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. 2025 Dec 11.
doi: 10.1245/s10434-025-18802-8. Online ahead of print.

Clinical Benefit and Cost-Effectiveness of FOLFOX Versus LCCRT in Neoadjuvant Treatment for Patients with Locally Advanced Rectal Cancer: An Economic Analysis of the FOWARC and PROSPECT Trial

Tiantian Zhang #  1   2 , Lishuo Shi #  3   4   5   6 , Liuying Jian #  2   7 , Jie Jiang #  2 , Yijin Qiu  2 , Feng Xie  8   9 , Jianwei Zhang  10   3   4   5 , Hui Peng  10 , Lixing Zhong  10 , Yexin Chen  2 , Yunwu Zhong  2 , Yanhong Deng  11   12   13   14 ; FOWARC Group
Affiliations

Clinical Benefit and Cost-Effectiveness of FOLFOX Versus LCCRT in Neoadjuvant Treatment for Patients with Locally Advanced Rectal Cancer: An Economic Analysis of the FOWARC and PROSPECT Trial

Tiantian Zhang et al. Ann Surg Oncol. .

Abstract

Background: FOLFOX has emerged as a new treatment paradigm for locally advanced rectal cancer (LARC). However, whether FOLFOX, which replaces radiotherapy with chemotherapy, offers comprehensive clinical and economic advantages over conventional long-course chemoradiotherapy (LCCRT), especially in high-risk patients, remains unclear.

Methods: We conducted both within-trial and Markov model-based lifetime analyses to evaluate the short- and long-term economic and health outcomes of FOLFOX compared with LCCRT. Data were derived from the 3 and 10 year follow-up of the FOWARC trial (NCT01211210) in China and published data from the PROSPECT trial (NCT01515787) in the USA. Main outcomes included health utility, patient-reported outcomes of adverse events, costs, and quality-adjusted life years (QALYs). Costs were evaluated from the healthcare perspective in 2023 US dollars. Subgroup, scenario, and sensitivity analyses were performed.

Results: Within-trial analysis showed that the FOLFOX group had an increasing utility trend, while LCCRT decreased. FOWARC found that LCCRT patients experienced more severe depression and social life impact compared with PROSPECT. Over 45.2 months, FOLFOX cost $3503 less and gained 0.18 more QALYs than LCCRT. Lifetime analysis estimated that FOLFOX gained 0.81 and 0.56 more QALYs, with cost savings of $12,018 and $87,643 compared with LCCRT in China and the USA, respectively. FOLFOX remained cost-effective in high-risk patients requiring supplementary radiotherapy, with LCCRT becoming preferable only when the proportion of these patients reached 64%.

Conclusions: Selective radiotherapy avoidance with FOLFOX may be recommended for neoadjuvant treatment of LARC, even in high-risk patients. This substitution could save significant healthcare resources while improving QALYs globally. Trial Registration ClinicalTrials.gov NCT01211210, NCT01515787.

Keywords: Cost-effectiveness; FOLFOX; LCCRT; Locally advanced rectal cancer; Neoadjuvant treatment.

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Conflict of interest statement

Disclosure: The authors declare that they have no competing interests. Ethical Approval: This study was deemed exempt from review by the Sixth Affiliated Hospital, Sun Yat-sen University Review Board owing to the use of deidentified data. Consent for Publication: All authors have read and approved the final manuscript.

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