Survey of modalities of toxicity assessment and reporting in noncomparative prospective studies of chemotherapy in breast cancer

Francesco Perrone, Ermelinda De Maio, Paolo Maione, Massimo Di Maio, Alessandro Ottaiano, Matilde Pensabene, Giuseppe Di Lorenzo, Alessandra Vernaglia Lombardi, Ciro Gallo

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Abstract

Purpose: To review how toxicity, a main end point of phase II studies, is assessed and reported in published phase II chemotherapy trials in breast cancer. Methods: A survey was performed by hand-searching studies published in seven distinguished journals between 1995 and 1999. All selected articles were independently evaluated by two investigators using an ad hoc study report form. Descriptive statistics, contingency tables, and the χ2 test were applied. Results: Overall, 122 articles were found; 65.6% lacked a statistical study design. Planned modalities for assessment of toxicity were inadequately reported in 20.5% of the studies. The scheduling of assessment of hematologic toxicity varied greatly. Toxicity was predominantly summarized per patient (69.7%). Although overall the World Health Organization scale was adopted more frequently (45.9%), the Common Toxicity Criteria (in different versions) were used more frequently in studies published in journals with a high impact factor (P = .001), in more recently initiated studies (P = .03), in sponsored studies (P = .0006), and in studies with an identifiable statistical design (P = .006). Conclusion: The wide diversity in modalities of toxicity assessment and reporting observed in this study suggests that the reliability of the body of published data on the toxicity of chemotherapy in breast cancer may be questionable. Current standards should be revised and harmonized to improve the reliability of such data. A checklist is proposed to help editorial evaluation of assessment and reporting of toxicity in phase II studies.

Original languageEnglish
Pages (from-to)52-57
Number of pages6
JournalJournal of Clinical Oncology
Volume20
Issue number1
DOIs
Publication statusPublished - Jan 1 2002

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  • Oncology

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Survey of modalities of toxicity assessment and reporting in noncomparative prospective studies of chemotherapy in breast cancer. / Perrone, Francesco; De Maio, Ermelinda; Maione, Paolo; Di Maio, Massimo; Ottaiano, Alessandro; Pensabene, Matilde; Di Lorenzo, Giuseppe; Lombardi, Alessandra Vernaglia; Gallo, Ciro.

In: Journal of Clinical Oncology, Vol. 20, No. 1, 01.01.2002, p. 52-57.

Research output: Contribution to journalArticle

Perrone, Francesco ; De Maio, Ermelinda ; Maione, Paolo ; Di Maio, Massimo ; Ottaiano, Alessandro ; Pensabene, Matilde ; Di Lorenzo, Giuseppe ; Lombardi, Alessandra Vernaglia ; Gallo, Ciro. / Survey of modalities of toxicity assessment and reporting in noncomparative prospective studies of chemotherapy in breast cancer. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 1. pp. 52-57.
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AU - Ottaiano, Alessandro

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AU - Di Lorenzo, Giuseppe

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