Publications by authors named "Jennifer Lerademacher"
Introduction: Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) therapy is the standard of care for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). However, detailed delineation of toxicity data is limited and has not been examined by age. We sought to examine adverse event data in patients receiving R-CHOP from the Cancer and Leukemia Group B (CALGB) 50303 trial to determine if there were differences in grade 3+ toxicities by age cohort or ECOG performance status (PS), and if outcome was impacted by age cohort or toxicity occurrence.
View Article and Find Full Text PDFArticle Synopsis
- Palbociclib is a common treatment for advanced breast cancer in older adults, but its safety and tolerability for those aged 70 and older is not well established based on current studies.
- A phase 2 study was conducted with 90 participants (median age 74) to assess safety, finding that 75.6% experienced grade 3 or higher adverse events within six months, with the most common being neutropenia.
- The study revealed that older participants (≥75 years) tended to have higher rates of early treatment discontinuations due to adverse events compared to younger older adults (70-74 years), indicating the need for further research on treatment delivery in this age group.
Background: The 8th edition American Joint Committee on Cancer staging system combined anatomic stage (AS) with receptor status and grade to create prognostic stage (PS). PS has been validated in single-institution and cancer registry studies; however, missing human epidermal growth factor receptor 2 (HER2) status and variable treatment and follow-up create limitations.
Objective: Our objective was to compare the relative prognostic ability of PS versus AS to predict survival using breast cancer clinical trial data.
Article Synopsis
- The study focuses on the prognosis of patients with Waldenström macroglobulinemia (WM) and reassesses traditional prognostic scoring systems in light of new therapies and genetic data.
- Researchers analyzed records of 889 treatment-naïve WM patients to identify clinical predictors influencing overall survival, leading to a new prognostic model based on factors like age and serum levels.
- The newly developed Modified Staging System for WM (MSS-WM) successfully categorizes patients into four distinct risk groups based on their clinical data, demonstrating significant differences in 5-year overall survival rates.
Article Synopsis
- The study examined whether reducing the dose of apixaban from 5 mg to 2.5 mg twice daily is safe for patients with cancer-associated venous thromboembolism (VTE) who have already undergone 6-12 months of anticoagulation therapy.
- In a trial involving 360 cancer patients, the incidence of major and clinically relevant nonmajor bleeding was similar between the 2.5 mg and 5 mg groups, with rates of 8.9% and 12.2%, respectively.
- The findings suggest that reducing the dose of apixaban does not significantly affect bleeding risks, recurrent VTE, or mortality rates in cancer patients, indicating that the
Background: Knowing the predictive factors of the variation in a center-level continuous outcome of interest is valuable in the design and analysis of parallel-arm cluster randomized trials. The symbolic two-step method for sample size planning that we present incorporates this knowledge while simultaneously accounting for patient-level characteristics. Our approach is illustrated through application to cluster randomized trials in cancer care delivery research.
View Article and Find Full Text PDFArticle Synopsis
- Social determinants of health are crucial for improving cancer care, particularly among Asian Americans with hepatocellular carcinoma, a group that is often inadequately treated.
- The study reviewed medical records to gather data on factors like housing instability, transportation issues, financial concerns, and social isolation, but found a high percentage of incomplete responses in these areas.
- The high rates of noncompletion in essential social determinants indicate a challenge in understanding these issues and highlight the need for better methods to collect this data for underserved populations.
Article Synopsis
- - Traditional clinical trials focus on explaining the biological cause and effect of new treatments, but their strict criteria can limit who benefits and make the trials complex and lengthy.
- - Pragmatic clinical trials offer an alternative by evaluating how treatments work in real-world settings, considering patient diversity and clinical practice operations.
- - There exists a continuum between explanatory and pragmatic trials, emphasizing the importance of scientific rigor while improving efficiency and ensuring findings are applicable to a wider patient population.
Article Synopsis
- The purpose of the study is to find effective ways to measure patients' symptoms during cancer treatment trials to improve cancer-related toxicities.* -
- The authors share their experience in symptom-control trials, emphasizing that patient-reported outcomes are better for accurately capturing treatment-related symptoms compared to healthcare provider assessments.* -
- They recommend using validated, user-friendly measurement tools; when these aren't available, simple numerical rating scales can effectively document symptoms and treatment side effects.*
Article Synopsis
- SMART designs are useful for evaluating adaptive treatments, allowing patient re-randomization based on intermediate outcomes to make more personalized treatment decisions.* -
- The paper focuses on designing a two-stage SMART with binary tailoring variables and survival endpoints, using chronic lymphocytic leukemia as a case study to explore various statistical aspects.* -
- Simulations show that the response rate of tailoring variables significantly affects statistical power, and an R-shiny app is provided for calculating power based on sample sizes in SMART designs.*
Article Synopsis
- The study explores how a comprehensive geriatric assessment can predict clinical outcomes in older adults (65+) with chronic lymphocytic leukemia (CLL), focusing on various geriatric domains such as social activity and nutritional status.
- It involves 369 patients aged 65 and older, analyzing their functional, psychological, and social factors in relation to treatment outcomes in a trial comparing different therapies for CLL.
- Results show that social activity and recent weight loss significantly impact patients' progression-free survival (PFS) and overall survival (OS), underlining the need for thorough geriatric evaluations to identify those at higher risk.
Purpose: A protocol was developed to evaluate the value of an NK-1 receptor antagonist for preventing nausea and vomiting resulting from highly emetogenic chemotherapy when an olanzapine-based antiemetogenic regimen was used.
Materials And Methods: A221602, a prospective double-blind, placebo-controlled clinical trial, was developed to compare 2 -olanzapine-containing antiemetic regimens, one with an NK-1 receptor antagonist (aprepitant or fosaprepitant) and one without. Trial patients had a malignant disease for which they received intravenous highly emetogenic chemotherapy (single day cisplatin ≥ 70 mg/m2 or doxorubicin plus cyclophosphamide on 1 day).
Article Synopsis
- The study examines outcomes of older patients (60+) with Acute Myeloid Leukemia (AML) based on whether they received treatment at community or academic cancer centers during clinical trials.
- Results indicate that there were similar levels of adverse events, 1-month mortality rates, and overall survival between the two types of centers, with 17% of participants enrolled in community centers.
- The findings suggest that intensive chemotherapy trials can be effectively conducted in select community cancer centers, offering comparable treatment outcomes to those at academic institutions for older patients with complex health needs.
Article Synopsis
- Risk-stratified follow-up guidelines for breast cancer may enhance follow-up quality and efficiency by considering the timing of recurrence based on patients' anatomic stage and receptor status.
- The study analyzed data from 8,007 breast cancer patients enrolled in clinical trials, focusing on the time from treatment to first recurrence with findings showing significant variations in recurrence timing by receptor types and stages.
- Results indicated that ER-negative/PR-negative/Her2neu-negative tumors have the highest and earliest risk of recurrence, prompting the development of tailored follow-up recommendations based on these factors.
Background . Social determinants of health lead to better cancer care. This multi-site, single-institution study sought to capture data on social determinants of health data in Asian Americans with hepatocellular carcinoma; this group constitutes 60% of patients with this malignancy and are often undertreated or not treated at all.
View Article and Find Full Text PDFArticle Synopsis
- The study aimed to assess local and regional recurrence rates in women who underwent breast-conserving surgery as part of older clinical trials, while also examining how these rates vary based on the tumor's receptor subtype.
- Data from 4,404 women diagnosed with breast cancer between 1997 and 2010 was analyzed, revealing a 5-year overall recurrence rate of 4.6%, which was lower than previous estimates, particularly for patients with hormone receptor-positive tumors.
- The findings indicated that triple-negative breast cancer had the highest recurrence rate (7.1%), and factors like increased lymph node involvement and triple-negative subtype were significantly linked to higher recurrence risks.
Article Synopsis
- Many cancer patients are older adults (65+), but they are often not well-represented in clinical trials, leading to a lack of relevant data for treating this group.
- Recommendations from a working group suggest designing trials specifically for older adults or including them in existing trials through various cohort methods to improve participation.
- Key considerations for these trials include taking into account the varied fitness levels of older adults and incorporating geriatric assessments to ensure appropriate patient selection and trial integrity.
Integrating Geriatric Assessment Measures into National Cancer Institute Clinical Trials.
J Natl Cancer Inst Monogr
December 2022
To improve the care of older adults with cancer, the traditional approach to clinical trial design needs to be reconsidered. Older adults are underrepresented in clinical trials with limited or no information on geriatric-specific factors, such as cognition or comorbidities. To address this knowledge gap and increase relevance of therapeutic clinical trial results to the real-life population, integration of aspects relevant to older adults is needed in oncology clinical trials.
View Article and Find Full Text PDFPurpose: Chemotherapy can cause hiccups but few randomized controlled trials have focused on hiccups. This trial examined the feasibility of such research.
Methods: This single-institution, multi-site trial used phone recruitment for patients: (1) 18 years or older, (2) able to speak/read English, (3) with a working e-mail address, (4) with hiccups 4 weeks prior to contact, and (5) with ongoing oxaliplatin or cisplatin chemotherapy.
Associations between body mass index, weight loss and overall survival in patients with advanced lung cancer.
J Cachexia Sarcopenia Muscle
December 2022
Background: Weight loss (WL) has been associated with shorter survival in patients with advanced cancer, while obesity has been associated with longer survival. Integrating body mass index (BMI) and WL provides a powerful prognostic tool but has not been well-studied in lung cancer patients, particularly in the setting of clinical trials.
Methods: We analysed patient data (n = 10 128) from 63 National Cancer Institute sponsored advanced non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) trials.
Article Synopsis
- Survival analyses are vital in medical research, with multistate models gaining attention for their ability to evaluate multiple disease pathways, unlike traditional methods like Kaplan-Meier curves and Cox models.
- They allow researchers to estimate clinically significant quantities such as the probability of being in a certain state over time, average duration in that state, and expected visits to that state, addressing absolute risks of events.
- The review recommends embracing multistate models for time-to-event data analysis due to their flexible framework and capability to enhance understanding of complex diseases' natural history.