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. 2025 Jul 30;13(8):e70286.
doi: 10.1002/rcr2.70286. eCollection 2025 Aug.

Regorafenib Induced Interstitial Pneumonia in a Patient With Refractory Rectal Cancer

Tomo Tsunoda  1 , Yoshiyuki Oyama  1 , Ryota Miyamoto  1 , Taisuke Ito  1 , Takuro Akashi  1 , Kazuo Tsuchiya  1 , Masaki Ikeda  1
Affiliations

Regorafenib Induced Interstitial Pneumonia in a Patient With Refractory Rectal Cancer

Tomo Tsunoda et al. Respirol Case Rep. .

Abstract

Regorafenib, a multi-targeted tyrosine kinase inhibitor (TKI), is indicated for refractory colorectal carcinoma, gastrointestinal stromal tumours (GIST), and hepatocellular carcinoma (HCC). We present a case involving a 66-year-old male patient with refractory colorectal cancer who developed interstitial pneumonia as a consequence of regorafenib therapy. Three months following the initiation of regorafenib administration, a chest computed tomography scan revealed bilateral ground-glass opacities, a characteristic finding in interstitial lung disease. This case illustrates a relatively rapid progression of regorafenib-induced interstitial lung disease following its radiographic manifestation. Clinicians should remain vigilant for this potential pulmonary toxicity in patients receiving regorafenib, even with an apparently short latency period after treatment commencement. Early recognition and prompt intervention are crucial in managing this adverse event.

Keywords: colorectal cancer; drug‐induced interstitial lung disease; interstitial pneumonia; multi‐targeted tyrosine kinase inhibitor; regorafenib.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
(a, b) High‐resolution chest tomography (HRCT) image at 3 months after starting regorafenib. Ground‐glass opacity (GGO) appeared in both lung fields. (c, d) HRCT image at 1 week after GGO appearance. Patchy infiltration shadow and consolidation replaced GGO in both lung fields.
FIGURE 2
FIGURE 2
Histological findings of the transbronchial lung biopsy specimen. A histological examination was performed with Haematoxylin and Eosin staining. The square area of the low‐magnification photomicrograph is shown as a high‐magnification photomicrograph. The arrows indicate the infiltration of foamy macrophages and the arrowheads indicate the infiltration of eosinophils into the alveolar interstitium. A scale bar is shown in each figure.
FIGURE 3
FIGURE 3
Clinical course of the patient after admission. AZM, Azithromycin; CTRX, ceftriaxone; LDH, lactate dehydrogenase.
See this image and copyright information in PMC

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References

    1. Wilhelm S. M., Dumas J., Adnane L., et al., “Regorafenib (BAY73‐4506): A New Oral Multikinase Inhibitor of Angiogenic, Stromal and Oncogenic Receptor Tyrosine Kinases With Potent Preclinical Antitumor Activity,” International Journal of Cancer 129 (2011): 245–255. - PubMed
    1. Grothey A., Van Cutsem E., Sobrero A., et al., “Regorafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer (CORRECT): An International, Multicentre, Randomised, Placebo Controlled, Phase 3 Trial,” Lancet 381 (2013): 303–312. - PubMed
    1. Demetri G. D., Reichardt P., Kang Y. K., et al., “Efficacy and Safety of Regorafenib for Advanced Gastrointestinal Stromal Tumours After Failure of Imatinib and Sunitinib (GRID): An International, Multicentre, Randomised, Placebo‐Controlled, Phase 3 Trial,” Lancet 381 (2013): 295–302. - PMC - PubMed
    1. Bruix J., Qin S., Merle P., et al., “Regorafenib for Patients With Hepatocellular Carcinoma Who Progressed on Sorafenib Treatment (RESORCE): A Randomised, Double‐Blind, Placebo‐Controlled, Phase 3 Trial,” Lancet 389 (2017): 56–66. - PubMed
    1. Bayer , Guide to Proper Use of Regorafenib for HCC/Colorectal Cancer/GIST, 2025, https://pharma‐navi.bayer.jp/stivarga/usage‐safety/postmarket‐safety‐inf....

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