Maintenance tegafur-uracil does not improve survival in locally advanced cervical cancer

Continuous administration of low-dose tegafur-uracil (UFT) for 2 years after curative concurrent chemoradiotherapy (CCRT) did not improve median progression-free survival (PFS) or median overall survival (OS), results of the GOTIC-002 LUFT trial demonstrated.

The current standard therapy for locally advanced cervical cancer (LACC) is CCRT followed by brachytherapy. However, there is room to improve survival, e.g. by giving maintenance chemotherapy after CCRT. Maintenance with UFT improves survival in gastric, lung, colon, and breast cancer [1–5]. The GOTIC-002 LUFT trial (jRCTs031180174) evaluated the efficacy and safety of low-dose UFT for 2 years as maintenance chemotherapy after curative CCRT for patients with LACC. Prof. Keiichi Fujiwara (Saitama Medical University, Japan) presented the results [5].

During 8 years, the study enrolled 351 patients with LACC (FIGO 1B2-IVa) with a partial or complete response after curative CCRT. Participants were 1:1 randomised to maintenance UFT (300 mg or 400 mg every day for 2 years) or observation. The primary endpoint was PFS; secondary endpoints included OS, safety and quality-of-life.

Maintenance UFT did not improve median PFS over observation (62.0% vs 61.3%; HR 0.92; P=0.634) or median OS (76.1% vs 77.6%; HR 1.04; P=0.869). Maintenance UFT was well tolerated, with grade ≥3 adverse events observed in 22.6% of participants in the UFT arm compared with 15.9% of observed participants).

Based on these results, Prof. Fujiwara acknowledged that “continuous administration of low-dose UFT for 2 years after curative CCRT does not improve PFS or OS.”

1. Nakajima T, et al. Br J Surg. 2007;94(12):1468–1476.
2. Kato H, et al. N Engl J Med. 2004;350(17):1713–1721.
3. Akasu T, et al. Jpn J CLin Oncol. 2006;36(4):237–2344.
4. Kasumi F, et al. Oncology. 2003;64(2):146–153.
5. Fujiwara K, et al. Randomized phase III trial of maintenance chemotherapy with tegafur-uracil versus observation following concurrent chemoradiotherapy for locally advanced cervical cancer, GOTIC-002 LUFT trial. Abstract LBA31, ESMO Congress 2022, 09–13 September, Paris, France.

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Posted on 17 November 202217 May 2024