title: VP-16-213 in the treatment of stage III and IV diffuse lymphocytic lymphoma of the large cell (histiocytic) variety: an interim report.
abstract: A pilot study has previously demonstrated antitumor activity for the epipodophyllotoxin VP-16-213 in patients with diffuse lymphocytic lymphoma of the large cell (histiocytic) variety. To define this observation further, a prospective randomized trial was undertaken in patients with stage III and IV disease, comparing this agent used alone (group 1, 41 patients) to the response obtained when the same schedule of VP-16-213 was combined with either cyclophosphamide (group 2, 36 patients) or doxorubicin (group 3, 41 patients). The quantity of VP-16-213 given to patients in the three groups was equivalent. Of these 118 patients, three were lost to followup and thus were excluded from further study. Specifically included were 12 patients who died within 1 month of diagnosis while still receiving induction chemotherapy. For the three groups, complete remission rates were 39%, 26%, and 54%, and additional partial remissions were obtained in 20%, 11%, and 10% of the patients, respectively. The lower remission rates obtained in patients receiving cyclophosphamide combined with VP-16-213 are statistically significant (P less than 0.05), but no explanation for this is evident since the distribution of poor prognostic factors among the three groups was uniform. The higher percent of complete remission and the greater number of patients remaining free from disease in group 3 demonstrate the superiority of the combination of VP-16-213 with the anthracycline antibiotic doxorubicin.
mesh_terms: D000505:Alopecia / Q000139:chemically induced; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008214:Lymphocytes; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011034:Podophyllotoxin / Q000031:analogs & derivatives*; D011336:Probability; D011897:Random Allocation
chemical_list: D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D011034:Podophyllotoxin