Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria

Study Overview
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Brief Summary
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The aim of this non-interventional study is to assess oral vinorelbine dose schedules (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of treatment under routine conditions in Germany together with the underlying reasons for the respective chosen schedules.

Official Title
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Assessment of Initial Oral Vinorelbine Dosing Schedules Used for the Treatment of Advanced Non-small-cell Lung Cancer and Metastatic Breast Cancer in Clinical Routine in Germany and Austria (StepUp)

Conditions
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Non-Small-Cell Lung Cancer, Breast Cancer

Intervention / Treatment
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* Drug: Vinorelbine oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent of the patient with regard to the pseudonymized documentation and processing of his/her disease data Legally capable male or female NSCLC patient or legally capable female MBC patient; in both situations: ≥ 18 years of age (no upper limit) Presence of any of the following two tumor entities: Advanced NSCLC (stage III or IV) Anthracycline- and taxane-resistant MBC (stage IV) in women Planned systemic chemotherapy and planned regimen with oral vinorelbine in any palliative setting (decision on treatment must have been made before inclusion in this study); included treatments: Monotherapy or any combination therapy with oral vinorelbine Inclusion of patients with hybrid-treatment involving i.v. and oral vinorelbine in one treatment cycle is allowed Exclusion Criteria: Presence of any contraindication with regard to oral vinorelbine treatment (and with regard to i.v. vinorelbine in case of hybrid-treatment) according to the respective Summary of Product Characteristics (SmPC) Oral vinorelbine based palliative treatment already ongoing or planned oral vinorelbine starting dose of >60 mg/m2 Presence of a Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2 Simultaneous participation in an interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vinorelbine oral|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study | The outcome will be calculated together with its negative (i.e. the rate of patients without such dose increase). Reasons for increasing and for not increasing the dose will be analyzed. | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight [kg] at baseline and changes during the study | Baseline and 8 weeks of treatment | 
| Body mass index | Body mass index [kg/m^2] at baseline and changes during the study | Baseline and 8 weeks of treatment | 
| Body surface area | Body surface area [m^2] at baseline and changes during the study | Baseline and 8 weeks of treatment | 
| ECOG performance status | ECOG performance status [grades 0-5] at baseline and changes during the study | Baseline and 8 weeks of treatment | 
| Treatment regimen | Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed. | Baseline | 
| Treatment changes | Frequency analysis of dose changes and of the underlying reasons | 8 weeks of treatment | 
| Relationships between oral vinorelbine dose increases and patient and disease characteristics | Generalized linear mixed model with the variable dose increase as binary response variable | Baseline and 8 weeks of treatment | 
| Assessment of initial tumor response (based on clinical or imaging assessment) |  | 8 weeks of treatment | 
| Patient's quality of life | Evaluation of the patient's quality of life [Short Form (SF)-12] | Baseline and 8 weeks of treatment | 
| Patient's treatment satisfaction | Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)] | 8 weeks of treatment | 
| Physician's treatment satisfaction | Evaluation of the physician's treatment satisfaction [5 point scale] | 8 weeks of treatment | 
| Adverse drug reactions | Evaluation of adverse drug reactions using CTCAE v4.03 | 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Vinorelbine, Advanced Non-Small-Cell Lung Cancer, Metastatic Breast Cancer