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Etoposide versus etoposide plus high‐dose cisplatin in the management of advanced non‐small cell lung cancer: Results of a prospective randomized fonicap trial
Author(s) -
Rosso Riccardo,
Salvati Franco,
Ardizzoni Andrea,
Curcio Corrado Gallo,
Rubagotti Alessandra,
Belli Mario,
Castagneto Bruno,
Fusco Vittorio,
Sassi Maurizio,
Ferrara Giuseppe,
Pizza Antonietta,
Pedicini Tonino,
Soresi Enzo,
Scoditti Sergio,
Cioffi Riccardo,
Folco Ugo,
Monaco Michele,
Merlano Marco,
Rimoldi Roberto,
Tonachella Riccardo,
Cruciani Annarita,
Colantuoni Giuseppe,
Rinaldi Massimo,
Portalone Luigi,
Bruzzi Paolo,
Santi Leonardo
Publication year - 1990
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19900701)66:1<130::aid-cncr2820660123>3.0.co;2-p
Subject(s) - etoposide , medicine , leukopenia , cisplatin , gastroenterology , lung cancer , nausea , chemotherapy , urology , surgery
Two hundred sixteen patients with unresectable non‐small cell lung carcinoma were randomly allocated to receive etoposide (120 mg/m 2 , days 1–3) either alone or in combination with high‐dose cisplatin (60 mg/m 2 , days 1–2). The patients' distribution and characteristics were similar in the two treatment arms. The objective response rate for etoposide was 7% versus 25.8% for etoposide plus cisplatin ( P < 0.005). Median progression‐free survival in etoposide arm was 3.5 months versus 5 months in the combination arm ( P = 0.43). The median survival time for etoposide was 6 months compared with 8 months for etoposide combined with cisplatin ( P = 0.87). Significantly more nausea/vomiting ( P < 0.005), serum creatinine elevation ( P < 0.005), hearing loss and/or tinnitus ( P < 0.005), peripheral neuropathy ( P < 0.005), leukopenia ( P < 0.025), and anemia ( P < 0.005) occurred in the etoposide plus cisplatin arm. No statistically significant difference was recorded between the two arms in terms of performance status changes. in conclusion the addition of high‐dose cisplatin to single‐agent etoposide significantly increases the chance of obtaining tumor response in advanced non‐small cell lung cancer at the cost of an increased toxicity without any significant long‐term impact on survival and progression‐free survival.