Perceptions of patients and medical oncologists toward biospecimen donation in the setting of abnormal breast imaging findings

Breast Cancer Research and Treatment - We sought to understand the attitudes of individuals with abnormal breast imaging findings prompting a diagnostic breast biopsy toward donation of blood,...     

Statistical consequences of a successful lung allocation system – recovering information and reducing bias in models for urgency

The lung allocation system has reduced the number of waitlist deaths by ranking transplant candidates on the basis of a lung allocation score that requires estimation of the current 1‐year restricted mean waitlist survival (urgency). Fewer waitlist deaths and the systematic removal of candidates from the waitlist for transplantation present statistical challenges that must be addressed when using recent waitlist data. Multiple overlapping 1‐year follow‐up windows are used in a restricted mean model that estimates patient urgency on the basis of updated risk factors at the start of the window. In simulation studies, our proposed multiple imputation procedure was able to produce unbiased parameter estimates with similar efficiency to those obtained if censoring had never occurred. The analysis of 10,740 lung transplant candidates revealed that for most risk factors incorporating additional follow‐up windows produced more efficient estimates. Copyright © 2017 John Wiley & Sons, Ltd.     

A comparison between the pregnancy outcome of women with gestation diabetes treated with glibenclamide and those treated with insulin

The pregnancy outcome of 33 women with gestational diabetes who were treated with glibenclamide and changed to insulin if glibenclamide failed, were compared with the pregnancy outcome of 21 women with gestational diabetes treated conventionally with insulin. The pregnancy outcome, with regard to the overall glycaemic control, rates of preterm labour, neonatal hypoglycaemia, fetal macrosomia, perinatal morbidity and mortality, were not statistically different between the two treatment groups. The limited number of women studied, and the non-random allocation of these women to each treatment group however, could have influenced these results. There were a few observed differences in the pregnancy outcome between the two treatment groups, which although were not statistically significant, caused some concern. In particular we noted an increased rate of fetal macrosomia in the glibenclamide treated group, which in theory could have been drug mediated.     

Ultrasound demonstration of increased frequency of functional ovarian cysts in women using progestogen-only oral contraception

Asymptomatic volunteer women with a regular pattern of uterine bleeding and using the progestogen-only oral contraceptive pill were compared with control women who were not exposed to hormones. Pelvic ultrasound scanning at the end of the next bleeding episode after recruitment demonstrated functional cysts with maximum diameters ranging between 30 and 58 mm in eight of the 21 pill users, four of whom also had palpable ovaries, three cysts regressed during the next cycle. Of the 13 women with normal ovaries initially, four developed a new functional cyst of which two were associated with pain. Of the 12 women with cysts seven complained of pain at some time during the monitored cycle. Among 21 control women only one symptom-free (42 mm) cyst was shown on the initial postmenstrual ultrasound scan and this resolved painlessly during the scanned cycle with ovulation from the opposite ovary. Ovulation was also demonstrated in 16 of the remainder; but in none of the three control women who developed asymptomatic functional cysts (35-47 mm in size) while under observation. Since 11 of the 14 pill-users who failed to ovulate also had a functional cyst, the contraceptive efficacy may depend in part on this association. Pain symptoms may make the method less acceptable and give rise to diagnostic problems and inappropriate therapies.     

Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer

Background

In early trials, hypersensitivity reactions (HSRs) to paclitaxel were common, thus prompting the administration of antihistamines and corticosteroids before every paclitaxel dose. We tested the safety of omitting corticosteroids after cycle 2 during the paclitaxel portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)–paclitaxel regimen.

Patients, Materials, and Methods

In this prospective, single-arm study, patients who completed four cycles of DD-AC for stage I–III breast cancer received paclitaxel 175 mg/m² every 2 weeks for four cycles. Patients received a standard premedication protocol containing dexamethasone, diphenhydramine, and a histamine H2 blocker prior to the first two paclitaxel cycles. Dexamethasone was omitted in cycles three and four if there were no HSRs in previous cycles. We estimated the rate of grade 3–4 HSRs.

Results

Among 127 patients enrolled, 125 received more than one dose of protocol therapy and are included in the analysis. Fourteen (11.2%; 90% confidence interval, 6.9%–20.0%) patients had any-grade HSRs, for a total of 22 (4.5%; 3.1%–6.4%) HSRs over 486 paclitaxel cycles. Any-grade HSRs occurred in 1.6% (0.3%–5.0%), 6.5% (3.3%–11.3%), 7.4% (3.9%–12.5%), and 2.6% (0.7%–6.6%) of patients after paclitaxel cycles 1, 2, 3, and 4, respectively. Dexamethasone use was decreased by 92.8% in cycles 3 and 4. Only one patient experienced grade 3 HSR in cycles 3 or 4, for a rate of grade 3/4 HSR 0.4% (0.02%–2.0%) (1/237 paclitaxel infusions). That patient had grade 2 HSR during cycle 2, and the subsequent grade 3 event occurred despite usual dexamethasone premedication. A sensitivity analysis restricted to patients not known to have received dexamethasone in cycles 3 and 4 found that any-grade HSRs occurred in 2.7% (3/111; 0.7%–6.8%) and 0.9% (1/109; 0.05%–4.3%) of patients in cycle 3 and 4, respectively.

Conclusion

Corticosteroid premedication can be safely omitted in cycles 3 and 4 of dose-dense paclitaxel if HSRs are not observed during cycles 1 and 2.

Implications for Practice

Because of the potential for hypersensitivity reactions (HSRs) to paclitaxel, corticosteroids are routinely prescribed prior to each dose, on an indefinite basis. This prospective study, including 125 patients treated with 486 paclitaxel cycles, demonstrates that corticosteroids can be safely omitted in future cycles if HSRs did not occur during cycles 1 and 2 of paclitaxel and that this strategy reduces the use of corticosteroids in cycles 3 and 4 by 92.8% relative to current standard of care.

     

Contoured Harrington instrumentation in the treatment of unstable spinal fractures. The effect of supplementary sublaminar wires

Twenty-nine patients with major fractures and fracture-dislocations of the thoracic and lumbar spine were treated by spinal fusion and contoured Harrington distraction instrumentation. Two groups of patients were identified. Group I (16 patients) had sublaminar wires. Group II (13 patients) had no wiring. Satisfactory alignment was achieved in all patients. There were several complications in both groups. None of the patients in Group I had postoperative cast immobilization. The addition of sublaminar wiring appears to eliminate the need for rigid external immobilization and is beneficial only for patients who cannot tolerate body casts. This technique is a disadvantage, however, when a short-length fusion is desired.