Allogeneic Stem Cell Transplant, Graft Versus Host Disease, Hematologic Malignancy, Stem Cell Transplant Complications
Conditions
Keywords
enteral nutrition, parenteral nutrition, artificial nutrition support, non-relapse mortality, survival
Brief summary
Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.
Detailed description
This is a retrospective case-note review of adults undergoing haematopoietic cell transplantation to treat a haematological malignancy who have been admitted to Hammersmith Hospital from 2000 to 2014. All patients receiving an allogeneic haematopoietic cell transplant from a matched sibling or identically matched unrelated donor will be included. We will record the route and assess the broad adequacy of nutritional intakes to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation. Our outcomes are graft versus host disease incidence and severity, transplant related (early) mortality and overall survival.
Interventions
None listed
Sponsors
Imperial College Healthcare NHS Trust
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing their first HCT for a hematologic malignancy * Undergoing HCT using a sibling or unrelated donor * Undergoing HCT infusion between January 2000 and December 2014
Exclusion criteria
* HCT using umbilical cord blood donors * HCT using haploidentical donors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | 100 days after the date of hematopoietic cell infusion | Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for \> 20 years by most transplant centres to improve comparability between publications. |
| Non Relapse Mortality | 100 days after the date of hematopoietic cell infusion | Defined as death without previous relapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Versus Host Disease-free and Relapse-free Survival | 5 years after the date of hematopoietic cell infusion | GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death |
| 5 Year Survival | 5 years after the date of hematopoietic cell infusion | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adequate Enteral Nutrition Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding. | 245 |
| Adequate Parenteral Nutrition Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition. | 148 |
| Inadequate Nutrition Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment. | 91 |
| Total | 484 |
Baseline characteristics
| Characteristic | Inadequate Nutrition | Adequate Parenteral Nutrition | Total | Adequate Enteral Nutrition |
|---|---|---|---|---|
| Age, Customized Age <20 years | 2 Participants | 5 Participants | 10 Participants | 3 Participants |
| Age, Customized Age 21-40 | 41 Participants | 84 Participants | 212 Participants | 87 Participants |
| Age, Customized Age 41-60 | 40 Participants | 53 Participants | 227 Participants | 134 Participants |
| Age, Customized Age >60 years | 8 Participants | 6 Participants | 35 Participants | 21 Participants |
| BMI (kg/m^2) Healthy (20 - 24.9) | 28 Participants | 63 Participants | 181 Participants | 90 Participants |
| BMI (kg/m^2) Obese (over 30) | 11 Participants | 21 Participants | 51 Participants | 19 Participants |
| BMI (kg/m^2) Overweight (25 - 30) | 45 Participants | 50 Participants | 216 Participants | 121 Participants |
| BMI (kg/m^2) Underweight (less than 20) | 7 Participants | 14 Participants | 36 Participants | 15 Participants |
| Cells infused Bone marrow (BM) | 37 Participants | 59 Participants | 155 Participants | 59 Participants |
| Cells infused PBSC | 54 Participants | 88 Participants | 326 Participants | 184 Participants |
| Cells infused PBSC + BM | 1 Participants | 2 Participants | 6 Participants | 3 Participants |
| Cluster of differentiation 34 (CD34+) cells infused Less than 4.00 x 10^6 | 29 Participants | 46 Participants | 115 Participants | 40 Participants |
| Cluster of differentiation 34 (CD34+) cells infused Missing data | 9 Participants | 15 Participants | 56 Participants | 32 Participants |
| Cluster of differentiation 34 (CD34+) cells infused More than 3.99 x 10^6 | 53 Participants | 87 Participants | 313 Participants | 173 Participants |
| Conditioning Myeloablative | 56 Participants | 131 Participants | 285 Participants | 98 Participants |
| Conditioning Reduced intensity | 35 Participants | 17 Participants | 199 Participants | 147 Participants |
| Diagnosis Acute leukaemia | 28 Participants | 57 Participants | 158 Participants | 73 Participants |
| Diagnosis CML | 35 Participants | 70 Participants | 186 Participants | 81 Participants |
| Diagnosis Lymphoma & CLL MDS | 15 Participants | 12 Participants | 83 Participants | 56 Participants |
| Diagnosis MDS | 6 Participants | 4 Participants | 37 Participants | 27 Participants |
| Diagnosis Myeloma | 7 Participants | 5 Participants | 20 Participants | 8 Participants |
| Donor CMV serology Missing data | 1 Participants | 2 Participants | 8 Participants | 5 Participants |
| Donor CMV serology Negative | 43 Participants | 64 Participants | 238 Participants | 131 Participants |
| Donor CMV serology Positive | 47 Participants | 82 Participants | 238 Participants | 109 Participants |
| Donor match Matched sibling | 56 Participants | 56 Participants | 248 Participants | 136 Participants |
| Donor match Matched unrelated | 25 Participants | 71 Participants | 182 Participants | 86 Participants |
| Donor match Mismatch unrelated | 10 Participants | 21 Participants | 54 Participants | 23 Participants |
| Era (years) 2000 - 2004 | 47 Participants | 70 Participants | 199 Participants | 82 Participants |
| Era (years) 2005 - 2009 | 18 Participants | 42 Participants | 138 Participants | 78 Participants |
| Era (years) 2010 - 2014 | 26 Participants | 36 Participants | 147 Participants | 85 Participants |
| European Group for Blood and Marrow Transplantation (EBMT)disease risk Early staged | 44 Participants | 75 Participants | 229 Participants | 110 Participants |
| European Group for Blood and Marrow Transplantation (EBMT)disease risk Intermediate staged | 22 Participants | 47 Participants | 139 Participants | 70 Participants |
| European Group for Blood and Marrow Transplantation (EBMT)disease risk Late staged | 25 Participants | 26 Participants | 116 Participants | 65 Participants |
| Hematopoietic cell transplant co-morbidity index (HCT-CI) 0-1 | 50 Participants | 70 Participants | 250 Participants | 130 Participants |
| Hematopoietic cell transplant co-morbidity index (HCT-CI) 2-3 | 18 Participants | 55 Participants | 148 Participants | 75 Participants |
| Hematopoietic cell transplant co-morbidity index (HCT-CI) missing data | 5 Participants | 7 Participants | 30 Participants | 18 Participants |
| Hematopoietic cell transplant co-morbidity index (HCT-CI) more than 3 | 18 Participants | 16 Participants | 56 Participants | 22 Participants |
| Patient cytomegalovirus (CMV) serology Missing data | 2 Participants | 0 Participants | 5 Participants | 3 Participants |
| Patient cytomegalovirus (CMV) serology Negative | 58 Participants | 77 Participants | 277 Participants | 142 Participants |
| Patient cytomegalovirus (CMV) serology Positive | 31 Participants | 71 Participants | 202 Participants | 100 Participants |
| Patient / Donor Sex Male / Female | 19 Participants | 24 Participants | 99 Participants | 56 Participants |
| Patient / Donor Sex Missing data | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Patient / Donor Sex Other combination | 72 Participants | 124 Participants | 384 Participants | 188 Participants |
| Previous autograft no | 79 Participants | 139 Participants | 437 Participants | 219 Participants |
| Previous autograft yes | 12 Participants | 9 Participants | 47 Participants | 26 Participants |
| Sex: Female, Male Female | 36 Participants | 47 Participants | 179 Participants | 96 Participants |
| Sex: Female, Male Male | 55 Participants | 101 Participants | 305 Participants | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 245 | 0 / 148 | 0 / 91 |
| serious Total, serious adverse events | 0 / 245 | 0 / 148 | 0 / 91 |
Outcome results
Primary
Non Relapse Mortality
Defined as death without previous relapse
Time frame: 100 days after the date of hematopoietic cell infusion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adequate Enteral Nutrition | Non Relapse Mortality | 8.2 percentage of participants |
| Adequate Parenteral Nutrition | Non Relapse Mortality | 17.6 percentage of participants |
| Inadequate Nutrition | Non Relapse Mortality | 27.5 percentage of participants |
Primary
Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade
Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for \> 20 years by most transplant centres to improve comparability between publications.
Time frame: 100 days after the date of hematopoietic cell infusion
Population: There were 439 and 438 evaluable cases respectively for acute GvHD grade II or greater and gastrointestinal acute GvHD of any grade after exclusion of patients that died before day 100 without acute GvHD.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adequate Enteral Nutrition | Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Acute GvHD grade II-IV | 75 Participants |
| Adequate Enteral Nutrition | Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Gut Acute GvHD any grade | 63 Participants |
| Adequate Parenteral Nutrition | Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Acute GvHD grade II-IV | 73 Participants |
| Adequate Parenteral Nutrition | Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Gut Acute GvHD any grade | 63 Participants |
| Inadequate Nutrition | Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Acute GvHD grade II-IV | 31 Participants |
| Inadequate Nutrition | Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Gut Acute GvHD any grade | 27 Participants |
Secondary
5 Year Survival
Time frame: 5 years after the date of hematopoietic cell infusion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adequate Enteral Nutrition | 5 Year Survival | 53.877 percentage of participants |
| Adequate Parenteral Nutrition | 5 Year Survival | 45.946 percentage of participants |
| Inadequate Nutrition | 5 Year Survival | 41.758 percentage of participants |
Secondary
Graft Versus Host Disease-free and Relapse-free Survival
GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death
Time frame: 5 years after the date of hematopoietic cell infusion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adequate Enteral Nutrition | Graft Versus Host Disease-free and Relapse-free Survival | 39.183 percentage of participants |
| Adequate Parenteral Nutrition | Graft Versus Host Disease-free and Relapse-free Survival | 29.729 percentage of participants |
| Inadequate Nutrition | Graft Versus Host Disease-free and Relapse-free Survival | 27.472 percentage of participants |