Table 2.
Treatment and Outcomes
| Number Patients | Percent | |
|---|---|---|
| Total Cycles of Treatment Received | ||
| 1 Cycle | 7 | 21 |
| 2 – 5 Cycles | 9 | 27 |
| ≥ 6 Cycles | 17 | 52 |
| Median (Range) | 6 (1 – 22) | |
| Total Cycles Treatment Given | 238 | |
| Dose Modified | ||
| No | 26 | 79 |
| Yes | 7 | 21 |
| Dose Modified (n=7) | ||
| Atezolizumab | 2 | |
| Guadecitabine | 5 | |
| Dose Interrupted Due to Toxicity | ||
| No | 8 | 24 |
| Yes | 25 | 76 |
| Evaluable for Response | ||
| Yes | 33 | 100 |
| Best Response During the First 6 Cycles | ||
| CR | 1 | 3 |
| Marrow CR | 5 | 15 |
| PR | 1 | 3 |
| SD with HI | 3 | 9 |
| SD | 12 | 36 |
| PD | 5 | 15 |
| Failure | 3 | 9 |
| Non-Responder | 3 | 9 |
| Response Rate During 1st 6 Cycle (CR, mCR, PR, HI) | 10 | 30 (95% CI: 16%, 49%) |
| Best Response During Treatment | ||
| CR | 2 | 6 |
| Marrow CR | 5 | 15 |
| PR | 1 | 3 |
| HI | 3 | 9 |
| SD | 11 | 33 |
| PD | 5 | 15 |
| Failure | 3 | 9 |
| Non-Responder | 3 | 9 |
| Overall Response Rate (CR, mCR, PR, HI) | 11 | 33 (95% CI: 19%, 52%) |
| Time Start Response After Treatment Start (n=11) | ||
| Median (Range) | 3.9 (1.8 – 15.1) months | |
| Duration of Response (n=11) | ||
| Median (Range) | 10.1 (1.8–47.6) months | |
| Ever experienced Any Grade 4 Toxicity, Any Attribution | ||
| No | 12 | 36 |
| Yes | 21 | 64 |
| Off Treatment | ||
| No | 1 | 3 |
| Yes | 32 | 97 |
| Off Treatment Reason (n=32) | ||
| Disease Progression/Clinical Deterioration | 16 | 50 |
| Unacceptable Toxicity | 5 | 16 |
| Death While On Treatment | 4 | 13 |
| Physician’s Decision | 4 | 13 |
| Patient Withdrawal | 3 | 9 |
| Median (Range) Months on Treatment | 5.5 (0.2 – 32.8) | |
| Median (Range) Months on Study | 6.0 (0.2 – 35.2) | |
| Died within 30 Days after Treatment Start | ||
| Yes | 3 | 9 |
| Overall Survival | ||
| Median (95% CI) | 15.1 (8.5, 25.3) Months | |
| Progression Free Survival | ||
| Median (95% CI) | 7.2 (3.6, 13.8) Months | |
| Follow-Up Time | ||
| Median (Range) | 30.1 (11.1 – 51.6) months |