One institution's strategies for outpatient administration of VYXEOS for appropriate patients1,a-c
Preparation1
- Designate a team of healthcare professionals, including registered nurses, pharmacists, APPs, and physicians
- Thoroughly train all personnel in managing outpatient care
- Ideally, allocate space for a dedicated patient center
Patient selection1
- Assess patient suitability for outpatient care:
- Ensure patients are compliant and/or have a suitable caregiver
- Limit a patient's commute to a treatment center to no more than 60 minutes
- Evaluate patient's overall health fitness (eg, ECOG performance status, risk for complications, comorbidities, etc)
- Consider each patient's treatment goals and preferences
Patient education1
- Arrange calendar development and medication review
- Educate patients and caregivers on recognizing and reporting signs and symptoms of serious complications
Patient monitoring1
- Anticipate 2-3 monitoring visits per week, although frequency should be tailored to each patient
- Start infusions in the morning to allow time for monitoring
- Coordinate supportive care (eg, transfusions) to be administered following treatment/monitoring visits (same day)
- Carefully monitor for any signs and symptoms of toxicity
Adapted from Talati et al. Future Oncol. 2020;16(7):281-291.
- In the Phase 3 trial, site of induction and consolidation administration—inpatient vs outpatient—was not defined. The decision was left to the discretion of the investigators according to the standard practices of their institution.2,3
- Most patients in the Phase 3 trial received induction in an inpatient setting.2
- Outpatient administration may decrease the number of days a patient needs to be hospitalized for treatment.3
Other strategies for outpatient treatment with VYXEOS
Timely access to supportive care is important in outpatient management. Supportive care may include:
Blood and platelet transfusion support1,4,5
- Patients may require frequent transfusions during outpatient care
Prophylactic antimicrobial implementation1,5
- Prophylaxis with antibacterials, antifungals, and antivirals may be recommended if a patient is considered at high risk for infection
Supportive care1
- Supportive care such as hydration, antiemetic support, and correction of electrolyte imbalances are vital to patient care
Additional considerations for outpatient treatment
- Inpatient access allows for unplanned admission due to urgent adverse events or if a patient requires frequent monitoring and/or transfusion support5
- Some institutions may prefer preplanned admission to monitor patients more closely6
- A patient who does not experience any major complications may be able to complete all treatment in an outpatient setting1
Institutions have evaluated administering VYXEOS in the outpatient setting6,7
In two small, postapproval, single-institution studies, over one-half of patients received VYXEOS induction in the outpatient setting6,7
Kubal et al6
In a small, single-center pilot study by Kubal et al, 22 patients received a full induction course of VYXEOS6
- Patients were evaluated each day with CBC, CMP, and uric acid and phosphorus measures
- Planned admission occurred on Day 6 for continued care
- 64% (n=14; median age 69) received induction in an IPOP setting, and 93% of those patients (n=13) were admitted for continued care on Day 6, as planned
- One patient was admitted on Day 2 of induction
Deutsch et al7
In a small, single-center pilot study by Deutsch et al, 12 patients received a full induction course of VYXEOS7
- Patients were monitored at least every other day until count recovery and admitted for continued care if complications occurred
- 58% (n=7; median age 72) received induction in an IPOP setting
- Of these 7 patients, 86% (n=6) were eventually admitted for continued care; all admissions were due to infection complications
- One patient was admitted prior to completing the third induction dose
These two studies assessed the feasibility of adult patients receiving VYXEOS induction in the inpatient/outpatient setting6,7,d
Exclusion criteria for outpatient administration were similar across these 2 studies6,7
| Kubal et al study (n=22)6 | Deutsch et al study (n=12)7 |
|---|---|
| Increased risk for tumor lysis including white count >50K | At risk for tumor lysis syndrome |
| Active cardiopulmonary symptoms | Signs or symptoms of active infection or cardiopulmonary disease |
| ECOG PS >2 | ECOG PS >2 |
| Lacked a caregiver or were unable to reside within 60 minutes of the treating facility | Lacked an appropriate caregiver or transportation to the cancer center |
| Increased creatinine or uric acid |
Treatment in an IPOP setting enables appropriate patients to receive induction in an outpatient setting, with inpatient admission scheduled as needed for continued monitoring and care or for treatment for adverse events6,7
- Most patients in the Phase 3 trial received induction in an inpatient setting2
