PMID- 10925367 OWN - NLM STAT- MEDLINE DCOM- 20000816 LR - 20160303 IS - 0020-7136 (Print) IS - 0020-7136 (Linking) VI - 87 IP - 5 DP - 2000 Sep 1 TI - Gemcitabine, ifosfamide, cisplatin (GIP) for the treatment of advanced non-small cell lung cancer: a phase II study of the italian oncology group for clinical research (GOIRC). PG - 724-7 AB - The purpose of this study was to evaluate the activity and the toxicity of the combination of gemcitabine with ifosfamide and cisplatin (GIP) in chemonaive patients with advanced non small cell lung cancer (NSCLC). Eighty chemonaive patients with Stage IIIB-IV NSCLC were treated with the combination of gemcitabine 1 g/m(2) on Days 1 and 8, ifosfamide 2 g/m(2) on Day 1 and cisplatin 80 mg/m(2) on Day 2. Cycles were administered on an outpatient basis every 3 weeks. Hematologic toxicity was the main side effect; Grade III-IV thrombocytopenia was observed in 54 (67%) patients and Grade III-IV leucopenia in 44 (55%) patients, with 4 episodes of febrile neutropenia and 1 toxic death. Thirteen patients received platelet transfusions and 38 were transfused with packed red cells. All patients were evaluable for response. The overall response rate was 54% (95% confidence interval 43 to 65%) with 1 complete response. In patients with Stage IIIB and IV disease, response rates were 58% and 52%, respectively. Median time to progression was 40 weeks (range 0-114) and median overall survival was 12 months (16.6 months for stage IIIB and 10.4 months for stage IV). Median and minimum follow-up were 19 and 12 months, respectively. The GIP combination shows a response rate and overall survival of clinical interest. Hematologic toxicity was the main toxic effect, especially in patients with low performance status. This regimen will be tested in a Phase III randomized trial. CI - Copyright 2000 Wiley-Liss, Inc. FAU - Boni, C AU - Boni C AD - Medical Oncology Service, Arcispedale S. Maria Nuova, Reggio Emilia, Italy. boni.corrado@asmn.re.it FAU - Bisagni, G AU - Bisagni G FAU - Savoldi, L AU - Savoldi L FAU - Moretti, G AU - Moretti G FAU - Rondini, E AU - Rondini E FAU - Sassi, M AU - Sassi M FAU - Zadro, A AU - Zadro A FAU - De Pas, T AU - De Pas T FAU - Franciosi, V AU - Franciosi V FAU - Pazzola, A AU - Pazzola A FAU - Vignoli, R AU - Vignoli R FAU - Banzi, M C AU - Banzi MC FAU - Pajetta, V AU - Pajetta V LA - eng PT - Clinical Trial PT - Clinical Trial, Phase II PT - Journal Article PL - United States TA - Int J Cancer JT - International journal of cancer JID - 0042124 RN - 0W860991D6 (Deoxycytidine) RN - Q20Q21Q62J (Cisplatin) RN - UM20QQM95Y (Ifosfamide) RN - GIP protocol SB - IM MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Cisplatin/administration & dosage/adverse effects MH - Deoxycytidine/administration & dosage/adverse effects MH - Female MH - Humans MH - Ifosfamide/administration & dosage/adverse effects MH - Lung Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Neutropenia/chemically induced MH - Thrombocytopenia/chemically induced EDAT- 2000/08/05 11:00 MHDA- 2000/08/19 11:00 CRDT- 2000/08/05 11:00 PHST- 2000/08/05 11:00 [pubmed] PHST- 2000/08/19 11:00 [medline] PHST- 2000/08/05 11:00 [entrez] AID - 10.1002/1097-0215(20000901)87:5<724::AID-IJC15>3.0.CO;2-N [pii] PST - ppublish SO - Int J Cancer. 2000 Sep 1;87(5):724-7.