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Capturing Hyperprogressive Disease with Immune-Checkpoint Inhibitors Using RECIST 1.1 Criteria
Ignacio Matos1,2, Juan Martin-Liberal3, Alonso García-Ruiz4
1Department of Medical Oncology, Vall d'Hebron University Hospital. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. egarralda@vhio.net imatos@vhio.net.
Summary
Hyperprogression disease (HPD) impacts survival in patients treated with immune-checkpoint inhibitors (ICIs) when assessed by RECIST criteria, but not by tumor growth rate (TGR). A novel RECIST-based HPD definition is proposed for clinical use.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trial Design
Background:
- Hyperprogression disease (HPD) is a challenging phenomenon in cancer treatment, with definitions primarily based on tumor growth rate (TGR) lacking consensus.
- Accurate assessment of HPD is crucial for understanding treatment outcomes, particularly with novel immunotherapies and targeted agents.
Purpose of the Study:
- To develop and evaluate a Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-based definition for hyperprogression disease (HPD).
- To compare the incidence and impact on overall survival (OS) of HPD using both RECIST and TGR criteria in patients receiving immune-checkpoint inhibitors (ICIs) or targeted agents (TAs).
Main Methods:
- Two independent cohorts of advanced solid tumor patients from phase I trials were analyzed: one treated with PD-1/PD-L1 inhibitors (ICIs) and another with targeted agents (TAs).
- A RECIST 1.1-based definition for HPD was established, and HPD rates were assessed using both RECIST and TGR criteria.
- The primary endpoint was the impact on overall survival (OS) for patients classified as HPD versus non-HPD progressors.
Main Results:
- Among 270 patients treated with ICIs, 10.7% met the RECIST definition of HPD, exhibiting significantly lower OS compared to non-HPD progressors (P=0.04).
- Using TGR criteria in 221 patients, 6.3% were classified as HPD, but this did not significantly impact OS.
- In 239 patients treated with TAs, HPD rates were 10.9% by RECIST and 6% by TGR, with no significant OS differences observed between HPD and non-HPD groups.
Conclusions:
- Hyperprogression disease (HPD) occurs in patients treated with both ICIs and TAs, but its impact on survival was only evident in the ICI cohort when assessed by RECIST criteria.
- The study proposes a novel, intuitive RECIST-based definition for HPD, suitable for daily clinical practice.
- This RECIST-based approach offers a more consistent and clinically relevant method for evaluating HPD and its prognostic implications.
