257
Views
2
CrossRef citations to date
0
Altmetric
Reviews

Systematic review reveals urgent need to homogenize endpoints choices and definitions in marginal zone lymphomas trials

, , , , ORCID Icon &
Pages 1544-1555 | Received 20 Nov 2021, Accepted 11 Jan 2022, Published online: 24 Feb 2022

References

  • Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the world health organization classification of lymphoid neoplasms. Blood. 2016;127(20):2375–2390.
  • Zucca E, Arcaini L, Buske C, et al. Marginal zone lymphomas: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(1):17–29.
  • Lenglet J, Traullé C, Mounier N, et al. Long-term follow-up analysis of 100 patients with splenic marginal zone lymphoma treated with splenectomy as first-line treatment. Leuk Lymphoma. 2014;55(8):1854–1860.
  • Cerhan JR, Habermann TM. Epidemiology of marginal zone lymphoma. Ann Lymphoma. 2021;5:1–1.
  • Zucca E, Conconi A, Martinelli G, et al. Final results of the IELSG-19 randomized trial of mucosa-associated lymphoid tissue lymphoma: improved event-free and progression-free survival with rituximab plus chlorambucil versus either chlorambucil or rituximab monotherapy. J Clin Oncol. 2017;35(17):1905–1912.
  • Food and Drug Administration, U.S. Department of Health and Human Services, Oncology Center of Excellence, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; 2018. Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
  • European Medicines Agency. Evaluation of anticancer medicinal products in man; 2020. Available from: https://www.ema.europa.eu/en/evaluation-anticancer-medicinal-products-man.
  • 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):3059–3068.
  • Matutes E, Oscier D, Montalban C, et al. Splenic marginal zone lymphoma proposals for a revision of diagnostic, staging and therapeutic criteria. Leukemia. 2008;22(3):487–495.
  • Copie-Bergman C, Wotherspoon AC, Capella C, et al. Gela histological scoring system for post-treatment biopsies of patients with gastric MALT lymphoma is feasible and reliable in routine practice. Br J Haematol. 2013;160(1):47–52.
  • Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1.
  • Ouzzani M, Hammady H, Fedorowicz Z, et al. Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210.
  • Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
  • Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71.
  • Liu L, Wang H, Chen Y, et al. Splenic marginal zone lymphoma: a population-based study on the 2001-2008 incidence and survival in the United States. Leuk Lymphoma. 2013;54(7):1380–1386.
  • Khalil MO, Morton LM, Devesa SS, et al. Incidence of marginal zone lymphoma in the United States, 2001-2009 with a focus on primary anatomic site. Br J Haematol. 2014;165(1):67–77.
  • Thieblemont C, Molina T, Davi F. Optimizing therapy for nodal marginal zone lymphoma. Blood. 2016;127(17):2064–2071.
  • Arcaini L, Rossi D, Paulli M. Splenic marginal zone lymphoma: from genetics to management. Blood. 2016;127(17):2072–2081.
  • Morschhauser F, Fowler NH, Feugier P, et al. Rituximab plus lenalidomide in advanced untreated follicular Lymphoma. N Engl J Med. 2018;379(10):934–947.
  • Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011;377(9759):42–51.
  • Punt CJA, Buyse M, Köhne CH, et al. Endpoints in adjuvant treatment trials: a systematic review of the literature in Colon cancer and proposed definitions for future trials. J Natl Cancer Inst. 2007;99(13):998–1003.
  • Dennis K, Jamani R, McGrath C, et al. A systematic review of methodologies, endpoints, and outcome measures in randomized trials of radiation therapy-induced nausea and vomiting. Support Care Cancer. 2017;25(6):2019–2033.
  • Buggy DJ, Freeman J, Johnson MZ, et al. Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes. Br J Anaesth. 2018;121(1):38–44.
  • Grayling MJ, Dimairo M, Mander AP, et al. A review of perspectives on the use of randomization in phase II oncology trials. J Natl Cancer Inst. 2019;111(12):1255–1262.
  • Gorst SL, Gargon E, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: an updated review and user survey. Garattini S, ed. PLOS One. 2016;11(1):e0146444.
  • Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86–89.
  • Moher D, Glasziou P, Chalmers I, et al. Increasing value and reducing waste in biomedical research: who’s listening? Lancet. 2016;387(10027):1573–1586.
  • Kemp R, Prasad V. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? BMC Med. 2017;15(1):134.
  • Gyawali B, Hey SP, Kesselheim AS. Evaluating the evidence behind the surrogate measures included in the FDA’s table of surrogate endpoints as supporting approval of cancer drugs. EClinicalMedicine. 2020;21:100332.
  • Shi Q, Flowers CR, Hiddemann W, et al. Thirty-Month complete response as a surrogate end point in first-line follicular lymphoma therapy: an individual patient-level analysis of multiple randomized trials. J Clin Oncol. 2017;35(5):552–560.
  • Shi Q, Schmitz N, Ou FS, et al. Progression-free survival as a surrogate end point for overall survival in first-line diffuse large B-cell lymphoma: an individual patient-level analysis of multiple randomized trials (SEAL). J Clin Oncol. 2018;36(25):2593–2602.
  • Kim C, Prasad V. Strength of validation for surrogate end points used in the US food and drug administration’s approval of oncology drugs. Mayo Clin Proc. 2016 May 10:S0025-6196(16)00125-7.
  • Gyawali B, Hey SP, Kesselheim AS. Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Intern Med. 2019;179(7):906–913.
  • Chen EY, Raghunathan V, Prasad V. An overview of cancer drugs approved by the US food and drug administration based on the surrogate end point of response rate. JAMA Intern Med. 2019;179(7):915–921.
  • Noy A, de Vos S, Thieblemont C, et al. Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017;129(16):2224–2232.
  • Fowler NH, Samaniego F, Jurczak W, et al. Umbralisib, a dual PI3Kδ/CK1ε inhibitor in patients with relapsed or refractory indolent lymphoma. J Clin Oncol. 2021;39(15):1609–1618.
  • Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.
  • Lo CKL, Mertz D, Loeb M. Newcastle-Ottawa scale: comparing reviewers’ to authors’ assessments. BMC Med Res Methodol. 2014;14(1):45.
  • Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol. 2010;25(9):603–605.
  • Grellety T, Petit-Monéger A, Diallo A, et al. Quality of reporting of phase II trials: a focus on highly ranked oncology journals. Ann Oncol. 2014;25(2):536–541.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.