52 CHAPTER 2 Extended Data Table 5. Adverse events in the MSI cohort (continued) A. Adverse event Grade 3 Grade 4 Grade 5 Gastric hemorrhage 1 GGT ↑ 2 1 Hypertension 3 Hypoalbuminemia 1 Hypotension 1 Nausea 3 Serum amylase ↑ 1 Urinary tract obstruction 1 Vomiting 1 B. Any adverse event Grade ≥3 Grade ≥4 Grade ≥5 n 14 2 2 % (95% CI) 46.7% (28.3 – 65.7%) 6.7% (0.8 – 22.1%) 6.7% (0.8 – 22.1%) Extended Data Table 6. Treatment with pembrolizumab in the cohort of patients with MSS colorectal cancer with a high mutational load (between 140 and 290) Overview of baseline characteristics and clinical benefit in ten patients who were treated within the cohort ‘pembrolizumab for patients with colorectal cancer with a high mutational load (between 140 and 290)’. Clinical benefit is defined as complete or partial response or absence of disease progression at ≥16 weeks. The reasons for early withdrawal from the study (other than progressive disease) included death (n = 1 patient) or adverse event (n = 1 patient), and were classified as having no clinical benefit. n = 10 Gender Male 9 90% Female 1 10% Age (approximately at consent) Median (range) 65 (59 –71) WHO Performance Status WHO 0 4 40% WHO 1 6 60% Number of prior systemic therapies Median (range) 4 (2 – 10) Mutational load Median (range) 189 (149 – 215) Clinical Benefit Yes 0 0% No 10 100%
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