On 23 rdJune 2017, in a Letterto the Editor of Blood Cancer Journal, Thomas E. Witzigand colleagues from the Mayo Clinic College of Medicineand Mayo Foundation, Rochester, provided an update on the results from the North Central Cancer Treatment Group(NCCTG) N1085 phase I and feasibility study ( NCT01334502) of everolimus in combination with standard R-CHOP in patients with untreated DLBCL. 1
Previous resultsfrom this phase I and feasibility study which were obtained at the time of the last follow up in March 2016, demonstrated that everolimus in combination with R-CHOP was safe and efficacious. At a median follow-up of 21.5 months, the Overall Response Rate (ORR) was 96% (23/24) and all patients who achieved a response also attained a functional Complete Response (CR) by Positron Emission Tomography (PET). Additionally, all twenty-four patients were event-free at 12 months and 9 patients, with sufficient follow-up data, were event-free at 24 months. 2
Witzig et al., provided an update on the Event Free Survival at 24 months (EFS24 [a surrogate for long-term outcome]) of all patients (n = 24) examined as of February 2017. Additionally, they reported on the time from Diagnosis to day 1 of Treatment (DtT), which has been reported to influence the rate of achieving EFS24. 3The median follow-up for patients was 37.2 months.
- All twenty-four patients were EFS24 and alive with no relapses
- Median DtT in all patients (n = 24); 14 days (range 5–48 days)
The authors highlighted that the “results from this small study of everolimus/R-CHOP continue to be promising, especially since the median DtT of the patients on this trial was 14 days”. Recent data have demonstrated that DLBCL patients with a DtT of ≤ 14 days treated with R-CHOP would have an expected EFS24 failure rate of 44% 3and thus the authors suggested that DtT should be used as “a stratification factor” in DLBCL patients “given its influence on EFS24”.
Witzig et al., concluded by proposing that newer trials in DLBCL patients should begin reporting EFS24 and DtT in order to allow better comparison across studies.