Skip to main content
SpringerLink
Log in

Study Design Solutions for Adjuvant and Maintenance Therapy in Cancer: Ovarian Cancer as an Example

  • Commentary
  • Published:
SN Comprehensive Clinical Medicine Aims and scope Submit manuscript

Abstract

High-quality randomized controlled trials (RCTs) are the best evidence for clinical practice guideline developers to make recommendations to improve patients’ outcomes. However, after we conducted two guidelines regarding maintenance therapy and neoadjuvant/adjuvant therapy in patients with newly diagnosed ovarian cancer, respectively, we realized that despite being statistically sound, some of the eligible RCTs in the current literature have methodological limitations, which resulted in challenges for making strong recommendations. During patients’ treatment processes, the timepoint when they should be randomized into experimental and controlled groups is a key issue and should be dependent on different study objectives. In this article, we provide some study design options in accordance with three different study objectives in front-line settings: Objective 1. To study a novel agent as an addition to standard adjuvant chemotherapy; Objective 2. To study a novel agent as maintenance therapy; and Objective 3. To study a novel agent as an addition to adjuvant chemotherapy AND continue as maintenance therapy in one trial. These study design options are not only suitable for ovarian cancer research, but also for other types of cancer research. Overall, it is crucial to consider methodological soundness in addition to the conventional statistical soundness when conducting a high-quality RCT.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Data availability

N/A.

Code availability

N/A.

References

  1. Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, Editors. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines: Institute of Medicion. Clinical practice guidelines we can trust. Washington, DC: National Academies Press. 2011; https://www.awmf.org/fileadmin/user_upload/Leitlinien/International/IOM_CPG_lang_2011.pdf. Accessed 7 December 2021

  2. Ledermann JA, Raja FA, Fotopoulou C, et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(Suppl 6):vi24-32.

    Article  Google Scholar 

  3. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Eng J of Med. 2018;379:2495–505.

    Article  CAS  Google Scholar 

  4. Hirte H, Yao X, Ferguson S, May T, Elit L. An Ontario Health (Cancer Care Ontario) clinical practice guideline: consolidation or maintenance systemic therapy for newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma. Curr Oncol. 2021;28:1114–24.

    Article  Google Scholar 

  5. Hirte H, Poon R, Yao X, et al. Neoadjuvant and adjuvant systemic therapy for newly diagnosed stage II-IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma: a practice guideline. Curr Oncol. 2022;29:231–42.

    Article  Google Scholar 

  6. West HJ, Jin J. Neoadjuvant therapy. JAMA. Oncol. 2015;1:550.

    Google Scholar 

  7. National Cancer Institute (accessed on July 16 2022) Adjuvant therapy. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adjuvant-therapy

  8. Madariaga A, Rustin GJS, Buckanovich RJ, et al. Wanna get away? Maintenance treatments and chemotherapy holidays in gynecologic cancers. Am Soc Clin Oncol Educ Book. 2019;39:e152–66.

    Article  Google Scholar 

  9. Hirte H, Yao X, Ferguson S, May T, Elit L. Consolidation or maintenance systemic therapy for newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma: a systematic review. Crit Rev Oncol Hematol. 2021;162:103336.

  10. Hirte H, Poon R, Yao X, et al. Neoadjuvant and adjuvant systemic therapy for newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma: a systematic review. Crit Rev Oncol Hematol. 2021;162:103324.

  11. Perren TJ, Swart AM, Pfisterer J, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Eng J of Med. 2011;365:2484–96.

  12. Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Eng J of Med. 2011;365:2473–83.

  13. Alberts DS, Hannigan EV, Liu PY, et al. Randomized trial of adjuvant intraperitoneal alpha-interferon in stage III ovarian cancer patients who have no evidence of disease after primary surgery and chemotherapy: An intergroup study. Gyne Oncol. 2006;100:133–213.

Download references

Author information

Authors and Affiliations

  1. Department of Oncology, McMaster University, Juravinski Site, 699 Concession Street, Hamilton, ON, L8V 5C2, Canada

    Xiaomei Yao, Raymond Poon, Laurie Elit & Hal Hirte

  2. Department of Health Research Methods, Evidence, and Impact, McMaster University, 175 Longwood Road South, Hamilton, ON, L8P 0A1, Canada

    Xiaomei Yao & Jinhui Ma

  3. Center for Clinical Practice Guideline Conduction and Evaluation, Children’s Hospital of Fudan University, Shanghai, China

    Xiaomei Yao

  4. Division of Cancer Care and Epidemiology, Department of Oncology and Medicine, Cancer Research Institute, Cancer Centre of Southeastern Ontario, Queen’s University, Kingston, ON, Canada

    Josee-Lyne Ethier

  5. Division of Gynecologic Oncology, Princess Margaret Cancer Center, Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada

    Sarah E. Ferguson & Taymaa May

Authors
  1. Xiaomei Yao
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Raymond Poon
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Laurie Elit
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Josee-Lyne Ethier
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sarah E. Ferguson
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Hal Hirte
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Taymaa May
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Jinhui Ma
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

XY drafted the first manuscript. Other authors reviewed and revised it carefully. All the authors approved the final version.

Corresponding authors

Correspondence to Xiaomei Yao or Jinhui Ma.

Ethics declarations

Ethics approval

N/A.

Consent to participate

N/A.

Consent for publication

N/A.

Conflict of interest

The authors declare no competing interests.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This article is part of the Topical Collection on Medicine

Rights and permissions

Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Yao, X., Poon, R., Elit, L. et al. Study Design Solutions for Adjuvant and Maintenance Therapy in Cancer: Ovarian Cancer as an Example. SN Compr. Clin. Med. 4, 186 (2022). https://doi.org/10.1007/s42399-022-01265-3

Download citation

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s42399-022-01265-3

Keywords

Search

Navigation