Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma

Study Overview
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Brief Summary
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Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known. In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.

Official Title
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Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initial diagnosis of classical HL Optional histopathology confirmation of relapse/refractory HL, (2) age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2 Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study, Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study. Exclusion Criteria: - radiotherapy in the treatment after anti-PD1

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 Sequential strategy<br>Patients for whom anti-PD-1 therapy was stopped with the introduction of a new treatment line (19 patients, 63%). | Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy<br>* Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).<br>|
| Group 2 Concomitant strategy<br>Patients for whom a combination of CT with anti-PD-1 therapy was initiated (11 patients, 37 %). | Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy<br>* Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate after re-exposure to chemotherapy | Patient evaluation was timed by treating physicians according to the policy of each center, and all patients were evaluated after a median of 10 weeks (min 7 weeks, max 12 weeks) with PET/CT using Lugano criteria | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best response obtained (Group 1) | the best response obtained with CT after anti-PD-1 | 10 weeks | 
| Best response obtained (Group 2) | the best response obtained with CT after the combination anti-PD-1 and CT | 10 weeks | 
| The toxicities experienced during CT or anti-PD-1 plus CT combination | The toxicities were graded retrospectively according to the National Cancer Institute Common Toxicity Criteria for AEs (version 4.0). | 10 weeks | 
| Outcomes including PFS | PFS was defined as the time from first relapse, or progression, to the next event (defined as either second relapse/progression, change of therapy, or death from any cause) | up to 12 months | 
| Outcomes including overall survival (OS). | OS was defined as the time from first relapse, or progression, to death from any cause. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, chemotherapy, anti-PD1, re-sensibilization