Advertisement

International Journal of Colorectal Disease

, Volume 34, Issue 12, pp 2143–2150 | Cite as

ECOG performance score 0 versus 1: impact on efficacy and safety of first-line 5-FU-based chemotherapy among patients with metastatic colorectal cancer included in five randomized trials

  • Omar Abdel-RahmanEmail author
Original Article
  • 40 Downloads

Abstract

Background

Within the context of metastatic colorectal cancer, patients with Eastern Cooperative Oncology Group (ECOG) performance score 0–1 are usually pooled together in clinical practice guidelines and clinical trials’ reports. The current study aims to delineate potential differences in outcomes between metastatic colorectal cancer patients with ECOG score 0 versus 1 who are treated with currently accepted first-line fluorouracil (5FU)-based chemotherapy.

Methods

The current study is based on a pooled dataset from five clinical trials of 5FU-based treatment for metastatic colorectal cancer (NCT00272051; NCT00115765; NCT00305188; NCT00364013; and NCT00384176). Patients with metastatic colorectal cancer and ECOG score of 0–1 were eligible for the current study. Multivariable logistic regression analysis was used to assess the relationship between ECOG performance status and the development of different toxicities. Kaplan-Meier survival estimates were used to clarify the impact of the ECOG score on overall and progression-free survivals. Multivariable Cox regression analysis was then used to evaluate the impact of ECOG score on overall and progression-free survivals.

Results

A total of 3143 patients were included in the current analysis. Within multivariable logistic regression analysis, patients with an ECOG score of 0 have a lower probability of serious adverse events (OR 0.678; 95% CI 0.583–0.788; P < 0.001), fatal adverse events (OR 0.552; 95% CI 0.397–0.766; P < 0.001), high-grade anemia (OR 0.426; 95% CI 0.252–0.721; P = 0.001), and high-grade nausea/vomiting (OR 0.697; 95% CI 0.509–0.955; P = 0.024). Through Kaplan-Meier survival analysis, patients with an ECOG score of 0 have better overall and progression-free survivals (P < 0.001 for both endpoints). Median overall survival was 27.63 months among patients with an ECOG score of 0 versus 20.00 months among patients with an ECOG score of 1. Within multivariable Cox regression analysis, patients with ECOG score of 0 were associated with better overall and progression-free survivals (HR for overall survival 0.613; 95% CI 0.556–0.676; P < 0.001); (HR for progression-free survival 0.765; 95% CI 0.705–0.829; P < 0.001).

Conclusion

Compared with patients with ECOG score of 1, patients with ECOG score of 0 have better overall and progression-free survival, and less probability of serious and fatal adverse events. This distinction in outcomes should be noted when choosing appropriate therapeutic strategies and when designing/reporting the results of clinical trials.

Keywords

ECOG Performance Efficacy Toxicity Outcomes 

Notes

Acknowledgments

This publication is based on the research using information obtained from www.projectdatasphere.org, which is maintained by Project Data Sphere, LLC. Neither the Project Data Sphere, LLC nor the owner(s) of any information from the website have contributed to, approved, or are in any way responsible for the contents of this publication.

References

  1. 1.
    Abdel-Rahman O (2019) Prognostic value of baseline ALBI score among patients with colorectal liver metastases: a pooled analysis of two randomized trials. Clin Colorectal Cancer 18(1):e61–ee8CrossRefGoogle Scholar
  2. 2.
    Abdel-Rahman O, Karachiwala H (2019) Impact of age on toxicity and efficacy of 5-FU-based combination chemotherapy among patients with metastatic colorectal cancer; a pooled analysis of five randomized trials. Int J Color DisGoogle Scholar
  3. 3.
    Abdel-Rahman O (2019) Impact of sex on chemotherapy toxicity and efficacy among patients with metastatic colorectal cancer: pooled analysis of 5 randomized trials. Clin Colorectal Cancer 18(2):110–5.e2CrossRefGoogle Scholar
  4. 4.
    Zacharakis M, Xynos ID, Lazaris A, Smaro T, Kosmas C, Dokou A et al (2010) Predictors of survival in stage IV metastatic colorectal cancer. Anticancer Res 30(2):653–660PubMedGoogle Scholar
  5. 5.
    D’Andre S, Sargent DJ, Cha SS, Buroker TR, Kugler JW, Goldberg RM, O’Connell MJ, Poon MA (2005) 5-fluorouracil–based chemotherapy for advanced colorectal cancer in elderly patients: a North Central Cancer Treatment Group study. Clin Colorectal Cancer 4(5):325–331CrossRefGoogle Scholar
  6. 6.
    Gustavsson B, Carlsson G, Machover D, Petrelli N, Roth A, Schmoll H-J, Tveit KM, Gibson F (2015) A review of the evolution of systemic chemotherapy in the management of colorectal cancer. Clin Colorectal Cancer 14(1):1–10CrossRefGoogle Scholar
  7. 7.
  8. 8.
    Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M et al (2014) Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol 25(7):1346–1355CrossRefGoogle Scholar
  9. 9.
    Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG (2009) A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 27(5):672–680CrossRefGoogle Scholar
  10. 10.
    Schmoll HJ, Cunningham D, Sobrero A, Karapetis CS, Rougier P, Koski SL, Kocakova I, Bondarenko I, Bodoky G, Mainwaring P, Salazar R, Barker P, Mookerjee B, Robertson J, van Cutsem E (2012) Cediranib with mFOLFOX6 versus bevacizumab with mFOLFOX6 as first-line treatment for patients with advanced colorectal cancer: a double-blind, randomized phase III study (HORIZON III). J Clin Oncol 30(29):3588–3595CrossRefGoogle Scholar
  11. 11.
    Rocha LSDS, Riechelmann RP (2018) Treatment of patients with metastatic colorectal cancer and poor performance status: current evidence and challenges. Clinics (Sao Paulo, Brazil) 73(suppl 1):e542s-esGoogle Scholar
  12. 12.
    Abdel-Rahman O (2019) Impact of diabetes comorbidity on the efficacy and safety of FOLFOX first-line chemotherapy among patients with metastatic colorectal cancer: a pooled analysis of two phase-III studies. Clin Transl Oncol 21(4):512–518CrossRefGoogle Scholar
  13. 13.
    Abdel-Rahman O (2019) Effect of body mass index on 5-FU-based chemotherapy toxicity and efficacy among patients with metastatic colorectal cancer; a pooled analysis of 5 randomized trials. Clin Colorectal CancerGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Oncology, Cross Cancer InstituteUniversity of AlbertaEdmontonCanada

Personalised recommendations