Title | Progression‐free survival, overall survival, time to treatment failure |
Number of Patients Enrolled | 36 |
Number of Patients Evaluated for Efficacy | 34 |
(Median) Duration Assessments PFS | 5.8 months, CI: 5.3–10.0 |
(Median) Duration Assessments Duration of Treatment | 4.2 months |
Outcome Notes |
Kaplan‐Meier curves for PFS and OS of the 34 patients are displayed in Figures 3 and 4, respectively; however, the data of PFS and OS are preliminary and immature at the data cut‐off date (January 10, 2019). The median PFS of the 34 patients was 5.8 months (95% CI, 5.3–10.0; Fig. 3). The median PFS of patients with left‐sided tumors was 5.8 months (95% CI, 5.4–15.7), whereas that of patients with right‐sided tumors was 4.9 months (95% CI, 1.9–not available). The 6‐ and 12‐month OS rates for the 34 patients were 84.9% (95% CI, 73.5–98.0) and 69.9% (95% CI, 54.9–88.9), respectively (Fig. 4). The 6‐ and 12‐month OS rates for those with left‐sided tumors were 87.8% (95% CI, 75.7–100) and 78.5% (95% CI, 63.4–97.3), respectively, whereas for those with right‐sided tumors they were 75.0% (95% CI, 50.3–100) and 37.5% (95% CI, 13.0–100), respectively. The median TTF was 4.2 months (95% CI, 3.1–5.8). |
Title | Treatment delivery |
Outcome Notes |
The median number of panitumumab doses administered was 8 (range, 1–16). Eleven patients (30.6%) had doses reduced by one level, and four patients (11.1%) had doses reduced by two levels. Sixteen patients (44.4%) discontinued study treatment because of progressive disease. Two patients (5.6%) discontinued treatment and received surveillance after CR, two patients (5.6%) underwent conversion therapy, and one patient (2.8%) received palliative radiation therapy for distance metastasis after tumor shrinkage. Five patients (13.9) discontinued treatment because of toxicities; one experienced paronychia grade 3, stomatitis grade 1, and fatigue grade 1; one experienced rash grade 2, fatigue grade 2, stomatitis grade 1, and hypomagnesemia grade 2; one experienced sarcopenia; one experienced hypomagnesemia grade 2 and one experienced infusion reaction grade 3. Five patients (13.9%) were unable to start the next cycle within four weeks; two because of hypomagnesemia; two because of rash; and one because of both hypomagnesemia and rash. Three patients (8.3%) discontinued treatment because of other reasons. Two patients (5.6%) have continued treatment until this analysis. |