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Volumn 96, Issue 8, 2011, Pages 1106-1112

Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission

Author keywords

Clinical trial interpretation; Immunotherapy; Leukemia free survival; Overall survival; Statistical analyses

Indexed keywords

HISTAMINE; RECOMBINANT INTERLEUKIN 2;

EID: 79961097283     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2010.039131     Document Type: Article
Times cited : (37)

References (39)
  • 1
    • 52649094924 scopus 로고    scopus 로고
    • Surrogate endpoints for overall survival in advanced colorectal cancer: A clinician's perspective
    • Piedbois P, Miller CJ. Surrogate endpoints for overall survival in advanced colorectal cancer: a clinician's perspective. Stat Methods Med Res. 2008;17(5):519-27.
    • (2008) Stat Methods Med Res , vol.17 , Issue.5 , pp. 519-527
    • Piedbois, P.1    Miller, C.J.2
  • 2
    • 33745636985 scopus 로고    scopus 로고
    • End points for adjuvant therapy trials: Has the time come to accept disease-free survival as a surrogate end point for overall survival?
    • Gill S, Sargent D. End points for adjuvant therapy trials: has the time come to accept disease-free survival as a surrogate end point for overall survival? Oncologist. 2006;11(6):624-9.
    • (2006) Oncologist , vol.11 , Issue.6 , pp. 624-629
    • Gill, S.1    Sargent, D.2
  • 3
    • 36849078044 scopus 로고    scopus 로고
    • Progression-free survival is a surrogate for survival in advanced colorectal cancer
    • Buyse M, Burzykowski T, Carroll K, Michiels S, Sargent DJ, Miller LL, et al. Progression-free survival is a surrogate for survival in advanced colorectal cancer. J Clin Oncol 2007;25(33):5218-24.
    • (2007) J Clin Oncol , vol.25 , Issue.33 , pp. 5218-5224
    • Buyse, M.1    Burzykowski, T.2    Carroll, K.3    Michiels, S.4    Sargent, D.J.5    Miller, L.L.6
  • 6
    • 35649022759 scopus 로고    scopus 로고
    • Surrogate end points for median overall survival in metastatic colorectal cancer: Literature- based analysis from 39 randomized controlled trials of first-line chemotherapy
    • Tang PA, Bentzen SM, Chen EX, Siu LL. Surrogate end points for median overall survival in metastatic colorectal cancer: literature- based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol. 2007;25(29):4562-8.
    • (2007) J Clin Oncol , vol.25 , Issue.29 , pp. 4562-4568
    • Tang, P.A.1    Bentzen, S.M.2    Chen, E.X.3    Siu, L.L.4
  • 7
    • 42949145995 scopus 로고    scopus 로고
    • Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer
    • Burzykowski T, Buyse M, Piccart-Gebhart MJ, Sledge G, Carmichael J, Lück HJ, et al. Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer. J Clin Oncol. 2008;26(12):1987-92.
    • (2008) J Clin Oncol , vol.26 , Issue.12 , pp. 1987-1992
    • Burzykowski, T.1    Buyse, M.2    Piccart-Gebhart, M.J.3    Sledge, G.4    Carmichael, J.5    Lück, H.J.6
  • 8
    • 42949158252 scopus 로고    scopus 로고
    • Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer
    • Piccart-Gebhart MJ, Burzykowski T, Buyse M, Sledge G, Carmichael J, Lück HJ, et al. Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol. 2008;26(12):1980-6.
    • (2008) J Clin Oncol , vol.26 , Issue.12 , pp. 1980-1986
    • Piccart-Gebhart, M.J.1    Burzykowski, T.2    Buyse, M.3    Sledge, G.4    Carmichael, J.5    Lück, H.J.6
  • 10
    • 41749103582 scopus 로고    scopus 로고
    • Clinical endpoints for drug development in prostate cancer
    • Ramiah V, George DJ, Armstrong AJ. Clinical endpoints for drug development in prostate cancer. Curr Opin Urol. 2008;18 (3):303-8.
    • (2008) Curr Opin Urol , vol.18 , Issue.3 , pp. 303-308
    • Ramiah, V.1    George, D.J.2    Armstrong, A.J.3
  • 12
    • 34047238978 scopus 로고    scopus 로고
    • The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme
    • Ballman KV, Buckner JC, Brown PD, Giannini C, Flynn PJ, LaPlant BR, Jaeckle KA. The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Neuro Oncol. 2007;9(1):29-38.
    • (2007) Neuro Oncol , vol.9 , Issue.1 , pp. 29-38
    • Ballman, K.V.1    Buckner, J.C.2    Brown, P.D.3    Giannini, C.4    Flynn, P.J.5    Laplant, B.R.6    Jaeckle, K.A.7
  • 13
    • 63149171415 scopus 로고    scopus 로고
    • Prediction of survival benefits from progression- free survival in patients with advanced non small cell lung cancer: Evidence from a pooled analysis of 2,838 patients randomized in 7 trials
    • Buyse ME, Squifflet P, Laporte S, et al. Prediction of survival benefits from progression- free survival in patients with advanced non small cell lung cancer: evidence from a pooled analysis of 2,838 patients randomized in 7 trials. J Clin Oncol 2008;26(15 suppl):428s.
    • (2008) J Clin Oncol , vol.26 , Issue.15 SUPPL.
    • Buyse, M.E.1    Squifflet, P.2    Laporte, S.3
  • 14
    • 67049167808 scopus 로고    scopus 로고
    • Time to progression as a surrogate marker for overall survival in patients with advanced nonsmall cell lung cancer
    • Hotta K, Fujiwara Y, Matsuo K, Kiura K, Takigawa N, Tabata M, et al. Time to progression as a surrogate marker for overall survival in patients with advanced nonsmall cell lung cancer. J Thorac Oncol. 2009;4(3):311-7.
    • (2009) J Thorac Oncol , vol.4 , Issue.3 , pp. 311-317
    • Hotta, K.1    Fujiwara, Y.2    Matsuo, K.3    Kiura, K.4    Takigawa, N.5    Tabata, M.6
  • 15
    • 63149095503 scopus 로고    scopus 로고
    • Surrogate endpoints for overall survival in locally advanced head and neck cancer: Meta-analyses of individual patient data
    • Michiels S, Le Maître A, Buyse M, Burzykowski T, Maillard E, Bogaerts J, et al. Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data. Lancet Oncol. 2009;10(4):341-50.
    • (2009) Lancet Oncol , vol.10 , Issue.4 , pp. 341-350
    • Michiels, S.1    Le Maître, A.2    Buyse, M.3    Burzykowski, T.4    Maillard, E.5    Bogaerts, J.6
  • 16
    • 82355193006 scopus 로고    scopus 로고
    • Disease-free survival as a surrogate endpoint for overall survival in an adjuvant trial of curatively resected stomach cancer using individual patient data meta-analysis
    • Burzykowski T, Bank Y. Disease-free survival as a surrogate endpoint for overall survival in an adjuvant trial of curatively resected stomach cancer using individual patient data meta-analysis. J Clin Oncol. 2009;27(15 suppl):206s.
    • (2009) J Clin Oncol , vol.27 , Issue.15 SUPPL.
    • Burzykowski, T.1    Bank, Y.2
  • 17
    • 70350162393 scopus 로고    scopus 로고
    • Surrogate endpoints for overall survival (OS) in advanced pancreatic cancer (APC): Analysis of randomized clinical trials (RCTS) exploring gemcitabine (G)-based combinations
    • Milella M, Bria E, Carlini P, et al. Surrogate endpoints for overall survival (OS) in advanced pancreatic cancer (APC): analysis of randomized clinical trials (RCTS) exploring gemcitabine (G)-based combinations. J Clin Oncol 2007;25(18 suppl):216s.
    • (2007) J Clin Oncol , vol.25 , Issue.18 SUPPL.
    • Milella, M.1    Bria, E.2    Carlini, P.3
  • 18
    • 36849069358 scopus 로고    scopus 로고
    • Toward progression-free survival as a primary end point in advanced colorectal cancer
    • Yothers G. Toward progression-free survival as a primary end point in advanced colorectal cancer. J Clin Oncol. 2007;25(33): 5153-4.
    • (2007) J Clin Oncol , vol.25 , Issue.33 , pp. 5153-5154
    • Yothers, G.1
  • 19
    • 34447626313 scopus 로고    scopus 로고
    • Impact of phase II trials with progression-free survival as end-points on survival-based phase III studies in patients with anaplastic gliomas
    • Levin VA, Ictech S, Hess KR. Impact of phase II trials with progression-free survival as end-points on survival-based phase III studies in patients with anaplastic gliomas. BMC Cancer. 2007;7:106.
    • (2007) BMC Cancer , vol.7 , pp. 106
    • Levin, V.A.1    Ictech, S.2    Hess, K.R.3
  • 20
    • 33846577679 scopus 로고    scopus 로고
    • Very poor survival of patients with AML who relapse after achieving a first complete remission: The Eastern Cooperative Oncology Group experience
    • Rowe JM, Xiaochun L, Cassileth PA, et al. Very poor survival of patients with AML who relapse after achieving a first complete remission: The Eastern Cooperative Oncology Group experience. Blood. 2005; 106(11):162a-3a.
    • (2005) Blood , vol.106 , Issue.11
    • Rowe, J.M.1    Xiaochun, L.2    Cassileth, P.A.3
  • 22
    • 20244361887 scopus 로고    scopus 로고
    • Prognostic index for adult patients with acute myeloid leukemia in first relapse
    • Breems DA, van Putten WL, Huijgens PC, et al. Prognostic index for adult patients with acute myeloid leukemia in first relapse. J Clin Oncol. 2005;23(9):1969-78.
    • (2005) J Clin Oncol , vol.23 , Issue.9 , pp. 1969-1978
    • Breems, D.A.1    van Putten, W.L.2    Huijgens, P.C.3
  • 23
    • 0001863948 scopus 로고    scopus 로고
    • The validation of surrogate endpoints in meta-analyses of randomized experiments
    • Buyse M, Molenberghs G, Burzykowski T, Renard D, Geys H. The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics. 2000;1 (1):49-67.
    • (2000) Biostatistics , vol.1 , Issue.1 , pp. 49-67
    • Buyse, M.1    Molenberghs, G.2    Burzykowski, T.3    Renard, D.4    Geys, H.5
  • 24
    • 78650937136 scopus 로고    scopus 로고
    • Leukemia-free survival (LFS) as a surrogate for overall survival (OS) in AML patients in remission: A trial of a novel immunotherapy with histamine dihydrochloride plus low-dose IL-2 (HDC/IL-2)
    • Buyse ME, Squifflet P, Allard SE, Bhagwat D, Rowe JM. Leukemia-free survival (LFS) as a surrogate for overall survival (OS) in AML patients in remission: a trial of a novel immunotherapy with histamine dihydrochloride plus low-dose IL-2 (HDC/IL-2). Haematologica. 2008;93(suppl 1):209-10.
    • (2008) Haematologica , vol.93 , Issue.SUPPL. 1 , pp. 209-10
    • Buyse, M.E.1    Squifflet, P.2    Allard, S.E.3    Bhagwat, D.4    Rowe, J.M.5
  • 25
    • 33745714215 scopus 로고    scopus 로고
    • Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: Results of a randomized phase 3 trial
    • Brune M, Castaigne S, Catalano J, Gehlsen K, Ho AD, Hofmann WK, et al. Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial. Blood. 2006;108(1):88-96.
    • (2006) Blood , vol.108 , Issue.1 , pp. 88-96
    • Brune, M.1    Castaigne, S.2    Catalano, J.3    Gehlsen, K.4    Ho, A.D.5    Hofmann, W.K.6
  • 26
    • 78650943715 scopus 로고    scopus 로고
    • Quality of life during remission maintenance immunotherapy in acute myeloid leukemia: A prospective assessment using EORTC QLQ-C30 in a randomized phase III trial of histamine dihydrochloride plus low-dose interleukin-2
    • Wallhult EA, Whisnant JK, Nilsson BI, Bhagwat D, Hellstrand K, Brune ML. Quality of life during remission maintenance immunotherapy in acute myeloid leukemia: a prospective assessment using EORTC QLQ-C30 in a randomized phase III trial of histamine dihydrochloride plus low-dose interleukin-2. Haematologica. 2008;93(suppl 1):316.
    • (2008) Haematologica , vol.93 , Issue.SUPPL. 1 , pp. 316
    • Wallhult, E.A.1    Whisnant, J.K.2    Nilsson, B.I.3    Bhagwat, D.4    Hellstrand, K.5    Brune, M.L.6
  • 27
    • 33646460814 scopus 로고    scopus 로고
    • What do, can and should we learn from models to evaluate potential anticancer agents?
    • Burchill SA. What do, can and should we learn from models to evaluate potential anticancer agents? Future Oncol. 2006;2(2): 201-11.
    • (2006) Future Oncol , vol.2 , Issue.2 , pp. 201-211
    • Burchill, S.A.1
  • 28
    • 52649120836 scopus 로고    scopus 로고
    • Practical issues arising in an exploratory analysis evaluating progression- free survival as a surrogate endpoint for overall survival in advanced colorectal cancer
    • Hughes MD. Practical issues arising in an exploratory analysis evaluating progression- free survival as a surrogate endpoint for overall survival in advanced colorectal cancer. Stat Methods Med Res. 2008;17 (5):487-95.
    • (2008) Stat Methods Med Res , vol.17 , Issue.5 , pp. 487-495
    • Hughes, M.D.1
  • 29
    • 52649088322 scopus 로고    scopus 로고
    • Surrogate endpoints for overall survival in early colorectal cancer from the clinician's perspective
    • Grothey A. Surrogate endpoints for overall survival in early colorectal cancer from the clinician's perspective. Stat Methods Med Res. 2008;17(5):529-35.
    • (2008) Stat Methods Med Res , vol.17 , Issue.5 , pp. 529-535
    • Grothey, A.1
  • 30
    • 52649122745 scopus 로고    scopus 로고
    • Use of progression- free survival as a surrogate marker in oncology trials: Some regulatory issues
    • Chakravarty A, Sridhara R. Use of progression- free survival as a surrogate marker in oncology trials: some regulatory issues. Stat Methods Med Res. 2008;17(5):515-8.
    • (2008) Stat Methods Med Res , vol.17 , Issue.5 , pp. 515-518
    • Chakravarty, A.1    Sridhara, R.2
  • 31
    • 33644834827 scopus 로고    scopus 로고
    • Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20,898 patients on 18 randomized trials
    • Sargent DJ, Wieand HS, Haller DG, Gray R, Benedetti JK, Buyse M, et al. Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials. J Clin Oncol 2005;23(34):8664-70.
    • (2005) J Clin Oncol , vol.23 , Issue.34 , pp. 8664-8670
    • Sargent, D.J.1    Wieand, H.S.2    Haller, D.G.3    Gray, R.4    Benedetti, J.K.5    Buyse, M.6
  • 32
    • 0035648331 scopus 로고    scopus 로고
    • Validation of surrogate endpoints in multiple randomized clinical trials with failure-time endpoints
    • Burzykowski T, Molenberghs G, Buyse M, Geys H, Renard D. Validation of surrogate endpoints in multiple randomized clinical trials with failure-time endpoints. J R Stat Soc C. (Appl Stat) 2001;50:405-22.
    • (2001) J R Stat Soc C. (Appl Stat) , vol.50 , pp. 405-422
    • Burzykowski, T.1    Molenberghs, G.2    Buyse, M.3    Geys, H.4    Renard, D.5
  • 34
    • 24944582166 scopus 로고    scopus 로고
    • Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals
    • Collette L, Burzykowski T, Carroll KJ, Newling D, Morris T, Schroder FH. Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals. J Clin Oncol. 2005;23(25):6139-48.
    • (2005) J Clin Oncol , vol.23 , Issue.25 , pp. 6139-6148
    • Collette, L.1    Burzykowski, T.2    Carroll, K.J.3    Newling, D.4    Morris, T.5    Schroder, F.H.6
  • 35
    • 33745532038 scopus 로고    scopus 로고
    • Adjuvant procarbazine, lomustine, and vincristine improves progressionfree survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: A randomized European Organisation for Re - search and Treatment of Cancer phase III trial
    • Van den Bent MJ, Carpentier AF, Brandes AA, et al. Adjuvant procarbazine, lomustine, and vincristine improves progressionfree survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Re - search and Treatment of Cancer phase III trial. J Clin Oncol. 2006;24(18):2715-22.
    • (2006) J Clin Oncol , vol.24 , Issue.18 , pp. 2715-2722
    • van den Bent, M.J.1    Carpentier, A.F.2    Brandes, A.A.3
  • 36
    • 53949108399 scopus 로고    scopus 로고
    • Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): A trial coordinated by the Eastern Cooperative Oncology Group
    • Atkins MB, Hsu J, Lee S, Cohen GI, Flaherty LE, Sosman JA, et al. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008;26(35):5748-54.
    • (2008) J Clin Oncol , vol.26 , Issue.35 , pp. 5748-5754
    • Atkins, M.B.1    Hsu, J.2    Lee, S.3    Cohen, G.I.4    Flaherty, L.E.5    Sosman, J.A.6
  • 37
    • 57149096463 scopus 로고    scopus 로고
    • Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for meta - static breast cancer
    • Di Leo A, Gomez HL, Aziz Z, Zvirbule Z, Bines J, Arbushites MC, et al. Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for meta - static breast cancer. J Clin Oncol. 2008; 26(34):5544-52.
    • (2008) J Clin Oncol , vol.26 , Issue.34 , pp. 5544-5552
    • Di Leo, A.1    Gomez, H.L.2    Aziz, Z.3    Zvirbule, Z.4    Bines, J.5    Arbushites, M.C.6
  • 38
    • 58149384555 scopus 로고    scopus 로고
    • Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure
    • Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, et al. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood 2008;112(12):4445-51.
    • (2008) Blood , vol.112 , Issue.12 , pp. 4445-4451
    • Wang, M.1    Dimopoulos, M.A.2    Chen, C.3    Cibeira, M.T.4    Attal, M.5    Spencer, A.6
  • 39
    • 84857105246 scopus 로고    scopus 로고
    • National Cancer Institute. SEER Survival Data 1988-2005 (SEER 9). Available at:, Accessed February 3, 2010
    • National Cancer Institute. SEER Survival Data 1988-2005 (SEER 9). Available at: http://seer.cancer.gov/faststats/selections.p hp?series=cancer. Accessed February 3, 2010.


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