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Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer.

Publication ,  Journal Article
Kemeny, N; Jarnagin, W; Paty, P; Gönen, M; Schwartz, L; Morse, M; Leonard, G; D'Angelica, M; DeMatteo, R; Blumgart, L; Fong, Y
Published in: J Clin Oncol
August 1, 2005

PURPOSE: To determine the maximum-tolerated dose (MTD) of concurrent systemic oxaliplatin (Oxal) combinations plus hepatic arterial infusion (HAI) in patients with unresectable hepatic metastases from colorectal cancer. PATIENTS AND METHODS: Thirty-six patients (89% previously treated) with unresectable liver metastases were treated with concurrent HAI and systemic Oxal plus irinotecan (CPT-11; group A) or Oxal, fluorouracil (FU), and leucovorin (LV; group B). Systemic chemotherapy was administered every 2 weeks concurrent with 2 weeks of HAI floxuridine (FUDR) and dexamethasone (Dex) every 28 days. RESULTS: The MTD for patients in group A was Oxal 100 mg/m(2), CPT-11 150 mg/m(2), and FUDR 0.12 mg/kg x 30 mL divided by pump flow rate. The MTD for group B was Oxal 100 mg/m(2), LV 400 mg/m(2), and FU 1,400 mg/m(2) by continuous infusion over 48 hours, with the same FUDR dose as in group A. Grade 3 or 4 toxicities in groups A and B included diarrhea (24% and 20%), neutropenia (10% and 7%), neurotoxicity (24% and 20%), and bilirubin more than 3 mg/mL (5% and 7%, respectively). The complete and partial response rate totaled 90% for group A and 87% for group B. Median survival time was 36 and 22 months for groups A and B, respectively. Seven patients in group A were ultimately able to undergo liver resection. CONCLUSION: Combination therapy with HAI FUDR and Dex plus systemic Oxal combinations may be safely administered to patients with colorectal cancer. The high response rate (88%) and the possibility of conversion to resectability, despite disease progression on prior systemic regimens, suggest that these combinations should be evaluated in larger studies as first- or second-line therapy in patients with hepatic metastases from colorectal cancer.

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Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

August 1, 2005

Volume

23

Issue

22

Start / End Page

4888 / 4896

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Oxaliplatin
  • Organoplatinum Compounds
  • Oncology & Carcinogenesis
  • Middle Aged
  • Maximum Tolerated Dose
  • Male
  • Liver Neoplasms
  • Leucovorin
 

Citation

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Kemeny, N., Jarnagin, W., Paty, P., Gönen, M., Schwartz, L., Morse, M., … Fong, Y. (2005). Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer. J Clin Oncol, 23(22), 4888–4896. https://doi.org/10.1200/JCO.2005.07.100
Kemeny, Nancy, William Jarnagin, Philip Paty, Mithat Gönen, Lawrence Schwartz, Meroë Morse, Gregory Leonard, et al. “Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer.J Clin Oncol 23, no. 22 (August 1, 2005): 4888–96. https://doi.org/10.1200/JCO.2005.07.100.
Kemeny N, Jarnagin W, Paty P, Gönen M, Schwartz L, Morse M, et al. Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer. J Clin Oncol. 2005 Aug 1;23(22):4888–96.
Kemeny, Nancy, et al. “Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer.J Clin Oncol, vol. 23, no. 22, Aug. 2005, pp. 4888–96. Pubmed, doi:10.1200/JCO.2005.07.100.
Kemeny N, Jarnagin W, Paty P, Gönen M, Schwartz L, Morse M, Leonard G, D’Angelica M, DeMatteo R, Blumgart L, Fong Y. Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer. J Clin Oncol. 2005 Aug 1;23(22):4888–4896.

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

August 1, 2005

Volume

23

Issue

22

Start / End Page

4888 / 4896

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Oxaliplatin
  • Organoplatinum Compounds
  • Oncology & Carcinogenesis
  • Middle Aged
  • Maximum Tolerated Dose
  • Male
  • Liver Neoplasms
  • Leucovorin