Table 1.
Baseline patient characteristics (ITT population)
| Characteristic | Masitinib (n = 23) | Sunitinib (n = 21) | P-valuea |
|---|---|---|---|
| Baseline characteristics | |||
| Gender (female) | 12 (52%) | 10 (48%) | 1.000 |
| Age (years) | 62 (31–82) | 67 (41–85) | 0.424 |
| ECOG PS: [0] | 14 (61%) | 12 (57%) | 1.000 |
| QLQ-C30 Global; mean (SD) | 65 (21) | 60 (20) | 0.486 |
| Disease characteristics | |||
| Years since diagnosis | 4.9 (1.2–11.7) | 4.9 (0.2–12.6) | 0.605 |
| Primary tumor localization | |||
| Small bowel | 11 (48%) | 11 (52%) | 0.582 |
| Gastroesophageal | 8 (35%) | 6 (27%) | |
| Other | 4 (17%) | 4 (19%) | |
| Tumor classification confirmed | |||
| Locally advanced | 2 (9%) | 3 (14%) | 0.658 |
| Metastatic | 21 (91%) | 18 (86%) | |
| Metastases tumor localization | |||
| Liver | 18 (78%) | 13 (62%) | 0.481 |
| Peritoneum | 6 (26%) | 8 (38%) | |
| Lung | 2 (9%) | 1 (5%) | |
| Pelvis (nonbone) | 0 (0%) | 2 (10%) | |
| Otherb | 11 (48%) | 9 (43%) | |
| KIT exon mutation | |||
| Not done | 4 (17%) | 4 (17%) | 1.000 |
| Exon 11 | 15 (79%) | 14 (82%) | |
| Exon 9 | 3 (16%) | 2 (12%) | |
| Exon 13 | 0 | 1 (6%) | |
| None (wild-type) | 1 (5%) | 0 | |
| Ratio exon 11 : 9 | 5 : 1 | 7 : 1 | |
| Maximal prior imatinib dose | |||
| 400 mg | 16 (70%) | 17 (81%) | 0.494 |
| 800 mg | 7 (30%) | 4 (19%) | |
| Cumulative prior exposure (months); median (range) | 33 (9–103) | 28 (5–114) | 0.707 |
Unless stated otherwise, data are mean (range) or number (%).
aFisher's exact test was used for comparison of qualitative variables, Wilcoxon test used for comparison of quantitative variables.
bOther = single occurrence per location. Location of ‘other’ metastases tumor for masitinib treatment arm: mediastinum, stomach, kidney, pancreas, bone, lymph nodes, pelvis abdominal, mesenteric mass, right iliac lesion, pelvic, right iliac, left hypochondrium, and mesentery. Location of ‘other’ metastases tumor for sunitinib treatment arm: colon/large intestine, pleura, soft tissue, rectum, mediastinum, stomach, interportal cava, surrenal mass, diaphragm, posterior thoracic, thoracic, retroperitoneal mass.
ECOG PS, Eastern Cooperative Oncology Group Performance Status; SD, standard deviation; QLQ-C30 Global, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire core 30 item global health status.