Progression-free survival at 2 years post-autologous transplant: a surrogate end point for overall survival in follicular lymphoma.
Ana Jiménez-UbietoCarlos GrandeDolores CaballeroLucrecia YáñezSilvana NovelliMiguel T HernándezMaría ManzanaresReyes ArranzJosé Javier FerreiroSabela BobilloSantiago MercadalAndrea GalegoJavier López JiménezJosé María MoraledaCarlos VallejoCarmen AlboElena PérezCarmen MarreroLaura MagnanoLuis PalomeraIsidro JarqueErika CoriaAntonia RodriguezAlejandro MartínArmando López-GuillermoAntonio SalarJuan José Lahuertanull nullPublished in: Cancer medicine (2017)
Overall survival (OS) is the gold-standard end point for studies evaluating autologous stem cell transplantation (ASCT) in follicular lymphoma (FL), but assessment may be elusive due to the lengthy disease course. We analyzed the validity of two earlier end points, proposed in the setting of first-line chemo-/immunotherapy, as surrogates for OS-progression-free survival (PFS) status at 24 months (PFS24) and complete response at 30 months (CR30) post-ASCT. We also have investigated the clinical features of patients with early progression after ASCT. Data were available for 626 chemosensitive FL patients who received ASCT between 1989 and 2007. Median follow-up was 12.2 years from ASCT. In the PFS24 analysis, 153 (24%) patients progressed within 24 months and 447 were alive and progression-free at 24 months post-ASCT (26 who died without disease progressions within 24 months were excluded). Early progression was associated with shorter OS (hazard ratio [HR], 6.8; P = 0.00001). In the subgroup of patients who received an ASCT in the setting or relapse after being exposed to rituximab, the HR was 11.3 (95% CI, 3.9-30.2; P < 0.00001). In the CR30 analysis, 183 of 596 (31%) response-evaluable patients progressed/died with 30 months post-ASCT. The absence of CR30 was associated with shorter OS (HR, 7.8; P < 0.00001), including in patients with prior rituximab (HR, 8.2). PFS24 and CR30 post-ASCT are associated with poor outcomes and should be primary end points. Further research is needed to identify this population to be offered alternative treatments.
Keyphrases
- free survival
- stem cell transplantation
- end stage renal disease
- newly diagnosed
- ejection fraction
- bone marrow
- peritoneal dialysis
- diffuse large b cell lymphoma
- adipose tissue
- photodynamic therapy
- clinical trial
- metabolic syndrome
- high dose
- type diabetes
- randomized controlled trial
- cell therapy
- mass spectrometry
- electronic health record
- high resolution
- machine learning
- mesenchymal stem cells
- high speed
- locally advanced
- hodgkin lymphoma