SAH and Neutron Therapeutics Inc. enter into agreement to develop Boron Neutron Capture Therapy

September 10th, 2019 – Atlanta, Georgia U.S.A.

SAH Global and neutron Therapeutics Inc (NTI) have entered into agreement to develop Boron Neutron Capture Therapy (BNCT).

BNCT is a powerful alternative to traditional radiotherapy and proton therapy, with the ability to deliver targeted radiation to cancer cells while sparing surrounding healthy tissue. 

In BNCT treatment, a boron carrier compound injected into the blood stream is selectively absorbed by tumor cells. The tumor is irradiated with a therapeutic neutron beam. The neutron beam reacts with the boron, while safely passing through surrounding tissue. The boron reaction produces highly excited alpha particles of very short path lengths (5–9 µm) that destroy tumor cells from the inside with minimal effect on immediately surrounding tissue. BNCT has successfully been used to treat cancer patients in cases where other treatment options have been exhausted. Typical BNCT therapies utilize two patient treatments vs. dozens for traditional radiotherapy, reducing stress on patients while enhancing treatment center efficiency and patient throughput.

NTI’s unique and patented neutron source replaces the nuclear reactor in traditional BNCT research platforms. Engineered from the ground up for high reliability and ease of maintenance, NTI’s platform can enable the widespread adoption of BNCT.

SAH is committed to the development and introduction of state-of-the-art cancer treatment technology in the Middle-East, Africa, Latin America, and Asia.

Through this agreement, SAH and NTI will collaborate to secure FDA and CE marks, and to introduce BNCT as a treatment for cancer patients worldwide.

About SAH Global

Strategic Alliance Holdings Global, LLC (“SAH Global”), is a holding company founded in 2005 to establish highly specialized projects in areas such as healthcare. SAH Global has actively pioneered the effort to bring vital cancer treatment solutions to the Middle East. SAH Global believes in building a strong sustainable society, and as such, will leverage the success of its global ventures to make long-term contributions to the community, promote the growth of their employees, and help create a greener environment.

About SAH Care

SAH Care was established to ensure that patients from across the world can have access to the best treatments available. We work tirelessly with local physicians and a global network of leading healthcare providers to bring excellent quality cancer care to our patients. Our team, partners, and supporters share a commitment to improve the delivery of high-quality, patient-centric cancer care.
Through travel medicine, we have found a way to provide access to advanced cancer care for those who live in areas where proton therapy centers are yet to be built. We believe that patients deserve to receive the most advanced cancer treatment in the world today despite geographic boundaries and limitations. The SAH Care team provides this compassionate, comprehensive care to patients wherever they live.

About NTI

Neutron Therapeutics is a Boston-area medical equipment company founded in 2015 by New Zealander, Bill Buckley. The mission of NTI is to provide innovative technology solutions that will enable BNCT to realize its maximum potential in the treatment of difficult cancers.

The Neutron Therapeutics neutron source is not approved for commercial or clinical use by the FDA or EMA or other regulatory body.

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Proton therapy: the current status of the clinical evidences – by Dongryul Oh

Precision and Future Medicine 2019

Proton Therapy Clinical Evidences – Dongryul Oh

The dosimetric advantages of proton therapy—compared with photon therapy—have been clearly defined in many comparison studies involving various tumor sites. There are now accumulating clinical data demonstrating that this dosimetric advantage can lead to better outcomes such as reduced RT toxicity and improved treatment outcomes. 

Pediatric Tumors

RT has an important role in treating pediatric tumors including central nervous system (CNS) tumors, extra-cranial sarcomas, neuroblastoma, and hematopoietic tumors. Long-term toxicities, including secondary malignancies, neurocognitive dysfunctions, growth and musculoskeletal problems, and cardiac problems, are major concerns in pediatric patients who undergo RT. There have been many efforts to reduce the RT dose and volume to avoid these RT-related toxicities.

Proton therapy is one of the best options to reduce unnecessary irradiation dose and volume in pediatric patients.

More than 30 pediatric tumor types were treated, mainly with curative intent: 48% were CNS, 25% extra-cranial sarcomas, 7% neuroblastoma, and 5% hematopoietic tumors

Head and Neck Tumors

Retrospective data have demonstrated better local control (LC) and overall survival (OS) with proton therapy than with photon therapy including IMRT and stereotactic body radiation therapy (SBRT).

Proton therapy has also demonstrated better survival rates in nasal cavity and paranasal sinus tumors.

In oropharyngeal cancers, proton therapy can reduce toxicity to normal tissues.

Proton therapy can also reduce toxicities in unilateral irradiation, such as in cases involving major salivary gland tumor and oral cavity cancers, because the exit dose of the proton beam is essentially negligible

CNS tumors

Cognitive impairment has been one of major concerns following RT for CNS tumors. Proton therapy has a potential benefit to reduce the irradiated dose to normal brain tissue to prevent cognitive dysfunction. In addition, a dose escalation could be possible in radioresistant brain tumors such as high-grade gliomas.

Gastrointestinal tumors

Proton therapy can spare the surrounding normal tissues when it is used to treat gastrointestinal tumors. In the management of hepatocellular carcinoma (HCC), it is very important to spare liver function. Because the liver is an organ with parallel functional subunit in the model of radiation response of normal tissues, liver toxicity is more sensitive to irradiated volume. Proton therapy has a major advantage in reducing the irradiated volume of remnant liver when irradiating the tumor. In many retrospective trials, proton therapy resulted in favorable outcomes.

Re-irradiation

Proton therapy has the advantage of irradiating the target while reducing the dose to the surrounding normal tissues; thus, it has a potential benefit in re-irradiation. Many retrospective studies investigating re-irradiation in various tumor sites have been reported.

Non-Small Cell Lung Cancer

Low-dose shower is a major risk for radiation pneumonitis (RP) when treating non-small cell lung cancer (NSCLC) with photon therapy. If the lateral beam placement is avoided to reduce the lung dose, the irradiated dose to heart is consequently increased and results in increased cardiac death in long-term follow-up. In many dosimetric studies, proton therapy demonstrated advantages in lung and heart dose compared with photon therapy. Several clinical studies have reported treatment outcomes and toxicities of proton therapy in early-stage disease, locally advanced disease, re-irradiation, and in postoperative settings 

Indications for Proton Therapy

American Society for Radiation Oncology (ASTRO)  has updated the recommendations for insurance coverage. The ASTRO recommendation is based on four selection criteria:

  1. a decrease in dose inhomogeneity in a large treatment volume is required to avoid an excessive dose “hotspot” within the treated volume to lessen the risk for excessive early or late normal tissue toxicity;
  2. the target volume is in close proximity to ≥1 critical structure(s), and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s);
  3. a photon-based technique would increase the probability of clinically meaningful normal tissue toxicity by exceeding an integral dose-based metric associated with toxicity;
  4. and, finally, the same or an immediately adjacent area has been previously irradiated, and the dose distribution in the patient must be carefully modelled to avoid exceeding the cumulative tolerance dose to nearby normal tissues.

Based on the above medical necessity requirements and published clinical data, group 1, which is recommended coverage is listed as follows:

  • ocular tumors, including intraocular melanomas;
  • skull base tumors, primary or metastatic tumors of the spine, where spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated;
  • hepatocellular cancer;
  • pediatric tumors;
  • patients with genetic syndromes making total volume of radiation minimization crucial;
  • malignant and benign primary CNS tumors;
  • advanced and/or unresectable H&N cancers;
  • the paranasal sinuses and other accessory sinuses cancers;
  • non-metastatic retroperitoneal sarcomas;
  • and cases requiring re-irradiation.

Read the full study on Precision and Future Medicine 2019

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Advantage of proton-radiotherapy for pediatric patients and adolescents with Hodgkin’s disease

a Areas in which the VMAT / IMRT plans will deliver more dose to organs at risk or the body compartment. b Areas in which the proton plan delivers more dose to organs at risk or the body compartment compared to the VMAT / IMRT plant

“Proton therapy for mediastinal lymphoma reduces significantly the dose to organs at risk and the integral body dose. It might lead to reduced late toxicities and secondary malignancies. This is especially important for children and young adults. It should be considered for both sexes, as both male and female patients benefit from the unique features of particle irradiation. Whenever proton for mediastinal lymphoma is not available or technical not feasible the alternative photon concepts have to be chosen carefully. Depending on the used technique certain organs at risk, i.e. the breasts in young females, can be spared with higher priority. However, with all photon techniques that comes at the cost of higher doses to the other organs at risk. If available, proton therapy should be the standard pattern of care for mediastinal lymphoma for young adults below 30 years of age, no matter if male or female.”

S. Lautenschlaeger, G. Iancu, V. Flatten, K. Baumann, M. Thiemer, C. Dumke, K. Zink, H. Hauswald, D. Vordermark, C. Mauz-Körholz, R. Engenhart-Cabillic & F. Eberle
Radiation Oncology volume 14, Article number: 157 (2019) 

https://ro-journal.biomedcentral.com/articles/10.1186/s13014-019-1360-7

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Feroz AGAD, Founder, Chairman and Chief Executive of SAH Global and SAH Care, appointed to the Advisory Board of Neutron Therapeutics Inc.

Noah SMICK, COO of Neutron Therapeutics Inc., and Feroz AGAD, Chairman of SAH Global

August 9th, 2019 – Atlanta, Georgia U.S.A.

Feroz AGAD, Founder, Chairman and Chief Executive of SAH Global and SAH Care has been appointed to Neutron Therapeutics Inc. Board of Advisors.

Neutron Therapeutics Inc. (NTI) is a Medical Equipment Company founded in 2005 to bring Boron Neutron Capture Therapy (BNCT) out of the realm of medical research and transform it into a widely available first-line cancer therapy.

NTI has developed an accelerator-based, in-hospital neutron source composed of a 2.6 MeV electrostatic proton accelerator and a rotating, solid lithium target for generating neutrons. NTI will provide this neutron source as part of a comprehensive therapeutic treatment suite, that will combine all of the necessary components for BNCT treatment into a user-friendly package.

BNCT is a unique type of radiation therapy that enables targeting of cancer at the cellular level and treating cancer with a non-invasive two-step process. First, patients are injected with a tumor-seeking drug containing a non-radioactive isotope (boron-10) with a high neutron capture cross-section. In the second step, the patient is exposed to a beam of low energy neutrons, many of which are absorbed by the boron-10. The absorption initiates a reaction that emits short-range, high-energy charged particles. Which systematically destroy the tumor cells while imparting relatively little damage to adjacent areas of healthy tissue.

Feroz AGAD is an accomplished executive, investor and entrepreneur with over 15 years experience of managing multimillion-dollar corporations in industries including healthcare, real estate, communications, tourism and information technology. By capitalizing on his business acumen, technical expertise, interpersonal skills and strategic mindset, Mr. Agad has been instrumental in penetrating new markets and achieving significant sales growth for the companies he has previously founded and managed. Mr. Agad presently sits on the board of directors at four companies and sits on three advisory boards, a committee for a non-profit humanitarian organization and a committee on education.

He established SAH in 2004 with the vision of using the company as a catalyst to bring cutting edge Healthcare technology to the developing world. SAH Global is currently focused on establishing a global network of Proton Therapy Cancer Centers, while SAH Care is the medical treatment abroad division which currently brings cancer patients from around the world to SAH’s network of Cancer Centers for treatment in the USA.

In his overall reach in the fight against cancer, Feroz AGAD has particularly impacted the Industry of Proton Therapy and has demonstrated an exceptional spirit of Innovation to ensure patients from across the world have access to best treatment available. Feroz AGAD defines the future readiness of the Oncology organizations to not only meet the market demand, but to provide compassionate and comprehensive care to patients wherever they live.

With this appointment, NTI will use the experience of Feroz AGAD and of the SAH teams to develop its business, to get the regulatory approvals such as FDA and CE marks, and to conduct the necessary clinical studies to make BNCT available to more of the patients who could benefit from this exciting technique.

About SAH Global

Strategic Alliance Holdings Global, LLC (“SAH Global”), is a holding company founded in 2005 to establish highly specialized projects in areas such as healthcare. SAH Global has actively pioneered the effort to bring vital cancer treatment solutions to the Middle East. SAH Global believes in building a strong sustainable society, and as such, will leverage the success of its global ventures to make long-term contributions to the community, promote the growth of their employees, and help create a greener environment.

Read more on https://www.sahglobal.com

About SAH Care

SAH Care was established to ensure that patients from across the world can have access to the best treatments available. We work tirelessly with local physicians and a global network of leading healthcare providers to bring excellent quality cancer care to our patients. Our team, partners, and supporters share a commitment to improve the delivery of high-quality, patient-centric cancer care.
Through travel medicine, we have found a way to provide access to advanced cancer care for those who live in areas where proton therapy centers are yet to be built. We believe that patients deserve to receive the most advanced cancer treatment in the world today despite geographic boundaries and limitations. The SAH Care team provides this compassionate, comprehensive care to patients wherever they live.

Read more on https://www.sahcare.com

About NTI

Neutron Therapeutics is a Boston-area medical equipment company founded in 2015 by New Zealander, Bill Buckley. The mission of NTI is to provide innovative technology solutions that will enable BNCT to realize its maximum potential in the treatment of difficult cancers.

The Neutron Therapeutics neutron source is not approved for commercial or clinical use by the FDA or EMA or other regulatory body.

Read more on https://www.neutrontherapeutics.com

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You’re welcome !

Our Patients Coordinators are our heroes. And when we thank them for the tremendous work they perform every day for our patients, they simply answer “You’re welcome !”.

They answer any single request about Proton Therapy and take care of our patients and their families.

They collect the full set of medical records which we need to analyse the situation correctly and advise rightly.

They coordinate the best treatment plan with our medical teams worldwide.

They manage the day to day operations for all patients traveling abroad for treatment, including coordination of proton therapy and other ancillary treatments.

Upon request, they can provide assistance with transportation, accommodation, translation, or any other tiny service that helps our patients feel comfortable so they can concentrate on getting better.

Once the treatment abroad is completed, they make sure our patients travel safely back home, and they ensure the follow-up plan defined by the medical staff is provided by local physicians with the high level of quality care all patients deserve. 

We sincerely thank all our Patients Coordinators for treating each patient like family, and for placing them in our hands to get them safely to timely treatment.


“Once the decision is made for proton therapy, we usually send the patient to the overseas committee which will collaborate with SAH in the United States. The process is very, very simple, quick and easy. The patient, within one to two weeks of the decision making, will be sent abroad to the United States for the treatment. He or she will stay there and receive great care from the SAH team.
Every patient who returns from treatment praises the team at SAH Care. From their departure from Bahrain to their arrival in the States and throughout the course of their treatment, patients praise the team.
They talk about the good company they had, the good treatment they received, the perfect communication with the staff, the doctors, and the therapists – with everything. When we see patients who have fully recovered, cured from the cancer, we are more than excited. It’s a present for us. We don’t need anything else. The patient is happy.”

Dr Hanadi Malik, M.D., MSc.Radiation Oncologist, SMC, The Kingdom of Bahrain

You can read more patients stories and physicians’ testimonials on SAHcare.com


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The complexity of designing, developing and operating a Proton Therapy cancer center.

This TV production by BBC highlights the complexity of designing, developing and operating a Proton Therapy cancer center.

Proton beam therapy is the one of the most technologically advanced though expensive cancer treatments in the world – but it has the potential to save the lives of children with otherwise incurable cancers.

Over two years, Horizon follows the engineers, scientists and medics as they race to build two new centres.

At the cutting edge of particle physics, proton beam therapy involves splitting hydrogen atoms to create a beam of protons travelling at two-thirds the speed of light, which target tumours with millimetre precision. But doing this in the heart of two of our biggest cities is no easy feat. The process generates so much radiation it needs to be housed in a maze-like nuclear bunker, with walls four metres thick. 2,000 tonnes of precision instruments are installed – more than four jumbo jets worth – and it all has to work perfectly.

This special BBC Two programme goes behind the scenes on the £250 million cancer cure – from digging the big and wide hole to the treatment of the first patients.

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Proton therapy has the potential to reduce cardiac toxicities compared to photon therapy

Photon vs proton therapy for reduction of cardiac toxicities in locally advanced lung cancer

S. Teoh,F. Fiorini,B. George,K.A. Vallis,F. Van den Heuvel https://www.sciencedirect.com/science/article/pii/S0167814019323515

Proton therapy has the potential to reduce cardiac toxicities compared to photon therapy. This analysis suggests that patients with tumour extension to and below T7 vertebrae would benefit most from proton therapy over photon therapy. The absolute benefit is higher in patients with underlying cardiac disease.

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Proton therapy significantly decreased the dose to critical structures (heart, lungs, esophagus, thyroid, and non-target body), specifically in patients with mediastinal lymphomas.

Everett AS, Hoppe BS, Louis D, McDonald AM, Morris CM, Mendenhall NP, Li Z, Flampouri S,

Comparison of Techniques for Involved-Site Radiation Therapy in Patients with Lower Mediastinal Lymphoma, Practical Radiation Oncology (2019), doi: https://doi.org/10.1016/ j.prro.2019.05.009.

In this study, various radiation techniques and doses to Organs At Risk (OARs) are compared to determine the optimal treatment technique in patients with lower mediastinal lymphoma involvement.

In patients with lower mediastinal lymphoma, radiation delivery is particularly challenging because of the proximity of the target to critical structures, such as the heart and its substructures, lungs, breast, and esophagus. Therefore, PT has been increasingly used in patients with mediastinal lymphoma given its ability to improve dose conformity and decrease radiation to normal tissues while providing equivalent target coverage

Patients with lower mediastinal lymphoma (LML) benefit dosimetrically from proton therapy (PT) compared with intensity-modulated radiotherapy (IMRT). The added dosimetric benefit of deep-inspiration breath-hold (DIBH) is unknown; therefore, we evaluated IMRT versus PT and free-breathing (FB) versus DIBH among patients with LML.

Proton therapy significantly decreased the dose to critical structures (heart, lungs, esophagus, thyroid, and non-target body), specifically in patients with mediastinal lymphomas. Therefore, when PT is available and the patient has lower mediastinal involvement, PT should be considered to maximally reduce the dose to nearby normal structures and decrease the risk of late toxicity associated with LM lymphoma radiation treatment.

CONCLUSION
Among patients with lower mediastinal lymphoma involvement, PT significantly reduces radiation to the lung, heart, esophagus, thyroid, and non-target body compared with IMRT.

PT can provide a significant benefit over IMRT techniques and should be considered in patients with lower mediastinal lymphoma involvement.

Figure 2. Colorwash dose distribution for a representative patient showing (A) free-breathing intensity-modulated radiation therapy, (B) free-breathing proton therapy, (C) deep inspiration breath-hold intensity-modulated radiation therapy, and (D) deep-inspiration breath-hold proton therapy. Image borrowed with permission from Hoppe BS, Mendenhall NP, Louis D, et al. Comparing Breath Hold and Free Breathing during Intensity-Modulated Radiation Therapy and Proton Therapy in Patients with Mediastinal Hodgkin Lymphoma. International Journal of Particle Therapy. 2017;3(4):492-496. 10.14338/ijpt-17-000
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Proton therapy for cancer lowers risk of side effects

by Julia Evangelou Strait, Washington University School of Medicine

Proton therapy results in fewer side effects than traditional X-ray radiation therapy for many cancer patients, according to a new study led by Washington University School of Medicine in St. Louis and the Perelman School of Medicine at University of Pennsylvania. Even with reduced side effects, proton therapy resulted in cure rates similar to those of X-ray radiation therapy.

Proton therapy for cancer lowers risk of side effects
A new study led by Brian Baumann, M.D., of Washington University School of Medicine in St. Louis, found that proton therapy (bottom) is associated with fewer severe side effects than conventional X-ray radiation therapy (top) for many cancer patients. Credit: Brian Baumann/Mike Worful

The study is the first major side-by-side comparison of side effects related to proton therapy and X-ray radiation therapy. It included almost 1,500 patients receiving combined chemotherapy and radiation therapy for lung, brain, head and neck, gastrointestinal and gynecologic cancers that had not yet spread to other parts of the body. Such patients receive both radiation and chemotherapy, a treatment regimen that often cures nonmetastatic cancer. But it also causes severe side effects—such as difficulty swallowing, nausea and diarrhea—that reduce quality of life and can, in some cases, require hospitalization.

After controlling for differences between the groups, such as age and additional medical problems, the researchers found that patients receiving proton therapy experienced a two-thirds reduction in the relative risk of severe side effects within 90 days of treatment, compared with patients receiving X-ray radiation therapy. Forty-five of 391 patients receiving proton therapy experienced a severe side effect in the 90-day time frame (11.5 percent). In the X-ray radiation therapy group, 301 of 1,092 patients experienced a severe side effect in the same period (27.6 percent). Patient data on side effects were gathered as the trial was ongoing, rather than after the fact.

“Proton therapy was associated with a substantial reduction in the rates of severe acute side effects—those that cause unplanned hospitalizations or trips to the emergency room—compared with conventional photon, or X-ray, radiation for patients treated with concurrent radiation and chemotherapy,” said Baumann, an assistant professor of radiation oncology at Washington University and an adjunct assistant professor of radiation oncology at Penn. “The opportunity to reduce the risk of severe side effects for patients and thereby improve their quality of life is very exciting to me. While there have been other studies suggesting that proton therapy may have fewer side effects, we were somewhat surprised by the large magnitude of the benefit.”

The researchers focused their study on what are called grade 3 adverse events, which are severe enough to require hospitalization. These can include pain, difficulty swallowing that might result in weight loss, difficulty breathing, and nausea and diarrhea severe enough to cause dehydration.

The researchers also found no differences between the two groups in survival, suggesting that proton therapy was just as effective in treating the cancer even as it caused fewer side effects. Overall survival at one year for the proton therapy group was 83 percent of patients versus 81 percent for the X-ray radiation therapy group. This difference was not statistically significant.

This study is the first large review of data across several cancer types to show a reduced side-effect profile for proton therapy compared with X-ray radiation therapy for patients receiving combined chemotherapy and radiation. Both types of radiation therapy are approved by the Food and Drug Administration for cancer treatment. Protons are relatively heavy, positively charged particles that hit their target and stop. X-ray beams consist of photons, which are much smaller particles that have almost no mass, allowing them to travel all the way through the body, passing through healthy tissue on the way out.

https://medicalxpress.com/news/2019-05-proton-therapy-cancer-lowers-side.html

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Montefiore Study May Help Establish Patient Criteria for Proton Therapy

N. Patrik Brodin, PhD

Data supporting the efficacy of proton therapy are robust for pediatric cancers, brain and base-of-skull tumors, and complex-shaped tumors near critical structures (…)

Proton therapy has emerged as an attractive option for patients with head and neck cancer. This is due to proton therapy beam technology, which precisely destroys cancers with an unmatched ability to stop at precise locations within the body.

Protons also have significantly fewer adverse effects (AEs) and toxicities than most other cancer therapies, because of the protons’ unique ability to sculpt radiation doses according to the shapes and sizes of tumors. This is particularly important for head and neck cancers, which frequently are close to or impeding on vocal cords, air passageways, swallowing muscles, salivary glands, and the oral mucosa. The opportunity to preserve healthy tissue is considerable.

AEs estimated to be significantly less prominent include swallowing difficulties, inflammation of the esophagus, and reduced saliva production. For people suffering from head and neck cancer and their families, the ability to avoid these types of complications makes an overwhelmingly important difference in QoL.

Younger patients, non-smokers, and patients with HPV p16- positive tumors will most likely benefit from proton therapy (…)

The highest expense in cancer therapy involves the regrowth of cancer—large sums are required to prolong survival and maintain QoL. By increasing cure rates and improving patients’ QoL, we can increase cost-effectiveness.

It is important for healthcare providers not only to educate our patients and their families about each treatment’s ability to destroy cancers, but also to manage expectations about different treatments and what life may look like “post cancer.”

Proton therapy is one of the most modern therapies available, and its ability to minimize AEs such as trouble swallowing, reduced ability to eat, dental problems, and difficulty digesting food can’t be understated for some of our patients (…) By increasing cure rates and improving patients’ Quality of Life, we can increase cost-effectiveness.

https://www.onclive.com/publications/oncology-live/2019/vol-20-no-11/montefiore-study-may-help-establish-patient-criteria-for-proton-therapy

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