Geriatric Assessment, Solid Cancers
Conditions
Brief summary
This study is a multicenter, prospective, observational study. The study included patients aged 65 and older with solid tumors requiring systemic anti-tumor therapy. All patients underwent screening using the sG8 scale before the start of treatment, followed by routine treatment based on a plan developed through clinician decision-making. The study did not intervene in any way with the patients' diagnosis and treatment, and relevant clinical data during the treatment process were recorded accurately for follow-up patients. Study data were obtained from the electronic medical record databases and hospital information systems of multiple centers, including Sichuan Cancer Hospital. Patient clinicopathological features, pathological diagnoses, clinical stages, previous treatment histories, as well as anti-tumor treatment regimens after patient enrollment, drug dosages per cycle, treatment start times, incidence and grades of adverse events (AEs), and tumor response were extracted and collected from the medical records. All data were entered, managed, quality-controlled, exported, and analyzed through a real-world data management platform (RWDMP).
Interventions
Geriatric screening using the sG8 scale
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients aged 65 years or older. 2. Patients with confirmed malignant tumors based on definitive pathological data. 3. Patients who are assessed by clinicians to have indications for systemic anti-tumor therapy. 4. Patients with a survival time greater than 12 weeks.
Exclusion criteria
1. Patients who do not meet the above inclusion criteria or are considered unsuitable for this study by the investigator due to other circumstances. 2. Patients who are unwilling to cooperate in completing the sG8 scale assessment. 3. Patients who do not understand the content of this study or are unwilling to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of unplanned treatment delays and treatment interruptions | From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months | The incidence of unplanned treatment delays and treatment interruptions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TRAE | From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months | Number and percentage of patents with treatment-related adverse events assessed by CTCAE v5.0. |
| ORR | From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months | the sum percentage of participants with CR and PR assessed by RECIST v1.1 criteria every 8-12 weeks. |
| PFS | From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months. | Systemic Progression-Free Survival assessed by the investigators using RECIST V1.1. |
Other
| Measure | Time frame | Description |
|---|---|---|
| OS | From date receiving anti-tumor therapy after the first screening assessment until date of death or the end of study, whichever came first, assessed up to 12 months | Overall survival |