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Table 1 Baseline and clinical characters characteristics of gastric or GEJ cancer patients receiving ramucirumab

From: Ramucirumab for the treatment of patients with gastric or gastroesophageal junction cancer in community oncology practices

Analysis variable Total study cohort (N = 505) Monotherapy subgroup (n = 115) Combination therapy subgroup (n = 390) P value
Monotherapy use at index, n (%) 115 (22.77%)    
Combination therapy use at index, n (%) 390 (77.23%)    
Age at index (years)     0.0006d
 Mean (SD) 64.41 (11.42) 67.74 (11.63) 63.42 (11.19)  
 Median (IQR) 65.06 (57.39,72.31) 67.50 (60.42,75.81) 64.11 (56.97,70.95)  
Gender, n (%)     0.7486e
 Female 126 (24.95%) 30 (26.09%) 96 (24.62%)  
 Male 379 (75.05%) 85 (73.91%) 294 (75.39%)  
Race, n (%)     0.9558e
 Black 32 (6.34%) 8 (6.96%) 24 (6.15%)  
 White 407 (80.59%) 93 (80.87%) 314 (80.51%)  
 Other 25 (4.95%) 6 (5.22%) 19 (4.87%)  
 Not documented 41 (8.12%) 8 (6.96%) 33 (8.46%)  
Ethnicity, n (%)     0.2817e
 Hispanic or Latino 75 (14.85%) 13 (11.30%) 62 (15.90%)  
 Not Hispanic or Latino 392 (77.62%) 90 (78.26%) 302 (77.44%)  
 Not documented 38 (7.53%) 12 (10.44%) 26 (6.67%)  
Geographic region, n (%)     0.0037e
 Midwest 64 (12.67%) 19 (16.52%) 45 (11.54%)  
 Northeast 19 (3.76%) 7 (6.09%) 12 (3.08%)  
 South 289 (57.23%) 49 (42.61%) 240 (61.54%)  
 West 133 (26.34%) 40 (34.78%) 93 (23.85%)  
Payer information, n (%)     0.0220c
 Medicaid 22 (4.36%) 3 (2.61%) 19 (4.87%)  
 Medicare 197 (39.01%) 54 (46.96%) 143 (36.67%)  
 Private 174 (34.46%) 30 (26.09%) 144 (36.92%)  
 Other 18 (3.56%) 1 (0.87%) 17 (4.36%)  
 Not documented 94 (18.61%) 27 (23.48%) 67 (17.18%)  
Physician specialty, n (%)     0.7943c
 Hematology and medical oncology 450 (89.11%) 104 (90.44%) 346 (88.72%)  
 Internal medicine 1 (0.20%) 0 (0.00%) 1 (0.26%)  
 Not documented 54 (10.69%) 11 (9.57%) 43 (11.03%)  
Physician patient volume, n (%)     0.0205c
 < 100 patients/year 374 (74.06%) 96 (83.48%) 278 (71.28%)  
 100–199 patients/year 121 (23.96%) 17 (14.78%) 104 (26.67%)  
 200 + patients/year 10 (1.98%) 2 (1.74%) 8 (2.05%)  
BMI category at baseline, n (%)     0.6063c
 Normal 216 (42.77%) 53 (46.09%) 163 (41.80%)  
 Obese 95 (18.81%) 18 (15.65%) 77 (19.74%)  
 Overweight 114 (22.57%) 27 (23.48%) 87 (22.31%)  
 Underweight 74 (14.65%) 14 (12.17%) 60 (15.39%)  
 Not documented 6 (1.19%) 3 (2.61%) 3 (0.77%)  
Smoking status at baseline, n (%)     0.4618c
 Current 76 (15.05%) 15 (13.04%) 61 (15.64%)  
 Former 238 (47.13%) 60 (52.17%) 178 (45.64%)  
 Never 186 (36.83%) 39 (33.91%) 147 (37.69%)  
 Not documented 5 (0.99%) 1 (0.87%) 4 (1.03%)  
Histological subtype, n (%)     0.4091c
 Adenocarcinoma 30 (5.94%) 3 (2.61%) 27 (6.92%)  
 Signet ring cell carcinoma 4 (0.79%) 1 (0.87%) 3 (0.77%)  
 Not documented 471 (93.27%) 111 (96.52%) 360 (92.31%)  
Time from initial gastric or GEJ cancer diagnosis to start of ramucirumab (m)     0.0318d
 Patients with available data 503 115 388  
 Mean (SD) 14.70 (14.69) 16.86 (15.81) 14.06 (14.29)  
 Median (IQR) 10.09 (5.78,18.13) 12.55 (6.57,22.73) 9.69 (5.50,17.56)  
Time since prior therapy to start of ramucirumab (m)     0.1151d
 Patients with available data 433 90 343  
 Mean (SD) 2.07 (2.62) 1.42 (1.22) 2.24 (2.86)  
 Median (IQR) 0.99 (0.69,2.33) 0.92 (0.69,1.71) 0.99 (0.69,2.63)  
Primary tumor locations, n (%)     0.5943f
 Greater curvature 11 (2.18%) 5 (4.35%) 6 (1.54%)  
 Lesser curvature of stomach, unspecified 13 (2.57%) 3 (2.61%) 10 (2.56%)  
 Cardio-esophageal junction 14 (2.77%) 3 (2.61%) 11 (2.82%)  
 Antrum of stomach NOS 23 (4.55%) 5 (4.35%) 18 (4.62%)  
 Lower thoracic esophagus 25 (4.95%) 4 (3.48%) 21 (5.38%)  
 Body of stomach 26 (5.15%) 6 (5.22%) 20 (5.13%)  
 Lower third of esophagus 46 (9.11%) 6 (5.22%) 40 (10.26%)  
 Gastroesophageal junction 93 (18.42%) 19 (16.52%) 74 (18.97%)  
 Other 41 (8.12%) 10 (8.70%) 31 (7.95%)  
 Not documented 213 (42.18%) 54 (46.96%) 159 (40.77%)  
Stage at initial gastric or GEJ cancer diagnosis, n (%)     0.9717c
 I 19 (3.76%) 4 (3.48%) 15 (3.85%)  
 II 72 (14.26%) 16 (13.91%) 56 (14.36%)  
 III 99 (19.60%) 24 (20.87%) 75 (19.23%)  
 IV 285 (56.44%) 62 (53.91%) 223 (57.18%)  
 Not documented 30 (5.94%) 9 (7.83%) 21 (5.39%)  
Prior cancer diagnosis, n (%)     0.5587e
 No 451 (89.31%) 101 (87.83%) 350 (89.74%)  
 Yes 54 (10.69%) 14 (12.17%) 40 (10.26%)  
Prior cancer diagnosis location (if applicable), n (%)     
 Pancreas 5 (0.99%) 1 (0.87%) 4 (1.03%) 1.000c
 Prostate 5 (0.99%) 0 (0.00%) 5 (1.28%) 0.2224c
 Cancer, unknown primary 8 (1.58%) 2 (1.74%) 6 (1.54%) 1.000c
 Breast cancer, female 9 (1.78%) 4 (3.48%) 5 (1.28%) 0.1247c
 Other 31 (6.14%) 7 (6.09%) 24 (6.15%) 0.9790e
Use of ramucirumab before/after November 2014 combination therapy approval, n (%)     < 0.0001e
 Monotherapy prior to November 2014 FDA approval 71 (53.79%)    
 Combination therapy prior to November 2014 FDA approval 61 (46.21%)    
 Monotherapy after November 2014 FDA approval 44 (11.80%)    
 Combination therapy after November 2014 FDA approval 329 (88.20%)    
Number of agents used in line of therapy prior to ramucirumab (excluding mesna and leucovorin)     < 0.0001d
 Patients with available data 432 90 342  
 Mean (SD) 2.38 (0.79) 2.01 (0.79) 2.47 (0.76)  
 Median (IQR) 2 (2,3) 2 (1,3) 3 (2,3)  
Number of prior LOTs, n (%)     0.2155c
 1 338 (66.93%) 75 (65.22%) 263 (67.44%)  
 2 79 (15.64%) 11 (9.57%) 68 (17.44%)  
 3 + 15 (2.97%) 4 (3.48%) 11 (2.82%)  
 No prior treatment documented in EHRa 72 (14.26%) 25 (21.74%) 47 (12.05%)  
 Number of prior LOTs undefinedb 1 (0.20%) 0 (0.00%) 1 (0.26%)  
Prior treatments for gastric or GEJ cancer prior to ramucirumab initiation, n (%) 433 (85.74%) 90 (78.26%) 343 (87.95%) 0.0090e
 Anti-angiogenic-containing 1 (0.20%) 0 (0.00%) 1 (0.26%) 1.000c
 Antineoplastic-containing 6 (1.19%) 0 (0.00%) 6 (1.54%) 0.1809c
 Irinotecan-containing 48 (9.51%) 17 (14.78%) 31 (7.95%) 0.0281e
 Anthracycline-containing 67 (13.27%) 8 (6.96%) 59 (15.13%) 0.0232e
 Trastuzumab-containing 75 (14.85%) 16 (13.91%) 59 (15.13%) 0.7474e
 Taxane-containing 146 (28.91%) 38 (33.04%) 108 (27.69%) 0.2660e
 Platinum-containing 316 (62.57%) 47 (40.87%) 269 (68.97%) < 0.0001e
 Fluoropyrimidine-containing 334 (66.14%) 49 (42.61%) 285 (73.08%) < 0.0001e
Evidence of metastatic disease at baseline, n (%)     0.5435c
 No 16 (3.17%) 2 (1.74%) 14 (3.59%)  
 Yes 489 (96.83%) 113 (98.26%) 376 (96.41%)  
Location of metastases (if applicable), n (%)     
 Brain 14 (2.77%) 7 (6.09%) 7 (1.80%) 0.0138e
 Bone 60 (11.88%) 16 (13.91%) 44 (11.28%) 0.4435e
 Lung 63 (12.48%) 12 (10.44%) 51 (13.08%) 0.4511e
 Peritoneum 96 (19.01%) 21 (18.26%) 75 (19.23%) 0.8158e
 Liver 152 (30.10%) 38 (33.04%) 114 (29.23%) 0.4334e
 Other 110 (21.78%) 17 (14.78%) 93 (23.85%) 0.0385e
 Not documented 289 (57.23%) 67 (58.26%) 222 (56.92%)  
ECOG performance score at initiation of ramucirumab use, n (%)     0.4136c
 0 25 (4.95%) 3 (2.61%) 22 (5.64%)  
 1 182 (36.04%) 41 (35.65%) 141 (36.15%)  
 2 + 51 (10.10%) 13 (11.30%) 38 (9.74%)  
 Not documented 247 (48.91%) 58 (50.44%) 189 (48.46%)  
Weight loss (3 months prior to initiation of ramucirumab), n (%)     0.5878c
 < 10% 124 (24.55%) 31 (26.96%) 93 (23.85%)  
 ≥ 10% 10 (1.98%) 1 (0.87%) 9 (2.31%)  
 No weight loss 371 (73.47%) 83 (72.17%) 288 (73.85%)  
Comorbidities at initiation of ramucirumab, n (%)     
 Liver 5 (0.99%) 1 (0.87%) 4 (1.03%) 1.000c
 Renal 9 (1.78%) 3 (2.61%) 6 (1.54%) 0.4323c
 Diabetes 21 (4.16%) 1 (0.87%) 20 (5.13%) 0.0587c
 Pulmonary 36 (7.13%) 6 (5.22%) 30 (7.69%) 0.3647e
 Neuropathy 43 (8.52%) 6 (5.22%) 37 (9.49%) 0.1494e
 Cardiovascular 45 (8.91%) 7 (6.09%) 38 (9.74%) 0.2265e
 Hematological 120 (23.76%) 34 (29.57%) 86 (22.05%) 0.0962e
 Other 223 (44.16%) 43 (37.39%) 180 (46.15%) 0.0963e
Toxicity/symptoms at initiation of ramucirumab (60-day period before index event), n (%)     
 Neutropenia 22 (4.36%) 8 (6.96%) 14 (3.59%) 0.1201e
 Edema 24 (4.75%) 7 (6.09%) 17 (4.36%) 0.4440e
 Abdominal pain/bloating 24 (4.75%) 2 (1.74%) 22 (5.64%) 0.1306c
 Neuropathy 25 (4.95%) 7 (6.09%) 18 (4.62%) 0.5226e
 Diarrhea 28 (5.55%) 7 (6.09%) 21 (5.39%) 0.7724e
 Nausea 102 (20.20%) 13 (11.30%) 89 (22.82%) 0.0069e
 Other 46 (9.11%) 9 (7.83%) 37 (9.49%) 0.5864e
  1. aThese patients may have prior treatment outside of the US Oncology Network (USON)
  2. bThis patient had evidence of prior treatment within the USON but the number of LOTs was not defined in the EHR database
  3. cP value calculated based on a Fisher’s Exact test
  4. dP value calculated based on a Kruskal–Wallis test
  5. eP value calculated based on a χ2 test
  6. fMonte Carlo estimate