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A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma.

Publication ,  Journal Article
Rothenberg, ML; Abbruzzese, JL; Moore, M; Portenoy, RK; Robertson, JM; Wanebo, HJ
Published in: Cancer
August 1, 1996

BACKGROUND: Using classical endpoints, such as response rate and survival, as the sole measures of benefit, little progress has been made in the treatment of advanced pancreatic carcinoma in the past 30 years. We challenge the assumption that response rate and survival are the only appropriate endpoints for clinical trials in this disease setting. METHOD: A review of the literature and roundtable discussion were undertaken. RESULTS: Using current imaging techniques, it is inherently difficult to distinguish pancreatic tumor from normal pancreas, inflammatory tissue, local fibrosis, and unopacified bowel. As a result, objective tumor measurements are often imprecise, unreliable, and irreproducible. This difficulty may explain the wide variation in response rates reported in clinical trials even when the same therapies are used. Tumor-related symptoms, such as anorexia, weight loss, severe pain (requiring opioid analgesia), and impaired functional status, are prevalent and debilitating characteristics of this disease. Tools that can assess these symptoms in a consistent fashion over time have been developed and have been integrated into clinical trials to evaluate new drugs in this setting. CONCLUSIONS: Systematic assessment of the impact of a new therapy on tumor-related symptoms may provide a sensitive and accurate way to identify useful new treatments for patients with advanced pancreatic carcinoma. Such analyses can be a useful complement to the classical endpoints of response rate and survival.

Duke Scholars

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

August 1, 1996

Volume

78

Issue

3 Suppl

Start / End Page

627 / 632

Location

United States

Related Subject Headings

  • Pancreatic Neoplasms
  • Oncology & Carcinogenesis
  • Humans
  • Clinical Trials as Topic
  • 4206 Public health
  • 3211 Oncology and carcinogenesis
  • 1117 Public Health and Health Services
  • 1112 Oncology and Carcinogenesis
 

Citation

APA
Chicago
ICMJE
MLA
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Rothenberg, M. L., Abbruzzese, J. L., Moore, M., Portenoy, R. K., Robertson, J. M., & Wanebo, H. J. (1996). A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma. Cancer, 78(3 Suppl), 627–632. https://doi.org/10.1002/(SICI)1097-0142(19960801)78:3<627::AID-CNCR43>3.0.CO;2-Y
Rothenberg, M. L., J. L. Abbruzzese, M. Moore, R. K. Portenoy, J. M. Robertson, and H. J. Wanebo. “A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma.Cancer 78, no. 3 Suppl (August 1, 1996): 627–32. https://doi.org/10.1002/(SICI)1097-0142(19960801)78:3<627::AID-CNCR43>3.0.CO;2-Y.
Rothenberg ML, Abbruzzese JL, Moore M, Portenoy RK, Robertson JM, Wanebo HJ. A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma. Cancer. 1996 Aug 1;78(3 Suppl):627–32.
Rothenberg, M. L., et al. “A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma.Cancer, vol. 78, no. 3 Suppl, Aug. 1996, pp. 627–32. Pubmed, doi:10.1002/(SICI)1097-0142(19960801)78:3<627::AID-CNCR43>3.0.CO;2-Y.
Rothenberg ML, Abbruzzese JL, Moore M, Portenoy RK, Robertson JM, Wanebo HJ. A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma. Cancer. 1996 Aug 1;78(3 Suppl):627–632.
Journal cover image

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

August 1, 1996

Volume

78

Issue

3 Suppl

Start / End Page

627 / 632

Location

United States

Related Subject Headings

  • Pancreatic Neoplasms
  • Oncology & Carcinogenesis
  • Humans
  • Clinical Trials as Topic
  • 4206 Public health
  • 3211 Oncology and carcinogenesis
  • 1117 Public Health and Health Services
  • 1112 Oncology and Carcinogenesis