Carcinoma, Renal Cell, Lymphoma, Mantle-Cell
Conditions
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
Interventions
OTHERTemsirolimus (Non-Interventional Study)
There is not any intervention in this study.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | From initiation of treatment up to disease progression (up to 80 months) | 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. |
| Percentage of Participants With Objective Response | From initiation of treatment up to disease progression (up to 80 months) | 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.) |
| Duration of Response (DOR) | From initiation of treatment up to disease progression (up to 80 months) | 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. |
| Overall Survival (OS) | From initiation of treatment untill death (up to 80 months) | 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. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline to the 28 calendar days after the last administration of study drug (upto 80 months) | 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). |
Countries
Spain
Participant flow
Pre-assignment details
A total of 243 participants were enrolled in the study, out of which 242 participants received treatment in reporting group RCC: Temsirolimus, MCL: Temsirolimus or MCL: Temsirolimus + Rituximab
Participants by arm
| Arm | Count |
|---|---|
| RCC: Temsirolimus Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | 193 |
| MCL: Temsirolimus Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | 23 |
| MCL: Temsirolimus + Rituximab Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. | 26 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | 3 yr Temsirolimus treatment (no disease) | 1 | 0 | 0 |
| Overall Study | Bleeding from cavernous haemangioma | 1 | 0 | 0 |
| Overall Study | CD, associated leukaemia | 1 | 0 | 0 |
| Overall Study | CD, Suspected disease progression (DP) | 1 | 0 | 0 |
| Overall Study | Choledocolithiasis and pancreatitis | 1 | 0 | 0 |
| Overall Study | Clinical decline (CD) | 2 | 0 | 0 |
| Overall Study | Death | 2 | 0 | 0 |
| Overall Study | Death from septic shock | 1 | 0 | 0 |
| Overall Study | Intestinal obstruction with necrosis | 1 | 0 | 0 |
| Overall Study | Investigator's decision | 2 | 0 | 0 |
| Overall Study | Investigator's opinion, stable disease | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | low grade toxicities + stable disease | 1 | 0 | 0 |
| Overall Study | No clinical benefit | 1 | 0 | 0 |
| Overall Study | Overall decline | 1 | 0 | 0 |
| Overall Study | Overall status worsens to grade 4 | 1 | 0 | 0 |
| Overall Study | Palliative. Overall decline | 1 | 0 | 0 |
| Overall Study | Patient asks for rest + slow progression | 1 | 0 | 0 |
| Overall Study | Patient's Wish | 1 | 0 | 0 |
| Overall Study | Progression | 137 | 0 | 0 |
| Overall Study | Progression and death | 8 | 0 | 0 |
| Overall Study | Rejection of treatment | 1 | 0 | 0 |
| Overall Study | Stabilisation + frequent infections | 1 | 0 | 0 |
| Overall Study | Suspected DP/suspected active infection | 1 | 0 | 0 |
| Overall Study | Toxicity | 16 | 0 | 0 |
| Overall Study | Uncontrolled pain | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | Total |
|---|---|---|---|---|
| Age, Continuous | 65.27 years STANDARD_DEVIATION 11.14 | 70.56 years STANDARD_DEVIATION 11.07 | 72.34 years STANDARD_DEVIATION 7.11 | 66.54 years STANDARD_DEVIATION 11.04 |
| Sex: Female, Male Female | 57 Participants | 3 Participants | 3 Participants | 63 Participants |
| Sex: Female, Male Male | 136 Participants | 20 Participants | 23 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 142 / 193 | 18 / 23 | 14 / 26 |
| serious Total, serious adverse events | 18 / 193 | 3 / 23 | 7 / 26 |
Outcome results
Primary
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.
Time frame: From initiation of treatment up to disease progression (up to 80 months)
Population: Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RCC: Temsirolimus | Duration of Response (DOR) | 13.21 months |
| MCL: Temsirolimus | Duration of Response (DOR) | 7.28 months |
| MCC: Temsirolimus + Rituximab | Duration of Response (DOR) | 8.82 months |
Primary
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).
Time frame: Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)
Population: Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RCC: Temsirolimus | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 145 participants |
| RCC: Temsirolimus | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 18 participants |
| MCL: Temsirolimus | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 19 participants |
| MCL: Temsirolimus | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 participants |
| MCC: Temsirolimus + Rituximab | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 16 participants |
| MCC: Temsirolimus + Rituximab | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 7 participants |
Primary
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.
Time frame: From initiation of treatment untill death (up to 80 months)
Population: Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RCC: Temsirolimus | Overall Survival (OS) | 10.81 months |
| MCL: Temsirolimus | Overall Survival (OS) | 19.233 months |
| MCC: Temsirolimus + Rituximab | Overall Survival (OS) | 18.667 months |
Primary
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.)
Time frame: From initiation of treatment up to disease progression (up to 80 months)
Population: Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RCC: Temsirolimus | Percentage of Participants With Objective Response | SD | 46.6 percentage of participants |
| RCC: Temsirolimus | Percentage of Participants With Objective Response | CR | 0.5 percentage of participants |
| RCC: Temsirolimus | Percentage of Participants With Objective Response | DP | 38.6 percentage of participants |
| RCC: Temsirolimus | Percentage of Participants With Objective Response | PR | 14.3 percentage of participants |
| MCL: Temsirolimus | Percentage of Participants With Objective Response | SD | 26.1 percentage of participants |
| MCL: Temsirolimus | Percentage of Participants With Objective Response | PR | 17.4 percentage of participants |
| MCL: Temsirolimus | Percentage of Participants With Objective Response | DP | 21.7 percentage of participants |
| MCL: Temsirolimus | Percentage of Participants With Objective Response | CR | 34.8 percentage of participants |
| MCC: Temsirolimus + Rituximab | Percentage of Participants With Objective Response | DP | 11.5 percentage of participants |
| MCC: Temsirolimus + Rituximab | Percentage of Participants With Objective Response | CR | 30.8 percentage of participants |
| MCC: Temsirolimus + Rituximab | Percentage of Participants With Objective Response | PR | 50.0 percentage of participants |
| MCC: Temsirolimus + Rituximab | Percentage of Participants With Objective Response | SD | 7.7 percentage of participants |
Primary
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.
Time frame: From initiation of treatment up to disease progression (up to 80 months)
Population: Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RCC: Temsirolimus | Progression-free Survival (PFS) | 4.04 months |
| MCL: Temsirolimus | Progression-free Survival (PFS) | 7.467 months |
| MCC: Temsirolimus + Rituximab | Progression-free Survival (PFS) | 13.233 months |