Consolidative autologous hematopoietic cell transplant plus Rituxan versus Rituxan alone didn’t present a major distinction in survival amongst sure sufferers with mantle cell lymphoma.
Sufferers with mantle cell lymphoma (MCL) didn’t reveal improved survival outcomes in a section 3 research after receiving consolidative autologous hematopoietic cell transplant (auto-HCT) with Rituxan (rituximab) of their first full remission (CR) with undetectable minimal residual illness (MRD).
Information from an evaluation of the section 3 ECOG-ACRIN EA4151/BMT-CTN 1601 trial was introduced in the course of the 2024 ASH Annual Assembly.
Between August 2017 and July 15, 2024, 650 sufferers had been enrolled within the research. Sufferers who had an MRD-negative CR underwent randomization to auto-HCT plus Rituxan for 3 years (group A; 257 sufferers), or Rituxan alone for 3 years (group B; 259 sufferers). Those that had a partial response (MRD-positive or -negative) or an MRD-positive CR went onto the registration cohort (not randomly assigned) and acquired autoHCT plus Rituxan for 3 years (group C; 49 sufferers); those that had been deemed MRD indeterminate additionally had autoHCT plus Rituxan for 3 years (group D; 85 sufferers).
Glossary
Autologous hematopoietic cell transplant (auto-HCT): accumulating a affected person’s wholesome stem cells earlier than remedy and returning the wholesome cells to them after most cancers remedy.
Full remission: sufferers now not present indicators or signs of most cancers.
Minimal-residual illness (MRD): microscopic traces of most cancers cells that stay within the physique.
Total survival (OS): time sufferers stay with most cancers, no matter their illness standing, till demise of any trigger.
Development-free survival (PFS): time sufferers stay with out their most cancers worsening or spreading.
The first evaluation inhabitants included all randomized sufferers, however a treated-as-assigned evaluation was additionally performed as a result of 25.3% of sufferers in group A and 0.8% in group B refused their assigned remedy.
The research confirmed that in all randomized sufferers, the three-year general survival (OS) fee was 82.1% for auto-HCT plus Rituxan in contrast with 82.7% within the Rituxan-alone group; these charges had been 86.2% versus 84.8% within the treated-as-assigned group.
“Because of this the chance of detecting vital distinction, even when the research is extra absolutely learn out, is very unbelievable,” lead research writer Dr. Timothy Fenske, a medical oncologist at Medical School of Wisconsin, stated in an oral presentation in the course of the assembly. “On this preliminary evaluation, within the period of extremely efficient induction and upkeep regimens, [patients with] mantle cell lymphoma in first full response with undetectable MRD didn’t profit from consolidative autologous transplant. Longer follow-up shall be vital to verify these findings.”
To be eligible for research enrollment, sufferers with MCL should have been between the ages of 18 and 70 years and in first remission. Rituxan-containing induction regimens had been allowed and included these with BTK inhibitors.
Sufferers could possibly be enrolled on the research earlier than, throughout or after induction therapies. If clonal markers had been current in molecular testing, sufferers went to post-induction restaging and submission of blood for MRD evaluation; if no markers had been discovered, they had been recognized as MRD indeterminate.
The first finish level was OS between the auto-HCT plus upkeep Rituxan versus upkeep Rituxan alone. Secondary measures included progression-free survival (PFS) in group A versus group B, in addition to PFS in teams C and D and conversion fee of MRD-positive sufferers in group C to undetectable MRD following auto-HCT.
Research investigators assumed a six-year OS fee of 76% in the usual Rituxan upkeep group and focused to detect a ten% enchancment to 86% at six years when auto-HCT was added.
Survival Outcomes Amongst Remedy Teams
Findings from the research additionally confirmed that there was no vital distinction noticed in PFS outcomes between teams A and B. Three-year PFS charges within the all-randomized group had been 76.6% and 77.4% for teams A and B, respectively; these charges had been 81.5% and 80.4%, respectively, within the treated-as-assigned group.
When OS was measured between teams A and B evaluating induction remedy depth, it was discovered that the three-year OS charges had been 83.0% for group A versus 86.2% for group B. Within the non-intensive induction group, the three-year OS charges had been 79.5% versus 72.8%, respectively.
“As we’d anticipate, the survival seems considerably superior in sufferers receiving intensive induction,” Fenske stated. “Nevertheless, receipt of autologous transplant was not related to a major enchancment in general survival no matter induction depth.”
OS was additionally evaluated in sufferers who had been enrolled in teams C and D. Right here, the three-year OS charges had been 81.9% and 85.1%, respectively. Three-year PFS charges had been 76.9% and 73.4%, respectively.
Research investigators performed an exploratory evaluation of the MRD-positive sufferers that comprised group C of posttransplant MRD standing. The three-year PFS charges had been related at 100% versus 48.8%, respectively, “suggesting that MRD-positive sufferers should profit from autologous transplant,” Fenske stated, and famous the small subgroup measurement.
Thirty-four deaths had been reported on research, occurring from lymphoma (group A, 4.7%; group B, 3.5%; group C, 2.0%; group D, 2.4%), COVID-19 (5.1%; 6.6%; 2.0%; 3.5%), different (3.5%; 3.1%; 6.1%; 5.8%) and unknown causes (1.6%; 1.5%; 2.0%; N/A).
Reference
“Lack of good thing about autologous hematopoietic cell transplantation (auto-HCT) in mantle cell lymphoma (MCL) sufferers (pts) in first full remission (CR) with undetectable minimal residual illness (uMRD): preliminary report from the ECOG-ACRIN EA4151 section 3 randomized trial” by Dr. Timothy Fenske. Blood.
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