Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS

Regimen A or regimen B is used for HER2-overexpressing breast cancer.

RegimenB is used for HER2-overexpressing unresectable advanced or recurrent gastric cancer in combination with other anti tumor agent(s).

Regimen A: The recommended dose for trastuzumab (genetical recombination) [Trastuzumab Biosimilar 3] in adult patients is 4 mg/kg (weight) at initial dose and 2 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every week.

Regimen B: The recommended dose for trastuzumab (genetical recombination) [Trastuzumab Biosimilar 3] in adult patients is 8 mg/kg (weight) at initial dose and 6 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every 3 weeks.

If the initial dose is well tolerated, the dosing time after the second dose can be shortened up to 30 minutes.

An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and/or 150mg [Pfizer] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to this drug was assessed.

The physician in charge evaluated the effectiveness of this drug based on the best overall response [complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), inevaluable (NE) or Non-CR/Non-PD] using the effectiveness assessment items in the RECIST Version 1.1 at the end of the observation period or at discontinuation.

The physician identified target lesions and non-target lesions in the classification of tumor lesions at the start of administration of this drug, and confirmed the presence or absence of new lesions in addition to the results of assessment of tumor response in each tumor lesion during the observation period, and then evaluated overall response.

The total proportion of participants with CR + PR was evaluated as an overall response (OR) rate along with a 95% confidence interval.

Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and/or 150mg [Pfizer], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.

An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and/or 150mg [Pfizer] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to this drug was assessed.

The SAS comprised of participants who satisfied the inclusion criteria and had received TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and/or 150mg [Pfizer]. Participants who did not provide informed consent was excluded.

Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and/or 150mg [Pfizer], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.