Disease and treatment information for the 4 patients who received long-term treatment with bortezomib in CAN2007
| Characteristic/parameter . | Patient 1 . | Patient 2 . | Patient 3 . | Patient 4 . |
|---|---|---|---|---|
| Gender | Male | Male | Female | Female |
| Age at study entry, years | 53 | 53 | 55 | 54 |
| Dose level, mg/m2 | 1.3 QW | 0.7 BIW | 1.6 QW | 1.3 BIW |
| KPS | 90 | 90 | 100 | 90 |
| AL type | IgA λ | IgG κ | IgG λ | λ light chain |
| Time since diagnosis, months | 16.0 | 38.0 | 14.0 | 44.0 |
| Organ involvement | 2: cardiac, renal | 1: GI* | 2: GI, other sites | 2: cardiac, GI |
| Prior therapy (best response achieved) | Melphalan plus ASCT (PR) | ASCT (PR) | ASCT (SD) | Cardiac allograft then ASCT (PR) |
| Cycles of bortezomib | 57 | 47 | 39 | 57 |
| Months/years on bortezomib | 66.8/5.6 | 52.0/4.3 | 44.7/3.7 | 41.4/3.5 |
| Planned cumulative dose, mg/m2 | 296.4 | 131.6 | 249.6 | 296.4 |
| Cumulative dose received, mg/m2 | 190.5 | 77.7 | 167.7 | 173.7 |
| % cumulative/planned dose | 64.3 | 59.0 | 67.2 | 58.6 |
| Dose intensity, mg/mg2/cycle | 3.3 | 1.7 | 4.3 | 3.0 |
| Grade 3/4 AEs, dose modifications | No grade 3/4 AEs | No grade 3/4 AEs | Grade 3 paralytic ileus, cycle 8, dose reduced to 1.3 then 1.0 mg/m2 | Grade 3 vasculitis, cycle 2 (dose reduced to 1.0 mg/m2, cycle 3); grade 3 volvulus, cycle 16 (dose reduced to 0.7 mg/m2); other grade 3 AEs: pneumonia, hemoptysis, and C difficile diarrhea |
| Adjusted to 1.3 mg/m2 Q2W, cycle 18, due to other reason | Adjusted to 0.7 mg/m2 QW, cycle 10, due to grade 2 pain in extremity | |||
| Hematologic response | CR | SD | PR | PR |
| Organ responses | Renal: response | Renal: response | Renal: NC | Renal: response |
| Cardiac: NC | Cardiac: NC | Cardiac: NC | Cardiac: NC | |
| Status | Ongoing, progression-free | Progressed, in remission on lenalidomide/dexamethasone | Ongoing, progression-free | Ongoing, progression-free |
| Characteristic/parameter . | Patient 1 . | Patient 2 . | Patient 3 . | Patient 4 . |
|---|---|---|---|---|
| Gender | Male | Male | Female | Female |
| Age at study entry, years | 53 | 53 | 55 | 54 |
| Dose level, mg/m2 | 1.3 QW | 0.7 BIW | 1.6 QW | 1.3 BIW |
| KPS | 90 | 90 | 100 | 90 |
| AL type | IgA λ | IgG κ | IgG λ | λ light chain |
| Time since diagnosis, months | 16.0 | 38.0 | 14.0 | 44.0 |
| Organ involvement | 2: cardiac, renal | 1: GI* | 2: GI, other sites | 2: cardiac, GI |
| Prior therapy (best response achieved) | Melphalan plus ASCT (PR) | ASCT (PR) | ASCT (SD) | Cardiac allograft then ASCT (PR) |
| Cycles of bortezomib | 57 | 47 | 39 | 57 |
| Months/years on bortezomib | 66.8/5.6 | 52.0/4.3 | 44.7/3.7 | 41.4/3.5 |
| Planned cumulative dose, mg/m2 | 296.4 | 131.6 | 249.6 | 296.4 |
| Cumulative dose received, mg/m2 | 190.5 | 77.7 | 167.7 | 173.7 |
| % cumulative/planned dose | 64.3 | 59.0 | 67.2 | 58.6 |
| Dose intensity, mg/mg2/cycle | 3.3 | 1.7 | 4.3 | 3.0 |
| Grade 3/4 AEs, dose modifications | No grade 3/4 AEs | No grade 3/4 AEs | Grade 3 paralytic ileus, cycle 8, dose reduced to 1.3 then 1.0 mg/m2 | Grade 3 vasculitis, cycle 2 (dose reduced to 1.0 mg/m2, cycle 3); grade 3 volvulus, cycle 16 (dose reduced to 0.7 mg/m2); other grade 3 AEs: pneumonia, hemoptysis, and C difficile diarrhea |
| Adjusted to 1.3 mg/m2 Q2W, cycle 18, due to other reason | Adjusted to 0.7 mg/m2 QW, cycle 10, due to grade 2 pain in extremity | |||
| Hematologic response | CR | SD | PR | PR |
| Organ responses | Renal: response | Renal: response | Renal: NC | Renal: response |
| Cardiac: NC | Cardiac: NC | Cardiac: NC | Cardiac: NC | |
| Status | Ongoing, progression-free | Progressed, in remission on lenalidomide/dexamethasone | Ongoing, progression-free | Ongoing, progression-free |
ASCT, autologous stem cell transplantation; GI, gastrointestinal; NC, no change; Q2W, every two weeks; SD, stable disease.
Biopsy-confirmed GI involvement in the ascending transverse and descending colons and stomach.