Table 2.
Efficacy measures and reasons for treatment discontinuation.
| Efficacy measure | Number of patients, N = 28 (%) |
|---|---|
| Median follow-up (months, range) | 22.8 (9.2–35.7) |
| Median DFS (months, 95% CI) | 12.9 (8.2–27.2+) |
| Number of events | 15 (54)a |
| One-year DFS (%, 95% CI) | 55.2% (34.8–71.7) |
| Median OS (months, 95% CI) | NR |
| Number of events | 7 (25)b |
| One-year OS (%, 95% CI) | 85.7% (66.3–94.4) |
| Best ORR to neoadjuvant therapyc | |
| Complete response | 0 |
| Partial response | 0 |
| Stable disease | 27 (96) |
| Progression of disease | 1 (4) |
| Pathologic response to neoadjuvant therapy | |
| Major response (≤10% tumor viability) | 4 (14) |
| Partial response (≤50% tumor viability) | 8 (29) |
| Minor response (51%–100% tumor viability) | 16 (57) |
| Reason for study treatment discontinuation | |
| Completed therapy | 18 (64) |
| Toxicity | 0 |
| Noncomplianced | 3 (11) |
| Physician discretione | 1 (4) |
| Withdrawal of consentd | 4 (14) |
| Recurrence of disease | 2 (7) |
| Death | 0 |
Abbreviations: CI, confidence interval; NR, not reached; +, censored at last follow-up as of data cutoff.
aIncludes deaths, 5 of 15 patients had recurrence and death whereas 2 of 15 experienced death without recurrence.
bTwo of seven died without evidence of recurrence.
cDetermined by RECIST v1.1.
dSeven patients with study visit noncompliance or withdrawal of consent were removed from study treatment after declining to return for their adjuvant infusions, citing distance from the institution and resource constraints, not toxicity.
ePatient elected to come off study treatment to pursue adjuvant concurrent reirradiation with chemotherapy post-op due to high-risk pathologic features.