|Treatments:||Biologic therapy||Hospital:||Okayama University Hospital|
Patients: This Phase I study involved 15 patients (14 men, 1 woman, median age 58 years) with advanced non-small-cell lung cancer. The patients also carried genetic mutations for the tumor suppressor gene p53. All but one of the patients failed to respond to prior platinum-based chemotherapy.
Treatment: Treatment consisted of injections of the biological therapeutic agent Ad5CMV-p53 (Advexin). Six of the patients also received cisplatin as part of their treatment regimen.
Toxicity: No grade 4-5 toxicities were observed. Grade 3 toxicities included fever, dyspnea, and pneumonia. Among patients who also received cisplatin, grade 3 toxicities included anemia and weight loss.
Results: Although the median overall survival was not reported, the authors claimed that 40% of patients survived after 12 months. The authors concluded, "Multiple courses of intratumoral Ad5CMV-p53 injection alone or in combination with intravenous administration of cisplatin were feasible and well tolerated in advanced NSCLC patients, and appeared to provide clinical benefit."
Support: Introgen Therapeutics supported this study, and one of the authors is employed by Introgen. Introgen manufactures and/or markets Advexin.
Correspondence: Toshiyoshi Fujiwara, MD