3
Indication details
- Combined Agent(s)
- ChT (cisplatin + capecitabine or 5-FU)
- Control Arm
- ChT
- Therapeutic Indication
- HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction in patients who have not received prior anti-cancer treatment for their metastatic disease
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Stomach or gastroesophageal junction cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- HER2+
- Trial Name
- ToGA
- NCT Number
- NCT01041404
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2010
- EMA Approval
- EMA (CHMP) approval December 2009 EC decision Feburary 2010
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 11.1 months
- OS Gain
- 2.7 months
- OS HR
- 0.74 (0.60-0.91)
Adjustments
- QoL Comment
-
Delayed deterioration in QoL but did not meet ESMO-MCBS QoL criteria for upgrade
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Final non-curative score
-
3
- Comment
-
Licensed biosimilar formulations are available for this medicine and this may improve accessibility and sustainability
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 295
- Scorecard version
- 1
- Issue date
- 17.09.2021
- Last update
- 28.11.2023
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.