Analysis of factors influencing inclusion of 102 patients with stage III/ IV Hodgkin's lymphoma in a randomized trial for first-line chemotherapy

Annals of Oncology

Volumn 19, Issue 11, 2008, Pages 1915-1920

  Biasoli, I ^a   Franchi Rezgui, P ^b   Sibon, D ^b   Briere J ^b   De Kerviler, E ^b   Thieblemont, C ^b   Levy, V ^b   Gisselbrecht, C ^b   Brice, Pauline ^b  

^a FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

^b SAINT LOUIS HOSPITAL   (France)

Author keywords

Advanced stages; Hodgkin's lymphoma; Patient refusal of treatment; Randomized clinical trial; Recruitment

Indexed keywords

BLEOMYCIN; CYCLOPHOSPHAMIDE; DACARBAZINE; DOXORUBICIN; ETOPOSIDE; PREDNISONE; PROCARBAZINE; VINBLASTINE; VINCRISTINE;

ADOLESCENT; ADULT; AGED; ARTICLE; CANCER STAGING; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HODGKIN DISEASE; HUMAN; INFERTILITY; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; MEDICAL DECISION MAKING; MULTIPLE CYCLE TREATMENT; OUTCOME ASSESSMENT; PATIENT REFERRAL; PATIENT SELECTION; PHYSICIAN; PRIORITY JOURNAL; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; TREATMENT REFUSAL;

EID: 54949116235     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdn391     Document Type: Article

References (26)

1. Diehl V, Fuchs M. Early, Intermediate and advanced Hodgkin's lymphoma: modern treatment strategies. Ann Oncol 2007; 18 (Suppl 9.): Ix-71-ix79.
2. Duggan DB, Petroni GR, Johnson JL et al. Randomized comparison of ABVD and MOPP/ABV hybrid for the treatment of advanced Hodgkin's disease: report of an intergroup trial. J Clin Oncol 2003; 21: 607-614.
3. Ferme C, Sebban C, Hennequin C et al. Comparison of chemotherapy to radiotherapy as consolidation of complete or good partial response after six cycles of chemotherapy for patients with advanced Hodgkin's disease: results of the groupe d'etudes des lymphomes de l'Adulte H89 trial. Blood 2000; 95: 2246-2252.
4. Diehl V, Franklin J, Pfreundschuh M et al. Standard and increased-dose BEACOPP chemotherapy compared Wth COPP-ABVD for advanced Hodgkin's disease. N Engl J Med 2003; 348: 2386-2395.
5. Tournoux C, Katsahian S, Chevret S, Levy V. Factors influencing inclusion of patients with malignancies in clinical trials. Cancer 2006; 106: 258-270.
6. Mengis C, Aebi S, Tobler A et al. Assessment of differences in patient populations selected for excluded from participation in clinical phase III acute myelogenous leukemia trials. J Clin Oncol 2003; 21: 3933-3939.
7. Wright JR, Whelan TJ, Schiff S et al. Why cancer patients enter randomized clinical trials: Exploring the factors that influence their decision. J Clin Oncol 2004; 22: 4312-4318.
8. Avis NE, Smith KW, Link CL et al. Factors associated Wth participation in breast cancer treatment clinical trials. J Clin Oncol 2006; 24: 1860-1867.
9. Wright JR, Crooks D, Ellis PM et al. Factors that influence the recruitment of patients to phase III studies in oncology: The perspective of the clinical research associate. Cancer 2002; 95: 1584-1591.
10. Hasenclever D, Diehl V. A prognostic score for advanced Hodgkin's disease. International Prognostc Factors Project on advanced Hodgkin's disease. N Engl J Med 1998; 339: 1506-1514.
11. INSEE. Institut National de la Statistique et des Études Économiques. http://www.insee.fr/fr/nom_def_met/nomenclatures/ naf/nlst17.htm (4 June 2008, date last accessed).
12. Ferme C, Mounier N, Casasnovas O et al. Long-term results and competing risk analysis of the H89 trial in patients with advanced-stage Hodgkin's lymphoma: A study by the Groupe d'Etude des Lymphomes de l'Adulte (GELA). Blood 2006; 107: 4636-4642.
13. Cheson BD, Horning SJ, Coiffier B et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol 1999; 17: 1244.
14. Harter P, du Bois A, Schade-Brittinger C et al. Non-enrolment of ovarian cancer patients in clinical trials: Reasons and background. Ann Oncol 2005; 16: 1801-1805.
15. Lewis JH, Kilgore ML, Goldman DP et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 2003; 21: 1383-1389.
16. Elting LS, Cooksley C, Bekele BN et al. Generalizability of cancer clinical trial results: Prognostic differences between participants and nonparticipants. Cancer 2006; 106: 2452-2458.
17. Kemeny MM, Peterson BL, Komblith AB et al. Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol 2003; 21: 2268-2275.
18. Behringer K, Breuer K, Reineke T et al. Secondary amenorrhea after Hodgkin's lymphoma is influenced by age at treatment, stage of disease, chemotherapy regimen, and the use of oral contraceptives during therapy: a report from the German Hodgkin's Lymphoma Study Group. J Clin Oncol 2005; 23: 7555-7564.
19. Josting A, Wiedenmann S, Franklin J et al. Secondary myeloid leukemia and myelodysplasdc syndromes in patients treated for Hodgkin's disease: a report from the German Hodgkin's Lymphoma Study Group. J Clin Oncol 2003; 21: 3440--3446.
20. Partridge AH, Gelber S, Peppercom J et al. Web-based survey of fertility issues in young women with breast cancer. J Clin Oncol 2004; 22: 4174-4183.
21. Ross S, Grant A, Counsell C et al. Barriers to participaton in randomised controlled trials: A systematic review. J Clin Epidemiol 1999; 52: 1143-1156.
22. Mills EJ, Seely D, Rachlis B et al. Barriers to participation in clinical trials of cancer: A meta-analysis and systematic review of patient-reported factors. Lancet Oncol 2006; 7: 141-148.
23. Lara PN Jr, Paterniti DA, Chiechi C et al. Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol 2005; 23: 9282-9289.
24. Dann EJ, Bar-Shalom R, Tamir A et al. Risk-adapted BEACOPP regimen can reduce the cumulative dose of chemotherapy for standard and high-risk Hodgkin's lymphoma with no impairment of outcome. Blood 2007; 109: 905-909.
25. Diehl V, Brilliant C, Franklin J et al. BEACOPP chemotherapy for advanced Hodgkin's disease: Results of further analyses of the HD9- and HD12-trials of the German Hodgkin Study Group (GHSG). Blood 2004; 104: 307a (Abstr).
26. Gallamini A, Hutchings M, Rigacci L et al. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: A report from a joint Italian-Danish study. J Clin Oncol 2007; 25: 3746-3752.