title: Rationale of a phase III study comparing a standard cisplatin regimen (mitomycin/ifosfamide/cisplatin) with cisplatin and gemcitabine in non-small cell lung cancer.
abstract: Cisplatin-based combination chemotherapy is currently considered the most active treatment for advanced non-small cell lung cancer (NSCLC). A recent meta-analysis of eight randomized trials comparing supportive care versus supportive care plus cisplatin-based chemotherapy showed a small (10%) but significant survival benefit at 1 year. However, there is no consensus on a specific reference regimen for NSCLC. Our previous experience comparing cisplatin/etoposide (PE) with mitomycin/ifosfamide/cisplatin (MIC) demonstrated a significantly better response rate (40% v 23%) and survival advantage of the three-drug MIC combination versus PE. Among the new drugs, the nucleoside analogue gemcitabine produced response rates of approximately 20% in advanced NSCLC. In phase I/II studies, response rates as high as 54% and median survival of up to 13 months were seen when gemcitabine was combined with cisplatin. Therefore, a phase III study was planned to evaluate the gemcitabine/cisplatin combination versus the MIC regimen. This multicenter trial is currently ongoing in Italy.
authors.affiliation: Medical Oncology Division, Policlinico Hospital, Perugia, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Tonato
authors.forename: L
authors.initials: L
authors.lastname: Crinó
authors.forename: A M
authors.initials: AM
authors.lastname: Mosconi
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy*; D016685:Mitomycin / Q000008:administration & dosage; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors*; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D016685:Mitomycin; D012264:Ribonucleotide Reductases; D002945:Cisplatin; D007069:Ifosfamide; D000093542:Gemcitabine