LOBAPLATIN (D-19466) IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG-CANCER - A TRIAL OF THE ASSOCIATION-FOR-MEDICAL-ONCOLOGY (AIO) PHASE-II STUDY-GROUP

Background: Lobaplatin, D-19466, 1,2-diaminomethyl cyclobutane platinu m(II)lactate, is a new, water-soluble platinum complex which we expect ed would have a better therapeutic index than either cisplatin or carb oplatin, since various murine and human tumor models had previously in dicated effectiveness. Furthermore, a phase I study demonstrated that Lobaplatin was successful in the treatment of bronchogenic carcinomas. Patients and Methods: A total of 39 patients with inoperable advanced non-small-cell lung cancer (NSCLC), previously untreated by chemother apy or radiotherapy, were included to receive Lobaplatin in a dose of 50 mg/m(2) once every 4 weeks as a single bolus injection. Results: Of the 39 patients included, 33 were evaluable for response according to protocol. There were no complete remissions, and only 1 patient (3%) had a partial response. Most of the patients showed no change (54.5%), with the time to progression ranging between 8 and 28+ weeks. The dat a of 38 patients were used for the toxicity analysis. Nausea and vomit ing were the leading clinical problems in nonhematological toxicity an d appeared in 27 (71%) patients (in 18% of patients with WHO grade III ). Regarding hematological toxicity, the leading problem was thrombocy topenia: with WHO grades III and IV in 6 and 5 patients, respectively. Conclusion: Lobaplatin was well tolerated when applied as a 50 mg/m(2 ) single bolus intravenously in 4-week intervals. However, regarding i ts effectiveness, our phase II study found it to be only marginally ef fective in the dose and schedule used. Therefore, our results provide no support for further use of this treatment plan in patients with NSC LC.