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已发表论文
乳腺癌乳腺内局部病灶控制的导管内化疗探索性研究
Authors Lin X, Li X, Wei Q, Yuan H, Zhong M, Qiao J, Gong J, Li Y
Received 17 June 2025
Accepted for publication 18 November 2025
Published 25 December 2025 Volume 2025:17 Pages 1321—1339
DOI https://doi.org/10.2147/BCTT.S547684
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Professor Pranela Rameshwar
Xin Lin,1 Xinzhuo Li,2 Qingping Wei,1 Hao Yuan,1 Ming Zhong,1 Jianlan Qiao,3 Jianzhong Gong,3 Yongping Li4
1Department of Breast Surgery, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, 201399, People’s Republic of China; 2Fudan University, Shanghai, 200433, People’s Republic of China; 3Department of Radiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, 201399, People’s Republic of China; 4Department of General Surgery of Shanghai Eighth People’s Hospital, Shanghai, 200235, People’s Republic of China
Correspondence: Yongping Li, Department of General surgery of Shanghai Eighth People’s Hospital, Xuhui District, Shanghai, 200235, People’s Republic of China, Tel +86 18930038167, Email liyongpingdt@sina.com Jianzhong Gong, Department of Radiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Pudong New Area, Shanghai, 201399, People’s Republic of China, Tel +8618918355119, Email 18918355119@163.com
Objective: The standard treatment for locally advanced breast cancer (LABC) is neoadjuvant therapy combined with surgery with chemotherapy as the main means. Elderly female patients often lose treatment opportunities due to the cardiotoxicity and other intolerable adverse reactions of chemotherapy drugs and their inoperability. Most breast cancers originate from the epithelial cells lining the ducts of the breast. We proposed that for the treatment of LABC, intraductal infusion of chemotherapeutic drugs could lead to high local exposure of the drug to the mammary ducts and avoid systemic toxicity. In order to verify its safety, we conducted a series of studies.
Methods: We perfused two different chemotherapeutic drugs into the mammary ducts of pigs or dogs, observed their skin toxicity and measured the drug distribution and concentration in tissues and blood. Strictly select clinical cases, perform intraductal chemotherapy, and observe their skin toxicity and systemic toxicity. In addition, drug transport pathways in the breast of Beagle dogs were clarified by combining contrast-enhanced magnetic resonance imaging (MRI) with gadolinium dimeglumine injection with advanced image processing techniques and computational fluid dynamics (CFD) simulations.
Results: In animal experiments, no grade II ~ IV skin toxicity related to perfusion drugs was observed. Strictly screened clinical cases significantly reduced tumor lesions by intraductal chemotherapy, and no significant cutaneous or systemic toxicity was observed. Validated models showed that the transport of contrast agent within the breast ducts mainly relies on convection and diffusion mechanisms, and convection shows a significantly higher transport efficiency than diffusion.
Conclusion: This study demonstrates the safety and feasibility of intraductal chemotherapy, provides preliminary data supporting the further investigation of intraductal chemotherapy as a potential local treatment strategy for LABC patients who cannot tolerate intravenous chemotherapy and cannot be operated on, and provides a valuable theoretical and computational basis for the selection of delivery routes and pharmacokinetic analysis of anticancer drugs.
Registration Details: This trial was approved by the Ethics Committee of Pudong Hospital Affiliated to Fudan University [Clinical Trial Number: (2021) Ethics Approval No. (QWJWZY-01)].
Keywords: intraductal administration, chemotherapy therapy, breast cancer, focal lesion
1Department of Breast Surgery, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, 201399, People’s Republic of China; 2Fudan University, Shanghai, 200433, People’s Republic of China; 3Department of Radiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, 201399, People’s Republic of China; 4Department of General Surgery of Shanghai Eighth People’s Hospital, Shanghai, 200235, People’s Republic of China
Correspondence: Yongping Li, Department of General surgery of Shanghai Eighth People’s Hospital, Xuhui District, Shanghai, 200235, People’s Republic of China, Tel +86 18930038167, Email liyongpingdt@sina.com Jianzhong Gong, Department of Radiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Pudong New Area, Shanghai, 201399, People’s Republic of China, Tel +8618918355119, Email 18918355119@163.com
Objective: The standard treatment for locally advanced breast cancer (LABC) is neoadjuvant therapy combined with surgery with chemotherapy as the main means. Elderly female patients often lose treatment opportunities due to the cardiotoxicity and other intolerable adverse reactions of chemotherapy drugs and their inoperability. Most breast cancers originate from the epithelial cells lining the ducts of the breast. We proposed that for the treatment of LABC, intraductal infusion of chemotherapeutic drugs could lead to high local exposure of the drug to the mammary ducts and avoid systemic toxicity. In order to verify its safety, we conducted a series of studies.
Methods: We perfused two different chemotherapeutic drugs into the mammary ducts of pigs or dogs, observed their skin toxicity and measured the drug distribution and concentration in tissues and blood. Strictly select clinical cases, perform intraductal chemotherapy, and observe their skin toxicity and systemic toxicity. In addition, drug transport pathways in the breast of Beagle dogs were clarified by combining contrast-enhanced magnetic resonance imaging (MRI) with gadolinium dimeglumine injection with advanced image processing techniques and computational fluid dynamics (CFD) simulations.
Results: In animal experiments, no grade II ~ IV skin toxicity related to perfusion drugs was observed. Strictly screened clinical cases significantly reduced tumor lesions by intraductal chemotherapy, and no significant cutaneous or systemic toxicity was observed. Validated models showed that the transport of contrast agent within the breast ducts mainly relies on convection and diffusion mechanisms, and convection shows a significantly higher transport efficiency than diffusion.
Conclusion: This study demonstrates the safety and feasibility of intraductal chemotherapy, provides preliminary data supporting the further investigation of intraductal chemotherapy as a potential local treatment strategy for LABC patients who cannot tolerate intravenous chemotherapy and cannot be operated on, and provides a valuable theoretical and computational basis for the selection of delivery routes and pharmacokinetic analysis of anticancer drugs.
Registration Details: This trial was approved by the Ethics Committee of Pudong Hospital Affiliated to Fudan University [Clinical Trial Number: (2021) Ethics Approval No. (QWJWZY-01)].
Keywords: intraductal administration, chemotherapy therapy, breast cancer, focal lesion