RESUMEN
BACKGROUND: The current standard first-line treatment for hormone receptor-positive/human epidermal growth factor receptor 2 negative (HR + /HER2 -) advanced breast cancer (ABC) is a combination of aromatase inhibitor (AI) plus CDK4/6 inhibitors (CDK4/6i). Direct comparison trials of different CDK4/6i are scarce. This real-world study compared the effectiveness of first-line AI plus ribociclib versus palbociclib. METHODS: This multicenter retrospective cohort study, conducted in six cancer centers in Thailand, enrolled patients with HR + /HER2 - ABC treated with first-line AI, and either ribociclib or palbociclib. Propensity score matching (PSM) was performed. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), time to chemotherapy (TTC), and adverse events. RESULTS: Of the 250 patients enrolled, 134 patients with ribociclib and 49 patients with palbociclib were captured after PSM. Baseline characteristics were well-balanced between groups. Median PFS in patients receiving ribociclib and palbociclib were 27.9 and 31.8 months, respectively (hazard ratio: 0.87; 0.55-1.37). The median OS in the AI + ribociclib arm was 48.7 months compared to 59.1 months in the AI + palbociclib arm (hazard ratio: 0.55; 0.29-1.05). The median TTC in the AI + palbociclib group was 56 months, but not reached in the AI + ribociclib group (p = 0.42). The ORR of AI + ribociclib and AI + palbociclib were comparable (40.5% vs. 53.6%, p = 0.29). Patients receiving palbociclib demonstrated a higher proportion of neutropenia compared to those receiving ribociclib, despite a similar dose reduction rate (p = 0.28). Hepatitis rate was similar between the ribociclib (21%) and palbociclib groups (22%). Additionally, a low incidence of QT prolongation was observed in both the ribociclib (5%) and palbociclib groups (4%). CONCLUSION: This preliminary analysis of a real-world study demonstrated the comparable effectiveness of ribociclib and palbociclib with AI as an initial therapy for HR + /HER2 - ABC. No statistically significant difference in PFS, OS, and TTC was found in patients treated with AI combined with palbociclib or ribociclib. Longer follow-up and further prospective randomized head-to-head studies are warranted.
Asunto(s)
Aminopiridinas , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias de la Mama , Piperazinas , Purinas , Piridinas , Receptor ErbB-2 , Receptores de Estrógenos , Humanos , Piperazinas/administración & dosificación , Piperazinas/efectos adversos , Piperazinas/uso terapéutico , Femenino , Piridinas/administración & dosificación , Piridinas/uso terapéutico , Piridinas/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Aminopiridinas/administración & dosificación , Aminopiridinas/uso terapéutico , Aminopiridinas/efectos adversos , Purinas/administración & dosificación , Purinas/efectos adversos , Persona de Mediana Edad , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Estudios Retrospectivos , Tailandia/epidemiología , Anciano , Receptor ErbB-2/metabolismo , Adulto , Receptores de Estrógenos/metabolismo , Inhibidores de la Aromatasa/administración & dosificación , Inhibidores de la Aromatasa/uso terapéutico , Receptores de Progesterona/metabolismo , Supervivencia sin ProgresiónRESUMEN
BACKGROUND: Regular history assessments and physical examination with annual breast imaging have been recommended as the standard surveillance protocol for breast cancer patients who underwent curative-intent therapy. Based on randomized studies conducted in the 2000s, surveillance with regular chest or abdominal imaging, chemistry panels, or tumor marker measurements does not improve survival in such patients. Given the remarkable recent improvements of systemic therapy, we hypothesized that more intensive surveillance may lead to early detection and improve treatment outcomes in the modern era. METHODS: We retrospectively evaluated the follow-up strategies and benefits of investigations used in usual practice. Breast cancer patients who had initial adjuvant therapy were recruited and classified according to the receipt of standard follow-up (history, physical examination, and annual breast imaging) or alternative follow-up (surveillance with at least annual chest or abdominal imaging or biannual liver function testing). The primary outcome was overall survival. Secondary outcomes included disease-free survival and the indicator of recurrence detection. RESULTS: Of 412 recruited patients, 213 (51.7%) and 199 patients (49.3%) were included in the standard follow-up group and alternative follow-up group, respectively. Among 90 patients (21%) with disease recurrence, the most frequent indicators of recurrence were newly reported symptoms or physical examination abnormalities (64%), followed by abnormal breast imaging (23%) and abnormal chest X-ray (10%). After a median follow-up of 85 months, approximately 90% of patients remained alive after 5 years in both groups. The mean overall survival was similar between the standard and alternative follow-up groups (154.5 months vs. 151.9 months, p = 0.54). There was no difference in terms of the proportion of interval visits, specific cancer treatment received, and disease-free survival. CONCLUSION: Standard follow-up with history assessments, physical examination, and annual breast imaging remains the recommended surveillance strategy in the modern era. Alternative follow-up strategy did not improve oncologic outcomes.