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4

Indication details

Combined Agent(s)
Best supportive care + octreotide
Control Arm
Octreotide
Therapeutic Indication
Unresectable or metastatic, progressive, well-differentiated (Grade 1 and Grade 2), somatostatin receptor positive-GEP-NETs in adults
Tumour Type
Endocrine Tumours
Tumour Sub-type
Neuroendocrine Tumour - Midgut
Tumour Stage
Unresectable or metastatic
Trial Name
NETTER-1
NCT Number
NCT01578239
Trial Phase
Phase III

Primary Outcome(s)

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

Outcome Data

PFS Control
8.4 months
PFS Gain
31.6 months (Calculated estimate of gain based on point estimate HR 0.21)
PFS HR
0.214 (0.13-0.33)
OS Control
36.3 months
OS Gain
11.7 months
OS HR
0.84 (0.60-1.17) not significant

Adjustments

QoL Comment
Improvement in QoL; favourable safety profile

Final Score (after adjustments)

Preliminary non-curative score

3

QoL adjustment
1+
Final non-curative score

4

Comment
EMA (CHMP) July 2017 EC approval September 2017
FDA approval January 2018

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
152
Scorecard version
1
Issue date
12.03.2020
Last update
08.03.2023
177Lu-DOTATATE NETTER-1

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Improved QoL
177Lu-DOTATATE NETTER-1

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
4
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Endocrine Tumours
Unresectable or metastatic, progressive, well-differentiated (Grade 1 and Grade 2), somatostatin receptor positive-GEP-NETs in adults
177Lu-DOTATATE + Best supportive care + octreotide
Octreotide

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    Legend

    Information about symbols, abbrevations and color codes

    Red = negative
    Green = positive
    Grey = neutral
    ? Grey + ? = neutral with pending data
    DFS
    Disease-Free Survival
    DoR
    Duration of Response
    EFS
    Event-Free Survival
    HR
    Hazard Ratio
    NEB
    No evaluable benefit
    NI
    Non-inferiority Study
    ORR
    Overall Response Rate
    OS
    Overall Surival
    pCR
    Pathological Complete Response/Remission
    PFS
    Progression-Free Survival
    QoL
    Quality of Life
    RFS
    Relapse-Free Survival
    RR
    Response Rate

    QoL adjustments

    Other adjustments*

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    QoL adjustments

    Red = negative / deterioration

    Green = positive / improvement

    Other adjustments*

    Red = negative / deterioration

    Green = positive / improvement

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    * Other adjustments include:

    - Long-term plateau in the survival curve
    - Long-term plateau in the PFS curve
    - Early stopping or crossover
    - Only improved PFS mature data shows no OS advantage and no improved Qol.

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