Table 2.
The feasibility of initiating a combination treatment regimen of up to four targeted agents is represented in the above table, with 84% of subjects able to start all recommended agents during cycle 1. All related and unexpected adverse events of grade 3 or higher were collected for this clinical trial and reported to the BCC. Only one grade 3 related and unexpected hematologic toxic effect occurred during this trial. Six grade 3 and one grade 4 non‑hematologic toxic effects that were related and unexpected occurred during the trial. Toxicity-associated events attributable to MGT causing a delay or reduction in treatment, such as medication holds, dose reductions, medication discontinuations, and cycle delays, were captured during cycles 1 and 2 via a retrospective roadmap review. Since this trial involved combination agents, these events were captured by the total number of events and the total number of subjects who experienced an event since subjects may have had > 1 drug held or reduced in dosage
| NMTRC009 MGT feasibility and safety profile | N = 144 | ||
|---|---|---|---|
| Started at least one tumor board recommended agent, no. of patients (%) | 144 (100%) | ||
| Started 100% of tumor board recommended agents, no. of patients (%) | |||
| Cycle 1 | 121 (84.03%) | ||
| Cycle 2 | 12 (8.33%) | ||
| Cycle 3 | 3 (2.08%) | ||
| Cycle 5 | 1 (0.69%) | ||
| Never | 7 (4.86%) | ||
| Cycles, no. of patients (%) | |||
| 1 cycle | 19 (13.19%) | ||
| 2 cycles | 45 (31.25%) | ||
| 3–10 cycles | 57 (39.58%) | ||
| > 10 cycles | 23 (15.97%) | ||
| Grade 3 | Grade 4 | Grade 5 | |
| Hematologic toxic effects (related and unexpected), no. of patients (%) | |||
| Anemia | |||
| Lymphocytopenia | |||
| Neutropenia | |||
| Thrombocytopenia | |||
| Leukopenia | 1 (< 1%) | ||
| Non-hematologic toxic effects (related and unexpected), no. of patients (%) | |||
| Elevated ALT | |||
| Elevated AST | 1 (< 1%) | 1 (< 1%) | |
| Dehydration | 1 (< 1%) | ||
| Infection | 2 (< 2%) | ||
| Oral mucositis | 1 (< 1%) | ||
| Pancreatitis | 1 (< 1%) | ||
| No. of events | No. of patients (%) | ||
| Cycle 1 toxicity-associated events | |||
| Medication holds | 90 | 45 (31.25%) | |
| Dose reductions | 9 | 9 (6.25%) | |
| Medication discontinuations | 9 | 8 (5.56%) | |
| Cycle delays | 0 | 0 (0%) | |
| Cycle 2 toxicity-associated events | |||
| Medication holds | 105 | 52 (41.60%) | |
| Dose reductions | 45 | 31 (24.80%) | |
| Medication discontinuations | 21 | 15 (12.00%) | |
| Cycle delays | 12 | 12 (9.60%) | |