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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 481
- 试验地点
- 1
- 主要终点
- Number of Participants With Different Type of Adverse Events
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
Number of Participants With Different Type of Adverse Events
时间窗: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
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.
Number of Participants With Serious Adverse Events
时间窗: 6 months
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.
Duration From Treatment Initiation to Onset of Adverse Events
时间窗: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
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.
Duration of Adverse Events From Onset to Resolution
时间窗: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
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.
Number of Adverse Events Classified According to Type of Management Strategy
时间窗: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
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.
Duration of Treatment Interruption for Axitinib
时间窗: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 month
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.
Maximum Axitinib Dose Reduction
时间窗: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
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.
次要结局
未报告次要终点