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

Briasoulis, E./ Samantas, E./ Kalofonos, H./ Skarlos, D./ Makatsoris, T./ Christodoulou, C./ Fountzilas, G./ Bamias, A./ Dimopoulos, M. A./ Kosmidis, P./ Pavlidis, N.

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.
Institution and School/Department of submitter: Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής
Keywords: Aged,Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use,Bone Neoplasms/drug therapy/secondary,Brain Neoplasms/drug therapy/secondary,Camptothecin/administration & dosage/adverse effects/analogs & derivatives,Carcinoma, Small Cell/*drug therapy/pathology,Cisplatin/administration & dosage/adverse effects,Etoposide/administration & dosage/adverse effects,Female,Humans,Liver Neoplasms/drug therapy/secondary,Lung Neoplasms/*drug therapy/pathology,Male,Maximum Tolerated Dose,Middle Aged,Survival Analysis
ISSN: 0344-5704
Appears in Collections:Άρθρα σε επιστημονικά περιοδικά ( Ανοικτά)

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