Phase II study of oxaliplatin in patients with unresectable, metastatic, or recurrent hepatocellular cancer a California cancer consortium trial

Y. Yen, Dean W. Lim, Vincent Chung, Robert J. Morgan, Lucille A. Leong, Stephen I. Shibata, Stephen D. Wagman, Howard Marx, Peiguo G. Chu, Jeffrey A. Longmate, Heinz Josef Lenz, Ramesk K Ramanathan, Chandra P. Belani, David R. Gandara

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Purpose: Prolonged survival for patients with unresectable hepatocellular carcinoma (HCC) is consistently reported at lower than 6 months. Oxaliplatin has recently demonstrated activity in HCC. The objective of this study was to determine the response rate, survival, time to progression, and toxicity in patients with poor prognosis HCC when treated with oxaliplatin. Experimental Design: Patients were required to have measurable recurrent, metastatic or unresectable HCC, and to have previously been exposed to no more than 2 prior chemotherapy regimens. Karnofsky performance of 70% or above and adequate organ and hematologic function were required. All patients received treatment with oxaliplatin 100 mg/m2 on day 1 and 15 as a 2-hour intravenous infusion and were pretreated with antiemetics. Treatment was repeated every 28 days. Results: Thirty-six patients were enrolled and evaluated, although 6 expired before the first planned evaluation. Karnofsky performance status was 70/80/90/100% in 5/9/9/13 patients, respectively. The median time to progression was 2 months; median survival was 6 months. The 6-month overall survival was 55% (95% confidence interval 41%-74%), and the 6 month event-free survival was 11% (95% confidence interval 4%-28%). Conclusion: Single agent, oxaliplatin, has produced one partial response of good duration in 36 patients, but failed to meet the a priori criterion for promise in this trial. Sixteen patients were observed to have stable disease with a well tolerated toxicity profile. The combination of oxaliplatin and other agents should be considered to treat HCC in those patients with good functional status.

Original languageEnglish (US)
Pages (from-to)317-322
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume31
Issue number4
DOIs
StatePublished - Aug 2008
Externally publishedYes

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oxaliplatin
Liver Neoplasms
Hepatocellular Carcinoma
Neoplasms
Survival
Confidence Intervals
Karnofsky Performance Status
Antiemetics

Keywords

  • Cancer
  • Capecitabine
  • HCC
  • Hepatitis C
  • Hepatocellular
  • Oxaliplatin

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

Cite this

Phase II study of oxaliplatin in patients with unresectable, metastatic, or recurrent hepatocellular cancer a California cancer consortium trial. / Yen, Y.; Lim, Dean W.; Chung, Vincent; Morgan, Robert J.; Leong, Lucille A.; Shibata, Stephen I.; Wagman, Stephen D.; Marx, Howard; Chu, Peiguo G.; Longmate, Jeffrey A.; Lenz, Heinz Josef; Ramanathan, Ramesk K; Belani, Chandra P.; Gandara, David R.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 31, No. 4, 08.2008, p. 317-322.

Research output: Contribution to journalArticle

Yen, Y, Lim, DW, Chung, V, Morgan, RJ, Leong, LA, Shibata, SI, Wagman, SD, Marx, H, Chu, PG, Longmate, JA, Lenz, HJ, Ramanathan, RK, Belani, CP & Gandara, DR 2008, 'Phase II study of oxaliplatin in patients with unresectable, metastatic, or recurrent hepatocellular cancer a California cancer consortium trial', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 31, no. 4, pp. 317-322. https://doi.org/10.1097/COC.0b013e318162f57d
Yen, Y. ; Lim, Dean W. ; Chung, Vincent ; Morgan, Robert J. ; Leong, Lucille A. ; Shibata, Stephen I. ; Wagman, Stephen D. ; Marx, Howard ; Chu, Peiguo G. ; Longmate, Jeffrey A. ; Lenz, Heinz Josef ; Ramanathan, Ramesk K ; Belani, Chandra P. ; Gandara, David R. / Phase II study of oxaliplatin in patients with unresectable, metastatic, or recurrent hepatocellular cancer a California cancer consortium trial. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2008 ; Vol. 31, No. 4. pp. 317-322.
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abstract = "Purpose: Prolonged survival for patients with unresectable hepatocellular carcinoma (HCC) is consistently reported at lower than 6 months. Oxaliplatin has recently demonstrated activity in HCC. The objective of this study was to determine the response rate, survival, time to progression, and toxicity in patients with poor prognosis HCC when treated with oxaliplatin. Experimental Design: Patients were required to have measurable recurrent, metastatic or unresectable HCC, and to have previously been exposed to no more than 2 prior chemotherapy regimens. Karnofsky performance of 70{\%} or above and adequate organ and hematologic function were required. All patients received treatment with oxaliplatin 100 mg/m2 on day 1 and 15 as a 2-hour intravenous infusion and were pretreated with antiemetics. Treatment was repeated every 28 days. Results: Thirty-six patients were enrolled and evaluated, although 6 expired before the first planned evaluation. Karnofsky performance status was 70/80/90/100{\%} in 5/9/9/13 patients, respectively. The median time to progression was 2 months; median survival was 6 months. The 6-month overall survival was 55{\%} (95{\%} confidence interval 41{\%}-74{\%}), and the 6 month event-free survival was 11{\%} (95{\%} confidence interval 4{\%}-28{\%}). Conclusion: Single agent, oxaliplatin, has produced one partial response of good duration in 36 patients, but failed to meet the a priori criterion for promise in this trial. Sixteen patients were observed to have stable disease with a well tolerated toxicity profile. The combination of oxaliplatin and other agents should be considered to treat HCC in those patients with good functional status.",
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T1 - Phase II study of oxaliplatin in patients with unresectable, metastatic, or recurrent hepatocellular cancer a California cancer consortium trial

AU - Yen, Y.

AU - Lim, Dean W.

AU - Chung, Vincent

AU - Morgan, Robert J.

AU - Leong, Lucille A.

AU - Shibata, Stephen I.

AU - Wagman, Stephen D.

AU - Marx, Howard

AU - Chu, Peiguo G.

AU - Longmate, Jeffrey A.

AU - Lenz, Heinz Josef

AU - Ramanathan, Ramesk K

AU - Belani, Chandra P.

AU - Gandara, David R.

PY - 2008/8

Y1 - 2008/8

N2 - Purpose: Prolonged survival for patients with unresectable hepatocellular carcinoma (HCC) is consistently reported at lower than 6 months. Oxaliplatin has recently demonstrated activity in HCC. The objective of this study was to determine the response rate, survival, time to progression, and toxicity in patients with poor prognosis HCC when treated with oxaliplatin. Experimental Design: Patients were required to have measurable recurrent, metastatic or unresectable HCC, and to have previously been exposed to no more than 2 prior chemotherapy regimens. Karnofsky performance of 70% or above and adequate organ and hematologic function were required. All patients received treatment with oxaliplatin 100 mg/m2 on day 1 and 15 as a 2-hour intravenous infusion and were pretreated with antiemetics. Treatment was repeated every 28 days. Results: Thirty-six patients were enrolled and evaluated, although 6 expired before the first planned evaluation. Karnofsky performance status was 70/80/90/100% in 5/9/9/13 patients, respectively. The median time to progression was 2 months; median survival was 6 months. The 6-month overall survival was 55% (95% confidence interval 41%-74%), and the 6 month event-free survival was 11% (95% confidence interval 4%-28%). Conclusion: Single agent, oxaliplatin, has produced one partial response of good duration in 36 patients, but failed to meet the a priori criterion for promise in this trial. Sixteen patients were observed to have stable disease with a well tolerated toxicity profile. The combination of oxaliplatin and other agents should be considered to treat HCC in those patients with good functional status.

AB - Purpose: Prolonged survival for patients with unresectable hepatocellular carcinoma (HCC) is consistently reported at lower than 6 months. Oxaliplatin has recently demonstrated activity in HCC. The objective of this study was to determine the response rate, survival, time to progression, and toxicity in patients with poor prognosis HCC when treated with oxaliplatin. Experimental Design: Patients were required to have measurable recurrent, metastatic or unresectable HCC, and to have previously been exposed to no more than 2 prior chemotherapy regimens. Karnofsky performance of 70% or above and adequate organ and hematologic function were required. All patients received treatment with oxaliplatin 100 mg/m2 on day 1 and 15 as a 2-hour intravenous infusion and were pretreated with antiemetics. Treatment was repeated every 28 days. Results: Thirty-six patients were enrolled and evaluated, although 6 expired before the first planned evaluation. Karnofsky performance status was 70/80/90/100% in 5/9/9/13 patients, respectively. The median time to progression was 2 months; median survival was 6 months. The 6-month overall survival was 55% (95% confidence interval 41%-74%), and the 6 month event-free survival was 11% (95% confidence interval 4%-28%). Conclusion: Single agent, oxaliplatin, has produced one partial response of good duration in 36 patients, but failed to meet the a priori criterion for promise in this trial. Sixteen patients were observed to have stable disease with a well tolerated toxicity profile. The combination of oxaliplatin and other agents should be considered to treat HCC in those patients with good functional status.

KW - Cancer

KW - Capecitabine

KW - HCC

KW - Hepatitis C

KW - Hepatocellular

KW - Oxaliplatin

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