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Results for “Randomized trial”

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At least 1,189 records · Page 66Linked to original sources

PubMed1997

A prospective randomized trial of interstitial radiofrequency therapy versus transurethral resection for the treatment of benign prostatic hyperplasia.

OBJECTIVE: To carry out a prospective randomized trial comparing interstitial radiofrequency therapy (IRFT) with transurethral resection of the prostate (TURP) in the treatment of bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia. PATIENTS AND METHODS: The change in detrusor pressure at maximum flow (PdetQmax) was chosen as the primary measure of outcome but the symptom score, Qmax and residual volume were also measured. Patients with urodynamic evidence of BOO were randomized to receive IRFT (n = 25) or TURP (n = 25); the urodynamics were repeated 6 months after treatment. RESULTS: There was a statistically significant reduction in PdetQmax at 6 months for TURP (P < 0.001) and IRFT (P < 0.01) although the change seen in the latter group was probably not clinically relevant. Nevertheless, a clinically relevant reduction in symptom score occurred in both groups. Both techniques were associated with a low morbidity. CONCLUSION: IRFT is a cheap and safe technique which may be useful in the treatment of lower urinary tract symptoms in certain groups of patients in whom symptomatic improvement is a priority rather than objective outcome. The underlying mechanism for this symptomatic improvement is at present unclear.

Aged↗

PubMed2002

A phase III randomized trial of combined chemoradiotherapy versus radiotherapy alone in locally advanced non-small-cell lung cancer.

A phase III randomized trial was conducted to investigate whether induction chemotherapy followed by radiation can influence survival as compared with radiation alone in unresectable, locally advanced non-small-cell lung cancer (LADNSCLC). A total of 101 patients with unresectable stage IIIA or IIIB NSCLC were enrolled. Patients were stratified by performance status, weight loss, histology and stage, and then randomized to receive combined chemoradiotherapy or radiotherapy alone. Radiotherapy was administered in 1.8 Gy to 2.0 Gy standard fractions daily 5 times weekly for a total dose of 60 Gy to 65 Gy. The combined group received induction of cisplatin, etoposide, and vinblastine (PEV) chemotherapy with cisplatin 20 mg/m2 on days 1 to 5, etoposide 100 mg/m2 on days 2 to 4, and vinblastine 6 mg/m2 on day 1, which wasrepeated every 3 weeks for 3 courses, after which time the patients underwent radiotherapy. Of 101 patients registered, 89 patients (43 combined, 46 radiotherapy alone) were eligible for analysis. The response rates for the combined and radiotherapy groups were 65% (28/43) and 70% (32/46), respectively. The median survival time (MST) showed a tendency to be more prolonged in the combined group than in the group receiving radiotherapy alone (13.8 vs. 8.5 months). The MST in patients with nonsquamous histology was strikingly prolonged in the combined group as compared with the radiotherapy group (14 vs. 3.6 months, p 0.027). Likewise, the MST in patients with stage IIIB was significantly prolonged in the combined group as compared with the radiotherapy group (11.1 vs. 7.2 months, p 0.045). Together, the MST of the high-risk group with nonsquamous or stage IIIB was significantly higher in the combined group than that seen in the radiotherapy group (11.6 vs. 8 months, p 0.046), whereas the MST of the low-risk group, defined as having both squamous histology and stage IIIA, was similar in the two treatment groups (18.3 vs. 20.8 months, p = 0.293). In conclusion, induction PEV chemotherapy plus radiotherapy is superior to radiotherapy alone in high-risk subsets of unresectable LAD-NSCLC and therapeutic strategy should be based on the identification of prognostic factors.

Adult↗

PubMed1988

Randomized trial of combined modality therapy with and without thymosin fraction V in the treatment of small cell lung cancer.

A randomized trial of thymosin fraction V (60 mg/m2 s.c. twice weekly) given during induction chemotherapy and radiation therapy was performed in 91 patients with small cell carcinoma of the lung. Induction chemotherapy consisted of four cycles of an alternating combination of drugs (cyclophosphamide/Adriamycin/vincristine and cisplatin/etoposide). Radiation to the primary complex was given to patients with limited disease. All patients received prophylactic cranial irradiation. There were 35 patients with limited disease (18 randomized to thymosin and 17 to no thymosin) and 56 with extensive disease (28 thymosin and 28 no thymosin). Pretreatment immunological parameters were comparable between the two groups. For limited disease patients the overall response rate was 100%, including 66% (21 of 32) complete responders. The median duration of response was 19 mo (range, 5-57 mo) and survival 21 mo (range, 4 days to 57 mo). The 3-yr survival was 32%. For ED patients the overall response rate was 95% with 29% (13 of 48) complete. The median duration of response was 10 mo and the median duration of survival 12 mo with 13% alive at 2 yr. A comparison of the thymosin-versus no thymosin-treated patients revealed no difference in response rate, response duration, or survival whether analyzed as a whole or by extent of disease. An analysis based on pretreatment immune function and total white blood cell and absolute lymphocyte count revealed no difference in the survival distributions. No differences in the pattern of toxicity were observed between the thymosin- versus no thymosin-treated patients. The addition of thymosin fraction V during induction chemotherapy and consolidation radiotherapy did not alter outcome.

Carcinoma, Small Cell↗

PubMed2006

Distal splenorenal shunt versus transjugular intrahepatic portal systematic shunt for variceal bleeding: a randomized trial.

BACKGROUND & AIMS: Variceal bleeding refractory to medical treatment with beta-blockers and endoscopic therapy can be managed by variceal decompression with either surgical shunts or transjugular intrahepatic portal systemic shunts (TIPS). This prospective randomized trial tested the hypothesis that patients receiving distal splenorenal shunts (DSRS) would have significantly lower rebleeding and encephalopathy rates than TIPS in management of refractory variceal bleeding. METHODS: A prospective randomized controlled clinical trial at 5 centers was conducted. One hundred forty patients with Child-Pugh class A and B cirrhosis and refractory variceal bleeding were randomized to DSRS or TIPS. Protocol and event follow-up for 2-8 years (mean, 46 +/- 26 months) for primary end points of variceal bleeding and encephalopathy and secondary end points of death, ascites, thrombosis and stenosis, liver function, need for transplant, quality of life, and cost were evaluated. RESULTS: There was no significant difference in rebleeding (DSRS, 5.5%; TIPS, 10.5%; P = .29) or first encephalopathy event (DSRS, 50%; TIPS, 50%). Survival at 2 and 5 years (DSRS, 81% and 62%; TIPS, 88% and 61%, respectively) were not significantly different (P = .87). Thrombosis, stenosis, and reintervention rates (DSRS, 11%; TIPS, 82%) were significantly (P < .001) higher in the TIPS group. Ascites, need for transplant, quality of life, and costs were not significantly different. CONCLUSIONS: DSRS and TIPS are similarly efficacious in the control of refractory variceal bleeding in Child-Pugh class A and B patients. Reintervention is significantly greater for TIPS compared with DSRS. Because both procedures have equivalent outcomes, the choice is dependent on available expertise and ability to monitor the shunt and reintervene when needed.

Adult↗

PubMed2004

Early individualized postoperative occupational therapy training in 100 patients improves ADL after hip fracture: a randomized trial.

BACKGROUND: It is not clear whether occupational therapy is of value for hip fracture patients. PATIENTS AND METHODS: In a randomized trial we studied the effects of an early, individualized, postoperative occupational training (OT) program on the ability of hip fracture patients to perform ADL and IADL. Secondary endpoints were self-reported fear of pain and pain when performing ADL and IADL. The need for technical aids and/or home adaptations was also investigated. 100 eligible patients (aged > or = 65 years, with independent residence) were randomized 50:50 to an OT or control group (conventional care). During their hospital stay, members of the OT group received individual daily training which included the use of technical aids. Before discharge, the occupational therapist paid a home visit together with the patient. All patients were assessed 2-4 days after surgery, at discharge and after 2 months, using the Klein-Bell ADL scale and a modified version of the Disability Rating Index. RESULTS: At discharge, the OT group had better ability to dress, to take care of personal hygiene and bathing activities independently, and to make toilet visits. Age, sex, type of fracture or length of stay at the hospital made no significant contribution to explaining the better ADL ability on discharge. After 2 months, all patients had regained their ADL and IADL abilities. Half of the patients required technical aids and adaptations in their homes. INTERPRETATION: Individualized OT-training speed up the ability of patients to perform ADL, thus enhancing the likelihood of patients returning to independent living and reducing the need for postoperative care at home.

Activities of Daily Living↗

PubMed1992

Prevention of deep vein thrombosis with low molecular-weight heparin in patients undergoing total hip replacement. A randomized trial. The German Hip Arthroplasty Trial (GHAT) Group.

In a double-blind, randomized multicentre trial, the efficacy and safety of two regimens for the prevention of postoperative venous thrombo-embolism, low-molecular-weight heparin (LMWH) CY 216 and unfractionated heparin (UH), were compared in 341 patients undergoing elective total hip replacement. A group of 169 patients received one subcutaneous injection of 48 mg (approximately 10,000 anti-Xa IC units) LMWH and two placebo injections per day and 172 patients received a fixed dose of 5000 IU UH t.i.d. Deep vein thrombosis was assessed by bilateral phlebography on day 14 +/- 1 after surgery. Phlebography was successfully performed in 136 patients in the LMWH group and 137 patients in the UH group. Deep vein thrombosis occurred in 45 of 137 patients (33.1%) treated with LMWH CY 216 and in 47 of 136 patients (34.3%) who received UH. Pulmonary embolism occurred in 2 of 167 evaluable patients (1.2%) in the LMWH group and in 6 of 168 patients (3.6%) in the UH group. In addition, the incidence of proximal deep vein thrombosis was evaluated and was found to be 10.3% (14/137 patients) in the LMWH group and 19% (26/136 patients) in the UH group (P = 0.044, two-sided). The safety of the treatments, as assessed by the incidence of major haemorrhage, intra- and postoperative blood loss, transfusion requirements, haemoglobin drop and frequency of wound haematomata, was similar in the two groups. It is concluded that prophylaxis of postoperative thrombo-embolism in hip surgery with one subcutaneous injection (48 mg) of LMWH CY 216 is as effective and as safe as prevention with fixed low-dose heparin (5000 IU t.i.d.). A tendency to reduced rates of pulmonary embolism (3.6% vs. 1.2%) and proximal deep vein thrombosis (19% vs. 10.3%) was observed in favour of LMWH CY 216.

Aged↗

PubMed1987

Intrahepatic or systemic infusion of fluorodeoxyuridine in patients with liver metastases from colorectal carcinoma. A randomized trial.

OBJECTIVE: To compare the efficacy of direct hepatic arterial chemotherapy with systemic chemotherapy in patients with liver metastases from colorectal carcinoma. DESIGN: Randomized trial with crossover allowed from systemic to intrahepatic therapy if tumor progression occurred on systemic therapy. SETTING: Academic medical center, referral-based clinic. PATIENTS: One hundred sixty-two patients with hepatic metastases from colorectal carcinoma agreed to be randomly assigned to treatment groups. At laparotomy, 63 were excluded from the study: 25 had hepatic resection; 33, extrahepatic disease; 1, infection; and 4, no tumor. INTERVENTION: Fourteen-day continuous infusion of fluorodeoxyuridine each month using an infusaid pump (0.3 and 0.15 mg/kg body weight X d in the intrahepatic and systemic arms, respectively). MAIN RESULTS: Intrahepatic therapy produced a significantly higher complete and partial response rate, 50%, compared with 20% for systemic therapy (p = 0.001). After tumor progression, 60% of the systemic patients crossed over to intrahepatic therapy; 25% then had a partial response, and 33% a minor response or stabilization of disease on intrahepatic therapy. Toxicity included ulcer disease (17%) and biliary sclerosis (8%) in patients receiving intrahepatic therapy and diarrhea (70%) in patients receiving systemic therapy. Extrahepatic disease occurred in 56% and 37% of the patients in the intrahepatic and systemic groups, respectively (p = 0.092). The median survivals were 17 and 12 months, for the intrahepatic and systemic groups, respectively. CONCLUSION: When compared with systemic therapy, hepatic arterial chemotherapy significantly increases response rate for hepatic metastases from colorectal carcinoma and appears to be a more effective treatment.

Adenocarcinoma↗

PubMed2001

Result of two randomized trials comparing nolatrexed (Thymitaq) versus methotrexate in patients with recurrent head and neck cancer.

We report on two randomized trials performed in the USA and Europe, which compared methotrexate and nolatrexed as treatment for patients with recurrent head and neck cancer. Eligibility criteria included: histologically confirmed squamous-cell carcinoma, measurable disease, adequate hematological, renal and hepatic functions, failure of a first-line chemotherapy, and informed consent. Methotrexate 40 mg/m2 was weekly given by short infusion, and nolatrexed 725 mg/m2 per day was administered as a five-day continuous infusion, every three weeks. A total of 139 patients (63 in the USA. 76 in Europe) were randomized based on a ratio of 2/1: 93 and 46 received nolatrexed and methotrexate, respectively. Patient characteristics included 115 males and 24 females; median age 60 years. In the nolatrexed arm, the following grade 3-4 toxicities occurred: neutropenia (29.9%) with 3.1% of febrile neutropenia, mucositis (33.3%), and vomiting (10.3%). In the MTX arm, the grade 3-4 toxicities were neutropenia (7.1%) and mucositis (6.9%). There was no difference in activity between the nolatrexed and the methotrexate treatment: 3.3% and 10.8% of objective responses, 1.9 versus 1.5 months of disease-free progression and 3.5 versus 3.7 months of overall survival, respectively. Nolatrexed has demonstrated a similar activity to methotrexate.

Adult↗

PubMed1998

Endoscopic versus traditional saphenous vein harvesting: a prospective, randomized trial.

BACKGROUND: Saphenous vein harvested with a traditional longitudinal technique often results in leg wound complications. An alternative endoscopic harvest technique may decrease these complications. METHODS: One hundred twelve patients scheduled for elective coronary artery bypass grafting were prospectively randomized to have vein harvested using either an endoscopic (group A, n = 54) or traditional technique (group B, n = 58). Groups A and B, respectively, were similar with regard to length of vein harvested (41 +/- 8 cm versus 40 +/- 14 cm), bypasses done (4.1 +/- 1.1 versus 4.2 +/- 1.4), age, preoperative risk stratification, and risks for wound complication (diabetes, sex, obesity, preoperative anemia, hypoalbuminemia, and peripheral vascular disease). RESULTS: Leg wound complications were significantly (p < or = 0.02) reduced in group A (4% [2 of 51] versus 19% [11 of 58]). Univariate analysis identified traditional incision (p < or = 0.02) and diabetes (p < or = 0.05) as wound complication risk factors. Multiple logistic regression analysis identified only the traditional harvest technique as a risk factor for leg wound complications with no significant interaction between harvest technique and any preoperative risk factor (p < or = 0.03). Harvest rate (0.9 +/- 0.4 cm/min versus 1.2 +/- 0.5 cm/min) was slower for group A (p < or = 0.02) and conversion from endoscopic to a traditional harvest occurred in 5.6% (3 of 54) of patients. CONCLUSIONS: In a prospective, randomized trial, saphenous vein harvested endoscopically was associated with fewer wound complications than the traditional longitudinal method.

Age Factors↗

PubMed1999

A prospective randomized trial of the anti-emetic efficacy of ondansetron and granisetron during bone marrow transplantation.

To determine the comparative anti-emetic efficacy of ondansetron and granisetron in patients undergoing bone marrow transplantation, we performed a double-blind, randomized trial in pediatric and adult patients receiving transplants at the University of Minnesota. The results in 187 patients stratified by age (<18 years, n = 51; > or =18 years, n = 136) were analyzed. The average number of emetic episodes in the entire group from day -7 to 2 was 0.86/day for patients receiving ondansetron and 0.73/day for those receiving granisetron (p = 0.32). No differences were noted between the two drugs in total days of complete or major control of emesis or in the number of requests for additional drugs to alleviate symptoms of nausea. The use of total-body irradiation-containing conditioning regimens was associated with a decreased number of emetic episodes compared with regimens of chemotherapy alone. Perceived nausea was evaluated using a nausea scoring system, and no differences were apparent between the granisetron and ondansetron groups; however, reported nausea was significantly higher in females (p<0.01) and in the adult population (p = 0.05). We conclude that both ondansetron and granisetron provide good control of nausea and vomiting experienced with conditioning regimens for bone marrow transplantation. The relative cost of the drugs within an institution must be considered in developing standard anti-emetic regimens for bone marrow transplantation.

Adolescent↗

PubMedDate not supplied

Chemotherapy combined with or without hyperthermia for patients with oesophageal carcinoma: a prospective randomized trial.

From 1990 to 1991, 40 patients with squamous cell carcinoma of the thoracic oesophagus were admitted to our institutions and chemotherapy (oil Bleomycin p.o. and CDDP d.i.v.) either combined with or without hyperthermia was performed, in a prospective randomized trial carried out to investigate the effects of hyperthermia. The two groups (group A, consisting of 20 patients given chemotherapy alone; and group B, made up of 20 given chemotherapy with hyperthermia) were comparable with regard to various prognostic factors. Following the above treatment regimens, an oesophagectomy was done in 16 and 17 patients from groups A and B, respectively. A subjective improvement of dysphagia was seen in 8 (40.0%), and in 14 patients (70.0%), while a radiographic improvement was recognized in 5 (25.0%) and 10 cases (50.0%) in groups A and B, respectively. In the resected specimen of 16 (group A) and 17 patients (group B), histopathological evidence of the effectiveness of the treatments were recognized in 3 (18.8%) and 7 (41.2%) from groups A and B, respectively. Excluding the cases of superficial carcinoma (T1 tumour), histologic effectiveness of the treatments were recognized in 2 (14.3%) and 7 (58.3%) in groups A and B, respectively (p < 0.05). There was no difference in the occurrence of side effects between the groups. Therefore, the clinical and pathological effects were favourable in the hyperthermia combined with chemotherapy group, especially in the cases with advanced oesophageal cancer.

Aged↗

PubMed2002

The effect of a single remote course versus weekly courses of antenatal corticosteroids on functional residual capacity in preterm infants: a randomized trial.

OBJECTIVE: There are no randomized data on the effect of repeat courses of corticosteroids during pregnancy on newborn pulmonary function. Our objective was to compare the effect of a single remote course of antenatal steroids (AS) with weekly courses of AS on functional residual capacity (FRC) and respiratory compliance in preterm infants. STUDY DESIGN/METHODS: Pregnant women 25 to 33 weeks' gestation, who remained undelivered 1 week after their first course of antenatal corticosteroids (two 12-mg doses of betamethasone) were randomized to weekly courses of corticosteroids versus weekly placebo until delivery or 34 weeks' gestation. FRC was measured with the nitrogen washout technique and respiratory compliance with the single breath occlusion technique within 48 hours of life. RESULTS: Thirty-seven infants (mean gestational age at delivery approximately 32.5 weeks) were studied. Maternal and infant demographics were similar. There was no significant difference in FRC (28.5 vs 27.5 mL/kg) or respiratory compliance between the infants who received a single remote course of antenatal corticosteroids and those who received weekly courses of corticosteroids until delivery. There was no significant difference in admission head circumference or birth weights between the groups. CONCLUSIONS: Our results demonstrate that weekly repetitive courses of AS do not significantly increase FRC or respiratory compliance in preterm infants when compared with a single remote course of steroids given at a mean gestational age of 29 weeks.

Double-Blind Method↗

PubMed2006

Video information combined with individualized information sessions: Effects upon emotional well-being following coronary artery bypass surgery--A randomized trial.

OBJECTIVE: To test the efficacy of an information intervention upon emotional recovery following coronary artery bypass surgery. METHODS: Randomized trial. Video information was combined with individualized information sessions carried out by nurses at admission and at discharge from the hospital. The video was shown pre-operatively and again during the session at admission. Patients were helped to express their questions and worries and congruent information and support was provided. Control group patients received standardized information and no video. Recordings were made at baseline, discharge from hospital and during a 2 years follow-up period. RESULTS: One hundred and nine patients were randomized to the intervention or the control groups. A MANOVA was used to test of the variance of the outcome variables at each time point. At discharge intervention patients reported less anxiety (p = 0.046) and better subjective health (p = 0.005). They reported better subjective health during the whole follow-up period (0.040 > or = p > or = 0.000), less anxiety up to 1 year (0.042 > or = p > or = 0.004), and less depression from 6 months to 2 years following discharge (0.023 > or = p > or = 0.004). CONCLUSION: The effects of the intervention probably relate to the combined use of the video and patient centered information sessions. PRACTICE IMPLICATIONS: The intervention can easily be implemented in clinical practice and nurses strongly identified with its principles.

Anxiety↗

PubMed1998

Transurethral electrovaporization of the prostate--a possible alternative to transurethral resection: a one-year follow-up of a prospective randomized trial.

OBJECTIVE: To compare the efficacy, safety and durability of transurethral electrovaporization of the prostate (TUVP) with standard transurethral resection (TURP) in a prospective randomized trial. PATIENTS AND METHODS: The study included 104 consecutive men with symptomatic benign prostatic hyperplasia (BPH) admitted for surgery who were randomized to TUVP or TURP. The variables evaluated included the duration of surgery, catheterization and hospital stay, the International Prostate Symptom Score (IPSS), a quality-of-life assessment (QOL), the maximum urinary flow rate (Qmax) and the postvoid residual urine volume (PVR). RESULTS: Both groups showed a comparable significant and maintained decline in the mean IPSS, from 26.5 to 4.4 (TUVP) and from 26.6 to 5.9 (TURP), and increase in mean Qmax, from 8.6 to 20.8 mL/s [corrected] (TUVP) and 8.6 to 22.8 mL/s (TURP) after 1 year. However, there were significant differences in the mean duration of catheterization (TUVP 20.9 h, TURP 46.6 h, P<0.001), hospital stay (TUVP 2.2 day, TURP 3.1 days, P<0.001), and the duration and volume of post-operative irrigation (TUVP none, TURP 18.1 h with 17.5 L of saline). Two patients in each group developed urethral strictures (4%) and two patients in each group required re-operation for residual adenoma (4%); two patients undergoing TURP had a bladder neck stricture (4%). CONCLUSION: The results suggest that TUVP is as effective as standard TURP in the treatment of moderate-sized BPH. TUVP offers the advantage of using established instruments, has excellent peri-operative haemostasis and requires a shorter hospital stay.

Aged↗

PubMed1989

Improving patient function: a randomized trial of functional disability screening.

STUDY OBJECTIVES: To test whether a 34-item functional status questionnaire measuring physical, psychological, and social function can be used by physicians in practice to help improve their patients' outcomes. DESIGN: Prospective randomized trial. SETTING: Community internal medicine practices. PATIENTS: Five hundred and ten continuing patients with functional disabilities who saw their physicians at least four times a year. PHYSICIANS: Seventy-six UCLA clinical volunteer faculty who are internists in community office practices. INTERVENTIONS: Physicians and their patients were randomly assigned to the experimental or the control group. Experimental group physicians attended a 2-hour multimedia educational session and received four functional status reports on each of their study patients over a 1-year period. Control group physicians received no education and no functional status feedback. Control group and experimental group patients were tested for functional status with the functional status questionnaire every 4 months for 1 year. Both groups also completed monthly diaries that measured use of health services. Experimental group physicians answered an anonymous evaluation questionnaire at 6 months after study entry. MEASUREMENTS AND MAIN RESULTS: Forty-three percent of experimental group physicians reported that they had used the functional status questionnaire to change therapy. Ninety-five percent reported that it was useful and accurate. Patient diaries did not show any difference between experimental group patients and control group patients in number of medications used, visits to physicians or other health professionals, equipment purchased, diet, or exercise programs. There were no significant differences between experimental and control group patients at exit from the study on any functional status or health outcome measure. CONCLUSION: A more powerful intervention than a 2-hour educational session and the regular provision of functional status information is needed to help office-based internists improve patient outcomes.

Activities of Daily Living↗

PubMed2005

Stratified analysis in randomized trials with noncompliance.

This article develops methods for stratified analyses of additive or multiplicative causal effect on binary outcomes in randomized trials with noncompliance. The methods are based on a weighted estimating function for an unbiased estimating function under randomization in each stratum. When known weights are used, the derived estimator is a natural extension of the instrumental variable estimator for stratified analyses, and test-based confidence limits are solutions of a quadratic equation in the causal parameter. Optimal weights that maximize asymptotic efficiency incorporate variability in compliance aspects across strata. An assessment based on asymptotic relative efficiency shows that a substantial enhancement in efficiency can be gained by using optimal weights instead of conventional ones, which do not incorporate the variability in compliance aspects across strata. Application to a field trial for coronary heart disease is provided.

Cholesterol↗

PubMed1997

Antiproliferative effect of the somatostatin analogue octreotide on growth hormone-producing pituitary tumors: results of a multicenter randomized trial.

OBJECTIVE: To determine and quantify the in vivo effects of octreotide on the cell cycle kinetics of growth hormone-producing pituitary adenomas. DESIGN: A multicenter randomized trial had been conducted to assess the clinical efficacy of octreotide, and we studied tissue specimens from pituitary macroadenomas in 32 patients with acromegaly from that trial-16 of whom had received 4 months of octreotide therapy before surgical resection and 16 of whom had undergone surgical resection only. MATERIAL AND METHODS: All tumors had been fully characterized on the basis of their immunophenotypic profile and their ultrastructural morphologic features. Included were 16 densely and 16 sparsely granulated somatotroph adenomas. In each case, immunostaining for the cell cycle-specific nuclear antigen Ki-67 was performed with use of the MIB-1 antibody. The staining reaction was manually quantified, and a tumor growth fraction was derived in each case. RESULTS: The mean growth fraction of tumors exposed to octreotide was suppressed by 83% in comparison with untreated surgical controls (0.011+/-0.004% versus 0.065+/-0.016%, respectively; P = 0.0068). The association between octreotide treatment and lower tumor growth fractions was statistically independent of tumor subtype, being evident among both sparsely and densely granulated somatotroph adenomas. CONCLUSION: Octreotide exerts a significant antineoplastic effect on somatotroph adenomas, one readily reflected at the level of the cell cycle. This antiproliferative response provides insight into several clinicopathologic issues surrounding octreotide therapy for these neoplasms.

Acromegaly↗

PubMed1996

A phase III randomized trial of cisplatin plus vindesine versus cisplatin plus vindesine plus mitomycin C versus cisplatin plus vindesine plus ifosfamide for advanced non-small-cell lung cancer.

A randomized trial of chemotherapy in 105 patients with advanced and metastatic non-small-cell lung cancer (NCSLC) was conducted in order to compare the effect of the additional drug mitomycin C (PVM) or ifosfamide (PVI), to the combination of cisplatin plus vindesine (PV). An objective response rate was observed in 42.8% of the patients treated with PVM, 42.4% with PVI and 28.6% with PV and these response rates were not statistically significant (P > 0.20). No patient achieved the complete response with either of the three regimens. Comparison of the median response durations among the three regimens showed an advantage of PVI over PVM (P < 0.02) and PV (P < 0.05). The median survival times (MST) were similar for all three regimens (PVM, 33.5; PVI, 40.0 and PV, 36.5 weeks); moreover, the difference in survival time between the three regimens of responders was not statistically significant. The univariate analysis showed that significant predictors of survival were performance status (PS) zero (P = 0.0002), limited disease (P = 0.004), no previous weight loss (P = 0.01) and normal serum albumin (P = 0.016), and in multivariate analysis by a stepwise Cox proportional hazard model, these were PS zero (a hazard ratio of 2.3, P = 0.0001) and limited disease (a hazard ratio of 1.9, P = 0.048). Toxicity did not differ among the three treatment regimens.

Aged↗