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Purpose <p>Regorafenib, a multikinase inhibitor for treating metastatic colorectal cancer (mCRC), induces fatigue in 40–50% of administered patients, including approximately 10% of grade ≥ 3 cases. Additionally, hypoalbuminemia is associated with cancer- and chemotherapy-induced fatigue and frequently observed in patients with advanced cancers. This study aimed to assess the impact of baseline hypoalbuminemia on the development of clinically problematic fatigue in a real-world regorafenib treatment for mCRC.</p> Methods <p>Patients with mCRC who underwent regorafenib (<i>n</i> = 102) were divided into the control (baseline serum albumin levels ≥ 3.5&#xa0;g/dL) and hypoalbuminemia (baseline serum albumin levels &lt; 3.5&#xa0;g/dL) groups, and retrospectively evaluated. The primary endpoint was comparison of grade ≥ 2 fatigue incidence during all treatment cycles. We also assessed the impact of grade ≥ 2 symptoms on the treatment efficacy.</p> Results <p>Incidence of grade ≥ 2 fatigue in all treatment cycles in the hypoalbuminemia group was 41.7%, which was significantly higher than that in the control group (14.1%, <i>P</i> = 0.008). In addition, grade ≥ 2 fatigue within the first cycle was significantly more confirmed in the hypoalbuminemia group than in the control group (37.5% vs. 11.5%, <i>P</i> = 0.01). Additionally, patients with early grade ≥ 2 fatigue within 14&#xa0;days from treatment initiation had a significantly shorter time to treatment failure or overall survival than those without the symptoms.</p> Conclusion <p>Patients with baseline hypoalbuminemia developed clinically problematic fatigue after regorafenib monotherapy for mCRC. Because regorafenib is a later-line mCRC treatment, successful management of emerging fatigue is crucial and requires further evaluation.</p>

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Baseline hypoalbuminemia enhances regorafenib-induced problematic fatigue development in real-world metastatic colorectal cancer treatment

  • 期刊论文

  • 发表日期：

    2025年10月29日

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  • Yoshitaka Saito,
  • Yoh Takekuma,
  • Yoshito Komatsu,
  • Mitsuru Sugawara

摘要

Purpose

Regorafenib, a multikinase inhibitor for treating metastatic colorectal cancer (mCRC), induces fatigue in 40–50% of administered patients, including approximately 10% of grade ≥ 3 cases. Additionally, hypoalbuminemia is associated with cancer- and chemotherapy-induced fatigue and frequently observed in patients with advanced cancers. This study aimed to assess the impact of baseline hypoalbuminemia on the development of clinically problematic fatigue in a real-world regorafenib treatment for mCRC.

Methods

Patients with mCRC who underwent regorafenib (n = 102) were divided into the control (baseline serum albumin levels ≥ 3.5 g/dL) and hypoalbuminemia (baseline serum albumin levels < 3.5 g/dL) groups, and retrospectively evaluated. The primary endpoint was comparison of grade ≥ 2 fatigue incidence during all treatment cycles. We also assessed the impact of grade ≥ 2 symptoms on the treatment efficacy.

Results

Incidence of grade ≥ 2 fatigue in all treatment cycles in the hypoalbuminemia group was 41.7%, which was significantly higher than that in the control group (14.1%, P = 0.008). In addition, grade ≥ 2 fatigue within the first cycle was significantly more confirmed in the hypoalbuminemia group than in the control group (37.5% vs. 11.5%, P = 0.01). Additionally, patients with early grade ≥ 2 fatigue within 14 days from treatment initiation had a significantly shorter time to treatment failure or overall survival than those without the symptoms.

Conclusion

Patients with baseline hypoalbuminemia developed clinically problematic fatigue after regorafenib monotherapy for mCRC. Because regorafenib is a later-line mCRC treatment, successful management of emerging fatigue is crucial and requires further evaluation.