Guideline: FDA issues warning on CDK inhibitors
Summary
The U.S. Food and Drug Administration issued a safety alert for CDK inhibitors, including Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib). (9/24/19)
Relevance
This article is most relevant for People currently taking a CDK inhibitor
Relevance: Medium-High
Research Timeline: Post Approval
Media Ratings
Who covered this study?
Targeted Oncology
FDA warns of lung inflammation from CDK4/6 inhibitor use in breast cancers
This article rates 3.5 out of 5 stars
docwire
FDA warns that several breast cancer drugs lead to lung inflammation
This article rates 3.0 out of 5 stars
Contents
| At a glance | Questions for your doctor |
| Findings | Resources |
STUDY AT A GLANCE
This study is about:
The U.S. Food and Drug Administration’s () safety alert warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) may cause a rare but severe inflammation of the lungs.
Why is this study important?
The approved Ibrance in 2015, and both Kisqali and Verzenio in 2017 to treat some patients with advanced breast cancer. These drugs, called CDK 4/6 inhibitors have been shown to significantly improve the amount of time a cancer does not grow and the patient is alive. However, in some patients they may cause rare but severe lung inflammation
findings:
CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor-positive, advanced or breast cancer.
The reviewed cases of lung disease associated with use of CDK 4/6 inhibitors. Cases were identified from both ongoing and completed clinical trials. Cases were also identified from the ’s drug safety database.
The found that, although rare, there were serious cases and/or deaths with Ibrance (palbociclib), Verzenio (abemaciclib), and Kisqali (ribociclib).
- Across clinical trials of these three CDK 4/6 inhibitors, 1 to 3 percent of patients had lung inflammation of any grade.
- Less than 1 percent of these patients had fatal outcomes.
- Less than 1 percent of these patients had fatal outcomes.
- Among patients who developed lung inflammation, including fatal cases, there were patients who had no risk factors for lung disease, but some patients had at least one risk factor.
Guidelines
The recommends that anyone taking these CDK inhibitors notify their health care provider if they have any new or worsening symptoms involving their lungs.
Symptoms to watch for include:
- Difficulty or discomfort with breathing
- Shortness of breath while at rest or with low activity
What does this mean for me?
Rarely, CDK 4/6 inhibitors can cause severe lung inflammation. However, the benefits of taking these medicines may outweigh this risk. The is urging patients to not stop taking a CDK 4/6 inhibitors without first talking to their health care provider.
It is important to know:
- All medicines have side effects even when used correctly as prescribed.
- People respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors.
Experts do not yet know the factors that make a patient high-risk for severe lung inflammation when taking Ibrance, Kisqali, or Verzenio.
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Posted 9/24/19
References
warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer. website. Posted September 13, 2019.
Disclosure
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
People currently taking a CDK inhibitor
This article is also relevant for:
Men with breast cancer
ER/PR +
People with a genetic mutation linked to cancer risk
Breast cancer survivors
Women under 45
Women over 45
Metastatic cancer
Be part of XRAY:
Questions To Ask Your Doctor
- Is it safe for me to continue to take my medication (CDK4/6 inhibitors)?
- I am worried I am risk for lung disease, should I continue to take my medication (CDK 4/6 inhibitor)?
- Are there other medications that are as effective for me as a CDK 4/6 inhibitor?
- What signs or symptoms of lung disease should I be looking for?
- Should I have a chest XRAY or other scan for lung disease?
Open Clinical Trials
The following studies are looking at management of side effects:
Multiple cancers
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- NCT04262180: Physical Activity Promotion for Breast and Endometrial Cancer Survivors. This study is looking at whether messaging and coaching can increase activity level and how moderate-to-vigorous activity improves symptoms and quality-of-life in women diagnosed with breast or endometrial cancer.
- EnergyPoints: A Mobile App Guiding Use of Acupressure for Cancer-related Fatigue and Sleep Disturbances. This study is looking at the use of acupressure to manage cancer-related fatigue and sleep disturbances.
Breast cancer
- NCT04621721: Physical Activity at Home for Relief from Neuropathy Caused by Taxanes in People with Breast Cancer. This study will look at the effects of gain and balance training and resistance exercise (using bands) on gait, balance, and lower extremity muscle strength after a 16-week home-based exercise program compared to educational materials without an exercise program.
- NCT04586530: Telehealth and Memory Study (TAMS). The overall purpose of this trial is to confirm the effectiveness of Memory and Attention Adaptation Training (a cognitive-behavioral therapy) as a treatment for chemotherapy-related dysfunction among breast cancer survivors.
- NCT02290834: Chemotherapy-induced and brain changes in older adults with breast cancer. The study will investigate abilities and brain images before and after chemotherapy to identify people at risk for side effects and to better understand the effects of treatment on brain structure and function.
- NCT04906200: Web-Based Symptom Monitoring and Self-Management Portal for Adolescent and Young Adult Breast Cancer Survivors. This compares a web-based patient-reported symptom-monitoring and self-management portal to standard therapy in young breast cancer survivors.
- NCT04049695: Improving Cognition After Cancer (ICAN). This study will test whether physical activity can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
- NCT04086875: A Text-based Tool to Improve Adherence to Hormone Therapy in Patients With Hormone Positive Breast Cancer. This trial studies how well text messaging works to improve adherence to hormone therapy in people with breast cancer.
- NCT04837820: The Effect of Acupuncture on Cancer-Related Difficulties. This study will test whether acupuncture can improve thinking and insomnia in breast cancer survivors. This study will also look at insomnia's link to difficulties.
- NCT03996265: Bupropion in Reducing Cancer Related Fatigue in I-III Breast Cancer Survivors. This will study how well the drug bupropion (welbutrin) reduces cancer-related fatigue in I-III breast cancer survivors.
- NCT02831582: Omega-3 Supplementation to Prevent Aromatase Inhibitor-Induced in Patients With I-III Breast Cancer. This study looks at omega-3 fatty acid supplementation to prevent aromatase inhibitor-induced side effects in patients with I-III breast cancer.
- NCT03879629: TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC). Breast cancer patients receiving Herceptin or other HER2-directed therapy are at risk of heart damage. This study is looking at whether beta-blocker drugs could help prevent this from happening.
- NCT01802346: Low Calorie Diet to Reduce Side Effects and Increase Response to Chemo in People With Breast or Cancer. This studies a low calorie diet to reduce side effects and increase response to chemotherapy in patients with breast or cancer.
Colorectal cancer
- NCT04763174: An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE). The study will look at a mobile health tool to meet the multiple symptom needs and stage-of-life challenges faced by colorectal cancer survivors.
Endometrial cancer
- NCT04713618: Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy. This study looks at changes in physical measures and patient-reported outcomes of sexual function, intimacy and quality of life.
- NCT04298827: Gyn Onc Prehab Study. This study will compare physical therapy, nutritional counseling and behavioral therapy with physical therapy alone as part of a prehabilitation program. Return of function after surgery, quality of life, patient satisfaction and compliance will be measured.
Ovarian cancer
- NCT04533763: Living WELL: A Web-Based Program for Ovarian Cancer Survivors. This studies a group-based and web-delivered tool for ovarian cancer survivors in increasing quality of life and decreasing stress, depressive mood, anxiety, and fatigue across a 12-month period.
- NCT05047926: Prehabilitation for Advanced Ovarian Cancer Patients. Prehabilitation may improve peri-operative outcomes in patients undergoing cancer surgery. This study will look at structured activity for women undergoing chemotherapy to improve their physical state prior to surgical intervention and thus improve outcomes.
cancer
- NCT03971591: Men Moving Forward: A Lifestyle Program for African-American Cancer Survivors (MMF). This study will look at Men Moving Forward (MMF), a community-based lifestyle intervention that supports adherence to nutrition and physical activity guidelines to promote improved body composition and lessen the side effects of treatment.
- NCT05155501: Pelvic Fascia spARing Radical Prostatectomy TrIAL (PARTIAL). This clinical trial is studying whether pelvic fascia-sparing radical prostatectomy has similar cancer control and sexual function outcomes; and significantly better urinary function, less penile deformity and inguinal hernia risks as compared to radical prostatectomy.
- NCT01802346: Low Calorie Diet to Reduce Side Effects and Increase Response to Chemo in People With Breast or Cancer. This studies a low calorie diet to reduce side effects and increase response to chemotherapy in patients with breast or cancer.
Updated: 02/15/2023
Related Resources
FORCE XRAYS: CDK inhibitor
Medwatch: Safety Information and Reporting Program
Medwatch: Form for reporting and
Related Resources
The following organizations have resources related to treatment side effects.
- FORCE related resources:
- Information: Chemotherapy side effects
- Information: Hormone therapy side effects
- Information: side effects
- Information: Radiation side effects
- Information: Surgery side effects
- Information: side effects
- Information: Well-being and survivorship
- XRAY category: Side effects
- MedWatch: Online side effect reporting form
- National Cancer Institute: Cancer treatment side effects
- Centers for Disease Control: Cancer treatment side effects
- HairToStay helps cancer patients cover the cost of scalp cooling.
- Unite for Her provides financial support for services that help improve quality of life in people diagnosed with breast or ovarian cancer.
Updated: 08/06/2022
Who covered this study?
Targeted Oncology
FDA warns of lung inflammation from CDK4/6 inhibitor use in breast cancers
This article rates 3.5 out of 5 stars
docwire
FDA warns that several breast cancer drugs lead to lung inflammation
This article rates 3.0 out of 5 stars
Yahoo! Finance
Breast cancer drugs may inflame lungs per FDA safety alert
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Medscape
Breast cancer drugs may severely inflame lungs, FDA warns
This article rates 3.0 out of 5 stars