Phase I study of etoposide, cisplatin and irinotecan triplet in patients with advanced-stage small-cell lung cancer

Autor: Briassoulis, E. Ch, Samantas, E., Kalofonos, H. P., Skarlos, Dimosthenis V., Makatsoris, T., Christodoulou, C., Fountzilas, George, Bamias, A. T., Dimopoulos, M. A., Kosmidis, Paraskevas A., Pavlidis, Nicholas
Přispěvatelé: Pavlidis, Nicholas [0000-0002-2195-9961], Kalofonos, H. P. [0000-0002-3286-778X]
Rok vydání: 2005
Předmět:
Drug dose regimen
Male
Lung Neoplasms
Toxicology
Gastroenterology
Antineoplastic Combined Chemotherapy Protocols
Pharmacology (medical)
Treatment outcome
Etoposide
Survival time
Brain Neoplasms
Liver Neoplasms
Cisplatin/administration & dosage/adverse effects
Multicenter study
Clinical trial
Phase i
Oncology
Granulocyte colony stimulating factor
Cancer chemotherapy
Cohort analysis
Human
Diarrhea
medicine.medical_specialty
Bone marrow suppression
Clinical article
Febrile neutropenia
Liver Neoplasms/drug therapy/secondary
Bone Neoplasms
Maximum tolerated dose
Carcinoma
Small Cell/*drug therapy/pathology
Irinotecan
Article
Small-cell lung cancer
Lung Neoplasms/*drug therapy/pathology
Humans
Lung small cell cancer
neoplasms
Aged
Pharmacology
Cisplatin
Drug infusion
Confidence interval
Artery disease
Phase 1 clinical trial
Survival analysis
medicine.disease
Survival Analysis
Regimen
Brain neoplasms
Asthenia
Etoposide/administration & dosage/adverse effects
Atropine
Cancer Research
Camptothecin/administration & dosage/adverse effects/analogs & derivatives
Randomization
Lung neoplasms
Liver neoplasms
Furosemide
Ischemia
Nausea and vomiting
Brain Neoplasms/drug therapy/secondary
Small cell
Carcinoma
Small Cell
Middle aged
Fatigue
Priority journal
biology
Bone neoplasms
Middle Aged
Toxicity
Female
Abdominal cramp
medicine.drug
Adult
Neutropenia
Maximum Tolerated Dose
Chemotherapy induced emesis
Granisetron
Advanced cancer
Antineoplastic combined chemotherapy protocols
Internal medicine
Neurotoxicity
medicine
Lung cancer
business.industry
Topoisomerase
Carcinoma
Bone Neoplasms/drug therapy/secondary
Alopecia
Thrombosis
Thrombocytopenia
Cancer survival
Surgery
Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
biology.protein
Camptothecin
business
Zdroj: Cancer chemotherapy and pharmacology
ISSN: 1432-0843
0344-5704
DOI: 10.1007/s00280-004-0994-8
Popis: AIM: The irinotecan-cisplatin combination has emerged as a new standard for the treatment of advanced-stage small-cell lung cancer (AS-SCLC). To move forward we developed a 3-day regimen of cisplatin, etoposide and irinotecan. METHODS: Successive cohorts of AS-SCLC patients were treated with irinotecan administered as a single 1-h infusion in combination with fixed doses of cisplatin (20 mg/m(2)) and etoposide (75 mg/m(2)), both given for three consecutive days (ECI regimen). Irinotecan dose was escalated from 60 mg/m(2) by 40-mg/m(2) increments. At mid-step between the maximum tolerated dose (MTD) and the previous dose level, patients were randomized for the day of administration of irinotecan (day 1 vs day 3). RESULTS: A total of 36 AS-SCLC patients received 166 courses of treatment at four dose levels. The MTD of irinotecan was 140 mg/m(2) (three dose-limiting toxicities, DLTs), and the recommended optimal dose (ROD) 120 mg/m(2) (two DLTs). DLTs were febrile neutropenia and grade 3 diarrhea. Other toxicities were mild. No difference in toxicity was seen between the two time schedules. A 77% (95% CI 63.25-90.75%) response rate was recorded among 31 evaluable patients and the median survival was 12 months. CONCLUSIONS: The ECI regimen was well tolerated and showed considerable activity in patients with AS-SCLC. Phase II/III evaluation is ongoing. Cancer Chemother Pharmacol
Databáze: OpenAIRE
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