To evaluate the feasibility and potential effects of qigong Baduanjin for reversing frailty status among older cancer survivors.
Twenty-eight older cancer survivors screened as pre-frail or frail ...were recruited. They were randomly assigned (1:1) to receive a sixteen-week Baduanjin intervention or an active control condition (light flexibility exercise). Frailty status (primary outcome) and secondary outcomes (physical performance, activities of daily living performance, psychological well-being, and health-related quality of life) were measured by physical performance tests and questionnaires. Qualitative interviews were conducted to explore participants' perspectives on the intervention.
Twenty-one participants (75%) completed the study, with reasons of withdrawal mainly relating to the COVID-19 pandemic. Attendance at Baduanjin sessions and adherence to self-practice were satisfactory, with all retained participants attending all sessions and 81.8% practicing Baduanjin for more than 90 min per week. Qualitative findings demonstrated that participants accepted Baduanjin. The proportion of improvement in frailty status at post-intervention appeared to be higher in the intervention group (26.7%; 95% confidence interval CI, 10.1% to 54.0%) than the control group (15.4%; 95% CI, 3.7% to 46.0%); yet the difference was not statistically significant (p = 0.461).
Baduanjin qigong appears to be feasible and acceptable among older cancer survivors. To confirm the intervention effect, an adequately powered trial is warranted.
ClinicalTrials.gov, NCT04694066. Retrospectively registered 5 January 2021, https://clinicaltrials.gov/ct2/show/NCT04694066.
Taxanes with trastuzumab and pertuzumab for initial treatment of human epidermal growth factor receptor 2 (ERBB2, formerly HER2)-positive metastatic breast cancer is associated with improved ...progression-free survival (PFS) and overall survival. While continued use of trastuzumab in therapeutic combinations after disease progression is standard, the efficacy of continuing pertuzumab is unknown.
To evaluate the efficacy and safety of pertuzumab in combination with gemcitabine and trastuzumab after prior treatment with pertuzumab for ERBB2-positive metastatic breast cancer.
This is a phase 2 single-arm clinical trial of dual anti-ERBB2 therapy after prior treatment with pertuzumab. The study took place at a single academic center from March 2015 to April 2017 among women with ERBB2-positive metastatic breast cancer, prior pertuzumab-based treatment, and 3 or fewer prior chemotherapy regimens. Data were analyzed between January 2019 and March 2019.
Treatment consisted of gemcitabine, 1200 mg/m2 (later amended to 1000 mg/m2) on days 1 and 8 every 3 weeks, plus trastuzumab (8-mg/kg loading dose, then 6 mg/kg) and pertuzumab (840-mg loading dose, then 420 mg) once every 3 weeks.
The primary end point was 3-month PFS. Based on prior trials, a target rate of 70% or higher was selected as the promising progression-free rate at 3 months. Secondary outcomes included safety, tolerability, and overall survival.
A total of 45 patients (median range age, 57.1 31.7-77.2 years) were enrolled; 22 (49%) were treated in the second-line setting, and 23 (51%) were treated in the third-line setting or beyond. Of these, 22 (49%) received prior trastuzumab emtansine (T-DM1). At a median (range) follow-up of 27.6 (8.3-36.0) months, 3-month PFS was 73.3% (95% CI, 61.5%-87.5%). Overall, median PFS was 5.5 months (95% CI, 5.4-8.2 months). Treatment was well tolerated, with no occurrences of febrile neutropenia or symptomatic left ventricular systolic dysfunction.
In this phase 2 trial, treatment with gemcitabine, trastuzumab, and pertuzumab after prior pertuzumab-based therapy for ERBB2-positive metastatic breast cancer was associated with a 3-month PFS rate of 73.3% and was well tolerated. Continuation of pertuzumab beyond progression was associated with apparent clinical benefit.
ClinicalTrials.gov identifier: NCT02252887.
This paper considers the problem of error correction for a cooperative data exchange (CDE) system, where some clients are compromised or failed and send false messages. Assuming each client possesses ...a subset of the total messages, we analyze the error correction capability when every client is allowed to broadcast only one linearly-coded message. Our error correction capability bound determines the maximum number of clients that can be compromised or failed without jeopardizing the final decoding solution at each client. We show that deterministic, feasible linear codes exist that can achieve the derived bound. We also evaluate random linear codes, where the coding coefficients are drawn randomly, and then develop the probability for a client to withstand a certain number of compromised or failed peers and successfully deduce the complete message for any network size and any initial message distributions.
Preclinical models suggest that the use of anti-vascular endothelial growth factor (anti-VEGF) therapy with antiestrogens may prevent or delay the development of endocrine therapy resistance. We ...therefore performed a feasibility study to evaluate the safety of letrozole plus bevacizumab in patients with hormone receptor-positive metastatic breast cancer (MBC).
Patients with locally advanced breast cancer or MBC were treated with the aromatase inhibitor (AI) letrozole (2.5 mg orally daily) and the anti-VEGF antibody bevacizumab (15 mg/kg intravenously every 3 weeks). The primary end point was safety, defined by grade 4 toxicity using the National Cancer Institute Common Toxicity Criteria, version 3.0. Secondary end points included response rate, clinical benefit rate, and progression-free survival (PFS). Prior nonsteroidal AIs (NSAIs) were permitted in the absence of progressive disease.
Forty-three patients were treated. After a median of 13 cycles (range, 1 to 71 cycles), select treatment-related toxicities included hypertension (58%; grades 2 and 3 in 19% and 26%), proteinuria (67%; grades 2 and 3 in 14% and 19%), headache (51%; grades 2 and 3 in 16% and 7%), fatigue (74%; grades 2 and 3 in 19% and 2%), and joint pain (63%; grades 2 and 3 in 19% and 0%). Eighty-four percent of patients had at least stable disease on an NSAI, confounding efficacy results. Partial responses were seen in 9% of patients and stable disease >or= 24 weeks was noted in 67%. Median PFS was 17.1 months.
Combination letrozole and bevacizumab was feasible with expected bevacizumab-related events of hypertension, headache, and proteinuria. Phase III proof-of-efficacy trials of endocrine therapy plus bevacizumab are in progress (Cancer and Leukemia Group B 40503).
Purpose:
The purpose of this study was to evaluate the age- and race-dependence of the breast fibroglandular tissue density based on three-dimensional breast MRI.
Methods:
The normal breasts of 321 ...consecutive patients including Caucasians, Asians, and Hispanics were studied. The subjects were separated into three age groups: Younger than 45, between 45 and 55, and older than 55. Computer algorithms based on body landmarks were used to segment the breast, and fuzzy c-means algorithm was used to segment the fibroglandular tissue. Linear regression analysis was applied to compare mean differences among different age groups and race/ethnicity groups. The obtained parameters were not normally distributed, and the transformed data, natural log (ln) for the fibroglandular tissue volume, and the square root for the percent density were used for statistical analysis.
Results:
On the average, the transformed fibroglandular tissue volume and percent density decreased significantly with age. Racial differences in mean transformed percent density were found among women older than 45, but not among women younger than 45. Mean percent density was higher in Asians compared to Caucasians and Hispanics; the difference remained significant after adjustment for age, but not significant after adjusted for both age and breast volume. There was no significant difference in the density between the Caucasians and the Hispanics.
Conclusions:
The results analyzed using the MRI-based method show age- and race-dependence, which is consistent with literature using mammography-based methods.
This paper discusses bit-level soft decoding of triple-parity Reed-Solomon (RS) codes through automorphism permutation. A new method for identifying the automorphism groups of RS binary images is ...first developed. The new algorithm runs effectively, and can handle more RS codes and capture more automorphism groups than the existing ones. Utilizing the automorphism results, a new bit-level soft-decision decoding algorithm is subsequently developed for general (n,n-3,4) RS codes. Simulation on (31,28,4) RS codes demonstrates an impressive gain of more than 1 dB at the bit error rate of 10 -5 over the existing algorithms.
Micro-Abstract Treatment of human epidermal growth factor receptor-2 (HER2)-positive breast cancer with dual anti-HER2 therapy has been shown to improve outcomes. In the present pilot phase II study, ...patients with early-stage HER2-positive breast cancer received adjuvant treatment with dose-dense paclitaxel, trastuzumab, and lapatinib. However, this combination was not feasible because of unexpected toxicity.
Doxorubicin and cyclophosphamide (AC) every 3 weeks has been associated with frequent asymptomatic declines in left ventricular ejection fraction (LVEF). Dose-dense (dd) AC followed by paclitaxel (P) ...is superior to the same regimen given every third week. Herein, we report the early cardiac safety of three sequential studies of ddAC alone or with bevacizumab (B).
Patients with HER2-positive breast cancer were treated on two trials: ddAC followed by P and trastuzumab (T) and ddAC followed by PT and lapatinib. Patients with HER2-normal breast cancer were treated with B and ddAC followed by B and nanoparticle albumin-bound P. Prospective LVEF measurement by multigated radionuclide angiography scan before and after every 2 week AC for 4 cycles and at month 6 from all three trials were aggregated to determine the early risks of cardiac dysfunction.
From January 2005 to May 2008, 245 patients were enrolled. The median age was 47 years (range, 27 to 75 years). Median LVEF pre-ddAC was 68% (range, 52% to 82%). LVEF post-ddAC was available in 241 patients (98%) and the median was unchanged at 68% (range, 47% to 81%). Per protocol no patients were ineligible for subsequent targeted biologic therapy based on LVEF decline post-ddAC. In addition, LVEF was available in 222 patients (92%) at 6 months, at which time the median LVEF was similar at 65% (range, 24% to 80%). Within 6 months of initiating chemotherapy, three patients (1.2%; 95% CI, 0.25% to 3.54%) developed CHF, all of whom received T.
Dose-dense AC with or without concurrent bevacizumab is not associated with frequent acute or short-term declines in LVEF.
Micro-Abstract The use of sunitinib at conventional doses (50 mg/d, 4 weeks of treatment, then 2 weeks of no treatment) in Asian patients is associated with high toxicities. We evaluated 160 patients ...with metastatic renal cell carcinoma in Singapore, of which 127 were treated with an attenuated-dose regimen (37.5 mg/d, 4 weeks of treatment, then 2 weeks of no treatment). We observed comparable progression-free survival and overall survival between 2 regimens, and significant reduction in toxicities for patients treated with the attenuated regimen.
Dose-dense (dd) doxorubicin and cyclophosphamide (AC) followed by paclitaxel (P) is superior to every 3-weekly AC followed by P. Given the demonstrated cardiac safety for trastuzumab (T) with ...conventionally scheduled AC followed by P, we tested the safety of dd AC followed by P with T. The primary end point was cardiac safety, and the secondary end points were time to recurrence and overall survival.
Patients with HER-2/neu immunohistochemistry (IHC) 3+ or fluorescent in situ hybridization (FISH)-amplified breast cancer and baseline left ventricular ejection fraction (LVEF) of >or= 55% were enrolled, regardless of tumor size or nodal status. Treatment consisted of AC (60/600 mg/m(2)) x 4 followed by P (175 mg/m(2)) x 4 every 2-weekly with pegfilgrastim (6 mg on day 2) + T x1 year. LVEF by radionuclide scan was obtained at baseline, at months 2, 6, 9, and 18.
From January 2005 to November 2005, 70 patients were enrolled. The median age was 49 years (range, 27 to 72 years); median LVEF at baseline was 68% (range, 55% to 81%). At month 2 in 70 of 70 patients, the median LVEF was 67% (range, 58% to 79%); at month 6 in 67 of 70 patients, it was 66% (range, 52% to 75%); at month 9 in 68 of 70 patients, it was 65% (range, 50% to 75%); and at month 18 in 48 of 70 patients, it was 66% (range, 57% to 75%). As of December 1, 2007, the median follow-up was 28 months (range, 25 to 35 months). One patient (1%) experienced congestive heart failure (CHF). There were no cardiac deaths.
Dose-dense AC followed by P/T followed by T is feasible and is not likely to increase the incidence of cardiac events compared to established regimens.
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