IceCure's Cryoablation Combined with Radiation Therapy Achieves 74% Five-Year Survival in Stage I Lung Cancer
核心洞察
A Japanese study of 64 patients with stage I non-small cell lung cancer showed that combining stereotactic body radiation therapy with IceCure's cryoablation system achieved a 74% five-year overall survival rate, significantly higher than the 41-52% reported with radiation alone.
The combination therapy produced survival outcomes comparable to surgery, which has a five-year overall survival rate of 67-82% according to published studies, while maintaining a 93% local control rate.
The treatment demonstrated a 92% disease-specific five-year survival rate with no treatment-related mortality, offering a potentially less invasive alternative for patients with larger tumors measuring 2 cm or greater.
A new study published in PLOS One demonstrates that combining stereotactic body radiation therapy (SBRT) with IceCure Medical's cryoablation system significantly improves survival outcomes for patients with stage I non-small cell lung cancer (NSCLC), achieving a 74% five-year overall survival rate compared to 41-52% with radiation therapy alone.
The independent retrospective observational study, led by Dr. Hiroaki Nomori of the Department of Thoracic Surgery at Kashiwa Kousei General Hospital in Japan, evaluated 64 patients with stage I NSCLC tumors measuring 2 cm or larger. The research team included investigators from Tokyo University Hospital, Kashiwa Kousei General Hospital, and Sonodakai Radiation Clinic in Tokyo.
Superior Survival Outcomes
The combination therapy demonstrated remarkable efficacy across multiple survival metrics. Patients treated with SBRT followed by cryoablation achieved a 93% five-year local control rate and a 92% disease-specific five-year survival rate. The three-year disease-specific survival reached 96%, with no treatment-related mortality observed during the study period.
"While radiation therapy is the standard of care for inoperable stage I NSCLC patients, using SBRT alone unfortunately results in far lower overall survival and lower local control than surgery in certain patients," stated Eyal Shamir, Chief Executive Officer of IceCure Medical. "This study, which focused on people with relatively larger tumors, indicative of later stage disease, provides very encouraging results confirming that combining SBRT with our cryoablation system offers inoperable patients longer life expectancy."
Comparable to Surgical Outcomes
The study's most significant finding was that the combination therapy produced five-year overall survival outcomes similar to surgery, which remains the standard treatment for stage I NSCLC with a five-year overall survival rate of 67-82% according to published studies. This represents a substantial improvement over SBRT monotherapy, which has demonstrated limitations in local control and survival rates for certain patient populations.
The 64 patients in the study had tumors with a mean diameter of 2.7 ± 0.5 cm, ranging from 2.0 to 4.0 cm. The median follow-up duration was 74 months, with a range of 3-111 months, providing robust long-term survival data.
Safety Profile and Complications
The treatment demonstrated an acceptable safety profile, with pneumothorax being the most frequent complication post-cryoablation, occurring in 40% of patients at CTCAE grade 2. Importantly, no treatment-related deaths were recorded, suggesting the combination approach maintains the safety advantages of minimally invasive procedures.
Clinical Context and Market Impact
Lung cancer represents a significant global health burden, being the most frequently diagnosed cancer worldwide with an incidence of 2.5 million cases annually. According to a study published in CA: A Cancer Journal for Clinicians, lung cancer was responsible for almost 2.5 million new cases in 2022, representing one in eight cancers worldwide (12.4% of all cancers), followed by breast cancer at 11.6% globally.
The results align with prior findings from independent studies, including a previous study by Nomori et al. that reported recurrence-free rates of 67-100% in lung cancer patients treated with IceCure's cryoablation system.
Technology and Clinical Applications
IceCure's ProSense® system utilizes liquid nitrogen-based cryoablation technology to destroy tumors by freezing. The minimally invasive approach creates large lethal zones for maximum efficacy in tumor destruction across various cancer types, including breast, kidney, lung, and liver cancers.
The ProSense® Cryoablation System holds the distinction of being the first and only medical device to receive FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives.
Shamir noted that "the results of this study may be highly impactful in our major markets including the U.S. and Europe," suggesting potential broader clinical adoption of the combination therapy approach for stage I NSCLC patients with larger tumors who may not be optimal surgical candidates.