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Continuous treatment (CT) versus fixed duration of therapy (FDT) in newly diagnosed myeloma patients: PFS1, PFS2, OS endpoints.
J Clin Oncol 32:5s, 2014 (suppl; abstr 8515)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Continuous therapy significantly prolongs remission duration, resistant relapse may reduce the duration of subsequent remission which can negatively impact on OS. PFS1 defines the time from start of therapy to the occurrence of 1st relapse. PFS2 is defined as per EMA as the time from start of therapy to the occurrence of 2nd relapse, incorporating the duration of both 1st and 2nd remission. We evaluated PFS1, PFS2 and OS in newly diagnosed multiple myeloma (NDMM) patients who received CT or FDT. Methods: Patients were enrolled in 2 phase III randomized trials, comparing CT vs FDT (RVMM209: lenalidomide-based induction, consolidation, followed by maintenance [CT] vs lenalidomide-based induction, consolidation, no maintenance [FDT]; GIMEMA0305: bortezomib-based induction followed by maintenance (CT) vs bortezomib-based induction, no maintenance [FDT]). At diagnosis, in all randomized patients, we evaluated PFS1 (time: diagnosis followed by 1st relapse), PFS2 (time: diagnosis followed by 2nd relapse), and OS (time: diagnosis followed by death). In patients who experienced 1st relapse we tested 2nd PFS (time: 1st relapse followed by 2nd relapse) and survival from relapse (time: 1st relapse followed by death). Results: In the pooled analysis, 452 patients received CT and 461 patients received FDT. Median follow-up was 52 months [mo]. CT significantly prolonged PFS1 (median 35 vs 24 mo, HR 0.58; P<0.0001), PFS2 (median 63 vs 47 mo, HR 0.69, p=0.0001) and OS (median not reached [NR] vs 70 mo, HR 0.70, P=0.0019) in comparison with FDT. 2nd PFS and OS from relapse were similar among patients who received CT or FDT upfront. Results were similar in the single studies (Table). Conclusions: In NDMM patients, CT significantly improved PFS1, PFS2, and OS. Prolongation of PFS2 suggests that the clinical benefit observed during 1st remission is not cancelled by a shorter 2nd remission. PFS2 should be included in all CT vs FDT studies to evaluate the risk of tumor-resistance induced by CT. Clinical trial information: NCT01063179 and NCT00551928.
|(Median, mo)||(Median, mo)|
|From 1st relapse|
Abstracts by Antonio Palumbo:
A randomized, double-blind, multinational trial comparing denosumab with zoledronic acid for treatment of bone disease in adults with newly diagnosed multiple myeloma.
Pomalidomide plus low-dose dexamethasone (POM plus LoDEX) versus high-dose dexamethasone (HiDEX) for relapsed or refractory multiple myeloma (RRMM): Overall survival (OS) results of MM-003 after adjustment for crossover.
Presentations by Antonio Palumbo:
A phase III trial of melphalan/prednisone/lenalidomide (MPR) versus melphalan (200 mg/m2) and autologous transplantation (MEL200) in newly diagnosed myeloma patients.Session: Myeloma (Oral Abstract Session)
Bortezomib, melphalan, prednisone, and thalidomide (VMPT) followed by maintenance with bortezomib and thalidomide (VT) for initial treatment of elderly multiple myeloma patients.Session: Myeloma (Oral Abstract Session)