Metronomic Chemo-Endocrine Therapy (FulVEC) as a Salvage Treatment for Patients with Advanced, Treatment-Refractory ER+/HER2-Breast Cancer—A Retrospective Analysis of Consecutive Patients Data

Abstract

Background: Breast cancer, with 2.3 million new cases and 0.7 million deaths every year, represents a great medical challenge worldwide. These numbers confirm that approx. 30% of BC patients will develop an incurable disease requiring life-long, palliative systemic treatment. Endocrine treatment and chemotherapy administered in a sequential fashion are the basic treatment options in advanced ER+/HER2- BC, which is the most common BC type. The palliative, long-term treatment of advanced BC should not only be highly active but also minimally toxic to allow long-term survival with the optimal quality of life. A combination of metronomic chemotherapy (MC) with endocrine treatment (ET) in patients who failed earlier lines of ET represents an interesting and promising option. Methods: The methodology includes retrospective data analyses of pretreated, metastatic ER+/HER2- BC (mBC) patients who were treated with the FulVEC regimen combining fulvestrant and MC (cyclophosphamide, vinorelbine, and capecitabine). Results: Thirty-nine previously treated (median 2 lines 1–9) mBC patients received FulVEC. The median PFS and OS were 8.4 and 21.5 months, respectively. Biochemical responses (CA-15.3 serum marker decline ≥50%) were observed in 48.7%, and any increase in CA-15.3 was observed in 23.1% of patients. The activity of FulVEC was independent of previous treatments with fulvestrant of cytotoxic components of the FulVEC regimen. The treatment was safe and well tolerated. Conclusions: Metronomic chemo-endocrine therapy with FulVEC regimen represents an interesting option and compares favorably with other approaches in patients’ refractory to endocrine treatments. A phase II randomized trial is warranted.

Towards Agility in Breast Cancer Treatment Principles as Adopted from Agile Software Engineering

“…Metronomic chemo-endocrine therapy with the FulVEC regimen is a novel approach that compares favorably to other approaches in patients who are resistant to endocrine therapies. 39 Similarly, clinical findings proved that medium-to-high physical fitness exercise improves chemotherapy treatment completion. 38 Another finding is that radiotherapy could be reduced from about 4–6 weeks to 3 weeks for early-stage breast cancer women who have had surgery to remove a tumor with a high risk of recurrence.…”

“…For example, the work of combining metronomic chemo-endocrine therapy with a FulVEC regimen resulted in a high rate of clinical benefits, particularly for patients with endocrine treatment (ET) and metronomic chemotherapy (CT) resistance. 39 The literature contains numerous studies concerning dose adjustment or treatment combinations recommended according to patient health characteristics and response. 40 , 41 Incorporating new research findings: as new research and clinical trial results emerge, the treatment team may consider incorporating promising new medicines or treatment techniques into the patient’s plan, particularly if they have the potential to be more effective and safer than existing approaches.…”

Chemotherapy combined with endocrine neoadjuvant therapy for hormone receptor-positive local advanced breast cancer: a case report and literature review

“…Additionally, Anna et al. ( 26 ), through retrospective data analysis, investigated ER+/HER2- MBC patients administered with FUL combined with MC (cyclophosphamide, vinorelbine, as well as capecitabine), revealing the mPFS of 8.4 months as well as the mOS of 21.5 months. These findings together demonstrate the safety and effectiveness of combining capecitabine with FUL in managing HR+/HER2- advanced BC.…”

Strikingly high activity of metronomic chemotherapy in a patient with locally advanced, life-threatening cutaneous squamous-cell cancer — case report and discussion of the literature

“…Metronomic chemotherapy is a reasonable therapeutic approach in many patients with advanced, non-rapidly proliferating cancers, especially those who are elderly or have significant comorbidities [6][7][8][9][10][11][12]. The oral-intravenous approach presented in this article represents smart combined chemotherapy designed to activate all possible mechanisms of the cytotoxic drugs used.…”