N/A
N=102
Observational Study Evaluating The Efficacy And Effects On Quality Of Life Of Targeted Treatments Following TKIs In mRCC
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02315755 ↗Enrolled (actual)
102
Serious AEs
4.9%
Results posted
Jul 2019
Primary outcome: Primary: Progression Free Survival (PFS) — NA months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
NA | — |
| PRIMARY Percentage of Participants With Overall Objective Response |
23.5; 38.2; 18.6 | — |
| PRIMARY Functional Assessment of Cancer Therapy Kidney Symptom Index - 15 (FKSI-15) Score at Baseline |
26 | — |
| PRIMARY Change From Baseline in FKSI-15 Score at Month 3 |
1.2 | — |
| PRIMARY Change From Baseline in FKSI-15 Score at Month 6 |
1.21 | — |
| PRIMARY Change From Baseline in FKSI-15 Score at Month 9 |
1.38 | — |
| PRIMARY Change From Baseline in FKSI-15 Score at Last Follow-up |
0.67 | — |
| PRIMARY EuroQol-5 Dimension-3 Level (EQ5D-3L) Scores at Baseline |
0.522 | — |
| PRIMARY Change From Baseline in EQ5D-3L Scores at Month 3 |
-0.07 | — |
| PRIMARY Change From Baseline in EQ5D-3L Score at Month 6 |
-0.11 | — |
| PRIMARY Change From Baseline in EQ5D-3L Score at Month 9 |
-0.06 | — |
| PRIMARY Change From Baseline in EQ5D-3L Score at Last Follow-up |
-0.05 | — |
| PRIMARY Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) Score at Baseline |
14.56 | — |
| PRIMARY Change From Baseline in FKSI-DRS Score at Month 3 |
1.13 | — |
| PRIMARY Change From Baseline in FKSI-DRS Score at Month 6 |
1.04 | — |
| PRIMARY Change From Baseline in FKSI-DRS Score at Month 9 |
0.68 | — |
| PRIMARY Change From Baseline in FKSI-DRS Score at Last Follow-up |
1.6 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Overall Survival at Year 1: Percentage of Participants Who Survived at Year 1 |
79.9 | — |
| SECONDARY Time to Treatment Failure |
4 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
33; 5 | — |
| SECONDARY Number of Participants With Grade 3 or Higher Severe Adverse Events (AEs) Based on NCI CTCAE Version 4.03 |
13 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) During Third Line Targeted Treatment |
6 | — |
| SECONDARY Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events |
7; 13; 4; 58; 5; 7 | — |
| SECONDARY Correlation Coefficient Between Efficacy and Dose Modifications Due to AEs |
NA | — |
| SECONDARY Correlation Coefficient Between Efficacy and High Blood Pressure (>150 / 90 Millimeter of Mercury ) |
NA | — |
Summary
Metastatic renal cell carcinoma (mRCC) is the most common malignant tumour of the kidneys. Targeted therapies, which were recently introduced in the treatment of mRCC, have become the standard treatment in these patients. With improved survival rate and a tolerable side effect profile, Tyrosine Kinase Inhibitors (TKIs) have largely replaced conventional immunotherapies worldwide.
In Turkey, due to reimbursement conditions, cytokine (interferon alpha) treatment is the standard treatment as first-line therapy.
Therefore, the data on quality of life (QoL) from the pivotal studies with standard TKI treatment does not reflect the QoL status of patients treated with TKIs as second or third line treatment in Turkey. In this study, the clinical outcomes and the impact on quality of life of targeted treatments following TKIs will be explored. To our knowledge, since there is no similar reimbursement condition in the world placing IFN as the first line standard treatment, this will be the first study evaluating the QoL status with targeted therapies used as 3rd line treatment in mRCC patients.
Eligibility Criteria
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Histologically confirmed metastatic renal cell cancer patients who have already been using targeted therapies for up to 3 months as 3rd line treatment
- Patients older than 18 years
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
- Patients with contraindications for the use of the study medications
- Patients with (suspected) pregnancy or in lactation period
- Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
- Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before included in the current study.
Data sourced from ClinicalTrials.gov (NCT02315755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.