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Combination of chemotherapy and recombinant alpha-interferon in advanced non-small cell lung cancer: Multicentric randomized FONICAP trial report

1993; Wiley; Volume: 72; Issue: 10 Linguagem: Inglês

10.1002/1097-0142(19931115)72

1097-0142

Andrea Ardizzoni, Franco Salvati, Riccardo Rosso, Paolo Bruzzi, A. Rubagotti, M.C. Pennucci, G Mariani, Filippo de Marinis, Giovanni Pallotta, A Antilli, Anna Maria Cruciani, Massimo Rinaldi, Riccardo Tonachella, Marina Fioretti, Santi Barbera, E Mantellini, E. Soresi, G Pastorino, M Belli, Giuseppe Ferrara, Marco Venturini, Giorgio V. Scagliotti, Leonardo Santi,

Lung Cancer Research Studies

Background. Preclinical data suggested that alphainterferon (IFN) may potentiate chemotherapy cytotoxicity. Methods. A prospective multicentric randomized trial was initiated to assess the clinical benefit of adding recombinant alpha-2-IFN to combination chemotherapy in patients with metastatic non-small cell lung cancer. A total of 182 patients were randomized to receive either cisplatin-epidoxorubicin-cyclophosphamide (CEP) combination chemotherapy (cisplatin, 60 mg/m2; epidoxorubicin, 50 mg/m2; and cyclophosphamide, 400 mg/m2 intravenously) alone on day 1 or the same chemotherapy plus recombinant alpha-2-IFN at the dose of 5 MU intramuscularly from day – 2 to +4, then 3 times weekly. Results. The median survival was 6 months in the CEP plus IFN arm versus 5.5 months in the control arm. The log-rank test showed a marginal statistically significant difference (P = 0.045) in favor of CEP chemotherapy, which disappeared when survival curves were adjusted for prognostic factors. Progression-free survival was similar in the two treatment arms. Considering all eligible patients, the response rate was 7.6% in the CEP arm versus 18.9% in the CEP plus IFN arm (P = 0.042). Nearly 40% of the patients receiving IFN had grade 3–4 nadir leukopenia versus 15% in the control arm (P = 0.01) and 12.5% versus 4.2% had grade 3–4 thrombocytopenia. Apart from the usual constitutional symptoms, IFN was also responsible for increased emesis and mucositis. Conclusions. This study indicates that the addition of recombinant alpha-IFN to CEP chemotherapy can increase response rate and toxicity to treatment without a positive effect on progression-free survival and survival.