Media
The Metastatic Breast Cancer Alliance has summarized the PCDI's mission in three words: 'Personalization Innovation Communication' and published the results from our patient and oncologists surveys on their website. Read here what patients and oncologists have said about treatment-related side effects, their impact on quality of life, and the steps the FDA has begun taking to address the toxicity of cancer drugs.
Our amazing PCDI members Sheila McGlown and Julia Maues were interviewed by Dr. Moyez Jiwa, in the 5/1/2022 Health Design podcast. Listen to their stories and learn why they believe that patient-centered dosing conversations between physicians and patients are so important!
In the Friends of Cancer Research (“Friends”) Annual Meeting in Nov. 2021, representatives from Friends, the FDA, pharmaceutical companies, and the PCDI discussed the FDA’s guidance in moving away from the Maximum Tolerated Dose in favor of optimizing the dose in oncology drug development. This represents a major shift from the decades-long paradigm that “more is better.,” Please watch the conference here: https://www.youtube.com/watch?v=tO_Ta9KG988
A summary of the above Friends of Cancer Research Annual Meeting in Nov. 2021 was provided in the ASCO Post article, “Friends of Cancer Research Releases White Paper on Optimizing Dosing in Oncology Drug Development" in which the FDA clearly states, “The prevailing mindset in drug development that ‘more is better’ is loud and clear from our patients: the drugs are too toxic.” The article further describes the FDA’s updated perspective in which the Maximum Tolerated Dose needs to be revised in favor of dose optimization. Dose optimization is a logical approach that takes both toxicity and efficacy into account, rather than toxicity alone. Anne Loeser, PCDI Founder, stated in the article that as a result of dose optimization, “Patients may no longer need to skip a scheduled treatment or completely stop a working treatment as often as they do now. The need for acute care, such as emergency room visits, may diminish. And, finally, these patients may not suffer as many or as severe cumulative side effects as they proceed from one treatment to the next. This in turn may allow them to take full advantage of a complete list of therapies that are available to them, instead of opting out of treatment prematurely because their bodies can no longer withstand the toxicity.” https://ascopost.com/news/november-2021/friends-of-cancer-research-releases-white-paper-on-optimizing-dosing-in-oncology-drug-development/
The PCDI’s ASCO 2021 presentation is summarized in a video by internationally recognized breast cancer expert Lisa A. Carey, MD, FASCO, beginning at minute 19:40 and ending at 23:30: https://www.lbbc.org/news-opinion/highlights-2021-asco-annual-meeting-lisa-carey-md-fasco?utm_source=newsletter&utm_medium=email&utm_campaign=june
Listen to Dr. Maryam Lustberg, Director of The Breast Center at Smilow Cancer Hospital and Chief of Breast Medical Oncology at Yale Cancer Center, discuss the Patient-Centered Dosing Initiative and how it is transforming perceptions about dosing. Dr. Lustberg states, “It is the beginning of a dialogue to really look at how we really dose drugs and whether pushing the dose at the Maximum Tolerated Dose may not be the right choice for many patients… it’s the beginning of really thinking as a scientific community and as a patient community how we approach dosing in oncology.” https://www.obroncology.com/video/sabcs-2021-improving-the-patient-experience
The PCDI was proud to participate in the FDA’s Oncology Center of Excellence Conversations on Cancer discussion “More Isn’t Always Better: Understanding Cancer Treatment Tolerability.” Speakers discussed the importance of the patient experience in evaluating tolerability, clinician consideration of patient-reported tolerability, the impact of tolerability on treatment decisions, and dose optimization. https://www.youtube.com/watch?v=k9081xEHbO0
Oncology Nurse Advisor: "Periodic patient–physician discussions to assess the physical attributes and circumstances of patients with metastatic breast cancer... may help determine the optimal dosages for treatment initiation and following, and most patients would be receptive to having these discussions. These findings were reported at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting." https://www.oncologynurseadvisor.com/home/headlines/conference-coverage/asco-2021/most-breast-cancer-patients-personalized-dosage-options-risk/
Medicine Matters - Oncology: "The high side-effect burden of metastatic breast cancer treatments warrants the development of innovative dosing strategies to maintain quality of life, suggest the results of an advocate-led survey of patients." https://oncology.medicinematters.com/asco-2021/breast-cancer/patient-advocate-led-survey-innovative-drug-dosing/19251100
Living Beyond Breast Cancer: "This survey was the first step in an effort to change the way doctors recommend treatment doses in metastatic breast cancer.. These advocates are asking whether people can discuss with doctors getting a lower dose to start if appropriate based on their individual features, rather than changing treatment after going through distressing side effects... The final results of this effort may take time to realize, but this survey being featured at the ASCO Annual Meeting shows a positive effort in welcoming the voices of people affected by breast cancer into research conferences." https://www.lbbc.org/news-opinion/patient-advocates-ask-if-maximum-dose-always-right-dose-metastatic-breast-cancer
After 20 Years - Exploring progress in cancer research from the patient perspective: "It’s long been thought that the “right dose” of a cancer medication is the maximum dose that most people receiving the drug can tolerate. This thinking began with chemotherapy and is often extended to other types of cancer drugs. A group of metastatic breast cancer patient (MBC) advocates is now questioning that paradigm and is urging a new approach that is more attuned to the needs of individuals." https://after20yrs.com/2021/07/28/finding-the-right-dose/
Cancer Today: "The FDA will start requiring drug companies to test the efficacy of multiple drug doses during clinical trials, rather than focusing all efforts on finding the highest tolerable dose... For patients, the need to move away routinely administering the MTD is urgent." https://www.cancertodaymag.org/Pages/cancer-talk/Moving-Away-From-the-Maximum-Tolerated-Dose.aspx
Taking Drug Dosing Off Autopilot: https://www.cancertodaymag.org/Pages/cancer-talk/Taking-Drug-Dosing-Off-Autopilot.aspx
Cancer Therapy Advisor Article: https://www.cancertherapyadvisor.com/home/cancer-topics/general-oncology/oncology-clinical-trials-routine-drug-monitor-questionable-practice/
MED SHADOW: Balancing the Risks and Benefits of Medicines: https://medshadow.org/cancer-treating-drugs-and-other-drugs-too-can-be-effective-at-lower-doses/