A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma
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Le résumé fourni par la source
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. Cancer 1996;78:627-32.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A rationale for expanding the endpoints for clinical trials in advanced pancreatic carcinoma
- Date Crossref
- 01/08/1996
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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The University of Texas at San Antonio Health Science Center pays non établi dans la noticeUniversité ou école supérieure
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The University of Texas MD Anderson Cancer Center pays non établi dans la noticeÉtablissement de santé
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Princess Margaret Cancer Centre pays non établi dans la noticeÉtablissement de santé
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Memorial Sloan Kettering Cancer Center pays non établi dans la noticeÉtablissement de santé
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University of Michigan Department of Radiation Oncology pays non établi dans la noticeUniversité ou école supérieure
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Roger Williams Medical Center pays non établi dans la noticeÉtablissement de santé
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University of Texas Health Science Center Division of Medical Oncology pays non établi dans la noticeUniversité ou école supérieure
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Department of Gastrointestinal Oncology pays non établi dans la noticeInstitution
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Princess Margaret Hospital Department of Medicine pays non établi dans la noticeÉtablissement de santé
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Department of Neurology pays non établi dans la noticeInstitution
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Brown University School of Medicine Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
The University of Texas at San Antonio Health Science Center, The University of Texas MD Anderson Cancer Center et Princess Margaret Cancer Centre, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.