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

Completed

Interventions: Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 1 Sequential strategy	Evaluate the improvement in response from the end of anti-PD-1 monotherapy	Patients for whom anti-PD-1 therapy was stopped with the introduction of a new treatment line (19 patients, 63%).
Group 2 Concomitant strategy	Evaluate the improvement in response from the end of anti-PD-1 monotherapy	Patients for whom a combination of CT with anti-PD-1 therapy was initiated (11 patients, 37 %).

Primary Outcome Measures

Name	Time	Method
Overall response rate after re-exposure to chemotherapy	10 weeks	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

Secondary Outcome Measures

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

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