Docetaxel as Salvage Therapy in Advanced Gastric Cancer

A Phase II Study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.)

Francesco Giuliani, Vittorio Gebbia, Francesco De Vita, Evaristo Maiello, Maurizio Di Bisceglie, Giuseppe Catalano, Nicolo Gebbia, Giuseppe Colucci

Research output: Contribution to journalArticle

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Abstract

Background: Docetaxel (DCT), a semisynthetic taxoid, has demonstrated cytotoxic activity against gastric cancer in early phase II studies producing an overall response rate of 17-24%. The Gruppo Oncologico Italia Meridionale (G.O.I.M.) started a confirmatory multicenter phase II trial to evaluate the clinical activity and toxicity of single agent TXT in the treatment of advanced gastric cancer patients who had failed a first-line chemotherapy. Materials and Methods: Thirty patients with advanced gastric carcinoma refractory to first-line ECF or PELF chemotherapy were treated with DCT administered at the dosage of 100 mg/mq given as a 1-hour i.v. infusion every three weeks. All patients received a premedication with dexamethasone 8 mg i.v. 12 hours and 1 hour before, and 12 hours after DCT administration. Granulocyte colony stimulating factor was employed in case of febrile neutropenia as needed. The first evaluation of disease status was planned after three cycles. Results: We observed 5 partial responses without any complete response for an overall response rate of 17% (95% CI=6-36%, intent-to-treat analysis). Nine patients showed stable disease and 14 patients progressed. The duration of objective partial responses were 5, 6, 6, 9 and 12 months, respectively. The median overall survival was 6 months and the 1-year survival rate was 20.6%. No chemotherapy-related toxic death was observed. Haematological grade 3-4 side-effects were respectively: anemia (7%), leucopenia (7%) and neutropenia (18%); in 13 patients (45%) G-CSF was employed to avoid severe leukopenia. Conclusion: This multinstitutional single-step phase II study confirms that single-agent docetaxel is active in advanced gastric cancer progressing after first-line chemotherapy. The most frequent toxicity is neutropenia, which may be managed by G-CSF and/or dose adjustments. Docetaxel is therefore worthy of further study in combination with other active drugs.

Original languageEnglish
Pages (from-to)4219-4222
Number of pages4
JournalAnticancer Research
Volume23
Issue number5 B
Publication statusPublished - Sep 2003

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docetaxel
Salvage Therapy
Stomach Neoplasms
Granulocyte Colony-Stimulating Factor
Drug Therapy
Leukopenia
Neutropenia
Taxoids
Febrile Neutropenia
Premedication
Poisons
Dexamethasone
Anemia
Stomach
Survival Rate
Carcinoma

Keywords

  • Docetaxel
  • Gastric cancer
  • Metastases

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Docetaxel as Salvage Therapy in Advanced Gastric Cancer : A Phase II Study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.). / Giuliani, Francesco; Gebbia, Vittorio; De Vita, Francesco; Maiello, Evaristo; Di Bisceglie, Maurizio; Catalano, Giuseppe; Gebbia, Nicolo; Colucci, Giuseppe.

In: Anticancer Research, Vol. 23, No. 5 B, 09.2003, p. 4219-4222.

Research output: Contribution to journalArticle

Giuliani, F, Gebbia, V, De Vita, F, Maiello, E, Di Bisceglie, M, Catalano, G, Gebbia, N & Colucci, G 2003, 'Docetaxel as Salvage Therapy in Advanced Gastric Cancer: A Phase II Study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.)', Anticancer Research, vol. 23, no. 5 B, pp. 4219-4222.
Giuliani, Francesco ; Gebbia, Vittorio ; De Vita, Francesco ; Maiello, Evaristo ; Di Bisceglie, Maurizio ; Catalano, Giuseppe ; Gebbia, Nicolo ; Colucci, Giuseppe. / Docetaxel as Salvage Therapy in Advanced Gastric Cancer : A Phase II Study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.). In: Anticancer Research. 2003 ; Vol. 23, No. 5 B. pp. 4219-4222.
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title = "Docetaxel as Salvage Therapy in Advanced Gastric Cancer: A Phase II Study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.)",
abstract = "Background: Docetaxel (DCT), a semisynthetic taxoid, has demonstrated cytotoxic activity against gastric cancer in early phase II studies producing an overall response rate of 17-24{\%}. The Gruppo Oncologico Italia Meridionale (G.O.I.M.) started a confirmatory multicenter phase II trial to evaluate the clinical activity and toxicity of single agent TXT in the treatment of advanced gastric cancer patients who had failed a first-line chemotherapy. Materials and Methods: Thirty patients with advanced gastric carcinoma refractory to first-line ECF or PELF chemotherapy were treated with DCT administered at the dosage of 100 mg/mq given as a 1-hour i.v. infusion every three weeks. All patients received a premedication with dexamethasone 8 mg i.v. 12 hours and 1 hour before, and 12 hours after DCT administration. Granulocyte colony stimulating factor was employed in case of febrile neutropenia as needed. The first evaluation of disease status was planned after three cycles. Results: We observed 5 partial responses without any complete response for an overall response rate of 17{\%} (95{\%} CI=6-36{\%}, intent-to-treat analysis). Nine patients showed stable disease and 14 patients progressed. The duration of objective partial responses were 5, 6, 6, 9 and 12 months, respectively. The median overall survival was 6 months and the 1-year survival rate was 20.6{\%}. No chemotherapy-related toxic death was observed. Haematological grade 3-4 side-effects were respectively: anemia (7{\%}), leucopenia (7{\%}) and neutropenia (18{\%}); in 13 patients (45{\%}) G-CSF was employed to avoid severe leukopenia. Conclusion: This multinstitutional single-step phase II study confirms that single-agent docetaxel is active in advanced gastric cancer progressing after first-line chemotherapy. The most frequent toxicity is neutropenia, which may be managed by G-CSF and/or dose adjustments. Docetaxel is therefore worthy of further study in combination with other active drugs.",
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T2 - A Phase II Study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.)

AU - Giuliani, Francesco

AU - Gebbia, Vittorio

AU - De Vita, Francesco

AU - Maiello, Evaristo

AU - Di Bisceglie, Maurizio

AU - Catalano, Giuseppe

AU - Gebbia, Nicolo

AU - Colucci, Giuseppe

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AB - Background: Docetaxel (DCT), a semisynthetic taxoid, has demonstrated cytotoxic activity against gastric cancer in early phase II studies producing an overall response rate of 17-24%. The Gruppo Oncologico Italia Meridionale (G.O.I.M.) started a confirmatory multicenter phase II trial to evaluate the clinical activity and toxicity of single agent TXT in the treatment of advanced gastric cancer patients who had failed a first-line chemotherapy. Materials and Methods: Thirty patients with advanced gastric carcinoma refractory to first-line ECF or PELF chemotherapy were treated with DCT administered at the dosage of 100 mg/mq given as a 1-hour i.v. infusion every three weeks. All patients received a premedication with dexamethasone 8 mg i.v. 12 hours and 1 hour before, and 12 hours after DCT administration. Granulocyte colony stimulating factor was employed in case of febrile neutropenia as needed. The first evaluation of disease status was planned after three cycles. Results: We observed 5 partial responses without any complete response for an overall response rate of 17% (95% CI=6-36%, intent-to-treat analysis). Nine patients showed stable disease and 14 patients progressed. The duration of objective partial responses were 5, 6, 6, 9 and 12 months, respectively. The median overall survival was 6 months and the 1-year survival rate was 20.6%. No chemotherapy-related toxic death was observed. Haematological grade 3-4 side-effects were respectively: anemia (7%), leucopenia (7%) and neutropenia (18%); in 13 patients (45%) G-CSF was employed to avoid severe leukopenia. Conclusion: This multinstitutional single-step phase II study confirms that single-agent docetaxel is active in advanced gastric cancer progressing after first-line chemotherapy. The most frequent toxicity is neutropenia, which may be managed by G-CSF and/or dose adjustments. Docetaxel is therefore worthy of further study in combination with other active drugs.

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