Phase II study of the efficacy and safety of cisplatin-epinephrine injectable gel administered to patients with unresectable hepatocellular carcinoma

Thomas W T Leung, S. Yu, P. J. Johnson, J. Geschwind, T. J. Vogl, K. Engelmann, G. J. Gores, M. Giovannini, J. O'Grady, M. Heneghan, M. Stewart, E. K. Orenberg, P. J. Thuluvath

Research output: Contribution to journalArticle

Abstract

Purpose: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC). Patients and Methods: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured ≤ 7 cm, total tumor volume ≤ 200 cm3). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points. Results: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects. Conclusion: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.

Original languageEnglish (US)
Pages (from-to)652-658
Number of pages7
JournalJournal of Clinical Oncology
Volume21
Issue number4
DOIs
StatePublished - Feb 15 2003
Externally publishedYes

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Cisplatin
Epinephrine
Hepatocellular Carcinoma
Gels
Safety
Injections
Neoplasms
Therapeutics
Necrosis
Tomography
Survival
Tumor Burden
Survival Rate
Liver

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II study of the efficacy and safety of cisplatin-epinephrine injectable gel administered to patients with unresectable hepatocellular carcinoma. / Leung, Thomas W T; Yu, S.; Johnson, P. J.; Geschwind, J.; Vogl, T. J.; Engelmann, K.; Gores, G. J.; Giovannini, M.; O'Grady, J.; Heneghan, M.; Stewart, M.; Orenberg, E. K.; Thuluvath, P. J.

In: Journal of Clinical Oncology, Vol. 21, No. 4, 15.02.2003, p. 652-658.

Research output: Contribution to journalArticle

Leung, TWT, Yu, S, Johnson, PJ, Geschwind, J, Vogl, TJ, Engelmann, K, Gores, GJ, Giovannini, M, O'Grady, J, Heneghan, M, Stewart, M, Orenberg, EK & Thuluvath, PJ 2003, 'Phase II study of the efficacy and safety of cisplatin-epinephrine injectable gel administered to patients with unresectable hepatocellular carcinoma', Journal of Clinical Oncology, vol. 21, no. 4, pp. 652-658. https://doi.org/10.1200/JCO.2003.04.152
Leung, Thomas W T ; Yu, S. ; Johnson, P. J. ; Geschwind, J. ; Vogl, T. J. ; Engelmann, K. ; Gores, G. J. ; Giovannini, M. ; O'Grady, J. ; Heneghan, M. ; Stewart, M. ; Orenberg, E. K. ; Thuluvath, P. J. / Phase II study of the efficacy and safety of cisplatin-epinephrine injectable gel administered to patients with unresectable hepatocellular carcinoma. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 4. pp. 652-658.
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abstract = "Purpose: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC). Patients and Methods: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured ≤ 7 cm, total tumor volume ≤ 200 cm3). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points. Results: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53{\%} (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52{\%}) subsequently developed progressive disease, but in most of them (93{\%}), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79{\%}, 56{\%}, and 14{\%} respectively. The procedure was well tolerated with only minor side effects. Conclusion: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.",
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T1 - Phase II study of the efficacy and safety of cisplatin-epinephrine injectable gel administered to patients with unresectable hepatocellular carcinoma

AU - Leung, Thomas W T

AU - Yu, S.

AU - Johnson, P. J.

AU - Geschwind, J.

AU - Vogl, T. J.

AU - Engelmann, K.

AU - Gores, G. J.

AU - Giovannini, M.

AU - O'Grady, J.

AU - Heneghan, M.

AU - Stewart, M.

AU - Orenberg, E. K.

AU - Thuluvath, P. J.

PY - 2003/2/15

Y1 - 2003/2/15

N2 - Purpose: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC). Patients and Methods: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured ≤ 7 cm, total tumor volume ≤ 200 cm3). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points. Results: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects. Conclusion: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.

AB - Purpose: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC). Patients and Methods: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured ≤ 7 cm, total tumor volume ≤ 200 cm3). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points. Results: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects. Conclusion: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.

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