Randomized 2 x 2 trial evaluating hormonal treatment and the duration of chemotherapy in node-positive breast cancer patients. German Breast Cancer Study Group.

Schumacher, Martin; Bastert, G.; Bojar, Hans; Hübner, K.; Olschewski, Manfred; Sauerbrei, Willi; Schmoor, Claudia; Beyerle, C.; Neumann, R. L. A.; Rauschecker, H.

doi:10.1200/jco.1994.12.10.2086

Cited by 189 publications

(130 citation statements)

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“…[1]; [2]) and other clinical interventions (see, e.g., [3]; [4]). How patient preference influences outcome is not precisely understood, but the idea that it does affect results has been posited.…”

Section: Introductionmentioning

confidence: 99%

The effect of patient choice of intervention on health outcomes

Clark

Janz

Dodge

et al. 2008

Contemporary Clinical Trials

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Section: Introductionmentioning

confidence: 99%

The effect of patient choice of intervention on health outcomes

Clark

Janz

Dodge

et al. 2008

Contemporary Clinical Trials

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“…As an example, we use 415 patients with primary non-metastatic, nodepositive breast cancer who have been treated between 1984 and 1989 within two studies of the German Breast Cancer Study Group (GBSG) uniformly with six cycles of chemotherapy following mastectomy [2,3]. For illustrative purposes, we imagine the situation where these 415 uniformly treated patients had been the study population of a randomized clinical trial comparing two hypothetical treatments.…”

Section: Methodsmentioning

confidence: 99%

On Problems Related to Subgroup Analyses in Clinical Trials

Schmoor¹

2000

Oncol Res Treat

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Background: The intention of randomized clinical trials is usually the comparison of two or more treatments in a population of patients with a specific disease. Most often, the trial is planned for an overall comparison of the treatment groups. During data analysis of the trial often further questions emerge for treatment differences in certain subgroups of patients defined by prognostic factors. In extreme situations, this may lead to a division into many different subgroups. The treatment groups are then compared with respect to the outcome of interest in each subgroup. Material and Methods: The probable consequences of this procedure are illustrated by means of a ‘hypothetical clinical trial’ in breast cancer patients. Results: It is shown that ‘significant’ differences between treatment groups can emerge just by chance. Conclusion: With an extensive subgroup analysis the probability of falsely judging a non-existing difference as significant is no longer controlled and the results may be misleading.

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“…Histopathologic classification was re-examined, and grading was performed centrally in two histopathologic reference centers. Methods for determination of the factors have been described previously [2,5]. Patients were followed up at regular intervals to ensure detection of any kind of recurrence at the earliest time possible.…”

Section: Methodsmentioning

confidence: 99%

Long-Term Follow-Up of Patients in Four Prospective Studies of the German Breast Cancer Study Group (GBSG): A Summary of Key Results

Schmoor

Olschewski²,

Sauerbrei³

et al. 2002

Oncol Res Treat

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Evaluation of treatment modalities and prognostic factors in early breast cancer requires a long-term follow-up of patients in prospective studies. The German Breast Cancer Study Group (GBSG) started four nationwide studies in 1983 in which a total of 2,746 patients have been enrolled and followed for about 10 years. Questions that have been addressed in these studies are still relevant today and comprise the role of breast-conserving therapy, the duration of adjuvant chemotherapy, and whether adjuvant radiotherapy is needed. The key results of these studies are highlighted including some important findings on prognosis, e.g., the role of isolated locoregional recurrence and the prognosis of patients with 10 or more positive lymph nodes. The data of all randomized patients were regularly included into the overviews of the Early Breast Cancer Trialists’ Collaborative Group; the data of the nonrandomized patients have been used to examine the external validity of treatment comparisons. Overall, it can be concluded that the GBSG studies have made valuable and internationally recognized contributions to the prognosis and treatment of patients with early breast cancer.

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Randomized 2 x 2 trial evaluating hormonal treatment and the duration of chemotherapy in node-positive breast cancer patients. German Breast Cancer Study Group.

Abstract: At this stage of follow-up, six courses of CMF are not superior to three courses with respect to recurrence-free survival.

Cited by 189 publications

References 0 publications

The effect of patient choice of intervention on health outcomes

The effect of patient choice of intervention on health outcomes

On Problems Related to Subgroup Analyses in Clinical Trials

Long-Term Follow-Up of Patients in Four Prospective Studies of the German Breast Cancer Study Group (GBSG): A Summary of Key Results

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