Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With First Line Treatment Regimen
研究概览
简要总结
The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older in the year of the index first line therapy prescription.
- •2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date.
- •2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.)
- •Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates.
- •Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data
排除标准
- •Received advanced treatment prior to the study index date.
- •Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed.
- •Only one RCC diagnosis in the 12 months prior or one mont post index date.
- •Patients with data for analysis (< 3 months post index date)
研究组 & 干预措施
Patients with advanced renal cell carcinoma (RCC)
干预措施: Tyrosine kinase inhibitor (TKI) (Drug)
Patients with advanced renal cell carcinoma (RCC)
干预措施: Immuno-oncology (IO) (Drug)
结局指标
主要结局
Number of Participants With First Line Treatment Regimen
时间窗: At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months
Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Monotherapy and Combination Therapy
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Participants who received monotherapy and combination therapy by line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Time to First Line Therapy
时间窗: From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months
Time to first line therapy was defined as length of time (days) from the first RCC diagnosis to first line therapy prescription. Index date was defined as the date of initiation of the aRCC treatment.
Duration of Treatment According to Each Line of Therapy
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Duration of treatment as per each line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Treatment Continuation
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Treatment continuation was considered when there was no more than (\>) 30-day gap (i.e., persistent treatment) for the index medication during follow-up period. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Treatment Interruption
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Treatment Interruption was considered in participants with gaps in treatment greater than allowable gap but who restart the same medication with no indication of switching or augmentation. Index date was defined as the date of initiation of the aRCC treatment.
Time to Treatment Interruption
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Time from index medication to treatment discontinuation for those within treatment interruptions (\>30 day gaps). Represents the time between index and end of last treatment, including any treatment gaps. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Treatment Switch or Augmentation
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of participants who had treatment switch or augmentation were reported in this outcome measure. Augmentation was defined as addition of treatment to initial therapy prescribed, i.e, initiation of a new therapy different from the initial therapy while continuation of the initial therapy. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants According to Lines of Therapy
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of participants as per the lines of treatment were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Time to Treatment Failure (TTF)
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
TTF was defined as the time from first-line therapy start to treatment discontinuation for any reason, including switched, augmented therapy, end of enrollment or death. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of participants according to the sequence of therapies received for mRCC were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants According to Their Status at End of Follow-up
时间窗: At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)
Number of participants according to their status (death, end of enrollment and end of data availability) at end of follow-up were observed and included in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Percentage of Participants With Treatment Discontinuation
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Percentage of participants with treatment discontinuation was defined as the percentage of participants with gap in therapy greater than 30 days and who did not begin a new treatment. Index date was defined as the date of initiation of the aRCC treatment.
Percentage of Participants Alive at 3 Months
时间窗: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of participants who were alive at 3 months is reported in this outcome measure.
Percentage of Participants Alive at 6 Months
时间窗: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of participants who were alive at 6 months is reported in this outcome measure.
Percentage of Participants Alive at 12 Months
时间窗: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of participants who were alive at 12 months is reported in this outcome measure.
Overall Survival
时间窗: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
OS is defined as the length of time from index date to participant's death. Index date was defined as the date of initiation of the aRCC treatment.
次要结局
未报告次要终点