GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.

Time frame: After 12 months

Population: Per protocol set (PPS): This set included all patients who gave their informed consent, did not violate any inclusion or exclusion criterion and have at least one documented administration of afatinib.

Percentage of participants with controlled disease (CR + PR + stable disease (SD)) as best unconfirmed response. CR, PR and SD were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate

Time frame: From the initial dose of study drug until end of the treatment period, up to 48 months.

Population: PPS

Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response. Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.

Time frame: From the initial dose of study drug until end of the treatment period, up to 48 months.

Population: PPS

Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).

Time frame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.

Population: Treated set (TS): This patient set included all patients who received at least one dose of afatinib.

Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.

Time frame: From the initial dose of study drug until end of the treatment period, up to 48 months.

Population: TS

PFS was measured from start of therapy until progression or death, whichever came first. Progression was defined as the minimum of the first examination with progression and the date of progression documented by the treating physician. One day was added to the corresponding date. Patients without documented progression and not known to have died were censored at their date of last examination and one day was added. Median was derived by Kaplan Meier methods.

Time frame: From first administration of the trial drug until objective tumour progression or death, up to 48 months.

Population: PPS

Symptom control was evaluated for cough, dyspnea and pain. Time to deterioration was calculated from date of baseline European Organisation for Research and Treatment of Cancer (EORTC) questionnaire until date of the EORTC questionnaire, where the first deterioration was measured. Patients without deterioration were censored at their date of last answered EORTC questionnaire, where the corresponding scale is evaluable. Participants had to select one answer on a scale ranging from 1=Not at All to 4=Very Much for questions 1 to 28 and 31 to 43 and on scale ranging from 1=Very Bad to 7=Excellent for questions 29 and 30. Afterwards, these scale scores were linearly transformed such that all scales ranged from 0 to 100, where higher scores represented higher level of symptoms.

Time frame: Up to 48 months

Population: TS

Toxicity and side-effect profile: incidence of diarrhea, skin reactions, stomatitis and paronychia. Skin reactions: acne, dermatitis acneiform, dry skin, pruritus, rash, rash maculo-papular, rash pustular.

Time frame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.

Population: TS

Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration.

Time frame: From the initial dose of study drug until end of the treatment period, up to 48 months.

Population: TS