Phase 1 Lymfactin® Study: 24-month Efficacy and Safety Results of Combined Adenoviral VEGF-C and Lymph Node Transfer Treatment for Upper Extremity Lymphedema




Leppäpuska Ida-Maria, Hartiala Pauliina, Suominen Sinikka, Suominen Erkki, Kaartinen Ilkka, Mäki Maija, Seppänen Marko, Kiiski Juha, Viitanen Tiina, Lahdenperä Outi, Vuolanto Antti, Alitalo Kari, Saarikko Anne M.

2022

Journal of Plastic, Reconstructive and Aesthetic Surgery

Journal of plastic, reconstructive & aesthetic surgery : JPRAS

J Plast Reconstr Aesthet Surg

75

11

3938

3945

1748-6815

1878-0539

DOIhttps://doi.org/10.1016/j.bjps.2022.08.011

https://www.sciencedirect.com/science/article/pii/S1748681522004545?via%3Dihub

https://research.utu.fi/converis/portal/detail/Publication/176815782



BACKGROUND
Lymphedema is a common problem after breast cancer treatment. Lymfactin® is a prolymphangiogenic growth factor vector inducing the expression of human vascular endothelial growth factor C (VEGF-C). It promotes growth and repair of lymphatic vessels.

METHODS
Lymfactin® was combined with microvascular lymph node transfer surgery (VLNT) to study the safety and efficacy of the treatment in breast cancer-related upper limb lymphedema (BCRL) patients. This is a continuation study with a 3 year efficacy and 5 year safety follow-up.

RESULTS
Fifteen patients were recruited in the study between June 2016 and February 2018. Three patients received a lower dose (1 × 1010 viral particles (vp)), and 12 patients received a higher dose (1 × 1011 vp) of Lymfactin®, respectively. In the higher dose group, the reduction of excess arm volume was on average 46% after the 12 month follow-up, and the transport index was improved in 7/12 patients. At baseline, removal of the compression garment for 7 days resulted in significant arm swelling (105.7±161.0 ml, p=0.0253). However, at 12 months, there was less and not significant swelling after removal of the garment (84.4±143.0 ml, p=0.0682). Lymphedema Quality of Life Inventory (LQOLI or LyQLI) questionnaire showed significant and sustained improvement of quality of life.

CONCLUSIONS
During 24 months' of follow-up, the results indicate that Lymfactin® is well tolerated. The most promising findings were a 46% reduction in excess arm volume and a nonsignificant volume increase after garment removal at 12 months, suggesting that there is potential for the reduction of lymphedema.


Last updated on 2024-26-11 at 11:34