Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer: A Multicenter Randomized Clinical Trial.

Importance: Patients with head and neck cancer who undergo radiotherapy can develop chronic radiation-induced xerostomia. Prior acupuncture studies were single center and rated as having high risk of bias, making it difficult to know the benefits of acupuncture for treating radiation-induced xerostomia. Objective: To compare true acupuncture (TA), sham acupuncture (SA), and standard oral hygiene (SOH) for treating radiation-induced xerostomia. Design, Setting, and Participants: A randomized, blinded, 3-arm, placebo-controlled trial was conducted between July 29, 2013, and June 9, 2021. Data analysis was performed from March 9, 2022, through May 17, 2023. Patients reporting grade 2 or 3 radiation-induced xerostomia 12 months or more postradiotherapy for head and neck cancer were recruited from community-based cancer centers across the US that were part of the Wake Forest National Cancer Institute Community Oncology Research Program Research Base. Participants had received bilateral radiotherapy with no history of xerostomia. Interventions: Participants received SOH and were randomized to TA, SA, or SOH only. Participants in the TA and SA cohorts were treated 2 times per week for 4 weeks. Those experiencing a minor response received another 4 weeks of treatment. Main Outcomes and Measures: Patient-reported outcomes for xerostomia (Xerostomia Questionnaire, primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General) were collected at baseline, 4 (primary time point), 8, 12, and 26 weeks. All analyses were intention to treat. Results: A total of 258 patients (201 men [77.9%]; mean [SD] age, 65.0 [9.16] years), participated from 33 sites across 13 states. Overall, 86 patients were assigned to each study arm. Mean (SD) years from diagnosis was 4.21 (3.74) years, 67.1% (n = 173) had stage IV disease. At week 4, Xerostomia Questionnaire scores revealed significant between-group differences, with lower Xerostomia Questionnaire scores with TA vs SOH (TA: 50.6; SOH: 57.3; difference, -6.67; 95% CI, -11.08 to -2.27; P = .003), and differences between TA and SA (TA: 50.6; SA: 55.0; difference, -4.41; 95% CI, -8.62 to -0.19; P = .04) yet did not reach statistical significance after adjustment for multiple comparisons. There was no significant difference between SA and SOH. Group differences in Functional Assessment of Cancer Therapy-General scores revealed statistically significant group differences at week 4, with higher scores with TA vs SOH (TA: 101.6; SOH: 97.7; difference, 3.91; 95% CI, 1.43-6.38; P = .002) and at week 12, with higher scores with TA vs SA (TA: 102.1; SA: 98.4; difference, 3.64; 95% CI, 1.10-6.18; P = .005) and TA vs SOH (TA: 102.1; SOH: 97.4; difference, 4.61; 95% CI, 1.99-7.23; P = .001). Conclusions and Relevance: The findings of this trial suggest that TA was more effective in treating chronic radiation-induced xerostomia 1 or more years after the end of radiotherapy than SA or SOH. Trial Registration: ClinicalTrials.gov Identifier: NCT02589938.

Retrospective Safety Evaluation of a Pharmacist-Assisted Total Dose Iron Sucrose Protocol in Hospital Inpatients With Iron Deficiency Anemia.

BACKGROUND: Intravenous (IV) iron sucrose can be used for iron deficiency anemia (IDA), but little information exists on total dose infusion (TDI) of this drug. At a tertiary hospital, an iron sucrose TDI protocol was implemented with staff pharmacists aiding physicians in appropriate dosing. OBJECTIVES: We sought to define the safety and efficacy of this protocol in adults ≥18 years old with IDA. METHODS: We conducted a retrospective chart review of patients who received iron sucrose TDI. Inclusion criteria included patients ≥18 years old who were hospitalized and received iron sucrose in doses ≥300 mg. We reviewed the medical record for adverse reactions to any TDI of iron sucrose as well as pre-TDI and post-TDI hemoglobin (Hgb) levels to assess efficacy. RESULTS: A total of 238 patients received iron sucrose TDI for IDA during the study period. One hundred ninety-three (81%) patients were female, and the mean age in our cohort was 60.6 years. Mean pre-TDI Hgb was 8.76 g/dL. The mean total dose of iron sucrose in the total cohort was 680 mg (range: 300-2500 mg). Adverse effects attributable to iron sucrose were reported in 15 patients, with nausea being the most common effect (7/238, 2.9%). When matching patients' preadmission and postadmission records, a Hgb increase of 2.1 g/L was found (P < .001). No increase in liver function tests was found in any patient. CONCLUSIONS: A pharmacist-assisted iron sucrose TDI protocol for patients with IDA successfully increased serum Hgb and was well tolerated. Anaphylaxis was not reported.

Relapsed/refractory diffuse large B-cell lymphoma: review of the management of transplant-eligible patients.

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is difficult to treat, with limited therapeutic options. Review of prognostic indices, DLBCL genetic classification, previous rituximab exposure, interval from previous therapy, chemosensitivity to salvage therapy and response on imaging is helpful when deciding upon appropriate candidates for further therapy. For appropriately selected patients, the primary strategy is to obtain remission with salvage therapy and proceed to autologous stem cell transplant (ASCT). However, salvage therapy and transplant conditioning regimens are suboptimal, as are therapeutic options for patients who relapse following ASCT. Recent research highlights the ongoing difficulty in the treatment of relapsed/refractory DLBCL, and novel treatments are needed.

Fludarabine: a review of the clear benefits and potential harms.

BACKGROUND: Fludarabine successfully treats chronic lymphocytic leukemia (CLL); however, its use may lead to significant myelosuppression and other toxicities. This article weighs the benefits against potential harms, highlighting strategies for appropriate patient selection and administration. METHODS: Relevant studies were identified upon literature review, which were combined with our clinical and institutional experience. RESULTS: Fludarabine-based regimens result in an overall response rate of approximately 95% and of untreated CLL patients. Fludarabine also causes potentially irreversible grade 3 or 4 cytopenias and infection in the majority of patients. Furthermore, future hematopoietic cell mobilization may be difficult and secondary myelodysplastic syndrome and leukemia occur in at least 3% of patients. CONCLUSION: Fludarabine should be used judiciously in older patients, and avoided entirely in patients with renal insufficiency. Close monitoring of blood cell counts with appropriate dose reduction/omission is vital. Finally, alternatives such as pentostatin and bendamustine should be considered.

The treatment of adolescents and young adults with acute lymphoblastic leukemia.

Adolescents and young adult (AYA) patients with acute lymphoblastic leukemia (ALL), 16-40 years of age, were historically not the focus of prospective studies on ALL treatment. This population has unique genetic, immunophenotypic, and clinical features, differing from both pediatric and older adult patients, with outcomes somewhere between these two populations. However, it has been suggested that outcomes (event-free and overall survival) for these patients are better when they are treated with pediatric-inspired therapeutic regimens. This has been attributed to increased dose and frequency of non-myelosuppressive therapy, earlier and more frequent central nervous system prophylaxis, and longer maintenance therapy. However, management by the treating oncologist and adherence by the patients are equally vital. Ultimately, the combination of improved treatment regimens and organizational management are required to improve outcomes of ALL in the AYA population.

Defining incidence, risk factors, and impact on survival of central line-associated blood stream infections following hematopoietic cell transplantation in acute myeloid leukemia and myelodysplastic syndrome.

Central line-associated blood stream infections (CLABSI) commonly complicate the care of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic stem cell transplantation (HCT). We developed a modified CLABSI (MCLABSI) definition that attempts to exclude pathogens usually acquired because of disruption of mucosal barriers during the vulnerable neutropenic period following HCT that are generally included under the original definition (OCLABSI). We conducted a retrospective study of all AML and MDS patients undergoing HCT between August 2009 and December 2011 at the Cleveland Clinic (N = 73), identifying both OCLABSI and MCLABSI incidence. The median age at transplantation was 52 years (range, 16 to 70); 34 had a high (≥3) HCT comorbidity index (HCT-CI); 34 received bone marrow (BM), 24 received peripheral stem cells (PSC), and 15 received umbilical cord blood cells (UCB). Among these 73 patients, 23 (31.5%) developed OCLABSI, of whom 16 (69.6%) died, and 8 (11%) developed MCLABSI, of whom 7 (87.5%) died. OCLABSI was diagnosed a median of 9 days from HCT: 5 days (range, 2 to 12) for UCB and 78 days (range, 7 to 211) for BM/PSC (P < .001). MCLABSI occurred a median of 12 days from HCT, with similar earlier UCB and later BM/PSC diagnosis (P = .030). Risk factors for OCLABSI in univariate analysis included CBC (P < .001), human leukocyte antigen (HLA)-mismatch (P = .005), low CD34(+) count (P = .007), low total nucleated cell dose (P = .016), and non-Caucasian race (P = .017). Risk factors for OCLABSI in multivariable analysis were UCB (P < .001) and high HCT-CI (P = .002). There was a significant increase in mortality for both OCLABSI (hazard ratio, 7.14; CI, 3.31 to 15.37; P < .001) and MCLABSI (hazard ratio, 6.44; CI, 2.28 to 18.18; P < .001). CLABSI is common and associated with high mortality in AML and MDS patients undergoing HCT, especially in UCB recipients and those with high HCT-CI. We propose the MCLABSI definition to replace the OCLABSI definition, given its greater precision for identifying preventable infection in HCT patients.