Incidence and evolution of oxaliplatin-induced eripheral sensory neuropathy in diabetic patients with colorectal cancer: A pooled analysis of three phase III studies

Ramesk K Ramanathan, M. L. Rothenberg, A. de Gramont, C. Tournigand, R. M. Goldberg, S. Gupta, T. André

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Background: The purpose of this study was to determine whether the presence of diabetes mellitus (DM) influences the incidence, severity, and/or course of peripheral sensory neuropathy (PSN) after oxaliplatin (FOLFOX) therapy in patients with colorectal cancer (CRC). Methods: A retrospective pooled analysis incorporating three phase III studies was conducted: Multicenter International Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) (adjuvant treatment; stage II/III colon cancer), EFC4584 (second-line treatment; metastatic CRC), and EFC2962 (first- line treatment; metastatic CRC). Patients were ineligible for the studies if they had known PSN (EFC4584) or PSN grade ‡1 (MOSAIC and EFC2962) at baseline. The incidence of PSN was evaluated retrospectively in patient subgroups with or without DM at baseline that received FOLFOX. Kaplan-Meier curves were used to assess the probability of PSN with increasing cumulative oxaliplatin dose. Results: Of 1587 patients enrolled across the three studies, 135 (8.5%) had DM at baseline. The incidence of PSN (non-DM/DM) was 45.0%/46.7% (grade 1), 28.6%/26.7% (grade 2), and 13.0%/12.6% (grade 3). The probability of PSN by cumulative dose of oxaliplatin was similar in DM and non-DM patients. Conclusions: This retrospective analysis indicates that oxaliplatin-based therapy does not influence the incidence, severity, or time to onset of PSN in asymptomatic DM patients with CRC who meet eligibility criteria for clinical trials.

Original languageEnglish (US)
Pages (from-to)754-758
Number of pages5
JournalAnnals of Oncology
Volume21
Issue number4
DOIs
StatePublished - Nov 3 2009
Externally publishedYes

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oxaliplatin
Diabetic Neuropathies
Peripheral Nervous System Diseases
Colorectal Neoplasms
Diabetes Mellitus
Incidence
Colonic Neoplasms
Therapeutics
Leucovorin

Keywords

  • Colon cancer
  • Diabetes mellitus
  • Folfox
  • Neuropathy
  • Oxaliplatin

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Incidence and evolution of oxaliplatin-induced eripheral sensory neuropathy in diabetic patients with colorectal cancer : A pooled analysis of three phase III studies. / Ramanathan, Ramesk K; Rothenberg, M. L.; de Gramont, A.; Tournigand, C.; Goldberg, R. M.; Gupta, S.; André, T.

In: Annals of Oncology, Vol. 21, No. 4, 03.11.2009, p. 754-758.

Research output: Contribution to journalArticle

Ramanathan, Ramesk K ; Rothenberg, M. L. ; de Gramont, A. ; Tournigand, C. ; Goldberg, R. M. ; Gupta, S. ; André, T. / Incidence and evolution of oxaliplatin-induced eripheral sensory neuropathy in diabetic patients with colorectal cancer : A pooled analysis of three phase III studies. In: Annals of Oncology. 2009 ; Vol. 21, No. 4. pp. 754-758.
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abstract = "Background: The purpose of this study was to determine whether the presence of diabetes mellitus (DM) influences the incidence, severity, and/or course of peripheral sensory neuropathy (PSN) after oxaliplatin (FOLFOX) therapy in patients with colorectal cancer (CRC). Methods: A retrospective pooled analysis incorporating three phase III studies was conducted: Multicenter International Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) (adjuvant treatment; stage II/III colon cancer), EFC4584 (second-line treatment; metastatic CRC), and EFC2962 (first- line treatment; metastatic CRC). Patients were ineligible for the studies if they had known PSN (EFC4584) or PSN grade ‡1 (MOSAIC and EFC2962) at baseline. The incidence of PSN was evaluated retrospectively in patient subgroups with or without DM at baseline that received FOLFOX. Kaplan-Meier curves were used to assess the probability of PSN with increasing cumulative oxaliplatin dose. Results: Of 1587 patients enrolled across the three studies, 135 (8.5{\%}) had DM at baseline. The incidence of PSN (non-DM/DM) was 45.0{\%}/46.7{\%} (grade 1), 28.6{\%}/26.7{\%} (grade 2), and 13.0{\%}/12.6{\%} (grade 3). The probability of PSN by cumulative dose of oxaliplatin was similar in DM and non-DM patients. Conclusions: This retrospective analysis indicates that oxaliplatin-based therapy does not influence the incidence, severity, or time to onset of PSN in asymptomatic DM patients with CRC who meet eligibility criteria for clinical trials.",
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T1 - Incidence and evolution of oxaliplatin-induced eripheral sensory neuropathy in diabetic patients with colorectal cancer

T2 - A pooled analysis of three phase III studies

AU - Ramanathan, Ramesk K

AU - Rothenberg, M. L.

AU - de Gramont, A.

AU - Tournigand, C.

AU - Goldberg, R. M.

AU - Gupta, S.

AU - André, T.

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N2 - Background: The purpose of this study was to determine whether the presence of diabetes mellitus (DM) influences the incidence, severity, and/or course of peripheral sensory neuropathy (PSN) after oxaliplatin (FOLFOX) therapy in patients with colorectal cancer (CRC). Methods: A retrospective pooled analysis incorporating three phase III studies was conducted: Multicenter International Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) (adjuvant treatment; stage II/III colon cancer), EFC4584 (second-line treatment; metastatic CRC), and EFC2962 (first- line treatment; metastatic CRC). Patients were ineligible for the studies if they had known PSN (EFC4584) or PSN grade ‡1 (MOSAIC and EFC2962) at baseline. The incidence of PSN was evaluated retrospectively in patient subgroups with or without DM at baseline that received FOLFOX. Kaplan-Meier curves were used to assess the probability of PSN with increasing cumulative oxaliplatin dose. Results: Of 1587 patients enrolled across the three studies, 135 (8.5%) had DM at baseline. The incidence of PSN (non-DM/DM) was 45.0%/46.7% (grade 1), 28.6%/26.7% (grade 2), and 13.0%/12.6% (grade 3). The probability of PSN by cumulative dose of oxaliplatin was similar in DM and non-DM patients. Conclusions: This retrospective analysis indicates that oxaliplatin-based therapy does not influence the incidence, severity, or time to onset of PSN in asymptomatic DM patients with CRC who meet eligibility criteria for clinical trials.

AB - Background: The purpose of this study was to determine whether the presence of diabetes mellitus (DM) influences the incidence, severity, and/or course of peripheral sensory neuropathy (PSN) after oxaliplatin (FOLFOX) therapy in patients with colorectal cancer (CRC). Methods: A retrospective pooled analysis incorporating three phase III studies was conducted: Multicenter International Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) (adjuvant treatment; stage II/III colon cancer), EFC4584 (second-line treatment; metastatic CRC), and EFC2962 (first- line treatment; metastatic CRC). Patients were ineligible for the studies if they had known PSN (EFC4584) or PSN grade ‡1 (MOSAIC and EFC2962) at baseline. The incidence of PSN was evaluated retrospectively in patient subgroups with or without DM at baseline that received FOLFOX. Kaplan-Meier curves were used to assess the probability of PSN with increasing cumulative oxaliplatin dose. Results: Of 1587 patients enrolled across the three studies, 135 (8.5%) had DM at baseline. The incidence of PSN (non-DM/DM) was 45.0%/46.7% (grade 1), 28.6%/26.7% (grade 2), and 13.0%/12.6% (grade 3). The probability of PSN by cumulative dose of oxaliplatin was similar in DM and non-DM patients. Conclusions: This retrospective analysis indicates that oxaliplatin-based therapy does not influence the incidence, severity, or time to onset of PSN in asymptomatic DM patients with CRC who meet eligibility criteria for clinical trials.

KW - Colon cancer

KW - Diabetes mellitus

KW - Folfox

KW - Neuropathy

KW - Oxaliplatin

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