440 Superiority of tandem high-dose (HDC) over conventionally-dosed chemotherapy(CDC) in patients (Pts) with metastatic breast cancer (MBC): Updated results of the international randomised breast cancer dose-intensity study (IBDIS)

Crown, J.; Leyvraz, Serge; Verrill, Mark; Guillém, Vicente; Efremedis, A.; Garcia, Jeremy; Conde-Bru, R.Welsh; Montes, Ana; Leonard, R. C. F.; Baselga, José

doi:10.1016/s1359-6349(03)90472-1

Cited by 12 publications

(10 citation statements)

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“…Early findings from randomized trials reported in 2000 and 2001 concluded no improved survival benefit attributable to HDC with AHST. 11,12 In contrast, findings reported in 2003 9 showed a high tumor response rate for patients with MBC assigned to HDC with AHST. Such contradictory findings contributed to the persistence of controversy regarding this treatment strategy.…”

Section: Journal Of Clinical Oncology O R I G I N a L R E P O R Tmentioning

confidence: 94%

“…In addition, we (Fig 1; Appendix, online only) identified six trials. 9,11,12,[15][16][17] The trials were initiated between 1990 and 1998. We solicited and received individual patient data from all six trialists.…”

Section: Methodsmentioning

confidence: 99%

“…Accrual was slow and in some cases even failed. 9 Reasons for the difficulties in accrual included the fact that HDC and Ctrl are different in terms of tolerability and perception of the potential for cure. In 2001, a case of fraudulent reporting surfaced, 10 which cast a pall over the concept.…”

Section: Journal Of Clinical Oncology O R I G I N a L R E P O R Tmentioning

confidence: 99%

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High-Dose Chemotherapy With Autologous Hematopoietic Stem-Cell Transplantation in Metastatic Breast Cancer: Overview of Six Randomized Trials

Berry

Ueno

Johnson

et al. 2011

JCO

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A B S T R A C T PurposeHigh doses of effective chemotherapy are compelling if they can be delivered safely. Substantial interest in supporting high-dose chemotherapy with bone marrow or autologous hematopoietic stem-cell transplantation in the 1980s and 1990s led to the initiation of randomized trials to evaluate its effect in the treatment of metastatic breast cancer. MethodsWe identified six randomized trials in metastatic breast cancer that evaluated high doses of chemotherapy with transplant support versus a control regimen without stem-cell support. We assembled a single database containing individual patient information from these trials. The primary analysis of overall survival was a log-rank test comparing high dose versus control. We also used Cox proportional hazards regression, adjusting for known covariates. We addressed potential treatment differences within subsets of patients. ResultsThe effect of high-dose chemotherapy on overall survival was not statistically different (median, 2.16 v 2.02 years; P ϭ .08). A statistically significant advantage in progression-free survival (median, 0.91 v 0.69 years) did not translate into survival benefit. Subset analyses found little evidence that there are groups of patients who might benefit from high-dose chemotherapy with hematopoietic support. ConclusionOverall survival of patients with metastatic breast cancer in the six randomized trials was not significantly improved by high-dose chemotherapy; any benefit from high doses was small. No identifiable subset of patients seems to benefit from high-dose chemotherapy.

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Section: Journal Of Clinical Oncology O R I G I N a L R E P O R Tmentioning

confidence: 94%

Section: Methodsmentioning

confidence: 99%

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High-Dose Chemotherapy With Autologous Hematopoietic Stem-Cell Transplantation in Metastatic Breast Cancer: Overview of Six Randomized Trials

Berry

Ueno

Johnson

et al. 2011

JCO

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“…Results from seven of these trials have already been published [92, 95–100], and for one trial, an updated report was also published after longer follow-up [93]. Results for the remaining trial have only been published in preliminary form [94]. Together, these eight trials enrolled more than 1,000 patients.…”

Section: Microscopic Treatment In Metastatic Breast Cancermentioning

confidence: 99%

Improvement of survival and prospect of cure in patients with metastatic breast cancer

Cheng

Ueno

2011

Breast Cancer

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Patients with metastatic breast cancer have traditionally been considered incurable with conventional treatment. However, 5–10% of those patients survive more than 5 years, and 2–5% survive more than 10 years. Recent studies suggest that the survival of patients with metastatic breast cancer has been slowly improving. In this review, we examine the possible curative approach for a certain group of patients with metastatic breast cancer. We identify that patients most likely to benefit from such an aggressive approach are young and have good performance status, adequate body functional reserve, long disease-free interval before recurrence, oligometastatic disease, and low systemic tumor load. An aggressive multidisciplinary approach including both local treatment of macroscopic disease and systemic treatment of microscopic disease can result in prolonged disease control in certain patients with metastatic breast cancer. Whether patients with prolonged disease control are “cured” remains controversial.

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“…[29][30][31][32] However, since this procedure can now be considered safe and demonstrated a high level of activity, many investigators have tried to identify subsets of patients in whom the activity of HDCT can be translated into an advantage in survival.…”

Section: Discussionmentioning

confidence: 99%

HER2 overexpression as a prognostic factor in metastatic breast cancer patients treated with high-dose chemotherapy and autologous stem cell support

Guarneri

Bengala²,

Orlandini³

et al. 2004

Bone Marrow Transplant

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Summary:We retrospectively evaluated the predictive and prognostic role of HER2 expression in 44 metastatic breast cancer (MBC) patients treated with high-dose consolidation chemotherapy (HDCT) and autologous stem cell support after induction chemotherapy (IC) with six courses of epirubicin þ paclitaxel (22 patients) or gemcitabine þ epirubicin þ paclitaxel (22 patients). HER2 expression was evaluated by an immunohistochemical method (Herceptest, Dako). A total of 13 patients (29.5%) showed a HER2 overexpression (score 3 þ ). After IC, nine patients were in complete response (CR), 30 in partial response (PR), and five in stable disease (SD); after HDCT, 20 (45.5%) obtained a CR, and 23 were in PR, for a conversion rate of 48.5%. Conversion rate for HER2-positive patients was 87.5 vs 37% for HER2-negative patients (P ¼ 0.018). The median progressionfree (PFS) and overall survivals (OS) were 17.6 (95% CI 13.2-22.0) and 44 (95% CI 25.9-62.3) months, respectively. Patients with HER2 overexpression experienced a significantly (P ¼ 0.0042) shorter median PFS (15.3 months, 95% CI 11.1-19.5) compared to HER2-negative patients (21.3 months,). The median OS was 27.6 months (95% CI 4.5-50.7) in HER2-positive patients and 50.3 months (95% CI 38.7-62.0) in HER2-negative patients (P ¼ 0.345). These results indicate that HER2 overexpression predicts a worse outcome for patients with MBC treated with HDCT, despite the high CR rate obtained in this subset of patients.

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440 Superiority of tandem high-dose (HDC) over conventionally-dosed chemotherapy(CDC) in patients (Pts) with metastatic breast cancer (MBC): Updated results of the international randomised breast cancer dose-intensity study (IBDIS)

Cited by 12 publications

References 0 publications

High-Dose Chemotherapy With Autologous Hematopoietic Stem-Cell Transplantation in Metastatic Breast Cancer: Overview of Six Randomized Trials

High-Dose Chemotherapy With Autologous Hematopoietic Stem-Cell Transplantation in Metastatic Breast Cancer: Overview of Six Randomized Trials

Improvement of survival and prospect of cure in patients with metastatic breast cancer

HER2 overexpression as a prognostic factor in metastatic breast cancer patients treated with high-dose chemotherapy and autologous stem cell support

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