Table 1.

Characteristics of participants and biopsies studied

Duodenal polyp burdenDrug exposureEndoscopic tissues for mRNA analysis
Patient numberGermline APC mutationSample numberSexAgeArmBase sum diamEndpoint sum diamChangeAvg daily dose erlotinib (mg)Adverse eventsBaseline uninvolvedEndpoint uninvolvedEndpoint polyp(s) size (in mm)Tumor purity
1c.3927_3931del5008Female41Drug9532−66%47Mucositis (1)YesYes4a0.67
2c.1660C>T017Male45Drug5626−54%58Rash (1)YesYes4a; 5; 6; 60.52; 0.79; 0.80; 0.85
3c.426_427delAT028Male55Drug225−77%70Rash (1)YesYes20.56
4c.1690C>T027Female40Drug8531−64%46Rash (1)YesYes3a,b0.46
5c.426_427delAT055Male53Drug134−69%27Mucositis (1); rash (1)YesYes2b0.47
6clinical dx073Female47Drug4223−45%45Rash (1)YesYes3a0.51
7c.426_427delAT155Female58Drug6323−63%49Mucositis (1); rash (1)NoYes3a0.7
8del promoter 1B173Female44Drug4928−43%21Rash (1)YesYes3a0.54
9del promoter 1B176Male28Drug134−69%21Mucositis (2); rash (2)YesYes20.57
10c.4612_4613delGA005Male56Drug7007000%c75Mucositis (2); rash (1)YesYes6; 6; 6; 60.76; 0.78; 0.67; 0.70
11c.531+2_531+3insT021Male52Placebo61163167%NAYesYes8; 60.68; 0.71
12c.2093T>G024Male46Placebo1225108%NARash (1)YesYes20.67
13c.2093T>G031Female56Placebo2251132%NAMucositis (1)YesYes4b; 4a0.49; 0.65
14del exon 11-18072Female50Placebo558351%NAYesYes3a0.54
15c.694C>T080Female37Placebo2061205%NAYesYes2b0.44
16c.904C>T095Male59Placebo10718573%NAYesYes4b; 4a0.49; 0.64
17del promoter 1B150Male54Placebo11218162%NANoYes4a; 40.63; 0.58
18c.4612_4613delGA151Female38Placebo3898158%NANoYes3a0.55
19c.531+2_531+3insT175Male19Placebo122175%NAYesYes4a0.8
20c.3927_3931del5013Female58Placebo9813538%NAYesYes8, 6, 40.66; 0.72; 0.75
  • NOTE: The “sum diam” refers to the sum of the diameter of all polyps endoscopically identified as described previously (17).

  • aIndicates 3 to 4 mm polyp used in Human Inflammation and Immunity Transcriptome panel (6 drug; 6 placebo).

  • bIndicates polyp excluded for differential expression analysis (<50% tumor purity; 2 drug; 3 placebo).

  • cPatient 10 was on drug and had no change in sum diameter but a reduction in volume due to a change in polyp height.