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)

C. Boni, G. Bisagni, L. Savoldi, G. Moretti, E. Rondini, M. Sassi, A. Zadro, T. De Pas, V. Franciosi, A. Pazzola, R. Vignoli, M. C. Banzi, V. Pajetta

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Abstract

The purpose of this study was to evaluate the activity and the toxicity of the combination of gemcitabine with ifosamide 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 I 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 I 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. (C) 2000 Wiley-Liss, Inc.

Original languageEnglish
Pages (from-to)724-727
Number of pages4
JournalInternational Journal of Cancer
Volume87
Issue number5
DOIs
Publication statusPublished - 2000

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gemcitabine
Ifosfamide
Medical Oncology
Non-Small Cell Lung Carcinoma
Cisplatin
Research
Poisons
Therapeutics
Febrile Neutropenia
Platelet Transfusion
Leukopenia
Thrombocytopenia

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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). / Boni, C.; Bisagni, G.; Savoldi, L.; Moretti, G.; Rondini, E.; Sassi, M.; Zadro, A.; De Pas, T.; Franciosi, V.; Pazzola, A.; Vignoli, R.; Banzi, M. C.; Pajetta, V.

In: International Journal of Cancer, Vol. 87, No. 5, 2000, p. 724-727.

Research output: Contribution to journalArticle

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abstract = "The purpose of this study was to evaluate the activity and the toxicity of the combination of gemcitabine with ifosamide 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 I 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 I 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. (C) 2000 Wiley-Liss, Inc.",
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AU - Boni, C.

AU - Bisagni, G.

AU - Savoldi, L.

AU - Moretti, G.

AU - Rondini, E.

AU - Sassi, M.

AU - Zadro, A.

AU - De Pas, T.

AU - Franciosi, V.

AU - Pazzola, A.

AU - Vignoli, R.

AU - Banzi, M. C.

AU - Pajetta, V.

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