Pertuzumab study in the neoadjuvant setting for HER2-positive nonmetastatic breast cancer in Australia (PeRSIA).

The pertuzumab study in the neoadjuvant setting for HER2+ nonmetastatic breast cancer in Australia (PeRSIA-ML39622) is an analysis of safety and effectiveness data from the pertuzumab patient registry. Although the prognosis of patients with early stage HER2+ breast cancer has been greatly improved by advances in chemotherapy approximately 25% to 30% of patients develop recurrent disease. Our study aimed to examine the effectiveness of neoadjuvant pertuzumab on surgical outcomes, describe the medium-term effectiveness outcomes of patients treated with pertuzumab, and describe the planned and actual anticancer treatment regimens that patients received. Deidentified data were collected from the patients' medical records and entered into REDCap, between March 2018 and July 2019 (n = 95). The adverse events (AEs) reported most frequently were diarrhea (20; 21.1%), rash (4; 4.2%), and LVSD (4; 4.2%; two patients during neoadjuvant treatment and two patients during adjuvant treatment). AEs, ≥Grade 3 were diarrhea (2; 2.1%) and LVSD (1; 1.1%). Following surgery, a breast pathological complete response (bpCR) was achieved in 65 patients (70.7%; 95% CI: 60.2%-79.7%) and total pathological complete response (tpCR) in 59 patients (64.1%; 95% CI: 53.4%-73.9%). All patients who did not achieve a tpCR obtained a partial response (33/92, 35.9%). Our study is the first to capture real-world data on the use of pertuzumab in the neoadjuvant setting in Australia. The effectiveness and safety data are consistent with those reported in clinical trials of pertuzumab in patients with HER2+ breast cancer, with no new safety concerns.

Treating Chronic Hypoventilation With Automatic Adjustable Versus Fixed EPAP Intelligent Volume-Assured Positive Airway Pressure Support (iVAPS): A Randomized Controlled Trial.

Objectives: New noninvasive ventilation (NIV) modes can automatically adjust pressure support settings to deliver effective ventilation in response to varying ventilation demands. It is recommended that fixed expiratory positive airway pressure (FixedEPAP) is determined by attended laboratory polysomnographic (PSG) titration. This study investigated whether automatically determined EPAP (AutoEPAP) was noninferior to FixedEPAP for the control of obstructive sleep apnea (OSA) during intelligent volume-assured pressure support (iVAPS) treatment of chronic hypoventilation. Methods: In this randomized, double-blind, crossover study, patients with chronic hypoventilation and OSA used iVAPS with AutoEPAP or FixedEPAP over two separate nights of attended PSG. PSG recordings were scored by an independent scorer using American Academy of Sleep Medicine 2012 criteria. Results: Twenty-five adults (14 male) with chronic hypoventilation secondary to obesity hypoventilation syndrome (n = 11), chronic obstructive pulmonary disease (n = 9), or neuromuscular disease (n = 5), all of whom were on established home NIV therapy, were included (age 57 ± 7 years, NIV for ≥3 months, apnea-hypopnea index [AHI] >5/hour). AutoEPAP was noninferior to FixedEPAP for the primary outcome measure (median [interquartile range] AHI 2.70 [1.70-6.05]/hour vs. 2.40 [0.25-5.95]/hour; p = .86). There were no significant between-mode differences in PSG sleep breathing and sleep quality, or self-reported sleep quality, device comfort, and patient preference. Mean EPAP with the Auto and Fixed modes was 10.8 ± 2.0 and 11.8 ± 3.9 cmH2O, respectively (p = .15). Conclusions: In patients with chronic hypoventilation using iVAPS, the AutoEPAP algorithm was noninferior to FixedEPAP over a single night's therapy.

Obstructive Sleep Apnea in Women: Specific Issues and Interventions.

Obstructive sleep apnea (OSA) has traditionally been seen as a male disease. However, the importance of OSA in women is increasingly being recognized, along with a number of significant gender-related differences in the symptoms, diagnosis, consequences, and treatment of OSA. Women tend to have less severe OSA than males, with a lower apnea-hypopnea index (AHI) and shorter apneas and hypopneas. Episodes of upper airway resistance that do not meet the criteria for apneas are more common in women. Prevalence rates are lower in women, and proportionally fewer women receive a correct diagnosis. Research has also documented sex differences in the upper airway, fat distribution, and respiratory stability in OSA. Hormones are implicated in some gender-related variations, with differences between men and women in the prevalence of OSA decreasing as age increases. The limited data available suggest that although the prevalence and severity of OSA may be lower in women than in men, the consequences of the disease are at least the same, if not worse for comparable degrees of severity. Few studies have investigated gender differences in the effects of OSA treatment. However, given the differences in physiology and presentation, it is possible that personalized therapy may provide more optimal care.

Impact of a New Nasal Pillows Mask on Patients' Acceptance, Compliance, and Willingness to Remain on CPAP Therapy.

Aim. Continuous positive airway pressure (CPAP) masks are a key factor in patient compliance. This program assessed the performance of a new nasal pillows mask (NPM) on a variety of new and established obstructive sleep apnea (OSA) patients using CPAP therapy. Methods. Five programs were developed to assess the new NPM [AirFit P10, ResMed] on naïve patients; patients established on another NPM; patients using a nasal mask; patients with low CPAP compliance; and patients who wished to stop using CPAP therapy. Results. A total of 212 patients were included. In naïve patients, CPAP usage after 3 months was 5.9 ± 1.7 hours/night, compared with the control group at 4.6 ± 2.4 hours/night (p < 0.05). In patients established on another NPM, usage improved to 7.4 ± 1.1 hours/night versus 6.7 ± 1.4 (p = 0.001). 78% of nasal mask users wished to continue using the new NPM. Low compliance patients improved with an average of 0.87 hours/night (p = 0.001) when using the new NPM. In patients at the point of quitting CPAP, 60% continued with therapy using the new NPM. Conclusion. The new NPM mask performed well in a variety of clinical groups of OSA patients receiving CPAP therapy and shows that technical advances in CPAP masks can improve patient compliance.

Study of a Novel APAP Algorithm for the Treatment of Obstructive Sleep Apnea in Women.

STUDY OBJECTIVES: To assess the efficacy of a novel female-specific autotitrating continuous positive airway pressure (CPAP) algorithm (AutoSet for her, AfH) in premenopausal women relative to a standard autotitrating algorithm (AutoSet, S9) (ResMed Ltd., Bella Vista, New South Wales, Australia). DESIGN: Prospective randomised crossover noninferiority trial. SETTING: Tertiary hospital sleep clinic and university research sleep laboratory. PARTICIPANTS: 20 female patients with obstructive sleep apnea (OSA) established on long-term CPAP treatment. INTERVENTIONS: Treatment with 1 night each of AfH and AutoSet while monitored with overnight laboratory-based polysomnography (PSG); order randomly allocated. MEASUREMENTS AND RESULTS: The primary outcome variables were the apnea-hypopnea index (AHI) and 3% oxygen desaturation index (ODI 3%) determined from PSG. Treatment efficacy on the AfH night was noninferior to the AutoSet night as assessed by median (IQR) AHI (1.2 [0.60-1.85]/h versus 1.15 [0.40-2.85]/h, respectively, P = 0.51) and 3% ODI (0.85 [0.25-1.5]/h versus 0.5 [0.25-2.55]/h, respectively, P = 0.83). Other PSG measures were similar, except for the percentage of the night spent in flow limitation, which was lower on the AfH (0.14%) than the AutoSet night (0.19%, P = 0.007). The device-downloaded 95th centile pressure on the AfH night was also lower than on the AutoSet night (10.6 ± 1.7 versus 11.6 ± 2.6 cmH2O, respectively; mean difference [95% confidence interval]: -1.1 [-2.13 to -0.01] cm H2O). CONCLUSION: Among premenopausal women a novel female-specific autotitrating algorithm (AfH) is as effective as the standard AutoSet algorithm in controlling obstructive sleep apnea (OSA). The new algorithm may reduce flow limitation more than the standard algorithm and achieve control of OSA at a lower (95th centile) pressure.