Two cohorts, one for patients with colon cancer and the second for all other patients. Of the 103 patients who completed treatment across both cohorts, 84 had a clinical complete response and 82 did not undergo surgery. Among the 117 total patients, recurrence-free survival at two years was 92%. Only 20-months follow up for now. It will be interesting to see how this goes with future updates but seems promising.
Among patients with mismatch repair—deficient (dMMR), locally advanced rectal cancer, neoadjuvant checkpoint blockade eliminated the need for surgery in a high proportion of patients. Whether this approach can be extended to all early-stage dMMR solid tumors, regardless of tumor site, is unknown.
We conducted a phase 2 study in which patients with stage I, II, or III dMMR solid tumors that were amenable to curative-intent surgery were treated with neoadjuvant dostarlimab, a programmed cell death 1 (PD-1) blocking agent, for 6 months. The response to treatment was assessed in two cohorts: patients in cohort 1 had dMMR, locally advanced rectal cancer, and patients in cohort 2 had dMMR nonrectal solid tumors. Patients with a clinical complete response could elect to proceed with nonoperative management; those with residual disease were to undergo resection. In this analysis, the primary end point, assessed in cohort 1, was a sustained clinical complete response at 12 months. Recurrence-free survival and safety were evaluated.
A total of 117 patients were included in the analysis. In cohort 1, all 49 patients who completed treatment had a clinical complete response and elected to proceed with nonoperative management. A total of 37 patients had a sustained clinical complete response at 12 months, a finding that met the criterion for efficacy. In cohort 2, a total of 35 of 54 patients who completed treatment had a clinical complete response, and 33 elected to proceed with nonoperative management. Among the 103 patients who completed treatment across both cohorts, 84 had a clinical complete response, and 82 did not undergo surgery. Among the 117 total patients, recurrence-free survival at 2 years was 92% (95% confidence interval, 86 to 99); the median follow-up for recurrence was 20.0 months (range, 0 to 60.8). The majority of patients (95%) had reversible, grade 1 or 2 adverse events (60%) or had no adverse events (35%). The option for curative resection was not compromised during or after treatment in any of the patients.
Among patients with early-stage dMMR solid tumors that were amenable to curative-intent surgery, neoadjuvant PD-1 blockade led to organ preservation in a high proportion of patients. (Funded by Swim Across America and others; ClinicalTrials.gov number, NCT04165772.)
This new subcutaneous anticoagulant, abelacimab, binds to the inactive form of FXI and blocks its activation by FXII. This drug seems significantly safer than DOAC’s in terms of bleeding risk. So much so that the study was stopped early due to a greater-than-expected reduction in bleeding events in the study arm. I hope this drug is also going to be studied for the treatment of VTE.
Pooled data of nearly 2000 patients across six trials in melanoma using IO therapy. It seems clear that high dose corticosteroid use was associated with worse outcomes, especially with high peak doses. What may be worth considering is if non-steroid based immunosuppression can be used as an adjunct to blunt this concerning effect.
I guess scalp cooling does have some objective evidence that it works. Still the expense and time constraints will need to be considered.
TIP will likely become the established salvage therapy for GCT’s if this study’s findings are confirmed in the ongoing Phase III TIGER trial.
Stimulant therapy with methylphenidate did not improve fatigue in a well-done, prospective, placebo-controlled trial. This refutes prior practices of using ADD medications to mitigate fatigue for patients on chemotherapy. I rarely use these in my own practice given the concern for weight loss and mood disorder.