A randomized phase II trial evaluating the addition of low dose, short course sunitinib to docetaxel in advanced solid tumours.

ABSTRACT:

Background

We previously reported that low-dose, short-course sunitinib prior to neoadjuvant doxorubicin-cyclophosphamide (AC) normalised tumour vasculature and improved perfusion, but resulted in neutropenia and delayed subsequent cycles in breast cancer patients. This study combined sunitinib with docetaxel, which has an earlier neutrophil nadir than AC.

Methods

Patients with advanced solid cancers were randomized 1:1 to 3-weekly docetaxel 75 mg/m², with or without sunitinib 12.5 mg daily for 7 days prior to docetaxel, stratified by primary tumour site. Primary endpoints were objective-response (ORR:CR + PR) and clinical-benefit rate (CBR:CR + PR + SD); secondary endpoints were toxicity and progression-free-survival (PFS).

Results

We enrolled 68 patients

SUBMITTER: Ang YLE 

PROVIDER: S-EPMC7672922 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature