Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Boehringer Ingelheim

This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.

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

An Observational Study of GIOTRIF (Afatinib) for First Line Therapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (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.

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.

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

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.

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

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.

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

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.

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

Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

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

Boehringer Ingelheim, Call Center

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.

Spots Global Cancer Trial Database for GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

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Study Description

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