Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma

A randomized phase III trial

Maria Di Bartolomeo, Roberto Buzzoni, Luigi Mariani, Erminia Ferrario, Dotti Katia, Arpine Gevorgyan, Nicoletta Zilembo, Roberto Bordonaro, Anna Maria Bochicchio, Bruno Massidda, Antonio Ardizzoni, Giovanni Marini, Enrico Aitini, Giuseppe Schieppati, Giuseppe Comella, Graziella Pinotti, Salvatore Palazzo, Giovanni Cicero, Emilio Bajetta

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Objective: Combination therapies of fluorouracil (FU) with irinotecan (CPT-11) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer. In this paper, we present the results of a phase III trial in which these two combinations given sequentially were compared to mitomycin C (MMC) monochemotherapy in an adjuvant setting. Methods: 169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m2 day 1), leucovorin (100 mg/m2 days 1-2), FU (400-600 mg/m2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m2 day 1), cisplatin (75 mg/m2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m2 days 1-2 as 2-hour infusion, q 42; for four cycles; arm B). All patients had histologically confirmed gastric carcinoma with nodal positivity or pT3/4. A total of 166 patients (85 in arm A and 81 in arm B) were treated. Adjuvant treatment was completed in 76% of the patients in arm A and in 70% of the patients in arm B. The main grade 3/4 side effects recorded were neutropenia in 35%, with only 1 febrile patient, and diarrhea in 11% in arm A, and thrombocytopenia in 10% and neutropenia in 7% in arm B. The FOLFIRI regimen and docetaxel/cisplatin given in sequence was well tolerated and feasible in adjuvant setting. This sequence treatment currently represents the experimental arm of an ongoing multicenter trial.

Original languageEnglish
Pages (from-to)341-346
Number of pages6
JournalOncology
Volume71
Issue number5-6
DOIs
Publication statusPublished - Oct 2007

Fingerprint

docetaxel
irinotecan
Cisplatin
Stomach
Adenocarcinoma
Mitomycin
Neutropenia
Fluorouracil
Stomach Neoplasms
Therapeutics
Leucovorin
Thrombocytopenia
Multicenter Studies
Diarrhea
Fever
Carcinoma

Keywords

  • Adjuvant chemotherapy
  • Docetaxel
  • Gastric cancer
  • Irinotecan

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma : A randomized phase III trial. / Di Bartolomeo, Maria; Buzzoni, Roberto; Mariani, Luigi; Ferrario, Erminia; Katia, Dotti; Gevorgyan, Arpine; Zilembo, Nicoletta; Bordonaro, Roberto; Bochicchio, Anna Maria; Massidda, Bruno; Ardizzoni, Antonio; Marini, Giovanni; Aitini, Enrico; Schieppati, Giuseppe; Comella, Giuseppe; Pinotti, Graziella; Palazzo, Salvatore; Cicero, Giovanni; Bajetta, Emilio.

In: Oncology, Vol. 71, No. 5-6, 10.2007, p. 341-346.

Research output: Contribution to journalArticle

Di Bartolomeo, M, Buzzoni, R, Mariani, L, Ferrario, E, Katia, D, Gevorgyan, A, Zilembo, N, Bordonaro, R, Bochicchio, AM, Massidda, B, Ardizzoni, A, Marini, G, Aitini, E, Schieppati, G, Comella, G, Pinotti, G, Palazzo, S, Cicero, G & Bajetta, E 2007, 'Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma: A randomized phase III trial', Oncology, vol. 71, no. 5-6, pp. 341-346. https://doi.org/10.1159/000108575
Di Bartolomeo, Maria ; Buzzoni, Roberto ; Mariani, Luigi ; Ferrario, Erminia ; Katia, Dotti ; Gevorgyan, Arpine ; Zilembo, Nicoletta ; Bordonaro, Roberto ; Bochicchio, Anna Maria ; Massidda, Bruno ; Ardizzoni, Antonio ; Marini, Giovanni ; Aitini, Enrico ; Schieppati, Giuseppe ; Comella, Giuseppe ; Pinotti, Graziella ; Palazzo, Salvatore ; Cicero, Giovanni ; Bajetta, Emilio. / Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma : A randomized phase III trial. In: Oncology. 2007 ; Vol. 71, No. 5-6. pp. 341-346.
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abstract = "Objective: Combination therapies of fluorouracil (FU) with irinotecan (CPT-11) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer. In this paper, we present the results of a phase III trial in which these two combinations given sequentially were compared to mitomycin C (MMC) monochemotherapy in an adjuvant setting. Methods: 169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m2 day 1), leucovorin (100 mg/m2 days 1-2), FU (400-600 mg/m2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m2 day 1), cisplatin (75 mg/m2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m2 days 1-2 as 2-hour infusion, q 42; for four cycles; arm B). All patients had histologically confirmed gastric carcinoma with nodal positivity or pT3/4. A total of 166 patients (85 in arm A and 81 in arm B) were treated. Adjuvant treatment was completed in 76{\%} of the patients in arm A and in 70{\%} of the patients in arm B. The main grade 3/4 side effects recorded were neutropenia in 35{\%}, with only 1 febrile patient, and diarrhea in 11{\%} in arm A, and thrombocytopenia in 10{\%} and neutropenia in 7{\%} in arm B. The FOLFIRI regimen and docetaxel/cisplatin given in sequence was well tolerated and feasible in adjuvant setting. This sequence treatment currently represents the experimental arm of an ongoing multicenter trial.",
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T1 - Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma

T2 - A randomized phase III trial

AU - Di Bartolomeo, Maria

AU - Buzzoni, Roberto

AU - Mariani, Luigi

AU - Ferrario, Erminia

AU - Katia, Dotti

AU - Gevorgyan, Arpine

AU - Zilembo, Nicoletta

AU - Bordonaro, Roberto

AU - Bochicchio, Anna Maria

AU - Massidda, Bruno

AU - Ardizzoni, Antonio

AU - Marini, Giovanni

AU - Aitini, Enrico

AU - Schieppati, Giuseppe

AU - Comella, Giuseppe

AU - Pinotti, Graziella

AU - Palazzo, Salvatore

AU - Cicero, Giovanni

AU - Bajetta, Emilio

PY - 2007/10

Y1 - 2007/10

N2 - Objective: Combination therapies of fluorouracil (FU) with irinotecan (CPT-11) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer. In this paper, we present the results of a phase III trial in which these two combinations given sequentially were compared to mitomycin C (MMC) monochemotherapy in an adjuvant setting. Methods: 169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m2 day 1), leucovorin (100 mg/m2 days 1-2), FU (400-600 mg/m2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m2 day 1), cisplatin (75 mg/m2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m2 days 1-2 as 2-hour infusion, q 42; for four cycles; arm B). All patients had histologically confirmed gastric carcinoma with nodal positivity or pT3/4. A total of 166 patients (85 in arm A and 81 in arm B) were treated. Adjuvant treatment was completed in 76% of the patients in arm A and in 70% of the patients in arm B. The main grade 3/4 side effects recorded were neutropenia in 35%, with only 1 febrile patient, and diarrhea in 11% in arm A, and thrombocytopenia in 10% and neutropenia in 7% in arm B. The FOLFIRI regimen and docetaxel/cisplatin given in sequence was well tolerated and feasible in adjuvant setting. This sequence treatment currently represents the experimental arm of an ongoing multicenter trial.

AB - Objective: Combination therapies of fluorouracil (FU) with irinotecan (CPT-11) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer. In this paper, we present the results of a phase III trial in which these two combinations given sequentially were compared to mitomycin C (MMC) monochemotherapy in an adjuvant setting. Methods: 169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m2 day 1), leucovorin (100 mg/m2 days 1-2), FU (400-600 mg/m2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m2 day 1), cisplatin (75 mg/m2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m2 days 1-2 as 2-hour infusion, q 42; for four cycles; arm B). All patients had histologically confirmed gastric carcinoma with nodal positivity or pT3/4. A total of 166 patients (85 in arm A and 81 in arm B) were treated. Adjuvant treatment was completed in 76% of the patients in arm A and in 70% of the patients in arm B. The main grade 3/4 side effects recorded were neutropenia in 35%, with only 1 febrile patient, and diarrhea in 11% in arm A, and thrombocytopenia in 10% and neutropenia in 7% in arm B. The FOLFIRI regimen and docetaxel/cisplatin given in sequence was well tolerated and feasible in adjuvant setting. This sequence treatment currently represents the experimental arm of an ongoing multicenter trial.

KW - Adjuvant chemotherapy

KW - Docetaxel

KW - Gastric cancer

KW - Irinotecan

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