List of the main criteria for HPD definition
HPD definition | Drug | Type of tumor | Patients (N) | HPD (%) | Predictive factors | Reference |
---|---|---|---|---|---|---|
PD RECIST and increase in TGR ≥ 2 | mAb anti PD-1/PD-L1 (phase I) | Various | 131 | 9% | Age ≥ 65 years | [6] |
PD RECIST and ΔTGR > 50% | mAb anti PD-1/PD-L1 | NSCLC | 406 | 13.8% | > 2 metastatic sites | [9] |
PD RECIST & increase in TGR ≥ 2 | CKI and costimulatory molecules | Various | 182 | 7% | Female | [8] |
Increase in TGK ≥ 2 | mAb anti PD-1/PD-L1 | HNSCC | 34 | 29% | Tumor relapse in RT | [12] |
PD RECIST and 3 criteria among: 1) TTF < 2 months; 2) increase ≥ 50% in sum of target diameters; 3) ≥ 2 new lesions in already involved organs; 4) Mets in new organs; 5) PS ECOG ≥ 2 | CKI | NSCLC | 152 | 25.7% | Myeloids cell density and MPO in the tumor & low PD-L1 | [14] |
TTF < 2 months and increase in tumor burden ≥ 50% and increase in pace of growth ≥ 2 | CKI and costimulatory molecules | Various | 155 | 4% | EGFR, MDM2/4, DNMT3A | [10] |
TTF < 2 months and increase ≥ 10 mm in mesurable lesions and increase ≥ 40% of tumor burden or > 20% with apperance of new lesions | CKI | Various | 214 | 15% | [11] | |
TTF < 2 months and TGK ≥ 2 and increase in tumor volume ≥ 50% | CKI | NSCLC | 135 | 13.1% | NLR > 4, LDH > UNL, STK11 | [15] |
PD RECIST and RECIST ≥ 50% and increase in TGR ≥ 2 | CKI | Various | 5 HPD patients | MDM2/4, EGFR | [16] |
PD: progressive disease; PS: performance status; mAb: monoclonal antibody; CKI: cyclin-dependent kinase inhibitors; HNSCC: head and neck squamous cell carcinoma; RT: radiotherapy; MPO: myeloperoxidase; MDM2/4: Mouse double minute 2/4 homolog; DNMT3A: DNA methyltransferase 3 alpha; NLR: neutrophil lymphocyte ratio; LDH: lactate dehydrogenase; UNL: upper normal limit; STK11: Serine/threonine kinase 11
MB, MO and SM contributed conception and writing of the manuscript; GLR, RF and MCG contributed to manuscript revision. All authors read and approved the submitted version.
MCG declares personal financial interests with the following organizations: AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda; she also declares Institutional financial interests with the following organizations: Eli Lilly, MSD, Pfizer (MISP), AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine; at the end, she has received research funding from the following organizations: AIRC, AIFA, Italian Moh, TRANSCAN, outside the submitted work. GLR declares personal fees from Eli Lilly, BMS and AstraZeneca, outside the submitted work. The other authors declare that they have no conflicts of interest.
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© The Authors 2020.