Randomized Phase II Trial of High-Dose 4’-Epi-Doxorubicin + Cyclophosphamide versus High-Dose 4’-Epi-Doxorubicin + Cisplatin in Previously Untreated Patients with Extensive Small Cell Lung Cancer

Abstract

One hundred and eleven previously untreated patients with extensive small cell lung cancer were included in a prospective randomized study with the aim to assess the efficacy and tolerance of high-dose epirubicin (120 mg/m²) in combination with either cyclophosphamide (800 mg/m²;arm 1) or cisplatin (60 mg/m²; arm 2). Ninety-six patients were evaluable for response and toxicity and additional 12 patients for toxicity only. The overall response rate (CR + PR) in arm 1 and 2 were 61.4 (27/44) and 67.3% (35/52), respectively. The mean duration of remission was 4.4 months (arm 1) and 4.9 months (arm 2). The mean survival time was 6.6 months in arm 1 and 7.7 months in arm 2. WHO grade 4 toxicity was encountered in 25.5 and 15.8% of patients in arm 1 and 2, respectively. One case of cardiotoxicity resulting in the patient’s death was observed in arm 1. Both combinations showed considerable antitumor activity. Toxicity was acceptable.

Is there a case for cisplatin in the treatment of small-cell lung cancer? A meta-analysis of randomized trials of a cisplatin-containing regimen versus a regimen without this alkylating agent

“…A total of 19 trials fulfilled the criteria of selection (Table 1; Eagan et al, 1981;Fukuoka et al, 1986Fukuoka et al, , 1991Evans et al, 1987;Haveman et al, 1987;Wolf et al, 1987;Chahinian et al, 1989;Sculier et al, 1990aSculier et al, , 1993Goodman et al, 1990;Smith et al, 1990;Wampler et al, 1991;Kanitz et al, 1992;Roth et al, 1992;Farris et al, 1993;Sculier et al, 1993;Joss et al, 1994;Veronesi et al, 1994;Souhami et al, 1997;Urban et al, 1999). One trial was rejected due to the fact that patients had received chemotherapy prior to randomization as it was a second-line chemotherapy study (O'Bryan et al, 1990).…”

“…vepeside administered similarly in both arms or not given in either arm). These trials included 1579 evaluable patients (Eagan et al, 1981;Wolf et al, 1987;Goodman et al, 1990;Sculier et al, 1990a Sculier et al, 1993 Smith et al, 1990, Kanitz et al, 1992Joss et al, 1994;Souhami et al, 1997). …”

“…Supported by a grant from the French League Against Cancer (Hérault committee). Overall Eagan, 1981Fukuoka, 1986 Haveman, 1987Evans, 1987Chahinian, 1989 Sculier, 1990Goodman, 1990Fukuoka, 1991 Smith, 1990Wampler, 1991Kanitz, 1992Roth, 1992 Sculier, 1993Farris, 1993Veronesi, 1994Joss, 1994Souhami, 1997 Urban, 1999 Meta-analysis of cisplatin in SCLC 13 …”