Copyright
©The Author(s) 2021.
World J Clin Oncol. Nov 24, 2021; 12(11): 1009-1022
Published online Nov 24, 2021. doi: 10.5306/wjco.v12.i11.1009
Published online Nov 24, 2021. doi: 10.5306/wjco.v12.i11.1009
Table 1 Baseline characteristics of the first 94 patients with metastatic castration-sensitive prostate cancer treated with docetaxel and androgen deprivation therapy between July 2015 and December 2017 in the Southeast Health Care region of Sweden
Total, n = 94 (%) | CHAARTED, ADT + Docetaxel | STAMPEDE, Standard of care + Docetaxel | |
Age, yr | |||
Median | 68.0 | 64 | 65 |
Range | 49-79 | 36-88 | 40-81 |
Prostate-specific antigen (μg/L), at diagnosis | |||
Median | 180 | 50.9 | 70 |
Range | 2-7367 | 0.2-8540.1 | 1-9999 |
Comorbidities, n (%) | 50 (53) | ||
Diabetes mellitus I and II | 16 (17) | 56 (9) | |
Hyperlipidemia | 23 (24) | 208 (35) | |
Hypertension | 38 (40) | ||
Previous malignant disease1 | 11 (11) | ||
Performance status (ECOG)2, n (%) | |||
0 | 46 (72) | 277 (69.8) | |
1 | 15 (23) | 114 (28.7) | |
2 | 3 (5) | 6 (1.5) | |
T category at diagnosis3, n (%) | |||
T1 | 6 (6) | 0 | |
T2 | 17 (18) | 60 (10) | |
T3 | 46 (49) | 390 (66) | |
T4 | 11 (12) | 105 (18) | |
TX | 4 (4) | 35 (6) | |
Not assessed | 10 (11) | ||
N category at diagnosis3, n (%) | |||
N0 | 29 (31) | 260 (44) | |
N1 | 42 (45) | 298 (50) | |
NX | 23 (24) | 34 (6) | |
Metastases3, n (%) | |||
Non-distant metastasis4 | 19 (20) | ||
Distant metastases | 75 (80) | 362 (61) | |
Location, n (%) | |||
Bone metastases | 74 (79) | 307 (52) | |
Liver metastases | 2 (2) | 6 (1) | |
Lung metastases | 12 (13) | 13 (2) | |
Lymph node metastases | 54 (57) | 102 (17) | |
Gleason sum score, n (%) | |||
≤ 6 | 2 (2) | 21 (5.3) | ≤ 7 |
7 | 27 (29) | 96 (24.2) | 110 (19%) |
8-10 | 60 (64) | 241 (60.7) | 436 (74%) |
Unknown | 5 (5) | 39 (9.8) | 46 (8%) |
Histology (WHO 2004), n (%) | |||
Acinar adenocarcinoma | 86 (92) | ||
Ductal carcinoma | 1 (1) | ||
Mixed type | 2 (2) | ||
Unknown | 5 (5) | ||
Follow-up, months | 20 | ||
Median (IQR) | 13-28 | ||
Status last follow-up, n (%) | |||
Alive, no disease progression | 15 (16) | ||
Alive, disease progression | 65 (69) | ||
Dead of disease | 14 (15) |
Table 2 Treatment data
Total, n = 94 (%) | |
ADT | |
GnRH and nonsteroidal antiandrogen | 82 (87) |
GnRH alone | 9 (10) |
Orchidectomy | 3 (3) |
ADT | |
Time from ADT start to Docetaxel start, days | |
Median (range) | 63 (8-400) |
ADT duration, days | |
Median (range) | 331 (5-1038) |
Docetaxel | |
751 mg/m² | 77 |
Adm mean dose % of full dose | 91 |
Mean adm dose, mg | 139 |
Mean acc dose, mg | 758 |
Completed all cycles | 63 (67) |
502 mg/m² | 8 |
Adm mean dose % of full dose | 83 |
Mean adm dose, mg | 86 |
Mean acc dose, mg | 610 |
Completed all cycles | 4 (50) |
Switch | 9 |
Adm mean dose % of full dose | 87 |
Mean adm dose, mg | 107 |
Mean acc dose, mg | 641 |
Completed all cycles | 9 (100) |
Dose reduction | 33 (35) |
Dose escalation | 13 (14) |
Unchanged | 47 (50) |
Missing | 1 (1) |
Best response at end of Docetaxel3 | |
CR | 6 (6) |
PR | 50 (53) |
SD | 15 (16) |
PD | 11 (12) |
NE | 12 (13) |
Est. PFS | Mean (95%CI) |
12 mo | |
CHAARTED/STAMPEDE | 75% (66-84) |
Swedish national guidelines | 71% (61-81) |
24 mo | |
CHAARTED/STAMPEDE | 58% (46-70) |
Swedish national guidelines | 55% (43-67) |
OS | |
12 mo | 93% (87-99) |
24 mo | 86% (76-96) |
Table 3 Progression-free survival (according to the CHAARTED and STAMPEDE definitions of progressive disease) age, PSA, comorbidities and bone metastases
Number of patients | Number of events | HR, 95%CI, P value (univariate) | HR, 95%CI, P value (multivariate) | |
Age, yr (median) | ||||
≤ 68 | 48 | 21 | 1.00 | 1.00 |
> 68 | 46 | 15 | 0.78, 0.40-1.51, 0.45 | 0.83, 0.42-1.67, 0.61 |
PSA (median) | ||||
≤ 180 | 48 | 12 | 1.00 | 1.00 |
> 180 | 46 | 24 | 2.86, 1.39-5.87, 0.0041 | 2.51, 1.21-5.19, 0.013 |
Comorbidities | ||||
No | 44 | 15 | 1.00 | 1.00 |
Yes | 50 | 21 | 1.15, 0.59-2.23, 0.68 | 1.19, 0.60-2.36, 0.63 |
Distant metastases | ||||
No | 19 | 3 | 1.00 | 1.00 |
Yes | 75 | 33 | 3.36, 1.03-10.96, 0.045 | 2.60, 0.78-8.65, 0.12 |
Table 4 Progression-free survival (according to Swedish national guidelines) age, PSA, comorbidities and bone metastases
Number of patients | Number of events | HR, 95%CI, P value (univariate) | HR, 95%CI, P value (multivariate) | |
Age, yr (median) | ||||
≤ 68 | 48 | 22 | 1.00 | 1.00 |
> 68 | 46 | 17 | 0.83, 0.44-1.56, 0.55 | 0.88, 0.46-1.71, 0.71 |
PSA (median) | ||||
≤ 180 | 48 | 13 | 1.00 | 1.00 |
> 180 | 46 | 26 | 2.86, 1.44-5.69, 0.0028 | 2.57, 1.28-5.16, 0.0081 |
Comorbidities | ||||
No | 44 | 17 | 1.00 | 1.00 |
Yes | 50 | 22 | 1.06, 0.56-2.00, 0.85 | 1.08, 0.56-2.07, 0.83 |
Distant metastases | ||||
No | 19 | 4 | 1.00 | 1.00 |
Yes | 75 | 35 | 2.69, 0.96-7.59, 0.061 | 2.11, 0.73-6.06, 0.17 |
Table 5 Side-effects reported
Total, n = 94 (%) | |
Reason for termination of treatment | |
Completed as planned | 74 (79) |
Adverse event | 11 (12) |
Fatigue | 5 (5) |
Tumor progression | 2 (2) |
Patient preference | 1 (1) |
Other | 1 (1) |
Bone marrow toxicity | |
Hemoglobin | |
Any grade | 16 (17) |
≥ grade 3-4 | 0 |
White blood cell count | |
Any grade | 20 (21) |
≥ grade 3-4 | 15 (16) |
Neutrophil count | |
Any grade | 19 (20) |
≥ grade 3-4 | 19 (20) |
Grade missing | 1 |
Platelet count | |
Any grade | 2 (2) |
≥ grade 3-4 | 0 |
Unplanned hospitalization under and within 30 d after chemotherapy | 24 (26) |
Febrile neutropenia | 20 (21) |
- Citation: Isaksson J, Green H, Papantoniou D, Pettersson L, Anden M, Rosell J, Åvall-Lundqvist E, Elander NO. Real-world evaluation of upfront docetaxel in metastatic castration-sensitive prostate cancer. World J Clin Oncol 2021; 12(11): 1009-1022
- URL: https://www.wjgnet.com/2218-4333/full/v12/i11/1009.htm
- DOI: https://dx.doi.org/10.5306/wjco.v12.i11.1009