Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer: A randomized study of two different schedules of oxaliplatin

Roberto Petrioli, Alessandra Pascucci, Edoardo Francini, Stefania Marsili, Angela Sciandivasci, Rossana Tassi, Serenella Civitelli, Gabriello Tanzini, Marco Lorenzi, Guido Francini

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Abstract

Purpose: The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods: Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m2 i.v. only on day 1, with leucovorin 100 mg/m2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m2/day and a 22-h infusion of 5-FU 600 mg/m2/day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results: The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1%) than in group B (18.5%) (P <0.001). Conclusions: This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.

Original languageEnglish
Pages (from-to)105-111
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume61
Issue number1
DOIs
Publication statusPublished - Jan 2008

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oxaliplatin
Chemotherapy
Fluorouracil
Colonic Neoplasms
Stomach Neoplasms
Appointments and Schedules
Leucovorin
Toxicity
Colon
Therapeutics
Adjuvant Chemotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology

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Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer : A randomized study of two different schedules of oxaliplatin. / Petrioli, Roberto; Pascucci, Alessandra; Francini, Edoardo; Marsili, Stefania; Sciandivasci, Angela; Tassi, Rossana; Civitelli, Serenella; Tanzini, Gabriello; Lorenzi, Marco; Francini, Guido.

In: Cancer Chemotherapy and Pharmacology, Vol. 61, No. 1, 01.2008, p. 105-111.

Research output: Contribution to journalArticle

Petrioli, Roberto ; Pascucci, Alessandra ; Francini, Edoardo ; Marsili, Stefania ; Sciandivasci, Angela ; Tassi, Rossana ; Civitelli, Serenella ; Tanzini, Gabriello ; Lorenzi, Marco ; Francini, Guido. / Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer : A randomized study of two different schedules of oxaliplatin. In: Cancer Chemotherapy and Pharmacology. 2008 ; Vol. 61, No. 1. pp. 105-111.
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abstract = "Purpose: The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods: Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m2 i.v. only on day 1, with leucovorin 100 mg/m2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m2/day and a 22-h infusion of 5-FU 600 mg/m2/day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results: The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1{\%} vs. 59.3{\%}: P = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1{\%}) than in group B (18.5{\%}) (P <0.001). Conclusions: This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.",
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T1 - Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer

T2 - A randomized study of two different schedules of oxaliplatin

AU - Petrioli, Roberto

AU - Pascucci, Alessandra

AU - Francini, Edoardo

AU - Marsili, Stefania

AU - Sciandivasci, Angela

AU - Tassi, Rossana

AU - Civitelli, Serenella

AU - Tanzini, Gabriello

AU - Lorenzi, Marco

AU - Francini, Guido

PY - 2008/1

Y1 - 2008/1

N2 - Purpose: The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods: Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m2 i.v. only on day 1, with leucovorin 100 mg/m2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m2/day and a 22-h infusion of 5-FU 600 mg/m2/day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results: The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1%) than in group B (18.5%) (P <0.001). Conclusions: This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.

AB - Purpose: The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. Methods: Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m2 i.v. only on day 1, with leucovorin 100 mg/m2 i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m2/day and a 22-h infusion of 5-FU 600 mg/m2/day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. Results: The percentage of patients presenting with grade ≥2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P = 0.02). There was a statistically lower percentage of cycles with grade ≥2 neurotoxicity in group A (6.1%) than in group B (18.5%) (P <0.001). Conclusions: This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.

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