Phase III trial with and without lonidamine in non-small cell lung cancer.
One hundred eighty four patients with advanced inoperable non-small cell lung cancer were treated with either lonidamine (A), mitomycin-C/vindesine (B), or mitomycin-C/vindesine plus lonidamine (C) in a prospective randomized trial. The response rates for each treatment arm were 3.4% (A), 22.4% (B) and 25.9% (C), respectively. This difference is statistically significant (P less than 0.01). The median survival time for patients treated with mitomycin-C/vindesine and mitomycin-C/vindesine plus lonidamine was 194 days and 221 days, respectively. In comparison with 145 days for lonidamine alone there is a statistically significant difference in survival between the chemotherapy groups (P less than 0.01). When combined with mitomycin-C/vindesine, lonidamine induces an increase in the response rate and there is a higher proportion of patients living after 12 months of treatment (32% v 20%) in comparison to mitomycin-C/vindesine alone. The subjective tolerance of all treatment groups was very good, toxicity was only mild without major differences between the treatment arms. Combination chemotherapy with mitomycin-C/vindesine plus or minus lonidamine could prolong survival in advanced inoperable nonsmall cell lung cancer significantly without severe toxicity.
Gatzemeier
U
U
Department of Thoracic Oncology Hospital Grosshansdorf, Hamburg, Germany.
Cavalli
F
F
Häussinger
K
K
Kaukel
E
E
Koschel
G
G
Martinelli
G
G
Neuhauss
R
R
von Pawel
J
J
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007191:Indazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin; D008937:Mitomycins / Q000008:administration & dosage* / Q000009:adverse effects; D009367:Neoplasm Staging; D011446:Prospective Studies; D012074:Remission Induction; D015996:Survival Rate; D013997:Time Factors; D014751:Vindesine / Q000008:administration & dosage* / Q000009:adverse effects
D000970:Antineoplastic Agents; D007191:Indazoles; D008937:Mitomycins; D016685:Mitomycin; D014751:Vindesine; C016371:lonidamine