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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

5202 - Real world incidence, severity and timing of adverse events (AEs) among patients with metastatic non-small cell lung cancer (NSCLC) receiving second-line (2L) immuno-oncology (IO) therapy vs chemotherapy (C)


20 Oct 2018


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


Management of Systemic Therapy Toxicities;  Cytotoxic Therapy;  Immunotherapy;  Supportive Care and Symptom Management

Tumour Site


Martin Gutierrez


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


M.E. Gutierrez1, A.D. Norden2, D.C. Lane3, B.F. Canavan4, E.D. Nwokeji3, Y. Xu5, S. Kaur2, S.L. Goldberg2, L. Noh2, L. Siegartel3, J. Whittington6, K. Tuell7, B. Korytowsky3

Author affiliations

  • 1 Medical Oncology, The John Theurer Cancer Center, 7601 - Hackensack/US
  • 2 Cota, Inc, 10004 - New York/US
  • 3 Us Hoer Oncology, Bristol-Myers Squibb, 08648 - Lawrenceville/US
  • 4 Medical Oncology, Regional Cancer Care Associates, 08820 - Edison/US
  • 5 Us Hoer Strategy, Bristol-Myers Squibb, 08648 - Lawrenceville/US
  • 6 Us Pharmaceuticals, Medical Oncology, Bristol-Myers Squibb, 08648 - Lawrenceville/US
  • 7 Us Hoer Emerging Health Sectors, Bristol-Myers Squibb, 08648 - Lawrenceville/US

Abstract 5202


Randomized clinical trials (RCTs) in metastatic NSCLC have demonstrated superior responses and lower rates of AEs with 2L IO compared with 2L C. Real-world data (RWD) are lacking to confirm tolerability of IO reported in the controlled environment of RCTs. This study examines RWD on AEs among patients (pts) with metastatic NSCLC receiving either 2L IO or C.


Cota database electronic health records (EHR) of 55 oncologists at 13 US centers (2 academic; 11 community) were reviewed to identify pts with stage IV NSCLC who received 2L therapy following prior first-line C (March 2015 - December 2017). EHR documented AEs were graded per CTCAE v4 criteria by trained oncology nurses.


Of 206 pts identified, 152 received 2L IO and 54 2L C. No differences were noted between cohorts in age (median [years]; IO: 70; C: 65; p = 0.21), sex (IO: 55% male, C: 41%; p = 0.08), or age-adjusted Charlson comorbidity index (IO: 4; C: 4; p = 0.92); more IO pts had squamous cell histology (IO: 23%; C: 9%; p = 0.03). Median duration of 2L therapy [mo (range)] was 2.3 (0-19.1) with IO and 1.7 (0-21.6) with C. AEs of grade 3-4 or any grade resulting in treatment change or discontinuation occurred in 39 (19%) pts; less frequently with IO (13%) vs C (35%; p < 0.01); with 87% of AEs occurring by 3 mo. Cumulative % of pts experiencing AEs by 1, 2, 3, and 4 mo of treatment was significantly lower (p < 0.05) at all time-points with IO vs. C (5.3, 8.6, 10.5, 10.5 vs. 25.9, 25.9, 33.3, 35.2, respectively). Unadjusted survival data were similar.Table: 1229P

Frequency of adverse events during initial 3 months of treatment

IO Cohort (n = 152)C Cohort (n = 54)p-value Grades 3-4
Adverse EventsGrade 2 with treatment discontinuedGrade 3-4Grade 2 with treatment discontinuedGrade 3-4
Blood and Lymphatic
--Anemia1 (0.7%)4 (2.6%)5 (9.3%)5 (9.3%)0.05
--Neutropenia0 (0%)0 (0%)1 (1.8%)3 (5.6%)0.02
Thrombocytopenia0 (0%)0 (0%)2 (3.7%)2 (3.7%)0.07
Cardiac disorders0 (0%)0 (0%)0 (0%)1 (1.8%)0.26
Endocrine1 (0.7%)0 (0%)0 (0%)0 (0%)1.00
Gastrointestinal0 (0%)1 (0.7%)3 (5.6%)0 (0%)1.00
Infectious0 (0%)0 (0%)0 (0%)1 (1.8%)0.26
Metabolism0 (0%)1 (0.7%)3 (5.6%)0 (0%)1.00
Musculoskeletal1 (0.7%)1 (0.7%)0 (0%)2 (3.7%)0.17
Other1 (0.7%)3 (2.0%)2 (3.7%)3 (5.6%)0.19
Neurologic1 (0.7%)1 (0.7%)2 (3.7%)1 (1.8%)0.46
Respiratory2 (1.3%)2 (1.3%)1 (1.8%)1 (1.8%)1.00
Vascular0 (0%)0 (0%)0 (0%)3 (5.6%)0.02


This retrospective study of RWD shows 2L therapy with IO, compared with C, is associated with a lower frequency of AEs of grade 3-4 or any grade leading to treatment discontinuation, over 1 to 4 months of therapy. A limitation is that spontaneous reporting of AEs in RWD likely captures fewer AEs compared with RCTs.

Clinical trial identification

Legal entity responsible for the study



Bristol Myers Squibb.

Editorial Acknowledgement


M.E. Gutierrez: Personal fees: Bristol-Myers Squibb, Merck, Eli Lilly, Guardant 360, Esanex, Foundation Medicine, AstraZeneca. A.D. Norden, S. Kaur, L. Noh: Employee: Cota. D.C. Lane, L. Siegartel, B. Korytowsky: Employee, Stock ownership: BMS. E.D. Nwokeji, Y. Xu, J. Whittington, K. Tuell: Employee: BMS. S.L. Goldberg: Employee, Stock ownership: Cota. All other authors have declared no conflicts of interest.

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