Recently, the European Society for Medical Oncology (ESMO) published its clinical practice guidelines on the diagnosis, treatment, and follow-up of early breast cancer (EBC). The general ESMO recommendations regarding (neo) adjuvant systemic treatment (N/AST) for EBC include the following:
• Adjuvant systemic therapy (AST) should be initiated within 3 to 6 weeks postsurgery and N/AST should be started as soon as the diagnosis and staging phase is completed, which should be within 2 to 4 weeks.
• Factors in deciding on AST include a patient’s assessed risk of relapse as determined by tumor burden and biology, predicted sensitivity to treatment regimens, risk (short- and long-term) versus benefit of treatment, patient age and general health status, as well as comorbidities and patient preferences.
• All luminal-like EBCs should be treated with endocrine therapy.
• For those with luminal-A like tumors, only those EBCs with high tumor burden (>4 lymph nodes, T3 or higher) should be considered for chemotherapy, as endocrine therapy alone is usually sufficient in most cases.
• In patients with luminal B-like HER2 (human epidermal growth factor receptor 2)-negative EBC, recommended therapy includes chemotherapy followed by endocrine therapy for the majority of patients; however, the use of chemotherapy depends on a patient’s risk of recurrence, projected response to treatment, and patient preferences.
• In patients with luminal B-like HER2-positive EBC, recommended therapy includes chemotherapy along with anti-HER2 treatment followed by endocrine therapy for all patients, except selected patients with low-risk disease (T1abN0) for whom a combination of anti-HER2 therapy and endocrine therapy alone may be utilized; additionally, if contraindications to the use of chemotherapy exist, endocrine therapy along with anti-HER2 treatment may be implemented, but there are no randomized data supporting this recommendation.
• When uncertainty exists regarding the indication for adjuvant chemotherapy, urokinase plasminogen activator-plasminogen activator inhibitor I or gene-expression assays can assist with decision making.
• Patients with triple-negative EBC should receive chemotherapy; however, exceptions may include those with secretory or adenoid cystic carcinomas or those with very early (T1aN0) tumors, which are considered low-risk ‘special histological subtypes.’
• Patients with HER2-positive EBC should be treated with chemotherapy plus anti-HER2 therapy with the possible exception of patients with very low risk, such as those with T1aN0 tumors.
• Whereas chemotherapy should not be used concomitantly with endocrine therapy, gonadotropin-releasing hormone analogues are used for ovarian protection.
• For patients with HER2-positive EBC, anti-HER2 therapy may be routinely combined with nonanthracycline-based chemotherapy, endocrine therapy, and radiotherapy.
• EBC patients can safely undergo radiotherapy while also receiving anti-HER2 therapy, endocrine therapy, and nonanthracycline, nontaxane-based chemotherapy.
• However, or in other cases, if chemotherapy and radiotherapy are required, chemotherapy should usually be given prior to radiotherapy.
• Five to 10 years of tamoxifen therapy is the standard of care for the management of premenopausal EBC patients.
• For women who become postmenopausal within the first 5 years of starting tamoxifen, a switch to letrozole may be considered depending on the patient’s predicted risk of late recurrence.
• In women requiring chemotherapy who have a return of menses in the first 1 to 2 years of diagnosis, the addition of ovarian-function suppression (with the use of luteinizing hormone-releasing hormone agonists) to endocrine therapy is strongly recommended.
• Aromatase inhibitors may replace tamoxifen in high-risk patients, but if used, effective ovarian-function suppression with regular biochemical control of estrogen levels needs to be maintained.
• Although the role of ovarian-suppression therapy in women under age 35 years who are not receiving chemotherapy remains unknown, poorer outcomes have been observed in young luminal EBC patients, favoring the use of endocrine therapy in combination with ovarian-suppression therapy in these patients.
• While ovarian-function suppression during chemotherapy provides some protection of ovarian function, it should not be the only fertility-preservation method utilized if a later pregnancy is desired.
The guidelines provide additional treatment recommendations for postmenopausal women, the use of chemotherapy, anti-HER2 therapy, primary N/AST, bisphosphonates for EBC, treatment of elderly patients, treatment of male breast cancer patients, and systemic adjuvant therapy for ductal carcinoma in situ.
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