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PubMed1989

Clodronate therapy of metastatic bone disease in patients with prostatic carcinoma.

Metastatic bone disease represents the most disabling complication in patients with prostatic carcinoma. In an open multicenter trial 80 out of 92 patients with bone metastasis due to prostatic carcinoma experienced a dramatic improvement of bone pain after treatment with 300 mg clodronate infused intravenously daily for 10 days. Further to this, 56 patients were randomly allocated to four single-blind controlled therapeutic trials, assessing bone pain by daily consumption of analgesic drugs and by visual analogue scale. In the first protocol the effects of 2 weeks' treatment with intravenous infusion of either 300 mg clodronate dissolved in 500 ml saline (7 patients) or 500 ml saline (6 patients) were compared. The differences in both pain score and analgesic consumption were so striking that the trial was not extended for ethical reasons and all patients on placebo were given clodronate intravenously. Oral administration of 1200 mg clodronate for 2 weeks was completely ineffective in 11 patients. Intramuscular administration of 100 mg clodronate for 2 weeks induced in 12 patients a significant fall in analgesic consumption but not in the pain score. In most of the 13 patients given clodronate intravenously for 2 weeks bone pain relapsed fairly soon. However, in 18 patients a maintenance therapy with 1200 mg clodronate/day for at least 6 weeks after a 2-week intravenous treatment course did prevent the relapse of bone pain. In all patients given clodronate routine biochemical examination was carried out during and after treatment. For an overall follow-up of 42 patient-years hematologic toxicity was never observed. These results confirm that clodronate represents the most effective and convenient conservative treatment of patients with painful bone metastasis from prostatic carcinoma.

Administration, Oral↗

PubMed1977

Hypertension during pregnancy, with and without specific hypotensive treatment. II. The growth and development of the infant in the first year of life.

The growth and development of three groups of infants were prospectively assessed from birth to 12 mth. In two groups the mothers had been hypertensive before the 28th wk of gestation; one group was randomly allocated to specific hypotensive therapy, the other group was allocated to no specific treatment. The third group was a sample of the hospital population. General health, and the incidence of sight and hearing problems did not differ. Infants in the treated hypertensive group had had more perinatal problems, and there was an excess of infants with relatively small heads for their gestational age at birth. At 6 mth their heads were still smaller than the hospital sample, but by the age of 1 yr the difference was no longer present. The neurological status of infants in the untreated hypertensive group was less favourable in the neonatal period, and there was still an excess of infants in this group rated questionable on neurological assessment at the age of 12 mth. In both hypertensive groups there was an excess of infants with delayed fine-motor function at 6 mth, and in the untreated group there was an excess with delayed gross-motor function at 12 mth compared with the hospital sample. Our varied findings draw attention to the dangers of assessing the effects of different pregnancy conditions in terms of neonatal mortality and morbidity alone. Our date indicate that follow-up should extend for longer than 12 mth when the effects of adverse pregnancy factors and their management are under consideration. Further evaluation will be made when these children are 4 yr old.

Child Development↗

PubMed1982

Community care compared with hospital outpatient care for hypertensive patients.

Three hundred and seventy-six patients with treated diastolic blood pressures of less than 105 mm Hg and no history of accelerated hypertension or renal failure were selected from among those attending the Hammersmith Hospital hypertension clinic. Their average lying treated blood pressure was 146 mm Hg systolic and 90 mm Hg diastolic and average age 56 years; 18% were black, 6% Asian, and 76% white. The patients were mostly having multiple treatment, 90% receiving a diuretic, 35% methyldopa, 33% propranolol, 18% atenolol, 9% hydrallazine, and 7% bethanidine. They were randomly allocated to either two years of further hospital outpatient care or referred back to their general practitioners. During the two years 19 (10%) of the 187 patients followed up in hospital defaulted and three had their treatment discontinued. Twelve (6%) of the 189 followed up by their general practitioners defaulted from follow-up and nine had their treatment discontinued. At the end of the trial the average lying blood pressure was 148 mm Hg systolic and 88 mm Hg diastolic in the hospital group and 149 mm Hg systolic and 90 mm Hg diastolic in the general practice group. The change in blood pressure was calculated for each individual and showed an average fall of 1.6 mm Hg in standing diastolic pressure in the hospital group and a rise of 1.4 mm Hg in the general practice group (p less than 0.05). The 90% confidence limits for a difference in standing diastolic pressure between the groups were 1 and 5 mm Hg with the pressure lower in the hospital group. General practice care was not quite as effective in controlling blood pressure as continued specialist supervision over two years in this selected group of treated outpatients with mild or moderate hypertension, but these results show that the discharge back to general practitioners of patients who are well controlled after hospital treatment is a sensible policy.

Adult↗

PubMed1984

Serum cholesterol during treatment of hypertension with diuretic drugs.

Twenty-three men had an increase in serum levels of total cholesterol and triglycerides after starting a diet to lower their serum cholesterol. They had simultaneously started therapy with, or increased the dosage of, chlorthalidone or hydrochlorothiazide for the treatment of hypertension. To evaluate a possible role of the diuretics in the increase in serum lipid concentrations, 11 of the men were randomly allocated to spironolactone therapy for two to four months. After receiving spironolactone, cholesterol levels decreased by 24 mg/dL, whereas cholesterol levels decreased by only 3 mg/dL in the 12 men still receiving chlorthalidone (P less than .05). The triglyceride level decreased by 58 mg/dL after the change to spironolactone therapy, whereas it decreased by 10 mg/dL during continued chlorthalidone treatment (P less than .05). When the 11 men again received chlorthalidone, their cholesterol levels increased 16 mg/dL, whereas cholesterol levels decreased by 11 mg/dL in men receiving uninterrupted chlorthalidone treatment (P less than .01). These observations suggest that spironolactone may be a preferable alternative to thiazide-type agents as first-line therapy for hypertension because of the more favorable influence on serum lipid concentrations.

Chlorthalidone↗

PubMed1987

[Definition and consequences of blocking the renin-angiotensin system by converting enzyme inhibition].

46 patients (39 males), mean age 51 years (range 33-66), were randomly allocated to two different groups of treatment if their diastolic blood pressure was superior to 90 mmHg after a one-month treatment by 20 mg of enalapril. In the first group (ENA), 23 patients were given higher dosages of enalapril (40 and, if necessary 60 mg once-a-day). In the second group (HCTZ) 23 patients were given enalapril 20 mg and hydrochlorothiazide 25 and, if necessary, 50 mg once-a-day. Dosages were eventually increased after 2 weeks and evaluation of the results was performed after 4 weeks on treatment. Blood pressure was monitored in the supine position, at 3 minutes interval for thirty minutes, by an automatic device based on oscillometric method. Two successive measurements with a standard sphygmomanometer were performed by the physician at the end of the recording. No patient withdrew from the study nor was lost to follow-up. At the end of the study, 14 patients in the ENA group were receiving enalapril 60 mg once-a-day and 8 patients in the HCTZ group were receiving 50 mg of hydrochlorothiazide. Blood pressure was significantly lower in teh HCTZ group with the automatic device (130 +/- 9/80 +/- 8 vs 141 +/- 5/86 +/- 8 mmHg, p less than 0.01/p less than 0.05) and with the sphygmomanometer (134 +/- 10/89 +/- 6 vs 149 +/- 16/94 +/- 5 mmHg, p less than 0.001/p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1986

A randomized trial of Citanest with Octapressin for relief of pain associated with laser vaporization of the cervix.

Fifty women undergoing laser vaporization of the cervix for cervical intraepithelial neoplasia were randomly allocated to one of two groups. In one group the patients received no anaesthesia, in the other the ectocervix was infiltrated with 2 ml of Citanest with Octapressin (prilocaine 3% with 0.03 i.u./ml. of felypressin) immediately before the procedure. The pain experienced by each group was assessed immediately after treatment by visual analogue and verbal rating scales. The pain experienced by those women receiving local anaesthesia was significantly reduced as assessed by the visual analogue scale (P = 0.011) and this reduction was not quite significant by the verbal rating scale (P = 0.06). The Citanest group had less troublesome bleeding but the difference in bleeding between the two groups was not significant.

Adult↗

PubMed1987

Efficacy and safety of bisoprolol and atenolol in patients with mild to moderate hypertension: a double-blind, parallel group international multicentre study.

Three hundred and fifteen patients were randomly allocated to treatment for six months with bisoprolol 5 or 10 mg day-1 or atenolol, 50 mg day-1, in a double-blind, double-dummy parallel group, international multicentre study. Two hundred and ninety-two (175 men and 117 women) were eligible for statistical follow-up. Their mean age was 52.6 years (range 28-70). All patients had a supine diastolic blood pressure of 95-120 mmHg on two occasions during the four weeks of placebo treatment. Twenty-four patients ended the study prematurely and a further 19 had their regimes changed because of an insufficient effect. The reasons for drop-out were similar in the three treatment groups. Thus, 249 patients continued to receive the treatment they were allocated to, with 80, 83 and 86 patients in the three respective groups. The sex and age distributions and the number of previously treated hypertensives were similar in the three groups. At the end of placebo treatment the supine blood pressures in the three groups (bisoprolol 5 or 10 mg day-1 or atenolol 50 mg day-1, respectively) were 163.9/102.5, 157.4/101.8 and 160.0/102.2 mmHg, respectively. The systolic blood pressure was higher (P less than 0.05) in the group receiving bisoprolol 5 mg day-1 than in the 10 mg day-1 group. After 26 weeks of treatment the supine blood pressures in the three groups were 150.6/90.8, 142.0/89.1 and 148.6/91.7 mmHg, respectively. The largest estimated difference in blood pressure reduction was 4.6/2.3 mmHg between the group receiving bisoprolol 10 mg day-1 and the group receiving atenolol 50 mg day-1. A reduction in mean blood pressure of greater than or equal to 10 mmHg was noted in 66% of the patients in the bisoprolol group (10 mg day-1), in the other groups 66 and 59%, n.s. Bisoprolol is effective, well-tolerated and safe in the treatment of hypertension. A daily dose of 5 mg seems recommendable for the majority of hypertensive patients and seems equipotent with 50 mg day-1 of atenolol in the present study.

Adult↗

PubMed1986

Activators and inhibitors of coagulation and fibrinolysis in patients with prostatic cancer treated with oestrogen or orchidectomy.

The treatment of prostatic cancer with oestrogen has been reported to be associated with cardiovascular side effects. Twenty patients with recently diagnosed prostatic cancer were randomly allocated to oestrogen therapy or orchidectomy. As compared to healthy age matched controls the patients with prostatic cancer had increased base-line levels of fibrinogen (5.2 +/- 1.9 g/l versus 3.7 +/- 1.0 g/l; p less than 0.002) and factor VIII:C (166 +/- 62% versus 110 +/- 29%; p less than 0.001). During oestrogen therapy factor VII increased from 99 +/- 22% to 150 +/- 47% (p less than 0.001), while the antithrombin III level fell from 93 +/- 10% to 81 +/- 13% (p less than 0.001). Both these changes are in the direction of a hypercoaguable state. Concomitantly plasminogen increased from 113 +/- 14% to 142 +/- 18% (p less than 0.001), urokinase inhibiting activity fell from 105 +/- 10% to 90 +/- 9% (p less than 0.001) and C1-esterase inhibitor fell from 110 +/- 17% to 86 +/- 22% (p less than 0.05) in the oestrogen therapy group. After orchidectomy there were no changes in the activators and inhibitors of coagulation and fibrinolysis studied as compared to base-line values. Furthermore the D dimer, a specific degradation product of crosslinked fibrin increased from a normal to a pathological value in 4 out of 8 tested patients after 6 weeks of oestrogen therapy, but in none out of 9 tested patients in the orchidectomy group. Briefly stated, patients with prostatic cancer treated with oestrogen have increased levels of factor VII, factor VIII:C and fibrinogen and a decreased level of antithrombin III.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

PubMed1988

Effect of house dust mite avoidance measures on adult atopic asthma.

Twenty one adult patients with asthma, with positive skin test responses to the European house dust mite, Dermatophagoides pteronyssinus, were randomly allocated to a control group or to a group applying house dust mite avoidance measures. These included an initial application of liquid nitrogen to mattresses and bedroom carpets to kill the live house dust mite population. Histamine airway responsiveness, symptom scores, peak expiratory flow rates (PEF), and house dust mite numbers were determined during the two week pretrial and eight week trial periods. Nine patients in each group completed the study. By the end of the study there was a significant reduction in live mites in the "avoidance" group but not in the control group. The avoidance group showed a significant improvement in symptom scores measured on a linear analogue scale, in the number of hours each day spent wheezing (mean reduced from 8.6 to 4.5 hours), and in PEF (l/min) both in the morning (from 364 to 388) and in the evening (from 368 to 392). These changes were not found in the control group. The provocative concentration (PC) of histamine causing a 20% fall in FEV1 (PC20FEV1) had increased significantly in the avoidance group at eight weeks (from 0.58 to 2.3 mg/ml), whereas no change was seen in the control group (from 0.93 to 1.21 mg/ml). These results show that house dust mite avoidance, combined with initial killing of the mite by liquid nitrogen, diminishes airway responsiveness and improves asthma symptom control over an eight week period in adult asthmatic patients with house dust mite allergy.

Adolescent↗

PubMed2001

Single- vs. multiple-set strength training in women.

The aim of this study was to compare the effects of single-set and multiple-set strength training in women. Twenty-seven women (aged 20-40 years) with basic experience in strength training were randomly allocated to either a single-set group (n = 9), a 3-set group (n = 9), or a nontraining control group (n = 9). Both training groups underwent a whole-body strengthening program, exercising 2 days a week for 6 weeks. Exercises included bilateral leg extension, bilateral leg curl, abdominal crunch, seated hip adduction/abduction, seated bench press, and lateral pull-down. The single-set group's program consisted of only 1 set of 6-9 repetitions until failure, whereas the multiple-set group trained with 3 sets of 6-9 repetitions until failure (rest interval between sets, 2 minutes). Two times before and 3 days after termination of the training program, subjects were tested for their 1 repetition maximum strength on the bilateral leg extension and the seated bench press machine. Data were analyzed using a repeated-measures analysis of variance, Scheffé tests, t-tests, and calculation of effect sizes. Both training groups made significant strength improvements in leg extension (multiple-set group, 15%; single-set group, 6%; p 0.05). However, in the seated bench press only the 3-set group showed a significant increase in maximal strength (10%). Calculation of effect sizes and percentage gains revealed higher strength gains in the multiple-set group. No significant differences were found in the control group. These findings suggest superior strength gains occurred following 3-set strength training compared with single-set strength training in women with basic experience in resistance training.

Adult↗

PubMed1989

Antihypertensive and anti-ischemic effects of nicardipine and nitroprusside in patients undergoing coronary artery bypass grafting.

The efficacy of nicardipine vs nitroprusside in controlling hypertension after sternotomy was compared in 120 patients undergoing coronary artery bypass grafting and anesthetized with fentanyl (100 micrograms/kg). All had good left ventricular function and had been receiving long term oral beta-blocking therapy. Patients were randomly allocated to 1 of 3 groups: group C, the control (n = 40), received no vasodilator; group N (n = 40) received intravenous nicardipine at an initial rate of 3 micrograms/kg/min; and group S (n = 40) received intravenous nitroprusside at an initial rate of 1 microgram/kg/min. Vasodilator infusion was begun before surgery and infusion rates were adjusted to maintain systolic blood pressure between 80 and 120% of postintubation (baseline) values. Additional measurements were obtained before incision and after sternotomy. In groups N and S, arterial blood pressure was effectively controlled in all patients. Before the incision, pulmonary artery pressure decreased in group S and systemic vascular resistance decreased in groups N and S. After sternotomy, mean arterial pressure, heart rate, pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac index and rate-pressure product increased in group C. At this time, pulmonary artery pressure returned to baseline values in group S. In groups N and S, heart rate, cardiac index and rate-pressure product increased, but, compared with baseline values, systemic vascular resistance remained low after sternotomy. Ischemic changes were seen in the electrocardiogram in 11 patients (28%) in group C, 10 patients (25%) in group S and 4 patients (10%) in group N. The concentration of creatine phosphokinase MB was not significantly different in the first 24 postoperative hours in any group.

Aged↗

PubMed1989

Etodolac versus diclofenac: double-blind cross-over study in rheumatoid arthritis.

A 14-day double-blind clinical study was conducted on 16 patients with clinically active rheumatoid arthritis to compare the effects of etodolac (600 mg daily) and diclofenac (150 mg daily). Admission criteria were: functional impairment between Steinbrocker's classes I to III, Ritchie's index greater than 10 and erythrocyte sedimentation rate greater than 25 mm/h, and finally active involvement of the small joints of the hands. Following a wash-out period of at least two days from their previous non-steroidal anti-inflammatory drugs, trial patients received etodolac or diclofenac for five consecutive days by random allocation; after that, and after another two day wash-out period, all patients were crossed-over to the alternate drug for another five consecutive days. One day before intake and on the last day of each treatment lap, each patient was examined in regard to the circadian grip strength (of the more severely affected hand), Ritchie's index and acute phase reactants; at the end of the second treatment period, subjective drug preference was explored. Grip strength was assessed by the patients themselves with a dynamometer at 08h00 and every two hours thereafter until 20h00. The overall daily value was calculated by measuring the area under curve (AUC) depicting the grip strength profile. Both groups of patients showed significant improvement of the Ritchie's index (p less than 0.01) and grip strength AUC (p less than 0.05), while taking medication, whereas no significant variations were noted in regard to the values of the acute phase parameters both between the two treatment groups, and within each treatment group. At termination, four patients expressed preference for etodolac, eight were in favour of diclofenac, and four gave an indifferent judgement. No statistically significant differences were detected between the two treatment groups; also no adverse events were seen in this short-term study. The results confirm the effectiveness and tolerability of etodolac in the acute stage of rheumatoid arthritis.

Adult↗

PubMed1989

Therapeutic efficacy of the combination of aztreonam with cefotaxime in the treatment of severe nosocomial pneumonia. Comparative study against amikacin combined with cefotaxime.

The combination aztreonam + cefotaxime (AZ + CE) was compared to amikacin + cefotaxime (AM + CE) in the treatment of nosocomial pneumonia acquired at the intensive-care unit. This study included a total of 33 patients fulfilling criteria for nosocomial pneumonia. 16 of them were randomly allocated to the AZ + CE group and 17 to the AM + CE group. The empirical treatment was effective for 78% of AZ + CE cases and 92% of AM + CE cases (p = NS). Clinical care was observed in 77% of cases (10 out of 13 evaluable) in the AZ group and in 75% of the group treated with AM (12 cases out of 16 evaluable; p = NS). In the evaluable cases, treatment failure was associated with injections due to the following organisms: Acinetobacter calcoaceticus (1) and Pseudomonas aeruginosa (1) in the AZ group and A. calcoaceticus (1) in the AM group. Superinfections were observed only in the AM group P. aeruginosa. A. calcoaceticus, Streptococcus viridans, Candida albicans, Aspergillus fumigatus and Serratia marcescens. Both the peak and through serum concentrations of AZ and AM were maintained within normal ranges. Finally, an impairment of renal tubular function was observed in the group of patients treated with AM, as measured by urinary levels of N-acetyl-beta-D-glucosaminidase and leucine aminopeptidase sequentially during the treatment. These changes in renal functions alterations mentioned were not observed in the AZ group. It is concluded that the AZ + CE combination is an effective empirical and active antibiotic treatment against severe nosocomial pneumonia. Aztreonam has no renal toxicity, which is an advantage to take into account in patients with altered renal function.

Adult↗

PubMed1985

Hyperbaric oxygen therapy for acute acoustic trauma.

We conducted a study on the effect of hyperbaric oxygen therapy on 122 soldiers following acute acoustic trauma. The patients included in this study, after the effect of spontaneous recovery had largely been excluded, were randomly allocated to four treatment groups. The results of our studies show that hyperbaric oxygen therapy shortens the course of healing with respect to high-pitch perception dysacusis. The results of treatment after an observation period of 6 weeks is also more favorable when patients are treated with oxygen when compared to patients given infusions or vasoactive substances. Similarly, the use of hyperbaric oxygen therapy also reduces the frequency of relapse following discharge from hospital. In contrast, the vasoactive substance chosen in our studies (betahistine) failed to have a favorable effect on the course of healing. Our study has also shown that no method can compare with hyperbaric therapy in eliminating tinnitus following acoustic trauma.

Adult↗

PubMed1991

[Pharmacokinetics of propofol injected after deliberate preoperative hemodilution].

The effects of acute isovolaemic haemodilution (AIH) on propofol pharmacokinetics were studied in 16 male patients scheduled for prostatectomy. They were all ranked ASA 1, and were randomly allocated to two groups, group I (n = 8), who did not undergo any haemodilution, and group II (n = 8), in whom AIH was carried out. Anaesthesia was induced with a single 2.5 mg.kg-1 propofol bolus given in 30 s; maintenance was achieved with fentanyl 2 micrograms.kg-1, atracurium 1 mg.kg-1, and a ventilation with a mixture of nitrous oxide in oxygen 50 %, with enflurane 1 %. Those patients due to be haemodiluted had blood withdrawn before surgery (1,387.5 +/- 423.3 ml), at the same time as they were given the same volume of modified fluid gelatin (Plasmion). The volume of blood to be withdrawn was calculated according to the initial haematocrit, and that required. Haematocrit was decreased to 32.3 +/- 3.9 % (extremes 27 and 37 %). Thereafter blood samples were then collected over a 24 h period, which included surgery. Propofol was assayed in whole blood using high performance liquid chromatography. Analysis with a three-compartment model was carried out. The AIH only altered the central compartment volume (65.5 +/- 15.6 l in the control group vs 83.6 +/- 13.3 l in group II, p less than 0.01). Initial concentrations were not significantly different in the two groups (2,892 +/- 762 ng.ml-1 in controls vs 2,373 +/- 589 ng.ml-1 in the others). Clinically, anaesthesia and recovery were uneventful. It is concluded that the induction dose of propofol in patients scheduled for haemodilution does not require any alteration.

Aged↗

PubMed1985

[Predictability and prevention of hypokalemia induced by hydrochlorothiazide].

In a double blind study, 104 hypertensive patients were randomly allocated to two different stepped care programs for 6 months. Following a placebo run-in-phase, patients were given either Enalapril (EN) 20 mg once-a-day, or a Placebo (PL). Drugs were added as follow in a parallel stepwise sequence, until the goal blood pressure was obtained. First Hydrochlorothiazide (HCTZ) and then, if necessary, Oxprenolol (OXP) and Dihydralazine (DIH). The two goals of this study were to lower diastolic blood pressure below 90 mmHg and to maintain plasma potassium above 3.5 mmol/l. Amiloride was prescribed if plasma potassium was lower than 3.5 mmol/l. At the end of the study the EN group's blood pressure was 130 +/- 12/83 +/- 6 mmHg, the tablet's daily number was 2.6 +/- 1.8 and Amiloride was necessary in 15 patients. These parameters were significantly different from those observed in the Pl group (BP: 136 +/- 9/87 +/- 5 mmHg, tablets 4.2 +/- 2.4; amiloride necessary in 34 patients). The effects of HCTZ were evaluated in 32 patients previously treated by EN compared to 39 patients receiving PL. The converting enzyme inhibition minimized the fall in plasma potassium induced by HCTZ (3.6 t +/- 0.4 vs 3.3 +/- 0.5 mmol/l, p less than 0.05). Related to the HCTZ dose (mg/kg), the plasma potassium fall is lower in the EN group (0.46 +/- 1.1) than in the PL group (0.94 +/- 0.9, p less than 0.05). The plasma potassium reduction could not be predicted by age, plasma renin activity, plasma and urinary aldosterone or urinary kallikrein.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗

PubMed1986

A study of intravenous sedation with diazepam and midazolam for dentistry in Hong Kong Chinese.

Fifty Hong Kong Chinese patients between 20-40 years, of ASA Gd I, undergoing third molar extraction were randomly allocated into two groups. For conscious sedation, to supplement local anaesthesia, one group received intravenous diazepam and the other intravenous midazolam. The majority in the study had never heard of intravenous sedation being available to supplement local anaesthesia during dental surgery and when given the chance to experience this method the majority found it highly acceptable. None preferred general anaesthesia for dental surgery. In this study midazolam had more advantages to the patient than diazepam; quicker onset of sedation, less pain during injection, profound anterograde amnesia and fewer postoperative complications being the main features. However, both drugs produced good operating conditions. Incidence of thrombophlebitis was low with both drugs, and may be so in Chinese compared with non-Chinese.

Adult↗

PubMed1986

A randomized trial of two regimens of cyclophosphamide, methotrexate, 5-fluorouracil, and prednisone in advanced breast cancer.

One-hundred evaluable patients with progressive advanced breast carcinoma untreated by cytotoxic chemotherapy but resistant to hormone therapy and irradiation were randomly allocated to receive either a combination of cyclophosphamide (600 mg/m2), methotrexate (40 mg/m2), 5-fluorouracil (600 mg/m2) IV every 3 weeks and prednisone 20 mg/m2 PO daily, with diminishing doses (intermittent group), or a combination of cyclophosphamide (100 mg/m2 PO on days 1-15, alternating with a 15-day rest period), methotrexate 20 mg/m2 IV, 5-fluorouracil 500 mg/m2 IV weekly for 20 weeks and prednisone 20 mg/m2 PO daily, with diminishing doses in the remission induction period, followed by a maintenance regimen of cyclophosphamide 100 mg/m2 PO on days 1-15, methotrexate 20 mg/m2 IV on days 1, 8 and 15, 5-fluorouracil 500 mg/m2 IV on days 1, 8, and 15, and prednisone 20 mg/m2 PO on days 1-15, with a 3-week rest period between the courses (intensive group). Entry was from 1 December 1982 to 30 November 1983. Objective responses were seen in 20/49 (41%) patients in the intermittent group and 34/51 (67%) in the intensive group (chi 2 = 6.72; P less than 0.01). The estimated median duration of response was 11 months in the intermittent group and 14 months in the intensive group. The estimated median survival was greater in the intensive group, but the difference was not statistically significant, although this parameter can be influenced with alternative additional chemotherapy. Toxicity was similar in both groups. These data suggest there are no therapeutic and survival advantages to the 3-weekly IV protocol compared with our previous regimen CMFP.

Adult↗