The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with
metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently
used schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in
a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the
standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while
in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly
Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye)
caused by dacryostenosis.
The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the
lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal
tears. Direct contact between Docetaxel containing tears and the epithelial lining causes
chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the
lacrimal outflow system i.e. the lacrimal puncta and canaliculi.
A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the
lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent
further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube
of Jones is required.
To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis.
The rationale of this randomized double blind interventional study is to investigate the
efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a
weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in
the lacrimal tears will be washed away by the repetitive use of eye drops. In addition, eye
drops containing corticosteroids have an anti-inflammatory effect and may further prevent the
formation of fibrosis.
A new treatment protocol will be investigated. Two different commercially available eye drops
will be compared: dexamethasone sodium phosphate (Maxidex®, Alcon) in one eye of the patient
and artificial tears (Lacrystat®, Viatris) in the other eye of the same patient. The study
period will start with topical eye treatment from day 1 of cycle 1 and will continue during
the administration of chemotherapy, with a final analysis at 26 weeks.