N/A
Completed N=157
"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT03538717 ↗
Enrolled (actual)
157
Serious AEs
9.6%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants — 58; 50; 33; 15 Participants — p=0.113
Summary
Retrospective study to collect data from Patients with advanced/metastatic renal cell carcinoma previously treated with Axitinib under standard clinical practice, to describe the clinical profile of the patients with a long response to Axitinib and to try to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants |
58; 50; 33; 15 | 0.113 |
| PRIMARY Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Before First Line Treatment Initiation: Long Responders Versus Refractory Participants |
49; 28; 23; 24; 3; 1 | 0.228 |
| PRIMARY Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants |
34; 10; 39; 34; 7; 8 | 0.020 sig |
| PRIMARY Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status on Axitinib Discontinuation: Long Responders Versus Refractory Participants |
16; 9; 32; 24; 13; 20 | 0.138 |
| PRIMARY Number of Participants With 1 or More Different Treatment Lines Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants |
58; 48; 18; 10; 15; 8 | 0.524 |
| PRIMARY Number of Participants With Nephrectomy Procedure Status Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants |
85; 58; 6; 8 | 0.265 |
| PRIMARY Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group Before First Line Treatment Initiation: Long Responders Versus Refractory Participants |
15; 7; 25; 21; 7; 16 | 0.035 sig |
| PRIMARY Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants |
13; 7; 28; 13; 24; 26 | 0.123 |
| PRIMARY Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants |
10; 6; 26; 20; 13; 18 | 0.327 |
| PRIMARY Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants |
6; 4; 37; 19; 22; 20 | 0.419 |
| PRIMARY Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants |
4; 5; 33; 15; 14; 24 | 0.010 sig |
| PRIMARY Number of Participants With Different Type of Renal Cells Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants |
72; 48; 8; 8; 7; 7 | 0.446 |
| PRIMARY Number of Participants With Duration of First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants |
6; 6; 7; 13; 6; 7 | 0.074 |
| PRIMARY Number of Participants With Best Response to First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants |
53; 24; 26; 24; 10; 11 | 0.070 |
| PRIMARY Number of Participants With 1 or More Metastatic Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before First Line Treatment Initiation: Long Responders Versus Refractory Participants |
56; 29; 23; 23; 12; 14 | 0.091 |
| PRIMARY Number of Participants With Different Metastatic Sites Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants |
28; 31; 3; 2; 9; 16 | 0.046 sig |
| PRIMARY Number of Participants With Laboratory Parameters at Initiation of First Line Treatment: Long Responders Versus Refractory Participants |
6; 7; 60; 44; 10; 27 | 0.555 |
| PRIMARY Number of Participants With Smoking Habits at Initiation of First Line Treatment: Long Responders Versus Refractory Participants |
34; 26; 13; 17; 38; 23 | 0.235 |
| SECONDARY Progression-free Survival (PFS) to Axitinib Treatment in Group of Long Responders |
18.136 | — |
| SECONDARY Time to Progression (TTP) to Axitinib Treatment in Group of Long Responders |
18.727 | — |
| SECONDARY Overall Survival (OS) From Axitinib Treatment in Group of Long Responders |
35.975 | — |
| SECONDARY Number of Participants With Best Response to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders |
25; 32; 0; 2; 15; 16 | — |
| SECONDARY Progression-free Survival (PFS) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders |
18.661; 16.559 | — |
| SECONDARY Objective Response Rate (ORR) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders |
25; 15 | — |
| SECONDARY Clinical Benefit Rate (CBR) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders |
57; 31 | — |
| SECONDARY Time to Progression (TTP) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders |
21.388; 18.136 | — |
| SECONDARY Overall Survival (OS) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders |
44.813; 26.513 | — |
| SECONDARY Duration of Axitinib Treatment: All Participants |
10.7 | — |
| SECONDARY Percentage of Participants With Titrated (Increased) Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants |
27.1 | — |
| SECONDARY Percentage of Participants With Reduced Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants |
72.9 | — |
| SECONDARY Number of Participants With Adverse Events (AE): All Participants |
116 | — |
| SECONDARY Number of Participants Receiving Subsequent Treatment Post Axitinib Treatment: All Participants |
94 | — |
| SECONDARY Number of Participants as Per Number of Subsequent Lines of Treatment Received Post Axitinib Treatment: All Participants |
94; 12; 7; 4 | — |
| SECONDARY Duration of Subsequent Treatments Post Axitinib Treatment: All Participants |
4.5 | — |
| SECONDARY Number of Participants With First Best Response to Subsequent Treatments Post Axitinib Treatment |
12; 35; 33; 14 | — |
| SECONDARY Number of Participants With Reasons to Discontinue Subsequent Treatments Post Axitinib Treatment: All Participants |
60; 9; 9; 2 | — |
| SECONDARY Overall Survival (OS) From Subsequent Treatments Post Axitinib Treatment |
24.706 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment
- Patients who had received Axitinib treatment in second or further line with a PFS ≥9 months or DP (disease progression) at the first tumor assessment.
- For the patients alive at the moment of the inclusion, patients must have a signed informed consent document
Exclusion Criteria
- Axitinib received out of the approved indication Patients who do not meet any of the inclusion criteria
Data sourced from ClinicalTrials.gov (NCT03538717). 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. Informational only — not medical advice.