November 2016 issue of the EQUATOR Oncology Project Quarterly Current Awareness Bulletin

Welcome to the November 2016 issue of our EQUATOR Oncology Project Current Awareness Bulletin.

We hope that this bulletin will help to keep you up-to-date with the latest issues in the reporting and methods in oncology research by highlighting links to interesting research papers, editorials, comments and other resources related to cancer research.

Topics covered in this issue include statistical issues, trial design, trial outcomes (i.e. endpoints, quality of life and patient-reported outcomes), harms (i.e. adverse events), trial participants and ethical issues.

The EQUATOR Oncology Project welcomes your feedback and involvement! Please share your comments about the Project and any problems you have encountered in the planning or reporting of cancer research with project lead Angela MacCarthy,  angela.maccarthy@ndorms.ox.ac.uk

The bulletin is a work in progress – look out for changes over the coming issues!

To sign up to receive this bulletin by email please email Shona Kirtley, shona.kirtley@csm.ox.ac.uk

With best wishes from the EQUATOR Oncology Project Team

EQUATOR Oncology Project Quarterly Current Awareness Bulletin – November 2016

Statistical issues
Filleron T, Kouokam W, Gilhodes J, Duhamel A, Penel N, Joly F, Tresch-Bruneel E, Kramar A, Houédé N. Statistical controversies in clinical research: should schedules of tumor size assessments be changed? Ann Oncol. 2016;27(11):1981-1987. PMID: 27502711

Michiels S, Ternès N, Rotolo F. Statistical controversies in clinical research: prognostic gene signatures are not (yet) useful in clinical practice. Ann Oncol. 2016 Sep 15. pii: mdw307. PMID: 27634691

Korn EL, Sachs MC, McShane LM. Statistical controversies in clinical research: assessing pathologic complete response as a trial-level surrogate end point for early-stage breast cancer. Ann Oncol. 2016;27(1):10-15. PMID: 26489443

Renfro LA, Sargent DJ. Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples. Ann Oncol. 2016 Oct 11. pii: mdw413. PMID: 27733372

Gleiss A, Zeillinger R, Braicu EI, Trillsch F, Vergote I, Schemper M. Statistical controversies in clinical research: the importance of importance. Ann Oncol. 2016;27(7):1185-9. PMID: 27052655

Trial design
Del Paggio JC, Azariah B, Sullivan R, Hopman WM, James FV, Roshni S, Tannock IF, Booth CM. Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit? Ann Oncol. 2016 Oct 13. pii: mdw538. PMID: 27742650

Mansouri A, Shin S, Cooper B, Srivastava A, Bhandari M, Kondziolka D. Randomized controlled trials and neuro-oncology: should alternative designs be considered?
J Neurooncol. 2015;124(3):345-56. PMID: 26297044

Zaorsky NG, Egleston BL, Horwitz EM, Dicker AP, Nguyen PL, Showalter TN, Den RB. The Missing Pieces in Reporting of Randomized Controlled Trials of External Beam Radiation Therapy Dose Escalation for Prostate Cancer. Am J Clin Oncol. 2016;39(4):321-6. PMID: 27322694

Trial outcomes
Ascierto PA, Long GV. Progression-free survival landmark analysis: a critical endpoint in melanoma clinical trials. Lancet Oncol. 2016;17(8):1037-9. PMID: 27324281

Schandelmaier S, Conen K, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Olu KK, Tikkinen KA, Neumann I13, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Sun X, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M, Kasenda B; DISCO study group. Planning and reporting of quality-of-life outcomes in cancer trials. Ann Oncol. 2015;26(9):1966-73. PMID: 26133966

Hagelstein V, Ortland I, Wilmer A, Mitchell SA, Jaehde U. Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™). Ann Oncol. 2016 Sep 28. pii: mdw422. PMID: 27681863

Shi Q, Mendoza TR, Wang XS, Cleeland CS. Using a symptom-specific instrument to measure patient-reported daily functioning in patients with cancer. Eur J Cancer. 2016;67:83-90. PMID: 27620946

de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araújo FS, Hlubocky F, Nicholas LH, O’Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity. Cancer. 2016 Oct 7. PMID: 27716900

Harms (i.e. adverse events)
Cabarrou B, Boher JM, Bogart E, Tresch-Bruneel E, Penel N, Ravaud A, Escudier B, Mahier Ait-Oukhatar C, Delord JP, Roché H, Filleron T. How to report toxicity associated with targeted therapies? Ann Oncol. 2016;27(8):1633-8. PMID: 27217543

Trial participants
Le Saux O, Falandry C, Gan HK, You B, Freyer G, Péron J. Inclusion of elderly patients in oncology clinical trials. Ann Oncol. 2016;27(9):1799-1804. PMID: 27358382

Ethical issues
Vera-Badillo FE, Napoleone M, Krzyzanowska MK, Alibhai SM, Chan AW, Ocana A, Templeton AJ, Seruga B, Amir E, Tannock IF. Honorary and ghost authorship in reports of randomised clinical trials in oncology. Eur J Cancer. 2016;66:1-8. PMID: 27500368

National Cancer Research Institute (NCRI) 2016 conference
The EQUATOR Oncology Project lead (Angela MacCarthy) recently attended the National Cancer Research Institute (NCRI) 2016 conference in Liverpool, UK.  Angela presented a poster, describing (i) some recent research on the quality of oncology trial reporting for publication and (ii) the EQUATOR Oncology Project. View the poster (PDF)

Visit the EQUATOR website to browse the 38 oncology-specific reporting guidelines currently available.

Visit the EQUATOR Oncology Project web page for further information and other interesting and useful references.

To read previous EQUATOR Oncology Project bulletins please visit our bulletin web page.