Trial Outcomes & Findings for To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma (NCT NCT04682587)

NCT ID: NCT04682587

Last Updated: 2025-01-03

Results Overview

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

• Recruitment status: COMPLETED
• Target enrollment: 481 participants
• Primary outcome timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
• Results posted on: 2025-01-03

Participant Flow

Data of participants with advanced Renal cell carcinoma (RCC) who received first line therapy of Axitinib in combination with Immuno-oncology (IO) therapy was observed in this study. Oncologists abstracted data from medical charts of eligible participants using an online electronic case report form (eCRF). Abstracted data was evaluated over 1.5 months of this retrospective study.

Participant milestones

Measure	Axitinib + IOs Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Overall Study STARTED	481
Overall Study COMPLETED	481
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma

Baseline characteristics by cohort

Measure	Axitinib + IOs n=481 Participants Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Age, Continuous	61.9 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants
Sex: Female, Male Male	320 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	15 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	76 Participants n=5 Participants
Race/Ethnicity, Customized White	358 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	6 Participants n=5 Participants
Race/Ethnicity, Customized Missing	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Population: All eligible participants whose data were extracted from medical records and observed in the study.

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

Outcome measures

Measure	Axitinib + IOs n=481 Participants Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Number of Participants With Different Type of Adverse Events Fatigue	232 Participants
Number of Participants With Different Type of Adverse Events Diarrhea	184 Participants
Number of Participants With Different Type of Adverse Events Nausea	141 Participants
Number of Participants With Different Type of Adverse Events Hypertension	106 Participants
Number of Participants With Different Type of Adverse Events Palmar-plantar erythrodysesthesia	54 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All eligible participants whose data were extracted from medical records and observed in the study.

AE was considered serious when it: resulted in death, life-threatening, requires in-participant hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may jeopardize the participant or may require intervention to prevent one of the outcomes listed above. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

Outcome measures

Measure	Axitinib + IOs n=481 Participants Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Number of Participants With Serious Adverse Events	130 Participants

PRIMARY outcome

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Population: All eligible participants whose data were extracted from medical records and observed in the study.

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. In this outcome measure time from index date to occurrence of incidence of any AE is reported. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

Outcome measures

Measure	Axitinib + IOs n=481 Participants Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Duration From Treatment Initiation to Onset of Adverse Events	1.0 Months Interval 0.3 to 2.0

PRIMARY outcome

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Population: All eligible participants whose data were extracted from medical records and observed in the study.

The time to resolution from AE onset and from initiation of management strategy was calculated for all AEs experienced including repeated AEs. The time to resolution of AE (from the onset of AE and from the initiation of management strategies) was separately estimated using Kaplan-Meier analysis; median time to event will be reported. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

Outcome measures

Measure	Axitinib + IOs n=729 Adverse Events Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Duration of Adverse Events From Onset to Resolution Overall	21.0 Days Interval 9.0 to 33.0
Duration of Adverse Events From Onset to Resolution Severe AE's	17.0 Days Interval 6.0 to 31.0

PRIMARY outcome

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Population: All eligible participants whose data were extracted from medical records and observed in the study.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

Outcome measures

Measure	Axitinib + IOs n=729 Adverse Events Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Number of Adverse Events Classified According to Type of Management Strategy No Action	198 Adverse Events
Number of Adverse Events Classified According to Type of Management Strategy Axitinib modifications (with or without supportive care)	251 Adverse Events
Number of Adverse Events Classified According to Type of Management Strategy Axitinib modifications with IO treatment modification	96 Adverse Events

PRIMARY outcome

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 month

Population: All eligible participants whose data were extracted from medical records and observed in the study.

Duration of treatment interruption was calculated as the total days of treatment interruption. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

Outcome measures

Measure	Axitinib + IOs n=481 Participants Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Duration of Treatment Interruption for Axitinib	13.0 Days Interval 7.0 to 21.0

PRIMARY outcome

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Population: All eligible participants whose data were extracted from medical records and observed in the study.

Maximum axitinib dose reduction was calculated as the difference between axitinib dose at AE onset and the minimum axitinib dose recorded between the date of AE onset and either the date of AE resolution (if the AE had a reported resolution date) or the end of follow up (if the AE did not have a reported resolution date).Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

Outcome measures

Measure	Axitinib + IOs n=481 Participants Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
Maximum Axitinib Dose Reduction	3.0 Milligrams twice daily Interval 2.0 to 3.5

Adverse Events

Axitinib + IOs

Serious events: 130 serious events

Other events: 265 other events

Deaths: 32 deaths

Serious adverse events

Measure	Axitinib + IOs n=481 participants at risk Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
General disorders Fatigue	4.4% 21/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Gastrointestinal disorders Diarrhoea	10.6% 51/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Gastrointestinal disorders Nausea	3.5% 17/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Vascular disorders Hypertension	5.8% 28/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	2.7% 13/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.

Other adverse events

Measure	Axitinib + IOs n=481 participants at risk Participants with advanced RCC who received first-line axitinib in combination with IO (avelumab or pembrolizumab) in real world per routine clinical practice, their data were abstracted from medical charts and observed during this retrospective study.
General disorders Fatigue	22.2% 107/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Gastrointestinal disorders Diarrhoea	11.4% 55/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Gastrointestinal disorders Nausea	10.2% 49/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Vascular disorders Hypertension	8.5% 41/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	2.7% 13/481 • Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. AEs were reported as per participant's medical records. There was no specific medical dictionary.

Additional Information

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Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER