(Breast Cancer) Is Xeloda (Capecitabine) Effective in Early Triple-Negative Breast Cancer?
Medical Supporter — Informationshinweis
Dieser Artikel ist eine Zusammenfassung internationaler medizinischer Informationen und stellt keine medizinische Beratung dar; er ersetzt nicht die Diagnose oder den Behandlungsplan Ihres behandelnden Arztes. Die dargestellten Informationen stammen aus öffentlichen Veröffentlichungen und offiziellen Angaben führender japanischer medizinischer Einrichtungen; Eignung und Wirkung einer Therapie sind individuell und müssen von einem qualifizierten Arzt beurteilt werden.
On December 5, 2019, Dr. Ana Lluch published in the Journal of Clinical Oncology results from the GEICAM/2003-11_CIBOMA/2004-01 Phase 3 clinical trial evaluating the efficacy and safety of adjuvant Xeloda (capecitabine) monotherapy after neo-/adjuvant chemotherapy in early triple-negative breast cancer (TNBC) patients.
This Phase 3 trial randomized patients with early TNBC who had completed neo-/adjuvant chemotherapy into a Xeloda group (N=448) and an observation group (N=428). The primary endpoint was disease-free survival (DFS).
The trial was motivated by the poor 3-year DFS rates in early TNBC: Stage I: 8%, Stage II: 15%, Stage III: 40%, highlighting the need for more effective treatment options beyond current standards.
Patient Demographics:
Xeloda group: Caucasian 69.9%, Latin American 23.9%, African American 3.6% Observation group: Caucasian 72.2%, Latin American 22.7%, African American 2.6%
Disease stage distribution:
- Xeloda group: Stage I 13.8% / Stage II 60.3% / Stage III 23.7%
- Observation group: Stage I 17.3% / Stage II 63.3% / Stage III 18.7%
Results at median follow-up of 7.3 years:
Compared to the observation group, the Xeloda group showed an 18% risk reduction in the primary endpoint DFS (hazard ratio: 0.82), though the difference between the two groups was not statistically significant. The 5-year DFS rates were: Xeloda group 79.6% vs. observation group 76.8%.
In subgroup analysis, the DFS hazard ratios by subtype were: non-basal type 0.53 vs. basal type 0.94, suggesting potential benefit specifically in the non-basal subtype.
Safety:
Overall adverse event incidence: Xeloda group 95.4% vs. observation group 63.8%. Grade 3 or higher adverse events: 40.6% vs. 15.5%. Serious adverse events: 5.3% vs. 1.4%.
Conclusion: Dr. Lluch concluded that adjuvant Xeloda monotherapy after neo-/adjuvant chemotherapy did not significantly improve DFS overall in early TNBC patients compared to observation. However, there is potential for improved DFS specifically in non-basal subtype early TNBC patients treated with Xeloda monotherapy.
Disclaimer: Medical Supporter translates overseas clinical trial data and pharmaceutical information for informational purposes only. Translation materials are for reference only. Please consult your healthcare provider for medical decisions.
Source: Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01). Lancet Oncol. 2019 Dec 3. pii: S1470-2045(19)30735-1.
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Behandlung in Japan im Blick? Brauchen Sie Informationen und Unterstützung?
Wir helfen Ihnen, die für eine medizinische Reise nach Japan nötigen Informationen zu ordnen, kontaktieren japanische Einrichtungen und organisieren eine Zweitmeinungsberatung.Die Erstberatung ist kostenlos; ein Berater hilft Ihnen, die nächsten Schritte zu klären.
Figure 1
Figure 2
Figure 3
Figure 4