Vergleich von Trastuzumab-Biosimilar ABP 980 mit Referenz-Trastuzumab bei der neoadjuvanten Therapie von HER2-positivem Brustkrebs – Analyse eines großen universitären Brustkrebszentrums

Zusammenfassung

Hintergrund ABP 980 ist ein biosimilarer Antikörper von Referenz-Trastuzumab (RTZ). Ziel dieser Studie war es, die Ähnlichkeit von ABP 980 mit RTZ zu bestätigen in Bezug auf die klinische Wirksamkeit und Sicherheit in Patientinnen mit HER2-positivem Brustkrebs im Frühstadium, die sich einer neoadjuvanten Chemotherapie mit Trastuzumab unterziehen. Die Studie sollte reale klinische Bedingungen abbilden und schloss somit auch Patientinnen ein, die Pertuzumab erhielten.

Methoden Patientinnen mit HER2-positivem Brustkrebs im Frühstadium, die zwischen 12/2010 und 03/2020 in der Frauenklinik des Universitätsklinikums Tübingen, Deutschland, mindestens 4 Zyklen einer neoadjuvanten Chemotherapie (+/− Pertuzumab) in Kombination mit ABP 980 oder RTZ erhielten, wurden in diese retrospektive Analyse aufgenommen. Für die Wirksamkeitsanalyse wurden Patientinnen mit pathologischer Komplettremission (pCR = kein invasiver Tumor in der Brust und negativer Lymphknotenstatus) verglichen. Zur Beurteilung der Sicherheit von ABP 980 wurde die Anzahl an Patientinnen, die eine Minderung ihrer linksventrikulären Funktion (LVEF) von mehr als 10% aufwiesen, verglichen.

Ergebnisse Insgesamt wurden 124 Patientinnen in die Studie aufgenommen. Davon erhielten 46 (37,1 %) Frauen ABP 980, und 77 (62,9 %) Patientinnen wurden mit RTZ behandelt. Eine pCR stellte sich bei 77 (62,1 %) Patientinnen ein. Es gab keinen signifikanten Unterschied bezüglich der klinischen Wirksamkeit zwischen mit ABP 980 behandelten Patientinnen und den mit RTZ behandelten Patientinnen (die jeweiligen pCR-Raten betrugen 60,9% bzw. 62,8 %, p = 0,829), auch nicht in Bezug auf die kardiologische Sicherheit (eine LVEF-Minderung wurde bei 6,5% bzw. 2,6% der Fälle vermerkt, p = 0,274).

Schlussfolgerung Die Ähnlichkeit von ABP 980 und RTZ in einer realen klinischen Situation, die auch eine große Anzahl an mit Pertuzumab behandelten Patientinnen einschloss, konnte bestätigt werden.

Abstract

Background ABP 980 is a biosimilar antibody to reference trastuzumab (RTZ). Aim of the following study is to confirm the similarity of ABP 980 and RTZ in terms of clinical efficacy and safety in patients with HER2-positive early breast cancer (EBC) undergoing neoadjuvant trastuzumab-containing chemotherapy in a clinical real-world situation that also includes patients receiving pertuzumab.

Methods Patients with HER2-positive EBC, who were treated from 12/2010 to 03/2020 at the Department of Women’s Health at Tuebingen University Hospital, Germany, with at least four cycles of neoadjuvant chemotherapy (+/− pertuzumab) in combination with ABP 980 or RTZ were included in a retrospective analysis. For efficacy analysis patients achieving a pathologic complete remission (pCR = no invasive tumor in breast and lymph nodes) were compared. Safety was evaluated by comparing the number of patients with a decrease in left ventricular function (LVEF) of > 10%.

Results 124 patients were included of whom 46 (37.1 %) have received ABP 980 and 77 (62.9%) were treated with RTZ. A pCR was found in 77 patients (62.1 %). For patients treated with ABP 980 as compared to RTZ, there was no significant difference regarding efficacy (pCR-rates of 60.9% versus 62.8 %, p = 0.829) or cardiac safety (LVEF decline in 6.5% versus 2.6 %, p = 0.274).

Conclusion Similarity of ABP 980 as compared to RTZ was confirmed in a real-world situation, including a large proportion of patients that have also received pertuzumab treatment.

Keywords

trastuzumab - biosimilar - primary systemic therapy - pathological complete response

Schlüsselwörter

Trastuzumab - Biosimilar - primäre systemische Therapie - pathologische Komplettremission

Publication History

Article published online:
23 May 2024

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