Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

5751 - Prospective validation of prognostic scores to improve patient selection for immuno-oncology trials


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Clinical Research

Tumour Site


Christophe Massard


Annals of Oncology (2018) 29 (suppl_8): viii133-viii148. 10.1093/annonc/mdy279


C. Massard1, N.H. Segal2, D.C. Cho3, V.A. Papadimitrakopoulou4, N.A. Rizvi5, B.C. Cho6, L. Yu7, H. Yang7, H. Hsieh7, J. Zhang7, W. Zhao7, G. Gao7, X. Guo7, S. Abdullah8, J. Englert8, J. Soria8, M. Dar8, L. Roskos9, C. Ferte8, S.J. Antonia10

Author affiliations

  • 1 Drug Development Department, Institut Gustave Roussy Cancer Campus, 94805 - Villejuif/FR
  • 2 Gastrointestinal Oncology Service, Department Of Medicine, Memorial Sloan Kettering Cancer Center, NY 10065 - New York/US
  • 3 Department Of Medicine, New York University School of Medicine, New York/US
  • 4 Department Of Thoracic Head And Neck Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 5 Thoracic Oncology, Memorial Sloan Kettering Cancer Center and Columbia University Medical Center, 10032 - New York/US
  • 6 Medical Oncology, Yonsei University College of Medicine, 6273 - Seoul/KR
  • 7 Biostatistics, MedImmune, Gaithersburg/US
  • 8 Medical Oncology, MedImmune, MD 20878 - Gaithersburg/US
  • 9 Clinical Pharmacology & Dmpk, MedImmune, Gaithersburg/US
  • 10 Thoracic Oncology, Moffitt Cancer Center, 33612 - Tampa/US

Abstract 5751


Life expectancy estimation is critical to select patients in clinical trials, notably in the phase I setting. However, most protocols use subjective criteria to meet this goal. Several scores have been developed from retrospective studies, but their utility in the immuno-oncology (IO) context remains unknown. The recent recognition of fast progressors under IO treatment further underscores the need for more objective prediction.


NSCLC and UBC patients (n = 972) prospectively enrolled in 3 phase I trials investigating durvalumab (anti-PDL1) ± tremelimumab (anti-CTLA4) across 160 centers were analyzed. We assessed the variability in the 8- and 12-week life expectancy rate across centers. Clinicopathological variables were used to train (n = 648) and validate (n = 324) a tool (FastProgIO) predicting 12-week life expectancy using a multivariate regression method. We compared FastProgIO to existing published scores (RMH, GRIM, LIPI). The performance was assessed by time dependent true positive rate (TPR) and false positive rate (FPR).


Substantial variability was observed across sites with 26% and 65% of centers having enrolled > 15% of patients with life expectancy < = 8 and 12 weeks, respectively. FastProgIO includes neutrophils, AST, alkaline phosphatase and hemoglobin as the predictive markers. Overall, the TPR of FastProgIO was superior across a 4 to 12 weeks range to RMH, GRIM and LIPI. At 12 weeks, the TPR for FastProgIO was 73%, (90% CI: 67-80%) versus 69%, 65% and 41% for RMH, GRIM and LIPI, respectively. Furthermore, the FPR of FastProgIO (11%, 90%CI: 9.3-13%) was comparable to LIPI (10%), but better controlled than RMH and GRIM (20%, 17%).


The use of subjective criteria to estimate the 12-week life expectancy of patients enrolled in IO trials is clearly suboptimal and can lead to ethical, scientific, medical, and public health conundrums. In this large cohort of patients, FastProgIO appears superior to RMH, GRIM and LIPI to define life expectancy of patients based on easily available baseline clinical characteristics, and can be used to better select patients for IO clinical trials. An extended validation of this model in other tumor types is ongoing and will be presented.

Clinical trial identification

Study 006: NCT02000947 December 4, 2013 Study 1108: NCT01693562 September 26, 2012 Study 10: NCT02261220 October 10, 2014.

Legal entity responsible for the study




Editorial Acknowledgement


C. Massard: Advisory board member: Amgen, Astellas, AstraZeneca, Bayer, Celgene, Genentech, Ipsen, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, and Orion. N.H. Segal: Honoraria: MedImmune; Consulting or advisory role: Bristol-Myers Squibb, Pfizer, AstraZeneca, MedImmune, MacroGenics, Imugene, Roche, Genentech, Kyocera, Amgen, Calithera Biosciences; Research funding: MedImmune, Bristol-Myers Squibb, Pfizer, Roche, Genentech, Merck. D.C. Cho: Consultant or advisory board member: Pfizer, BMS, Genentech. Exelixis, Prometheus. V.A. Papadimitrakopoulou: Grant research support and consultancy or advisory board member role: AstraZeneca. N.A. Rizvi: Honoraria or consultants fees: Roche, AstraZeneca, Novartis, Merck, Pfizer, Lilly, and BMS; Equity ownership: Gritstone Oncology and Armo Biosciences. B.C. Cho: Research grant support: Novartis, AstraZeneca, Yuhan, Ono/BMS, MSD, and Bayer; Consultancy or advisory board member: AstraZeneca, Roche, Boehringer Ingelheim, Yuhan, BMS, MSD, and Novartis; Speaker's bureau: AstraZeneca, BMS, MSD, and Novartis; Honorarium: AstraZeneca, Roche, Boehringer Ingelheim, Yuhan, BMS, MSD, and Novartis. L. Yu H. Yang: Employment: MedImmune; Equity ownership: AstraZeneca. H-J. Hsieh: Employment: Genentech, AstraZeneca, and MedImmune; Equity ownership: Genentech. J. Zhang, W. Zhao, G. Gao, X. Guo, S. Abdullah, J. Englert, M. Dar, L. Roskos: Employment: MedImmune and AstraZeneca; Equity ownership: AstraZeneca. J-C. Soria: Employment: MedImmune and AstraZeneca; Equity ownership: AstraZeneca. C. Ferte: Employment: MedImmune and Astrazeneca; Honoraria: Roche, MSD, Merck, and BMS; Consultancy or advisory role: Roche, MSD, Merck, Amgen, and BMS; Travel expenses: BMS, MSD, Merck, Amgen. S.J. Antonia: Research grant support: Novartis; Consultancy or advisory role: BMS, Novartis, Merck; Honoraria: BMS, Novartis, Merck, CBMG, Boehringer Ingelheim, AstraZeneca, MedImmune, Memgen.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.