Matches in SemOpenAlex for { <https://semopenalex.org/work/W4283393229> ?p ?o ?g. }
- W4283393229 endingPage "1033" @default.
- W4283393229 startingPage "1032" @default.
- W4283393229 abstract "Background: Optimal consolidation for young R/R FL in the rituximab age remains uncertain and the benefit of ASCT is not clearly established. Aims: The FIL FLAZ12 trial (NCT01827605) is a prospective, multicenter, randomized, phase 3 trial, comparing RIT versus ASCT, as consolidation after chemoimmunotherapy, both followed by R maintenance in R/R FL. Methods: Pts aged 18-65 yrs, with R/R FL after 1 or 2 lines of chemoimmunotherapy, without significant comorbidities were enrolled. Patients received 3 courses of therapy chosen by the investigator among RCHOP, R-DHAP, R-FM, R-ICE, R-IEV or R-B. Pts achieving at least PR (according to Cheson et al. 2007) were randomized 1:1 to either RIT or ASCT before CD34+ collection. Conditioning for ASCT was BEAM or TEAM. RIT was given as previously described (Morschhauser et al., 2008). After consolidation, pts received R maintenance every 3 months for eight courses. Primary endpoint was PFS. Considering ASCT toxicity, it was hypothesized to be a superior choice, if capable of increasing 3-years PFS from 40% to 60% (two-side log-rank test with alpha of 5% and a power of 85%). Clinical secondary endpoints were ORR, CRR, OS, EFS and TTF. Results: Between Aug 2012, and Sep 2019, 164 pts were screened and 159 enrolled by 38 FIL Centers (enrolled population). Unfortunately, the study was prematurely closed due to low accrual. The data were analyzed on an ITT basis on May 2, 2021 with a median follow-up (mFU) from enrollment of 43 months and 75 PFS events. The two arms were clinically well balanced, with median age of 57 yrs (IQR 49- 62), 55% male, 57% stage IV, 20% bulky disease. Tumor re-biopsy was performed in 79% pts. POD-24, retrospectively assessed was observed in 32% of pts. Two pts (1%) did not start treatment (non-confirmed histology and withdrawal). Sixteen (10%) pts discontinued before randomization (7 SD, 3 PD, 3 AE, 1 withdrawal, 2 poor compliance) and 141 (89%) were randomized to either RIT (71) or ASCT (70) (randomized population). Of these 19 (13%) (RIT 8, ASCT 11) did not receive the planned consolidation due to 7 PD, 4 AE, 1 medical decision, 2 poor mobilization, 2 withdrawals, 1 poor compliance, 2 protocol breaches, while 63 (89%) received RIT and 59 (84%) ASCT. After RIT, 61% of pts achieved CR and 23% PR, while after ASCT these were 70% and 9%. Estimated PFS at 3 yrs was 60% (95% CI: 46%-71%) in the RIT arm vs. 59% (95% CI:45%-70%) in the ASCT arm, p = 0.8613 (HR 0.96, 95%CI: 0.57,1.59). (Figure 1) 3yrs-OS was again superimposable in the two arms: 83% (95%CI: 69%-91%) in the RIT vs 85% (95% CI: 72%-91%) in the ASCT, p = 0.8310 (HR 1.10, 95%CI: 0.45,2.72). Grade ≥ 3 hematological toxicity was 46% in the RIT vs 94% in the ASCT arm (p < 0.001). For ASCT vs RIT grade ≥3 neutropenia occurred in 94% vs 41% of pts (p < 0.001). During follow-up, 4 pts died in remission: 1 AML (RIT), 2 SARS- COV2 infections (RIT) and 1 pneumonia (ASCT). Second cancers occurred in 3 pts after RIT and 7 after ASCT (p = 0.480). Multivariable analysis for PFS indicated POD-24, male sex, LDH and refractory disease as adverse parameters. Subgroup analysis for PFS including gender, age, LDH, POD-24 and extranodal disease show no subgroup favoring RIT nor ASCT. Image:Summary/Conclusion: Even if prematurely interrupted, our study demonstrated no meaningful difference in efficacy between ASCT and RIT, but ASCT was more toxic and more demanding for pts and health service. Both strategies induced a similar and favorable long-term outcome suggesting that consolidation programs milder than ASCT require further investigation in R/R FL." @default.
- W4283393229 created "2022-06-25" @default.
- W4283393229 creator A5000403848 @default.
- W4283393229 creator A5001959672 @default.
- W4283393229 creator A5003717779 @default.
- W4283393229 creator A5006314162 @default.
- W4283393229 creator A5006828974 @default.
- W4283393229 creator A5007186664 @default.
- W4283393229 creator A5008077055 @default.
- W4283393229 creator A5008693201 @default.
- W4283393229 creator A5012076369 @default.
- W4283393229 creator A5012645361 @default.
- W4283393229 creator A5016803459 @default.
- W4283393229 creator A5018088213 @default.
- W4283393229 creator A5019034145 @default.
- W4283393229 creator A5019166778 @default.
- W4283393229 creator A5019805208 @default.
- W4283393229 creator A5022006811 @default.
- W4283393229 creator A5022330993 @default.
- W4283393229 creator A5022734562 @default.
- W4283393229 creator A5025882756 @default.
- W4283393229 creator A5028704362 @default.
- W4283393229 creator A5030900118 @default.
- W4283393229 creator A5037844904 @default.
- W4283393229 creator A5041745367 @default.
- W4283393229 creator A5042033969 @default.
- W4283393229 creator A5049017377 @default.
- W4283393229 creator A5051527224 @default.
- W4283393229 creator A5051830191 @default.
- W4283393229 creator A5061081687 @default.
- W4283393229 creator A5062268222 @default.
- W4283393229 creator A5064111633 @default.
- W4283393229 creator A5069410590 @default.
- W4283393229 creator A5070003191 @default.
- W4283393229 creator A5071732201 @default.
- W4283393229 creator A5072683195 @default.
- W4283393229 creator A5072927664 @default.
- W4283393229 creator A5073352185 @default.
- W4283393229 creator A5074069337 @default.
- W4283393229 creator A5076236981 @default.
- W4283393229 creator A5076298933 @default.
- W4283393229 creator A5077431006 @default.
- W4283393229 creator A5078186253 @default.
- W4283393229 creator A5079030265 @default.
- W4283393229 creator A5081247845 @default.
- W4283393229 creator A5082173177 @default.
- W4283393229 creator A5085955672 @default.
- W4283393229 date "2022-06-01" @default.
- W4283393229 modified "2023-09-27" @default.
- W4283393229 title "P1144: RADIOIMMUNOTHERAPY (RIT) VERSUS AUTOLOGOUS HEMATOPOIETIC STEM-CELL TRANSPLANTATION (ASCT) IN RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA: A FONDAZIONE ITALIANA LINFOMI (FIL) PHASE III TRIAL." @default.
- W4283393229 doi "https://doi.org/10.1097/01.hs9.0000847444.51476.b0" @default.
- W4283393229 hasPublicationYear "2022" @default.
- W4283393229 type Work @default.
- W4283393229 citedByCount "0" @default.
- W4283393229 crossrefType "journal-article" @default.
- W4283393229 hasAuthorship W4283393229A5000403848 @default.
- W4283393229 hasAuthorship W4283393229A5001959672 @default.
- W4283393229 hasAuthorship W4283393229A5003717779 @default.
- W4283393229 hasAuthorship W4283393229A5006314162 @default.
- W4283393229 hasAuthorship W4283393229A5006828974 @default.
- W4283393229 hasAuthorship W4283393229A5007186664 @default.
- W4283393229 hasAuthorship W4283393229A5008077055 @default.
- W4283393229 hasAuthorship W4283393229A5008693201 @default.
- W4283393229 hasAuthorship W4283393229A5012076369 @default.
- W4283393229 hasAuthorship W4283393229A5012645361 @default.
- W4283393229 hasAuthorship W4283393229A5016803459 @default.
- W4283393229 hasAuthorship W4283393229A5018088213 @default.
- W4283393229 hasAuthorship W4283393229A5019034145 @default.
- W4283393229 hasAuthorship W4283393229A5019166778 @default.
- W4283393229 hasAuthorship W4283393229A5019805208 @default.
- W4283393229 hasAuthorship W4283393229A5022006811 @default.
- W4283393229 hasAuthorship W4283393229A5022330993 @default.
- W4283393229 hasAuthorship W4283393229A5022734562 @default.
- W4283393229 hasAuthorship W4283393229A5025882756 @default.
- W4283393229 hasAuthorship W4283393229A5028704362 @default.
- W4283393229 hasAuthorship W4283393229A5030900118 @default.
- W4283393229 hasAuthorship W4283393229A5037844904 @default.
- W4283393229 hasAuthorship W4283393229A5041745367 @default.
- W4283393229 hasAuthorship W4283393229A5042033969 @default.
- W4283393229 hasAuthorship W4283393229A5049017377 @default.
- W4283393229 hasAuthorship W4283393229A5051527224 @default.
- W4283393229 hasAuthorship W4283393229A5051830191 @default.
- W4283393229 hasAuthorship W4283393229A5061081687 @default.
- W4283393229 hasAuthorship W4283393229A5062268222 @default.
- W4283393229 hasAuthorship W4283393229A5064111633 @default.
- W4283393229 hasAuthorship W4283393229A5069410590 @default.
- W4283393229 hasAuthorship W4283393229A5070003191 @default.
- W4283393229 hasAuthorship W4283393229A5071732201 @default.
- W4283393229 hasAuthorship W4283393229A5072683195 @default.
- W4283393229 hasAuthorship W4283393229A5072927664 @default.
- W4283393229 hasAuthorship W4283393229A5073352185 @default.
- W4283393229 hasAuthorship W4283393229A5074069337 @default.
- W4283393229 hasAuthorship W4283393229A5076236981 @default.
- W4283393229 hasAuthorship W4283393229A5076298933 @default.
- W4283393229 hasAuthorship W4283393229A5077431006 @default.
- W4283393229 hasAuthorship W4283393229A5078186253 @default.
- W4283393229 hasAuthorship W4283393229A5079030265 @default.
- W4283393229 hasAuthorship W4283393229A5081247845 @default.