· Worldwide in 2018, including both sexes and all ages, the number of new lung cancer cases was 2,093,876 with 1,761,007 deaths from the disease.1
· Estimated increase of 50% of the incidence rate for lung cancer by 2030 3
· Post-treatment mortality rates were higher after surgery compared to stereotactic body radiotherapy among patients older than 70 years. These mortality data may inform shared decision making among patients with early-stage lung cancer who are eligible for both interventions. 4
· While surgery is still the gold standard for lung cancer treatment, radiation therapy can offer a less invasive approach with quicker recovery times and potentially higher cost effectiveness compared to lobectomy 3,4
BioXmark® is under development and not yet CE marked
BioXmark® for lung cancer radiation therapy
For early-stage lung cancer patients who are otherwise healthy and good surgical candidates, lobar resection remains the treatment standard. However, it may be important to consider radiotherapy as alternative or complementary therapy for older patients who have a high risk of surgical complications. 4
Image guidance has improved the precision of lung cancer radiotherapy. Fiducial markers can be used as surrogates for the target positioning to support precision. Implantation of fiducial markers can be done both percutaneously for the peripheral tumours and endoscopically via bronchoscope or gastroscope for the central/mediastinal tumours and lymph nodes.
As a liquid fiducial marker BioXmark® have several potential advantages in the implantation process in lungs compared to solid or metal-based markers: BioXmark® is injected using the same equipment as in biopsy procedures and does not involve procedure specific techniques, potentially lowering the risk of procedure errors to the inexperienced user. The needle used for the injection is thin, typically 22-25G compared to the 19G needles or brushes used for implantation of solid metal markers, improving the maneuverability of the endoscope by reducing the rigidity.
Furthermore, with use of BioXmark® multiple injections can be performed without procedure interruptions, as the needle does not have to be reloaded between each marker implantation. Finally, the injection of liquid based fiducial markers allows for flexibility in size of the individual marker by variation of the volume per injection.
In clinical use, BioXmark® has been reported to be safe, positional stable, and visible throughout the treatment period of patients with lung cancer.5-7
An open label clinical feasibility study has evaluated the short and long-term clinical safety and performance of BioXmark® in 15 patients with locally advanced non-small cell lung cancer.5 It was concluded from the results that in this study BioXmark® was safe to endoscopically inject, using a 22G needle, into primary tumours and lymph nodes and provided adequate visibility and stability when acting as fiducial markers to leverage the value of image guided radiotherapy of lung cancers. No post treatment marker migration or early “wash out” was observed. No serious adverse events in relation to the injection procedure nor during treatment and a 38 months follow-up period were observed. Marker excursion in deep-inspiration breath-hold radiotherapy was evaluated as well.6
Another study investigated the clinical applicability of BioXmark® for image-guided proton therapy of locally advanced lung cancer.7 It was found that the maximum dose perturbations measured were small and clinically acceptable for proton therapy of locally advanced lung cancer patients. As a liquid, non-metallic fiducial marker, BioXmark® introduced a smaller dose perturbation compared to the solid fiducial markers investigated.
For information about BioXmark®, see BioXmark®
1. World Health Organization http://gco.iarc.fr/today/fact-sheets-cancers
2. The American Cancer Society http://www.cancer.org/cancer.html
3. Paix A. et al. Cost-effectiveness analysis of stereotactic body radiotherapy and surgery for medically operable early stage non small cell lung cancer. Radiotherapy and Oncology 2018; 128 534–540
4. W. A. Stokes at al,Post-Treatment Mortality After Surgery and Stereotactic Body Radiotherapy for Early-Stage
Non–Small-Cell Lung Cancer. J Clin Oncol 2018; 36:642-651
5. S. Riisgaard de Blanck et al. Long-term safety and visibility of a novel liquid fiducial marker for use in image guided radiotherapy of non-small cell lung cancer. Clinical and Translational Radiation Oncology 2018;13 24–28
6. J.S. Rydhög at al. Target position uncertainty during visually guided deep-inspiration breath-hold radiotherapy in locally advanced lung cancer. Radiotherapy and Oncology 2017;123 78–84
7. J.S. Rydhög at al. Liquid fiducial marker applicability in proton therapy of locally advanced lung cancer. Radiotherapy and Oncology 2017;122 393–399