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R R Hall

Publications and source records attributed to R R Hall.

At least 19 recordsLinked to original sources

Quality-adjusted survival (Q-TWiST) analysis of EORTC trial 30853: comparing goserelin acetate and flutamide with bilateral orchiectomy in patients with metastatic prostate cancer. European Organization for Research and Treatment of Cancer.

BACKGROUND: The first data analysis of the European Organization for Research and Treatment of Cancer (EORTC) 30853 trial indicated a significantly longer time to progression and duration of survival for the maximal androgen blockade (MAB) treatment arm. However, the MAB treatment arm had a higher frequency of reported side effects. METHODS: The quality-adjusted survival (Q-TWiST) method was applied to perform a secondary analysis of the EORTC 30853 trial in order to obtain a quality-adjusted survival (QAS) analysis. Two models with different definitions of the progression health state were used for the analysis. In the first model, progression was defined by both objective and subjective criteria, and in the second model only by increase in pain score. The approach was also extended to include an analysis using actual utility scores (Q-tility) of patients in the relevant health states. RESULTS: Based on Q-tility scores obtained from a separate study of a cohort of prostate cancer patients, the QAS analysis resulted in a 5.2-month difference (95% CI, -1.1; 11.5 months) in favor of zoladex and flutamide, equal in magnitude to the benefit found in the unadjusted survival analysis. CONCLUSIONS: A QAS analysis such as the Q-TWiST method may be preferred over the unadjusted approach in clinical trials where the health states are clearly distinct, and differ significantly in either duration or quality of life (QOL), or both. The second model, with progression defined as increase in pain score, made no difference to the results in this study because of the small difference in duration of the pain-progression health state between treatment arms. However, Q-tility scores from the separate cross-sectional study that was used in this Q-TWiST analysis showed that a subjective definition of health states better reflects differences in QOL between the health states that the patients experience during follow-up.

Antineoplastic Agents, Hormonal

Radical transurethral resection and chemotherapy in the treatment of muscle-invasive bladder cancer: a long-term follow-up.

OBJECTIVE: To evaluate the treatment of patients with muscle-invasive bladder cancer (T2-T4a) by radical transurethral resection (TUR) and cisplatin-methotrexate systemic chemotherapy. PATIENTS AND METHODS: Fifty patients with transitional cell carcinoma (TCC) of the bladder (nine T2, 36 T3 and five T4a) were treated by 'complete' TUR of the bladder tumour followed by 2-6 cycles of cisplatin (70 mg/m2) and methotrexate (40 mg/m2) chemotherapy. The median (range) tumour size was 3 (1-7 cm). In six patients, attempted TUR at the dome of the bladder led to intraperitoneal perforation; the tumour was excised by partial cystectomy in these patients. The latest follow-up results from 57 patients treated by radical TUR and methotrexate alone, reported previously, are included. RESULTS: At the first evaluation cystoscopy immediately after completing chemotherapy, 38 patients were tumour-free, eight had persistent muscle-invasive TCC and four had Ta, T1+CIS disease. With an overall median follow-up of 47 months, 10 additional patients relapsed with muscle-invasive carcinoma in the bladder after a median interval of 15.6 months; three patients developed Ta, T1 tumours, three Ta, T1 + CIS, and six CIS only. Six of the 10 recurrent invasive tumours were at the same site, but four were at a different site in the bladder. Although during follow-up 12 patients developed superficial recurrence that required endoscopic treatment, the bladder was preserved (free of muscle-invasive cancer) in 37 of 50 patients. In 30 of these 37, this was achieved with no need for salvage radiotherapy or cystectomy. Six patients died from metastatic TCC with no tumour in the bladder. CONCLUSION: In this selected group of patients, muscle-invasive bladder cancer was controlled by TUR and systemic chemotherapy, preserving normal bladder function in 60% of patients without apparently comprising overall survival.

Adult

Detecting and correcting hyperlipidemia.

The dangers of elevated serum cholesterol levels--and in particular, of increased concentrations of small, dense lipoproteins--have been fully delineated. Although effective therapies are available, too many physicians fail to look for hypercholesterolemia, or fail to treat it effectively. Adhering to therapeutic guidelines and encouraging patient compliance can be lifesaving.

Algorithms

Prostate cancer.

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Age Factors

Bladder cancer.

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Age Factors

Estrogen replacement therapy after coronary angioplasty in women.

OBJECTIVES: The purpose of this study was to assess the effects of estrogen replacement therapy on long-term outcome, including restenosis, myocardial infarction, stroke and death after a first percutaneous transluminal coronary angioplasty (PTCA) procedure, in postmenopausal women. BACKGROUND: Observational and epidemiologic studies, basic laboratory research and clinical trials consistently suggest that estrogen replacement therapy is associated with beneficial cardiovascular effects in women. These cardioprotective actions may be particularly relevant to women with coronary artery disease, such as those who have undergone PTCA. METHODS: This was a retrospective study that included 337 women who underwent elective PTCA between 1982 and 1994. The treatment group consisted of 137 consecutive women receiving long-term estrogen therapy at the time of elective PTCA and during follow-up. The control group comprised 200 women who were computer-matched with the estrogen group. The mean follow-up period was 65 +/- 35 months. RESULTS: Actuarial survival was superior in the estrogen group; the 7-year survival rate was 93% for the estrogen group versus 75% for the control group (p = 0.001). The cardiovascular event rate (death, nonfatal myocardial infarction or nonfatal stroke) was significantly lower in the estrogen group at 7 years (12% vs. 35% in the control group, p = 0.001). The need for subsequent revascularization during follow-up was similar in the two groups. Multivariable analysis identified diabetes, estrogen therapy (adjusted risk ratio 0.38, 95% confidence interval 0.19 to 0.79) and left ventricular ejection fraction < 40% as independent correlates of cardiovascular death or myocardial infarction during follow-up. CONCLUSIONS: Estrogen replacement therapy was associated with an improved long-term outcome after PTCA in postmenopausal women.

Actuarial Analysis

Application of clinical trials to the care of patients with bladder cancer.

Patients with bladder cancer are fortunate because much of the treatment they receive is based on the findings of randomized clinical trials that ensure a sound, scientific basis for the treatment decisions they will agree with their urologist. Patients with Ta or T1 transitional cell carcinoma will be distressed to learn their diagnosis but will be comforted to know that they are most unlikely to die of the disease. They will be well advised to have at least one instillation of intravesical chemotherapy and if they are confirmed to have a good-prognosis tumour, they will probably need only annual follow-up cystoscopies. Other patients will have to accept the inconvenience of more frequent cystoscopies. Should they develop multiple superficial recurrences, more intensive intravesical chemotherapy or BCG is effective. This should probably be repeated at 6-monthly intervals for up to 3 years, although the optimum duration of treatment and the best treatment regimens require further clarification. Patients with muscle invasive bladder cancer do not have a good prognosis and, unfortunately, the addition of systemic chemotherapy does not offer any clear survival advantage at the present time. New, more effective forms of treatment are awaited. The confidence with which bladder cancer patients can be treated is based on the results of collaborative, multicentre trials that have been conducted over the past two decades. The important lesson to be learned, by physician and patient alike, is that randomized clinical trials are worthwhile because the results influence clinical practice and assure best possible care.

Carcinoma in Situ

Chemoresection in Ta-T1 bladder cancer. Members of the EORTC Genito-Urinary Group.

OBJECTIVES: The authors present the results of two parallel phase II trials, instituted by the EORTC Genito-Urinary Group in 1986, whose aims were to assess the tolerability and ablative capacity of mitomycin C (study 30864) and epirubicin (study 30869) in patients with multiple primary or recurrent Ta-T1 bladder cancer. METHODS: A well-defined tumour (marker lesion) was left in the bladder after transurethral resection (TUR). All patients received 8 weekly instillations, after which cystoscopy with bladder biopsies +/- TUR was performed. Responses were rated as follows: (1) complete-no visible or microscopic bladder cancer; (2) no change-persistence of the marker lesion; (3) progression-increased marker lesion size, new tumour(s) or presence of muscle-invasive disease at any site. RESULTS: Ninety-six evaluable patients were treated with mitomycin and 36 with epirubicin. The overall bladder response in the former group was complete in 50%, no change in 30% and progression in 20% of patients, while the marker lesion response was complete in 57%, no change in 39% and progression in 4%. In the epirubicin group, 56% of the patients achieved a complete overall response, while there was no change in 22% and progression in 22%. The marker lesion response in this group was complete in 67%, no change in 31% and progression in 3%. Only 2 cases of progression were due to the presence of muscle-invasive disease. Both of these were in the mitomycin group; 1 was at the marker lesion site, and 1 was at a remote site. CONCLUSIONS: The present studies confirm the feasibility and safety of the marker lesion model for the objective evaluation of the antitumoural activity of intravesically administered drugs.

Administration, Intravesical

Screening and early detection of prostate cancer will decrease morbidity and mortality from prostate cancer: the argument against.

The ability of prostate specific antigen, digital rectal examination and transurethral ultrasound, either individually or in combination, to detect unsuspected prostate cancer is beyond doubt. Early detection programmes have revealed prostate cancer in 6% of men over 50 years of age. Most are stage T1c, or confined to the prostate but, protagonists claim that, on the basis of size, they are 'clinically significant'. Mortality from this disease should be reduced by their treatment. Available statistics suggest that the lifetime incidence of 'screen-detected' cancers will far exceed the likelihood of dying from prostate cancer. Given the current operative mortality of total prostatectomy and the physical and psychological morbidity of screening, biopsy and treatment, it is far from certain that mortality or morbidity from prostate cancer will be decreased. Long-term outcome data for T1c prostate cancer do not exist. Is the likelihood of prostate cancer death the same for prostate-specific antigen thresholds of 2, 3 or 4 ng/ml, or from tumours found in 1 of 6, or 1 of 12 needle biopsies? None of this is known. European men deserve the benefit of scientifically based information before being exposed to another North American fashion. Prospective randomised trials investigating mortality, quality of life and cost benefit are the only solution.

Aged

The effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: a further report with 7 years of follow up.

PURPOSE: We determined the role, if any, of 1 and 5 instillations of intravesical mitomycin C in the treatment of newly diagnosed superficial bladder cancer. MATERIALS AND METHODS: A multicenter randomized clinical trial was done involving 502 patients with newly diagnosed superficial bladder cancer. After complete transurethral resection patients with newly diagnosed superficial bladder cancer. After complete resection patients were randomized into 1 of 3 treatment arms: no further treatment, 1 instillation of mitomycin C at resection and 1 instillation at resection and at 3-month intervals for 1 year (total 5 instillations). The dose of mitomycin C used was 40 mg./40 ml. water. End points were interval to first superficial recurrence, recurrence rate (defined as the number of positive cystoscopies per year) and progression-free interval rate (progression defined as the development of muscle invasive or metastatic disease, or death from bladder cancer). RESULTS: After median followup of 7 years 1 and 5 instillations of mitomycin C resulted in decreased recurrence rates and increased recurrence-free interval. The benefit of mitomycin C was observed in patients at low, medium and high risk for subsequent recurrence. There was suggestive but not conclusive evidence that 5 instillations of mitomycin C offered a slight advantage over 1 instillation. CONCLUSIONS: Our analysis confirms the positive benefit of mitomycin C to decrease the number of subsequent recurrences and increase the recurrence-free interval.

Administration, Intravesical

Marker tumour responses to the sequential combination of intravesical therapy with mitomycin-C and BCG-RIVM in multiple superficial bladder tumours. Report from the European Organisation for Research and Treatment on Cancer-Genitourinary Group (EORTC 30897).

OBJECTIVES: To study the ablative activity of intravesical mitomycin C followed by intravesical bacillus Calmette-Guérin (BCG) on a papillary marker tumour and to determine the incidence of side effects. METHODS: Thirty-five patients with multiple pTa or pT1 bladder tumours were treated with 4 instillations of mitomycin C at weekly intervals followed by 6 instillations at weekly intervals of BCG-RIVM. All visible tumours were resected before starting intravesical instillations except one marker tumour. Response was determined 2 weeks after the last instillation. RESULTS: The incidence of adverse effects was similar to previously reported toxicity of either mitomycin C or BCG alone. Complete response, histologically proven, was observed in 16 of 35 patients and in 3 patients without histological confirmation. One patient showed progression. CONCLUSION: The sequential combination of mitomycin C and BCG is an efficacious treatment. The measurement of response to a marker tumour is a safe and efficient method to test new drugs or combinations of drugs.

Adjuvants, Immunologic

The persistence of bacille Calmette-Guérin in the bladder after intravesical treatment for bladder cancer.

OBJECTIVE: To determine the incidence of bacille Calmette-Guérin (BCG) bacilli persisting in the urinary tract of patients treated previously with intravesical BCG for carcinoma in situ or multiple Ta.T1 transitional cell carcinoma. PATIENTS AND METHODS: One-hundred and twenty-five patients were treated at the Freeman Hospital, Newcastle upon Tyne, UK over an 8-year period, 90 of whom submitted early morning urine samples for culture for acid-fast bacilli at varying intervals following BCG treatment. The records of all patients were reviewed to determine the incidence of caseating granulomata containing acid-fast bacilli together with the incidence of toxicity and the outcome of treatment. RESULTS: Five patients were found to have persisting acid-fast mycobacteria in their urine or bladder up to 16.5 months after completing intravesical instillations of BCG. In one patient this probably accounted for bladder symptoms that required palliative cystectomy. In four patients the 'infection' was not severe. Two patients were treated with antituberculous chemotherapy without complication. Three years after intravesical BCG therapy 36 of 69 patients (52%) had remained tumour free. CONCLUSION: BCG organisms can persist in the urinary tract for at least 16.5 months after the completion of intravesical BCG instillation therapy.

Administration, Intravesical

The application of a prognostic factor analysis for Ta.T1 bladder cancer in routine urological practice.

OBJECTIVE: To assess the reproducibility of the prognostic factor findings of Parmar et al. [1], in a routine urological practice. PATIENTS AND METHODS: The superficial tumour recurrence-free rate has been analysed for 232 newly diagnosed consecutive patients with Ta.T1 transitional cell carcinoma of the bladder. All patients were without carcinoma in situ or muscle invasion at the time of diagnosis. RESULTS: Applying the prognostic factors recommended (number of tumours at diagnosis; tumour recurrence at first 3-month cystoscopy) patients with Ta.T1 bladder cancer may be divided into three distinct groups with significantly different chances of superficial bladder tumour recurrence. CONCLUSION: Two simple clinical criteria provide a reliable guide to the likelihood of tumour recurrence in patients with Ta.T1 bladder cancer. The modification of follow-up cystoscopy schedules on this basis requires prospective study.

Carcinoma, Transitional Cell

Pain relief and quality-of-life assessment following intravenous and oral clodronate in hormone-escaped metastatic prostate cancer.

OBJECTIVE: To establish the efficacy of intravenous clodronate followed by maintenance oral clodronate in patients with painful bone metastases resulting from hormone-resistant prostate cancer. PATIENTS AND METHODS: A multicentre open study of 27 patients assessed the efficacy of clodronate treatment by estimating the reduction in World Health Organization (WHO) Pain Score, the increase in WHO Performance Status and by a novel quality-of-life/activity score. RESULTS: Ten of 27 patients achieved significant pain relief after receiving 300 mg/day of intravenous clodronate for 10 days. This was matched by an improvement in the activity score and WHO Performance Status. Three of 27 patients continued to have relief from pain after 3 months of oral clodronate therapy. CONCLUSION: Intravenous clodronate therapy was effective in relieving the pain resulting from prostate cancer bone metastases in 10 of 27 patients but the benefit was shortlived. The use of a personal quality-of-life/activity questionnaire which assesses aspects of everyday life that are important to the patient may be more appropriate for patients with very advanced prostate cancer than are other quality-of-life questionnaires in current use.

Administration, Oral