Skip to main content
Top
Published in: European Journal of Nuclear Medicine and Molecular Imaging 1/2018

01-01-2018 | Editorial

PET-guided clinical trials in Hodgkin lymphoma: to agree or not to agree, that is the reviewer’s question

Authors: A. Gallamini, M. Meignan

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 1/2018

Login to get access

Excerpt

In image-based clinical trials, when the study endpoint depends on treatment response assessment by imaging, blinded independent central review (BICR) is considered mandatory to overcome potential image reader bias leading to a systematic over- or under-interpretation of tumor shrinkage [1, 2]. …
Literature
1.
go back to reference Dodd LE, Korn EL, Freidlin B, et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol. 2008;26:3791–6.CrossRef Dodd LE, Korn EL, Freidlin B, et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol. 2008;26:3791–6.CrossRef
2.
go back to reference Amit O, Bushnell W, Dodd L, et al. Blinded Indipendent central review of progression-free survival endpoint. Oncologist. 2010;15:492–5.CrossRef Amit O, Bushnell W, Dodd L, et al. Blinded Indipendent central review of progression-free survival endpoint. Oncologist. 2010;15:492–5.CrossRef
3.
go back to reference Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059–68.CrossRef Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059–68.CrossRef
4.
go back to reference Barrington SF, Mikhaeel NG, Kostakoglu L, et al. Role of imaging in the staging and response assessment of lymphoma: consensus of the international conference on malignant lymphoma working group. J Clin Oncol. 2014;32:3048–58.CrossRef Barrington SF, Mikhaeel NG, Kostakoglu L, et al. Role of imaging in the staging and response assessment of lymphoma: consensus of the international conference on malignant lymphoma working group. J Clin Oncol. 2014;32:3048–58.CrossRef
5.
go back to reference Radford J, Illidge T, Counsell N, et al. Results of a trial of PET-directed therapy for early-stage Hodgkin’s lymphoma. N Engl J Med. 2015;372:1598–607.CrossRef Radford J, Illidge T, Counsell N, et al. Results of a trial of PET-directed therapy for early-stage Hodgkin’s lymphoma. N Engl J Med. 2015;372:1598–607.CrossRef
6.
go back to reference Straus DJ, Pitcher B, Kostakoglu L, et al. Initial Results of US Intergroup Trial of Response-Adapted Chemotherapy or Chemotherapy/Radiation Therapy Based on PET for Non-Bulky Stage I and II Hodgkin Lymphoma (HL) (CALGB/Alliance 50604). Blood. 2015;126:578. [abstr.] Straus DJ, Pitcher B, Kostakoglu L, et al. Initial Results of US Intergroup Trial of Response-Adapted Chemotherapy or Chemotherapy/Radiation Therapy Based on PET for Non-Bulky Stage I and II Hodgkin Lymphoma (HL) (CALGB/Alliance 50604). Blood. 2015;126:578. [abstr.]
7.
go back to reference André MPE, Girinsky T, Federico M, et al. Early positron emission tomography response-adapted treatment of stage I and II Hodgkin Lymphoma: final results of the randomized EORTC/LYSA/FIL H10 trial. J Clin Oncol. 2017;35(16):1786–94.CrossRef André MPE, Girinsky T, Federico M, et al. Early positron emission tomography response-adapted treatment of stage I and II Hodgkin Lymphoma: final results of the randomized EORTC/LYSA/FIL H10 trial. J Clin Oncol. 2017;35(16):1786–94.CrossRef
8.
go back to reference Gallamini A, Rossi A, Patti C, et al. Interim PET-adapted chemotherapy in advanced Hodgkin Lymphoma (HL). Results of the second interim analysis of the Italian GITIL/FIL HD 0607 trial. Hematol Oncol. 2015;33(Suppl. 1 June 2015):163. Abstract 118 Gallamini A, Rossi A, Patti C, et al. Interim PET-adapted chemotherapy in advanced Hodgkin Lymphoma (HL). Results of the second interim analysis of the Italian GITIL/FIL HD 0607 trial. Hematol Oncol. 2015;33(Suppl. 1 June 2015):163. Abstract 118
9.
go back to reference Johnson P, Federico M, Kirkwood A, et al. Adapted treatment guided by interim PET CT scan in advanced Hodgkin’s lymphoma. N Engl J Med. 2016;374:2419–29.CrossRef Johnson P, Federico M, Kirkwood A, et al. Adapted treatment guided by interim PET CT scan in advanced Hodgkin’s lymphoma. N Engl J Med. 2016;374:2419–29.CrossRef
10.
go back to reference Press OW, Li H, Shoder H, et al. US Intergroup trial of response adapted for stage III to IV Hodgkin Lymphoma using early interim Fluorodeoxyglucose -Positron Emission Tomography imaging: Southwest Oncology Group S 0816. J Clin Oncol. 2016;34:2020–7.CrossRef Press OW, Li H, Shoder H, et al. US Intergroup trial of response adapted for stage III to IV Hodgkin Lymphoma using early interim Fluorodeoxyglucose -Positron Emission Tomography imaging: Southwest Oncology Group S 0816. J Clin Oncol. 2016;34:2020–7.CrossRef
11.
go back to reference Borchmann P, Havenkamp H, Lohri A, et al. Progression-free survival of early interim PET-positive patients with advanced-stage Hodgkin’s lymphoma treated BEACOPP ESCALATED alone or in combination with Rituxinab (HD18): an open-label, international randomized phase 3study by the German Hodgkin Study Group. Lancet Oncol. 2017;18(4):454–63.CrossRef Borchmann P, Havenkamp H, Lohri A, et al. Progression-free survival of early interim PET-positive patients with advanced-stage Hodgkin’s lymphoma treated BEACOPP ESCALATED alone or in combination with Rituxinab (HD18): an open-label, international randomized phase 3study by the German Hodgkin Study Group. Lancet Oncol. 2017;18(4):454–63.CrossRef
12.
go back to reference Casasnovas O, Brice P, Bouabdallah R, et al. Randomized phase III trial comparing an early PET driven treatment de-escalation to a not PET-monitored strategy in patients with advanced stages Hodgkin Lymphoma: interim analysis of the AHL2011 Lysa Study. Blood. 2015;126:577. [abstr.] Casasnovas O, Brice P, Bouabdallah R, et al. Randomized phase III trial comparing an early PET driven treatment de-escalation to a not PET-monitored strategy in patients with advanced stages Hodgkin Lymphoma: interim analysis of the AHL2011 Lysa Study. Blood. 2015;126:577. [abstr.]
13.
go back to reference Barrington SF, Qian W, Somer EJ, et al. Concordance between four European centres of PET reporting criteria designed for use in multicentre trials in Hodgkin Lymphoma. Eur J Nucl Med Mol Imaging. 2010;37(10):1824–33.CrossRef Barrington SF, Qian W, Somer EJ, et al. Concordance between four European centres of PET reporting criteria designed for use in multicentre trials in Hodgkin Lymphoma. Eur J Nucl Med Mol Imaging. 2010;37(10):1824–33.CrossRef
14.
go back to reference Barrington SF, Kirkwood AA, Franceschetto A, et al. PET-CT for staging and early response: results from the response-adapted therapy in advanced Hodgkin Lymphoma study. Blood. 2016;127(12):1531–8.CrossRef Barrington SF, Kirkwood AA, Franceschetto A, et al. PET-CT for staging and early response: results from the response-adapted therapy in advanced Hodgkin Lymphoma study. Blood. 2016;127(12):1531–8.CrossRef
15.
go back to reference Biggi A, Gallamini A, Chauvie S, et al. International validation study for interim PET in ABVD-treated, advanced stage Hodgkin lymphoma: interpretation criteria and concordance rate among reviewers. J Nucl Med. 2013;54:683–90.CrossRef Biggi A, Gallamini A, Chauvie S, et al. International validation study for interim PET in ABVD-treated, advanced stage Hodgkin lymphoma: interpretation criteria and concordance rate among reviewers. J Nucl Med. 2013;54:683–90.CrossRef
16.
go back to reference Cohen J. A coefficient for agreement for nominal scales. Educ Psychol Meas. 1960;20:37–46.CrossRef Cohen J. A coefficient for agreement for nominal scales. Educ Psychol Meas. 1960;20:37–46.CrossRef
17.
go back to reference Hayes AS, Krippendorf K. Answering the call for a standard reliability measure for coding data. Commun Method Meas. 2007;1:77–89. Hayes AS, Krippendorf K. Answering the call for a standard reliability measure for coding data. Commun Method Meas. 2007;1:77–89.
18.
go back to reference Kobe C, Kuhnert G, Kahraman D, et al. Assessment of tumor size reduction improves outcome prediction of positron emission tomography/computed tomography after chemotherapy in advanced-stage Hodgkin lymphoma. J Clin Oncol. 2014;32:1776–81. Kobe C, Kuhnert G, Kahraman D, et al. Assessment of tumor size reduction improves outcome prediction of positron emission tomography/computed tomography after chemotherapy in advanced-stage Hodgkin lymphoma. J Clin Oncol. 2014;32:1776–81.
19.
go back to reference Meignan M, Itti E, Bardet S, et al. Development and application of a real-time on-line blinded independent central review of interim PET scans to determine treatment allocation in lymphoma trials. J Clin Oncol. 2009;27:2739–41. Meignan M, Itti E, Bardet S, et al. Development and application of a real-time on-line blinded independent central review of interim PET scans to determine treatment allocation in lymphoma trials. J Clin Oncol. 2009;27:2739–41.
20.
go back to reference Chauvie S, Biggi A, Stancu A et al: WIDEN: a tool for medical image management in clinical trials. Clinical Trial 2014;0:1–7. Chauvie S, Biggi A, Stancu A et al: WIDEN: a tool for medical image management in clinical trials. Clinical Trial 2014;0:1–7.
21.
go back to reference Ceriani L, Barrington S, Biggi A, et al. Training improves the interobserver agreement of the expert positron emission tomography review panel in primary mediastinal B-cell lymphoma: interim analysis in the ongoing International Extranodal Lymphoma Study Group-37 study. Hematol Oncol. 2016. https://doi.org/10.1002/hon.2339. Ceriani L, Barrington S, Biggi A, et al. Training improves the interobserver agreement of the expert positron emission tomography review panel in primary mediastinal B-cell lymphoma: interim analysis in the ongoing International Extranodal Lymphoma Study Group-37 study. Hematol Oncol. 2016. https://​doi.​org/​10.​1002/​hon.​2339.
Metadata
Title
PET-guided clinical trials in Hodgkin lymphoma: to agree or not to agree, that is the reviewer’s question
Authors
A. Gallamini
M. Meignan
Publication date
01-01-2018
Publisher
Springer Berlin Heidelberg
Published in
European Journal of Nuclear Medicine and Molecular Imaging / Issue 1/2018
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI
https://doi.org/10.1007/s00259-017-3841-y

Other articles of this Issue 1/2018

European Journal of Nuclear Medicine and Molecular Imaging 1/2018 Go to the issue