Salivary gland cancers are a rare, less than 5% of all head and neck tumors, and life threatening tumors and if diagnosed at an advanced stage they are commonly treated with palliative chemotherapy achieving limited efficacy results. The androgen receptor, however, has recently emerged as a new target for treatment strategies.
Dr. Lisa Licitra of the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, says, “Androgen, estrogen and progesterone play a key role in the growth and development of several cancer types, e.g. breast, endometrium and prostate, and since the discovery of androgen receptors in salivary gland tumors, it is thought androgen deprivation therapy might be beneficial for patients with salivary gland cancer. EORTC 1206 intergroup trial will evaluate the efficacy and safety of androgen deprivation therapy versus chemotherapy in patients with recurrent and/or metastatic, androgen receptor expressing, salivary gland cancer.”
Patients with no previous chemotherapy for recurrent or metastatic disease will be enrolled in Cohort A of EORTC trial 1206 and be randomized to receive either androgen deprivation therapy (triptorelin plus bicalutamide), 38 patients, or chemotherapy (cisplatin and doxorubicin or carboplatin and paclitaxel), 38 patients. As long as Cohort A is open to recruitment, patients previously treated with chemotherapy will be enrolled in Cohort B and receive androgen deprivation therapy.
The primary endpoint is progression-free survival for Cohort A and best overall response for Cohort B, both according to RECIST version 1.1. Patients who are ineligible for the study based on AR expression will be followed up at regular intervals and minimal data will be collected.
EORTC intergroup trial 1206 is coordinated by the EORTC Head and Neck Cancer Group in collaboration with the International Rare Cancer Initiative UK Salivary Gland Cancer Group. It will be conducted in approximately 30 sites in 12 countries: Austria, Belgium, France, Germany, Greece, Hungary, Italy, Portugal, Slovenia, Switzerland, The Netherlands, and the United Kingdom. This phase II trial is supported by a grant from AB InBev covering some EORTC internal costs and from Cancer Research UK for drug supply.
John Bean, PhD
EORTC, Medical Science Writer