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Proton Therapy Treatment & Research Amid COVID-19

Simone, Charles B. II MD

doi: 10.1097/01.COT.0000724652.36050.46
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Proton Therapy Treatment
Proton Therapy Treatment:
Proton Therapy Treatment

The COVID-19 pandemic has not only derailed diagnoses for millions of cancer patients worldwide, but it has potentially slowed the progress of paradigm-changing innovations in care that could improve the lives of future generations. Beyond the immediate concern that nearly 80 percent of patients in the United States have experienced delays in care, which could unfortunately result in thousands of excess cancer deaths, the long-term consequences of disruption to clinical trials and research could prove to be equally destructive and result in a chronic holding pattern for our pursuit of better health outcomes for oncology patients.

Yet as providers, we must strive to advance our work even amid such challenging conditions, and there is reason for hope that the impediments to care can and are going to be overcome, allowing stalled innovations the prospect of advancement.

Adapting to the New Normal

Running a state-of-the-art proton therapy radiation facility during and after the peak of the COVID-19 crisis in New York City has been among the most meaningful experiences of my life. Like every health care institution, the pandemic has forced us to be nimble in adapting to unprecedented challenges. With the implementation of rigid safety protocols and adaptations for our patients and staff, our team at the New York Proton Center (NYPC) has successfully maintained continuous treatment throughout the pandemic.

To ensure that success, we have instituted many safety precautions, including daily screenings of every staff member, patient, and visitor to the center; strict enforcement of mask wearing, social distancing, and hand sanitizing; limiting visitors; and frequent alcohol-based cleanings of all treatment and public areas throughout the building.

Our team has ramped up a strong telehealth platform, and we currently operate over half of our care through video encounters to mitigate risk of in-person virus transmission. The rise of telemedicine will likely become one of the defining influences of the pandemic on health care around the world. Given concerns about public transit during the first months of the pandemic, we also partnered with ride-share company Lyft to ensure patients had every resource necessary for their safe travel to and from their proton treatments.

Today, we continue to adhere to the same level of vigilance to create a safe treatment space as we instituted in the first days and weeks of the pandemic. All providers currently face a challenge of easing patient safety concerns to ensure that they pursue appropriate medical care. This is especially true of cancer providers, as our patients are among the most susceptible to the virus due to compromised immune systems. The health of our patients is always top priority, and it remains our plan to keep every safeguard possible in place until the risk of transmission recedes.

Benefits of Proton Therapy

FDA-approved since 1988, proton therapy has emerged as by far the most promising advancement in radiation oncology for patients with a wide range of cancers.

Compared to traditional (photon) radiation, proton therapy enables more precise targeting of cancers, which results in fewer side effects and improved health outcomes. It has proven highly effective in treating difficult-to-target cancers such as pediatric, head and neck, brain, thoracic, gastrointestinal, and breast tumors. It is also an especially viable option for larger or complex cases, as well as for patients who have received previous radiotherapy and have a new option of cure only with proton therapy.

Over the past 3 decades, 35 proton therapy centers—most of which are affiliated with world-class institutions and National Cancer Institute-designated comprehensive cancer centers—have opened across the United States. There has been a corresponding increase in the body of clinical evidence exemplifying proton therapy's value as a more effective or safe modality for a variety of malignancies and presentations.

Proton therapy has been demonstrated to have fewer side effects across numerous cancers compared to photon therapy, reducing costly side effects and hospitalizations during treatment. It has also been shown to lead to fewer secondary radiation-induced cancers and better preserve quality of life across several cancers compared with photon therapy. Cancer survivors are living longer due to effective treatments developed in the last few years, and it is more important than ever to preserve quality of life for long-term survivors.

Robust data have emerged over the past decade demonstrating the superiority of proton therapy across numerous individual disease sites. Compared with traditional photon therapy, proton therapy can:

  • improve overall survival and reduce high-grade complications for head and neck cancers;
  • improve tumor control and survival for base of skull cancers and chordomas;
  • reduce side effects for brain tumors;
  • improve survival for both locally advanced and early-stage lung cancer;
  • improve survival and reduce high-grade complications and costly hospitalizations for esophageal cancer,
  • improve survival and reduce complications for hepatocellular carcinoma,
  • reduce side effects for pancreatic and gastrointestinal tumors,
  • lead to excellent long-term outcomes with fewer long-term side effects for prostate cancer;
  • reduce acute and chronic lifelong side effects for pediatric cancers; and
  • expand curative options for patients with recurrent tumors.

Proving Demand

Patient volume is gradually increasing across many proton centers, especially in regions where transmission rates have remained low. At NYPC, following significant declines in patient volumes in April through June when patients were less comfortable receiving even necessary medical care and when cancer screening and biopsies were regularly being deferred in New York City, we began having an increase in patient volume by July. Today, we are treating approximately 90 patients per day, and as of October we have passed our pre-COVID patient volume.

For a proton therapy facility to achieve that volume during a pandemic is highly unprecedented, especially one that is located in the city that has been the epicenter of the pandemic and one that is just 1 year into operation. In fact, our pre-pandemic patient volume made NYPC the fastest growing proton center in the country; we were treating 70 patients daily just 5 months after opening, less than half the time our peer facilities took to achieve that patient number.

Now that we have regained that momentum, we are better positioned than ever to offer care to many difficult-to-treat tumors—even amid a treatment environment that makes pursuing care a more difficult negotiation than ever for cancer patients.

Proving demand is critical at a time when COVID-19 threatens to stall the progress of innovations in cancer radiation therapy. As one of the most advanced proton centers in the country, with the partnership of three highly regarded institutions—Memorial Sloan Kettering Cancer Center, Montefiore Health System, and Mount Sinai Health System—we are uniquely positioned to do so.

Resumption of Research & Clinical Trials

There is a large and growing body of clinical evidence testifying to the ability of proton therapy to significantly improve health outcomes and quality of life for patients living with a wide range of cancers. Despite this fact, however, health insurance coverage for proton therapy remains limited for many patients who could benefit greatly from its precision.

When we opened the NYPC in 2019, our goal was twofold: 1) provide unsurpassed patient care, and 2) create the most comprehensive research program of any proton center in the United States—with the fundamental goal of working to identify which patients stand to benefit most from proton therapy.

Our success in treating approximately 700 patients to date offers strong evidence of the need for proton therapy and its ability to improve outcomes for patients—in particular those with highly complex cases, including recurrent cancers and advanced tumors from a variety of cancer sites.

Now, the challenge is codifying the demand we see and the outcomes we know proton therapy delivers in the framework of robust clinical data. In the past, detractors of proton radiation have cited lack of high-impact, comprehensive studies proving its efficacy in comparison to traditional radiation. The studies being performed at the NYPC and other proton facilities will help the proton field make significant inroads in determining which patients benefit most from this advanced technology.

There is no question the pandemic has created new difficulties in enrolling patients on clinical trials; yet, it has also forced us to reconsider some of the bureaucratic red tape underlying status quo processes that do not serve medical innovation, which has been a positive reckoning process that hopefully allows us to streamline research in a post-COVID world.

Many large, multicenter trials—the kind that produce the strongest data needed to meaningfully change the conversation around broader application of proton therapy—have resumed this fall.

This month, we launch a nationwide federally funded clinical trial comparing the effectiveness of proton therapy versus photon therapy for breast cancer. This first-of-its-kind comparative analysis has the potential to steer payers and providers toward broader coverage of proton therapy, reshaping the treatment paradigm for future generations of breast cancer patients. This trial complements the existing high-quality, innovative clinical trials already open at NYPC for patients with lung cancer, head and neck cancers, prostate cancer, and pediatric cancers.

Trials in numerous additional disease sites, as well as for cancers that have recurrences following conventional radiation, will also soon be opened at NYPC.

Treatment for cancer and other life-threatening conditions must remain a priority despite the admittedly great hardships imposed by COVID-19. Similarly, research and developments that have the potential to advance the field and improve the care paradigm for future generations of oncology patients need to again take priority. It is encouraging to know there are so many in our field who are dedicated to these ideas, and I am proud to count myself among them.

CHARLES SIMONE, II, MD, is the Chief Medical Officer of the New York Proton Center and an internationally recognized expert in the use of proton therapy.

Charles Simone, II, MD
Charles Simone, II, MD:
Charles Simone, II, MD

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