Late-onset neutropenia (LON) following rituximab therapy is a recently recognized adverse effect occurring in various clinical settings. However, the true incidence and pathogenesis of this adverse effect are not fully understood. We retrospectively reviewed the medical records of 160 patients with diffuse large B-cell lymphoma (DLBCL) in complete remission (CR) following first-line treatment with rituximab-containing therapy. The incidence of LON was 26.9% (grade 1, 2, 3 and 4) and the incidence of severe LON (grade 3 and 4) was 7.5%. The risk factors for the occurrence of LON were not identified, and overall survival did not differ between patients who developed LON and those who did not. This study suggests that LON is a quite common complication to rituximab therapy. However, more studies are needed in order to elucidate the true mechanism behind and risk factors for LON.
New treatment approaches that include the use of aromatase inhibitors in adjuvant breast cancer management are associated with higher efficacy and increased drug costs. Our aim was to calculate the difference in total costs of care associated with two therapeutic options, anastrozole and tamoxifen, from the perspective of a healthcare provider. The cost of care and a decision tree analysis were used in this assessment. The efficacy of both drugs in terms of relapse rate was obtained from an ATAC (Arimidex, Tamoxifen Alone or in Combination) trial after the median observational time of 68 months. The total sum of all direct healthcare costs over a 60-month period was 14,438 and 8,009 Euros per person in the anastrozole and tamoxifen arm, respectively. Despite higher total costs of care associated with anastrozole, the drug cost ratio of anastrozole/tamoxifen=8.1/1 converted to a ratio of only 1.75/1 in favor of tamoxifen when costs of recurrence and adverse events were included. The total costs of care, including disease recurrences and adverse event management obtained in our analysis were similar to total costs of care values for other surveys, which lead us to believe that anastrozole is also a cost-effective alternative to tamoxifen in Slovenia.
BackgroundHyperthermic isolated limb perfusion (HILP) is a regional treatment of advanced limb cancers with antitumor drugs (melphalan and tumour necrosis factor (TNF)) under hyperthermic conditions. The use of TNF might be challenging as it can cause cardiogenic shock in pharmacological dosages. The Institute of Oncology Ljubljana (OIL) is one of a few institutions which have special accreditation for using TNF during HILP. HILP is indicated in patients with regionally advanced melanoma or limb sarcomas where amputation would be the only possible treatment.PurposeThe aim of this retrospective study was to assess regional and systemic toxicity and other postoperative complications in 51 cases of HILP. A review of the effectiveness of treatment with overall response rate is also included.Material and methodsFrom 2010 to 2015, 51 patients with in-transit melanoma or sarcoma metastases were treated with HILP at OIL. During the procedure, the vessels in the lower/upper limb are isolated and connected to the heart-lung machine. First, the isolated limb is warmed to about 40°C and leakage measurements are performed. If there is no leakage, antitumour drug is applied at a dosage 10–20 times higher than the maximal doses allowed for systemic application. At the end, the limb is washed out and the vessels are repaired. The Wieberdink grading system was used to evaluate the regional toxic effect. Most systemic side effects are caused by leakage of drugs into the systemic circulation.ResultsRegional toxicity was classified using the 5 grade Wieberdink system. In this study, most of the patients had grade I toxicity (70.58%), however in 1.96%, grade V regional toxicity occurred. In 6 cases systemic toxicity occurred; 3.92% of patents had muscle wasting with elevated myoglobin, 1.96% of patients had thrombosis and 5.88% of patients had systemic inflammatory response syndrome. 10 patients had treatment related complications such as lymphoedema, bleeding, paresis and infection.ConclusionHILP is an effective treatment with complete response rates reaching up to 90% in patients with melanoma and sarcoma. Due to the systemic and local toxicity of antitumour drugs, close collaboration between the clinical pharmacist and surgeon during HILP is highly recommended.No conflict of interest.
BackgroundOxaliplatin is an effective medicine for adjuvant or metastatic treatment of patients with colorectal cancer (CRC). Common side-effects include acute cold-induced as well as chronic neurotoxicity resulting in dose reduction or even complete oxaliplatin discontinuation and treatment modification. For patients receiving high cumulative doses of oxaliplatin (780 to 850 mg/m2), the incidence of grade 2 or 3 neurotoxicity has been shown to be 12% to 18%.1 PurposeThe aim of our study was to investigate both the incidence and significance of neurotoxicity in patients receiving cumulative oxaliplatin doses of 1000 mg/m2 or higher. We could then determine whether the pre-emptive intervention of a clinical pharmacist is justified.Material and methodsIn the period from January 2016 to July 2017, 484 patients diagnosed with CRC received oxaliplatin as part of their treatment regimen. Among them, 40 patients who had received cumulative doses of 1000 mg/m2 or more were selected for evaluation of neurotoxicity symptoms based on their clinical records. An oxaliplatin-specific scale (NCI-CTC 2.0) was used to assess the level of neurotoxicity.2 ResultsSymptoms presented as moderate paraesthaesia (grade 1) occurred in 11 patients (28%), while six patients (15%) reported mild or moderate objective sensory loss (grade 2). Dose-limiting neurotoxicity (grade 2 and 3) was observed in nine patients (22.5%) with a complete oxaliplatin discontinuation being required in three patients (7.5%) due to sensory loss, polyneuropathy and pain (grade 3). Eleven patients (27.5%) remained asymptomatic according to the NCI-CTC scale.ConclusionThe results of our study are in agreement with published data. Based on the findings that over one-fifth of patients receiving high cumulative doses of oxaliplatin experience significant neurotoxicity, a clinical pharmacist’s intervention in the form of a consultation with the physician is thereby warranted in order to re-evaluate the benefit of chemotherapy treatment versus the impact on a patient’s quality of life.References and/or Acknowledgements1. de Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol2000;18:2938–2947.2. Greothey A. Oxaxliplatin-safety profile: neurotoxicity. Seminars in OncologyAugust 2003;30(No. 4, Suppl. 15):5–13.No conflict of interest
Background The Oncology Institute of Ljubljana (OIL) is the main cancer care institution in Slovenia. Extravasation is a serious complication of intravenous chemotherapy. Clinical outcomes vary from minor symptoms to severe tissue damage. The aim of the guidelines is to provide appropriate, professional and clear instructions on how to treat the patients in whom extravasations occur. Purpose To develop guidelines for treating anticancer drug extravasation, which contain the management algorithm of antidotes and treatments that should be performed, as well as risk factors and strategies to prevent extravasation. Furthermore, to statistically review all documented cases of anticancer drug extravasations from January 2010 to September 2013. Materials and methods 47 different intravenous anticancer drugs are available in chemotherapy protocols in OIL. Our extravasation guidelines were based on a literature review, through research and analysis of guidelines and articles obtained. Results Anticancer drugs are classified according to their damage-causing potential as vesicant, non vesicant and irritant; this determines the treatment regimens recommended. From the literature reviewed it was obvious that some anticancer drugs differ in classification according to their injury-inflicting potential and treatment regimens. In our guidelines we did not consider that distinction between vesicant and non-vesicant drugs to be absolute. The measures to be taken when chemotherapy extravasation occurs are based on the classification of their potential, ATC classification and knowledge of the actions of the drug and its antidote. Our guidelines include three specific antidotes: dimethyl sulfoxide, hyaluronidase and dexrazoxane, found in the literature review. A total of 47 anticancer drugs available in our guidelines were divided into 10 vesicants, 10 irritants and 16 non-vesicant drugs. 8 drugs were classified as both vesicant and irritant and 3 drugs as both irritant and non vesicant. Topical application of cold packs is recommended for 20 anticancer drugs, warm packs for 4 drugs, for 5 drugs we can use either of them and 18 drugs require none of the above. Specific management of some anticancer drugs (packs, antidotes) is changed when a large volume and high concentration is extravasated. In the events reported, the extravasated drugs were classified as vesicant in 59% of cases, irritant in 17% and non-vesicant in 24% of cases. In 60 cases specific antidotes and in 77 cases cold packs were administered but in 32 cases further action was required. Antidotes were administered in 11% of cases studied: mainly dimethyl sulfoxide (48%) and hyaluronidase (41%) but also dexrazoxane. Conclusions The guidelines are a valuable tool for our institute as well as for other medical centres throughout Slovenia. In addition each case of extravasation is documented through an anticancer drug extravasation documentation form. No conflict of interest.
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