A Canadian perspective on the subcutaneous administration of rituximab in non-Hodgkin lymphoma.

Rituximab is widely used for the treatment of non-Hodgkin lymphoma, being a key component in most therapeutic regimens. Administration of the intravenous (IV) formulation is lengthy and places a significant burden on health care resources and patient quality of life. A subcutaneous (sc) formulation that provides a fixed dose of rituximab is being examined in a number of studies. Results indicate that the pharmacokinetics are noninferior and response rates are comparable to those obtained with the IV formulation. Moreover, the sc formulation is preferred by patients and health care providers and reduces administration and chair time. Additional advantages include a lesser potential for dosing errors, shorter preparation time, reduced drug wastage, and fewer infusion-related reactions. Despite the success of the sc formulation, correct administration is needed to reduce administration-related reactions. By using a careful procedure, the sc formulation can be given safely and effectively, potentially reducing the burden on health care resources and improving quality of life for patients.

A Canadian perspective on the safe administration of bendamustine and the prevention and management of adverse events.

Although bendamustine has been used to treat lymphoproliferative disorders for decades, it has only recently been approved for use in Canada. Thus, Canadian recommendations on the administration of bendamustine and the management of common adverse events (aes) are needed. This article highlights effective management and assessment strategies recommended by Canadian nurses and pharmacists for the most common aes arising from the use of bendamustine in patients with chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma. Those strategies include administering bendamustine over 60 minutes instead of 30 minutes, administering pre-medications to control infusion-related reactions and nausea, hydrating patients to minimize fatigue, and using free-flowing saline at the closest port to prevent phlebitis.

A mixed-method evaluation of nurse-led community-based supportive cancer care.

GOALS OF WORK: The study purpose was to evaluate a nurse-led supportive care clinical case management program in the community using multi-methods to delineate care processes prior to outcome evaluation. MATERIALS AND METHODS: Multiple data sources including program service records, chart reviews and interviews with nurses and key interdisciplinary informants were used to identify population served (coverage and reach), processes of care (implementation), and providers' perceptions of the effectiveness of the nurse-led program (reaction). MAIN RESULTS: The program provided care to over 700 cancer patients in a 1-year period. Nurse-led support interventions were focused on direct care inclusive of teaching/coaching for symptom management, counseling and support, and mobilization of services through system navigation based on an initial comprehensive assessment of supportive care needs. CONCLUSIONS: Nurse-led models of supportive care have the potential to reduce unmet supportive care needs, improve continuity of care, and overall health-related quality of life that should be tested in future trials.

Alendronate for steroid-induced osteopenia in children with acute lymphoblastic leukaemia or non-Hodgkin's lymphoma: results of a pilot study.

BACKGROUND/OBJECTIVES: Osteopenia is a significant morbidity in children undergoing therapy for acute lymphoblastic leukaemia (ALL) or non-Hodgkin's lymphoma (NHL). We conducted a pilot study to assess the impact of alendronate on whole body bone mineral content (WB-BMC), lumbar spine bone mineral density (LS-BMD), biochemical measures of bone mineral metabolism, as well as gross motor function and health-related quality of life (HRQL) in children undergoing therapy for ALL or NHL. METHODS: Ten children (nine boys) between the ages of 3.6 and 14.6 years, on identical maintenance chemotherapy for ALL or NHL were treated with oral alendronate once weekly, and daily calcium supplementation, for a period of six months. Outcome measures were WB-BMC and LS-BMD; biochemical measures of bone mineral metabolism including plasma osteocalcin, C-terminal telopeptide of type I collagen (CTx), serum calcium, 25-hydroxy-vitamin D (25-OHD), and parathyroid hormone (PTH); as well as assessments of motor function and HRQL. RESULTS: A gain in Z score was observed in 7/9 evaluable patients for WB-BMC (mean increase of 0.49) and LS-BMD (0.51). Plasma osteocalcin and CTx showed a change in bone turnover favouring formation over resorption. Serum calcium and 25-OHD remained normal throughout treatment. After an initial spike, serum PTH returned to baseline values at week 4. Measures of motor function showed some improvement and there were modest gains in HRQL. CONCLUSIONS: Alendronate therapy was tolerated well. Further study in a larger sample of children with ALL or NHL is warranted, in the context of a randomized clinical trial.

A preoperative protocol for the prevention of infection in children with tunnelled right atrial catheters.

The use of central venous lines has come to be widely accepted by children with cancer and their families. However, attendant infection is a cause of considerable morbidity. Coagulase-negative staphylococci, the predominant aerobic species on the skin, are now the commonest cause of catheter-related bacteremia. We introduced a protocol to reduce the colonization of the skin at the catheter insertion site. Antiseptic skin scrubs, with 4% chlorhexidine gluconate, were performed on the neck and anterior chest the night before and again on the morning of the surgical procedure. A single dose of cephalothin (or vancomycin for penicillin-allergic patients) was administered IV immediately before the operation. Compared to the 12 month period prior to initiation of this protocol, the rate of infections (occurring within 30 days of catheter placement) in the 3.5 year period of intervention dropped from 8 to 4.9 per 1,000 catheter days. The proportion of infections that were staphylococcal was reduced from 93 to 63% and the proportion of non-ports removed within 30 days of placement fell from 45 to 0%. Despite these changes, the major contribution to improved infection control appeared to be the use of an increased proportion of ports (a rise from <10 to almost 60%).

Stability and sterility of recombinant tissue plasminogen activator at -30 degrees C.

We assessed whether frozen recombinant tissue plasminogen activator (rt-PA) remains stable and sterile for up to 22 weeks at -30 degrees C. Our findings confirm that rt-PA is a cost-effective alternative to urokinase for restoring patency to occluded central venous catheters.

Open-label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy.

BACKGROUND: Nausea and vomiting are among the most unpleasant adverse side effects of cancer therapy. PROCEDURE: An open-label dose-escalation study was conducted to assess the appropriate intravenous dose of dolasetron for pediatric patients undergoing chemotherapy. Patients received dolasetron in single intravenous doses of 0.6 (n = 10), 1.2 (n = 12), 1.8 (n = 12), or 2.4 (n = 12) mg/kg 30 min before receiving emetogenic chemotherapy. Pharmacokinetic parameters were evaluated at each dose level and efficacy was evaluated over the first 24 hr following the administration of dolasetron. RESULTS: A complete response was achieved in 10% of patients given 0.6 mg/kg, 25% of patients given 1. 2 mg/kg, 67% of patients given 1.8 mg/kg, and 33% of patients given 2.4 mg/kg. Peak plasma concentrations (Cmax) were observed between 0. 33 and 0.75 hr following dolasetron infusion. Cmax and area under plasma concentration-time (AUC) increased with larger doses of dolasetron, while terminal disposition half-life (t1/2) and apparent clearance (Clapp) were not significantly changed with respect to dose. For 1.8-mg/kg dolasetron, the t1/2 was 4.98 hr and the maximum plasma concentration (tmax) 0.47 hr. Adverse events were mild to moderate. No serious events occurred. Conclusions. This study suggests that a single intravenous dose of 1.8 mg/kg is the optimum single intravenous dose for controlling chemotherapy-induced emesis in pediatric patients.

Disseminated Langerhans cell histiocytosis in identical twins unresponsive to recombinant human alpha-interferon and total body irradiation.

Monozygotic twin boys presented at 1 year of age with seborrheic skin rash, otorrhea, and hepatosplenomegaly. Skin biopsy confirmed Langerhans cell histiocytosis. Treatment with conventional antineoplastic drugs and with calf thymus extract was ineffective. The disease remained refractory to recombinant human alpha-interferon and to low-dose total body irradiation, and the children died between 3 and 3 1/2 years of age.

Bacterial colonization of tunneled right atrial catheters in pediatric oncology: a comparison of sterile saline and bacteriostatic saline flush solutions.

In a double-blind, randomized controlled trial, children with malignant diseases had their tunneled right atrial catheters flushed with either sterile saline or bacteriostatic saline, once per week for 26 weeks. There was no significant difference in the rates of catheter colonization between the two groups, which did differ, however, in terms of the time from entry into the study to the first infective event (64 +/- 34 days vs. 146 +/- 27 days; p less than 0.001). This was strongly suggestive of a seasonal effect, as all of the colonizations in the bacteriostatic saline group were delayed until the summer months. We conclude that the use of a bacteriostatic saline flush solution for tunneled right atrial catheters is beneficial in efforts to prevent catheter colonization.

Evaluation of a home intravenous antibiotic program in pediatric oncology.

We conducted a pilot program of home intravenous antibiotic therapy for the management of febrile neutropenic episodes in a population of children with cancer. During a 6-month period, 13 children/families participated in the successful treatment of 22 episodes of infection. A cost analysis of the program indicates that home therapy is considerably cheaper than in-hospital treatment. Although the program represents an incremental cost to the hospital, it does provide for more efficient health care delivery. Feedback from parents who participated was highly favorable. We believe that home intravenous antibiotic therapy is a safe and efficacious alternative to hospital management of children with malignant diseases admitted with fever and neutropenia.

Free and liposomal doxorubicin treatment of intraperitoneal colon 26 tumor: therapeutic and pharmacologic studies.

Intraperitoneal (i.p.) chemotherapy is being investigated as an adjunct to surgery to kill residual cancer cells, inhibit cancer cell seeding, local recurrence, and metastases for ovarian, gastric, and colon cancers. In this report, the therapeutic effects of Doxorubicin (Dox) and liposome-entrapped Dox (Dox-Lip) against i.p. mouse colon 26 (C26) tumor were compared. It was found that Dox-Lip was less toxic than Dox after i.p. administration in non-tumor bearing animals. I.P. Dox and Dox-Lip significantly inhibited the growth of C26 tumor when the treatment was initiated 1 day after tumor cell inoculation, but both administration forms were ineffective against well-established (8-day) tumors. Multiple dose schedules did not improve the therapeutic response. Dox-Lip was not therapeutically superior to Dox at equal doses or at approximately equi-toxic doses. In addition, the relative retention of Dox and Dox-Lip in the peritoneal cavity and their plasma pharmacokinetics were investigated. It was found that Dox levels in the peritoneal cavity were maintained for longer periods after i.p. Dox-Lip was administered. However, the results show that maintenance of elevated drug levels in the peritoneal cavity does not necessarily lead to increased therapeutic effects.