Article Figures & Data
Figures
- Figure 1.
A, Waterfall plot of maximum percent change in tumor size from baseline as measured by irRECIST. B, Time on treatment. C, Longitudinal change in irRECIST percentage from baseline. PD, progressive disease.
- Figure 2.
Genomic profiles and the CMS of colorectal cancer.
Tables
- Table 1.
Baseline characteristics.
Cohort A (MSI-H) Cohort B (MSS) Characteristics (n = 10, %) (n = 40, %) Median age, years (range) 53 (30–77) 63 (25–79) Sex Male 5 (50.0) 17 (42.5) Female 5 (50.0) 23 (57.5) ECOG PS 0 10 (100) 34 (85.0) 1 0 (0) 6 (15.0) Primary site Right-sided colon 10 (100) 27 (67.5) Left-sided colon 0 (0) 13 (32.5) Metastatic organ Liver 2 (20.0) 28 (70.0) Lung 2 (20.0) 29 (72.5) Lymph node 7 (70.0) 17 (42.5) Peritoneum 7 (70.0) 12 (30.0) Number of prior chemotherapy ≤2 6 (60.0) 12 (30.0) ≥3 4 (40.0) 28 (70.0) Prior regimens Fluoropyrimidine 10 (100) 40 (100) Oxaliplatin 10 (100) 40 (100) Irinotecan 10 (100) 40 (100) Angiogenesis inhibitor 9 (90.0) 40 (100) Anti-EGFR inhibitor 2 (20.0) 17 (42.5) Regorafenib 1 (10.0) 17 (42.5) TAS-102 0 (0) 23 (57.5) RAS status Wild-type 5 (50.0) 14 (35.0) Mutant 5 (50.0) 25 (62.5) Unknown 0 (0) 1 (2.5) BRAF V600E status Wild-type 5 (50.0) 28 (70.0) Mutant 2 (20.0) 2 (5.0) Unknown 3 (30.0) 10 (25.0) MSI or MMR status MSI-high or MMR-deficient 10 (100) 0 (0) MSS or MMR-proficient 0 (0) 40 (100) Abbreviation: ECOG, Eastern Cooperative Oncology Group.
- Table 2.
Tumor responses according to irRECIST.
Cohort A (MSI-H) Cohort B (MSS) (n = 10) (n = 40) Best response, n (%) CR 1 (10.0) 0 (0) PR 4 (40.0) 4 (10.0) SD 4 (40.0) 14 (35.0) Disease progression 1 (10.0) 21 (52.5) Not evaluated 0 (0) 1 (2.5) ORR, % (95% CI) 50.0 (18.7–81.3) 10.0 (2.8–23.7) DCR, % (95% CI) 90.0 (55.5–99.7) 45.0 (29.3–61.5) DOR, months, median (95% CI) NR (7.9–NR) 9.0 (1.7–9.0) - Table 3.
Treatment-related adverse events (≥ 10% or any toxicities with grade 3 or higher).
Cohort A (MSI-H) Cohort B (MSS) n = 10 n = 40 Adverse event, n (%) All grades Grade ≥3 All grades Grade ≥3 All events 10 (100) 1 (10) 40 (100) 10 (25) Diarrhea 8 (80) 0 (0) 35 (87.5) 2 (5.0) Decreased appetite 0 (0) 0 (0) 13 (32.5) 3 (7.5) Nausea 4 (40) 0 (0) 11 (27.5) 1 (2.5) Vomiting 1 (10) 0 (0) 7 (17.5) 0 (0) Fever 4 (40) 1 (10) 6 (15.0) 0 (0) Malaise 0 (0) 0 (0) 6 (15.0) 0 (0) Fatigue 0 (0) 0 (0) 5 (12.5) 0 (0) Hypothyroidism 2 (20) 0 (0) 5 (12.5) 0 (0) Rash 2 (20) 0 (0) 3 (7.5) 1 (2.5) Abdominal pain 2 (20) 0 (0) 2 (5.0) 1 (2.5) Anemia 0 (0) 0 (0) 2 (5.0) 1 (2.5) Hypokalemia 0 (0) 0 (0) 2 (5.0) 1 (2.5) Alanine aminotransferase increased 0 (0) 0 (0) 2 (5.0) 0 (0) Infusion-related reaction 1 (10) 0 (0) 1 (2.5) 0 (0) Hearing impaired 0 (0) 0 (0) 1 (2.5) 1 (2.5) Colitis 0 (0) 0 (0) 1 (2.5) 1 (2.5) Serum amylase increased 0 (0) 0 (0) 1 (2.5) 1 (2.5) Alkaline phosphatase increased 0 (0) 0 (0) 1 (2.5) 1 (2.5) Platelet count decreased 1 (10) 0 (0) 0 (0) 0 (0) Cheilitis 1 (10) 0 (0) 0 (0) 0 (0)
Supplementary Data
- Supplementary Data - Supplementary Data
- Supplementary Data - Supplementary Data
- Figure S1 - Figure S1. Consort diagram
- Figure S2 - Figure S2. Computed tomography during the study treatment of the 4 patients with objective response in cohort B
- Figure S3 - Figure S3. (A) Kaplan-Meier plots of progression-free survival in cohort A. (B) Progression-free survival in cohort B. (C) Overall survival in cohort A. (D) Overall survival in cohort B.
November 2020
Volume 26, Issue 22
Volume 26, Issue 22
Multicenter Phase I/II Trial of Napabucasin and Pembrolizumab in Patients with Metastatic Colorectal Cancer (EPOC1503/SCOOP Trial)
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