| Related Articles |
Br J Cancer. 2020 Apr 02;:
Authors: Mukai H, Yamaguchi T, Takahashi M, Hozumi Y, Fujisawa T, Ohsumi S, Akabane H, Nishimura R, Takashima T, Park Y, Sagara Y, Toyama T, Imoto S, Mizuno T, Yamashita S, Fujii S, Uemura Y
Abstract
BACKGROUND: The effectiveness of a therapeutic strategy that switches chemotherapy, based on Ki-67 tumour expression after initial therapy, relative to that of standard chemotherapy, has not been evaluated.
METHODS: Patients were randomly assigned to the control arm or the Ki-67 response-guided arm (Ki-67 arm). Primary tumour biopsies were obtained before treatment, and after three once-weekly doses of paclitaxel and trastuzumab to assess the interim Ki-67 index. In the control arm, paclitaxel and trastuzumab were continued for a total of 12 doses, regardless of the interim Ki-67 index. In the Ki-67 arm, subsequent treatment was based on the interim Ki-67 index. Ki-67 early responder is defined as the absolute Ki-67 value that was <10%, and the percentage of Ki-67-positive tumour cells was reduced by >30% compared with before treatment. Early Ki-67 responders continued to receive the same treatment, while early Ki-67 non-responders were switched to epirubicin plus cyclophosphamide. The primary endpoint was the pathological complete response (pCR) rate.
RESULTS: A total of 237 patients were randomised. There was almost linear correlation between the Ki-67 reduction rate at interim assessment and the pCR rate. The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025).
CONCLUSIONS: The standard chemotherapy protocol remains as the recommended strategy for patients with HER2-positive breast cancer.
CLINICAL TRIAL REGISTRATION: Clinical Trial Registration: UMIN-CTR as UMIN000007074.
PMID: 32238920 [PubMed - as supplied by publisher]
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου