Assessment of differences in patient populations selected for or excluded from participation in clinical phase III acute myelogenous leukemia trials

Journal of Clinical Oncology

Volumn 21, Issue 21, 2003, Pages 3933-3939

  Mengis, Catherine ^a   Aebi, Sfefan ^a   Tobler, Andreas ^a   Dähler, Werner ^a   Fey, Martin F ^a  

^a UNIVERSITY OF BERN   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ACUTE GRANULOCYTIC LEUKEMIA; ARTICLE; CANCER SURVIVAL; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL; COMORBIDITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE CLASSIFICATION; HUMAN; MAJOR CLINICAL STUDY; PATIENT ASSESSMENT; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT RESPONSE; ADOLESCENT; ADULT; AGE; AGED; COMPARATIVE STUDY; FEMALE; MALE; MEDICAL RECORD; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; RETROSPECTIVE STUDY; STANDARD; SWITZERLAND;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; CLINICAL TRIALS, PHASE III; COMORBIDITY; FEMALE; HUMANS; LEUKEMIA, MYELOCYTIC, ACUTE; MALE; MEDICAL RECORDS; MIDDLE AGED; PATIENT SELECTION; RETROSPECTIVE STUDIES; SWITZERLAND;

EID: 0642373288     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.03.186     Document Type: Article

References (27)

1. Cottin V, Arpin D, Lasset C, et al: Small-cell lung cancer: Patients included in clinical trials are not representative of the patient population as a whole. Ann Oncol 10:809-815, 1999
2. Mayers C, Panzarella T, Tannock IF: Analysis of the prognostic effects of inclusion in a clinical trial and of myelosuppression on survival after adjuvant chemotherapy of breast carcinoma. Cancer 91:2246-2257, 2001
3. Fopp M, Gratwohl A, Tschopp L, et al: Non-cross resistant chemotherapy of adults with untreated acute myeloid leukemia (AML) using three drug combinations including amsacrine (AMSA)/etoposide (VP-16) and high-dose (HD) cytosine-arabinoside (Ara-C). Proc Am Soc Clin Oncol 6:1152, 1987 (abstr 598)
4. Fopp M, Fey MF, Bacchi M, et al: Post-remission therapy of adult acute myeloid leukemia: One cycle of high-dose versus standard-dose cytarabine-Leukaemia Project Group of the Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol 8:251-257, 1997
5. Löwenberg B, Boogaerts MA, Daenen SMGJ, et al: Value of different modalities of granulocyte-macrophage colony-stimulating factor applied during or after induction therapy of acute myeloid leukemia. J Clin Oncol 15:3496-3506, 1997
6. Löwenberg B, van Putten W, Gmür J, et al: Chemotherapy priming with granulocyte-colony-stimulating factor (G-CSF) in acute myeloid leukemia (AML) improves relapse free survival: Report of a prospective randomized multicenter study. N Engl J Med 349:743-752, 2003
7. Fenaux P, Chastang C, Chevret S, et al: A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia: The European APL Group. Blood 94:1192-1200, 1999
8. Dombret H, Chastang C, Fenaux P, et al: A controlled study of recombinant human granulocyte colony-stimulating factor in elderly patients after treatment for acute myelogenous leukemia: AML Cooperative Study Group. N Engl J Med 332:1678-1683, 1995
9. Löwenberg B, Downing JR, Burnett A: Acute myeloid leukemia. N Engl J Med 341:1051-1062, 1999
10. Keating MJ, Smith TL, Gehan A, et al: A prognostic factor analysis for use in development of predictive models for response in adult acute leukemia. Cancer 50:457-465, 1982
11. Büchner T, Heinecke A: The role of prognostic factors in acute myeloid leukemia. Leukemia 10:S28-S29, 1996 (suppl 1)
12. Bennett JM, Catovsky D, Daniel MT, et al: Proposals for the classification of the acute leukemias: The French-American-British (FAB) Cooperative Group. Br J Haematol 33:451-458, 1976
13. Bennett JM, Catovsky D, Daniel MT, et al: Proposed revised criteria for the classification of acute myeloid leukemia: A report of the French-American-British (FAB) Cooperative Group. Ann Intern Med 103:626-629, 1985
14. Bennett JM, Catovsky D, Daniel MT, et al: Criteria for the diagnosis of acute leukemia of megakaryocyte lineage (M7): A report of the French-American-British (FAB) Cooperative Group. Ann Intern Med 103:460-462, 1985
15. Bennett JM, Catovsky D, Daniel MT, et al: Proposals for the recognition of minimally differentiated acute myeloid leukaemia (AML-M0): The French-American-British (FAB) Cooperative Group. Br J Haematol 78:325-329, 1991
16. Morphologic, immunologic, and cytogenetic (MIC) working classification of the acute myeloid leukemias: Report of the Workshop held in Leuven, Belgium, September 15-17, 1986-Second MIC Cooperative Study Group. Cancer Genet Cytogenet 30:1-15, 1988
17. Bennett JM, Catovsky D, Daniel MT, et al: Proposals for the classification of the myelodysplastic syndromes: The French-American-British (FAB) Cooperative Group. Br J Haematol 51:189-199, 1982
18. Levine EG, Bloomfield CD: Leukemias and myelodysplastic syndromes secondary to drug, radiation and environmental exposure. Semin Oncol 19:47-84, 1992
19. Mrózek K, Heinonen K, de la Chappelle A, et al: Clinical significance of cytogenetics in acute myeloid leukemia. Semin Oncol 24:17-31, 1997
20. Kaplan EL, Meier P: Non parametric estimation from incomplete observation. J Am Stat Assoc 53:457-481, 1958
21. Mantel N: Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50:163-170, 1966
22. Cox DR: Regression models and life-tables (with discussion). J R Stat Soc B 34:187-220, 1972
23. Hutchins LF, Unger JM, Crowley JJ, et al: Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 341:2061-2067, 1999
24. Karjalainen S, Palva I: Do treatment protocols improve end results? A study of survival of patients with multiple myeloma in Finland. BMJ 299:1069-1072, 1989
25. Bennett JM, Young ML, Andersen JW, et al: Long-term survival in acute myeloid leukemia: The Eastern Cooperative Oncology Group Experience. Cancer 80:2205-2209, 1997 (suppl II)
26. Zittoun R, Mandelli F, Willemze R, et al: Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia. N Engl J Med 332:217-223, 1995
27. Mayer RJ, Davis RB, Schiffer CA, et al: Intensive postremission chemotherapy in adults with acute myeloid leukaemia. N Engl J Med 331:896-903, 1994