Gleason score 8–10, and/or PSA > 20 to < 50 ng/l; regionally metastatic: T4 and/or N1, and/or PSA > 50 to < 100 ng/l, and no distant metastases; distant metastases: M1 and/or PSA > 100; missing: missing information for categorization).

^cEach man was assigned to one single primary treatment.

^dBicalutamide only.

ADT, androgen deprivation therapy; ALP, alkaline phosphatase; CRPC, castration-resistant prostate cancer; GnRH, gonadotropin-releasing hormone; HSPC, hormone-sensitive prostate cancer; m, metastatic; nm, non-metastatic; PSA, prostate-specific antigen; SD, standard deviation.

Figure 1. Transitions between disease states for men with advanced prostate cancer. A man can be included in more than one disease state due to transitioning between states. CRPC, castration-resistant prostate cancer; HSPC, hormone-sensitive prostate cancer; m, metastatic; nm, non-metastatic.

Figure 2. Time from entry into disease state to progression or death. A man can be included in more than one disease state due to transitioning between states. Stacked cumulative incidence analysis. CRPC, castration-resistant prostate cancer; HSPC, hormone-sensitive prostate cancer; m, metastatic; nm, non-metastatic.

Figure 3. Time from entry into disease state to death from any cause. A man can be included in more than one disease state due to transitioning between states. Kaplan–Meier analysis. CI, confidence interval; CRPC, castration-resistant prostate cancer; HSPC, hormone-sensitive prostate cancer; m, metastatic; nm, non-metastatic.

Figure 4. Prostate cancer treatments by disease state. A man can be included in more than one disease state due to transitioning between states. Men may have received more than one treatment. ^aAntiandrogen includes: bicalutamide; ^bOther chemotherapy includes: cisplatin, cyclophosphamide, estramustine, etoposide gemcitabine, carboplatin, methotrexate or mitoxantrone; ^cART includes: enzalutamide or abiraterone. ART, androgen receptor-targeted therapy; CRPC, castration-resistant prostate cancer; GnRH, gonadotropin-releasing hormone; HSPC, hormone-sensitive prostate cancer; m, metastatic; nm, non-metastatic.

Figure 5. Annual mean HRU costs per patient by disease state. A man can be included in more than one disease state due to transitioning between states. Costs are based on list prices and are provided in SEK 2018. ^aIncludes nurse visits, telephone consultations, imaging examinations, and laboratory tests (PSA and ALP). n = 363, n = 282, n = 112, and n = 1,084 for nmHSPC, mHSPC, nmCRPC, and mCRPC, respectively. ALP, alkaline phosphatase; CRPC, castration-resistant prostate cancer; HSPC, hormone-sensitive prostate cancer; m, metastatic; nm, non-metastatic; PSA, prostate-specific antigen; SEK, Swedish krona.

Data availability statement

Access to anonymized, individual, participant-level data will not be provided for this trial, as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under “Sponsor Specific Details for Astellas.” The ethical approval limits the access to data.