Antineoplastics
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Reactions Monitor Rapid, comprehensive identification of all adverse drug expe ri ence reports from 1700 international medical journals , presented as either summaries or citations to produce a complete fi le Antineoplastics Thrombosis: inc idence study Women < 70 years of age with histologically confirmed stage II breast cancer were entered into a trial within 6 weeks of surgery. After baseline assessment patients were randomised to treatment with IV methotrexate 35 mg/m 2 /week , oral cyclophosphamide 80 mg/m 2 / day, and IV flu orouracil 500 mg/m 2 /week for 8 weeks with IV vincristine 1 m g/m 2 /week for 4 weeks then 1 mg/m 2 in weeks 6 , 8, 10 and 12, oral prednisone 50 mg/day for 10 days, tapered over 20 days, then 5 mg/day to 12 weeks, IV doxorubicin 20 mg/m 2 /week in weeks 9-12 and oral tamoxifen 10mg bid for 12 weeks , in a 12-week treatment course (n = 103), or oral cyclophosphamide 80 mg /m 2 /week for 36 weeks , IV methotrexate 28 mg/m 2 /week and IV fluorouracil 500 mg/m 2 /week for 8 weeks then in alternate weeks to 36 weeks , IV vincristine 1.4 mg/m 2 /week for 4 weeks then monthly, and oral prednisone 30 mg/m 2 /day for 10 days tapered ove ceo days then 5 mg/day for 3 weeks, in a 36-week treatment course (102). 14 patients (6.8%) had thrombotic complications confirmed by objective testing . Patients receiving the 12- vs the 36-week course of therapy had proximal deep-vein thrombosis (3 vs 4) , pulmonary embolism (1 vs 0) , pulmonary embolism and deep-vein thrombosis (0 vs 1) , brachial artery thrombosIs (1 vs 0) , subclavian vein thrombosis (0 vs 1) or superfic ial raphenous vein thromboplebitis (0 vs 1) . 12 episodes occurred when patients had discontinued, or were receiving a relatively low dose of prednisone. The 3 patients with superficial thrombophlebitis were treated with anticoagulants and bed rest and the remaining 11 patients were hospitalised for treatment. Pat ients were followed up for a median of 20 months; 979 patient- months of chemotherapy and 2413 patient-months without chemotherapy. All thrombotic events occurred during 4 REACTIONS" 12 March 1988 drug treatmen t (p < 0.0001) . Five patients in the 36-week treatment group had a thrombotic event in weeks 13-36 vs no patients in the 12- week treatment group (p = 0.03). 13 of the 14 patients were over 50 years of age vs 113 of 191 without thrombosis (p = 0. 02) . Breast cancer recurrence, number of positive axillary codes and levels of estrogen or progesterone receptors were not associated with thrombosis. 'Our res ults suggest that the relation between chemotherapy and thrombosis is causal.' Further study of the association of thrombosis and chemotherapy is recommended . LeVine MN, Gent M, Hirsh J, Arnold A, Goodyear MD. et al New England Journal of MediCine 318 404-407 . 18 Feb 1988 61'1 0157 -72 71 / 88/ 0312-0004/ 0$01 .00/ 0 © ADIS Press
Transcript of Antineoplastics
Reactions Monitor Rapid, comprehensive identification of all adverse drug experience reports from 1700 international medical journals, presented as either summaries or citations to produce a complete file
Antineoplastics Thrombosis: incidence study
Women < 70 years of age with histologically confirmed stage II breast cancer were entered into a trial within 6 weeks of surgery. After baseline assessment patients were randomised to treatment with IV methotrexate 35 mg/m2/week , oral cyclophosphamide 80 mg/ m2/ day, and IV fluorouracil 500 mg/m2/week for 8 weeks with IV vincristine 1 mg/m2/week for 4 weeks then 1 mg/m2 in weeks 6 , 8, 10 and 12, oral prednisone 50 mg/day for 10 days, tapered over 20 days, then 5 mg/day to 12 weeks, IV doxorubicin 20 mg/m2/week in weeks 9-12 and oral tamoxi fen 10mg bid for 12 weeks, in a 12-week treatment course (n = 103), or oral cyclophosphamide 80 mg/m2/week for 36 weeks , IV methotrexate 28 mg/m2/week and IV fluorouracil 500 mg/m2/week for 8 weeks then in alternate weeks to 36 weeks , IV vincristine 1.4 mg/m2/week for 4 weeks then monthly, and oral prednisone 30 mg/m2/day for 10 days tapered ove ceo days then 5 mg/day for 3 weeks, in a 36-week treatment course (102).
14 patients (6.8%) had thrombotic complications confirmed by objective testing . Patients receiving the 12- vs the 36-week course of therapy had proximal deep-vein thrombosis (3 vs 4), pulmonary embolism (1 vs 0) , pulmonary embolism and deep-vein thrombosis (0 vs 1), brachial artery thrombosIs (1 vs 0), subclavian vein thrombosis (0 vs 1) or superfic ial raphenous vein thromboplebitis (0 vs 1). 12 episodes occurred when patients had discontinued, or were receiving a relatively low dose of prednisone. The 3 patients with superficial thrombophlebitis were treated with anticoagulants and bed rest and the remaining 11 patients were hospitalised for treatment. Patients were followed up for a median of 20 months ; 979 patientmonths of chemotherapy and 2413 patient-months without chemotherapy. All thrombotic events occurred during
4 REACTIONS" 12 March 1988
drug treatment (p < 0.0001). Five patients in the 36-week treatment group had a thrombotic event in weeks 13-36 vs no patients in the 12-week treatment group (p = 0.03). 13 of the 14 patients were over 50 years of age vs 113 of 191 without thrombosis (p = 0.02). Breast cancer recurrence, number of positive axillary codes and levels of estrogen or progesterone receptors were not associated with thrombosis . 'Our results suggest that the relation between chemotherapy and thrombosis is causal.' Further study of the association of thrombosis and chemotherapy is recommended . LeVine MN, Gent M, Hirsh J, Arnold A, Goodyear MD. et al New England Journal of MediCine 318 404-407 . 18 Feb 1988 61'1
0157-7271 / 88/ 0312-0004/ 0$01 .00/ 0 © ADIS Press
