High-Dose Chemotherapy With Autologous Hematopoietic Stem-Cell Support Compared With Standard-Dose Chemotherapy in Breast Cancer Patients With 10 or More Positive Lymph Nodes: First Results of a Randomized Trial

Zander, Axel R.; Kröger, Nicolaus; Schmoor, Claudia; Krüger, William; Möbus, V.; Frickhofen, N; Metzner, Bernd; Schultze, Wolfgang; Berdel, Wolfgang E.; Koenigsmann, Michael; Thiel, Eckhard; Wandt, Hannes; Possinger, K.; Trümper, Lorenz; Kreienberg, R.; Carstensen, M. H.; Schmidt, Eva; Jänicke, F.; Schumacher, Martin; Jonat, W.

doi:10.1200/jco.2004.07.026

Cited by 75 publications

(47 citation statements)

References 29 publications

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“…Results presented here cannot be compared with previous reports of SDC and the controversy about the efficacy of HDC for high-risk BC remains unsettled. The available results of six large phase 3 studies, [13][14][15][26][27][28] only one having been published in a peer-reviewed journal, 13 are still too preliminary, while in two studies the control arms were not conventional therapies. 13,14 In the 921 patients with IBC, our data suggest an apparent advantage in DFS rates from the inclusion of HDC in the multidisciplinary management of this disease.…”

Section: Discussionmentioning

confidence: 99%

Autologous hematopoietic stem cell transplantation for breast cancer in Europe: critical evaluation of data from the European Group for Blood and Marrow Transplantation (EBMT) Registry 1990–1999

Pedrazzoli

Ferrante

Kulekci³

et al. 2003

Bone Marrow Transplant

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Summary:The aim of this study was to identify trends in high-dose chemotherapy (HDC) with autologous hematopoietic stem cell transplantation (ASCT) and to assess survival in a large cohort of breast cancer (BC) patients receiving this therapy in Europe from 1990 to 1999. A total of 7471 patients who received HDC with ASCT between January 1, 1990 and December 31, 1999 were reported to the European Group for Blood and Marrow Transplantation Registry. Data required for demographics and survival analysis were available for 2679 patients with high-risk primary BC; 921 patients with inflammatory BC (IBC), and 2295 patients with metastatic disease. The main evaluation parameters were progression-free survival (PFS) and overall survival (OS). Between 1990 and 1998, autotransplants for BC increased 30-fold. Significant trends included use of blood-derived rather than marrow-derived stem cells, increment of reporting centers and decrease of mortality within 100 days from transplantation. The 5-year PFS and OS probabilities were 53 and 68% for high-risk disease and 42 and 53% for IBC, respectively. For metastatic disease 5-year PFS and OS probabilities in the whole cohort were 18 and 27%, respectively, while for women transplanted in complete remission the 5-year PFS was 29%. In conclusion, HDC with ASCT has been increasingly used until 1998 and the 100-day mortality rate has been constantly less than 2% from 1995 to date. The 5-year survival of high-risk BC is related to the number of axillary nodes involved at surgery. Outcome of patients with IBC is encouraging, suggesting the need for randomized trials. Patients with metastatic disease responding to pretransplant chemotherapy and harboring ER+ tumors have a better outcome.

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Section: Discussionmentioning

confidence: 99%

Autologous hematopoietic stem cell transplantation for breast cancer in Europe: critical evaluation of data from the European Group for Blood and Marrow Transplantation (EBMT) Registry 1990–1999

Pedrazzoli

Ferrante

Kulekci³

et al. 2003

Bone Marrow Transplant

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“…1 In selected patients however, high-dose chemotherapy results in improved disease-free survival and probably also in overall survival. [2][3][4][5][6] High-dose chemotherapy-related mortality, originally reported to be around 20%, 7 is consistently below 1% in more recent studies. This improvement is mostly due to advances in supportive care, the introduction of peripheral stem-cell reinfusion instead of BM reinfusion, the choice of cytostatic agents used for the high-dose chemotherapy regimen, the use of hematopoietic growth factors and the growing experience with the procedure.…”

Section: Introductionmentioning

confidence: 98%

Factors influencing catheter-related infections in the Dutch multicenter study on high-dose chemotherapy followed by peripheral SCT in high-risk breast cancer patients

Nieboer

Vries

Mulder

et al. 2008

Bone Marrow Transplant

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Neutropenia following high-dose chemotherapy leads to a high incidence of infectious complications, of which central venous catheter-related infections predominate. Catheter-related infections and associated risk factors in 392 patients participating in a randomized adjuvant breast cancer trial and assigned to receive high-dose chemotherapy and peripheral stem-cell reinfusion were evaluated. Median catheter dwell time was 25 days (range 1-141). Catheter-related infections were seen in 28.3% of patients (11 infections per 1000 catheter-days). Coagulase-negative staphylococci were found in 104 of 186 positive blood cultures (56%). No systemic fungal infections occurred. Cox regression analysis showed that duration of neutropenia 410 days (P ¼ 0.04), using the catheter for both stem-cell apheresis and high-dose chemotherapy (P ¼ o0.01), and use of total parenteral nutrition (TPN, P ¼ 0.04) were predictive for catheter-related infections. In conclusion, a high incidence of catheter-related infections after high-dose chemotherapy was seen related to duration of neutropenia, use of the catheter for both stem-cell apheresis and high-dose chemotherapy, and use of TPN. Selective use and choice of catheters could lead to a substantial reduction of catheter-related infectious complications.

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“…Some other trials show a nonsignificant trend in favor of transplant, like the National Dutch (9) and the International Breast Cancer Study Group trials (10). Finally, there are trials that show no significant differences in all of the accrued patients, but do suggest a possible benefit from HDC among those patients with longest FU, such as the Anglo-Celtic (11) and the German Autologous Bone Marrow Group studies (12).…”

Section: Discussionmentioning

confidence: 99%

Long-Term Analysis and Prospective Validation of a Prognostic Model for Patients with High-Risk Primary Breast Cancer Receiving High-Dose Chemotherapy

Nieto¹,

Nawaz²,

Shpall

et al. 2004

Clinical Cancer Research

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Purpose: We described previously a prognostic model for high-risk primary breast cancer patients receiving highdose chemotherapy (HDC). Such model included nodal ratio (no. involved nodes:no. dissected nodes), tumor size, hormone receptors, and HER2. In the present study we intended to test this model prospectively in a second patient cohort. In addition, we analyzed the long-term overall outcome of our HDC trials.Experimental Design: We analyzed all 264 patients enrolled since 1990 in our prospective trials for 4 -9؉, >10؉ nodes, or inflammatory disease. Patients of the second cohort (treated since 1997) had their prognostic score estimated prospectively before receiving HDC.Results: Fourteen patients (5.3%) died from HDCrelated complications. At median follow-up of 7.1 years, relapse-free survival and overall survival of the whole group were 69.8% and 73%, respectively. Median time to relapse was 14 months (63.5% relapses within the first 2 years, 6.7% after year 5). The model was validated in the second cohort, establishing the following pretransplant risk categories: low risk (low score, HER2؊), 44% patients, 87% freedom from relapse (FFR); intermediate risk (low score, HER2؉), 29% patients, 68% FFR; and high risk (high score, any HER2), 27% patients, 49% FFR.Conclusions: Few relapses are seen after year 5 of follow-up, which indicates the need for mature results of the randomized trials before their final interpretation or metaanalysis. Our prospectively validated prognostic model, if additionally confirmed in the randomized trial populations, may provide an insight into the relative benefit of HDC in different risk patient subsets.

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High-Dose Chemotherapy With Autologous Hematopoietic Stem-Cell Support Compared With Standard-Dose Chemotherapy in Breast Cancer Patients With 10 or More Positive Lymph Nodes: First Results of a Randomized Trial

Abstract: There was a trend in favor of HD-CT with respect to event-free survival, but without statistical significance. Further follow-up and a meta-analysis of all randomized studies will reveal the effect of HD-CT as compared with SD-CT as adjuvant treatment in high-risk primary breast cancer.

Cited by 75 publications

References 29 publications

Autologous hematopoietic stem cell transplantation for breast cancer in Europe: critical evaluation of data from the European Group for Blood and Marrow Transplantation (EBMT) Registry 1990–1999

Autologous hematopoietic stem cell transplantation for breast cancer in Europe: critical evaluation of data from the European Group for Blood and Marrow Transplantation (EBMT) Registry 1990–1999

Factors influencing catheter-related infections in the Dutch multicenter study on high-dose chemotherapy followed by peripheral SCT in high-risk breast cancer patients

Long-Term Analysis and Prospective Validation of a Prognostic Model for Patients with High-Risk Primary Breast Cancer Receiving High-Dose Chemotherapy

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