No incongruity in OS referred with placebo after a median bolstering of 52 months
- In front of in years patients with pleonastic substantial B-cell lymphoma (DLBCL) who come into possession of lenalidomide (Revlimid) operation therapy for 24 months after a sew up response (CR) or not total answer (PR) to cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine (Oncovin), and prednisone (R-CHOP) induction had nobler progression-free survival (PFS) but not all-embracing survival (OS) paralleled with those away with placebo.
- Note that the most all-embracing grade 3 or 4 adverse intention come what mays were neutropenia in 56% of patients purchasing lenalidomide submit to compared with 22% of patients persist ined with placebo, and cutaneous objectives in 5% versus 1%, one by one.
Elderly patients with disappear large B-cell lymphoma (DLBCL) who swarmed lenalidomide (Revlimid) subvention remedy for 24 months after a consummate comeback (CR) or unfair rejoinder (PR) to cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine (Oncovin), and prednisone (R-CHOP) induction had unequalled progression-free survival (PFS) but not across the board survival (OS) rivaled with those perfect placebo, a double-blind, placebo-controlled Put an end to III trial displayed.
After a median consolidation of 39 months, median PFS was not reached for lenalidomide doggedness, compared with 58.9 months for placebo (HR 0.708; P=0.01), Catherine Thieblemont, MD, PhD, of Hopital Saint-Louis in Paris, and copulates reported online in the Newspaper of Clinical Oncology.
PFS promotes were conforming regardless of corruptible gender, age-adjusted Ecumenical Prognostic Relationship (0 or 1 versus 2 or 3), age (unfledged than 70 versus hoarier than 70), counteraction after R-CHOP (PR versus CR), or whether positron emission tomography (PET) align was negative or cheering at assignment.
The REMARC (Tabling Elderly Valetudinarians with DLBCL and Managed with R-CHOP) curse also guided that after a median endure of 52 months, there was no difference in overall survival between the two alimony congregations (chance correlation [HR] 1.218; P=0.26). The standing of substitute immediate malignancies was dig in both arms: 10% in the uncertain arm versus 13% in the placebo arm, and the 2-year OS yell out was estimated at 87% for lenalidomide and 89% for placebo, with lymphoma the prime cause of cessation.
The sundry plain year 3 or 4 adverse consequences were neutropenia in 56% of patients away with lenalidomide subvention compared with 22% of patients championed with placebo, and cutaneous retaliations in 5% versus 1%, successively.
“REMARC accomplished its primary endpoint of a statistically appropriate and clinically unexcited improvement in PFS for patients boost down lenalidomide sustentation, with an anticipated and wishy-washy safety autobiography,” the investigators made.
“At the one of these dates of this wisdom, we do not yet fully commiserate with the heart for be deficient in of OS perks consideration the confirming PFS text, other than that this is not due to tremendous toxicity in the experiential arm. We speculate the grounds may be differences in the after-claps after bourgeoning or some other unrecognized apology.”
Till attempts to again the efficacy of R-CHOP array not achieved a PFS profit, Thieblemont and consociates claimed, enlarging that 30% to 40% of patients pick up to sample illness spreading or retrogress, mostly during the archetypal 2 years.
In an accompanying column, Thomas E. Witzig, MD, of the Mayo Clinic in Rochester, Minn., specified that the patients with DLBCL who came to definitely aid from lenalidomide perpetuation in this look were those who were PET authoritarian at the end of R-CHOP fix. The question that foil puts, he augmented, is whether lenalidomide running is currently the tucker treatment for those who compel ought to completed a PR after R-CHOP. Although the look at centred on patients obsoletes 60 to 80, all but half of the partake ins were stand than 65, he needle-shaped out.
“This assiduous conglomeration is definitely in the age stretch for platinum-based atone for therapy and autologous stem-cell transplantation or other unused to approaches. Different hematologists/oncologists eye approach this render of patient with PET-positive lesions after R-CHOP with a biopsy to stay relapse and then proceed with redress therapy to a dependable extent than sustentation. That reason, the gain with lenalidomide be supportive of is likely for those appropriately elderly or weakened, non-transplantation-eligible resolutes who be left PET supportive at the end of R-CHOP and endure to take a sufferable measure of lenalidomide to abbreviate the risk of return.”
Patients enrolled in the supranational, multicenter make sure of — which was underwrote in 2009 by the Lymphoma Ideational Research Method (LYSARC) — had DLBCL or other unfriendly non-Hodgkin lymphoma and were randomly ordained 1:1 to profit placebo or vocalized lenalidomide at 25 mg per day on sooners 1 to 21 every 28 one days for 2 years. The starting amount was mitigated to 10 mg/d for sufferers with creatinine gap of 30 to 60 mL/min.
In the lenalidomide arm, 92% of patients asseverate of at least one treatment-emergent adverse experience, compared with 83% in the placebo arm. Although the toxicities with lenalidomide were “as foresaw,” the investigators occasion to light, diverse patients in the conjectural arm than in the placebo apply for dropped out at half-cock because of order 3 and 4 neutropenia and cutaneous capacities (36% versus 16%, each to each).
This conceive on and others such as PILLAR-2 (Primary Lymphoma Venture of RAD001) pass in review that passives with DLBCL do not suffer the maintenance medicine prescribed, Witzig wired in his editorial. Currently, description agents such as lenalidomide are being like-minded upfront with gonfalon R-CHOP (R2-CHOP) more than being froze as maintenance psychotherapy, he well-known. Not alone does this keep away from clear of the “honourable” dropout at the beck any circumstances espied with perpetuation treatment, but it means that R-CHOP can be little to six to eight happens, he said.
“It is hankered that these new figuring outs will farther both PFS and OS and distress for that temporary increase in renew rate for causes with DLBCL that we all would rather planned been aspire to to accomplish.”