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• W2013973263 abstract "Exploration of high-dose chemotherapy (HDC) for metastatic breast cancer (MBC) began in the mid 1980s, stimulated by Frei’s preclinical studies demonstrating a steep dose-response effect for DNA-damaging drugs [1Frei III, E. Canellos G.P. Dose: a critical factor in cancer chemotherapy.Am J Med. 1980; 69: 585-594Abstract Full Text PDF PubMed Scopus (693) Google Scholar]. The first clinical trial of HDC for MBC, published in 1986 by Peters and colleagues [2Peters W.P. Eder J.P. Henner W.D. et al.High-dose combination chemotherapy with autologous bone marrow support: a phase I trial.J Clin Oncol. 1986; 4: 646-654Crossref PubMed Scopus (115) Google Scholar], included patients with refractory disease treated with cyclophosphamide/cisplatin/BCNU (STAMP I) and resulted in the highest response and complete response rates reported to that date in MBC. Subsequent phase 2 trials moved STAMP-I (or other all-alkylator-based regimens, such as cyclophosphamide/thiotepa ± carboplatin) upfront in the treatment of the disease, targeting less pretreated metastatic patients as well as patients with high-risk primary breast cancer (HRPBC). During those years, the introduction of myeloid growth factors posttransplant, peripheral blood progenitor cells (PBPCs) in place of bone marrow, and other advances in supportive care reduced the treatment mortality rate from the initial 15% to 20% to less than 5%. The highly encouraging results of the early phase 2 trials rapidly prompted randomized phase 3 trials testing the first-generation HDC regimens. They also generated an unbridled enthusiasm among physicians and breast cancer patients and a premature transfer of stem cell transplant technology in the 1990s from the academic environment to community hospitals. Proponents and detractors of HDC intensely debated in the editorial pages of scientific journals, lay press, and in the courts. In the middle of this euphoria and raging controversy it became clear that the majority of MBC patients still relapsed after HDC. While waiting for the results of the phase 3 randomized trials, a few academic centers maintained their research efforts focusing on 2 main directions. One approach was attempts to develop more active HDC, by incorporation of new and potentially more effective drugs [3Stemmer S.M. Cagnoni P.J. Shpall E.J. et al.High-dose paclitaxel, cyclophosphamide, and cisplatin with autologous hematopoietic progenitor-cell support: a phase I trial.J Clin Oncol. 1996; 14: 1463-1472Crossref PubMed Scopus (70) Google Scholar, 4Nieto Y. Shpall E.J. Bearman S.I. et al.Phase I and pharmacokinetic study of docetaxel combined with melphalan and carboplatin, with autologous hematopoietic progenitor cell support, in patients with advanced refractory malignancies.Biol Blood Marrow Transplant. 2005; 11: 297-306Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar], the design of sequential multicycle strategies based on the interplay of timing, dose, and the appearance of acute in vivo resistance [5Teicher B.A. Ara G. Keyes S.R. Herbst R.S. Frei III, E. Acute in vivo resistance in high-dose therapy.Clin Cancer Res. 1998; 4: 483-491PubMed Google Scholar, 6Elias A.D. Ibrahim J. Richardson P. et al.The impact of induction duration and the number of high-dose cycles on the long-term survival of women with metastatic breast cancer treated with high-dose chemotherapy with stem cell rescue: an analysis of sequential phase I/II trials from the Dana Farber/Beth Israel STAMP program.Biol Blood Marrow Transplant. 2002; 8: 198-205Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar], and the development of synergistic combinations of HDC with targeted therapeutics [7Nieto Y. Vredenburgh J.J. Shpall E.J. et al.Pilot study of concurrent administration of trastuzumab with high-dose cyclophosphamide, cisplatin, and BCNU, with autologous hematopoietic progenitor-cell support, in patients with advanced HER2-positive breast cancer.Clin Cancer Res. 2004; 10: 7136-7143Crossref PubMed Scopus (16) Google Scholar]. The second approach aimed at effective and safe purging of the PBPC grafts of contaminating breast cancer cells. Initial purging strategies targeted the tumor cells by pharmacologic or immunomagnetic methods, and achieved around a 3- to 4-log depletion of tumor cells [8Shpall E.J. Jones R.B. Bast R.C. et al.4-Hydroperoxycyclophosphamide purging of breast cancer from the mononuclear cell fraction of bone marrow in patients receiving high-dose chemotherapy and autologous marrow support: a phase I trial.J Clin Oncol. 1991; 9: 85-93Crossref PubMed Scopus (86) Google Scholar, 9Shpall E.J. Bast R.C. Joines W.T. et al.Immunomagnetic purging of breast cancer from bone marrow for autologous transplantation.Bone Marrow Transplant. 1991; 7: 145-151PubMed Google Scholar]. These “negative” purging methods often produced substantial engraftment delays. In contrast, “positive” selection of the normal stem cells in the graft targeted the CD34 antigen, expressed on both committed and long-term reconstituting progenitors and not on breast cancer cells. Using a first-generation immunoadsorption device, Shpall et al. [10Shpall E.J. Jones R.B. Bearman S.I. et al.Transplantation of enriched CD34-positive autologous marrow into breast cancer patients following high-dose chemotherapy: influence of CD34-positive peripheral-blood progenitors and growth factors on engraftment.J Clin Oncol. 1994; 12: 28-36Crossref PubMed Scopus (421) Google Scholar] achieved a 2-log tumor-cell depletion with comparable engraftment times to those of patients receiving unmanipulated grafts. A subsequent randomized trial comparing CD34-selected PBPC with a more advanced device, to unselected PBPC in patients with stage II-IV disease showed equivalent engraftment times between both groups [11Yanovich S. Mitsky P. Cornetta K. et al.Transplantation of CD34+ peripheral blood cells selected using a fully automated immunomagnetic system in patients with high-risk breast cancer: results of a prospective randomized multicenter clinical trial.Bone Marrow Transplant. 2000; 25: 1165-1174Crossref PubMed Scopus (20) Google Scholar]. No outcome differences were detected in that small trial. In this issue, Muller and colleagues at Stanford report the long-term results of a prospective breast cancer phase 2 trial of a positive selection method using flow-activated cell sorting targeting the CD34 and Thy-1 antigens, which resulted in a 5- to 6-log tumor cell depletion [12Muller A. Kohrt H. Cha S. Long-term outcome of patients with metastatic breast cancer treated with high-dose chemotherapy and transplantation of purified autologous hematopoietic stem cells.Biol Blood Marrow Transplant. 2012; 18: 125-133Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar]. Twenty-two patients with soft tissue, bone, or bone marrow metastases received STAMP-I followed by highly purified CD34+ Thy-1+ PBPC grafts. More than 12 years after the end of this study, 5 patients are alive, and 4 of them remain free of progression with normal hematopoietic function. Although the depth of tumor purging is remarkable, these results need to be interpreted with several caveats. Patients with soft tissue/bone/bone marrow involvement without visceral disease, which is of the most powerful adverse prognostic factors for HDC for MBC, can enjoy very prolonged overall and progression-free survivals. In that light, the retrospective comparison to a concurrent patient group, one-third of whom had visceral metastases, treated at the same center with STAMP-I and unselected PBPC, should be interpreted with caution. Importantly, there is still no convincing evidence of a direct role of occult tumor cells contaminating PBPC grafts of MBC patients in posttransplantation relapse. Rather, the bulk of the data from other studies suggests insufficient antitumor capacity of the HDC regimen as the main cause of post-HDC relapse [13Cooper B.W. Moss T.J. Ross A.A. Ybanez J. Lazarus H.M. Occult tumor contamination of hematopoietic stem-cell does not affect clinical outcome of autologous transplantation in patients with metastatic breast cancer.J Clin Oncol. 1998; 16: 3509-3517Crossref PubMed Scopus (72) Google Scholar, 14Rizzieri D.A. Vredenburgh J.J. Jones R.B. et al.Prognostic and predictive factors for patients with metastatic breast cancer undergoing aggressive induction therapy followed by high-dose chemotherapy with autologous stem-cell support.J Clin Oncol. 1999; 17: 3064-3074Crossref PubMed Scopus (60) Google Scholar]. Finally, most purging methods, including the employed by the authors, deplete the graft of lymphocytes and slows CD4 immune reconstitution. Pretransplant immunity and early postttransplantation immune recovery may have an important effect on outcome in MBC [15Porrata L.F. Ingle J.N. Litzow M.R. et al.Prolonged survival associated with early lymphocyte recovery after autologous hematopoietic stem cell transplantation for patients with metastatic breast cancer.Bone Marrow Transplant. 2001; 28: 865-871Crossref PubMed Scopus (86) Google Scholar, 16Bewick M. Conlon M. Parissenti A.M. et al.Soluble Fas (CD95) is a prognostic factor in patients with metastatic breast cancer undergoing high-dose chemotherapy and autologous stem cell transplantation.J Hematother Stem Cell Res. 2001; 10: 759-768Crossref PubMed Scopus (25) Google Scholar, 17Rosinski S. McNiece I. Shpall E. Russell P. Nieto Y. Peripheral T-cell levels correlate with outcome of patients undergoing autologous stem cell transplant.Bone Marrow Transplant. 2005; 36: 425-430Crossref PubMed Scopus (7) Google Scholar, 18Nieto Y. Shpall E.J. McNiece I.K. et al.Prognostic evaluation of the early lymphocyte recovery in patients with advanced metastatic and non-metastastic breast cancer receiving high-dose chemotherapy with an autologous stem-cell transplant.Clin Cancer Res. 2004; 10: 5076-5086Crossref PubMed Scopus (41) Google Scholar]. Thus, if occult tumor cells in the graft merely represent a marker of widespread micrometastatic disease, there may be a deleterious effect of purging PBPC products of MBC patients. It is possible that the optimal scenario to test this purging method might be the adjuvant setting. Twenty-five years after that first trial of HDC for MBC, how does the current article affect the overarching evaluation of the use of transplant in breast cancer? All randomized trials in the MBC and HRPBC settings, 6 and 15, respectively, have been analyzed and have largely failed to show an overall survival benefit from HDC. Although many of those trials were underpowered to detect realistic survival differences, the recently published meta-analyses did not show a global overall survival benefit in either setting [19Berry D.A. Ueno N.T. Johnson M.M. et al.High-dose chemotherapy with autologous stem-cell support as adjuvant therapy in breast cancer: overview of 15 randomized trials.J Clin Oncol. 2011; : 3214-3223Crossref PubMed Scopus (86) Google Scholar, 20Berry D.A. Ueno N.T. Johnson M.M. et al.High-dose chemotherapy with autologous stem-cell transplantation in metastatic breast cancer: overview of six randomized trials.J Clin Oncol. 2011; : 3224-3231Crossref PubMed Scopus (67) Google Scholar]. Those overviews, however, detected a statistically significant 13% decrease of risk of relapse in HRPBC and a 24% decrease of risk of progression in MBC. The use of HDC for breast cancer has almost ceased with no registered active trials in the United States. In our view, the data do not justify the abandonment of the transplant approach to breast cancer, whereas, in the article authors’ own words, there is an immense need for curative treatment strategies for its advanced stages. Clearly, a fraction of patients may benefit from a high-dose approach, such as those with oligometastatic disease [21Nieto Y. Nawaz S. Jones R.B. et al.Prognostic model for relapse after high-dose chemotherapy with autologous stem-cell transplantation for stage IV oligometastatic breast cancer.J Clin Oncol. 2002; 20: 707-718Crossref PubMed Scopus (116) Google Scholar]. Personalized medicine has reemphasized the importance of evaluating small subsets of patients that achieve uncommon benefit following a novel treatment. For example, many trials of HDC for MBC demonstrated that 5% to 15% patients with advanced disease experienced >5-year relapse-free survival. If a substantial fraction of these patients continue in remission 10 to 15 years later, might this observation suggest a reexamination of the “incurability” of metastatic breast cancer for a small and undefined group of patients? These types of long-term follow-ups, as in the current article, should be reported. It would be of interest if personalized medicine concepts induce a reexamination of the importance of the “tail” of the Kaplan-Meier curves, which might reflect a subset of cured patients. Financial disclosure: The authors have nothing to disclose." @default.
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• W2013973263 title "High-Dose Chemotherapy with Autologous Stem Cell Transplant for Breast Cancer: What Have We Learned 25 Years Later?" @default.
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