P. Libert

A randomized study comparing cisplatin or carboplatin with etoposide in patients with advanced non-small-cell lung cancer: European Organization for Research and Treatment of Cancer Protocol 07861.

The European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer Working Party conducted a randomized trial comparing cisplatin (CDDP; 120 mg/m2, day 1) and carboplatin (CBDCA; 325 mg/m2, day 1) in combination with etoposide (VP16; 100 mg/m2, days 1, 2, and 3) in advanced non-small-cell lung cancer (NSCLC). Two hundred twenty-eight patients were eligible for survival and 202 assessable for response. We obtained 27 of 100 objective responses (ORs; 27%) in the CDDP arm and 16 of 102 (16%) in the CBDCA arm (P = .07). There was no significant difference in survival. Toxicity, consisting mainly of myelosuppression and renal function impairment, was significantly increased in the patients receiving the CDDP treatment. We conclude that CDDP plus VP16 was more active but also more toxic than CBDCA plus VP16 in advanced NSCLC.

Prognostic factors for patients with small cell lung carcinoma

The purposes of this study were to identify prognostic factors for response to chemotherapy, overall survival, and long term survival of patients with small cell lung carcinoma and to construct a classification of patients on the basis of their expected overall survival.

A randomized study comparing a high and a standard dose of cisplatin in combination with etoposide in the treatment of advanced non-small-cell lung carcinoma.

We conducted a randomized trial comparing a high (120 mg/m2 day 1) v a standard (60 mg/m2 day 1) dose of cisplatin in combination with etoposide (120 mg/m2 days 3, 5, and 7) in advanced non-small-cell lung carcinoma (NSCLC). Two hundred forty-one patients were evaluable for survival and 207 for response. We obtained a 25% objective response rate in the standard-dose arm and 29% in the high-dose arm; this difference was not statistically significant. There was no significant improvement in the overall survival or survival of responders with the high-dose regimen. However, toxicity (mainly myelosuppression) was significantly increased in the patients receiving the higher dose of cisplatin. An analysis of prognostic factors showed that disease progression, loss of body weight, performance status, and prior therapy were predictive parameters of survival.

Cisplatin versus cisplatin plus etoposide in the treatment of advanced non-small-cell lung cancer. Lung Cancer Working Party, Belgium.

We conducted a randomized study comparing the survival after treatment with cisplatin (120 mg/m2) or cisplatin plus etoposide (100 mg/m2 on days 1, 2, and 3) in 162 evaluable patients with advanced non-small-cell lung cancer (NSCLC). No statistically significant difference in survival was detected; the median survival was 26 and 22 weeks, respectively, for patients receiving cisplatin and for those receiving cisplatin plus etoposide. The objective response rate was 19% for cisplatin and 26% for the combination; the corresponding response rates were 17% and 43% in patients with limited disease. No significant differences were detected between the two study arms as far as toxicity was concerned, except for alopecia and granulocytopenia, which occurred more frequently in patients treated with cisplatin plus etoposide.

A phase II study evaluating CAVi (cyclophosphamide, adriamycin, vincristine) potentiated or not by amphotericin B entrapped into sonicated liposomes, as salvage therapy for small cell lung cancer

Abstract Two consecutive trials were conducted, testing the CAVi (cyclophosphamide 1 g/m 2 ; doxorubicin (adriamycin) 45 mg/m 2 ; vincristine 1.4 mg/m 2 ; all i.v. on day 1; every 3 weeks) combination as salvage therapy for small cell lung cancer (SCLC) after first line treatment with etoposide plus vindesine with or without cisplatin. In the first study, CAVi was used alone. In 45 evaluable patients, 6 objective responses were observed (13%; Confidence Limits (C.L.): 5.1–20.8). In the second study, CAVi was potentiated with 2 mg/kg of ampholiposomes given i.v., 24 h prior to chemotherapy. Ampholiposomes consisted of amphotericin B entrapped into sonicated liposomes made of egg lecithin, cholesterol and stearylamine in the molar ratio 4:3:1 (lipid concentration: 20 mg/ml). Among 11 evaluable patients, 6 objective responses were observed (55%; Confidence Limits: 23.4–83.3) and toxicity was not increased. These preliminary results suggest that ampholiposomes might overcome resistance to chemotherapy in SCLC and should encourage controlled studies.

Combination Chemotherapy with Ifosfamide and Nimustine (IMA) as Salvage Treatment for Small Cell Lung Cancer

SummaryA combination of two new drugs — ifosfamide and nimustine (ACNU), a water-soluble nitrosourea compound — was studied as salvage therapy for small cell lung cancer (SCLC). A phase I trial determined that nimustine 75 mg/m2 and ifosfamide 4 g/m2 given intravenously on day 1 was associated with moderate leucopenia as the main toxicity. A phase II trial was then conducted in 25 patients. As a second-line treatment, after initial therapy with a multiple drug regimen, 2 of 19 (10.5%) patients had an objective response; no responses were observed in 6 patients who received IMA as third-line treatment. The responses were observed in patients who had good response to first-line chemotherapy with a long (> 5 months) treatment-free interval.IMA was shown to have limited activity as salvage therapy for SCLC. Further investigations are necessary to determine the exact role of IMA as first-line treatment for SCLC.