Randomized Trial of FOLFOX 4 and FOLFIRI in The Treatment of Advance Colorectal Cancer

Randomized Trial of FOLFOX 4 and FOLFIRI

Authors

  • Reeta Kumari Department of Medical Oncology, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
  • Ghulam Haider Department of Medical Oncology, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
  • Nargis Aalam Department of Medical Oncology, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
  • Aamera Shah Department of Medical Oncology, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
  • Tooba Sarim Department of Medical Oncology, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
  • Khadijah Abid Department of Public Health, Shaheed Zulfikar Ali Bhutto Institute of Science and Technology, Karachi, Pakistan

DOI:

https://doi.org/10.54393/pjhs.v4i11.781

Keywords:

Colorectal Cancer, Colon, Chemotherapy Regimen, FOLFOX 4, FOLFIRI, Treatment Outcomes, Response Rate, Survival Time

Abstract

Colorectal cancer is a major global health concern, ranking third in prevalence and second in mortality. Developed countries have high incidence rates, while Pakistan is considered a low-risk region. Metastatic colorectal cancer requires targeted therapies like FOLFIRI and FOLFOX4, but their effectiveness in Pakistan is unknown. This study aims to provide insights, guide treatment decisions, and expand global understanding in the field. Objective: To compare therapeutic effects of FOLFOX4 and FOLFIRI for advanced colorectal cancer patients. Methods: The Medical Oncology Department of Jinnah Postgraduate and Medical Centre conducted a randomized controlled trial research from May 2022 to February 2023. Hundred patients of advanced colorectal cancer with a confirmed diagnosis of age 18 to 80 years, of either gender, were included. Randomly, 50 of these patients were in FOLFIRI group, and 50 in FOLFOX4 group. Both groups were compared for the treatment outcomes. Results: In the FOLFIRI group, the total response rate was 66%, whereas in the FOLFOX 4 group, it was 78%. In the FOLFIRI group, the median time to progression was 8 months, but in the FOLFOX 4 group, it was 9 months (p=0.06). In the FOLFIRI group, the total median survival time was 13 months, whereas in the FOLFOX 4 group, it was 14 months (p=0.280). Conclusions: The response rates between the two groups were similar, while FOLFOX 4 had a little higher rate of tumor control. FOLFIRI had a lower incidence of neutropenia, whereas FOLFOX 4 had a lower incidence of nausea and vomiting.  

References

Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, et al. Global burden of colorectal cancer in 2020 and 2040: Incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb; 72(2): 338-44. doi: 10.1136/gutjnl-2022-327736. DOI: https://doi.org/10.1136/gutjnl-2022-327736

Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Gastroenterology Review/Przegląd Gastroenterologiczny. 2019 Jan; 14(2): 89-103. doi: 10.5114/pg.2018.81072. DOI: https://doi.org/10.5114/pg.2018.81072

Shaikh Z and Haider G. Clinical spectrum of colorectal cancer: Experience of 186 patients from Jinnah Postgraduate Medical Centre Karachi. Journal of Fatima Jinnah Medical University. 2019 Apr; 13(1): 12-7.

Zhang X, Duan R, Wang Y, Liu X, Zhang W, Zhu X, et al. FOLFIRI (folinic acid, fluorouracil, and irinotecan) increases not efficacy but toxicity compared with single-agent irinotecan as a second-line treatment in metastatic colorectal cancer patients: a randomized clinical trial. Therapeutic Advances in Medical Oncology. 2022 Jan; 14: 17588359211068737. doi: 10.1177/17588359211068737. DOI: https://doi.org/10.1177/17588359211068737

Grothey A, Sargent D, Goldberg RM, Schmoll HJ. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. Journal of Clinical Oncology. 2004 Apr; 22(7): 1209-14. doi: 10.1200/JCO.2004.11.037. DOI: https://doi.org/10.1200/JCO.2004.11.037

Gustavsson B, Carlsson G, Machover D, Petrelli N, Roth A, Schmoll HJ, et al. A review of the evolution of systemic chemotherapy in the management of colorectal cancer. Clinical Colorectal Cancer. 2015 Mar; 14(1): 1-0. doi: 10.1016/j.clcc.2014.11.002. DOI: https://doi.org/10.1016/j.clcc.2014.11.002

Xu RH, Muro K, Morita S, Iwasa S, Han SW, Wang W, et al. Modified XELIRI (capecitabine plus irinotecan) versus FOLFIRI (leucovorin, fluorouracil, and irinotecan), both either with or without bevacizumab, as second-line therapy for metastatic colorectal cancer (AXEPT): a multicentre, open-label, randomised, non-inferiority, phase 3 trial. The Lancet Oncology. 2018 May; 19(5): 660-71. doi: 10.1016/S1470-2045(18)30140-2. DOI: https://doi.org/10.1016/S1470-2045(18)30140-2

Xu J, Kim TW, Shen L, Sriuranpong V, Pan H, Xu R, et al. Results of a randomized, double-blind, placebo-controlled, phase III trial of trifluridine/tipiracil (TAS-102) monotherapy in Asian patients with previously treated metastatic colorectal cancer: the TERRA study. Journal of Clinical Oncology. 2018 Feb; 36(4): 350-8. doi: 10.1200/JCO.2017.74.3245. DOI: https://doi.org/10.1200/JCO.2017.74.3245

Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, et al. Effect of fruquintinib vs placebo on overall survival in patients with previously treated metastatic colorectal cancer: the FRESCO randomized clinical trial. Jama. 2018 Jun; 319(24): 2486-96. doi: 10.1001/jama.2018.7855. DOI: https://doi.org/10.1001/jama.2018.7855

Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, et al. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. The lancet oncology. 2015 Jun; 16(6): 619-29. doi: 10.1016/S1470-2045(15)70156-7. DOI: https://doi.org/10.1016/S1470-2045(15)70156-7

Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N, et al. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell’Italia Meridionale. Journal of Clinical Oncology. 2005 Aug; 23(22): 4866-75. doi: 10.1200/JCO.2005.07.113. DOI: https://doi.org/10.1200/JCO.2005.07.113

Neugut AI, Lin A, Raab GT, Hillyer GC, Keller D, O’Neil DS, et al. FOLFOX and FOLFIRI use in stage IV colon cancer: analysis of SEER-medicare data. Clinical Colorectal Cancer. 2019 Jun; 18(2): 133-40. doi: 10.1016/j.clcc.2019.01.005. DOI: https://doi.org/10.1016/j.clcc.2019.01.005

Elzouki AN, Habel S, Alsoaeiti S, Abosedra A, Khan F. Epidemiology and clinical findings of colorectal carcinoma in two tertiary care hospitals in Benghazi, Libya. Avicenna Journal of Medicine. 2014 Oct; 4(04): 94-8. doi: 10.4103/2231-0770.140659. DOI: https://doi.org/10.4103/2231-0770.140659

Masi G, Vasile E, Loupakis F, Cupini S, Fornaro L, Baldi G, et al. Randomized trial of two induction chemotherapy regimens in metastatic colorectal cancer: an updated analysis. Journal of the National Cancer Institute. 2011 Jan; 103(1): 21-30. doi: 10.1093/jnci/djq456. DOI: https://doi.org/10.1093/jnci/djq456

Wu DM, Wang YJ, Fan SH, Zhuang J, Zhang ZF, Shan Q, et al. Network meta-analysis of the efficacy of first-line chemotherapy regimens in patients with advanced colorectal cancer. Oncotarget. 2017 Oct; 8(59): 100668-100677. doi: 10.18632/oncotarget.22177. DOI: https://doi.org/10.18632/oncotarget.22177

Ikoma N, Raghav K, Chang G. An update on randomized clinical trials in metastatic colorectal carcinoma. Surgical Oncology Clinics. 2017 Oct; 26(4): 667-87. doi: 10.1016/j.soc.2017.05.007. DOI: https://doi.org/10.1016/j.soc.2017.05.007

Idrees M and Tejani M. Current treatment strategies for elderly patients with metastatic colon cancer. Cureus. 2019 May; 11(5): 1-5. doi: 10.7759/cureus.4713. DOI: https://doi.org/10.7759/cureus.4713

Stintzing S, van Oostrum I, Pescott CP, Ronga P, Heeg B, Heinemann V. Cost-effectiveness of FOLFIRI+ cetuximab vs FOLFIRI+ bevacizumab in the first-line treatment of RAS wild-type metastatic colorectal cancer in Germany: data from the FIRE-3 (AIO KRK-0306) study. Journal of Medical Economics. 2020 May; 23(5): 448-55. doi: 10.1080/13696998.2019.1709848. DOI: https://doi.org/10.1080/13696998.2019.1709848

Watanabe T, Tsuji A, Shiozawa M, Ota H, Satake H, Yabuno T, et al. Safety analysis of the randomized phase II study of FOLFOXIRI plus cetuximab versus FOLFOXIRI plus bevacizumab as the first-line treatment in metastatic colorectal cancer with RAS wild-type tumors: The DEEPER trial (JACCRO CC-13). Journal of Clinical Oncology. 2021 Jan; 39(3): 86-. doi: 10.1200/JCO.2021.39.3_suppl.86. DOI: https://doi.org/10.1200/JCO.2021.39.3_suppl.86

Hoang T, Sohn DK, Kim BC, Cha Y, Kim J. Efficacy and safety of systemic treatments among colorectal cancer patients: A network meta-analysis of randomized controlled trials. Frontiers in Oncology. 2022 Feb; 11: 756214. doi: 10.3389/fonc.2021.756214. DOI: https://doi.org/10.3389/fonc.2021.756214

Downloads

Published

2023-11-30
CITATION
DOI: 10.54393/pjhs.v4i11.781
Published: 2023-11-30

How to Cite

Kumari, R., Haider, G., Aalam, N., Shah, A., Sarim, T., & Abid, K. (2023). Randomized Trial of FOLFOX 4 and FOLFIRI in The Treatment of Advance Colorectal Cancer : Randomized Trial of FOLFOX 4 and FOLFIRI . Pakistan Journal of Health Sciences, 4(11), 159–164. https://doi.org/10.54393/pjhs.v4i11.781

Issue

Section

Original Article

Plaudit