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5
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Genitourinary Cancers
Tumour Sub-type
Prostate cancer
Tumour stage
Metastatic
Combined Agent(s)
Best standard of care
Control Arm
Best standard of care + placebo
Treatment Setting
Late line and bone pain, castration-refractory, late line and bone pain
Trial Name
ALSYMPCA

Primary Outcome(s)

Primary Outcome(s)
OS
Form(s)
Form 2a

Outcome Data

OS Control
11.3 months
OS Gain
3.6 months
OS HR
0.70 (0.58-0.83)
QoL Comment
Improved

Final Score (after adjustments)

Preliminary non-curative score
4
QoL adjustment
1+
Final non-curative Score
5
Release date
11.12.2018

ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression

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