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Facts and Hopes in Neoadjuvant Immunotherapy: Current Approvals and Emerging Evidence
Poorva Vaidya1, Ezra E W Cohen1
1Department of Internal Medicine, Division of Hematology-Oncology, Moores Cancer Center, University of California, San Diego, La Jolla, California.
Abstract:
In 2021 and 2022, two immune checkpoint inhibitors received FDA approval in the neoadjuvant setting for the treatment of early-stage triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). Several more studies have since indicated the benefits, and challenges, of administering neoadjuvant immunotherapy prior to definitive surgery in the gastrointestinal, head and neck, and cutaneous realms. In addition, numerous ongoing phase II and phase III trials are investigating outcomes of neoadjuvant immune treatment in early-stage disease. As such, it is anticipated that more immune checkpoint inhibitors will receive approval for various neoadjuvant indications in the next several years. Medical oncologists, surgeons, and other providers in a multidisciplinary cancer care team will be presented with alternate treatment paradigms and clinical decisions regarding upfront surgery versus neoadjuvant treatment. Here, we describe the current evidence supporting use of immune checkpoint inhibitors for neoadjuvant treatment, ongoing studies, and clinical considerations of this treatment approach.
Insights
Neoadjuvant immunotherapy with immune checkpoint inhibitors is increasingly used for early-stage cancers like triple-negative breast cancer and non-small cell lung cancer. This approach offers new treatment options alongside surgery, with more approvals expected.
Area of Science:
- Oncology
- Immunotherapy
- Cancer Treatment
Background:
- Recent FDA approvals in 2021-2022 highlight immune checkpoint inhibitors in the neoadjuvant setting for early-stage triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC).
- Emerging studies demonstrate both benefits and challenges of neoadjuvant immunotherapy prior to surgery across gastrointestinal, head and neck, and cutaneous cancers.
- The landscape of cancer treatment is shifting towards incorporating neoadjuvant immune strategies for early-stage diseases.
Purpose of the Study:
- To review the current evidence supporting the use of immune checkpoint inhibitors in the neoadjuvant setting.
- To discuss ongoing clinical trials investigating neoadjuvant immune treatments for early-stage cancers.
- To outline key clinical considerations for multidisciplinary cancer care teams regarding neoadjuvant immunotherapy versus upfront surgery.
Main Methods:
- Literature review of recent FDA approvals and published studies on neoadjuvant immunotherapy.
- Summary of ongoing Phase II and Phase III clinical trials in various cancer types.
- Analysis of clinical decision-making factors for neoadjuvant treatment versus immediate surgical intervention.
Main Results:
- Immune checkpoint inhibitors have gained traction in neoadjuvant treatment for TNBC and NSCLC.
- Evidence suggests efficacy and identifies challenges in applying neoadjuvant immunotherapy to diverse cancer types.
- Numerous trials are underway, indicating a growing role for this treatment modality.
Conclusions:
- Neoadjuvant immunotherapy represents a significant evolution in cancer care, offering new paradigms for early-stage disease.
- Anticipated approvals will expand indications for immune checkpoint inhibitors in neoadjuvant settings.
- Careful consideration of evidence, ongoing research, and multidisciplinary input is crucial for optimal patient management.
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