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.
Study Type
OBSERVATIONAL
Enrollment
108
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.
Time frame: 8 weeks of treatment
Body weight
Body weight \[kg\] at baseline and changes during the study
Time frame: Baseline and 8 weeks of treatment
Body mass index
Body mass index \[kg/m\^2\] at baseline and changes during the study
Time frame: Baseline and 8 weeks of treatment
Body surface area
Body surface area \[m\^2\] at baseline and changes during the study
Time frame: Baseline and 8 weeks of treatment
ECOG performance status
ECOG performance status \[grades 0-5\] at baseline and changes during the study
Time frame: 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.
Time frame: Baseline
Treatment changes
Frequency analysis of dose changes and of the underlying reasons
Time frame: 8 weeks of treatment
Relationships between oral vinorelbine dose increases and patient and disease characteristics
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Unnamed facility
Braunau am Inn, Austria
Unnamed facility
Graz, Austria
Unnamed facility
Innsbruck, Austria
Unnamed facility
Klagenfurt, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Villach, Austria
Unnamed facility
Vöcklabruck, Austria
Unnamed facility
Aachen, Germany
Unnamed facility
Altötting, Germany
Unnamed facility
Amberg, Germany
...and 46 more locations
Generalized linear mixed model with the variable "dose increase" as binary response variable
Time frame: Baseline and 8 weeks of treatment
Assessment of initial tumor response (based on clinical or imaging assessment)
Time frame: 8 weeks of treatment
Patient's quality of life
Evaluation of the patient's quality of life \[Short Form (SF)-12\]
Time frame: Baseline and 8 weeks of treatment
Patient's treatment satisfaction
Evaluation of the patient's treatment satisfaction \[Cancer Therapy Satisfaction Questionnaire (CTSQ)\]
Time frame: 8 weeks of treatment
Physician's treatment satisfaction
Evaluation of the physician's treatment satisfaction \[5 point scale\]
Time frame: 8 weeks of treatment
Adverse drug reactions
Evaluation of adverse drug reactions using CTCAE v4.03
Time frame: 8 weeks of treatment