N/A
N=77
Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Complete Remission in Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01934452 ↗Enrolled (actual)
77
Serious AEs
69.7%
Results posted
Nov 2023
Primary outcome: Primary: Time to Diagnose Metastatic Renal Cell Carcinoma — 3.79; 0.21 Years — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- sunitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Diagnose Metastatic Renal Cell Carcinoma |
3.79; 0.21 | <0.001 sig |
| PRIMARY Number of Participants Categorized According to Presence of Nephrectomy |
35; 31; 0; 11 | 0.001 sig |
| PRIMARY Number of Participants Categorized According to Type of Nephrectomy |
30; 28; 4; 3; 15; 11 | 1.000 |
| PRIMARY Time to Nephrectomy From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) |
5.7; 10.0 | 0.230 |
| PRIMARY Number of Participants Categorized According to Pathological Classification |
33; 39; 2; 3; 1; 1 | 0.695 |
| PRIMARY Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification |
8; 8; 7; 8; 18; 15 | 0.316 |
| PRIMARY Tumour Size |
73.0; 75.5 | 0.778 |
| PRIMARY Number of Participants Categorized According to Fuhrman Nuclear Grade |
2; 4; 9; 11; 14; 12 | 0.812 |
| PRIMARY Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component |
14; 20; 19; 11; 12; 12 | 0.077 |
| PRIMARY Time to Initiation of Sunitinib From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) |
3.25; 2.69 | 0.865 |
| PRIMARY Number of Participants Categorized According to Location of Metastases |
15; 30; 20; 12; 5; 12 | 0.011 sig |
| PRIMARY Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site |
7; 16; 3; 7; 3; 11 | 1.000 |
| PRIMARY Number of Participants Categorized According to Recurrence at Nephrectomy Site |
6; 1; 29; 41 | 0.042 sig |
| PRIMARY Number of Participants Categorized According to Recurrence at Other Site |
3; 12; 32; 30 | 0.027 sig |
| PRIMARY Number of Metastatic Sites |
1.0; 2.0 | <0.001 sig |
| PRIMARY Number of Participants Categorized According to Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Classification |
14; 8; 12; 24; 0; 6 | 0.009 sig |
| PRIMARY Time to Achieve Complete Remission (CR) After Sunitinib Initiation: mRCC Participants With CR |
0.98 | — |
| PRIMARY Number of Participants Categorized According to Method of Achieving CR: mRCC Participants With CR |
14; 21 | — |
| PRIMARY Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR |
5; 2; 2; 8; 3 | — |
| PRIMARY Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR |
1; 4; 1; 5; 1; 1 | — |
| PRIMARY Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR |
35; 34; 34; 1; 34 | — |
| PRIMARY Number of Participants Categorized According to Therapeutic Strategy After CR: mRCC Participants With CR |
16; 19 | — |
| PRIMARY Number of Participants With Disease Evolution (DE) at Month 12 Follow-up Visit: mRCC Participants With CR |
21; 5; 3; 2 | — |
| PRIMARY Number of Participants With Ongoing Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR |
9; 20 | — |
| PRIMARY Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR |
1; 4; 4; 1; 6; 2 | — |
| PRIMARY Number of Participants Who Discontinued Sunitinib Temporarily at Month 12 Follow-up Visit: mRCC Participants With CR |
5; 21 | — |
| PRIMARY Number of Participants Categorized According to Number of Temporary Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR |
3; 2 | — |
| PRIMARY Number of Instances When Different Types of Reason Led to Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow up Visit: mRCC Participants With CR |
3; 1; 3 | — |
| PRIMARY Number of Instances When Participants Resumed Sunitinib Treatment After Temporary Discontinuation at Month 12: mRCC Participants With CR |
6; 1 | — |
| PRIMARY Duration of Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR |
15.0 | — |
| PRIMARY Number of Participants Who Discontinued Sunitinib Permanently at Month 12 Follow-up Visit: mRCC Participants With CR |
10; 17 | — |
| PRIMARY Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR |
1; 7; 1; 1 | — |
| PRIMARY Duration of Treatment With Sunitinib Since Complete Remission at Month 12 Follow-up Visit: mRCC Participants With CR |
6.00 | — |
| PRIMARY Number of Participants With Disease Evolution at Month 24 Follow-up Visit: mRCC Participants With CR |
19; 4; 1; 2 | — |
| PRIMARY Number of Participants With Ongoing Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR |
4; 21 | — |
| PRIMARY Number of Participants Who Discontinued Sunitinib Temporarily at Month 24 Follow-up Visit: mRCC Participants With CR |
2; 21 | — |
| PRIMARY Number of Participants Who Resumed Treatment at Month 24 Follow-up Visit: mRCC Participants With CR |
1 | — |
| PRIMARY Number of Days of Temporary Discontinuation of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR |
15 | — |
| PRIMARY Number of Participants Who Discontinued Sunitinib Permanently at Month 24 Follow-up Visit: mRCC Participants With CR |
11; 12 | — |
| PRIMARY Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR |
1; 3; 7 | — |
| PRIMARY Duration of Treatment With Sunitinib Since Complete Remission at Month 24 Follow-up Visit: mRCC Participants With CR |
7.62 | — |
| PRIMARY Time to Progression With Sunitinib Treatment From Complete Remission: mRCC Participants With CR |
12.65 | — |
| PRIMARY Duration of Additional Treatment With Sunitinib Since Complete Remission: mRCC Participants With CR |
10.0 | — |
| PRIMARY Number of Participants Categorized According to Types of Progression: mRCC Participants With CR |
1; 18 | — |
| PRIMARY Number of Participants Categorized According to Site of Progression: mRCC Participants With CR |
12; 7; 12; 7 | — |
| PRIMARY Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR |
7; 4; 0; 1; 2; 2 | — |
| PRIMARY Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site: mRCC Participants With CR |
3; 2; 2; 3 | — |
| PRIMARY Number of Participants Categorized According to Number of Metastatic Sites: mRCC Participants With CR |
14; 4; 1 | — |
| PRIMARY Number of Participants Who Received Systemic Treatment After Progression: mRCC Participants With CR |
16; 3 | — |
| PRIMARY Number of Participants Categorized According to Type of Systemic Treatment Received After Progression: mRCC Participants With CR |
11; 6; 3 | — |
| PRIMARY Number of Participants With Best Objective Response After Progression: mRCC Participants With CR |
7; 1; 7; 11 | — |
| PRIMARY Duration of Treatment With First Line Sunitinib Till Progression: mRCC Participants With CR |
24.5 | — |
| PRIMARY Number of Participants Who Were Early Terminated: mRCC Participants With CR |
2; 33 | — |
| PRIMARY Number of Participants Who Achieved Response: mRCC Participants With CR |
— | — |
| PRIMARY Number of Participants Categorized According to Number of Subsequent Treatment Lines From Progression/Post Complete Remission: mRCC Participants With CR |
— | — |
| PRIMARY Number of Participants Who Died: mRCC Participants With CR |
5 | — |
| PRIMARY Progression Free Survival: mRCC Participants With CR |
69.4 | — |
| PRIMARY Number of Participants With Adverse Events and Serious Adverse Events |
32; 41; 18; 35 | — |
| PRIMARY Number of Participants With Adverse Events and Serious Adverse Events Possibly Related to Drug Exposure |
15; 41; 3; 21 | — |
| PRIMARY Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs |
16; 72; 14; 118; 83; 330 | — |
Summary
This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions :
Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)
Eligibility Criteria
Inclusion Criteria
- Patients with metastatic renal cell carcinoma, histopathologically confirmed
- Treated with sunitinib according to Smpc
- For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA)
- For controls: Life expectancy > 3 months No prior Sunitinib treatment
- Patient >18 years
Exclusion Criteria
- Sunitinib administered in a non-approved label
- For cases: CR occurring without sunitinib treatment
- For controls: Prior systemic treatment
Data sourced from ClinicalTrials.gov (NCT01934452). 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.