Clinical trial NCT04682587: 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
Official title: A Panel-Based Chart Review Study to Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving First-Line Axitinib in Combination With Immune-Oncology Drugs for the Treatment of Advanced Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Advanced Renal Cell Carcinoma (aRCC)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aRCC

Brief summary: To assess how dose reductions or treatment interruptions related to axitinib can be implemented to manage and resolve adverse events occurring among patients with advanced renal cell carcinoma treated with first-line axitinib in combination with avelumab or pembrolizumab

Detailed description: The specific objectives of the study are as follows:

Describe incident adverse events (AEs) experienced among patients with advanced RCC who received first-line axitinib in combination with immuno-oncology (IO) therapies.

* Type and seriousness of AEs (ie, diarrhea, fatigue, hypertension, nausea, palmar plantar erythrodysesthesia \[hand-foot syndrome\]).
* Proportion of patients who experienced repeated AEs.
* Time from treatment initiation to AE onset, overall and by type and seriousness of AEs.

Among patients with advanced RCC who developed incident AEs while receiving first line axitinib in combination with IO therapies, characterize and describe management strategies for AEs, stratified by type and seriousness of AEs.

* Proportion of patients who used each of the following management strategies:
* No action for axitinib and IO therapy;
* No action for axitinib, but treatment modification for IO therapy (ie, treatment interruption, treatment discontinuation);
* Axitinib dose reduction, but no action for IO therapy;
* Axitinib treatment interruption, but no action for IO therapy;
* Axitinib treatment discontinuation, but no action for IO therapy;
* Axitinib dose reduction, and treatment modification for IO therapy;
* Axitinib treatment interruption, and treatment modification for IO therapy;
* Axitinib treatment discontinuation, and treatment modification for IO therapy.
* Average axitinib dose reduction (absolute and percentage change), where applicable.
* Duration of treatment interruption, where applicable.

Assess the frequency of and time to AE resolution (from AE onset and initiation of management strategy, separately) among patients with advanced RCC who developed incident AEs while receiving first-line axitinib in combination with IO therapies according to different management strategies implemented, stratified further by type and seriousness of AEs, as allowed by sample size.

The above objectives will also be conducted for repeated AEs of the same type

Eligibility criteria: Inclusion Criteria:

Physicians meeting the following criteria will be invited to participate in the chart review study:

* Specialty in oncology
* Access to complete medical records for at least one patient with advanced RCC who meets the patient eligibility criteria

Eligible oncologists will be asked to select up to three patients meeting the following criteria for inclusion in the chart review study:

* Confirmed diagnosis with advanced RCC
* Treated with first-line axitinib/IO combination therapy at or after diagnosis
* Experienced at least one AE (i.e., diarrhea, fatigue, nausea, hypertension, and palmar-plantar erythrodysesthesia \[hand-foot syndrome\]) while treated with axitinib/IO combination therapy
* Age 18 years or older at the time of advanced RCC diagnosis
* Initiated axitinib/IO combination therapy at least 3 months prior to the start date of medical chart abstraction to ensure sufficient follow-up time

Exclusion Criteria:

There are no exclusion criteria for this study

Primary outcomes:
measure: Number of Participants With Different Type of Adverse Events
timeFrame: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
measure: Number of Participants With Serious Adverse Events
timeFrame: 6 months
measure: Duration From Treatment Initiation to Onset of Adverse Events
timeFrame: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
measure: Duration of Adverse Events From Onset to Resolution
timeFrame: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
measure: Number of Adverse Events Classified According to Type of Management Strategy
timeFrame: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
measure: Duration of Treatment Interruption for Axitinib
timeFrame: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 month
measure: Maximum Axitinib Dose Reduction
timeFrame: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: