Sri Kota Puts the Nursing Lens On Recent Data With Sacituzumab Govitecan in TROPiCs-02


Sri Kota, MSN, BA, RN, OCN, unpacks data from the phase 3 TROPiCS-02 trial and highlights what nurses should know about sacituzumab govitecan for patients with advanced hormone receptor–positive, HER2-negative breast cancer.

 Sri Kota, MSN, BA, RN, OCN

Sri Kota, MSN, BA, RN, OCN

The efficacy profile that sacituzumab govitecan-hziy (Trodelvy) demonstrated in the phase 3 TROPiCS-02 trial (NCT03901339), is promising for patients with advanced hormone receptor–positive/HER2-negative metastatic breast cancer and whose disease has not responded to endocrine therapy, according to Sri Kota, MSN, BA, RN, OCN. Moreover, antibody-drug conjugates (ADCs), such as sacituzumab govitecan, are associated with higher tolerability than chemotherapy and other classes of drugs.

At the 2022 ESMO Congress, sacituzumab govitecan was associated with a median progression-free survival (PFS) of 5.5 months compared with 4.0 months for chemotherapy (HR, 0.66; 95% CI, 0.53-0.83; P = .0003). Moreover, the median overall survival with the experimental agent was 14.4 months vs 22.1 months with chemotherapy (HR, 0.789; 95% CI, 0.646-0.964; P = .02).

In light of these findings, the FDA has initiated a priority review of sacituzumab govitecan on the indication of unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. Under the Prescription Drug User Fee Act, the FDA is expected to make a decision on the application in February 2023.

In an interview with Oncology Nursing News®, Kota, who is a nurse clinician with the Rutgers Cancer Institute of New Jersey, offered a nursing perspective on the findings from TROPiCS-02. She also discusses what is known based on the agent’s approved other indications and what nurses should know in the event that this agent is to be further integrated into clinical practice.

Oncology Nursing News®: Please discuss the recently presented findings from TROPICs-02. What about the data stood out to you?

Kota: The data from TROPiCS-02 showed a significant PFS benefit with sacituzumab govitecan vs treatment of physician’s choice (TPC) in patients with hormone receptor–positive, HER2-negative metastatic breast cancer. Sacituzumab govitecan was also associated with a 34% reduction in risk of disease progression or death. This data is very promising for patients with advanced cancers that are resistant to endocrine therapy and have progressed after endocrine therapy, CDK4/6 inhibitors, and a taxane.

What are the current treatment options for patients with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer.

Initial therapy for patients with advanced hormone receptor–positive, HER2-negative metastatic breast cancer consists of aromatase inhibitors (letrozole, anastrozole, exemestane) or fulvestrant with CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib). Subsequent options may include PI3K inhibition (alpelisib) and mTOR inhibition (everolimus).

Chemotherapy options for patients with advanced hormone receptor–positive, HER2-negative metastatic breast cancer include taxanes (paclitaxel), anthracyclines (doxorubicin, liposomal doxorubicin), anti-metabolites (capecitabine, gemcitabine), microtubule inhibitors (eribulin, vinorelbine), sacituzumab govitecan. In certain circumstances, ixabepilone, platinum compounds (carboplatin), and cyclophosphamide may also be used.

What are some benefits of treating patients with an antibody-drug conjugate compared with chemotherapy and other classes of agents?

ADCs are a combination of monoclonal antibodies and traditional small molecule chemotherapy drugs. Since they are targeted to find the receptors in the body, they are more precise and deliver therapy directly to the cancer cells. As a result, cytotoxicity is lower, and specificity is higher.

Treatment resistance rates are also lower with ADCs. In traditional chemotherapy, the target cells are not specific and damage to normal cells is higher. ADCs are therefore tolerated better because of their limited systemic exposure.

What are some important considerations for nurses as this continues to be integrated into the treatment fold?

As more ADCs are approved for treatment, nurses should be aware and prepared to assess patients for infusion reactions, anaphylaxis, and interactions with other drugs. Management may include premedication with an antihistamine, acetaminophen, and corticosteroid prior to ADC infusion each cycle.

Nurses should also ensure that patients are educated on what symptoms need to be reported in a timely manner to avoid serious complications. An interdisciplinary approach can help deal with comorbidities that can be exacerbated by the use of certain ADCs.

Can you comment on the safety profile associated with this treatment? What do you think nurses should want to know about caring for a patient on sacituzumab govitecan?

Sacituzumab govitecan is a Trop-2-directed antibody drug conjugate with a higher drug-antibody ratio than other ADCs. Treatment is 10 mg/kg IV on days 1 and 8, every 21 days. Sacituzumab govitecan is also different from the older drugs in the class. The side effects are more pronounced, and patients may experience more diarrhea, alopecia, and nausea than some standard-of-care medications.

In pretreated patients, there is also a risk for febrile neutropenia that nurses need to be aware of and the use of peg-filgrastim (Neulasta) may be warranted in some patients.

Infusion reactions that within 24 hours of infusion, along with neutropenia, severe diarrhea, nausea, and vomiting are all important safety considerations with sacituzumab govitecan. The most common side effects include fatigue, alopecia, anemia, anorexia, constipation, rash, and abdominal discomfort.

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