PHASE-II TRIAL OF THE ORAL PLATINUM COMPLEX JM216 IN NON-SMALL-CELL LUNG-CANCER - AN EORTC EARLY CLINICAL-STUDIES GROUP INVESTIGATION

Background: JM216 is a new oral platinum complex with dose-limiting to xicity myelosuppression, now undergoing phase II evaluation, Patients and methods: JM216 was evaluated as first line therapy in non-small-ce ll lung cancer, Seventeen patients received 120 mg/m(2)/day for five d ays repeated every three weeks. Results: Toxicity was manageable, the commonest side-effects being nausea, vomiting, diarrhoea, constipation and asthenia, Myelososuppression was generally grade < 2 and there we re no cases of neutropenic sepsis or bleeding. Thirteen patients were fully evaluable for response, No sustained objectivity responses were reported. One patient was reported as stable disease had a partial res ponse after three courses but was progressing again after four, An add itional five patients had stable disease (46.2%). Conclusions. Althoug h some patients map have had useful palliation, JM216 did not appear t o have significant antitumour activity in non-small-cell lung cancer.