Table 4. Progression on lanreotide monotherapy among patients with GEP-NET.
| Progression on lanreotide monotherapy | All patients | Disease status at time of transition to lanreotide | ||
|---|---|---|---|---|
| Nonprogressive disease | Progressive disease | Unknown | ||
| Total patient sample (n, %) | 91, 100.0% | 52, 100.0% | 28, 100.0% | 11, 100.0% |
| Progressed on treatment with lanreotide monotherapy (n, %) | ||||
| Yes | 22, 24.2% | 9, 17.3% | 13, 46.4% | 0, 0.0% |
| No | 69, 75.8% | 43, 82.7% | 15, 53.6% | 11, 100.0% |
| Unknown | 0, 0.0% | 0, 0.0% | 0, 0.0% | 0, 0.0% |
| Among those who progressed, criteria used to assess progression (n, %) | ||||
| Imaging-MRI | 6, 27.3% | 4, 44.4% | 2, 15.4% | |
| Imaging-CT scan | 17, 77.3% | 6, 66.7% | 11, 84.6% | |
| Imaging-other | 2, 9.1% | 1, 11.1% | 1, 7.7% | |
| Any Imaging (MRI, CT scan, or other) | 20, 90.9% | 9, 100.0% | 11, 84.6% | |
| Symptoms-diarrhea | 6, 27.3% | 4, 44.4% | 2, 15.4% | |
| Symptoms-flushing | 2, 9.1% | 2, 22.2% | 0, 0.0% | |
| Symptoms-other | 2, 9.1% | 1, 11.1% | 1, 7.7% | |
| Biochemical tests | 3, 13.6% | 1, 11.1% | 2, 15.4% | |
| Other | 3, 13.6% | 2, 22.2% | 1, 7.7% | |
| Progression-free survival (months)a | ||||
| Progressed or died following treatment with lanreotide monotherapy (n, %) | 22, 24.2% | 9, 17.3% | 13, 46.4% | 0, 0.0% |
| Progression-free survival: time (months) from initiation of lanreotide monotherapy treatment, Kaplan-Meier estimate | ||||
| Mean (SE) | 19.6, 1.0 | 21.4, 1.2 | 14.6, 1.6 | |
| Median | 23.7 | 24.7 | 15.2 | |
| (95% CI) | 20.2–NE | 17.0–NE | 11.4–NE | |
| Q1, Q3 | 15.2, NE | 17.0, NE | 6.1, NE | |
| Censored (n, %) | 69, 75.8% | 43, 82.7% | 15, 53.6% | 11, 100.0% |
| Progression-free survival rate (%, SE) | ||||
| 6 months | 92.1%, 2.87% | 98.0%, 1.98% | 78.3%, 7.86% | |
| 12 months | 84.2%, 4.08% | 89.3%, 4.55% | 68.9%, 9.37% | |
| 24 months | 49.5%, 10.93% | 62.2%, 14.25% | ||
| Duration of response (months)b | ||||
| Progressed, died, or had an adverse event following treatment with lanreotide monotherapy (n, %) | 23, 25.3% | 10, 19.2% | 13, 46.4% | 0, 0.0% |
| Duration of response: time (months) from initiation of lanreotide monotherapy treatment, Kaplan-Meier estimate | ||||
| Mean (SE) | 19.4, 1.0 | 21.0, 1.2 | 14.6, 1.6 | |
| Median | 23.7 | 24.7 | 15.2 | |
| (95% CI) | 17.0−NE | 17.0−NE | 11.4−NE | |
| Q1, Q3 | 15.2, NE | 17.0, NE | 6.1, NE | |
| Censored (n, %) | 68, 74.7% | 42, 80.8% | 15, 53.6% | 11, 100.0% |
| Response rate (%, %SE) | ||||
| 6 months | 92.1%, 2.87% | 98.0%, 1.98% | 78.3%, 7.86% | |
| 12 months | 82.8%, 4.23% | 87.0%, 4.95% | 68.9%, 9.37% | |
| 24 months | 48.3%, 10.77% | 60.3%, 14.01% | ||
CI, confidence interval; NE, not estimable; SE, standard error; SD, standard deviation; Q1, first quartile; Q3, third quartile. a, investigator assessed disease progression includes radiographic progression, biomarker progression, symptom progression, and death. b, investigator assessed disease progression includes radiographic progression, biomarker progression, symptom progression, adverse events (as reason for stopping treatment) and death.