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Reducing dosage in maintenance treatment of schizophrenia. Review and prognosis.

This paper reviews the assumptions and efficacy of two strategies for dose reduction during maintenance treatment in schizophrenia: low dose and targeted medication. Studies of low-dose treatment suggest that it can be used for relatively short periods of time or if the dosage reduction is moderate. Studies of targeted treatment suggest that relapse risk increases significantly compared with standard-dose treatment and that there are few offsetting advantages. The paper also reports initial findings from the NIMH Treatment Strategies in Schizophrenia Study, which compares low dose, targeted treatment and a standard dose in the context of two forms of family treatment. Early stabilisation of patients is lower than expected, but patient characteristics are useful in predicting likelihood of stabilisation.

Antipsychotic Agents↗

Pharmacokinetics of piperacillin-tazobactam: intermittent dosing versus continuous infusion.

In the present study 24 hospitalized patients requiring empirical antibiotic treatment were randomly assigned to receive the beta-lactam antibiotic/beta-lactamase inhibitor combination piperacillin-tazobactam either as an intermittent or as a continuous infusion. According to pharmacokinetic modelling, the daily dose was reduced by 33% in patients receiving continuous infusion compared with intermittent infusion. Dose reduction because of impaired renal function was required in the intermittent dosing group for 5 of 12 patients compared with 1 of 12 patients in the continuous infusion group. However, the mean daily dose in the continuous group was 15% less than the intermittent infusion group. Mean serum concentrations of piperacillin were to 39.0 microg/ml after the end of bolus distribution, exceeding by far the minimal inhibitory concentration of the most clinically relevant pathogens. The corresponding mean value for tazobactam was 6.3 microg/ml. Pharmacokinetic/pharmacodynamic modelling suggests that both treatment schemes should produce virtually identical anti-infective responses to sensitive, intermediate and resistant strains. In the present study the continuous infusion of piperacillin/tazobactam provided adequate antibacterial activity over the 24-h dosing period and offers the potential for a substantial reduction in the total daily dose.

Adult↗

Linear accelerator radiosurgery for pituitary macroadenomas: a 7-year follow-up study.

BACKGROUND: A prospective study was conducted to assess the efficacy and side effects of linear accelerator (LINAC)-based radiosurgery (RS) performed with a reduced dose of therapeutic radiation for patients with surgically inaccessible pituitary macroadenomas. METHODS: From August 1990 through January 2004, 175 patients with pituitary macroadenomas were treated with LINAC-RS according to a prospective protocol. To minimize the risk for radiation-induced damage of the pituitary function, the therapeutic dose to be applied was limited to 20 grays. RESULTS: Among 175 patients, 142 patients who had a minimum follow-up of 12 months (mean +/- standard deviation, 81.9 +/- 37.2 months) were included in the current study. The local tumor control rate was 96.5%, and the tumor response rate was 32.4%. The mean time (+/- standard deviation) from LINAC-RS to normalization of pathologic hormone secretion was 36.2 +/- 24.0 months. The probability for normalization was 34.3% at 3 years and 51.1% at 5 years. The frequency of endocrine cure (defined as the normalization of hormone secretion without specific medication intake) was 35.2% (mean +/- standard deviation time to cure, 42.1 +/- 25.0 months). Patients with Cushing disease had a statistically significant greater chance of achieving a cure (P = .001). Side effects of LINAC-RS were deterioration of anterior pituitary function (12.3%), radiation-induced tissue damage (2.8%), and radiation-induced neuropathy (1.4%). CONCLUSIONS: LINAC-RS using a lower therapeutic radiation dose achieved local tumor control and normalization or cure of hormone secretion comparable to the results achieved with gamma-knife RS. Compared with the latter, the time to normalization or endocrine cure was delayed, most probably as a result of dose reduction. However, the lower therapeutic radiation dose did not prevent radiation-induced damage of pituitary function completely.

Adenoma↗

Comparative treatment planning on localized prostate carcinoma conformal photon- versus proton-based radiotherapy.

PURPOSE: To assess the potential benefit of proton-beam therapy in comparison to 3-D conformal photon therapy and photon- based intensity-modulated radiotherapy (IMRT) in prostate carcinoma for various stages of disease. MATERIAL AND METHODS: In five patients a 3-D conformal proton-based (two lateral beams) irradiation technique was compared with 3-D conformal photon-beam radiotherapy (four-field box) and IMRT (seven beams). For each patient different target volumes (CTVs) were defined according to early, intermediate and advanced stages of disease: CTV I consisted of the prostate gland, CTV II encompassed prostate and basis of seminal vesicles, and CTV III the prostate and seminal vesicles. Corresponding planning target volumes PTV I-III were defined by uniformly adding a margin of 5 mm to CTV I-III. Dose-volume histograms (DVHs) were analyzed for the different PTVs and various organs at risk (OARs), i.e., rectal wall, bladder, both femoral heads. In addition, maximum and mean doses were derived for the various structures and irradiated non-target tissue volumes were compared for PTV I-III and the different irradiation techniques. Finally, dose conformity and target dose homogeneity were assessed. RESULTS: With photon- and proton-based radiotherapy techniques similar dose distributions were determined for PTV I-III: mean and maximum PTV dose values were between 99-104% and 102-107% of the normalized total doses (70 Gy), respectively. Conformity indices varied from 1.4 to 1.5 for the photon techniques, whereas for proton-beam radiotherapy values ranged from 1.1 to 1.4. Both the 3-D conformal and the IMRT photon treatment technique resulted in increased mean doses (approximately 40-80%) for OARs when compared to protons. With both photon techniques non-target tissue volumes were irradiated to higher doses (mean dose difference > or = 70%) compared to proton-beam radiotherapy. Differences occurred mainly at the low and medium dose levels, whereas in high dose levels similar values were obtained. In comparison to conformal 3-D treatments IMRT reduced doses to OARs in the medium dose range, especially for the rectal wall. CONCLUSION: IMRT enabled dose reductions to OARs in the medium dose range compared to 3-D conformal radiotherapy. A rather simple two-field proton-based treatment technique further reduced doses to OARs compared to photon-beam radiotherapy. The advantageous dose distribution of proton-beam therapy for prostate cancer may result in reduced side effects, which needs to be confirmed in clinical studies.

Femur↗

A review: CNS effects and normal tissue tolerance in dogs.

Large animal studies have been utilized to define tolerance of normal brain to irradiation and verify treatment planning programs with two recently installed epithermal neutron beams. The normal brain tolerance studies utilized two biological endpoints, magnetic resonance visible damage only and neurologic signs progressing to death. The studies focused on defining the proton RBE for the contaminant fast neutrons, and from nitrogen capture of thermal neutrons and boron capture reaction biologic effect. The proton RBE was approximately 3.0 to 6.7, depending on whether a dose reduction factor for the low gamma dose rate was employed. The microscopic distribution of the boron compounds, coupled with the extremely short length of the fission fragments from thermal neutron capture by 10B yields an observed biologic effect much less than would be expected from such high LET irradiation. This observed biologic effect, which is a product of the microdistribution of the boron atom and the relative biologic effect of the fission fragments has been termed compound factor. The compound factor was based on the calculated physical dose from the fission fragment in blood based on measured blood 10B concentration. The approximate compound factor for BSH was studied at the two institutions and it ranged from 0.27 to 0.55, depending on the site and the endpoint chosen. The mean compound factor for BPA was only studied at one site and was found to be 1.1 for both endpoints. The increase in the compound factor for BPA is in keeping with previous calculations based on the differences in compound distribution. Results of these studies has helped the initiation of phase I and phase II clinical trials at Brook haven National Laboratory and the planned European clinical trials at Petten, The Netherlands.

Animals↗

A phase II study of high-dose epirubicin in ovarian cancer patients previously treated with cisplatin. EORTC Gynecological Cancer Cooperative Group.

BACKGROUND: In vitro data demonstrated a dose-response relationship for doxorubicin in ovarian cancer cell lines. However, this dose-response question for anthracyclines has never been adequately addressed in ovarian cancer patients. A phase I study with epirubicin gave support to these in vitro findings and recommended a dose of 150 mg/m2 for phase II testing. PATIENTS AND METHODS: The present report concerns the final analysis of an EORTC-Gynecological Cancer Cooperative Group (GCCG) phase II study of high-dose epirubicin (HDE) in cisplatin-pretreated patients with epithelial ovarian cancer. A total of 100 eligible patients were included; 34 had progressed during first-line therapy (group 1), 17 had persistent disease after first-line therapy (group 2) and 49 had relapsed following an initial response to first-line therapy (group 3). All patients had measurable or evaluable disease, were aged < 75 years, had a WHO performance status 0-2, had adequate vital organ function and gave consent. Epirubicin was administered by rapid i.v. infusion at a dose of 150 mg/m2 and given at three-week intervals. Escalation to 180 mg/m2 was to be carried out if white blood cell nadir count was > 2.0 x 10(9)/l and platelet nadir count was > 75 x 10(9)/l. RESULTS: A total of 361 HDE treatment cycles were administered, the median number per patient being 4. Of the 85 patients who received at least two cycles of protocol treatment, 26 (31%) did not have any dose modification, 23 (26%) had dose reduction, while 36 (43%) had the dose increased to 180 mg/m2, at least for one cycle. The response rate in all eligible patients was 20% (95% confidence interval 13%-30%), 15% in group 1, 12% in group 2 and 27% in group 3. Patients with a cisplatin-free interval of > 12 months responded in 41%. The median duration of response was nine months (range 19 weeks to 3 years). Main toxicities were myelosuppression (leucopenia, neutropenia), nausea, vomiting, alopecia and mucositis. There were three cases of excessive toxicity leading to early discontinuation of HDE treatment and in one patient this contributed to death. No serious cardiotoxicity was recorded. CONCLUSIONS: It is concluded that HDE is active in platinum-pretreated patients with epithelial ovarian cancer and should be further studied in first-line in combination with paclitaxel and a platinum compound.

Adult↗

Management of the relapsed/refractory myeloma patient: strategies incorporating lenalidomide.

The immunomodulatory drug (IMiD) lenalidomide is a more potent immunomodulator than thalidomide with respect to its effects on cytokine modulation and increased T-cell proliferation. Of all the IMiDs, clinical trial data are most mature for lenalidomide. In phase I studies, dose-limiting toxicities of lenalidomide were limited to myelosuppression and a response rate of 72% was seen in relapsed/refractory patients. Three phase II studies subsequently evaluated the efficacy of single-agent lenalidomide or lenalidomide in combination with dexamethasone. As a single agent for post-transplant salvage therapy, lenalidomide 25 mg every 3 weeks has shown response rates as high as 44%. For patients with relapsed/refractory multiple myeloma, the MM-007 study has shown that lenalidomide alone or in combination with dexamethasone provides response rates between 37% and 41%. In MM-007, median progression-free survival was 5.5 months at early analysis and the median overall survival has yet to be reached. Preliminary data for the single-arm, multicenter, open-label MM-014 study showed that median time to progression was 5.6 months. Response rates indicate that 70% of patients had stable disease or better as the best response to treatment. Two randomized, phase III trials (MM-009 and MM-010) evaluated lenalidomide with high-dose dexamethasone versus high-dose dexamethasone alone for the treatment of relapsed/refractory multiple myeloma. Both MM-009 and MM-010 provided remarkably similar response rates for patients receiving lenalidomide and dexamethasone. In both trials response rates with the combination were greater than twice the response rates seen with high-dose dexamethasone alone. Indeed, an independent Data Monitoring Committee determined that both trials exceeded the prespecified efficacy value of P<.0015, recommending that the trials be discontinued and that lenalidomide be offered to patients on the dexamethasone arm of the trial if clinically indicated. Toxicities observed in studies of lenalidomide alone were low; the incidence of peripheral neuropathy was significantly lower than those noted in trials using thalidomide. Thrombocytopenia was a significant grade 3 or 4 toxicity observed; however, it was manageable with dose reduction. In contrast with high-dose dexamethasone, deep vein thrombosis has emerged as an important toxicity. Lenalidomide is currently being tested in combination with both standard and novel agents, including bortezomib, for patients with relapsed/refractory multiple myeloma.

Antineoplastic Combined Chemotherapy Protocols↗

Scattered dose to thyroid from prophylactic cranial irradiation during childhood: a Monte Carlo study.

The purpose of this study was to estimate the scattered dose to thyroid from prophylactic cranial irradiation during childhood. The MCNP transport code and mathematical phantoms representing the average individual at ages 3, 5, 10, 15 and 18 years old were employed to simulate cranial radiotherapy using two lateral opposed fields. The mean radiation dose received by the thyroid gland was calculated. A 10 cm thick lead block placed on the patient's couch to shield the thyroid was simulated by MCNP code. The Monte Carlo model was validated by measuring the scattered dose to the unshielded and shielded thyroid using three different humanoid phantoms and thermoluminescense dosimetry. For a cranial dose of 18 Gy, the thyroid dose obtained by Monte Carlo calculations varied from 47 to 79 cGy depending upon the age of the child. Appropriate placement of the couch block resulted in a thyroid dose reduction by 39 to 54%. Thyroid dose values at all possible positions of the radiosensitive gland with respect to the inferior field edge at five different patient ages were found. The mean difference between Monte Carlo results and thyroid dose measurements was 9.6%.

Body Burden↗

Update on patient radiation doses at a large tertiary care medical center.

Radiation procedures in diagnostic radiology and nuclear medicine examinations, especially at referral centers, contribute a significant proportion to population dose; hence, there is a presumed detriment. Knowledge of the magnitude of dose from each type of exam is helpful in determining where to implement dose reduction efforts. Additionally, new records of dose data facilitate comparisons with past measurements. In this paper, updated patient exam dose data (frequency and effective dose equivalent) are provided for a large, comprehensive, tertiary care medical center that served more than 340,000 patients in 1997. Patient billing code data were used to study 31 different types of diagnostic exams encompassed in five major categories (angiography, fluoroscopy, radiography, nuclear medicine, and computerized tomography). Organ doses for each radiographic and nuclear medicine exam were estimated using published Monte Carlo conversion factors and appropriate exposure values. Estimates of organ doses were utilized to compute effective dose equivalent (EDE) per ICRP 26 and collective effective dose equivalent. Mean effective dose equivalent was also calculated for each exam category. Total collective effective dose equivalent had decreased from 1988 (2,030 person-Sv) to 1997 (1,817 person-Sv). The largest contributors to collective effective dose equivalent were angiography (768 person-Sv), computerized tomography (447 person-Sv), and nuclear medicine (355 person-Sv). Radiography (150 person-Sv) and fluoroscopy (97 person-Sv) contributed the least to collective effective dose equivalent. Mean effective dose equivalent contributions remained the same, with angiography accounting for the highest component, followed by nuclear medicine, computerized tomography, fluoroscopy, and radiography, respectively. Effective dose equivalent, collective effective dose equivalent, and mean effective dose equivalent values were calculated and tabulated in five major categories. These data provide updated information as to trends in exam and; collective dose from 31 common types of radiologic exams performed at a large medical center, which can be used as an up to date baseline for analyses of trends in U.S. radiation doses due to medical imaging procedures. Although minor changes were observed in comparing the mean effective dose equivalent data to those of a previous study, substantial differences were evident in the collective effective dose equivalent data. This was due primarily to variations in the number of patients examined and changes in technology and practice.

Angiography↗

Optimizing Initial Dosing for Tacrolimus and Mycophenolate in Living Donor Liver Transplantation: A Systematic Critical Review.

BACKGROUND: The pharmacokinetics (PK) of immunosuppressive agents in living donor liver transplantation (LDLT) recipients are expected to differ from those in deceased donor liver transplantation (DDLT) recipients because of the smaller initial liver volume transplanted and pathophysiological changes during liver regeneration. Consequently, the hepatic metabolism, CYP enzyme activity, and glucuronidation may be reduced. The PK of tacrolimus (metabolized by CYP3A5) and mycophenolate (metabolized through glucuronidation) are expected to be affected early post-LDLT. However, the initial dosing recommendations for post-LDLT remain unclear. PURPOSE: This study aimed to recommend initial dosing approaches for tacrolimus and mycophenolate in LDLT recipients based on available PK data in humans. METHODS: A PubMed search was conducted in March 2025 to identify studies investigating the PK data of immediate-release tacrolimus and mycophenolate in pediatric or adult LDLT recipients. RESULTS: After screening, 8 and 8 articles on tacrolimus and mycophenolates, respectively, met the review criteria. The current literature suggests that LDLT recipients require lower tacrolimus doses than DDLT recipients, particularly in the early post-transplant period. In addition, CYP3A5 polymorphisms in both donors and recipients contribute to interindividual variability in tacrolimus exposure, further complicating tacrolimus management. Studies on mycophenolate use in LDLT recipients are limited, with insufficient evidence to support dose reduction. CONCLUSIONS: Reducing the initial tacrolimus dose in LDLT recipients by 30%-50% compared with that in DDLT recipients would be reasonable while maintaining the same initial dose of mycophenolate between LDLT and DDLT recipients.

Humans↗

Diltiazem and propranolol, alone and in combination, on exercise performance and left ventricular function in patients with stable effort angina: a double-blind, randomized, and placebo-controlled study.

Diltiazem and propranolol alone and in combination as antianginal agents were compared with placebo in 12 patients with stable exertional angina at Stanford University Medical Center. The patients performed symptom-limited, multi-stage upright bicycle ergometric exercise while undergoing radionuclide angiographic studies every two weeks while being treated with 90 mg of diltiazem four times daily, 60 mg of propranolol four times daily, a combination of 90 mg of diltiazem and 60 mg of propranolol four times daily, and placebo. Diltiazem, propranolol and a combination all significantly increased exercise duration compared to placebo (526 +/- 149, 525 +/- 115, and 549 +/- 129 vs 430 +/- 132 sec.). Although rate pressure product and heart rate decreased with diltiazem therapy at submaximal workloads, these values were unchanged at peak exercise in contrast to propranolol or the combination of propranolol or diltiazem. Diltiazem decreased the sub-maximal and maximal degree of exercise-induced ST segment depression by over 50% compared to placebo (P less than 0.01 vs placebo). Diltiazem resulted in a higher exercise left ventricular ejection fraction compared to placebo, propranolol or the combination of diltiazem or propranolol (all less than P less than 0.05). Sinus bradycardia or orthostatic hypertension occurred in four patients on the high-dose combination therapy and required dose reduction. We concluded that high-dose diltiazem, appeared to be even more effective than moderate-dose propranolol or the combination of diltiazem and propranolol in improving exercise tolerance, electrocardiographic evidence of myocardial ischaemia and left ventricular function in patients with stable effort angina due to occlusive coronary artery disease.

Aged↗

Metabolic studies and clinical observations during L-dopa treatment of Parkinson's disease.

Twenty-two patients with Parkinson's disease were treated for the periods of up to six months with L-dopa. In nine of the male patients metabolic observations were made after oral administration of (14)C-L-dopa.Peak serum levels of total radioactivity represented small fractions of the dose given and occurred at one to two hours after ingestion. Two-thirds of the dose was excreted as metabolites in urine in eight hours. Insignificant fractions of the dose were excreted in stool and expired air. These results indicate rapid and complete absorption from the gastrointestinal tract, as well as rapid distribution and excretion. Clinical observations confirmed that L-dopa is an effective treatment for Parkinson's disease. Improvements in disability averaged 47% at 30 days, 55% at 50 days, and 60% at three months. Degree of improvement tended to be inversely related to age of patient, duration of illness, and severity of disease. Side-effects were seen in most patients, but were always reversible with dose reduction. Nausea was the chief dose-limiting side-effects in early therapy and choreoathetosis after two months of treatment. The average tolerated daily dose was 3 g. On the basis of this experience it seems that the drug can be used safely and effectively on an outpatient basis provided that dosage increments are introduced gradually, maximum dosage is limited to 4 g. a day, and supervision is both close and continuous.

Age Factors↗

The use of therapeutic drug monitoring in the management of protease inhibitor-related toxicity.

The aim of this project was to determine whether therapeutic drug monitoring (TDM) and subsequent dose modification is effective in the management of protease inhibitor (PI)-associated toxicity. A retrospective case-notes review of patients who had had TDM for suspected antiretroviral drug toxicity from November 2000 to March 2002 was carried out. This identified six symptomatic patients in whom high plasma drug levels of a PI had been found and subsequent dose modification was associated with improvement/resolution of symptoms. In 5/6 patients viral loads were below the level of detection prior to TDM and remained so after dose reduction of PI. TDM-directed dose modification of PI enables patients to continue effective regimens of highly active antiretroviral therapy, thus avoiding the need to switch the regimen.

Adult↗

[Reduced intensity stem cell transplantation for metastatic renal cell carcinoma].

PURPOSE: We reviewed reduced intensity stem cell transplantation (RIST) in metastatic renal cell cancer (RCC). PATIENTS AND METHODS: Two cases of lung metastasis of immunotherapy invalidity. Six days of fludarabine 30 mg/m2 and 2 days of busulfan 4 mg/kg were given as conditioning for mini-SCT. CyA and short-term MTX were used as immunosuppressive agents. RESULTS: Size reduction of tumor was observed with dose reduction of CyA. Following steroid therapy for the treatment of GVHD, the tumor progressed. No serious complications except for GVHD. CONCLUSION: These results suggested that RIST might be considered as salvage therapy in patients metastatic RCC.

Adult↗

A pilot clinical laboratory trial of paclitaxel and endobronchial brachytherapy in patients with non-small cell lung cancer.

Paclitaxel enhances microtubule assembly and causes a cell cycle arrest in mitosis, the most radiosensitive phase. We conducted this study to improve our understanding of paclitaxel effects in vivo and to determine the maximum tolerated dose of paclitaxel preceding endobronchial radiation therapy (brachytherapy). The treatment consisted of two cycles of paclitaxel infused over 24 hours followed by 192Ir brachytherapy; cycles were repeated every 3 weeks. Tumor samples were obtained at baseline, after each paclitaxel infusion, and 3 weeks after completion of therapy. Twenty-two non-small cell lung cancer patients with a documented endobronchial lesion were enrolled in the study and 20 patients received the therapy with different doses of paclitaxel, initially without and then later with granulocyte colony-stimulating factor (G-CSF) support (5 microg/kg subcutaneously on days 3 to 10). With the starting paclitaxel dose of 135 mg/m2, five of seven patients developed neutropenia and fever, which mandated a dose reduction to 120 mg/m2. At this dose level, three of three patients had neutropenic fever; thus, 120 mg/m2 of paclitaxel was considered above the maximum tolerated dose without G-CSF support. However, with G-CSF support the therapy was well-tolerated without dose-limiting toxicity and accrual is continuing at the paclitaxel 175-mg/m2 dose level. While no patient had achieved systemic tumor response, 11 patients achieved partial response of the endobronchial lesion, which represents 68.8% of 16 patients who received two courses of therapy and 91.8% of 12 patients who had full evaluation by bronchoscopy after completion of therapy. The in vivo paclitaxel effects were studied using the pre- and post-paclitaxel therapy tumor samples in eight patients. Four (50%) patients had a significant increase in mitotic cells after paclitaxel, as assessed by MPM-2 immunostaining that recognizes a large family of mitotic phosphoproteins. A substantial increase in the number of micronucleated apoptotic cells, another paclitaxel effect, was also found in six patients. These results clearly indicate that patients with endobronchial lesions from recurrent NSCLC could not tolerate this combined modality regimen without G-CSF support. However, this group of patients provided a unique opportunity to study in vivo paclitaxel effects in a clinical trial setting.

Aged↗

[Azathioprine treatment of Crohn disease].

Azathioprine/6MP (AZA/6MP) is effective in long-term treatment (> 3 months) of Crohn's disease and superior to other established medical treatments. The optimal dose remains to be defined. So far, effect has been demonstrated with 2-2.5 mg azathioprine/kg/day, but not with 1 mg/kg/day. A disease controlling effect has been demonstrated during up to four years of continuous treatment, after which data remains to be established. As part of remission-inducing combination therapy the effect of AZA/6MP can not be detected until two-three months after treatment start. High dose intravenous AZA/6MP administration does not shorten this interval. Reversible dose dependent side effects may require dose reduction or termination of treatment. Reversible dose independent side effects exclude further or repeated treatment. Some 10-15% stop treatment due to side effects. There is no increased death rate due to cancer in AZA/6MP treated Crohn patients. When giving the above full dose of AZA/6MP, monthly blood tests are recommended for the entire treatment period, more often during the first three months.

Antimetabolites↗

Rationale for integrating high-dose rate intraoperative radiation (HDR-IORT) and postoperative external beam radiation with subcutaneous amifostine for the management of stage III/IV head and neck cancer.

Locoregional recurrence remains a major obstacle to achieving cure of locally advanced head and neck cancers despite maximal resection and postoperative external beam radiation therapy (EBRT). Locoregional failure occurs in 30% to 40% of high-risk resected head and neck cancer patients after standard postoperative EBRT. In an effort to overcome this problem, a number of strategies have been designed to enhance the effectiveness of radiation including concurrent postoperative chemoradiation, accelerated radiation schedules, incorporation of targeted biologic therapies, and improved radiation delivery techniques such as intensity modulated radiation and high-dose rate (HDR) intraoperative radiation therapy. Intraoperative radiation therapy (IORT) represents an important approach to improve outcome in head and neck cancer patients treated with definitive surgery. High-dose rate IORT is defined as the delivery of a single, large dose of radiation at the time of surgery when the tumor bed is exposed. In conjunction with EBRT, HDR-IORT offers several advantages including: (1) conformal delivery of a large dose of radiation while the tumor bed is precisely defined, minimizing the risk of a geographic miss; (2) potential for subsequent dose reduction of EBRT; (3) shortening overall treatment time; and (4) dose-escalation. Because mucositis represents the dose-limiting acute toxicity and xerostomia ranks as the most common long-term quality-of-life complaint, a reduction of the EBRT dose may provide an important benefit in reducing toxicity, especially when combined with the radioprotectant amifostine (Ethyol, WR-2721; MedImmune, Inc, Gaithersburg, MD). The purpose of this article is to review the rationale for integrating HDR-IORT with a reduced dose of postoperative EBRT combined with amifostine to improve locoregional control and quality of life outcomes in advanced-stage resected head and neck cancer patients.

Amifostine↗

Neuroleptic reduction and/or cessation and neuroleptics as specific treatments for tardive dyskinesia.

BACKGROUND: Since the 1950s neuroleptic medication has been extensively used to treat people with chronic mental illnesses such as schizophrenia. These drugs, however, have been also associated with a wide range of adverse effects, including movement disorders such as tardive dyskinesia (TD). Various strategies have been examined to reduce a person's cumulative exposure to neuroleptics. These studies include dose reduction, intermittent dosing strategies such as drug holidays, and neuroleptic cessation. OBJECTIVES: To determine whether a reduction or cessation of neuroleptic drugs is associated with a reduction in TD, for people with schizophrenia (or other chronic mental illnesses) who have existing TD. Our secondary objective was to determine whether the use of specific neuroleptics for similar groups of people could be a treatment for TD that was already established. SEARCH STRATEGY: We updated previous searches of the Cochrane Schizophrenia Groups Register (1997), Biological Abstracts (1982-1997), EMBASE (1980-1997), LILACS (1982-1996), MEDLINE (1966-1997), PsycLIT (1974-1997), and SCISEARCH (1997) by searching the Cochrane Schizophrenia Groups Register (July 2003). We searched references of all identified studies for further trial citations. We also contacted the principal authors of trials for further unpublished trials. SELECTION CRITERIA: We included reports if they assessed people with schizophrenia or other chronic mental illnesses who had established neuroleptic-induced TD, and had been randomly allocated to (a) neuroleptic maintenance versus neuroleptic cessation (placebo or no intervention), (b) neuroleptic maintenance versus neuroleptic reduction (including intermittent strategies), and (c) specific neuroleptics for the treatment of TD versus, placebo or intervention. A post hoc decision was made to broaden comparison (c) to include specific neuroleptics versus other neuroleptics for the treatment of TD. DATA COLLECTION AND ANALYSIS: We (KSW, JR) independently inspected citations and, where possible, abstracts, ordered papers, and re-inspected and quality assessed these and extracted data. We analysed dichotomous data using random effects relative risk (RR) and estimated the 95% confidence interval (CI). Where possible we calculated the number needed to treat (NNT) or number needed to harm statistic (NNH). We excluded continuous data if more than 50% of people were lost to follow up, but, where possible, we calculated the weighted mean difference (WMD). It was assumed that those leaving the study early showed no improvement. MAIN RESULTS: We included five trials and excluded 102. One small two week study (n=18), reported on the 'masking' effects of molindone and haloperidol on TD, which favoured haloperidol (RR 3.44 CI 1.1 to 5.8). Two (total n=17) studies found no reduction in TD associated with neuroleptic reduction (RR 0.38 CI 0.1 to 1.0). One study (n=20) found no significant differences in oral dyskinesia (RR 2.45 CI 0.3 to 19.7) when neuroleptics were compared as a specific treatment for TD. Dyskinesia was found to be not significantly different (n=32, RR 0.62 CI 0.3 to 1.26) between quetiapine and haloperidol when these neuroleptics were used as specific treatments for TD, although the need for additional neuroleptics was significantly lower in the quetiapine group (n=47, RR 0.49 CI 0.2 to 1.0) than in those given haloperidol. AUTHORS' CONCLUSIONS: Limited data from small studies using neuroleptic reduction or specific neuroleptic drugs as treatments for TD did not provide any convincing evidence of the value of these approaches. There is a need for larger trials of a longer duration in order to fully investigate this area.

Antipsychotic Agents↗