Contributions
Abstract: PB1575
Type: Publication Only
Session title: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical
Background
Follicular lymphoma (FL) is a highly heterogeneous entity with variable clinical outcomes. In some patients, the disease follows an indolent course with durable remissions after treatment, while in others transformation or aggressive and chemotherapy-resistant disease develops (Tan et al., Blood 2013). Especially early relapse within 2 years (POD24) identifies a poor-prognosis group of patients with an unmet medical need (Casulo et al., J Clin Oncol 2015). Current knowledge is insufficient to identify patients with high-risk disease, nor to guide treatment decisions.
Aims
In this study we aim to define the prognosis of refractory/relapsed FL after second line therapy, to report current treatment strategies, and to provide rationale for the design of novel treatments strategies. In addition, the project provides ground for an international network of young lymphoma researchers and promotes multicentric collaborations. We here present preliminary data on patient and disease characteristics at diagnosis and at relapse.
Methods
We initiated an international, prospective, observational registry to study the clinical course of relapsed/ refractory (R/R) FL (NCT04587388). Patients with histologically confirmed FL are registered in the study at the time of the first event after first-line treatment, documented by biopsy, imaging, or clinical evaluation. Primary and secondary outcome measures are: (1) rate of progression of disease within 24 months from start of second line treatment (second POD24), (2) overall survival (OS), (3) progression-free survival after second line therapy (second PFS), and (4) complete response rate at 30 months (CR30) from start of second line treatment (second CR30). The study was approved by the Ethics Committee of all participating centers.
Results
The project was initiated in the Netherlands in 2019, and as of December 2020 46 consecutive R/R FL patients have been included at 11 sites in 6 countries. On 42 patients with available data, one third experienced relapse and one third progression of previously stable/responding disease, while 13 events occurred during treatment (either induction or maintenance therapy). The median time between initial diagnosis and relapse/ progression was 34 months (range 1-245; n = 38); relapse/ progression occurred within 24 months (POD24) in 12 patients. Details on patients and disease characteristics are summarized in Table 1. Although the number of patients does not allow correlative analysis, various findings stand out, a.o.: (1) the variable use of the FDG-PET scan, especially at initial diagnosis (60%); (2) the differences in choice of chemo-immunotherapy regimen; and (3) more strikingly the variance in application of maintenance therapy after first-line treatment (yes: 51%).
Conclusion
This is the first report on proceedings of the LUPIAE FL registry. Data on the first set of included patients confirm variability in diagnostic and therapeutic approaches in centers across Europe. We aim to further extend our registry (to 500 patients) to allow characterization of the clinical course of R/R FL. The ultimate goal is to understand the optimal management of patients with POD24 and use these data as a rationale for the design of an interventional trial for this group of patients. Ancillary biological studies will be planned depending on samples availability and enrolment.
Furthermore, this project has already shown the feasibility of a collaboration between junior hematologists across Europe, which will be the base for future initiatives. All hematologists (also from outside of Europe) are invited to join the project.
Keyword(s): Follicular lymphoma, Relapsed lymphoma
Abstract: PB1575
Type: Publication Only
Session title: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical
Background
Follicular lymphoma (FL) is a highly heterogeneous entity with variable clinical outcomes. In some patients, the disease follows an indolent course with durable remissions after treatment, while in others transformation or aggressive and chemotherapy-resistant disease develops (Tan et al., Blood 2013). Especially early relapse within 2 years (POD24) identifies a poor-prognosis group of patients with an unmet medical need (Casulo et al., J Clin Oncol 2015). Current knowledge is insufficient to identify patients with high-risk disease, nor to guide treatment decisions.
Aims
In this study we aim to define the prognosis of refractory/relapsed FL after second line therapy, to report current treatment strategies, and to provide rationale for the design of novel treatments strategies. In addition, the project provides ground for an international network of young lymphoma researchers and promotes multicentric collaborations. We here present preliminary data on patient and disease characteristics at diagnosis and at relapse.
Methods
We initiated an international, prospective, observational registry to study the clinical course of relapsed/ refractory (R/R) FL (NCT04587388). Patients with histologically confirmed FL are registered in the study at the time of the first event after first-line treatment, documented by biopsy, imaging, or clinical evaluation. Primary and secondary outcome measures are: (1) rate of progression of disease within 24 months from start of second line treatment (second POD24), (2) overall survival (OS), (3) progression-free survival after second line therapy (second PFS), and (4) complete response rate at 30 months (CR30) from start of second line treatment (second CR30). The study was approved by the Ethics Committee of all participating centers.
Results
The project was initiated in the Netherlands in 2019, and as of December 2020 46 consecutive R/R FL patients have been included at 11 sites in 6 countries. On 42 patients with available data, one third experienced relapse and one third progression of previously stable/responding disease, while 13 events occurred during treatment (either induction or maintenance therapy). The median time between initial diagnosis and relapse/ progression was 34 months (range 1-245; n = 38); relapse/ progression occurred within 24 months (POD24) in 12 patients. Details on patients and disease characteristics are summarized in Table 1. Although the number of patients does not allow correlative analysis, various findings stand out, a.o.: (1) the variable use of the FDG-PET scan, especially at initial diagnosis (60%); (2) the differences in choice of chemo-immunotherapy regimen; and (3) more strikingly the variance in application of maintenance therapy after first-line treatment (yes: 51%).
Conclusion
This is the first report on proceedings of the LUPIAE FL registry. Data on the first set of included patients confirm variability in diagnostic and therapeutic approaches in centers across Europe. We aim to further extend our registry (to 500 patients) to allow characterization of the clinical course of R/R FL. The ultimate goal is to understand the optimal management of patients with POD24 and use these data as a rationale for the design of an interventional trial for this group of patients. Ancillary biological studies will be planned depending on samples availability and enrolment.
Furthermore, this project has already shown the feasibility of a collaboration between junior hematologists across Europe, which will be the base for future initiatives. All hematologists (also from outside of Europe) are invited to join the project.
Keyword(s): Follicular lymphoma, Relapsed lymphoma