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  • 1
    In: Gynecologic Oncology, Elsevier BV, Vol. 131, No. 1 ( 2013-10), p. 231-240
    Type of Medium: Online Resource
    ISSN: 0090-8258
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2013
    detail.hit.zdb_id: 1467974-7
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  • 2
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 1511-1511
    Abstract: Abstract 1511 Background: Rituximab, a monoclonal antibody targeting CD20 receptors widely used in the treatment of non-hodgkin lymphoma, is now being used in various indications, on and off-label. For five University Hospitals in Quebec, Canada, rituximab represents more than 10% of the total drug expenses. Pharmacy managers gave the Therapeutic Drug Management Program (TDMP – www.pgtm.qc.ca) the mandate to evaluate rituximab use in those centers. Objectives: The objectives of the study were to describe rituximab use for all indications in our hospitals and to review the utilization of rituximab in maintenance therapy for follicular lymphoma according to predefined criteria. Methods: A review of pharmacy databases was performed to identify patients who received rituximab between April 1st 2008 and March 31st 2009. Every patient file containing rituximab was reviewed. Patients’ medical records were also reviewed for pathology and side effects. No sampling was performed. Results: At least one dose of rituximab was administered to 797 adult patients during the study period. Median age was 62. The most frequent indications were follicular lymphoma (36%) and diffuse large B-cell lymphoma (26%) followed by chronic lymphoid leukemia (CLL) (8%). Various off label indications, including idiopathic thrombocytopenic purpura, hemolytic anemia and Waldenstrom macroglobulinemia, represented 30% of our population. At the time of data analysis, 42% of patients were still treated with rituximab, 45% had finished their planned treatment and 6% had discontinued treatment because of adverse events or disease progression. Thirty-eight patients (4.8%) died during the study period. Rituximab was also used in 41 pediatric patients for various indications, mostly for nephrotic syndrome (27%). The evaluation of patients outcome for off-label indications could not be performed due to the complexity, variety and chronic courses of diseases treated. For the 232 patients receiving rituximab as maintenance therapy, only 76% of patients had follicular lymphoma. Of these, 53% received rituximab maintenance after first-line treatment with R-CVP and 19% after R-CHOP. Only one patient receiving maintenance treatment stopped therapy because of disease progression. No death was reported. Conformity to utilization criteria was excellent for dose and frequency (100% and 99%) but lower for duration and indication (87 % and 70%). Of note, 13% exceeded the planned two years treatment length and fourteen patients received maintenance therapy following induction chemotherapy for CLL. Conclusions: Rituximab was used in various on and off label indications and utilization criteria should be developed and followed in each centers. Pharmacy and therapeutics committees should also request an annual summary of efficacy and security for the off-label indications. Almost a third of patients treated with maintenance rituximab did not receive it for follicular lymphoma. A review of the literature should be performed and recommendations be made for other indications for maintenance treatment. Disclosures: Off Label Use: review of utilisation or rituximab: non hematologic indications.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
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  • 3
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 2073-2073
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 2073-2073
    Abstract: 2073 Background: Bevacizumab is widely used and may cause life-threatening bleeding, usually at sites of disease involvement such as the CNS. We attempted to identify clinical characteristics associated with CNS hemorrhage in a broad population. Methods: We did a retrospective review of the FDA Medwatch database of adverse events reported with bevacizumab from 11/1997 to 5/2009. Results: We searched the database for keywords bleeding, hemorrhage, cerebral, intracranial, subarachnoid, cerebellar, hemorrhagic stroke, and brain. 17,466 reports were included in the database: 154 described CNS hemorrhage in 99 patients, and 1041 reports described non-CNS bleeds. For CNS bleeds, cerebral hemorrhage was the most frequent event reported (n=39), followed by intracranial hemorrhage (n=20) and subarachnoid hemorrhage (n=18). Median age was 62 years; 54% of patients were female. Primary cancer was colorectal (42%), glioma (13%), and breast cancer (10%). Patients received a median of three (1-36) doses of bevacizumab prior to the bleed. 54% of patients received myelosuppressive chemotherapy, and 30% had documented history of hypertension. Sixteen patients with CNS hemorrhage were reported to have CNS metastases. For 70 patients, information on CNS involvement was not reported. Death was reported as a complication of hemorrhage in 48% of patients. Nine patients with brain metastases died and CNS hemorrhage was the cause of death in seven. Six patients with glioma died, and CNS hemorrhage was the cause in three. One patient with brain metastases, and one patient with glioma also experienced a non-CNS bleed. Five patients in each group had received heparin, warfarin or NSAIDs. Low platelet counts were reported in 3 patients with CNS metastases and 2 patients with glioma. The most common factor associated with CNS hemorrhage was medication predisposing to bleeding, followed by thrombocytopenia. Hypertension, a risk factor for CNS hemorrhage, was reported in 4 patients with brain metastases, and 2 patients with glioma. Conclusions: In this database, 154 of 1195 reports of bleeding associated with bevacizumab described a CNS bleed. Although CNS bleeds were not common, they were the reported cause of death in more than half of the cases.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e13027-e13027
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e13027-e13027
    Abstract: e13027 Background: Controversy surrounding weight in Carboplatin dosing is still current. Also, new methods of measuring serum creatinine have raised more questions regarding the precision of Carboplatin dose calculations. The two objectives of this study were to evaluate the impact of alternative weight indicators (actual and adjusted body weight) in the Cockcroft–Gault equation and the use of different creatinine measurements (standard and IDMS) in order to accurately predict Carboplatin dose. Methods: We performed a retrospective chart review on all patients who received at least one dose of Carboplatin between March 7 th and May 8 th 2010. The patients were divided into two groups according to their body mass index (BMI): 20 〈 BMI 〈 27 and BMI ≥ 27. The differential creatinine clearance and Carboplatin dose were assessed in each group using the actual body weight and the adjusted body weight with IDMS creatinine. Moreover, for patients who had their creatinine measurement at the CHUM hospital, we calculate the difference in Carboplatin dose by using the standard creatinine (SC) measurement and IDMS creatinine with the same weight. Results: A total of 95 patients, representing 119 Carboplatin doses, were included in the analysis. 82% were women and median age was 63. The average BMI was 26,6. The Carboplatin expected AUC was 5 for 89% of patients and Carboplatin was associated to Paclitaxel in 78% of patients. In patients with a 20 〈 BMI 〈 27 (44%), the average difference between the calculated dose using their actual body weight and adjusted body weight was +6.03% (95% CI, 5.2 to 6.9%). For patients with a BMI ≥ 27 (43%), the mean dose difference was +20.6% (95% CI, 18.8 to 22.5%). The use of SC or IDMS creatinine led to a discrepancy in doses of 5.2% (95% CI, 4.7 to 5.7%) for patients with BMI 〈 27 (35 patients) and 5.5% (95% CI, 4.9 to 6.2%) for those with BMI ≥ 27 (23 patients). Conclusions: Based on these findings, we decide in our clinic, to use the actual body weight for patients with a BMI between 20 and 27, and the adjusted body weight for those with a BMI ≥ 27. We also chose not to modify our doses based on the type of the serum creatinine measurement.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
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  • 5
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 1295-1295
    Abstract: Introduction Subcutaneous (SC) injection of bortezomib is more convenient for patients and staff. In September 2012, we standardised all bortezomib containing-protocols at our centre and changed the route of administration form intravenous to SC. Hematologic toxicity is commonly reported with these protocols. Currently, in our protocols, a complete blood count (CBC) is needed before every injection. Objectives This retrospective study aimed to analyse the rate of neutropenia and thrombocytopenia with Vel-Dex, VMP and CyBorD based on a threshold at day 1 to see if a CBC is needed before every injection in all patients. Blood pressure (BP) was measured before and after each SC injection to evaluate the risk of hypotension. Methods This retrospective study included all patients who received SC bortezomib in Vel-Dex, VMP and CyBorD protocols for multiple myeloma or amyloidosis at the Centre hospitalier de l'Université de Montréal (CHUM) between June 1, 2012 and May 31, 2013. Data was collected through medical and pharmaceutical patient records. Our local ethics board approved this study. Our main outcome is defined as the presence of neutropenia and thrombocytopenia for CyBorD (days 1, 8, 15 and 22 q 28 days), Vel-Dex (days 1, 4, 8 and 11 q 21 days) and VMP (days 1, 8, 22 and 29 q 42 days or days 1, 8, 15, 22 q 35 days) dichotomized at a threshold of ≥ 1.5 x 109 and ≥ 75 x 109respectively. A McNemar Test was used to estimate the association between the neutropenia and thrombocytopenia based on the dichotomized value on day 1. Results A total of 69 patients received bortezomib for MM (65 patients) or amyloidosis (4 patients). Median age was 67 years (SD ± 9.1) and 58 % of patients were male. Patients received Vel-Dex (23.2%), VMP (36.2%) and CyBorD (40.6%) protocols in 1st line eligible to stems cells transplant (26.2%), 1st line non-eligible (40.0%) or ≥ 2nd line (33.8%) for a total of 349 cycles. The median starting dose of bortezomib was 1.3 mg/m2 (SD ± 0.14). As shown in tables I and II, there is a statistical evidence of association when neutrophils ≥ 1.5 x 109 and platelets ≥ 75 x 109 at day 1 with the minimum of neutrophils and platelets on the CBC for the rest of the cycle of CyBorD and VMP. For Vel-Dex no significant association was seen because the incidence of neutropenia and thrombocytopenia is very low and doesn’t depend on a threshold at day 1. A patient, who has values above this threshold at day 1, could receive the rest of the cycle (Vel-Dex, CyBorD or VMP) without additional CBCs. When patients had blood counts below this threshold, chemotherapy was delayed 18 times (generally at day 1) or cancelled 39 times (other days). Patient previously exposed to many lines of therapy tend to have lower neutrophils or platelets counts. Also, a total of 1224 BP values before after SC bortezomib were analysed. No significant difference was detected between the average systolic (122 vs 122; p=0.43) and diastolic BP (70 vs 71; p=0.33) before and after treatment. Hypotension, defined as a drop of 20 mmHg of systolic BP, occurred 37 times (3.0%) but systolic BP was never below 90 mmHg and treatment was not necessary. A small increase of heart rate (82 vs 84; p 〈 0.001) was seen although it was not clinically significant. Table I: Rate of neutropenia during the cycle according to day-1 neutrophil counts Protocols CyBorD VMP Vel-Dex Neutrophils at day 1 of each cycle n ≥ 1.5 n 〈 1.5 p value n ≥ 1.5 n 〈 1.5 p value n ≥ 1.5 n 〈 1.5 p value Neutrophils ≥ 1.5 for the rest of the cycle 81.8 % 20 % p 〈 0.001 77.8 % 0 % p 〈 0.001 95.5 % 100 % NS Neutrophils 〈 1.5 for the rest of the cycle 18.1 % 80 % 22.2 % 100 % 4.5 % 0 % TOTAL of cycle 121 25 - - - 117 7 - - - 67 2 - - - Table II: Rate of thrombocytopenia during the cycle according to day-1 platelet counts Protocols CyBorD VMP Vel-Dex Platelets at day 1 of each cycle Plt ≥ 75 Plt 〈 75 p value Plt ≥ 75 Plt 〈 75 p value Plt ≥ 75 Plt 〈 75 p value Platelets ≥ 75 for the rest of the cycle 97.7 % 15.4 % p 〈 0.001 83 % 33.3 % p 〈 0.001 98.5 % 0 % NS Platelets 〈 75 for the rest of the cycle 2.3 % 84.6 % 17 % 66.7 % 1.5 % 100 % TOTAL of cycle 133 13 - - - 141 3 - - - 68 1 - - - Conclusion Our results demonstrate that the rate of thrombocytopenia and neutropenia was very low in patients who have neutrophils and platelets ≥ 1.5 x 109 and ≥ 75 x 109 at day 1 of each cycle of Vel-Dex, VMP and CyBorD. In these patients, no CBC seems necessary for the rest of cycle. Decreasing the number of CBC will use less resources, decrease costs and most importantly, improve the patient’s care by minimising interventions without increasing risk of adverse events. Disclosures Adam: Janssen: Honoraria. Lemieux-Blanchard:Celgene: Honoraria. Lemieux:Janssen: Honoraria.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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  • 6
    Online Resource
    Online Resource
    American Society of Hematology ; 2013
    In:  Blood Vol. 122, No. 21 ( 2013-11-15), p. 5610-5610
    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 5610-5610
    Abstract: Subcutaneous (SC) injection of bortezomib was reported to be safe and effective in myeloma patients. In September 2012, we standardised all bortezomib containing-protocols at our centre and changed the route of administration form intravenous (IV) to subcutaneous. This way of administration is more convenient for patients and staff and is reported to decrease the rate of peripheral neuropathies. Objectives This retrospective study aimed to describe the safety of this new administration technique, specifically regarding change in blood pressure and hematologic toxicity. Blood pressure (BP) was measured before and after each SC injection to evaluate the risk of hypotension, an adverse reaction frequently reported with IV bortezomib administration. Secondly, we wanted to analyse the rate of neutropenia and thrombocytopenia during the treatment to see if a complete blood count (CBC) is needed before every injection, versus only once weekly. Other adverse events were also collected. Methods This retrospective study included all patients who received bortezomib for multiple myeloma or amyloidosis at the Centre hospitalier de l'Université de Montréal (CHUM) between June 1, 2012 and May 31, 2013. Date was collected through medical and pharmaceutical patient records. Our local ethics board approved this study. Results A total of 45 patients received bortezomib for MM or amyloidosis with a median age of 68 years (SD ± 9.3) and 53.3 % were male. Patients received bortezomib in various protocols including Vel-Dex (42.2%), VMP (44.4%) and CyBorD (13.3%). The median starting dose of bortezomib was 1.3 mg/m2 (SD ± 0.13).  Patients received  SC only bortezomib injections (71.1%) or IV only (15.6%)  or were switched from IV to SC (13.3%) for a total of 157 cycles (786 doses). A total of 444 BP values before and 425 BP values after SC bortezomib were analysed. No significant difference was detected between the average systolic BP (125 vs 125; p=0.76), diastolic BP (70 vs 71; p=0.77) or heart rate (79 vs 78; p=0.89) between the 2 measurements. Hypotension, defined as a drop of 20 mmHg of systolic BP, occurred 18 times (4.2%) but systolic BP was never below 90 mmHg. One patient had a severe dysautomia, possibly related to bortezomib that required the discontinuation of the treatment. At our center, CBC are performed prior to each bortezomib dose. Neutropenia occurred in 10 % of the total doses received. Risk factors influencing neutropenia were the use of oral alkylating agent (melphalan and cyclophosphamide) in the regimen and baseline neutrophil count less than 2.0 x 109. Many patients also received bortezomib for a relapsed / refractory disease and were previously exposed to many lines of therapy. Thrombocytopenia occurred in 7,2% of doses received. Cutaneous toxicity occurred mostly with the first patients treated with the SC technique. With time, nursing changed their technique and further skin reactions were less reported. Neuropathy occurred in 21 patients (13 SC, 4 IV, 4 IV to SC), caused dose reductions in 7 patients (2 SC, 2 IV, 3 IV to SC) and treatment discontinuation in 2 patients (SC). Conclusion Our results demonstrate SC bortezomib was well tolerated. The rates of hypotension was quite low. Also rates and intensity of neutropenia and thrombocytopenia varied among different bortezomib containing regimens. Because of the low rate of profound neutropenia, Vel-Dex and VMP protocols can be modified to decrease the number of CBC to once weekly during the cycle rather than before every injection. More data are needed with CyBorD protocol before drawing any conclusions. Disclosures: Adam: Jansen Ortho: Honoraria. Lemieux-Blanchard:Celgene: Honoraria. Lemieux:Jansen Ortho: Honoraria.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
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  • 7
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2012
    In:  Cancer Chemotherapy and Pharmacology Vol. 69, No. 1 ( 2012-1), p. 107-113
    In: Cancer Chemotherapy and Pharmacology, Springer Science and Business Media LLC, Vol. 69, No. 1 ( 2012-1), p. 107-113
    Type of Medium: Online Resource
    ISSN: 0344-5704 , 1432-0843
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2012
    detail.hit.zdb_id: 1458488-8
    SSG: 15,3
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  • 8
    Online Resource
    Online Resource
    Elsevier BV ; 2012
    In:  Actualités Pharmaceutiques Vol. 51, No. 512 ( 2012-3), p. 8-9
    In: Actualités Pharmaceutiques, Elsevier BV, Vol. 51, No. 512 ( 2012-3), p. 8-9
    Type of Medium: Online Resource
    ISSN: 0515-3700
    Language: French
    Publisher: Elsevier BV
    Publication Date: 2012
    detail.hit.zdb_id: 2481757-0
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  • 9
    Online Resource
    Online Resource
    Elsevier BV ; 2012
    In:  Actualités Pharmaceutiques Vol. 51, No. 516 ( 2012-6), p. 6-8
    In: Actualités Pharmaceutiques, Elsevier BV, Vol. 51, No. 516 ( 2012-6), p. 6-8
    Type of Medium: Online Resource
    ISSN: 0515-3700
    Language: French
    Publisher: Elsevier BV
    Publication Date: 2012
    detail.hit.zdb_id: 2481757-0
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  • 10
    Online Resource
    Online Resource
    Elsevier BV ; 2012
    In:  Actualités Pharmaceutiques Vol. 51, No. 512 ( 2012-3), p. 6-7
    In: Actualités Pharmaceutiques, Elsevier BV, Vol. 51, No. 512 ( 2012-3), p. 6-7
    Type of Medium: Online Resource
    ISSN: 0515-3700
    Language: French
    Publisher: Elsevier BV
    Publication Date: 2012
    detail.hit.zdb_id: 2481757-0
    SSG: 15,3
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