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  • American Society of Clinical Oncology (ASCO)  (7)
  • Reimer, Peter  (7)
  • 1
    Online Resource
    Online Resource
    Cetuximab biweekly plus mFOLFOX6 as first-line therapy in patients (pts) with KRAS wild-type (wt) (exon 2) metastatic colorectal cancer (mCRC): Primary endpoint and subgroup analysis of the CEBIFOX trial.
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 15_suppl ( 2015-05-20), p. 3568-3568
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 15_suppl ( 2015-05-20), p. 3568-3568
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.15_suppl.3568
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
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  • 2
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    Cetuximab biweekly plus mFOLFOX6 as first-line therapy in patients (pts) with KRAS wild-type (wt) metastatic colorectal cancer (mCRC): An interim analysis of the CEBIFOX trial.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e14502-e14502
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e14502-e14502
    Abstract: e14502 Background: Combination of mFOLFOX6 with weekly cetuximab is a standard first line regimen in pts with KRAS wt mCRC. Weekly application of cetuximab increases the in-hospital time of pts with negative impact on quality of life. This multicentric phase II trial evaluates the efficacy of mFOLFOX6 + biweekly cetuximab as first line therapy in KRAS wt mCRC. Methods: Pts with KRAS wt mCRC who were not candidates for primary metastasectomy received cetuximab (500 mg/m 2 every 2 weeks) in combination with mFOLFOX6 (oxaliplatin 85 mg/m 2 , folinic acid 400 mg/m 2 , 5-FU 400 mg/m 2 bolus and 2,400mg/m 2 over 46 h q14d). Primary endpoint was objective response rate (ORR) per RECIST 1.0, secondary endpoints were safety, secondary resection rate, quality of life (QoL), progression-free survival (PFS) and overall survival. Data of a pre-specified interim analysis are presented in which 13 responders were needed in the first 37 pts (Simon stage I). Results: As of Dec 2012, 46 pts were registered. Fourty three pts received ≥1 course of treatment, and 34 pts were evaluable for response. Baseline characteristics of the ITT population and efficacy data are listed in the Table. Median follow-up was 14.6 months. Grade 3/4 adverse events occurred in 39% of pts, including leukocytopenia (11%), gastrointestinal toxicity (11%), and rash (9%). Median PFS was 9.6 months (95% CI: 5.0 to 14.1). QoL data will be presented. Conclusions: This pre-specified interim analysis supports efficacy and safety of biweekly cetuximab given in combination with mFOLFOX6 in pts with mCRC. A high rate of objective responses and secondary hepatic resections was achieved. Based on these results enrolment in CEBIFOX is continued. Clinical trial information: NCT01051167. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e14502
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Online Resource
    Autologous Stem-Cell Transplantation As First-Line Therapy in Peripheral T-Cell Lymphomas: Results of a Prospective Multicenter Study
    American Society of Clinical Oncology (ASCO) ; 2009
    In:  Journal of Clinical Oncology Vol. 27, No. 1 ( 2009-01-01), p. 106-113
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 1 ( 2009-01-01), p. 106-113
    Abstract: Peripheral T-cell lymphomas (PTCLs) are rare malignancies with poor outcome after conventional chemotherapy. The role of myeloablative therapy and autologous stem-cell transplantation (autoSCT) is still unclear. Therefore, we initiated the first prospective multicenter study on upfront autoSCT in PTCL and recently reported good feasibility and efficacy of this approach. Here, we present the final analysis of the study. Patients and Methods The treatment regimen consisted of four to six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone followed by mobilizing therapy with either the dexamethasone, carmustine, melphalan, etoposide, and cytarabine protocol or the etoposide, methylprednisolone, cytarabine, and cisplatin protocol and stem-cell collection. Patients in complete remission (CR) or partial remission (PR) underwent myeloablative chemoradiotherapy (fractionated total-body irradiation and high-dose cyclophosphamide) and autoSCT. Results From June 2000 to April 2006, 83 patients were enrolled onto the study. Main subgroups were PTCL not specified (n = 32) and angioimmunoblastic T-cell lymphoma (n = 27). Fifty-five (66%) of the 83 patients received transplantation. The main reason for not receiving autoSCT was progressive disease. In an intent-to-treat analysis, the overall response rate after myeloablative therapy was 66% (56% CR and 8% PR). With a median follow-up time of 33 months, 43 patients are alive; the estimated 3-year overall and disease-free survival rates for patients in CR (calculated from CR to the date of relapse) and 3-year progression-free survival rate were 48%, 53%, and 36%, respectively. Conclusion The results of this prospective study suggest a substantial impact on outcome for upfront autoSCT in PTCL and should be further evaluated in randomized trials. Pretransplantation treatment needs to be improved to increase the transplantation rate.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2008.17.4870
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2009
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  • 4
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    Online Resource
    Standard chemotherapy followed by allogeneic or autologous transplantation: The role of allogeneic transplantation in the AATT study.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 7534-7534
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 7534-7534
    Abstract: 7534 Background: Prognosis of relapsed and refractory T-cell lymphoma patients (pts) is devastating. Early results of the AATT study (Autologous or Allogeneic Transplantation in T-cell lymphoma, Schmitz et al. ASCO 2019; NCT00984412) showed that standard chemotherapy followed by allogeneic transplantation (alloSCT) compared to autoSCT did not improve outcome of poor-risk patients. We wanted to investigate the long-term clinical course of AATT patients (pts) focusing on pts receiving alloSCT off study. Methods: AATT was a randomized trial comparing alloSCT with autoSCT in younger pts (18-60 yrs) with newly diagnosed PTCL who achieved stable disease or better after 4 courses of CHOEP and 1 course of DHAP. Pts were to receive BEAM/autoSCT or myeloablative conditioning/alloSCT from matched related or unrelated donors for consolidation. Local investigators gave updated detailed reports on all further therapy until last follow up or death in order to report long-term EFS and OS focusing on patients receiving alloSCT off study and after failing autoSCT. Results: 103 pts (median age 50 years) randomized to autoSCT (n = 54) or alloSCT (n = 49) formed the full analysis set (FAS), 67 pts (65%) actually received autoSCT (n = 41) or alloSCT (n = 26) (per protocol set, PPS). Median observation time for EFS (OS) was 80 (84) months in the FAS and PPS population. At 7 years EFS and OS were 36% [95%CI: 27% - 46%] and 58% [48-68] for all 103 pts; EFS and OS for patients randomized to autoSCT vs. alloSCT were 34% [22-47] vs. 38% [25-52] and 61% [47-74] vs. 55% [41-69] . For patients actually transplanted 7-year-EFS and -OS were 50% [34-66] vs. 61% [42-80] and 72% [58-86] vs. 61% [42-80] . None of these survival rates differed significantly. TRM was 0/41 (0%) after autoSCT and 8/26 (31%) after alloSCT. Relapse rates were 15/36 (42%) vs. 1/21 (5%) for patients auto- or allografted. Overall, 26/ 50 pts received alloSCT off study because of early relapse/ progression before transplantation or after failing autoSCT. 7-year-OS for these pts is 62% (43-80). Ten of 15 pts relapsing after autoSCT received alloSCT as next therapy. Eight of these pts remain alive 39 – 94 mos after transplantation 5-year-OS of 24 pts who did not receive alloSCT was 17% (2-32). Conclusions: Seven-year OS-rates for the FAS- and the PPS cohort are remarkably high (58% and 68%) reflecting the high rate of long-term survivors after alloSCT also in pts with early relapse and after autoSCT. Pts not undergoing alloSCT had a dismal outcome. For T-cell lymphoma pts with early progression/ relapse after first-line therapy or failing autoSCT alloSCT offers cure in a significant portion of pts and should therefore be the preferred option for all transplant-eligible pts. Clinical trial information: NCT00984412.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.7534
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 5
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    Prognostic Impact of Minimal Residual Disease in CBFB-MYH11 –Positive Acute Myeloid Leukemia
    American Society of Clinical Oncology (ASCO) ; 2010
    In:  Journal of Clinical Oncology Vol. 28, No. 23 ( 2010-08-10), p. 3724-3729
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 28, No. 23 ( 2010-08-10), p. 3724-3729
    Abstract: To evaluate the prognostic impact of minimal residual disease (MRD) in patients with acute myeloid leukemia (AML) expressing the CBFB-MYH11 fusion transcript. Patients and Methods Quantitative reverse transcriptase polymerase chain reaction (PCR) was performed on 684 bone marrow (BM; n = 331) and/or peripheral blood (PB; n = 353) samples (median, 13 samples per patient) from 53 younger adult (16 to 60 years old) patients with AML treated in prospective German-Austrian AML Study Group treatment trials. Samples were obtained at diagnosis (BM, n = 45; PB, n = 48), during treatment course (BM, n = 153; PB, n = 122), and at follow-up (BM, n = 133; PB, n = 183). To evaluate the applicability of PB for MRD detection, 198 paired BM and PB samples obtained at identical time points were analyzed. Results The following three clinically relevant checkpoints were identified during consolidation and early follow-up that predicted relapse: achievement of PCR negativity in at least one BM sample during consolidation therapy (2-year relapse-free survival [RFS], 79% v 54% for PCR positivity; P = .035); achievement of PCR negativity in at least two BM or PB samples during consolidation therapy and early follow-up (≤ 3 months; 2-year RFS, P = .001; overall survival, P = .01); and conversion from PCR negativity to PCR positivity with copy ratios of more than 10 after consolidation therapy. Analysis of paired BM and PB samples revealed BM samples to be more sensitive during the course of therapy, whereas for follow-up, PB samples were equally informative. Conclusion We defined clinically relevant MRD checkpoints that allow for the identification of patients with CBFB-MYH11–positive AML who are at high risk of relapse. Monitoring of CBFB-MYH11 transcript levels should be incorporated into future clinical trials to guide therapeutic decisions.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2010.28.6468
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2010
    detail.hit.zdb_id: 2005181-5
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  • 6
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    Online Resource
    High-Dose Therapy and Autologous Stem-Cell Transplantation in Angioimmunoblastic Lymphoma: Complete Remission at Transplantation Is the Major Determinant of Outcome—Lymphoma Working Party of the European Group for Blood and Marrow Transplantation
    American Society of Clinical Oncology (ASCO) ; 2008
    In:  Journal of Clinical Oncology Vol. 26, No. 2 ( 2008-01-10), p. 218-224
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 26, No. 2 ( 2008-01-10), p. 218-224
    Abstract: Patients with angioimmunoblastic T-cell lymphoma (AITL) have poor prognoses with current conventional chemotherapy. The aim of this study was to evaluate the effect of high-dose therapy (HDT) followed by autologous stem-cell transplantation (ASCT) on patients with AITL. Patients and Methods We report a retrospective, multicenter study of 146 patients with AITL who received ASCT. The source of the stem cells was peripheral blood in 143 patients. The conditioning regimen varied, and 74% of the patients received carmustine and 1,3-bis(2-chloroethyl)-1-nitrosourea; etoposide; ara-C; and melphalan chemotherapy. Results After a median follow-up of 31 months (range, 3 to 174 months), 95 patients (65%) remained alive, and 51 patients (35%) died. Forty-two patients died as a result of disease progression, and nine died as a result of regimen-related toxicity. The cumulative incidence of nonrelapse mortality was 5% and 7% at 12 and 24 months, respectively. The actuarial overall survival (OS) was 67% at 24 months and 59% at 48 months. The cumulative incidence of relapse was estimated at 40% and 51% at 24 and 48 months, respectively. Disease status at transplantation was the major factor that impacted outcome. Patients who received a transplant during first complete remission (CR) had significantly superior progression-free survival and OS. The estimated PFS rates for patients who received their transplants in CR were 70% and 56% at 24 and 48 months, respectively; 42% and 30% for patients with chemotherapy-sensitive disease at those time points, respectively; and 23% at both time points for patients with chemotherapy-refractory disease. Conclusion This study shows that HDT and ASCT offers the possibility of long-term disease-free survival to patients with AITL. Early transplantation is necessary to achieve optimal results.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2008.12.6219
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2008
    detail.hit.zdb_id: 2005181-5
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  • 7
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    Online Resource
    First-line therapy of T-cell lymphoma: Allogeneic or autologous transplantation for consolidation—Final results of the AATT study.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 7503-7503
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 7503-7503
    Abstract: 7503 Background: In patients (pts) with peripheral T-cell lymphoma (PTCL) results of first-line therapy remain poor; guidelines recommend consolidation with autologous transplantation (autoSCT) in transplant-eligible pts. AATT (Autologous or Allogeneic Transplantation in T-cell lymphoma) sought to improve first-line therapy and compared alloSCT with autoSCT. Methods: This was a prospective randomized trial comparing autoSCT with alloSCT in younger pts (18-60 yrs) with newly diagnosed PTCL who had achieved CR, PR, or SD after 4 courses of CHOEP and 1 course of DHAP. Pts were to receive BEAM followed by autoSCT or myeloablative conditioning (fludarabine, busulfan, cyclophosphamide) followed by alloSCT from a matched related or unrelated donor. Primary endpoint was 3-year event-free survival (EFS). The study was stopped prematurely after a pre-planned interim analysis (JCO 33, 2015, suppl 8507a). Results: 103 pts randomized upfront to autoSCT (n=54) or alloSCT (n=49) formed the full analysis set. Median age was 50 years, 63% were male. 36 pts (35%) could not proceed to transplantation mostly due to early progression. Median observation time for EFS was 42 months. 3-year EFS and overall survival (OS) did not significantly differ between alloSCT and autoSCT (EFS: 43% (95% CI29-57%) vs. 38% (25-52%), p=0.58, OS: 57% (43-71%) vs. 70% (57-82%) (p=0.41). Comparing pts who actually received autoSCT (n=41) or alloSCT (n=26) EFS, PFS, and OS also showed no significant difference. No patient relapsed but eight pts (31%) died of treatment-related mortality (TRM) after alloSCT compared to 13 relapses (36%) but no TRM observed after autoSCT. Comparison of pts with aaIPI 2/3 vs. 0/1 showed significant differences for all endpoints. Conclusions: AlloSCT or autoSCT given to consolidate response in pts with PTCL showed no significant survival differences. While exerting a strong GvL-effect alloSCT resulted in substantial TRM. For younger pts with PTCL autoSCT remains the preferred consolidation, in particular, because pts. relapsing after autoSCT can be successfully salvaged with alloSCT. Clinical trial information: 2007-001052-39.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.7503
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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