Radiotherapy combined with low-dose cis-diammine dichloroplatinum (II) (CDDP) in inoperable nonmetastatic non-small...

A randomized Phase II study was carried out to assess the feasibility and tumor response of radiotherapy combined with low dose cis-diammine dichloroplatinum (II), (cDDP), in patients with inoperable non-small cell lung cancer (NSCLC). One hundred patients were treated with either radiotherapy alone (arm I), with radiotherapy plus cDDP given once a week (arm II), or daily (arm III). The endpoints were acute and late toxicity and tumor response. Esophagitis was observed more frequently in the cDDP arms, but was severe in only 4% of the patients. Nausea and vomiting were more frequent and more severe in patients treated with the combination therapy. In 37% they required medication or were intractable (WHO, grade 3-4). There were no deficits in renal function when hydration schemes were used. Lung fibrosis was similar in the three arms, with an average of 75% of which 50% was severe. Response (complete and partial remission) was observed in 21 out of 34 eligible patients in arm I, in 20 out of 30 patients in arm II, and 20 out of 30 patients in arm III. The 1- and 2-year survival data were 38% and 14% for radiotherapy alone, 49% and 17% for radiotherapy and cDDP given once a week, and 50% and 32% for radiotherapy combined with daily cDDP.

a combination of concomitant cDDP and radiotherapy is tolerable. Based on these results, the study has been continued as a Phase III study with survival as most important end point.