title: A phase II study of days 1 and 8 cisplatin and recombinant alpha-2B interferon in advanced non-small cell lung cancer.
abstract: Preclinical data from studies of human lung cancer xenografts suggest that the cytotoxic effects of cisplatin are enhanced by alpha-interferon. To verify the above observations, the authors initiated a Phase II trial in advanced non-small cell lung cancer (NSCLC). Cisplatin was given at 100 mg/m2 during a 28-day cycle in a divided day 1 and day 8 schedule. Starting on day 1, alpha-2B interferon was administered intramuscularly at a dose of 5 million units three times a week continuously for a minimum of 2 months. Between January 1989 and September 1989, 30 patients were evaluated for response and toxicity. According to the staging system proposed by Mountain, 20 patients had Stage IV disease, 7 had Stage IIIB disease, and 3 had Stage IIIA disease. Expression of neuron-specific enolase (NSE) and Leu-7 was immunohistochemically investigated to evaluate possible relationship to treatment response. The response rate was 13.3% (95% confidence interval [CI]: 1.2% to 25%). The four responders showed positivity for NSE, and two of them were positive for Leu-7. An average of three cycles was given. The mean dose intensity administered was 83% of the projected dose for cisplatin and 92% of the projected dose for alpha-2B interferon. A standard scale was used to assess interferon toxicity. Hematologic, renal, and systemic side effects were not significant. In advanced NSCLC the addition of alpha-2B interferon did not increase the cisplatin-induced response rate. Further studies should be performed to determine the real value of chemotherapy response in tumors showing positive immunoreactivity for neural markers such as NSE and Leu-7.
authors.affiliation: Medical Oncology Unit, Hospital Universitari Germans Trias i Pujol de Badalona, Barcelona, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Rosell
authors.forename: J
authors.initials: J
authors.lastname: Carles
authors.forename: A
authors.initials: A
authors.lastname: Ariza
authors.forename: I
authors.initials: I
authors.lastname: Moreno
authors.forename: N
authors.initials: N
authors.lastname: Ribelles
authors.forename: V
authors.initials: V
authors.lastname: Solano
authors.forename: I
authors.initials: I
authors.lastname: Pellicer
authors.forename: A
authors.initials: A
authors.lastname: Barnadas
authors.forename: A
authors.initials: A
authors.lastname: Abad
mesh_terms: D000328:Adult; D000368:Aged; D000943:Antigens, Differentiation / Q000032:analysis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018959:CD57 Antigens; D002289:Carcinoma, Non-Small-Cell Lung / Q000378:metabolism / Q000401:mortality / Q000473:pathology / Q000556:secondary / Q000628:therapy*; D002945:Cisplatin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques; D007371:Interferon-gamma / Q000009:adverse effects / Q000627:therapeutic use; D008175:Lung Neoplasms / Q000378:metabolism / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010751:Phosphopyruvate Hydratase / Q000378:metabolism; D010865:Pilot Projects; D011994:Recombinant Proteins; D015996:Survival Rate
chemical_list: D000943:Antigens, Differentiation; D018959:CD57 Antigens; D011994:Recombinant Proteins; D007371:Interferon-gamma; D010751:Phosphopyruvate Hydratase; D002945:Cisplatin