Interventional Oncology in the News: A 2015 Update

From investments to FDA clearance, CyberKnife development, SIRFLOX, SBRT, and SIR-Spheres to interventional oncology therapies, the past year has been rife with groundbreaking advancements in interventional oncology (IO) treatment, technologies and research. Below is a compilation of just a few of the many pertinent discoveries, developments and studies in the world of IO in the last year.

Industry Growth and Investment

Terumo Corporation and Quirem Medical, a Dutch company focused on radioembolization, announced Terumo made equity investments in Quirem Medical. Quirem Medical develops QuiremSpheres, microspheres for the radioembolization treatment of liver cancer.

In addition, Royal Philips and Profound Medical Corp. signed a joint development agreement to support Profound Medical’s Transurethral Ultrasound Ablation (TULSA) technology, designed to treat patients with prostate cancer on Ingenia and Achieva 3T MRI systems (Philips). The TULSA technology, a minimally invasive, whole-gland ablation of the prostate, has the potential for lower rates of side effects with its one session procedure. Profound Medical plans to release 12-month data from its 30-patient safety and feasibility study with the goal of obtaining a CE mark and commercialization in Europe and Canada in 2016.

Gynesonics announced it raised $43 million in equity financing, co-led by Endeavour Vision. The financing will be used to treat women who suffer from symptomatic uterine fibroids through the funding of Gynesonics’ clinical plan for its technology platform, Sonata. Sonata is an incision-free device that integrates radiofrequency energy to ablate fibroids under intrauterine sonography guidance, while preserving the uterus.

Separately, the Paps Corp Champions for Cancer Research awarded Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine a $3.6 million gift to advance research in prevision cancer medicine. The funding will support the basic and translations research at Sylvester that promotes discoveries of genetic markers for individual cancers and the development of targeted treatments that will lead to better outcomes.

Surefire Medical Receives FDA Clearance for Precision Direct-to-Tumor Embolization Device

Surefire Medical received 510(k) FDA clearance for Surefire Precision, a direct-to-tumor treatment delivery device with an expandable tip employed in minimally invasive chemoembolization and radioembolization procedures that increases drug delivery to the tumor while protecting healthy tissue. 

Recent clinical data showed that the technology enabled increased uptake of particles by an average of 68% compared to use of conventional end-hole catheters in treating primary liver cancer. Decreases in hepatic non-target embolization ranged from 24% to 89%, with a mean of 42%. Increased tumor deposition ranged from 33% to 90%, with a mean of 68%. Clinical trials are under way for treating additional medical conditions.

NanoKnife and CyberKnife Development

Data published in Annals of Surgery concluded, based on an analysis of irreversible electroporation (IRE) performed on 200 consecutive patients diagnosed with locally advanced pancreatic cancer, that IRE results in substantially prolonged survival of patients with LAPC compared with historical controls.

Furthering use of the technology, Alliance Oncology and Dignity Health Bay Area opened San Francisco CyberKnife, a new cancer treatment facility at Saint Francis Memorial Hospital. Patients will be offered outpatient cancer treatment with the CyberKnife Robotic Radiosurgery System, a noninvasive alternative to surgery for the treatment of cancerous and noncancerous tumors.

Separately, UPMC CancerCenter became the first in the world to treat a patient with the Cyberknife M6 System’s (Accuray) new multileaf collimator, which enables the precise shaping of radiation beams to any irregularly shaped tumor, sparing healthy surrounding tissues and reducing the time patients must undergo treatment. In a press release from Accuray, the company noted that Cyberknife was used on a 56-year-old patient being treated for a benign brain tumor, and the treatment lasted 22 minutes.

SIRFLOX Study Updates

Patients with unresectable metastatic colorectal cancer that has spread only to the liver experienced the greatest improvement in progression-free survival in the liver from the addition of SIR-Spheres Y-90 (Sirtex) resin microsphere to a current first-line chemotherapy regimen, according to new data from the SIRFLOX study. 

Liver tumors progressed after a median of 12.6 months in patients with mCRC who received only first-line chemotherapy, even with the optional addition of bevacizumab. Those who also received first-line treatment with SIR-Spheres Y-90 resin microspheres reached a median of 20.5 months before their liver disease progressed, an additional 7.9 months, and a 31% reduction in the risk of tumor progression. The 530-patient study is the largest randomized trial ever conducted that combined an interventional radiology procedure with chemotherapy in oncology.

The Latest in Stereotactic Body Radiotherapy 

Two studies from Johns Hopkins Kimmel Cancer Center researchers add to preliminary evidence that high-dose radiation treatment called stereotactic body radiotherapy (SBRT) appears to be safe and as effective as standard radiation treatment for some patients with pancreatic cancer whose tumors are advanced but have not spread. SBRT treatment can be delivered in doses over the course of 1 week, with some patients reporting significantly less pain and no decrease in their quality of life compared to traditional radiation therapy.

Additionally, patients with operable stage I non-small lung cell lung cancer (NSCLC) could achieve better overall survival rates if treated with stereotactic ablative radiotherapy (SABR) rather than the current standard of invasive surgery, according to research from a phase 3 randomized study from The University of Texas MD Anderson Cancer Center. The researchers studied overall survival, recurrence, and toxicity in 50 patients, showing estimated survival rates were 79% in the surgery group and 95% in the SABR group. Recurrence-free survival rates at 3 years were 80% and 86%, respectively; 6 patients in the surgery group died, compared to 1 death in the SABR group.

Next-Generation Interventional Oncology Therapies

Dartmouth investigators engineered therapeutic cells encapsulated in nanoporous capsules to secrete antitumor molecules from within the tumor and attack the perennial problem of systemic toxicity from typical chemotherapy treatments. The goal of localizing therapy to avoid systemic toxicity is the impetus for the effort to ultimately encapsulate a library of therapeutic cells that will take cues from their microenvironment and secrete appropriate antitumor molecules.

In a separate study, biomedical researchers at Princess Margaret Cancer Centre successfully converted microbubble technology already used in diagnostic imaging into nanoparticles that stay trapped in tumors to potentially deliver targeted, therapeutic payloads. The new type of microbubble was made using porphyrin, then burst using a low-frequency ultrasound. The resulting fragmented nanoparticles stayed within the tumor and could be tracked using imaging, unlike conventional microbubbles, which lose all intrinsic imaging and therapeutic properties once they burst. 

It was also announced that Vanderbilt University researchers achieved the first “image fusion” of mass spectrometry and microscopy, which could dramatically improve the diagnosis and treatment of cancer and redefine the surgical margin between cancer cells and normal cells. 

Scientists from the Helmholtz Zentrum München and the Ludwig-Maximilians-Unversität in Munich developed nanocarriers that site-selectively release drugs at the tumor site in human and mouse lungs, leading to a significant increase in the effectiveness of current cancer medicines in lung tumor tissue. Researchers took advantage of the high concentrations of certain proteases in lung tumor tissue by modifying the nanocarriers with a protective layer that only those proteases can break down, releasing the drug.

It was separately announced that 3-D printing could become a powerful tool in customizing interventional radiology treatments to individual patient needs after researchers and engineers printed catheters, stents, and filaments that were bioactive, providing the ability to deliver antibiotics and chemotherapeutic medications to targeted areas in cell cultures. Researchers found that the devices inhibited bacterial growth and saw that filaments carrying chemotherapeutic agents were able to inhibit the growth of cancer cells.

Recently presented research suggests that a weakened strain of Clostridium novyi kills cancer cells, after being injected into tumors. It was found that C. novyi thrives in low-oxygen areas and destroys tumors from the inside, while sparing normal tissue.

Hansen Medical announced the completion of the world’s first robotically assisted radioembolization procedures for cancer treatment, utilizing the Magellan Robotic System. The System drives Magellan Robotic Catheters and guide wires during minimally invasive endovascular procedures.

Patients Enroll in SIR-Spheres Y-90 Resin Microsphere Studies

Sirtex Medical announced the completion of patient enrollment in FOXFIRE and FOXFIRE Global, two multicenter studies that added liver-directed radiation therapy with SIR-Spheres Y-90 resin microspheres to a current standard of care chemotherapy regimen in the first-line treatment of more than 50 patients recently diagnosed with inoperable metastatic colorectal cancer. The data will be combined with the findings of the separate 500-patient SIRFLOX study to form a database of more than 1,000 patients to evaluate whether SIR-Spheres microspheres in combination with standard-of-care chemotherapy vs chemotherapy alone can significantly increase the overall survival of patients. The results are expected to be released in the first half of 2017.

Separately, the Cardiovascular and Interventional Radiological Society of Europe announced that the first patient was enrolled in a new registry, The CIRSE Registry for SIR-Spheres Therapy (CIRT), designed to capture information on patients with inoperable liver tumors who are treated with SIR-Spheres Y-90 resin microspheres. 

Editor’s note: This article first appeared in the Synergy Daily conference newspaper, available to attendees of the Synergy Miami interventional oncology meeting in November 2015. 

Suggested citation: Wolfgang K. Interventional oncology in the news: a 2015 update. Articles from the official show daily for Synergy 2015. Intervent Oncol 360. 2015;3(12):E155-E158.