INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus

Study Overview
=================
Brief Summary
-----------------
The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.

Detailed Description
-----------------
There is not sampling method

Official Title
-----------------
Inhibitor - Estudio Retrospectivo De Casos Clinicos De Pacientes Con Carcinoma De Celulas Renales Y Con Linforma De Celulas Del Manto Tratados Con Temsirolimus

Conditions
-----------------
Carcinoma, Renal Cell, Lymphoma, Mantle-Cell

Intervention / Treatment
-----------------
* Other: Temsirolimus (Non-Interventional Study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice. Exclusion Criteria: Patients that do not have a minimum (pre-specified) of data in their clinical record.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients that received treatment with Temsirolimus<br>Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice. | Other: Temsirolimus (Non-Interventional Study)<br>* There is not any intervention in this study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma. | From initiation of treatment up to disease progression (up to 80 months) | 
| Percentage of Participants With Objective Response | Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.) | From initiation of treatment up to disease progression (up to 80 months) | 
| Duration of Response (DOR) | Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2. | From initiation of treatment up to disease progression (up to 80 months) | 
| Overall Survival (OS) | Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive. | From initiation of treatment untill death (up to 80 months) | 
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs). | Baseline to the 28 calendar days after the last administration of study drug (upto 80 months) |