Local control, toxicity, and cosmesis in women younger than 50 enrolled onto the American Society of Breast Surgeons MammoSite Radiation Therapy System registry trial.

BACKGROUND: The American Society of Breast Surgeons enrolled women onto a registry trial to prospectively study patients treated with the MammoSite Radiation Therapy System (RTS) breast brachytherapy device. This report examines local recurrence (LR), toxicity, and cosmesis as a function of age in women enrolled onto the trial. METHODS: A total of 1449 primary early-stage breast cancers were treated in 1440 women. Of these, 130 occurred in women younger than 50 years of age. Fisher's exact test was performed to correlate age (<50 vs. > or = 50 years) with toxicity and with cosmesis. The association of age with LR failure times was investigated by fitting a parametric model. RESULTS: Women younger than 50 were more likely to develop fat necrosis: 4.6% (6 of 130) vs. 1.8% (24 of 1319) (P = .0456). Other toxicities were comparable. At 2 years, cosmesis was excellent or good in 87% of assessable women aged <50 years (n = 74) and in 94% of assessable older women (n = 751) (P = .0197). At 3 years, this difference disappeared: excellent or good in 90% (56 of 62) of younger women vs. 93% (573 of 614) of older women (P = .2902). The crude LR rate for the group was 1.7% (25 of 1449). There was no statistically significant difference in LR as a function of age. In women <50, 3.1% (4 of 130) developed a LR; in the older patients, 1.6% (21 of 1319) developed LR (3-year actuarial LR rates, 2.9% vs. 1.7%, respectively; P = .2284). CONCLUSIONS: Accelerated partial breast irradiation with the MammoSite RTS results in low toxicity and produces similar cosmesis and local control at 3 years in women younger than 50 when compared with older women.

The Therapeutic Realizations Scale-Revised (TRS-R): psychometric characteristics and relationship to treatment process and outcome.

Therapeutic realizations are one of five universal, session-level change processes explicated in the Generic Model of Psychotherapy. Realizations refer to session impacts, the moment-to-moment accomplishments that patients experience within sessions. This study establishes the psychometric characteristics and factor structure of a modified patient-rated measure of session-level effects, the Therapeutic Realization Scale-Revised (TRS-R). In addition, it shows the relationship of the TRS-R to treatment process and outcome from the perspective of both patients and therapists. The findings provide support for the TRS-R as a reliable and valid, multidimensional index of session-level treatment effects.

Intracavernous alprostadil alfadex (EDEX/VIRIDAL) is effective and safe in patients with erectile dysfunction after failing sildenafil (Viagra).

OBJECTIVES: Sildenafil (Viagra), an oral treatment for erectile dysfunction, has proved popular since its introduction in 1998. However, not all patients respond to this form of therapy. Consequently, this study investigated the efficacy of intracavernous alprostadil alfadex (EDEX/VIRIDAL) treatment in patients not responding to sildenafil. METHODS: In an open-label, multicenter study, patients with erectile dysfunction were treated with sildenafil for 4 weeks. The initial dose was 50 mg, which was increased to 100 mg if no response was achieved. Patients not responding to treatment, measured using the International Index of Erectile Function (IIEF) questionnaire, entered an alprostadil alfadex in-office titration phase, to determine the optimal dose, up to 40 microgram. A 6-week alprostadil alfadex at-home treatment phase followed. RESULTS: In 67 patients who did not respond satisfactorily to sildenafil, the alprostadil alfadex at-home therapy resulted in improvements in questions 3 and 4 of the IIEF in 60 (89.6%) and 57 (85.1%) patients, respectively. The mean improvement in IIEF score for these patients was 2.75 and 2.63 for questions 3 and 4, respectively. The most common side effect was penile pain in 25 (29. 4%) of 85 patients treated with alprostadil alfadex in-office and at home. CONCLUSIONS: Alprostadil alfadex therapy can be used effectively and safely in men who fail initial therapy with sildenafil.

Intracavernous alprostadil alfadex is more efficacious, better tolerated, and preferred over intraurethral alprostadil plus optional actis: a comparative, randomized, crossover, multicenter study.

OBJECTIVES: To compare the efficacy, safety, and patient preference of intracavernously administered alprostadil alfadex and intraurethrally administered alprostadil. METHODS: A crossover, randomized, open-label multicenter study of 111 patients with erectile dysfunction of at least 6 months' duration compared the efficacy, safety, and patient preference of intracavernosal alprostadil (EDEX/Viridal) with MUSE plus optional ACTIS. All patients underwent an in-office dose titration with either drug before undertaking an at-home treatment phase. The most frequently used doses during the at-home phase were 40 microg (44.1% of men) and 1000 microg (86.8% of men) for EDEX and MUSE, respectively; the mean doses were 26.1 microg and 922.5 microg for EDEX and MUSE, respectively. RESULTS: More EDEX than MUSE administrations resulted in an erection sufficient for sexual intercourse (82.5% versus 53.0%); significantly more patients using EDEX achieved at least one erection sufficient for sexual intercourse (92.6% versus 61.8%; P <0.0001); and EDEX use resulted in a significantly greater percentage of patients attaining at least 75% of erections sufficient for sexual intercourse (75% versus 36.8%; P <0.0001). Penile pain was the most common side effect for both medications: 20.0% versus 30.5% (in-office) and 33.8% versus 25.0% (at-home) for EDEX and MUSE, respectively. Similar numbers of adverse events were reported with either treatment during the at-home phase. Patient and partner satisfaction was greater with EDEX, and more patients preferred this therapy, choosing to continue it during a patient preference period at the end of the study. CONCLUSIONS: Since intracavernous injection therapy was more efficacious, better tolerated, and preferred by the patients and their partners, it should be offered as the first-choice treatment if oral therapy fails or is contraindicated.

Have family income mobility patterns changed?

We examine the mobility of individuals in the United States based on equivalent family income--that is, total income of all family members adjusted for family size according to the equivalence scale implicit in the U.S. poverty line. Our analysis, which tracks movements across quintiles, centers on four questions: How much movement is there across the family income distribution? How has this mobility changed over time? To what extent are the movements attributable to factors related to changes in family composition versus events in the labor markets? In light of major socioeconomic changes occurring in the quarter-century under study, have the determinants of mobility changed over time? Our findings indicate that mobility rates in the 1980s differed little from those in the 1970s. However, individuals in families headed by a young person or a person without a college education were less likely to experience upward mobility in the 1980s than in the 1970s.

Recollections of parental behaviour, adult attachment and mental health: mediating and moderating effects.

BACKGROUND: Attachment theory posits links between early experiences with parents, adult relationships and adult mental health, but does not specify whether these are independent, mediating, or moderating effects. METHODS: Associations of parent's behaviour on the Parental Bonding Instrument, adult attachment styles and three dimensions of mental health were investigated in a large sample of women and men. RESULTS: Men and women with secure styles recalled higher levels of care from both parents than those with fearful styles. Maternal and paternal control were more consistent predictors of increased distress for men than for women. Fearful and preoccupied adult styles were associated with higher levels of distress in both men and women. While adult styles had few mediating effects on the association of parental behaviour and mental health, interactions between the fearful style and parental variables suggested that this form of insecurity sometimes accentuated the impact of high parental care or low paternal control on mental health in both men and women; among women, however, the secure style seemed to buffer somewhat the negative effect of high parental control. CONCLUSION: Although the amount of variance explained by either parental behaviour or adult styles was modest, patterns of moderating effects of adult styles on associations between parental behaviour and mental health suggested that both continuity and discontinuity principles can be applied to understanding these links.

Leuprolide acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer.

Two open-label, multicenter studies were conducted to evaluate the efficacy and safety of a long-acting depot formulation of leuprolide acetate (22.5 mg) administered intramuscularly every 12 weeks to patients with stage D2 prostate cancer. Clinical evaluations were performed every 12 weeks, and serum testosterone levels were monitored biweekly or weekly for 24 weeks. Onset of castrate levels (< or = 50 ng/dL) of testosterone was achieved within 30 days of the initial depot injection in 87 (95%) of the 92 assessable patients enrolled in the two studies. Mean testosterone levels remained well within the castrate range throughout each dosing interval. Two patients experienced a transient escape (testosterone levels > 50 ng/dL on two consecutive determinations). Delay of an injection of up to 2 weeks did not have an effect on testosterone suppression: in 16 patients in whom the depot injection was delayed by 3 to 14 days, testosterone values remained within the castrate range. A favorable objective tumor response (no progression) to treatment occurred in 85% of the patients. Prostate-specific antigen and prostatic acid phosphatase decreased by 50% or more in 96% and 84% of patients, respectively, with elevated pretreatment values and at least one treatment value. Assessment of local disease status and overall performance status showed improvement or stability in most patients. The most common adverse events were hot flashes (59%), pain (27%), and testicular atrophy (21%). The 22.5-mg depot formulation of leuprolide, which acts in a manner similar to the monthly 7.5-mg depot formulation, was shown to be effective and safe in treating patients with advanced prostate cancer.

Laparoscopic versus conventional appendectomy.

BACKGROUND: The results of recent series suggest remarkable advantages of laparoscopic appendectomy over the conventional open appendectomy. To determine if clear advantages could be established, the charts of all patients admitted to our institution with a presumptive diagnosis of acute appendicitis and subsequent appendectomy were retrospectively reviewed. STUDY DESIGN: From January 1990 through June 1992, there were 300 conventional open appendectomies and 66 laparoscopic appendectomies performed. Data from both groups were compared with respect to anesthesia time, operative time, postoperative morbidity, postoperative pain, time to regular diet, hospitalization period, cost, and return to normal activities. RESULTS: There were no significant differences between the laparoscopic and open appendectomy groups with respect to operative complications, postoperative morbidity, pain medication requirements, and time to regular diet. There were significantly longer anesthesia times, operative times, and operating room costs in the laparoscopic group. For complicated appendicitis, the laparoscopic technique resulted in infectious complications that required readmission in 45.5 percent of the patients. CONCLUSIONS: Laparoscopic appendectomy is a safe alternative to conventional open appendectomy for simple acute appendicitis. However, laparoscopic appendectomy is not superior to the conventional method with regard to operative time, postoperative morbidity, pain medication requirements, time to regular diet, length of stay, cost, or return to normal activity. Laparoscopic appendectomy may be contraindicated in complicated appendicitis (gangrene, perforated with abscess, or peritonitis) due to an increased rate of infectious complications requiring readmission.

Two cases of endometrioma in cesarean scars.

The occurrence of endometrioma in cesarean scar is an infrequent event usually presenting as a tender abdominal wall mass. Two cases are reported here. Diagnosis is suggested when the symptoms are cyclic and associated with the patient's menstrual cycle, but this is not always the case. Surgical excision is the method of choice for diagnosing and ultimately treating the lesion.

Malignant hyperthermia associated with enflurane anesthesia.

Malignant hyperthermia is induced by potent inhalation anesthetics. Enflurane must be added to the list of those anesthetic agents (such as halothane and succinylcholine) that are associated with this condition. The patient in our study was a young woman with no history of prior exposure to general anesthetics, and no family history of complications following administration of anesthetics. The other possible causes of hyperthermia in the patient were investigated and eliminated, and the condition was finally associated with enflurane. Enflurane should not be used in patients with a family history of this rare but often lethal disorder.