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4
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour Sub-Group
EGFR+ (exon 19 deletion or L858R)
Tumour stage
Advanced
Control Arm
Gefitinib or erlotinib
Treatment Setting
Previously untreated EGFR mutated (exon 19 deletion or L858R)
Trial Name
FLAURA

Primary Outcome(s)

Primary Outcome(s)
PFS
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
10.2 months
PFS Gain
8.7 months
PFS HR
0.46 (0.37-0.57)
OS Control
31.8 months
OS Gain
6.8 months
OS HR
0.80 (0.64-1.00)
QoL Comment
Similar between arms
Toxicity Comment
Improved toxicity profile

Final Score (after adjustments)

Preliminary non-curative score
3
Toxicity adjustment
1+
Final non-curative Score
4
Release date
15.05.2019
Last update
30.04.2020

DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PFS, progression-free survival; PE, point estimate; 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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