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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

5162 - Refining criteria of Hyperprogression (HPD) with Immune Checkpoint Inhibitors (ICIs) to improve clinical applicability.

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Ignacio Matos Garcia

Citation

Annals of Oncology (2018) 29 (suppl_8): viii649-viii669. 10.1093/annonc/mdy303

Authors

I. Matos Garcia1, A. García Ruiz2, J. Martin-Liberal3, C. Hierro3, M. Ochoa De Olza Amat4, C. Viaplana5, G. Mur3, M. Vieito Villar1, I. Brana6, A. Azaro7, C. Perez1, V. Rodriguez Freixinos4, G. Argiles8, M. Oliveira4, E. Felip9, E. Muñoz-Couselo10, J. Tabernero4, R. Dienstmann11, E. Garralda12

Author affiliations

  • 1 Medical Oncology, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
  • 2 Radiomics Group, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
  • 3 Oncology, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
  • 4 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 5 Oncology Data Science (odyssey) Group, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 6 Department Of Medical Oncology, Vall D’Hebron Institute of Oncology, Barcelona/ES
  • 7 Oncology Department, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 8 Gastrointestinal And Endocrine Tumors Group, Vall d'Hebron Institute of Oncology, VHIO, Barcelona/ES
  • 9 Medical Oncology Service (lung Cancer Unit)  , Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 10 Medical Oncology, Vall d’Hebron Hospital, Barcelona/ES
  • 11 Oncology Data Science, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 12 Early Drug Development Unit, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
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Resources

Abstract 5162

Background

Rapid progression while on ICIs has been clinically described as HPD, however there is still not a consensus definition for this phenomenon. Institute Gustave Roussy (IGR) firstly described HPD as ≥ two-fold increase in tumor growth rate (TGR) during experimental period (EXP) vs. Reference period (REF). We recently described VHIO HPD using EXP only, as the following: PD at first restaging with ≥40% increase in sum of target lesions or ≥ 20% with appearance of multiple new lesions, with minimum absolute increase in measurable lesions of 10 mm (Matos I. et al. ASCO 2018).

Methods

Patients (pts) treated with ICIs in Ph1 trials at VHIO were analysed (n = 214). Our aim was to assess overall survival (OS) in pts who achieved PD as best response, evaluate HPD according to IGR or VHIO criteria and investigate discordances between both definitions.

Results

From Jan’12 to Oct’17, 214 pts were treated with ICIs (53% in combinations). Best response was PD in 47% pts (n = 101). Only 50 pts were evaluable for the primary endpoint (20 had PD before the first evaluation and 31 had no REF CT-scan). Using IGR criteria, median OS was 4.5 m (95% CI: 3.6-5.3) in HPD group (n = 15) versus 6.3 m (95% CI 1.7-10.9) in non-HPD group (HR = 1.85; 0.86-3.9; p = 0.11). Using VHIO criteria, median OS was 3.6 m (0.8-6.3) in HPD group (n = 21) versus 8.7 m (4.2-13.2) in non-HPD group (HR = 2.33; 1.10-4.95; p = 0.02). Overall concordance rate between the two criteria was 56% (p = 0.45). Most discordances were HPD by VHIO and non-HPD by IGR (28%). Baseline target lesion summatory in EXP was not different in pts with HPD by IGR or VHIO (p > 0.1). Importantly, pts with HPD by IGR had significantly lower TGR-REF (p < 0.001). Using VHIO criteria, we found no difference in TGR-REF between HPD vs non-HPD (p = 0.15). However, higher TGR-EXP was found in pts with HPD using VHIO criteria (p < 0.001).

Conclusions

We were able to validate IGR HPD criteria in our cohort, despite substantial loss in evaluable pts due to missing REF CT scans. No concordance was observed between IGR and VHIO HPD definitions. VHIO HPD criteria is strongly prognostic, easy-to-use in the clinic (EXP only) and biologically sound (not affected by small TGR during previous therapy and linked to high TGR during ICI exposure).

Clinical trial identification

Legal entity responsible for the study

Vall d'Hebron Institute Oncology.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

J. Tabernero: Advisory role: Bayer, Boehringer Ingelheim, Genentech/Roche, Lilly, MSD, Merck Serono, Merrimack, Novartis, Peptomyc, Roche Sanofi, Symphogen, Taiho. E. Garralda: Advisory boards: Roche, NeoMed Therapeutics, Ellypses Pharma. All other authors have declared no conflicts of interest.

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