Randomized trial on the effect of radiotherapy in addition to 6 cycles CMF in node-positive breast-cancer patients

Schmoor, Claudia; Bastert, G.; Dunst, Jürgen; Bojar, Hans; Christmann, D; Unbehaun, V.; Tummers, G; Bauer, Wolfgang; Sauerbrei, Willi; Schumacher, Martin

doi:10.1016/s1278-3218(00)00077-9

Cited by 5 publications

(17 citation statements)

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“…The sum of local and distant "first events" in the study of Schmoor et al (2000) was 52 vs. 36% (RR ϭ 0.71), figures corresponding more to the results of other long-term trials assessing distant events. Also Table II in Schmoor et al (2000), but not the text, shows a sum of all distant failures counted as events for survival free of distant disease as 52% vs. 42% in CT vs. CT ϩ RT arms, respectively. These figures confirm a substantial reduction of distant events by RT, with a 20% odds reduction (i.e., RR ϭ 0.80), in line with other published randomized trials.…”

Section: Systemic Relapsesmentioning

confidence: 58%

“…In the prior large randomized trials, including the recent EBCTCG meta-analysis, the RRs of nonbreast cancer deaths between irradiated and unirradiated cases were only moderately increased in irradiated patients, with a range of 1.2-1.5 (Table III). The risk of non-breast cancer deaths, however, was substantially higher in the study of Schmoor et al (2000), with RR ϭ 3.7.…”

Section: Systemic Relapsesmentioning

confidence: 76%

“…BREAST CANCER-RELATED EVENTS Table I shows the sum of breast cancer recurrences among irradiated and unirradiated patients in the study of Schmoor et al (2000). There is a significant improvement in the rate of locoregional events and a substantial reduction of distant metastases and breast cancer mortality.…”

Section: The Trial Of Schmoor Et Almentioning

confidence: 99%

“…With respect to overall survival, no difference could be demonstrated, but the power of the study was too low to detect small treatment effects. We review below the conclusions of this study in more detail.BREAST CANCER-RELATED EVENTS Table I shows the sum of breast cancer recurrences among irradiated and unirradiated patients in the study of Schmoor et al (2000). There is a significant improvement in the rate of locoregional events and a substantial reduction of distant metastases and breast cancer mortality.…”

mentioning

confidence: 99%

“…This was largely due to the evidence that distant relapses determine breast cancer death. However, following the methodology of "competing causes of events", Overgaard et al (1997Overgaard et al ( , 1999 and Schmoor et al (2000) counted distant relapses only if they occurred as a "first event". As a result, distant relapses developing after local recurrences in the study of Schmoor et al were not counted, and thus, the proportion of distant relapses as a first event was only 66% compared with 73% breast cancer deaths.…”

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confidence: 99%

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Wide‐field radiation as adjunct to adjuvant chemotherapy in high‐risk cases with early breast cancer: Do it or not?

Ragaz

2000

Int. J. Cancer

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Very few developments in the management of human malignancies have been as controversial as the role of locoregional (wide-field) radiotherapy (RT) in the adjuvant therapy of early breast cancer. This is mostly due to the fact that older trials using more obsolete radiation equipment and treatment planning, while showing a significant reduction of locoregional recurrences, indicated only a moderate improvement of systemic metastases. Also, because of cardiac toxicity, increased cardiovascular mortality counteracted the modest benefits on breast cancer mortality, resulting in no significant changes in overall survival (EBCTCG, 1995;Cuzick et al., 1994).The most recent Oxford EBCTCG metanalysis indicates in its recent update a more substantial breast cancer mortality reduction (p ϭ 0.0001), but because of increased non-breast cancer mortality, particularly evident in trials started before 1975, the overall survival was improved only marginally (37.1% vs. 35.9%, p ϭ 0.06). Editorial comments towards this latest development are provided at the end of this review.With improved radiation technology and radiation planning and with the introduction of systemic therapies, the results of radiation are changing. At least 4 large randomized trials using relatively modern RT equipment reported a benefit of locoregional RT in terms of significant reductions in systemic recurrence and breast cancer mortality (Arriagada et al., 1995;Overgaard et al., 1997Overgaard et al., , 1999Ragaz et al., 1997). Also, a meta-analysis of more recent RT trials restricted to those with systemic therapy showed a significant mortality reduction due to radiation (Whelan et al., 2000). Thus, these studies confirm that modern RT does have a potential to substantially improve the survival outcome in high-risk breast cancer subsets.The most recent randomized trial published in the May issue of this Journal is the German study of Schmoor et al. Between 1984 -1989, one hundred and ninety nine node-positive breast cancer treated with adjuvant CMF chemotherapy were randomized, after a modified radical mastectomy, into CMFϩRT versus CMF alone. This study therefore represents a "modern" radiation trial. As this is the last of the recent trials reported in a peer review literature, several comments will be provided to bring this trial into perspective with the four better-known larger trials and with the Oxford Overview, and to clarify its contribution to the recent radiation literature. THE TRIAL OF SCHMOOR ET AL.At a median follow-up, the study of Schmoor et al. showed a significant reduction in locoregional recurrences [relative risk (RR) ϭ 0.35]. Also improved in RT patients were survival free of distant failure (RR ϭ 0.8) and breast cancer-specific survival (RR ϭ 0.79), but these improvements were not statistically significant. There was an increase in patients from the RT arm of non-breast cancer-related events (second malignancy, non-cancerrelated deaths). Thus, while breast cancer mortality was reduced by 21%, overall mortality was reduced only marg...

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Section: Systemic Relapsesmentioning

confidence: 58%

Section: Systemic Relapsesmentioning

confidence: 76%

Section: The Trial Of Schmoor Et Almentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Wide‐field radiation as adjunct to adjuvant chemotherapy in high‐risk cases with early breast cancer: Do it or not?

Ragaz

2000

Int. J. Cancer

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Radiation therapy for early breast cancer

Koukourakis

2009

Clin Transl Oncol

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In women with early-stage breast cancer treated with surgery alone, microscopic residual disease may not be eliminated and can eventually cause life-threatening metastatic recurrence. Radiation therapy has been widely recommended for local control after breast-conserving surgery (BCS) and after a complete mastectomy in women at high risk of recurrence. However, even with widespread support for these recommendations within the medical community, they are not always heeded. Because local recurrence, when detected early, can often be treated with additional surgery alone, some physicians and patients still elect to avoid radiation therapy. It was felt, based upon individual trial data, that radiation therapy did not affect overall survival, but just decreased local relapse. The meta-analysis, published in the December 17/2005 Lancet, analysed individual data from 42,000 women, collected during 78 different randomised trials conducted since 1985. The availability of extensive 15-year survival data allowed the investigators to quantify the relationship between successful local control and long-term survivorship. Moreover, individual trials all show a benefit in local control and some trends toward survival advantages. The pooled meta-analysis of breast conservative surgery with or without radiation therapy Vinh Hung (2004) demonstrates a significant impact on local relapse and a small but significant impact on survival. It is considered that after BCS and in certain cases after mastectomy, radiation therapy is the standard treatment for improved local control and longterm survival.

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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 trial on the effect of radiotherapy in addition to 6 cycles CMF in node-positive breast-cancer patients

Cited by 5 publications

References 4 publications

Wide‐field radiation as adjunct to adjuvant chemotherapy in high‐risk cases with early breast cancer: Do it or not?

Wide‐field radiation as adjunct to adjuvant chemotherapy in high‐risk cases with early breast cancer: Do it or not?

Radiation therapy for early breast cancer

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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