Combination of gemcitabine and cisplatin in advanced non-small cell lung cancer.

A prospectively designed phase II study of non-small cell lung cancer stage IIIb and IV treated by gemcitabine and cisplatin was studied. The dosage of gemcitabine was 1 g/m2 weekly on day 1, 8 and 15. Cisplatin 100 mg/m2 was given on day 15 of each 28 day cycle. Twenty-eight patients were treated and all cases were evaluated for response. Survival and toxicity were determined in all enrolled patients. Thirteen (46.4%) achieved partial response (PR). By using Kaplan Meier's method the mean survival time was 19.8 months. One year survival was 66.6 per cent. Non hematologic toxicity consisted of mild nausea, vomiting, alopecia and hyperpigmentation of the skin. Rising creatinine of grade I was seen in 1.6 per cent. Anemia and leukopenia were common hematologic side effects with 27.5 per cent and 14.2 per cent of patients experiencing grade III and IV toxicity respectively. Both side effects were usually short lived and responsible for the delay of gemcitabine administration on day 8 and 15 in 18.3 per cent and 23.3 per cent on day 15 alone of chemotherapeutic courses respectively. We conclude that the combination of gemcitabine and cisplatin at this dosage achieved good response with moderate side effects.

Efficacy of UFT plus oral leucovorin in advanced colorectal cancer: a multicenter study.

PURPOSE: To evaluate the efficacy and toxicity of UFT plus oral leucovorin in advanced colorectal cancer. MATERIAL AND METHOD: Twenty cases of advanced colorectal cancer were entered into the study. All patients must have histologic proof and have measurable disease. Prior to the treatment all patients should have normal baseline hematology and normal liver and renal function, ECOG Performance status < or = 2 and age 18-75 years. Chemotherapeutic drugs consisted of UFT 350 mg/m2/day divided into 3 doses (8 hours apart) plus oral leucovorin 15 mg every 8 hours. Duration of treatment was 21 days per each cycle. Treatment was recycled every 28 days. RESULTS: Four cases (22.2%) had partial responses and six cases (33.3%) had stable disease. Duration of response was 4(+)-7+ months. Toxicity was darkened skin, mild diarrhea and mild alopecia. CONCLUSION: UFT plus oral leucovorin was one of the active regimens in the treatment of advanced colorectal cancer.

Phase II study of ifosfamide, carboplatin, etoposide and GM-CSF in small cell lung cancer.

Twenty patients with small cell lung cancer (SCLC) were entered to the study. Fourteen cases were male and six cases were female. Twelve cases were extensive disease, eight cases were limited disease. Median age was 60 years (range = 40-72 years), median performance status was 70 per cent (range = 60-80%). All patients were treated with combination chemotherapy consisting of ifosfamide 5 g/m2 intravenous infusion over 4 hours with mesna uroprotection, carboplatin 300 mg/m2 intravenous infusion over 2 hours on day 1, and etoposide 120 mg/m2 intravenous infusion over 4 hours on day 1-3. Chemotherapy was re-cycled every 28 days. Assessment of hematologic toxicity (CBC) was performed two times per week. If there was grade 3 or 4 neutropenia on any cycle of chemotherapy, GM-CSF was administered for febrile neutropenia and on the next cycle it was administered prophylactically on day 4-14. RESULTS: Seventeen cases were evaluable for response and toxicity (three cases were inevaluable due to loss to follow-up after the first cycle of chemotherapy). Fourteen cases (five limited disease, nine extensive disease) achieved partial response (82.5%). Two cases had stable disease, one case died on day 7. One year survival was 23.5 per cent. Seventy and a half percent grade 3 and 4 neutropenia was seen during the first cycle. One patient had febrile neutropenia. After being prophylactically treated with GM-CSF, grade 3 and 4 neutropenia was reduced from 70.5 per cent to 56.2 per cent, 46.7 per cent, 63.6 per cent, 42.8 per cent and 0 per cent in cycle 2-6 respectively. Major toxicity of GM-CSF consisted of transient chest distress, chills, sweating and hypotension which subsided in 5-10 minutes. No fever or skin rash was observed. CONCLUSION: Combination of ifosfamide, carboplatin and etoposide (ICE) is an active regimen for small cell lung cancer. However, because of its severe myelosuppression, this regimen needs hematopoietic growth factor support, and GM-CSF was used in this study. The administration of GM-CSF rendered ICE chemotherapy to be given safely.

Preliminary study of efficacy of intravenous cisplatin plus oral etoposide in small cell lung cancer.

Twenty-three patients with small cell lung cancer were treated with combination chemotherapy consisting of Cisplatin at 100 mg/m2 given by 2 hours intravenous infusion on day 1 and oral etoposide 25 mg/caplet given twice a day for 21 days repeated every 28 days for 6 cycles. Of 23 cases, four cases were not evaluable due to early death (three of them died from febrile neutropenia). Median age of the patients was 59 years (range = 45-76 years). Five cases were female and eighteen cases were male. Median Karnofsky performance status was 70 per cent (range = 50-90%). Five cases were extensive disease and eighteen cases were limited disease. Of 5 extensive disease cases, 1 complete response (20%) and 3 partial responses (60%) were achieved. Of 14 limited disease patients, 1 complete response (7.1%) and 11 partial responses (78.6%) were achieved. Hematologic toxicities were severe causing three patients to die because of febrile neutropenia, nine cases (10.7%) had grade 3 and 4 neutropenia. Grade 3 and 4 anemia and thrombocytopenia were seen in 28.6 per cent and 8.3 per cent respectively. Median survival time of all cases was 7 months. Thus, the combination of intravenous cisplatin and prolonged administration of oral etoposide could be administered to small cell lung cancer patients with high response rate, however, because of its severe toxicities, special caution should be considered and the optimal duration of oral etoposide should be evaluated.