Table 4. Treatment and Outcomes.
Complete hemoglobin recovery (cHR) and partial hemoglobin recovery (pHR) were defined as hemoglobin within 1g/dL and 2g/dL of the pre-treatment value, respectively, and without RBC transfusion within the preceding 2 weeks. Patients on any amount of immunosuppression could still achieve a cHR or pHR. Complete remission from AIHA (CR-AIHA) was defined as hemoglobin within 1g/dL of the pre-treatment value in the absence of immunosuppression and without features of ongoing hemolysis or red blood cell transfusion within the preceding 2 weeks.
| Pt | Treatment | Hgb recovery | CR-AIHA | Time to Hgb recovery (days) | ICPi initially held? | Re-challenged with ICPi? | IRAE with retreatment? | Response of malignancy to initial ICPia |
|---|---|---|---|---|---|---|---|---|
| 1 | Pred 1mg/kg PO QD tapered over 2 months, ritux 375mg/m2/week IV x4 | cHR | Y | 122 | Y | N | N/A | Partial response, progression in months |
| 2 | MP 100–200mg IV x4 doses, Pred 60mg PO QD tapered over 25 days | cHR | Y | 21 | Y | N | N/A | Partial response |
| 3 | Pred 60mg PO QD tapered over 5 weeks | cHR | Y | 32 | Y | Nivo | N | Complete response |
| 4 | Pred 70mg PO QD tapered over 8 weeks | cHR | Y | 47 | Y | Nivo | Nb | Complete response, recurrence in months |
| 5 | MP 100mg IV x1, Pred 60mg PO QD tapered over 2 weeks then restarted at 60mg PO QD due to pyrexia | cHR | N | 56 | N | Continued on Ipi/Nivo x4 cycles, then Nivo maintenance | AIHA, pyrexia | Stable disease, progression in months |
| 6 | Dex 10mg IV BID tapered over 7 weeks, continued on dex 6mg PO QD for brain metastases | pHR | N | 29 | N | Continued on Ipi | AIHA | Progression |
| 7 | 1. Pred 100mg PO QD tapered over 6 months and IVIG 0.5g/kg QD x2 days 2. Relapse: Pred 60mg PO QD tapered over 4 months, ritux 375mg/m2/week IV x4, IVIG 1g/kg/day x2 days |
cHR | N | 44 | Y | N | N/A | Partial response |
| 8 | MP 60mg IV x1, prednisone 60mg PO QD tapered over 2.5 months | pHR | N | 160 | Y | N | N/A | Stable disease |
| 9 | MP 1.25mg/kg IV QD x3, pred 1.5mg/kg PO QD tapered over 3.5 months | cHR | Y | 18 | Y | N | N/A | Not applicable (ICPi given as adjuvant treatment) |
| 10 | 1. Pred 60mg PO QD tapered over 2.5 months 2. Relapse: Pred 50mg PO QD tapered over 3.5 months, IVIG 1g/kg x2, ritux 375mg/m2 IV x4, azathioprine 150mg PO QD |
cHR | N | 49 | Y | N | N/A | Partial response |
| 11 | Pred 60mg PO QD tapered over 4 weeks | cHR | Y | 9 | Y | N | N/A | Partial response, progression in weeks |
| 12 | Dex 12mg IV x1, pred 1mg/kg PO QD tapered over 10 weeks | cHR | Y | 138 | Y | Ipi/Nivo held x2 cycles then continued | N | Progression |
| 13 | Pred 1mg/kg PO QD tapered over 4.5 months | cHR | Y | 64 | Y | Pembro | N | Progression |
| 14 | Dex 4mg PO BID tapered over 1 month | cHR | N | 46 | N | Continued on Pembro | ITP, AKI, hepatitis | Partial response |
| M (IQR) | 47 (30–62) |
As defined by the treating clinician.
This patient did not have a recurrence of ICPi-AIHA when treated re-challenged with nivolumab alone. However, after 8 months of single-agent nivolumab, the patient’s underlying malignancy recurred. The patient was subsequently treated with combination ipilimumab/nivolumab and experienced recurrent ICPi-AIHA within one week of treatment. ICPi-AIHA was refractory to prednisone and IVIG, though did respond to rituximab. As a result, ICPis were permanently discontinued.
Abbreviations: AKI, acute kidney injury; BID, twice per day; Dex, dexamethasone; Hgb, hemoglobin; ICPi, immune checkpoint inhibitor; Ipi, ipilimumab; IQR, intraquartile range; IRAEs, immune related adverse events; ITP, immune thrombocytopenia; IV, intravenous; IVIG, intravenous immune globulin; M; median; MP, methylprednisolone; N, no; N/a, not applicable; Nivo, nivolumab; Pembro, pembrolizumab; PO, by mouth; Pred, prednisone; QD, once/day; Ritux, rituximab; Y, yes.