Impact of BMI in Patients With Early Hormone Receptor-Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial.

PURPOSE: BMI affects breast cancer risk and prognosis. In contrast to cytotoxic chemotherapy, CDK4/6 inhibitors are given at a fixed dose, irrespective of BMI or weight. This preplanned analysis of the global randomized PALLAS trial investigates the impact of BMI on the side-effect profile, treatment adherence, and efficacy of palbociclib. METHODS: Patients were categorized at baseline according to WHO BMI categories. Neutropenia rates were assessed with univariable and multivariable logistic regression. Time to early discontinuation of palbociclib was analyzed with Fine and Gray competing risk models. Unstratified Cox models were used to investigate the association between BMI category and time to invasive disease-free survival (iDFS). 95% CIs were derived. RESULTS: Of 5,698 patients included in this analysis, 68 (1.2%) were underweight, 2,082 (36.5%) normal weight, 1,818 (31.9%) overweight, and 1,730 (30.4%) obese at baseline. In the palbociclib arm, higher BMI was associated with a significant decrease in neutropenia (unadjusted odds ratio for 1-unit change, 0.93; 95% CI, 0.91 to 0.94; adjusted for age, race ethnicity, region, chemotherapy use, and Eastern Cooperative Oncology Group at baseline, 0.93; 95% CI, 0.92 to 0.95). This translated into a significant decrease in treatment discontinuation rate with higher BMI (adjusted hazard ratio [HR] for 10-unit change, 0.75; 95% CI, 0.67 to 0.83). There was no significant improvement in iDFS with the addition of palbociclib to ET in any weight category (normal weight HR, 0.84; 95% CI, 0.63 to 1.12; overweight HR, 1.10; 95% CI, 0.82 to 1.49; and obese HR, 0.95; 95% CI, 0.69 to 1.30) in this analysis early in follow-up (31 months). CONCLUSION: This preplanned analysis of the PALLAS trial demonstrates a significant impact of BMI on side effects, dose reductions, early treatment discontinuation, and relative dose intensity. Additional long-term follow-up will further evaluate whether BMI ultimately affects outcome.

Pilot Feasibility Study of a Video Intervention to Educate Patients with Breast Cancer About Clinical Trials.

The purpose of this project was to develop and test the feasibility and preliminary efficacy of a video about cancer clinical trials (CCTs) developed for breast cancer patients. We developed 2 brief 7-min videos that focused on breast cancer patients describing their experiences participating in CCTs, supplemented with doctors and research staff explaining key research concepts. One video was culturally tailored to Black patients and the other to White patients. To assess feasibility study, participants and their care providers completed a survey to evaluate their satisfaction with the video. Eligibility criteria for the study included ≥ 21 years of age, English-speaking, no prior experience participating in a CCT, and being potentially eligible for breast CCT enrollment. Preliminary efficacy was evaluated with a pretest-posttest design using a single item asking about intent to enroll in a clinical trial. The mean age of the patient sample (n = 50) was 53.0 years, and 50.0% were Black. Participants reported that the video was in the right length, useful, and easy to understand. Providers' evaluation (n = 5) revealed that viewing the video helped prepare patients for further CCT discussion. Preliminary efficacy showed no statistically significant difference in participant interest in CCT enrollment pre- and post-video. Changes in patients' intent in enrollment were associated with age and education. Culturally adapted video interventions can be helpful in supporting both patients and providers throughout the CCT education process but additional work is needed to improve enrollment into clinical trials.

Clinical Cancer Advances 2020: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

A MESSAGE FROM ASCO'S PRESIDENT: Shortly before I was elected President of ASCO, I attended the 65th birthday party of a current patient. She had been diagnosed 10 years earlier with metastatic breast cancer and hadn't been sure she wanted to move forward with further treatment. With encouragement, she elected to participate in a clinical trial of an investigational drug that is now widely used to treat breast cancer. Happily, here we were, celebrating with her now-married daughters, their husbands, and three beautiful grandchildren, ages 2, 4, and 8. Such is the importance of clinical trials and promising new therapies.Clinical research is about saving and improving the lives of individuals with cancer. It's a continuing story that builds on the efforts of untold numbers of researchers, clinicians, caregivers, and patients. ASCO's Clinical Cancer Advances report tells part of this story, sharing the most transformative research of the past year. The report also includes our latest thinking on the most urgent research priorities in oncology.ASCO's 2020 Advance of the Year-Refinement of Surgical Treatment of Cancer-highlights how progress drives more progress. Surgery has played a fundamental role in cancer treatment. It was the only treatment available for many cancers until the advent of radiation and chemotherapy. The explosion in systemic therapies since then has resulted in significant changes to when and how surgery is performed to treat cancer. In this report, we explore how treatment successes have led to less invasive approaches for advanced melanoma, reduced the need for surgery in renal cell carcinoma, and increased the number of patients with pancreatic cancer who can undergo surgery.Many research advances are made possible by federal funding. With the number of new US cancer cases set to rise by roughly a third over the next decade, continued investment in research at the national level is crucial to continuing critical progress in the prevention, screening, diagnosis, and treatment of cancer.While clinical research has translated to longer survival and better quality of life for many patients with cancer, we can't rest on our laurels. With ASCO's Research Priorities to Accelerate Progress Against Cancer, introduced last year and updated this year, we've identified the critical gaps in cancer prevention and care that we believe to be most pressing. These priorities are intended to guide the direction of research and speed progress.Of course, the effectiveness or number of new treatments is meaningless if patients don't have access to them. High-quality cancer care, including clinical trials, is out of reach for too many patients. Creating an infrastructure to support patients is a critical part of the equation, as is creating connections between clinical practices and research programs. We have much work to do before everyone with cancer has equal access to the best treatments and the opportunity to participate in research. I know that ASCO and the cancer community are up for this challenge.Sincerely,Howard A. "Skip" Burris III, MD, FACP, FASCOASCO President, 2019-2020.

Evolution of Targeted Therapy in Breast Cancer: Where Precision Medicine Began.

As we consider best practices and approaches to targeted therapy in the clinic and in terms of trial design, breast cancer can serve as a useful model for other disease types, because estrogen receptor-positive and HER2-positive breast cancer have been known entities for several decades. In this review, we provide a history of the development of anti-estrogen therapy and anti-HER2-directed therapy and we discuss our growing understanding of resistance to targeted therapy as seen through this lens. We highlight some of the recent breakthroughs that have enhanced our understanding of resistance to endocrine and anti-HER2 therapy, and we discuss some of the ongoing research in the field.

Multidisciplinary Approaches to Chest Wall Recurrences of Breast Cancer.

The management of postmastectomy chest wall recurrences of breast cancer has long challenged clinicians. A tissue diagnosis combined with proper imaging and staging of patients to ensure the disease is localized are the first steps in management. Multimodal therapy offers patients the best chances of cure. In properly selected patients, complete surgical resection to negative margins, including full-thickness chest wall resection when required, followed by reconstruction that is well planned, can provide local control with very low surgical mortality and acceptable morbidity. Radiation therapy provides additional local control, while systemic therapy is an adjunct that prolongs survival in many cases. Multidisciplinary care combined with careful patient selection are the keys to successful chest wall resection for locally recurrent breast cancer after mastectomy.

Management of Breast Cancer Therapy-Related Sexual Dysfunction.

Sexual dysfunction is a prevalent concern among breast cancer survivors, and is often multifactorial in nature. Causes can be both physiologic and psychological; chemotherapy, endocrine therapy, and disfigurement from breast cancer surgery can all play a role. Sexual dysfunction can have a profound impact on quality of life and relationships and can also impact adherence to endocrine therapy. However, it can be a difficult topic for both patients and providers to bring up, and as a result, it is often inadequately addressed. Here, we will review the mechanisms of sexual dysfunction that occurs after breast cancer, offer some practical guidance on how to discuss this effectively with patients, and review the data and our recommendations for optimizing management.

For Our Patients, for Ourselves: The Value of Personal Reflection in Oncology.

Caring for patients with cancer is a great privilege as well as an emotionally and intellectually challenging task. Stress and burnout are prevalent among oncology clinicians, with serious repercussions for the care of patients. Professional societies must provide guidance for trainees and practicing physicians to mitigate the negative consequences of stress on their personal lives and medical practice. Reflection, reading, and writing about personal experiences provide outlets for fortifying personal reserves and promoting resilience to allow us to recognize the joy and meaning of our work and to forge connections with our peers. Herein, we present some of our own reflections on how and why one might take time to write, and about the power of the written word in oncology and medicine.