Patient characteristics, AEs, and response
| . | Case 1 . | Case 2 . | Case 3 . | Case 4 . |
|---|---|---|---|---|
| Age, y/Sex | 64/Female | 44/Female | 48/Male | 42/Male |
| Diagnosis | AML | AML with 3q26.2 abn | MK-AML | AML-MRC |
| Indication for FMT | Resistant | Resistant | Dependent | Resistant |
| GVHD stage (overall) | ||||
| Gut | 1 | 4 | 1 | 2* |
| Skin | 0 | 0 | 0 | 0 |
| Liver | 0 | 3 | 3 | 1 |
| GVHD grade (overall) | II | III | II | IV† |
| GVHD stage at start of FMT | ||||
| Gut | 1 | 4 | 1 | 2* |
| Skin | 0 | 0 | 0 | 0 |
| Liver | 0 | 0 | 0 | 1 |
| GVHD grade at start of FMT | II | III | II | IV† |
| Initial treatment dose of steroid | 2 mg/kg mPSL | 2 mg/kg mPSL | >2 mg/kg mPSL | 1-2 mg/kg mPSL |
| Dose of steroid at start of FMT | 1 mg/kg mPSL | 1 mg/kg mPSL | >2 mg/kg mPSL | 2 mg/kg mPSL |
| Treatment of GVHD other than systemic steroid | FK, beclomethasone | FK, beclomethasone, octreotide, loperamide, fentanyl | FK, beclomethasone | FK, beclomethasone, octreotide |
| Infectious complications and treatment at start of FMT | ||||
| Clostridium difficile toxin | — | — | — | — |
| Comorbid infection | CMV antigenemia | IPA CMV retinitis | IPA | Sepsis (catheter infection) CMV enteritis |
| Antibiotics | ST, TAZ/PIPC | LVFX | CFPM + VCM | CFPM |
| Cessation of antibiotics | Yes (TAZ/PIPC) | Yes | Yes | No |
| Antifungals | MCFG | VRCZ | L-AmphB | MCFG |
| Antivirals | Foscarnet | Ganciclovir (intraocular) Foscarnet | Aciclovir | Foscarnet |
| AEs (grade) | ||||
| First FMT | Abdominal pain (1) | Belch (1) | Diarrhea (1) | Hypoxia (2) |
| Pharyngolaryngeal pain (1) | Anemia (2→3)‡ | Delirium (1) | ||
| Diarrhea (2) | Thrombocytopenia (3→4)‡ | Lower GI hemorrhage (1) | ||
| Hypokalemia (L-AmphB induced) (2) | Hypothyroidism (1) | |||
| γGTP↑ (1→2) | ||||
| Second FMT | Abdominal pain (1) | Abdominal pain (1) | NA | Abdominal pain (1) |
| Pharyngolaryngeal pain (1) | Pharyngolaryngeal pain (1) | Fever (1)‡ | ||
| Nausea (1) | Diarrhea (2) | Blood bilirubin increased (1→3) | ||
| γGTP↑ (2→3) | ||||
| PAF (1) | ||||
| TA-TMA (2)§ | ||||
| Response|| | Complete response | Complete response | Complete response | Partial response |
| . | Case 1 . | Case 2 . | Case 3 . | Case 4 . |
|---|---|---|---|---|
| Age, y/Sex | 64/Female | 44/Female | 48/Male | 42/Male |
| Diagnosis | AML | AML with 3q26.2 abn | MK-AML | AML-MRC |
| Indication for FMT | Resistant | Resistant | Dependent | Resistant |
| GVHD stage (overall) | ||||
| Gut | 1 | 4 | 1 | 2* |
| Skin | 0 | 0 | 0 | 0 |
| Liver | 0 | 3 | 3 | 1 |
| GVHD grade (overall) | II | III | II | IV† |
| GVHD stage at start of FMT | ||||
| Gut | 1 | 4 | 1 | 2* |
| Skin | 0 | 0 | 0 | 0 |
| Liver | 0 | 0 | 0 | 1 |
| GVHD grade at start of FMT | II | III | II | IV† |
| Initial treatment dose of steroid | 2 mg/kg mPSL | 2 mg/kg mPSL | >2 mg/kg mPSL | 1-2 mg/kg mPSL |
| Dose of steroid at start of FMT | 1 mg/kg mPSL | 1 mg/kg mPSL | >2 mg/kg mPSL | 2 mg/kg mPSL |
| Treatment of GVHD other than systemic steroid | FK, beclomethasone | FK, beclomethasone, octreotide, loperamide, fentanyl | FK, beclomethasone | FK, beclomethasone, octreotide |
| Infectious complications and treatment at start of FMT | ||||
| Clostridium difficile toxin | — | — | — | — |
| Comorbid infection | CMV antigenemia | IPA CMV retinitis | IPA | Sepsis (catheter infection) CMV enteritis |
| Antibiotics | ST, TAZ/PIPC | LVFX | CFPM + VCM | CFPM |
| Cessation of antibiotics | Yes (TAZ/PIPC) | Yes | Yes | No |
| Antifungals | MCFG | VRCZ | L-AmphB | MCFG |
| Antivirals | Foscarnet | Ganciclovir (intraocular) Foscarnet | Aciclovir | Foscarnet |
| AEs (grade) | ||||
| First FMT | Abdominal pain (1) | Belch (1) | Diarrhea (1) | Hypoxia (2) |
| Pharyngolaryngeal pain (1) | Anemia (2→3)‡ | Delirium (1) | ||
| Diarrhea (2) | Thrombocytopenia (3→4)‡ | Lower GI hemorrhage (1) | ||
| Hypokalemia (L-AmphB induced) (2) | Hypothyroidism (1) | |||
| γGTP↑ (1→2) | ||||
| Second FMT | Abdominal pain (1) | Abdominal pain (1) | NA | Abdominal pain (1) |
| Pharyngolaryngeal pain (1) | Pharyngolaryngeal pain (1) | Fever (1)‡ | ||
| Nausea (1) | Diarrhea (2) | Blood bilirubin increased (1→3) | ||
| γGTP↑ (2→3) | ||||
| PAF (1) | ||||
| TA-TMA (2)§ | ||||
| Response|| | Complete response | Complete response | Complete response | Partial response |
All AEs that were obviously related to FMT (underlined) were mild and transient.
AML, acute myeloid leukemia; AML-MRC, AML with myelodysplasia-related changes; AML with 3q26.2 abn, AML with 3q26 abnormality; CFPM, cefepime; CMV, cytomegalovirus; FK, tacrolimus; GI, gastrointestinal; GTP, guanosine triphosphate; IPA, invasive pulmonary aspergillosis; L-AmphB, liposomal amphotericin B; LVFX, levofloxacin; MCFG, micafungin; MK-AML, AML with monosomal karyotype; NA, not applicable; ST, sulfamethoxazole/trimethoprim; TAZ/PIPC, tazobactam/piperacillin; TA-TMA, transplant-associated thrombotic microangiopathy; VCM, vancomycin; VRCZ, voriconazole.
Downgraded one stage because of CMV enteritis.
Graded as IV because of extremely poor performance status.
Recovered in 1 day.
TA-TMA was graded using the common toxicity criteria proposed by Ho et al.11
Response of FMT was evaluated 28 days after last infusion (cases 1-3) or as maximum response before rituximab administration (case 4).