A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer

Ramesh K. Ramanathan; Chandra P. Belani; Deepti A. Singh; Michael Tanaka; Heinz Josef Lenz; Yun Yen; Hedy L. Kindler; Syma Iqbal; Jeff Longmate; Philip C. MacK; Georg Lurje; Regina Gandour-Edwards; Janet Dancey; David R. Gandara

doi:10.1007/s00280-009-0927-7

A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer

Ramesh K. Ramanathan
, Chandra P. Belani
, Deepti A. Singh
, Michael Tanaka
, Heinz Josef Lenz
, Yun Yen
, Hedy L. Kindler
, Syma Iqbal
, Jeff Longmate
, Philip C. MacK
, Georg Lurje
, Regina Gandour-Edwards
, Janet Dancey
, David R. Gandara

Research output: Contribution to journal › Article › peer-review

281 Scopus citations

Abstract

Purpose: To evaluate the response to lapatinib, an inhibitor of epidermal growth factor receptors 1 and 2, in patients with advanced bilary tree cancer (BTC) and hepatocellular cancer (HCC). Methods: Lapatinib was dosed at 1,500 mg/day orally continuously. Results: Fifty-seven patients were accrued (BTC 17, HCC 40). Therapy was well tolerated. The response in BTC was 0% and in HCC was 5%. The progression free survival (PFS) for BTC and HCC patients was 1.8 (95% CI: 1.7-5.2) months and 2.3 (95% CI: 1.7-5.6) months. The median survival for BTC and HCC patients was 5.2 (95% CI 3.3-∞) months and 6.2 (95% CI: 5.1-∞) months. EGFR genotyping indicated HCC patients with <20 repeats have the lowest PFS. The occurrence of any skin rash significantly prolonged PFS and survival. Conclusions: Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.

Original language	English (US)
Pages (from-to)	777-783
Number of pages	7
Journal	Cancer Chemotherapy and Pharmacology
Volume	64
Issue number	4
DOIs	https://doi.org/10.1007/s00280-009-0927-7
State	Published - Sep 2009

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

All Science Journal Classification (ASJC) codes

Oncology
Toxicology
Pharmacology
Cancer Research
Pharmacology (medical)

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10.1007/s00280-009-0927-7

Cite this

Ramanathan, R. K., Belani, C. P., Singh, D. A., Tanaka, M., Lenz, H. J., Yen, Y., Kindler, H. L., Iqbal, S., Longmate, J., MacK, P. C., Lurje, G., Gandour-Edwards, R., Dancey, J., & Gandara, D. R. (2009). A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer. Cancer Chemotherapy and Pharmacology, 64(4), 777-783. https://doi.org/10.1007/s00280-009-0927-7

@article{752c3f66f3e74028b666e0c4b108544e,

title = "A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer",

abstract = "Purpose: To evaluate the response to lapatinib, an inhibitor of epidermal growth factor receptors 1 and 2, in patients with advanced bilary tree cancer (BTC) and hepatocellular cancer (HCC). Methods: Lapatinib was dosed at 1,500 mg/day orally continuously. Results: Fifty-seven patients were accrued (BTC 17, HCC 40). Therapy was well tolerated. The response in BTC was 0\% and in HCC was 5\%. The progression free survival (PFS) for BTC and HCC patients was 1.8 (95\% CI: 1.7-5.2) months and 2.3 (95\% CI: 1.7-5.6) months. The median survival for BTC and HCC patients was 5.2 (95\% CI 3.3-∞) months and 6.2 (95\% CI: 5.1-∞) months. EGFR genotyping indicated HCC patients with <20 repeats have the lowest PFS. The occurrence of any skin rash significantly prolonged PFS and survival. Conclusions: Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.",

author = "Ramanathan, \{Ramesh K.\} and Belani, \{Chandra P.\} and Singh, \{Deepti A.\} and Michael Tanaka and Lenz, \{Heinz Josef\} and Yun Yen and Kindler, \{Hedy L.\} and Syma Iqbal and Jeff Longmate and MacK, \{Philip C.\} and Georg Lurje and Regina Gandour-Edwards and Janet Dancey and Gandara, \{David R.\}",

note = "Funding Information: Acknowledgments This study was sponsored by the Cancer Therapy and Evaluation Program of the National Cancer Institute, Funding Information: All patients signed an informed consent prior to therapy, according to institutional and federal guidelines. The study was sponsored by the Cancer Therapy and Evaluation Program (CTEP) of the National Cancer Institute (NCI) and conducted by the phase II consortiums of California, Pittsburgh and the University of Chicago. Funding Information: Bethesda, MD 20892. Presented in part at the 42nd annual meeting of the American Society of Clinical Oncology, Orlando, FL. June 2006. Supported in part by NCI-NO1-CM-57018-16 (California Consortium), Dhont Foundation (HJ Lenz). P30CA47904 and NIH/NCCR/ GCRC \#5M01 RR 00056 (University of Pittsburgh Cancer Institute and Medical Center). The authors wish to thank Christine Garcia and Stella Chen, CCC-P coordinators for data management and coordination of study.",

year = "2009",

month = sep,

doi = "10.1007/s00280-009-0927-7",

language = "English (US)",

volume = "64",

pages = "777--783",

journal = "Cancer Chemotherapy and Pharmacology",

issn = "0344-5704",

publisher = "Springer Science and Business Media Deutschland GmbH",

number = "4",

}

Ramanathan, RK, Belani, CP, Singh, DA, Tanaka, M, Lenz, HJ, Yen, Y, Kindler, HL, Iqbal, S, Longmate, J, MacK, PC, Lurje, G, Gandour-Edwards, R, Dancey, J & Gandara, DR 2009, 'A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer', Cancer Chemotherapy and Pharmacology, vol. 64, no. 4, pp. 777-783. https://doi.org/10.1007/s00280-009-0927-7

TY - JOUR

T1 - A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer

AU - Ramanathan, Ramesh K.

AU - Belani, Chandra P.

AU - Singh, Deepti A.

AU - Tanaka, Michael

AU - Lenz, Heinz Josef

AU - Yen, Yun

AU - Kindler, Hedy L.

AU - Iqbal, Syma

AU - Longmate, Jeff

AU - MacK, Philip C.

AU - Lurje, Georg

AU - Gandour-Edwards, Regina

AU - Dancey, Janet

AU - Gandara, David R.

N1 - Funding Information: Acknowledgments This study was sponsored by the Cancer Therapy and Evaluation Program of the National Cancer Institute, Funding Information: All patients signed an informed consent prior to therapy, according to institutional and federal guidelines. The study was sponsored by the Cancer Therapy and Evaluation Program (CTEP) of the National Cancer Institute (NCI) and conducted by the phase II consortiums of California, Pittsburgh and the University of Chicago. Funding Information: Bethesda, MD 20892. Presented in part at the 42nd annual meeting of the American Society of Clinical Oncology, Orlando, FL. June 2006. Supported in part by NCI-NO1-CM-57018-16 (California Consortium), Dhont Foundation (HJ Lenz). P30CA47904 and NIH/NCCR/ GCRC #5M01 RR 00056 (University of Pittsburgh Cancer Institute and Medical Center). The authors wish to thank Christine Garcia and Stella Chen, CCC-P coordinators for data management and coordination of study.

PY - 2009/9

Y1 - 2009/9

N2 - Purpose: To evaluate the response to lapatinib, an inhibitor of epidermal growth factor receptors 1 and 2, in patients with advanced bilary tree cancer (BTC) and hepatocellular cancer (HCC). Methods: Lapatinib was dosed at 1,500 mg/day orally continuously. Results: Fifty-seven patients were accrued (BTC 17, HCC 40). Therapy was well tolerated. The response in BTC was 0% and in HCC was 5%. The progression free survival (PFS) for BTC and HCC patients was 1.8 (95% CI: 1.7-5.2) months and 2.3 (95% CI: 1.7-5.6) months. The median survival for BTC and HCC patients was 5.2 (95% CI 3.3-∞) months and 6.2 (95% CI: 5.1-∞) months. EGFR genotyping indicated HCC patients with <20 repeats have the lowest PFS. The occurrence of any skin rash significantly prolonged PFS and survival. Conclusions: Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.

AB - Purpose: To evaluate the response to lapatinib, an inhibitor of epidermal growth factor receptors 1 and 2, in patients with advanced bilary tree cancer (BTC) and hepatocellular cancer (HCC). Methods: Lapatinib was dosed at 1,500 mg/day orally continuously. Results: Fifty-seven patients were accrued (BTC 17, HCC 40). Therapy was well tolerated. The response in BTC was 0% and in HCC was 5%. The progression free survival (PFS) for BTC and HCC patients was 1.8 (95% CI: 1.7-5.2) months and 2.3 (95% CI: 1.7-5.6) months. The median survival for BTC and HCC patients was 5.2 (95% CI 3.3-∞) months and 6.2 (95% CI: 5.1-∞) months. EGFR genotyping indicated HCC patients with <20 repeats have the lowest PFS. The occurrence of any skin rash significantly prolonged PFS and survival. Conclusions: Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.

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UR - https://www.scopus.com/pages/publications/68149164263#tab=citedBy

U2 - 10.1007/s00280-009-0927-7

DO - 10.1007/s00280-009-0927-7

M3 - Article

C2 - 19169683

AN - SCOPUS:68149164263

SN - 0344-5704

VL - 64

SP - 777

EP - 783

JO - Cancer Chemotherapy and Pharmacology

JF - Cancer Chemotherapy and Pharmacology

IS - 4

ER -

A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer

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