| Patterns of chemotherapy and biologic therapy |
| • Treatment patterns will be analyzed based on histology and lines of treatment, as well as for predictive factors |
| • The frequency and duration of treatment will be determined for each line of treatment |
| • A list of the agents and regimens used will be compiled, with an investigation into the most common chemotherapy and biologic therapy regimens |
| Line of therapy |
| • First-line therapy: therapy received during the first 28 days after the initiation of treatment, with the number of cycles per regimen counted as intravenous (IV) administrations or prescription fills |
| • Maintenance therapy: therapy delivered after ≥4 cycles of first-line treatment without disease progression and subsequent treatment being initiated within 6 weeks of first-line therapy |
| • Second-line therapy: therapy received after ≥4 cycles of first-line treatment with a time gap of >6 weeks without chemotherapy/biologic treatment between 2 consecutive cycles of > 6 weeks; or if after <4 weeks of first-line therapy, a new treatment (that was not included in the first-line regimen) was administered, regardless of the length of time since the end of the first-line therapy. If one product from a combination regimen was discontinued, this did not constitute a change in the line of therapy |
| • Third-line therapy: a new line of therapy received after ≥4 cycles of second-line treatment with a time gap of > 6 weeks without chemotherapy/biologic treatment; or if after <4 cycles of second-line therapy, a new treatment (that was not included in the second-line regimen) was administered regardless of the length of time since the end of the second-line therapy. If one product from a combination regimen was discontinued, this did not constitute a change in the line of therapy |
| • Fourth-line and beyond: A gap of > 6 weeks in third-line therapy, or evidence of the administration of systemic therapy (excluding any agents used in the third-line regimen), regardless of the length of time since the end of the third-line therapy. |
| Duration of systemic therapy |
| • Determined by calculating the difference between the initial and last date at which the first drug of a regimen was administered |
| Treatment modification |
| • Defined as; dose reductions, treatment interruptions (temporary pause in treatment with intent to resume), and treatment discontinuation. Where available, the reason for the modification will be noted |
| Overall survival |
| • Interval between the date of diagnosis and the date of death (stratified by histology at diagnosis and from time of initiation of systemic therapy) |
| • Deaths will be verified using death certificate searches at sites, reports from caregivers, relatives, or other healthcare providers |
| • The in-hospital mortality rate will be calculated first, followed by analysis of overall survival |
| • Analyzed for each line of therapy and key treatment regimens |
| • Use of other cancer-directed therapies |
| • Surgery |
| • Radiation therapy |
| • Traditional Chinese medicine |
| Use of BSC and palliative care |
| • Best supportive and palliative care are intended to alleviate pain, relieve symptoms, improve quality of life, and enhance the compliance of anti-cancer treatment |
| Ancillary procedures |
| • The frequency of ancillary procedures, such as biopsies and biomarker tests, will be documented and analyzed, overall and for each line of therapy |
| Total direct health care costs |
| • Post-index direct health care costs will be calculated for each patient, overall, and for each line of therapy |
| • Total direct cancer-related costs will be stratified by inpatient and outpatient status |
