Non-Small-Cell Lung Cancer, Breast Cancer
Conditions
Keywords
Oral Vinorelbine, Advanced Non-Small-Cell Lung Cancer, Metastatic Breast Cancer
Brief summary
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.
Interventions
DRUGVinorelbine oral
Sponsors
Winicker Norimed GmbH
Pierre Fabre Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study | 8 weeks of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's treatment satisfaction | 8 weeks of treatment | Evaluation of the patient's treatment satisfaction \[Cancer Therapy Satisfaction Questionnaire (CTSQ)\] |
| Physician's treatment satisfaction | 8 weeks of treatment | Evaluation of the physician's treatment satisfaction \[5 point scale\] |
| Adverse drug reactions | 8 weeks of treatment | Evaluation of adverse drug reactions using CTCAE v4.03 |
| Body weight | Baseline and 8 weeks of treatment | Body weight \[kg\] at baseline and changes during the study |
| Body mass index | Baseline and 8 weeks of treatment | Body mass index \[kg/m\^2\] at baseline and changes during the study |
| Patient's quality of life | Baseline and 8 weeks of treatment | Evaluation of the patient's quality of life \[Short Form (SF)-12\] |
| ECOG performance status | Baseline and 8 weeks of treatment | ECOG performance status \[grades 0-5\] at baseline and changes during the study |
| Treatment regimen | Baseline | Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed. |
| Treatment changes | 8 weeks of treatment | Frequency analysis of dose changes and of the underlying reasons |
| Relationships between oral vinorelbine dose increases and patient and disease characteristics | Baseline and 8 weeks of treatment | Generalized linear mixed model with the variable dose increase as binary response variable |
| Assessment of initial tumor response (based on clinical or imaging assessment) | 8 weeks of treatment | — |
| Body surface area | Baseline and 8 weeks of treatment | Body surface area \[m\^2\] at baseline and changes during the study |
Countries
Austria, Germany
Outcome results
None listed