Stage II/III dMMR/MSI-H Locally Advanced Cancer of the Rectum Cancer of the Rectum
Conditions
Interventions
None listed
Sponsors
GlaxoSmithKline
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of stage II or stage III (T3-T4 and N0, or T any and N+) rectal cancer on or after 01 January 2013 to the latest date of data availability based on the start date of the study 2. Adults age = 18 years at diagnosis of stage II/III rectal cancer diagnosis date 3. Initiated SOC treatment (i.e., any observed real-world therapy, including surgery) for treatment of stage II/III rectal cancer following date of diagnosis 4. Lab results indicating dMMR status or MSI-H phenotype For patients to be eligible for this study, their dMMR/MSI-H confirmation is required any time prior to, or within 3 months following, the overall index date (i.e. initial SOC treatment initiation) and prior to any diagnosis of metastatic disease. Confirmation at any time prior the overall index date is acceptable, as long as the assessment of dMMR/MSI-H is related to their current rectal cancer diagnosis (i.e., assessment is not from a prior cancer). However, anyone whose dMMR/MSI-H confirmation is ONLY determined after 3 months following the overall index date or after any diagnosis of metastatic disease is NOT eligible for the current study. For the primary analysis, dMMR/MSI-H confirmation is required any time prior to, or within one month following, the overall index date and prior to any diagnosis of metastatic disease. Sensitivity analyses will also be conducted, respectively, among (1) patients with known dMMR/MSI-H status prior to or within 3 months following the overall index date, and prior to any diagnosis of metastatic disease; (2) patients with known dMMR/MSI-H status prior to the overall index date
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from this natural history study: Evidence of stage IV rectal cancer on or prior to the overall index date Evidence of malignancy other than rectal cancer, superficial skin cancer (i.e., nonmelanoma skin cancer), superficial bladder cancer, or other in situ cancer in the 2 years prior to date of stage II/III rectal cancer diagnosis Evidence of active treatment for malignancy other than rectal cancer, superficial skin cancer (i.e., non-melanoma skin cancer), superficial bladder cancer, or other in situ cancer in the 2 years prior to date of stage II/III rectal cancer diagnosis Evidence of initiation of ICIs, including dostarlimab, as the initial SOC treatment following diagnosis of stage II/III rectal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who maintain real-world clinical complete response (rw-cCR) for at least 12 months, among patients who are evaluable for rw-cCR12.The proportion of all patients who (a) achieve rw-cCR12 or (b) achieve real-world pathological complete response (rw-pCR) prior to being assessable for cCR12 among those who did receive primary rectal cancer surgery before receiving any subsequent SOC.The proportion of patients who are free from the following events: progression precluding surgery, local recurrence/regrowth, distant recurrence, and death due to any cause in the 3 years following the initiation of SOC treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients whose best response was CR/NED, partial response, stable disease, progressive disease, or indeterminate/not documented, summarized separately.The proportion of patients who have no evidence of rectal cancer surgery, no evidence of a permanent colostomy, and no death at any time in the 3 years following initiation of SOC treatment. | — |
Countries
France, Germany, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactZ. Zeliku
GlaxoSmithKline
Outcome results
None listed