DOSE-INTENSE THERAPY WITH ETOPOSIDE, IFOSFAMIDE, CISPLATIN, AND EPIRUBICIN (VIP-E) IN 100 CONSECUTIVE PATIENTS WITH, LIMITED-DISEASE AND EXTENSIVE-DISEASE SMALL-CELL LUNG-CANCER

Background. We conducted a phase I/II trial to assess the feasibility and activity of VIP-E chemotherapy in small-cell lung cancer. End-poin ts were treatment-related morbidity and mortality, response to treatme nt, duration of response, and survival. Patients and methods. Two cycl es of combination chemotherapy followed by granulocyte colony-stimulat ing factor (G-CSF) were given at a dose of etoposide (500 mg/m(2)), if osfamide (4000 mg/m(2)), cisplatin (50 mg/m(2)), and epirubicin (50 mg /m(2)) to 100 consecutive patients with SCLC. Thirty patients (19 with LD, and 11 with ED SCLC) proceeded to VIC-E high-dose chemotherapy wi th autologous peripheral blood stem cell transplantation (PBSCT) at a cumulative dose of etoposide 1500 mg/ m(2), ifosfamide 12,000 mg/m(2), carboplatin 750 mg/m(2) and epirubicin 150 mg/m(2) (VIC-E). Surgical resection of primary tumor was attempted at the earliest feasible poin t. Thoracic irradiation was given after completion of chemotherapy. Re sults of conventional-dose VIP-E: 97 patients were evaluable for respo nse. Objective response rate was 81% in LD-SCLC (33% CR, 48% PR; exclu ding patients in surgical CR) and 77% in ED-SCLC (18% CR, 58% PR). Tre atment mortality was 2%. Median survival was 19 months in LD-SCLC and 6 months in ED-SCLC. Two-year survival was 36% in LD and 0% in ED SCLC . Results of high-dose VIC-E: All 30 patients improved on or maintaine d prior responses. Four patients (13%) died of treatment-related compl ications. Median survival was 26 months in LD-SCLC and 8 months in ED- SCLC. Two-year survival was 53% in LD and 9% in ED SCLC. Conclusion: V IP-E chemotherapy is an effective induction therapy for SCLC. Compared with traditional protocols such as ACO or carboplatin/etoposide, resp onse rates are slightly improved, while survival is not different In t he LD SCLC subgroup, high-dose chemotherapy improved response rates an d survival, especially for patients in surgical CR prior to high-dose therapy. In ED SCLC, however, higher response-rates did not translate into improved survival. Selected LD-SCLC patients with good partial or complete remissions after prior therapy may benefit from HDC and PBSC T.