This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR/MSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.
The primary objective is to describe the activity of neoadjuvant dostarlimab in terms of objective response rate (RECIST 1.1). Secondary objectives are: 1. To describe the activity of neoadjuvant dostarlimab in terms of: * complete clinical response rate at 6 and 12 months * time to clinical complete response * duration of clinical complete response * near-complete clinical response rate at 6 and 12 months * duration of near-complete clinical response * duration of objective response * rate of surgery (total mesorectal excision or local excision) * pathological complete response rate * objective response rate (RECIST 1.1) assessed by central radiological review. 2. To describe the safety of neoadjuvant dostarlimab in terms of: Adverse events/SAE incidence and outcome, time and duration of toxicity according to CTCAE v5.0. 3. To descrive the efficacy of neoadjuvant dostarlimab in terms of: event free-survival (EFS), organ preservation at 3 years, time to ditance recurrence and overall survival (OS)
Study Type
OBSERVATIONAL
Enrollment
50
Dostarlimab 500 mg iv every 3 weeks for 9 cycles
ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica
Napoli, Italy
NOT_YET_RECRUITINGIRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale
Napoli, Italy
RECRUITINGObjective response rate (ORR)
Defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.
Time frame: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months
duration of clinical complete response
defined as the time from the first documented date of clinical complete response to the date of documented local tumor regrowth, disease recurrence, or last available follow-up, whichever occurs first.
Time frame: up to to 12 months
near-complete clinical response rate
absence of mass at digital rectal exam, small mucosal irregularity or superficial ulcer no more than 2 cm in diameter at endoscopic exam, and no metastatic nodes at MRI.
Time frame: at 6 and 12 months up to 12 months
duration of near-complete clinical response
defined as the time from the first documented date of near-complete clinical response to the date of documented conversion to complete clinical response, local tumor regrowth, disease recurrence, or last available follow-up, whichever occurs first.
Time frame: up to 12 months
rate of surgery (total mesorectal excision or local excision)
defined as the proportion of patients who undergo surgical resection of the primary tumor, including either total mesorectal excision (TME) or local excision
Time frame: at 6 months (at the end of neoadjuvant dostarlimab)
pathological complete response rate
defined as a Tumor Regression Grade (TRG) 1 according to Mandard modified scoring system.
Time frame: after surgery (at 6 months)
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objective response rate assessed by central radiological review
defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.
Time frame: fter 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months
safety of neoadjuvant dostarlimab
Adverse events/Serious adverse events incidence and grading according to NCI-CTCAE v. 5.0
Time frame: at the end of each cycle of dostarlimab (every 21 days ) up to 6 months
Event-free survival
defined as the time between dostarlimab starting and disease recurrence (local or distant), or disease progression (radiological or clinical) or second primary colorectal malignancy, or death from any cause, whichever comes first.
Time frame: up to 12 months
Time to distant recurrence
defined as the time between dostarlimab starting and distant disease recurrence or progression. Patients who do not have a distant recurrence and are alive at the end of the study will be censored at the date of the last assessment visit.
Time frame: up to 12 months
Overall survival
defined as the time between dostarlimab starting and death from any cause. Patients alive at the end of the study will be censored at the date of the last follow-up contact.
Time frame: up to 12 months