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R Blum

Publications and source records attributed to R Blum.

At least 37 records · Page 2Linked to original sources
PubMed1999

Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide.

BACKGROUND: For small-cell lung cancer confined to one hemithorax (limited small-cell lung cancer), thoracic radiotherapy improves survival, but the best ways of integrating chemotherapy and thoracic radiotherapy remain unsettled. Twice-daily accelerated thoracic radiotherapy has potential advantages over once-daily radiotherapy. METHODS: We studied 417 patients with limited small-cell lung cancer. All the patients received four 21-day cycles of cisplatin plus etoposide. We randomly assigned these patients to receive a total of 45 Gy of concurrent thoracic radiotherapy, given either twice daily over a three-week period or once daily over a period of five weeks. RESULTS: Twice-daily treatment beginning with the first cycle of chemotherapy significantly improved survival as compared with concurrent once-daily radiotherapy (P=0.04 by the log-rank test). After a median follow-up of almost 8 years, the median survival was 19 months for the once-daily group and 23 months for the twice-daily group. The survival rates for patients receiving once-daily radiotherapy were 41 percent at two years and 16 percent at five years. For patients receiving twice-daily radiotherapy, the survival rates were 47 percent at two years and 26 percent at five years. Grade 3 esophagitis was significantly more frequent with twice-daily thoracic radiotherapy, occurring in 27 percent of patients, as compared with 11 percent in the once-daily group (P<0.001). CONCLUSIONS: Four cycles of cisplatin plus etoposide and a course of radiotherapy (45 Gy, given either once or twice daily) beginning with cycle 1 of the chemotherapy resulted in overall two- and five-year survival rates of 44 percent and 23 percent, a considerable improvement in survival rates over previous results in patients with limited small-cell lung cancer.

Adult↗
PubMed1999

Trends in transition from pediatric to adult health care services for young adults with chronic conditions.

PURPOSE: The rationale underlying this study was the need to move the transition health services model from a theoretical framework to an empirically-based investigation. Thus, it was necessary to identify programs for youth with chronic or disabling conditions that assist in transitioning from child- to adult-focused health services by (a) discrete types, (b) functional categories, and (c) problems and issues faced by these programs. METHODS: Nominations for transition health services programs were solicited from 1025 organizational agencies at the local, state, regional, and national levels. Two solicitations yielded 277 nominees. After pilot testing, a survey of 163 forced responses and open-ended questions was mailed to each nominated transition health services program. A total of 122 programs returned completed surveys. RESULTS: Program services were categorized as adolescent-focused (38%), condition-focused (36%), and specialty-specific programs (26%). Few programs were primary care-based. Categories were subsequently collapsed into two types: adolescent-focused and condition-focused. No significant differences were noted between adolescent- and condition-focused programs regarding provision of mental health services, vocational counseling, self-efficacy training, or health education. The primary barriers to transition health services were identified as funding and access to key staff, rather than family and adolescent resistance. CONCLUSION: In general, self-identified transition health care programs do not achieve the goal of collaborative, coordinated, and integrative services to adolescents with chronic or disabling conditions. Furthermore, the barriers to attaining the goal are the limitations of the health care system itself.

Adolescent↗
PubMed1999

Intracellular localization and in vivo trafficking of p24A and p23.

Recently, p24A and p23 (also termed Tmp21), two members of the p24 protein family, have been proposed to function as integral receptors for the COPI-vesicle coat. This study describes the intracellular localization and trafficking of p24A in comparison to p23. For immunolocalization of p24A and p23, strong reduction and denaturation conditions were necessary to allow antibody interaction. Both p24A and p23 cycle continuously between intermediate compartment (IC) elements and the cis-Golgi network. In vivo trafficking of p24A and p23 tagged to green fluorescent protein (GFP) revealed that both proteins travel by large (up to 1 micrometer in length) microtubule-dependent pre-Golgi carriers with a maximum speed of up to 1.6 micrometer s-1 from the IC to the Golgi cisternae. Aluminum fluoride, a general activator of heterotrimeric G-proteins, blocked peripheral pre-Golgi movements of GFP-p24A/p23 and inhibited fluorescence recovery after photobleaching in the perinuclear Golgi area. p24A and p23 are predominantly colocalized. Overexpression of GFP-p24A, to an extent which did not destroy the Golgi complex, induced delocalization of part of the proteins into ER elements. This study therefore gives new insights into the localization and trafficking behavior of the two COPI-binding proteins p24A and p23.

Aluminum Compounds↗
PubMed1999

Computerized realistic simulation: a teaching module for crisis management in radiology.

OBJECTIVE: Computerized realistic simulation technology has been used as a training tool in fields such as aviation and military training and in the nuclear power industry. More recently, it has been adapted for use in anesthesia crisis resource management. We describe the effectiveness of a simulation program like that used by anesthesiology departments that we developed to teach radiologists the principles of crisis management. MATERIALS AND METHODS: A mock CT scanner and patient simulator were used to simulate the environment in which radiologists encounter crises. Twenty-four residents attended the training program, four at each half-day session. Two responded to and two observed an initial crisis, after which they attended a lecture and watched a videotape review. The second pair then participated in a different crisis scenario. The scenario order was randomized. All scenarios were videotaped and randomly reviewed by two physicians not involved with the course. The following behavioral qualities of the participating residents were evaluated using a five-point scale, ranging from poor (1) to excellent (5): global assessment, communication skills, use of support personnel, use of resources, and role clarity. Residents then rated the course on a five-point scale using the following criteria: overall course usefulness, attainment of course goals, realism of scenarios, quality of lecture, and quality of videotape review. RESULTS: The trainees who had attended the lecture and watched the videotape review before participating in a scenario consistently scored higher than those who had not in the following areas (score after training/score before training): global assessment, 4.08/2.50; communication skills, 4.09/2.67; use of support personnel, 4.17/3.00; use of resources, 4.00/2.92; and role clarity, 4.17/2.67. Moreover, the participants gave the course the following average ratings: overall usefulness, 4.93; attainment of course goals, 4.78; realism of scenarios, 4.63; quality of lecture, 4.63; and quality of videotape review, 4.85. CONCLUSION: Although the critical assessment of a teaching method is difficult and subjective by nature, the improvement in behavioral performance scores suggests that simulation technology effectively conveyed the principles of crisis management. The course ratings show that the program was well accepted by participants.

Clinical Competence↗
PubMed1999

A comparative study of rat and human Tmp21 (p23) reveals the pseudogene-like features of human Tmp21-II.

Tmp21 (p23) is involved in biosynthetic transport from the endoplasmic reticulum to the Golgi complex. We have recently characterized two cDNA-variants of human Tmp21, the Tmp21-isoforms-I and -II. Because of the lack of cDNA sequence data and protein expression data, it was not clear if Tmp21-II encodes a functional Tmp21-protein. Here we describe the cloning of the full length human Tmp21-II transcript. The putative open reading frame of Tmp21-II contains a reading frame jump and a nonsense mutation in comparison to all other Tmp21-I (p23) members. Our data indicate that hum-Tmp21-II is transcribed, but not translated. We conclude that Tmp21-II cDNA derives from a neutral pseudogene, which originates from a duplication event of the human Tmp21-isoform-I.

Amino Acid Sequence↗
PubMed1999

[Economics and ethics in public health?].

The topic suggests a conflict between ethics and economy in medical care. It is often argued that today's welfare state in affluent societies with their social insurance systems makes it easier for the doctor to translate ethical demands into reality without being hampered by economic restrictions. Both doctors and patients took advantage of this system of medical care by mingling social guarantees for health with the doctor's income. Hence, medical expenses expanded rapidly, additionally promoted by technical progress in medicine. This entailed a proportionate increase in medical expenses in relation to personal income, especially wage income. Budgets of state authorities were streamlined or deficits became larger. This state of affairs was promoted further by mechanisms of distribution of national income in accordance with the slogan "less state, more market". While national income continued to grow, although at a slower rate, the number of jobless persons grew continually and thus also the social expenses, this was not due, as is usually assumed and pretended, to an economic crisis. Society and economy are facing a crisis of distribution of national income under conditions of technical progress as a job killer, making economic production more productive and efficient. Not taking into account the new challenge of social market economy--the German innovation in market economy creating the economic miracle after World War II--reforms of the system of medical care took place and are still continuing along market principles, particularly the latest German reform law leading to individual contracts between patients and their doctors in respect of cost charging. However, marketing principles promote economy in medicine, but they do not promote medical ethics. Further German guidelines for medical care should take stock of past experiences. There will be more competition in the "growing market of medical care" (private and public) and this will need--as economic experience has shown and economists have affirmed--new organisational devices to ensure better outcomes for the individual patient as a consumer and the doctors as suppliers. More responsibility should be given to the different suppliers of collective security in medical care (private or social systems of insurance). No individual patient as a mere consumer has a genuine chance in handling contracts with doctors carefully who are considered to be "gods in white" according to a popular German saying. These consumers have only a slight chance when arguing in courts of justice for the performance of contracts. Diagnosis and therapy, the system of doctors who treat members of statutory social insurance schemes (National Health general practitioners in the U.K.) and doctors as "free entrepreneurs" in the growing market of medical care should be separated due to the different rules of charging costs and offering medical care. "Classless medical care" does not have a better chance by applying market principles. The same is true for ethics versus economy. Doctors as "free entrepreneurs" must learn that markets will not guarantee reimbursement of costs but react to supply and demand. Hence, regulation of medical care by economic instruments creates better chances even for ethics in medical care against economy.

Cost Control↗
PubMed1998

Characterization of cell volume-sensitive chloride currents in freshly prepared and cultured pancreatic acinar cells from early postnatal rats.

1. In freshly prepared and cultured exocrine pancreatic acinar cells from 5- to 7-day-old rats a chloride-selective membrane conductance could be activated by intracellular application of GTPgammaS (40-100 microM), by application of positive pressure (5 cmH2O) to the pipette interior or by challenging the cells with a hyposmolar bath solution. Hyperosmolar bath solutions inhibited the cell volume-sensitive chloride currents. 2. The anion permeability sequence of the cell volume-sensitive chloride conductance was I- > Cl- approximately Br- > F- > methanesulphonate- > glutamate-. I- had a higher permeability but lower conductance than Cl-. The permeability ratio for Pglutamate/PCl was 0.12. 3. The cell volume-sensitive chloride conductance showed outward rectification. Membrane depolarization to high positive voltages (>= +60 mV) caused a time-dependent decay in outward currents. 4. DIDS (4, 4'-diisothiocyanatostilbene-2,2'-disulphonic acid) and SITS (4-acetamido-4'-isothiocyanatostilbene-2,2'-disulphonic acid) reversibly inhibited the cell volume-sensitive chloride current in a voltage-dependent manner. NPPB (5-nitro-2-(3-phenylpropylamino)-benzoic acid), quinidine, quinine and tamoxifen caused voltage-independent current inhibition. 5. Combined fura-2 and whole-cell current measurements showed that activation of the cell volume-sensitive chloride current does not involve cytosolic Ca2+ signals. Furthermore, there is no evidence that Ca2+-activated chloride currents play a significant role in cultured pancreatic acinar cells from 5- to 7-day-old rats. 6. Polymerase chain reaction followed by DNA sequence analysis indicated the presence of mRNA homologous to the ClC-3 chloride channel in pancreatic tissue from 5-day-old rats.

Animals↗
PubMed1998

Expression of NHE1 and NHE4 in rat pancreatic zymogen granule membranes.

We previously characterized a Na+/H+ exchange activity in rat pancreatic zymogen granules [Anderie, I., and Thévenod, F. (1996) J. Membrane Biol, 152, 195-205]. Here we have identified the Na+/H+ exchanger (NHE) isoforms present in zymogen granules by functional studies with NHE inhibitors. The NHE1 specific blocker HOE 694 [3-(methylsulfonyl-4-piperidino-benzoyl)-guanidine methanesulfonate] inhibited zymogen granule Na+/H+ exchange in a concentration dependent manner, maximally to 53 +/- 5% of controls at 100nM. The remaining Na+/H+ exchange activity was inhibitable by EIPA [5-(N-ethyl-N-isopropyl)amiloride] (EC50 approximately 25 microM) or benzamil (EC50 approximately 100 microM). Amiloride inhibited weakly suggesting that "amiloride-resistant" and "amiloride-sensitive" NHE are expressed in zymogen granules. cDNA sequences encoding NHE1- and NHE4-specific transmembrane domains were detected by RT-PCR in rat pancreatic tissue and in the rat pancreatic acinar cell line AR4-2J. The presence of NHE1 and NHE4 in zymogen granule membranes was confirmed by immunoblots of zymogen granule membranes and by pre-embedding immunogold labeling of purified rat pancreatic zymogen granules with polyclonal NHE1 and NHE4 antibodies. Therefore, we propose that NHE1 and NHE4 are expressed in zymogen granule membranes of rat exocrine pancreas.

Amiloride↗
PubMed1998

Evaluating the safety of calcipotriene 30 g per day in patients with psoriasis: a parallel group, vehicle-controlled study.

Elevated blood and urine calcium levels have been reported with the use of high doses of calcipotriene ointment in patients with psoriasis. The objective of this study was to evaluate key measures of calcium metabolism in patients with psoriasis under supervised dosing conditions in a vehicle-controlled study. Of the 24 patients enrolled, 12 each were administered 15 g of ointment containing calcipotriene or vehicle twice a day for 14 days. Blood and urine samples and 24-hour urine collections were obtained at selected time points. All 24 patients completed the study with no significant differences between treatments in any of the laboratory parameters. Trend analysis failed to show any significant differences over time with the exception of calcium, which showed significant changes common to both the calcipotriene and vehicle groups, suggesting that these changes were unrelated to treatment. The results of this study show that the use of calcipotriene ointment at a dose of 30 g per day for 14 days did not produce any significant alterations in blood or urine calcium concentrations and was well tolerated.

Adult↗
PubMed1998

The relationship between suicide risk and sexual orientation: results of a population-based study.

OBJECTIVES: This study examined the relationship between sexual orientation and suicide risk in a population-based sample of adolescents. METHODS: Participants were selected from a cross-sectional, statewide survey of junior and senior public high school students. All males (n = 212) and females (n = 182) who described themselves as bisexual/homosexual were compared with 336 gender-matched heterosexual respondents on three outcome measures: suicidal ideation, intent, and self-reported attempts. Logistic regression analyses were used to examine the association between sexual orientation and outcome measures with adjustment for demographic characteristics. RESULTS: Suicide attempts were reported by 28. 1 % of bisexual/homosexual males, 20.5% of bisexual/homosexual females, 14.5% of heterosexual females, and 4.2% of heterosexual males. For males, but not females, bisexual/homosexual orientation was associated with suicidal intent (odds ratio [OR] = 3.61 95% confidence interval [CI = 1.40, 9.36) and attempts (OR=7.10; 95% CI=3.05, 16.53). CONCLUSIONS: There is evidence of a strong association between suicide risk and bisexuality or homosexuality in males.

Adolescent↗
PubMed1997

Ethnic differences in psychosocial and health behavior correlates of dieting, purging, and binge eating in a population-based sample of adolescent females.

OBJECTIVE: To examine ethnic differences in factors associated with disordered eating behaviors. METHOD: Data were collected from 17,159 adolescent females who completed a school-based health survey conducted in 1987. RESULTS: In all ethnic groups, dieting was associated in bivariate analyses with weight dissatisfaction, perceived overweight, and low body pride. Purging was associated with weight dissatisfaction, perceived overweight, low body pride, greater suicide risk, and greater alcohol use. Binge eating was associated with weight dissatisfaction, perceived overweight, low body pride, lower family connectedness, greater peer acceptance concerns, and emotional stress. DISCUSSION: Body dissatisfaction and perceived overweight are consistent correlates of dieting and binge eating in adolescent females of diverse ethnic groups. Ethnic subculture does not appear to protect against the broader sociocultural factors that foster body dissatisfaction among adolescent females. Implications for understanding sociocultural influences on dieting, obesity, and eating disorders are discussed.

Adaptation, Psychological↗
PubMed1996

Tmp21 and p24A, two type I proteins enriched in pancreatic microsomal membranes, are members of a protein family involved in vesicular trafficking.

We report here on the isolation, cloning, and expression of two Mr 21,000 proteins from rat pancreatic acinar cells, the rat-Tmp21 (transmembrane protein, Mr 21,000) and the rat-p24A. Both proteins are transmembrane proteins with type I topology and share weak but significant homology to one another (23% identity). We further show the cloning and characterization of the human homologs, hum-Tmp21, which is expressed in two variants (Tmp21-I and Tmp21-II), and hum-p24A. Tmp21 proteins and p24A have highly conserved COOH-terminal tails, which contain motifs related to the endoplasmic reticulum retention and retrieval consensus sequence KKXX. The rat-p24 sequence is identical to the hamster CHOp24, a recently characterized component of coatomer-coated transport vesicles, which defines a family of proteins (called the p24 family) proposed to be involved in vesicular transport processes (Stamnes, M. A., Craighead, M. W., Hoe, M. H., Lampen, N., Geromanos, S., Tempst, P., and Rothman, J. E.(1995) Proc. Natl. Acad. Sci. U. S. A. 92, 8011-8015). Sequence alignment and structural features identify the Tmp21 protein as a new member of this p24 family. Northern analysis of various tissues indicates that the Tmp21 proteins and the p24A protein are ubiquitously expressed. The integral membrane components Tmp21 and p24A are localized in microsomal membranes, zymogen granule membranes, and the plasma membrane and are absent from the cytosol. Both p24A and Tmp21 show weak homology to the yeast protein Emp24p, which recently has been shown to be involved in secretory protein transport from the endoplasmic reticulum to the Golgi apparatus. This leads us to conclude that the receptor-like Tmp21 and p24A are involved in vesicular targeting and protein transport.

Amino Acid Sequence↗
PubMed1996

The effects of a pulsed Nd:YAG laser on subgingival bacterial flora and on cementum: an in vivo study.

The purpose of this study was to compare the effects of scaling and Nd:YAG laser treatments with that of scaling alone on cementum and levels of Actinobacillus actinomycetemcomitans, Bacteroides forsythus, Porphyromonas gingivalis, and Treponema denticola. Study samples consisted of 14 patients, age 30 to 75 years, 8 females and 6 males, with a total of 150 periodontally involved sites with probing depth > or = 5 mm. Group A consisted of 100 pockets that were subdivided into 4 equal groups that were treated with conventional scaling and pulsed Nd:YAG laser using an optic fiber of 300 microns and 4 different power levels as follows: Group 1: P = 0.8 W, f = 10 Hz, E = 100 mJ/pulse; Group 2: P = 1.0 W, f = 1.0 Hz, E = 100 mJ/pulse; Group 3: P = 1.2 W, f = 12 Hz, E = 100 mJ/purse; and Group 4: P = 1.5 W, f = 15 Hz, E = 100 mJ/pulse. The time of each treatment was 60 sec per pocket in all 4 groups. Group B consisted of 50 pockets that were treated by conventional scaling alone and served as a control group. Microbiological samples from group A were collected before scaling; after scaling = before laser, just after laser, 2 weeks later, 6 weeks later, and 10 weeks later. Microbiological samples from group B were collected before scaling, after scaling, 6 weeks later, and 10 weeks later. Microbiological analysis of all samples was done by the Institute Für Angewandte Immunologie (IAI) method. The effects of laser on root surfaces were assessed by SEM examination and the sample consisted of 13 teeth from 5 different patients. Four sets of 3 teeth each were treated with Nd:YAG laser using 0.8, 1.0, 1.2, and 1.5 W, respectively. One tooth was just scaled and not treated with laser to serve as a control. Microbiological analysis of Group A samples indicated posttreatment reduction in levels of all 4 bacterial types tested compared to pretreatment levels and Group B controls. SEM examination of the specimens treated with Nd:YAG laser at different levels exhibited different features of root surface alterations.

Adult↗
PubMed1996

Pharmacokinetics of intravenous ciprofloxacin in normal and renally impaired subjects.

The pharmacokinetics of intravenous ciprofloxacin and its metabolites were characterized in 42 subjects with various degrees of renal function (group 1, Clcr (mL/min/1.73 m2) > 90, n = 10; group 2, Clcr 61-90, n = 11; group 3, Clcr 31-60, n = 11; group 4, Clcr < or = 30, n = 10). The dosage regimens were-groups 1 and 2: 400 mg i.v. at 8 hourly intervals; group 3: 400 mg i.v. at 12 hourly intervals and group 4: 300 mg i.v. at 12 hourly intervals. Subjects received a single dose on days 1 and 5 and multiple doses on days 2-4. Multiple plasma and urine samples were collected on days 1 and 5 for the analysis of ciprofloxacin and its metabolites (M1, M2 and M3). Plasma concentrations (Cmax and AUC) of ciprofloxacin and its M1 and M2 metabolites were significantly increased in subjects with reduced Clcr values (Clcr < 60 mL/min/1.73 m2) compared with normal subjects (Clcr > 90 mL/min/1.73 m2). A positive correlation was observed between ciprofloxacin clearance (Cl) and Clcr with a slope of 0.29 (r2 = 0.78) and between renal clearance (Clr) and Clcr with a slope of 0.19 (r2 = 0.84). For patients with severe infections a dosage regimen of 400 mg iv 8 hourly is appropriate in patients with Clcr > 60 mL/min/1.73 m2. In patients with Clcr values of 31-60 mL/min/1.73 m2 a dosage regimen of 400 mg 12 hourly provides similar plasma concentrations to those observed for subjects with Clcr 61-90 mL/min/1.73 m2 receiving 400 mg 8 hourly. Based on modeling of the plasma concentrations in subjects with Clcr < or = 30 ml/min/1.73 m2, a dosage regimen of 400 mg every 24 h will provide plasma concentrations similar to those observed in subjects with Clcr between 61-90 mL/min/1.73 m2 given 400 mg every 8 h.

Adult↗
PubMed1996

Phase II trial of paclitaxel and cisplatin in women with advanced breast cancer: an active regimen with limiting neurotoxicity.

PURPOSE: A phase II study of paclitaxel and cisplatin in patients with advanced breast cancer was performed to determine the objective response rate and make further observations about the toxicity of this regimen. PATIENTS AND METHODS: Patients were required to have histologically proven adenocarcinoma of the breast with no more than one chemotherapeutic treatment for advanced disease. Treatment consisted of paclitaxel 200 mg/m2 administered as a 24-hour intravenous (i.v.) infusion followed by cisplatin 75 mg/m2 i.v. Patients received granulocyte colony-stimulating factor (G-CSF) 5 micrograms/kg subcutaneously on day 3 until WBC recovery. Cycles were repeated every 21 days. Patients continued to receive therapy until disease progression or unacceptable toxicity. RESULTS: Forty-four patients entered the trial. Forty-two patients were assessable for response. Nineteen patients (43%) had no prior chemotherapy and 41 had no chemotherapy for metastatic disease. The median number of cycles administered per patient was five (range, one to seven). There were five complete responses (CRs) (11.9%) and 17 partial responses (PRs) (40.5%), with an overall response rate of 52.4% (95% confidence interval [CI], 36.4% to 68.0%). Nine patients had stage III disease. The response rate for this group was 66.7% (95% CI, 33.0% to 92.5%), with three CRs and three PRs. Among 35 patients with stage IV disease, there were two CRs and 14 PRs, with an overall response rate of 48.5% (95% CI, 30.8% to 66.5%). Overall, the median response duration was 10.6 months. Thirty patients (68%) developed transient grade 4 neutropenia. Cumulative neuropathy was the major dose-limiting toxicity. After five cycles of chemotherapy, 96% of patients had at least grade 1 neurotoxicity and 52% had at least grade 2 neurotoxicity. One patient had a toxic death after cycle 1 of therapy. CONCLUSION: The combination of paclitaxel and cisplatin as first-line chemotherapy for women with advanced breast cancer is an active regimen. However, the cumulative neurotoxicity was significant and dose-limiting in the majority of patients.

Adenocarcinoma↗
PubMed1996

Double-blind, randomized study of primary hormonal treatment of stage D2 prostate carcinoma: flutamide versus diethylstilbestrol.

PURPOSE: Patients with stage D2 prostate carcinoma are often treated initially with hormones to decrease endogenous testosterone. Therapy with diethylstilbestrol (DES), leuprolide, or bilateral orchiectomy has been reported to be equivalent. DES is the cheapest preparation, but has the potential for serious cardiovascular or thromboembolic complications. Flutamide is a novel antiandrogen with fewer side effects. PATIENTS AND METHODS: The Eastern Cooperative Oncology Group (ECOG) conducted a double-blind, randomized study to compare the efficacy of flutamide (250 mg three times daily) to DES (1 mg three times daily) as the primary hormonal therapy for patients with stage D2 prostate cancer. Patients were stratified by performance status, disease sites, and history of cardiovascular disease at randomization. RESULTS: Forty-eight patients received DES and 44 flutamide. Patient characteristics were evenly distributed between the two treatments. The overall response rate was similar (DES, 62%; flutamide, 50%). Grade III or worse cardiovascular or thromboembolic toxicity developed in 33.3% of patients on DES and in 17.6% on flutamide (P = .051). Other toxicities were similar between the two treatment arms. However, DES produced significantly longer time to treatment failure (26.4 v 9.7 months, P = .016) and longer survival than flutamide (43.2 v 28.5 months, P = .040). CONCLUSION: As the primary hormonal therapy for stage D2 prostate cancer, DES caused more serious cardiovascular or thromboembolic complications than flutamide. Despite this, flutamide was not as active an initial agent as DES. However, the effectiveness of flutamide in conjunction with other agents compared with DES remains undetermined, and the optimal initial hormone therapy of stage D2 prostate cancer requires further studies.

Administration, Oral↗
PubMed1995

Phase II trial of gallium nitrate, amonafide and teniposide in metastatic non-small cell lung cancer. An Eastern Cooperative Oncology Group study (E2588).

Fifty-five patients with metastatic non-small cell lung cancer (NSCLC) were entered into this phase II randomized study for evaluating three new agents: gallium nitrate, amonafide and teniposide. The patients had to have ECOG performance status 0 or 1, no prior chemotherapy, and adequate hematological, hepatic and renal functions. Forty-seven patients were eligible and evaluable. Fourteen were randomized to receive gallium nitrate, 18 to amonafide and 15 to teniposide. Seventy-four percent of eligible patients were male. The majority of patients (89%) had an ECOG performance status 1. ECOG grade 4 toxicity occurred twice in patients on gallium nitrate, seven times on amonafide and 18 times on teniposide. The cause of death was attributed to amonafide in one patients (from sepsis) and to teniposide in two patients (due to infection and leukopenia). There was no objective response in all the patients entered. The overall survival times ranged from 2 weeks to 156 weeks with a medium of 23 weeks. There were no survival differences among the three treatment arms. We conclude that gallium nitrate, amonafide and teniposide are inactive in metastatic NSCLC and do not warrant any further testing in this disease.

Adenine↗