Contributions
Abstract: PB1768
Type: Publication Only
Background
Peripheral T-cell lymphomas (PTCL) are a group of rare clinically aggressive heterogeneous diseases associated with a poor prognosis. Standard first-line chemotherapy achieves complete response (CR) rates ranging from 30% to 60% and long-term survival rates of only 15% to 25% at 5 years. Patients with relapsed/refractory (R/R) disease have an even worse prognosis with overall survival (OS) and progression-free survival (PFS) of 5.5 and 3.1 months, respectively. There is no consensus on the management of relapsed disease, primarily because the evidence supporting most treatment approaches is modest at best. Many approaches, deemed ‘standard-of-care,’ are often not well supported by the literature, and broad categorizations are commonly made regarding efficacy and toxicity without attention to differences between studies. Furthermore, treatments that have recently achieved regulatory approval with stringent independent assessment of pathology response are viewed as less established, or inferior to combination therapy.
Aims
In the effort to take a critical and comprehensive evidence-based approach to available standards in R/R PTCL we developed an objective scoring system for all types of studies published in the literature (eg, randomized phase 3, case match control, phase 2, phase 1, case reports and small series) to aid decision-making based on an assessment of all the available data.
Methods
We performed an extensive review on PubMed of the clinical trials published in the literature that included patients with R/R PTCL. We proposed a rigorous scoring system based on a survey from nearly 100 authorities in the field to assess the scientific impact of each study based on the agreed study characteristics, including type of study (ie, randomized phase 3, case match control analysis, phase 2 weighted based on number of PTCL patients [> 100 vs < 100 patients], phase 1 with > 5 or < 5 PTCL patients enrolled, and retrospective) weighted based on percent of PTCL patients included; weighting for inclusion of central pathology or response review; weighting for detailed reporting of study metrics (ORR, CR, DoR, PFS). The scoring system included a penalty of -0.5 each for ORR, DoR, or PFS not being reported and -0.2 for omitting previous lines of therapy. Studies that ranked 0 or below were all grouped under the minimum score of 0. The proposed scoring system was evaluated by a panel of experts belonging to different academic institutions in three different continents, actively involved in T-cell lymphoma clinical research. The scoring system was modified accordingly based on recommendations made by 2 or more of the panel members.
Results
We identified 58 original publications between 2004 and 2018 that involved clinical studies enrolling patients with R/R PTCL. The scoring system spanned from 0 to 9. Interestingly only 12 of the 58 studies had a score above 5; 15 out of 58 studies had a score between 1 and 5; and the remaining publications all scored between 0 to 1.
Conclusion
When compared to standard recommendations reported by various societies, our analysis suggests most practice patterns are based on studies with low priority scores, and underweight more robust clinical experiences. This analysis aims to guide physicians in critically evaluating the published literature when choosing salvage therapy for patients with R/R PTCL.
Session topic: 21. Aggressive Non-Hodgkin lymphoma - Clinical
Keyword(s): Clinical Trial, Peripheral T-cell lymphoma, Relapse, Treatment
Abstract: PB1768
Type: Publication Only
Background
Peripheral T-cell lymphomas (PTCL) are a group of rare clinically aggressive heterogeneous diseases associated with a poor prognosis. Standard first-line chemotherapy achieves complete response (CR) rates ranging from 30% to 60% and long-term survival rates of only 15% to 25% at 5 years. Patients with relapsed/refractory (R/R) disease have an even worse prognosis with overall survival (OS) and progression-free survival (PFS) of 5.5 and 3.1 months, respectively. There is no consensus on the management of relapsed disease, primarily because the evidence supporting most treatment approaches is modest at best. Many approaches, deemed ‘standard-of-care,’ are often not well supported by the literature, and broad categorizations are commonly made regarding efficacy and toxicity without attention to differences between studies. Furthermore, treatments that have recently achieved regulatory approval with stringent independent assessment of pathology response are viewed as less established, or inferior to combination therapy.
Aims
In the effort to take a critical and comprehensive evidence-based approach to available standards in R/R PTCL we developed an objective scoring system for all types of studies published in the literature (eg, randomized phase 3, case match control, phase 2, phase 1, case reports and small series) to aid decision-making based on an assessment of all the available data.
Methods
We performed an extensive review on PubMed of the clinical trials published in the literature that included patients with R/R PTCL. We proposed a rigorous scoring system based on a survey from nearly 100 authorities in the field to assess the scientific impact of each study based on the agreed study characteristics, including type of study (ie, randomized phase 3, case match control analysis, phase 2 weighted based on number of PTCL patients [> 100 vs < 100 patients], phase 1 with > 5 or < 5 PTCL patients enrolled, and retrospective) weighted based on percent of PTCL patients included; weighting for inclusion of central pathology or response review; weighting for detailed reporting of study metrics (ORR, CR, DoR, PFS). The scoring system included a penalty of -0.5 each for ORR, DoR, or PFS not being reported and -0.2 for omitting previous lines of therapy. Studies that ranked 0 or below were all grouped under the minimum score of 0. The proposed scoring system was evaluated by a panel of experts belonging to different academic institutions in three different continents, actively involved in T-cell lymphoma clinical research. The scoring system was modified accordingly based on recommendations made by 2 or more of the panel members.
Results
We identified 58 original publications between 2004 and 2018 that involved clinical studies enrolling patients with R/R PTCL. The scoring system spanned from 0 to 9. Interestingly only 12 of the 58 studies had a score above 5; 15 out of 58 studies had a score between 1 and 5; and the remaining publications all scored between 0 to 1.
Conclusion
When compared to standard recommendations reported by various societies, our analysis suggests most practice patterns are based on studies with low priority scores, and underweight more robust clinical experiences. This analysis aims to guide physicians in critically evaluating the published literature when choosing salvage therapy for patients with R/R PTCL.
Session topic: 21. Aggressive Non-Hodgkin lymphoma - Clinical
Keyword(s): Clinical Trial, Peripheral T-cell lymphoma, Relapse, Treatment