2020 ASCO, 2023 NCCN, 2023 MASCC/ESMO, and 2019 CCO: a comparison of antiemetic guidelines for the treatment of chemotherapy-induced nausea and vomiting in cancer patients.

Chemotherapy-induced nausea and vomiting (CINV) is a common toxicity that may impair the quality of life of patients with various malignancies ranging from early to end stages. In light of frequent changes to the guidelines for optimal management of CINV, we undertook this narrative review to compare the most recent guidelines published by ASCO (2020), NCCN (2023), MASCC/ESMO (2023), and CCO (2019). The processes undertaken by each organization to evaluate existing literature were also described. Although ASCO, NCCN, MASCC/ESMO, and CCO guidelines for the treatment and prevention of CINV share many fundamental similarities, the literature surrounding low and minimal emetic risk regimens is lacking. Current data regarding adherence to these guidelines is poor and warrants further investigation to improve care.

Development of a process map for the delivery of virtual clinical pharmacy services at Odette Cancer Centre during the COVID-19 pandemic.

Virtual methods have been innovatively utilized to provide clinical and supportive care to patients with cancer. Oncology pharmacists have been actively involved in this movement, in order to minimize patient contact and decrease the risk of viral transmission for this high-risk group. In response to COVID-19 restrictions, the Odette Cancer Centre pharmacy modified the delivery of clinical pharmacy services (CPS), including medication histories and patient education/counseling, to a remote telephone-based model. Process maps were created to visualize workflow before and after the pandemic. Process metrics were tracked over a 6-week period. From March 25th to May 1st, 2020, 202 best-possible medication histories and baseline assessments were completed; 149 of these (74%) were completed remotely. For medication therapy counsels, 72 of 199 were completed remotely (36%). Despite workflow disruptions caused by the pandemic, these results demonstrate that clinical pharmacy service levels could be maintained by incorporating remote delivery approaches without significant investment in resources. Challenges included acceptance by patients and lack of technology to support system-level processes. Further research to develop, refine, and individualize virtual clinical pharmacy care models will help to consolidate the role of these approaches in the post-COVID-19 era.

Hazardous drug residue on exterior vial surfaces: evaluation of a commercial manufacturing process.

PURPOSE: Hazardous drug residue on the exterior surface of drug vials poses a potential risk for exposure of health care workers involved in handling these products. The purpose of this article is to heighten the awareness of this serious issue and to evaluate a commercial manufacturing process for removing and containing hazardous drug (HD) residue on exterior vial surfaces. Additionally, findings from this study are interpreted, incorporated into the current body of evidence, and discussed by experts in this field. METHODS: This study includes separate evaluations for the presence or absence of surface drug contamination on the vials of 3 HD products: 5-fluorouracil, cisplatin, and methotrexate. The drug products were packaged in vials using a patented prewashing/decontamination method, application of a polyvinylchloride (PVC) base, and use of clear glass vials. An additional step of encasing the vial in a shrink-wrapped sheath was used for 5-fluorouracil and cisplatin. RESULTS: Of all 5-fluorouracil (110 vials), methotrexate (60 vials), and cisplatin (60 vials) tested, only 2 had detectable amounts of surface residue. One 5-fluorouracil vial was found to have approximately 4 mg of 5-fluorouracil on the surface of the vial. The second contaminated vial was cisplatin, which was discovered to have 131 ng of platinum, equal to 200 ng of cisplatin or 0.2 µL of cisplatin solution, on the vial sheath. CONCLUSION: Using validated extraction and analytic methods, all but 2 of the 230 tested vials were found to be free of surface drug contamination. Pharmacy leaders need to take an active role in promoting the need for clean HD vials. Manufacturers should be required to provide their clients with data derived from externally validated analytic studies, reporting the level of HD contamination on the exterior of their vial products.

Key components of intravenous chemotherapy labeling: a systematic review and practice guideline.

OBJECTIVE: To determine the necessary components and formatting of an intravenous chemotherapy label to maximize safe delivery and minimize errors. Date sources. The MEDLINE and EMBASE databases (up to April 2009) were searched for relevant evidence. Reference lists from retained studies were then searched for additional trials. An environmental scan was also conducted to locate other published and unpublished sources of information. Study selection. Relevant articles were selected and reviewed by one methodologist. Articles were selected for inclusion if they were published English language reports of Phases II or III randomized controlled trials, other comparative studies, single-arm studies, practice guidelines, or systematic reviews with or without meta-analyses, which related to the study question. MEDLINE and EMBASE searches yielded 685 potential studies of which 17 met the inclusion criteria. The environmental scan located one guideline. Three additional relevant studies were identified during the external review process. In total, 21 documents met the inclusion criteria. Data extraction. Data were extracted by one methodologist. Quality of systematic reviews was assessed using the AMSTAR tool. All other studies were evaluated based on study characteristics applicable to the particular study design. Data synthesis. The evidence collected and the consensus of expert opinion of Cancer Care Ontario's Chemotherapy Labeling Panel form the basis of a series of recommendations for the generation of intravenous chemotherapy labels including formatting, required information, and order of information. These guidelines inform the efficient, effective, and safe administration of intravenous chemotherapy. Illustrative examples are provided.

Stability of Generic Formulations of Bortezomib 1.0 and 2.5 mg/mL in Vials and Syringes Stored at 4°C and Room Temperature (23°C or 25°C).

BACKGROUND: The availability of generic versions of bortezomib raises questions about the reliability of extrapolating stability data from one brand to another. OBJECTIVE: To evaluate the stability of bortezomib formulations available from Janssen, Teva Canada, Actavis Pharma, Dr. Reddy's Laboratories, Apotex, and MDA, reconstituted with 0.9% sodium chloride (normal saline) to produce solutions of either 1.0 or 2.5 mg/mL and stored over at least 21 days under refrigeration (4°C) or at room temperature (either 23°C or 25°C) in the manufacturer's original glass vials or in polypropylene syringes. METHODS: On study day 0, solutions with concentration 1.0 mg/mL or 2.5 mg/mL of the Teva, Actavis, Dr. Reddy's, Apotex, and MDA generic formulations were prepared. Three units of each type of container (glass vials and syringes) were stored at 4°C and 3 units at room temperature. Concentration and physical inspection were completed on at least 8 study days (including day 0) over a 21- to 84-day study period. Bortezomib concentrations were determined by a validated stability-indicating liquid chromatographic method with ultraviolet detection. The end point of these studies was the time to reach 90% of the initial concentration (T-90) with 95% confidence, which is expressed as "T-9095%CI", where CI refers to the confidence interval. In addition to estimating the T-9095%CI, differences in stability among products from all manufacturers were compared using multiple linear regression. Previously published data for the Janssen product were included in the overall comparisons. RESULTS: In all of the studies, the analytical method separated degradation products from bortezomib, such that the concentration of bortezomib was measured specifically, accurately (deviations < 2.5%), and reproducibly (average replicate error 2.5%). During all studies, solutions retained more than 94% of the initial concentration at 4°C. The T-9095%CI exceeded the study period for all formulations under all combinations of concentration, container, and temperature, except the 84-day study for the MDA product. Multiple linear regression showed no significant differences among manufacturers (p = 0.57). CONCLUSIONS: In this study, formulations of bortezomib currently marketed in Canada (by Janssen, Teva Canada, Actavis Pharma, Dr. Reddy's Laboratories, Apotex, and MDA) were pharmaceutically equivalent and interchangeable. Given that there was no difference in stability related to manufacturer, nominal concentration, or container, we conclude that these formulations are physically and chemically stable for at least 35 days under refrigeration and at least 25 days at room temperature.

CONTEXTE: La disponibilité de versions génériques de bortezomib soulève des questions relatives à la fiabilité de l'extrapolation des données concernant la stabilité d'une marque à l'autre. OBJECTIF: Évaluer la stabilité des formules de bortezomib de Janssen, de Teva Canada, d'Actavis Pharma, des Laboratoires du Dr Reddy, d'Apotex et de MDA, reconstituées avec 0,9 % de chlorure de sodium (solution saline normale) pour produire des solutions de 1 ou de 2,5 mg/mL et réfrigérées au moins 21 jours à 4 °C ou à température ambiante (23 °C ou 25 °C), dans des fioles en verre du fabricant ou dans des seringues en polypropylène. MÉTHODES: La préparation des solutions avec une concentration de 1 mg/mL ou 2,5 mg/mL des formules génériques de Teva, d'Actavis, du Dr Reddy, d'Apotex et de MDA a eu lieu le jour 0 de l'étude. Trois unités de chaque contenant (fioles en verre et seringues) étaient stockées à 4 °C et 3 unités, à température ambiante. L'inspection de la concentration et l'inspection physique ont été réalisées pendant au moins 8 jours (y compris le jour 0) de l'étude qui a duré de 21 à 84 jours. Les concentrations de bortezomib ont été déterminées par une méthode chromatographique liquide validée, indiquant la stabilité à l'aide d'une détection par rayons ultraviolets. Le point final de ces études était le temps nécessaire pour que le produit atteigne 90 % de la concentration initiale (T-90) avec un seuil de confiance de 95 %, exprimé par T-90IC 95 %, IC indiquant l'intervalle de confiance. En plus de l'estimation du T-90IC 95 %, les différences de stabilité des produits de tous les fabricants ont été comparées à l'aide d'une régression linéaire multiple. Les données publiées précédemment sur le produit Jansen sont incluses dans les comparaisons globales. RÉSULTATS: La méthode analytique de toutes les études qui ont été menées a séparé les produits de dégradation du bortezomib de telle manière que la concentration était mesurée de manière spécifique, précise (déviations < 2,5 %) et reproductible (erreur de réplique 2,5 %). Tout au long des études, les solutions ont retenu plus de 94 % de la concentration initiale à 4 °C. Le T-90IC 95 % de toutes les formules dans toutes les combinaisons de concentration, de contenant et de température, dépassait la durée des études, à l'exception du produit MDA dans l'étude de 84 jours. La régression linéaire multiple n'a indiqué aucune différence importante parmi les fabricants (p = 0,57). CONCLUSIONS: Dans cette étude, les formules de bortezomib actuellement commercialisées au Canada (par Janssen, Teva Canada, Actavis Pharma, les Laboratoires du Dr Reddy, Apotex et MDA) étaient équivalentes et interchangeables d'un point de vue pharmaceutique. Puisqu'aucune différence de stabilité, de concentration nominale ou de contenant liée à l'un ou l'autre des fabricants n'a été révélée, nous concluons que ces formules sont physiquement et chimiquement stables pendant au moins 35 jours sous réfrigération et au moins 25 jours à température ambiante.

Selection of adjuvant chemotherapy for treatment of node-positive breast cancer.

Over the past two decades, several studies have suggested that regimens that contain anthracyclines are more effective than those that do not. A meta-analysis by the 2005 Early Breast Cancer Trialists' Collaborative Group confirmed that about 6 months of anthracycline-based polychemotherapy in the adjuvant setting reduced the yearly death rate from breast cancer by about 38% for women younger than 50 years and by 20% for women aged 50-69 years. Although this meta-analysis found that survival was better with regimens that contain anthracycline than with regimens based on cyclophosphamide, methotrexate, and fluorouracil, the best use of anthracycline-based regimens remains unclear. Adjuvant regimens in use can be categorised into three groups: standard-dose anthracycline; escalated-dose epirubicin; and anthracyclines and taxanes. The duration of treatment and combination of dose and drugs varies between these three categories. We reviewed the three types of regimen to establish which provide a better outcome in terms of safety, efficacy, cost, and convenience to patients. We found that both escalated-dose epirubicin and anthracycline-taxane regimens were most effective in terms of disease-free survival and overall survival. Of the specific anthracycline-based regimens, the docetaxel, doxorubicin, and cyclophosphamide regimen (TAC); the fluorouracil, 100 mg epirubicin, and cyclophosphamide regimen (FEC100); and the cyclophosphamide, epirubicin, and fluorouracil regimen (CEF) produced the greatest proportional decreases in 5-year death rate.

Bisphosphonate use for the management of breast cancer patients with bone metastases: a survey of Canadian Medical Oncologists.

BACKGROUND: The use of bisphosphonates (BP) in breast cancer patients with bone metastases (BM) has been shown to reduce bone pain and lower the risk of skeletal-related events (SREs). Many practice guidelines exist for the use of BPs in patients with BM. Unfortunately, none clearly address whether the benefits of BP use apply equally to all subgroups of patients, the duration of therapy, and when to discontinue BP therapy. A questionnaire was therefore developed and administered to determine how medical oncologists in Canada use BPs in clinical practice. METHODS: A structured mailing strategy was adopted. The population consisted of 100 medical oncologists with active breast cancer practices in Canada. All regions of Canada were represented. The questionnaire was developed to capture data on respondent demographics, BPs used, major factors influencing decision making, and clinical practice in situations where there is a lack of high-quality data. RESULTS: Completed questionnaires were returned by 76 medical oncologists. All treated breast cancer and the majority (68%) were based at teaching hospitals. Ninety-six percent of respondents regularly prescribed BPs, initiating therapy at the time the patient presented with BM. Although 79% of respondents recognized that there was no clear data to support the continued use of BP after bony progression, 53% stated that they rarely or never discontinue a BP once started. In situations where a BP was discontinued, the majority of respondents report the reason for discontinuation was a decrease in patient performance status. In the patient with clearly progressive visceral metastases and an estimated prognosis of less than 6 months, 75% of respondents would still commence BP therapy. CONCLUSIONS: This study confirms that most medical oncologists in Canada, while acknowledging lack of evidence, maintain patients on BP therapy when patients have an expected survival of less than 6 months or even after patients progress while on a BP. More research is needed to determine the role of continuing, switching, or discontinuing BP therapy in the context of disease progression or shortened expected survival.