Gemcitabine and Cisplatin Versus Mitomycin, Ifosfamide, and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Randomized Phase III Study of the Italian Lung Cancer Project

• Published in: Journal of clinical oncology Vol. 17; no. 11; pp. 3522 - 3530
• Main Authors: CRINO, L, SCAGLIOTTI, G. V, SASSI, M, BARNI, S, RAVAIOLI, A, ADAMO, V, PORTALONE, L, CRUCIANI, G, MASOTTI, A, FERRARA, G, GOZZELINO, F, TONATO, M, RICCI, S, DE MARINIS, F, RINALDI, M, GRIDELLI, C, CERIBELLI, A, BIANCO, R, MARANGOLO, M, DI COSTANZO, F
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 01-11-1999; Lippincott Williams & Wilkins
• Subjects: Adult; Aged; Antimetabolites, Antineoplastic - administration & dosage; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Dose-Response Relationship, Drug; Female; Humans; Ifosfamide - administration & dosage; Ifosfamide - adverse effects; Italy; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Mitomycin - administration & dosage; Mitomycin - adverse effects; Pharmacology. Drug treatments; Quality of Life; Sample Size; Survival Rate; Italy; Antineoplastic agent; Phase III trial; Gemcitabine; Bronchopulmonary; Randomization; Bronchus disease; Advanced stage; Pyrimidine nucleoside; Non small cell carcinoma; Platinum II Complexes; Human; Lung disease; Drug combination; Mitomycin; Respiratory disease; Ifosfamide; Malignant tumor; Cisplatin; Chemotherapy; Oxazaphosphinane derivatives; Treatment; Nitrogen mustard; Fluorine Organic compounds; Therapeutic protocol; Comparative study
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.1999.17.11.3522

To compare gemcitabine and cisplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) chemotherapy in patients with stage IIIB (limited to T4 for pleural effusion and N3 for supraclavicular lymph nodes) or stage IV non-small-cell lung cancer (NSCLC). The end points were the evaluation of quality of life (QoL), response rates, survival, and toxicity.
Three hundred seven patients were randomized to receive either gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 plus cisplatin 100 mg/m(2) on day 2, every 28 days, or mitomycin 6 mg/m(2), ifosfamide 3,000 mg/m(2), and mesna on day 1 plus cisplatin 100 mg/m(2) on day 2, every 28 days. The whole-blood cell count was repeated on day 1 in both arms and weekly in the GC arm before each gemcitabine administration.
No major differences in changes in QoL were observed between the two treatment arms. The objective response rate was 38% in the GC arm compared with 26% in the MIC arm (P =.029). The median survival time was 8.6 months in the GC arm and 9.6 months in the MIC arm (P =.877, log-rank test). Grade 3 and 4 thrombocytopenia was significantly worse in the GC arm (64% v 28%, P <.001), whereas grade 3 and 4 alopecia was reported more commonly in the MIC arm (39% v 12%, P <. 001).
We report an increased response rate without changes in QoL and a similar overall survival, time to progression, and time to treatment failure for the GC when compared with the MIC regimen in the treatment of advanced NSCLC.