P68 An alternative to the customary reporting of common toxicity criteria

152s Abstracts P68 AN ALTERNATIVE TO THE CUSTOMARY REPORTING OF COMMON TOXICITY CRITERIA Stewart Anderson, Authur Decillis and Wei Tian University of Pittsburgh and the NationalSurgical Adjuvant Breast and Bowel Project (NSABP) Pittsburgh, Pennsylvania Io most breast cancer treatment clinical trials, the hypotheses of interest involve comparing two or more agents with respect to their ability to reduce mortality and recurrence of the disease in certain populations of patients. Often, the agents of interest are administered over several courses. To adequately assess such agents, one must consider not only their associated efficacy but also adverse reactions that may occur with their administration. Such adverse reactions are often reported using a set of standards known as the common toxicity criteria. Common toxicity criteria are routinely summarized separately for each course of therapy. Such “marginal” summaries provide “snapshots” of a population’s well being at a given course but do not track each patient’s status over time. Alternatively, one could track each patient’s statns over the courses of therapy and then summarize by combining across patients. One can then analyze the population’s status by the use of Markov processes and other repeated measures techniques. In this presentation, we compare the two strategies for summarizing toxicity information for over 4800 node-positive patients randomized into NSABP Protocols B-22 and B-25. Patients in both of these studies are given a standard dose of Adriamycin (A) over four conrses of therapy. In B-22, patients were randomized into one of the following regimens of Cyclophosphamide (C): 600 mg/m* x 4 courses, 1200 mglm’x 2 courses or 1200 mg/m *x 4 courses. In B-25, patients were randomized into one of the following regimens of C: 1200 mglm’ x 4 courses, 2400 mg/m’ x 2 courses or 2400 mg/m’ x 4 courses. Patients in B-25 also received G-CSF support. We focus on the following questions: “Does toxicity increase with repeated administration of AC chemotherapy? n and “How should multiple toxicities per patient be presented?” P69 IMPROVING COMPLIANCE - THE ADMINISTRATION OF QUALITY OF LIFE QUESTIONNAIRES WITHIN CANCER CLINICAL TRIALS Karen Poulter, Maxine Stead and Julia Brown Yorkshire Clinical Trials and Research Unit Leeds, UnitedKingdom Measurement of the Qnality of Life (QoL) of cancer patients is now perceived as a major element of cancer treatment. Obtaining such information from these patients however can sometimes be difficult due to health status and it is therefore essential that procedures are adopted which will maximize the potential of gathering such information. QoL studies which have been carried out within several trials conducted by the Yorkshire Clinical Trials and Research Unit in Leeds have identified various areas as being conducive to obtaining good compliance rates. The following identified areas will be discussed:

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Transcript of P68 An alternative to the customary reporting of common toxicity criteria

152s Abstracts

P68 AN ALTERNATIVE TO THE CUSTOMARY REPORTING OF COMMON

TOXICITY CRITERIA

Stewart Anderson, Authur Decillis and Wei Tian University of Pittsburgh and the National Surgical Adjuvant

Breast and Bowel Project (NSABP) Pittsburgh, Pennsylvania

Io most breast cancer treatment clinical trials, the hypotheses of interest involve comparing two or more agents with respect to their ability to reduce mortality and recurrence of the disease in certain populations of patients. Often, the agents of interest are administered over several courses. To adequately assess such agents, one must consider not only their associated efficacy but also adverse reactions that may occur with their administration. Such adverse reactions are often reported using a set of standards known as the common toxicity criteria.

Common toxicity criteria are routinely summarized separately for each course of therapy. Such “marginal” summaries provide “snapshots” of a population’s well being at a given course but do not track each patient’s status over time. Alternatively, one could track each patient’s statns over the courses of therapy and then summarize by combining across patients. One can then analyze the population’s status by the use of Markov processes and other repeated measures techniques.

In this presentation, we compare the two strategies for summarizing toxicity information for over 4800 node-positive patients randomized into NSABP Protocols B-22 and B-25. Patients in both of these studies are given a standard dose of Adriamycin (A) over four conrses of therapy. In B-22, patients were randomized into one of the following regimens of Cyclophosphamide (C): 600 mg/m* x 4 courses, 1200 mglm’x 2 courses or 1200 mg/m *x 4 courses. In B-25, patients were randomized into one of the following regimens of C: 1200 mglm’ x 4 courses, 2400 mg/m’ x 2 courses or 2400 mg/m’ x 4 courses. Patients in B-25 also received G-CSF support. We focus on the following questions: “Does toxicity increase with repeated administration of AC chemotherapy? n and “How should multiple toxicities per patient be presented?”

P69 IMPROVING COMPLIANCE - THE ADMINISTRATION OF QUALITY OF LIFE

QUESTIONNAIRES WITHIN CANCER CLINICAL TRIALS

Karen Poulter, Maxine Stead and Julia Brown Yorkshire Clinical Trials and Research Unit

Leeds, United Kingdom

Measurement of the Qnality of Life (QoL) of cancer patients is now perceived as a major element of cancer treatment. Obtaining such information from these patients however can sometimes be difficult due to health status and it is therefore essential that procedures are adopted which will maximize the potential of gathering such information. QoL studies which have been carried out within several trials conducted by the Yorkshire Clinical Trials and Research Unit in Leeds have identified various areas as being conducive to obtaining good compliance rates. The following identified areas will be discussed: