Breaking Down the Study: What You Need to Know
When it comes to treating RAS wild-type metastatic colorectal cancer (mCRC), the medical community has been on the lookout for effective second-line treatments. A recent study published in ESMO Open might just have the answers we’ve been searching for.
The study focuses on the use of Ramucirumab plus FOLFIRI as a second-line treatment, following first-line anti-EGFR antibody therapy. The results are promising and could be a game-changer in the treatment landscape.
The Source Article Details
Ramucirumab plus FOLFIRI as second-line treatment for patients with RAS wild-type metastatic colorectal cancer previously treated with anti-EGFR antibody: JACCRO CC-16. by H Yasui et al. in 2023.
The Source Article's Abstract
Chemotherapy in combination with anti-epidermal growth factor receptor (EGFR) antibody is considered a first-line treatment regimen for RAS wild-type and left-sided metastatic colorectal cancer (mCRC), whereas second-line treatment regimens have not yet been established.
Patients and Methods
This non-randomized phase II trial investigated the clinical outcomes of second-line ramucirumab (RAM) plus fluorouracil, levofolinate, and irinotecan (FOLFIRI) after first-line anti-EGFR antibody in combination with doublet or triplet regimen in patients with RAS wild-type mCRC.
Ninety-two patients were enrolled in the study. The primary tumor was located on the left side in 86 (95.6%) patients. Six-month PFS rate was 58.2% with a median PFS of 7.0 months.
The Source Article References
- Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries by Sung, 2021 in CA Cancer J Clin
- Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen by Van Cutsem, 2012 in J Clin Oncol
- Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial by Bennouna, 2013 in Lancet Oncol
- Treatment of patients with late-stage colorectal cancer: ASCO resource-stratified guideline by Chiorean, 2020 in JCO Glob Oncol
- Pan-Asian adapted ESMO consensus guidelines for the management of patients with metastatic colorectal cancer: a JSMO-ESMO initiative endorsed by CSCO, KACO, MOS, SSO and TOS by Yoshino, 2018 in Ann Oncol
- Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer by Hashiguchi, 2020 in Int J Clin Oncol
- Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2 by Spratlin, 2010 in J Clin Oncol
- FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial by Heinemann, 2014 in Lancet Oncol
- Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study by Douillard, 2010 in J Clin Oncol
- Effect of first-line chemotherapy combined with cetuximab or bevacizumab on overall survival in patients with KRAS wild-type advanced or metastatic colorectal cancer: a randomized clinical trial by Venook, 2017 in JAMA
- Panitumumab vs bevacizumab added to standard first-line chemotherapy and overall survival among patients with RAS wild-type, left-sided metastatic colorectal cancer: a randomized clinical trial by Watanabe, 2023 in JAMA
- Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200 by Giantonio, 2007 in J Clin Oncol
- Impact of subsequent therapies on outcome of the FIRE-3/AIO KRK0306 trial: first-line therapy with FOLFIRI plus cetuximab or bevacizumab in patients with KRAS wild-type tumors in metastatic colorectal cancer by Modest, 2015 in J Clin Oncol
- Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings by Kubicka, 2013 in Ann Oncol
- Subgroup analysis in RAISE: a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression by Obermannova, 2016 in Ann Oncol
- Acquired resistance to the antitumor effect of epidermal growth factor receptor-blocking antibodies in vivo: a role for altered tumor angiogenesis by Viloria-Petit, 2001 in Cancer Res
- Antitumor activity of ZD6474, a vascular endothelial growth factor receptor tyrosine kinase inhibitor, in human cancer cells with acquired resistance to antiepidermal growth factor receptor therapy by Ciardiello, 2004 in Clin Cancer Res
- Plasma VEGF-D and PlGF levels according to prior use of biologics among metastatic colorectal cancer: preliminary results from GI-SCREEN CRC-Ukit study by Taniguchi, 2020 in J Clin Oncol
- Clinical development and evaluation of a VEGF-D assay in plasma from patients with metastatic colorectal cancer in the RAISE study by Taniguchi, 2021 in Curr Med Res Opin
- SPIRITT: a randomized, multicenter, phase II study of panitumumab with FOLFIRI and bevacizumab with FOLFIRI as second-line treatment in patients with unresectable wild type KRAS metastatic colorectal cancer by Hecht, 2015 in Clin Colorectal Cancer
Citing the Source Article (APA)
Yasui, H., Okita, Y., Nakamura, M., Sagawa, T., Watanabe, T., Kataoka, K., Manaka, D., Shiraishi, K., Akazawa, N., Okuno, T., Shimura, T., Shiozawa, M., Sunakawa, Y., Ota, H., Kotaka, M., Okuyama, H., Takeuchi, M., Ichikawa, W., Fujii, M., Tsuji, A. (2023). Ramucirumab plus FOLFIRI as second-line treatment for patients with RAS wild-type metastatic colorectal cancer previously treated with anti-EGFR antibody: JACCRO CC-16.. ESMO Open, 8(5), 101636-101636. 10.1016/j.esmoop.2023.101636
Key Findings: Numbers Speak Louder Than Words
The study enrolled 92 patients, and the primary endpoint was the 6-month progression-free survival (PFS) rate. The results were encouraging:
- 6-month PFS rate was 58.2%
- Median PFS of 7.0 months
- Median overall survival (OS) was 23.6 months
Implications: What Does This Mean for Oncology?
The study’s findings have significant implications for the field of oncology, particularly for those specializing in gastrointestinal cancers. The effectiveness of Ramucirumab plus FOLFIRI could pave the way for new treatment protocols, offering hope to patients who have limited options.
Moreover, the study adds valuable data to the ongoing debate about the best second-line treatments for mCRC, especially for those who have been previously treated with anti-EGFR therapies.
FAQ: Quick Answers to Burning Questions
Is this treatment regimen safe? The study reported no major safety concerns, making it a viable option for patients.
Who can benefit from this treatment? Patients with RAS wild-type mCRC, particularly those who have undergone first-line anti-EGFR antibody therapy, stand to benefit the most.
So, what do you think about these groundbreaking findings? Could Ramucirumab plus FOLFIRI be the second-line treatment we’ve been waiting for? Feel free to leave your thoughts in the comments below.