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Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer
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| Zeitschriftentitel: | Cancer Prevention Research |
|---|---|
| Personen und Körperschaften: | , , , , , , , , , , , , , , , , , |
| In: | Cancer Prevention Research, 5, 2012, 9, S. 1144-1154 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Association for Cancer Research (AACR)
|
| Schlagwörter: |
| author_facet |
Crew, Katherine D. Brown, Powel Greenlee, Heather Bevers, Therese B. Arun, Banu Hudis, Clifford McArthur, Heather L. Chang, Jenny Rimawi, Mothaffar Vornik, Lana Cornelison, Terri L. Wang, Antai Hibshoosh, Hanina Ahmed, Aqeel Terry, Mary Beth Santella, Regina M. Lippman, Scott M. Hershman, Dawn L. Crew, Katherine D. Brown, Powel Greenlee, Heather Bevers, Therese B. Arun, Banu Hudis, Clifford McArthur, Heather L. Chang, Jenny Rimawi, Mothaffar Vornik, Lana Cornelison, Terri L. Wang, Antai Hibshoosh, Hanina Ahmed, Aqeel Terry, Mary Beth Santella, Regina M. Lippman, Scott M. Hershman, Dawn L. |
|---|---|
| author |
Crew, Katherine D. Brown, Powel Greenlee, Heather Bevers, Therese B. Arun, Banu Hudis, Clifford McArthur, Heather L. Chang, Jenny Rimawi, Mothaffar Vornik, Lana Cornelison, Terri L. Wang, Antai Hibshoosh, Hanina Ahmed, Aqeel Terry, Mary Beth Santella, Regina M. Lippman, Scott M. Hershman, Dawn L. |
| spellingShingle |
Crew, Katherine D. Brown, Powel Greenlee, Heather Bevers, Therese B. Arun, Banu Hudis, Clifford McArthur, Heather L. Chang, Jenny Rimawi, Mothaffar Vornik, Lana Cornelison, Terri L. Wang, Antai Hibshoosh, Hanina Ahmed, Aqeel Terry, Mary Beth Santella, Regina M. Lippman, Scott M. Hershman, Dawn L. Cancer Prevention Research Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer Cancer Research Oncology |
| author_sort |
crew, katherine d. |
| spelling |
Crew, Katherine D. Brown, Powel Greenlee, Heather Bevers, Therese B. Arun, Banu Hudis, Clifford McArthur, Heather L. Chang, Jenny Rimawi, Mothaffar Vornik, Lana Cornelison, Terri L. Wang, Antai Hibshoosh, Hanina Ahmed, Aqeel Terry, Mary Beth Santella, Regina M. Lippman, Scott M. Hershman, Dawn L. 1940-6207 1940-6215 American Association for Cancer Research (AACR) Cancer Research Oncology http://dx.doi.org/10.1158/1940-6207.capr-12-0117 <jats:title>Abstract</jats:title> <jats:p>Epidemiologic data support an inverse association between green tea intake and breast cancer risk, and numerous experimental studies have shown the antitumor effects of its main component, epigallocatechin gallate (EGCG). We conducted a phase IB dose escalation trial in women with a history of stage I to III hormone receptor–negative breast cancer of an oral green tea extract, polyphenon E (Poly E) 400, 600, 800 twice daily or matching placebo for 6 months. The primary endpoint was to determine the maximum tolerated dose (MTD), defined as the dose that causes 25% dose-limiting toxicity (DLT, grade ≥II). Assignment to dose level was based upon an adaptive design, the continual reassessment method. A mammogram and random core biopsy of the contralateral breast were obtained at baseline and 6 months and serial blood/urine collections every 2 months for biomarker analyses. Forty women were randomized: 10 to placebo, 30 to Poly E (16 at 400 mg, 11 at 600 mg, 3 at 800 mg). There was one DLT at 400 mg (grade III rectal bleeding), three DLTs at 600 mg (grade II weight gain, grade III indigestion and insomnia), and one DLT at 800 mg (grade III liver function abnormality). The DLT rate at 600 mg was 27% (3 of 11). Pharmacologic levels of total urinary tea polyphenols were achieved with all three dose levels of Poly E. Using a novel phase I trial design, we determined the MTD for Poly E to be 600 mg twice daily. This study highlights the importance of assessing toxicity for any chemopreventive agent being developed for chronic use in healthy individuals. Cancer Prev Res; 5(9); 1144–54. ©2012 AACR.</jats:p> Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer Cancer Prevention Research |
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| title |
Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_unstemmed |
Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_full |
Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_fullStr |
Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_full_unstemmed |
Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_short |
Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_sort |
phase ib randomized, double-blinded, placebo-controlled, dose escalation study of polyphenon e in women with hormone receptor–negative breast cancer |
| topic |
Cancer Research Oncology |
| url |
http://dx.doi.org/10.1158/1940-6207.capr-12-0117 |
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2012 |
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1144-1154 |
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<jats:title>Abstract</jats:title>
<jats:p>Epidemiologic data support an inverse association between green tea intake and breast cancer risk, and numerous experimental studies have shown the antitumor effects of its main component, epigallocatechin gallate (EGCG). We conducted a phase IB dose escalation trial in women with a history of stage I to III hormone receptor–negative breast cancer of an oral green tea extract, polyphenon E (Poly E) 400, 600, 800 twice daily or matching placebo for 6 months. The primary endpoint was to determine the maximum tolerated dose (MTD), defined as the dose that causes 25% dose-limiting toxicity (DLT, grade ≥II). Assignment to dose level was based upon an adaptive design, the continual reassessment method. A mammogram and random core biopsy of the contralateral breast were obtained at baseline and 6 months and serial blood/urine collections every 2 months for biomarker analyses. Forty women were randomized: 10 to placebo, 30 to Poly E (16 at 400 mg, 11 at 600 mg, 3 at 800 mg). There was one DLT at 400 mg (grade III rectal bleeding), three DLTs at 600 mg (grade II weight gain, grade III indigestion and insomnia), and one DLT at 800 mg (grade III liver function abnormality). The DLT rate at 600 mg was 27% (3 of 11). Pharmacologic levels of total urinary tea polyphenols were achieved with all three dose levels of Poly E. Using a novel phase I trial design, we determined the MTD for Poly E to be 600 mg twice daily. This study highlights the importance of assessing toxicity for any chemopreventive agent being developed for chronic use in healthy individuals. Cancer Prev Res; 5(9); 1144–54. ©2012 AACR.</jats:p> |
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| author | Crew, Katherine D., Brown, Powel, Greenlee, Heather, Bevers, Therese B., Arun, Banu, Hudis, Clifford, McArthur, Heather L., Chang, Jenny, Rimawi, Mothaffar, Vornik, Lana, Cornelison, Terri L., Wang, Antai, Hibshoosh, Hanina, Ahmed, Aqeel, Terry, Mary Beth, Santella, Regina M., Lippman, Scott M., Hershman, Dawn L. |
| author_facet | Crew, Katherine D., Brown, Powel, Greenlee, Heather, Bevers, Therese B., Arun, Banu, Hudis, Clifford, McArthur, Heather L., Chang, Jenny, Rimawi, Mothaffar, Vornik, Lana, Cornelison, Terri L., Wang, Antai, Hibshoosh, Hanina, Ahmed, Aqeel, Terry, Mary Beth, Santella, Regina M., Lippman, Scott M., Hershman, Dawn L., Crew, Katherine D., Brown, Powel, Greenlee, Heather, Bevers, Therese B., Arun, Banu, Hudis, Clifford, McArthur, Heather L., Chang, Jenny, Rimawi, Mothaffar, Vornik, Lana, Cornelison, Terri L., Wang, Antai, Hibshoosh, Hanina, Ahmed, Aqeel, Terry, Mary Beth, Santella, Regina M., Lippman, Scott M., Hershman, Dawn L. |
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| description | <jats:title>Abstract</jats:title> <jats:p>Epidemiologic data support an inverse association between green tea intake and breast cancer risk, and numerous experimental studies have shown the antitumor effects of its main component, epigallocatechin gallate (EGCG). We conducted a phase IB dose escalation trial in women with a history of stage I to III hormone receptor–negative breast cancer of an oral green tea extract, polyphenon E (Poly E) 400, 600, 800 twice daily or matching placebo for 6 months. The primary endpoint was to determine the maximum tolerated dose (MTD), defined as the dose that causes 25% dose-limiting toxicity (DLT, grade ≥II). Assignment to dose level was based upon an adaptive design, the continual reassessment method. A mammogram and random core biopsy of the contralateral breast were obtained at baseline and 6 months and serial blood/urine collections every 2 months for biomarker analyses. Forty women were randomized: 10 to placebo, 30 to Poly E (16 at 400 mg, 11 at 600 mg, 3 at 800 mg). There was one DLT at 400 mg (grade III rectal bleeding), three DLTs at 600 mg (grade II weight gain, grade III indigestion and insomnia), and one DLT at 800 mg (grade III liver function abnormality). The DLT rate at 600 mg was 27% (3 of 11). Pharmacologic levels of total urinary tea polyphenols were achieved with all three dose levels of Poly E. Using a novel phase I trial design, we determined the MTD for Poly E to be 600 mg twice daily. This study highlights the importance of assessing toxicity for any chemopreventive agent being developed for chronic use in healthy individuals. Cancer Prev Res; 5(9); 1144–54. ©2012 AACR.</jats:p> |
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| spelling | Crew, Katherine D. Brown, Powel Greenlee, Heather Bevers, Therese B. Arun, Banu Hudis, Clifford McArthur, Heather L. Chang, Jenny Rimawi, Mothaffar Vornik, Lana Cornelison, Terri L. Wang, Antai Hibshoosh, Hanina Ahmed, Aqeel Terry, Mary Beth Santella, Regina M. Lippman, Scott M. Hershman, Dawn L. 1940-6207 1940-6215 American Association for Cancer Research (AACR) Cancer Research Oncology http://dx.doi.org/10.1158/1940-6207.capr-12-0117 <jats:title>Abstract</jats:title> <jats:p>Epidemiologic data support an inverse association between green tea intake and breast cancer risk, and numerous experimental studies have shown the antitumor effects of its main component, epigallocatechin gallate (EGCG). We conducted a phase IB dose escalation trial in women with a history of stage I to III hormone receptor–negative breast cancer of an oral green tea extract, polyphenon E (Poly E) 400, 600, 800 twice daily or matching placebo for 6 months. The primary endpoint was to determine the maximum tolerated dose (MTD), defined as the dose that causes 25% dose-limiting toxicity (DLT, grade ≥II). Assignment to dose level was based upon an adaptive design, the continual reassessment method. A mammogram and random core biopsy of the contralateral breast were obtained at baseline and 6 months and serial blood/urine collections every 2 months for biomarker analyses. Forty women were randomized: 10 to placebo, 30 to Poly E (16 at 400 mg, 11 at 600 mg, 3 at 800 mg). There was one DLT at 400 mg (grade III rectal bleeding), three DLTs at 600 mg (grade II weight gain, grade III indigestion and insomnia), and one DLT at 800 mg (grade III liver function abnormality). The DLT rate at 600 mg was 27% (3 of 11). Pharmacologic levels of total urinary tea polyphenols were achieved with all three dose levels of Poly E. Using a novel phase I trial design, we determined the MTD for Poly E to be 600 mg twice daily. This study highlights the importance of assessing toxicity for any chemopreventive agent being developed for chronic use in healthy individuals. Cancer Prev Res; 5(9); 1144–54. ©2012 AACR.</jats:p> Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer Cancer Prevention Research |
| spellingShingle | Crew, Katherine D., Brown, Powel, Greenlee, Heather, Bevers, Therese B., Arun, Banu, Hudis, Clifford, McArthur, Heather L., Chang, Jenny, Rimawi, Mothaffar, Vornik, Lana, Cornelison, Terri L., Wang, Antai, Hibshoosh, Hanina, Ahmed, Aqeel, Terry, Mary Beth, Santella, Regina M., Lippman, Scott M., Hershman, Dawn L., Cancer Prevention Research, Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer, Cancer Research, Oncology |
| title | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_full | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_fullStr | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_full_unstemmed | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_short | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| title_sort | phase ib randomized, double-blinded, placebo-controlled, dose escalation study of polyphenon e in women with hormone receptor–negative breast cancer |
| title_unstemmed | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer |
| topic | Cancer Research, Oncology |
| url | http://dx.doi.org/10.1158/1940-6207.capr-12-0117 |