Multicenter comparison of high-dose cytarabine-based regimens versus liposomal daunorubicin and cytarabine (CPX-351) in patients with secondary acute myeloid leukemia.

Liposomal daunorubicin/cytarabine (CPX-351) gained FDA approval for secondary AML after demonstrating improved outcomes over daunorubicin and cytarabine (7 + 3). A number of study limitations prompted a comparison of safety/efficacy of CPX-351 against regimens containing a purine analogue and high-dose cytarabine (HIDAC). This retrospective study compared complete response rates with/without count recovery (CR/CRi) between HIDAC-based regimens and CPX-351 in 169 patients with newly diagnosed sAML. The CR/CRi rate was 62.7% in the HIDAC-based therapy arm vs. 47.9% in the CPX-351 arm (p = 0.002 [one-sided for non-inferiority]). Median time to absolute neutrophil and platelet count recovery was shorter after HIDAC-based therapy (18 and 23 days, respectively) compared to CPX-351 (36 and 38 days; p < 0.001). Median overall survival was 9.8 months in the HIDAC-based group and 9.14 months in the CPX-351 group. 30-day mortality was greater with CPX-351 (8.5%) compared to HIDAC-based (1.3%; p = 0.039). These results reveal comparable efficacy and favorable safety with HIDAC-based regimens.

Patient engagement in first cycle comprehensive chemotherapy consultation pharmacist services and impact on patient activation.

BACKGROUND: Healthcare systems and policy makers worldwide are demonstrating interest in shared decision making, which requires patient activation. Patient activation can be measured using a validated tool called the patient activation measure-10. First cycle comprehensive chemotherapy consultation services (3CS) is provided by an oncology pharmacy team member during a patient encounter at the beginning of the patient's treatment for cancer. METHODS: This was a single center, prospective, non-randomized, observational clinical study in patients with cancer who required a new chemotherapy plan. A baseline patient activation measure-10 survey was administered and a pharmacy team member met with the patient to complete the first cycle 3CS encounter. Within two business days of that encounter, a second patient activation measure-10 survey was administered, and thus, patients served as their own control. RESULTS: Forty-nine patients who met the inclusion criteria were enrolled, of which 36 completed the study. Mean patient activation measure-10 scores measured at baseline and two business days after the 3CS encounter were significantly different (68.5 ± SD 14.7 vs. 75.0 ± SD 14.3, p = 0.001). This difference persisted when evaluated by gender (female: 70.0 ± SD 14.8 vs. 81.6 ± SD 10.5, p = 0.001; male: 66.1 ± SD 14.8 vs. 70.8 ± SD 14.7, p = 0.022). CONCLUSION: This study demonstrates that cancer patients had significantly increased patient activation scores after engagement in a 3CS encounter provided by an oncology pharmacy team. Further studies are needed to verify these data in a larger population, different healthcare settings, and to evaluate for patients who have solid tumor malignancies.

Clinical Outcomes of Acid Suppressive Therapy Use in Hematology/Oncology Patients at an Academic Medical Center.

BACKGROUND: Acid suppressive therapy (AST)-namely, proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs)-is routinely prescribed to hospitalized patients for stress ulcer prophylaxis (SUP). OBJECTIVE: To identify the incidence of and indications for AST use in the hematology/oncology population as well as to identify the occurrence of the following PPI-associated adverse events: pneumonia and Clostridium difficile-associated diarrhea (CDAD). METHODS: A retrospective chart review was conducted on adult hematology/oncology patients admitted to any oncology service for ≥48 hours from October 1, 2014, to December 31, 2014. RESULTS: Of the 298 patients who met the inclusion criteria, 73% (n = 218) received an AST during admission. The most common indication for an AST was SUP (63%). The incidence of hospital-acquired pneumonia (HAP) was 10%, 0%, and 4% in patients who received a PPI, H2RA, and no AST, respectively (14/142 vs 0/70 vs 3/80; odds ratio [OR] for PPI vs no AST = 2.68; 95% CI = 0.75-9.63). The incidence of CDAD was 3%, 1.3%, and 1.2% in patients who received a PPI, H2RA, and no AST, respectively (4/142 vs 1/70 vs 1/80; OR for PPI vs H2RA = 1.92; 95% CI = 0.21-17.47). CONCLUSION: This is the first study to describe the incidence of and indications for AST use in the hospitalized hematology/oncology population. There was a high occurrence of AST use, particularly PPIs, in these patients at our institution. Additionally, there was a trend toward an increased risk of HAP and CDAD in patients who received AST during admission.

Emerging Role of Olanzapine for Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting.

The prevention and treatment of chemotherapy-induced nausea and vomiting (CINV) continues to pose a challenge for clinicians. The development of 5-hydroxytryptamine (serotonin) antagonists and neurokinin-1 receptor antagonists (NK1 -RAs) have demonstrated significant improvements in acute and delayed CINV for highly and moderately emetogenic chemotherapy. Delayed and breakthrough CINV, however, continue to be difficult to manage despite available treatment agents. Randomized clinical trial data suggest that olanzapine, a second-generation thienobenzodiazepine, traditionally used in the treatment of manifestations of psychotic disorders, is an effective agent in these clinical settings. The short-term use of olanzapine has a favorable adverse event profile and was not associated with grade 3 or 4 toxicity in a phase III study. Olanzapine is recommended as an option within first-line prophylaxis for CINV in the National Comprehensive Cancer Network (NCCN) guidelines and is an option for treatment of refractory CINV in the Multinational Association of Supportive Care in Cancer/European Society for Medical Oncology and NCCN guidelines.

Fosaprepitant for the prevention of nausea and vomiting in patients receiving BEAM or high-dose melphalan before autologous hematopoietic stem cell transplant.

PURPOSE: To assess the impact of single-dose fosaprepitant on nausea and emesis after BEAM and high-dose melphalan conditioning regimens for autologous hematopoietic stem cell transplantation. METHODS: In a single-center cohort study patients receiving melphalan containing hematopoietic stem cell transplantation regimens who received a one-time dose of 150 mg IV fosaprepitant (n = 56) were compared to a historical control (n = 70). RESULTS: The primary endpoint of no emesis from melphalan administration through five days afterward was 80% for the fosaprepitant group versus 66% in the control group (p = 0.068). Addition of fosaprepitant demonstrated significant improvement in emetic episodes per patient during the entire assessment period (p = 0.011) and days 1-5 after melphalan (p = 0.045). Fosaprepitant resulted in no substantial nausea during the entire assessment period in 37% of high-dose melphalan patients and 57% of BEAM patients. CONCLUSIONS: Further studies are suggested to investigate the optimal number and timing of doses of fosaprepitant in this setting.