Appropriate Use of Advanced Technologies for Radiation Therapy and Surgery in Oncology Workshop Summary (2016) / Chapter Skim
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Workshop Summary
Workshop Summary
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, stereotactic, and proton beam radiation therapy, as well as laparoscopy and robotic surgery, can enhance clinicians' ability to treat conditions that were clinically challenging with conventional technologies, and may improve clinical outcomes or reduce treatment-related problems for some patients. Both patients and physicians seek access to these new technologies, which are rapidly being adopted into standard clinical practice.
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discussed topics related to radiation therapy and surgery for cancer, including • clinical benefits and comparative effectiveness of emerging advanced technologies for cancer treatment in radiation therapy and surgery, as well as research gaps that are challenging to close; • factors driving the diffusion of new technologies into oncology practice; • oversight, training, credentialing, and reimbursement for use of innovative technologies; • evidence on the overuse, underuse, or misuse of novel technologies; and • potential strategies to assess the value and promote optimal use of new technologies in cancer treatment. This report is a summary of the presentations and discussions at the workshop.
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• Reduce reliance on randomized controlled trials as the gold standard for evidence development to assess new technologies and use novel study methods to assess comparative effective ness. (Beyer, Dignam, Kessler, Mohler, Steinberg, Tunis)
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• Include cost-effectiveness assessments as secondary objectives in clinical trials. (Efstathiou)
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With head and neck cancer, IMRT reduces the radiation dose to the parotid gland and structures essential for swallowing, while in the brain it reduces the dose to the optic nerve and pituitary structures. In prostate cancer, IMRT reduces the dose of radiation to the rectum, while in gynecological cancers, it reduces the dose to the small bowel and bone marrow, said Steve Chmura, Associate Professor of Radiation and Cellular Oncology at the University of Chicago.
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Traditional X-rays weaken in intensity as they pass through the body; as a result, more radiation is deposited in the normal tissue above the tumor than in the tumor. Radiation is also deposited beyond the tumor site where the beam exits the body, explained Anthony Zietman, Shipley Professor of Radiation Oncology at M assachusetts General Hospital.
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"There is pretty much unanimity among the radiation oncology community globally that it is appropriate to treat children with proton beam therapy," he added. Whether PBRT improves outcomes in children has not been assessed with randomized controlled trials (RCTs)
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Because of PSA (prostate-specific antigen) testing that can identify low-risk prostate cancers that previously were not detected, "there is this huge uptick in men seeking proton beam radiation for their prostate cancer treatment ahead of the evidence," he said.
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Several studies found no difference in the 5-year disease-free survival and overall survival in patients who had laparoscopic surgery versus open surgery, relieving suspicions that the technique could worsen cancer spread (Fleshman et al., 2007; Nelson et al., 2004)
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However, studies have not yet demonstrated that the robotic procedure is superior to laparoscopic surgery, according to Whelan, and for gynecology surgeries, the complication rate is higher for robotic operations. "Unless the clinical results show robotic surgery to be superior in a meaningful way, it is going to be hard to justify the outlay of the high purchase price of the robot and the growth of this.
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He added that a primary advantage for robotics in gynecologic surgery is that they enable surgeons to do more technically challenging cases with a minimally invasive approach. Robotics started to diffuse into gynecologic cancer care around 2009, he said, although there are minimal data on robotic surgery outcomes.
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The bulk of the evidence regarding the comparative effectiveness of new radiation therapies and surgical technologies is derived from observational studies, as opposed to the gold standard of RCTs. Many findings are mixed or insufficient to justify the widespread use these innovative therapies have already had in the clinic, several speakers reported.
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. Jason Efstathiou, director of the Genitourinary Division in the Department of Radiation Oncology at Massachusetts General Hospital, also cited a British study that found that compared to conventional 2D radiation therapy, 3D conformal radiation therapy significantly reduced the incidence of proctitis in prostate cancer patients (Dearnaley et al., 1999)
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. A few studies using databases found PBRT was not more effective at treating prostate cancer than conventional therapies, as was expected (Coen et al., 2012; Sheets et al., 2012)
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. Robotic Surgery Considering the skill of the operator and the type of robotic device used is important when assessing the comparative effectiveness of a robotic surgical procedure, said James Hu, director of the LeFrak Center for
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With regard to prostatectomies, studies have not consistently shown a benefit of robotic surgery in terms of functional outcomes, such as urinary control and sexual function, nor is there evidence that it affects prostate cancer outcomes, according to Miller. Hu reported that his study using Medicare claims found that robotic surgery was associated with more diagnoses of erectile dysfunction and incontinence compared to open surgery (Hu et al., 2009)
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One trial done at Memorial Sloan K ettering Cancer Center randomized patients to have their bladders removed robotically or in an open surgery. This study found that patients had lower blood loss, but longer operating room time, with robotic surgery, and there was no difference in the length of hospital stay or rates of complications (Bochner et al., 2014)
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Hu responded that a study of robotic versus open surgery done by Sanda found that robotic surgery decreased the intersurgeon variation in results related to blood loss, length of stay, and operative time. He agreed, however, that with regard to sexual functioning and other quality of life variables, "one could question what does a 10 percent difference really mean in terms of functional status recovery." Hu pointed out that "there is still a need to define these benefits, although I think it will be difficult to turn back the clock on this no matter what." But Whelan countered, "The fact that the horse is out of the barn [for using robotic surgery]
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. James Dignam, associate professor of biostatistics at the University of Chicago, agreed and said that not only does the FDA require a lower level of evidence for devices versus drugs, but that "formal regulatory control is absent in surgery." Wright said this lack of regulation fostered the rapid adoption of robotic surgery.
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Also, unlike for drug clinical trials, in which there are fewer differences in how clinicians deliver the intervention being studied, studies on new surgical techniques are difficult to conduct reliably because of differences in surgical technique and expertise among participating clinicians, Hu asserted.
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Nobody legally has the authority to regulate procedures, and it's a gap that Congress should talk about filling." In the past, Congress has avoided regulating procedures because they are seen as falling under the practice of medicine, which government agencies cannot regulate, he said. Kessler also stressed that the general indications given for devices, such as for robotic surgery systems, enable them to enter the market without having to generate evidence to support more specific claims, such as the notion that they can lower the complication rate from prostatectomies, that are later made by those that produce or use the devices.
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The NRORb pilot in non-metastatic prostate cancer was a collab orative quality improvement initiative of the Radiation Oncology Institute (ROI) and the American Society for Radiation Oncology (ASTRO)
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. RAPID WIDESPREAD ADOPTION OF NEW TECHNOLOGIES Several speakers noted the rapid widespread adoption of new technologies in cancer care, which can be premature given the lack of evidence.
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According to Tina Shih from the MD Anderson Cancer Center, in 1999, there were only 2 robotic surgery machines in the United States, but by 2015 that number had risen to more than 2,200. Robotic surgery is now used for urological, gynecological, colorectal, endocrine, thoracic, and head and neck cancers, Miller reported (see Table 1)
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. Miller suggested that some use of robotic surgery as well as other technologies in this country may not be appropriate.
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is also used to treat prostate cancer. Ron Kline from the Centers for Medicare & Medicaid Services, said that few added benefits of PBRT have been definitively demon strated for prostate cancer in the 10 years it has been in use, and the treatment is three to five times the cost of conventional radiation therapy, so "it's hard to argue proton beam therapy for prostate cancer." Zietman agreed, noting that fewer prostate cancer patients are now being treated with PBRT.
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. Another study found that an increasing number of low-risk and elderly patients who are unlikely to die from prostate cancer are being treated with robotic prostatectomy and IMRT (Jacobs et al., 2013)
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SOURCE: Efstathiou presentation, July 21, 2015. professor of radiation oncology at the University of Michigan, described an innovative treatment for early-stage breast cancer, known as accelerated partial-breast irradiation (APBI)
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5.7 3.0 −2.7 <.001 1.0 1.5 0.5 0.30 Time from diagnosis to treatment (days) 80.0±35.9 71.2±31.1 −8.8 <.001 84.4±38.9 82.0±36.7 −2.4 0.39 NOTES: ADT = androgen deprivation therapy; AS = active surveillance; Brachy = brachytherapy; IMRT = intensity-modulated radiation therapy; NCCN = National Comprehensive Cancer Network; Rad Px = radical prostatectomy.
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Evidence that financial incentives influence which breast cancer treatments are prescribed is suggested by studies that found hypofractionated whole-breast radiation therapy was more quickly adopted in Canada, which has a universal health care system, than in the United States, Jagsi said (Ashworth et al., 2013; Bekelman et al., 2014)
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However, subsequent studies did raise concerns. For example, one study found that women with uterine leiomyosarcoma have a three-fold increase in the rate of death when undergoing power morcellation compared to those who had a hysterectomy without the morcellation procedure (Park et al., 2011)
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The cost of adopting IMRT was not excessive compared to the revenue that could be generated from it, and competition among radiation oncology providers is so great that many sought out the competitive advantage IMRT initially gave them. In addition, the skill set and team knowledge needed for IMRT are relatively accessible for most radiation oncology teams, and many viewed the technology as providing better clinical outcomes based on the evidence available at the time.
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Many residents are not trained in laparoscopic surgery, Wright noted, so "Until there is change in reimbursement policy, you'll continue to see uptake of robotic surgery." Yu and others also noted that overenthusiasm for new technologies can prompt widespread adoption that is premature. "How do we distinguish between when we're blinded by earnest enthusiasm or when we're advocating for a transformative technology?
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Similar conclusions were reached in a study by Williams in which he found a significantly increased use of IMRT to treat prostate cancer patients in integrated self-referring practices compared to nonintegrated practices, not only for high-risk patients, but also for favorable-risk patients, for whom practice guidelines recommend active surveillance rather than radiation therapy. Williams concluded, "There is a need for health policy reform to guide appropriate utilization so that we can optimize the treatment and care of our patients." Patricia Ganz, director of cancer prevention and control research at the University of California, Los Angeles (UCLA)
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It's a great idea where it can happen, but it's hard to throw that out into the world at large." Financial incentives can also foster the use of an expensive new technology, such as PBRT, for patients who may not benefit from it (e.g., patients with low-risk prostate cancers) to help pay for the cost of making the technology available for the rare pediatric cancer patients who are likely to benefit, said Peter Johnstone, radiation oncology clinical director at the Moffitt Cancer Center (see Box 5)
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Consequently, most PBRT facilities are built with the additional aim of treating simpler cases, most notably prostate cancer cases. "Kids are the people that need this the most and for whom it's best prescribed, but you lose money on kids," Johnstone said.
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But studies show CON laws have had little influence on the dissemination of robotic surgery for prostate cancer or the use of intensity-modulated radiotherapy in elderly patients with early cancers, Johnstone reported (Falchook and Chen, 2015; Jacobs et al., 2012)
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Beyer described a study which found that 45 percent of online promotions for robotic surgery were on hospital websites. There is a lot of such direct-to-consumer advertising as well as direct-to-provider marketing, Efstathiou noted.
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For example, the cost of treating prostate cancer with 3D conformational radiotherapy in 2005 was about $20,000 per patient, whereas the cost of IMRT was about $10,000 more than that, and the cost of PBRT was an additional $14,000 more, Yu reported (James et al., 2012; Nguyen et al., 2011)
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Robotic systems cost about $2 million, Whelan reported, plus there are yearly maintenance costs of about $150,000 per robot, and additional costs for the specialized tools needed for the robot. Miller noted that the disposable equipment alone for robotic surgery can cost $1,500 to $2,000 per patient.
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These costs include long functional recovery times, including delays in returning to work, and long-term complications of therapy or late disease recurrence, as can be seen in the second and third tiers of the diagram of costs of treatments for head and neck cancers in Figure 7 (de Souza and eiwert, 2013)
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activities Time to return-to-work Tier 2 Mucositis Radiation dermatitis Neutropenic fever G-tube placement Disutility of treatment Financial Toxicity Speech dysfunction process Treatment interruption due to toxicities Pain Acneiform rash Hearing loss Sustainability of health Event-free survival / Disease-free survival Tier 3 Xerostoma Hypothyroidism Long-term consequences of Secondary Cancers G-tube dependency therapy Pain Tracheostomy FIGURE 7 Dimensions of value in head and neck cancer treatment. SOURCE: Steinberg presentation, July 21, 2015.
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He added that payment systems should recognize and support the need for evidence development. Yu also noted, "The question is not simply whether a technology is efficacious, but could the money spent on it be used for other purposes as well." Steinberg also described the California Technology Assessment Forum's procedure for determining the value of new technologies, which have influenced payer coverage decisions (see Box 7)
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Precedents in other coverage decisions are also factored in, but as Jensen emphasized, "Any decision we make is always based on the evidence and that's how we defend it." For treatments that seem promising but for which there is not yet sufficient evidence for a definitive coverage decision, CMS can use "coverage with evidence development" (CED)
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But he noted that if precise criteria were used, there would probably be fewer positive coverage determinations because of the need to meet some statistical test "or hard and fast criteria rather than us using our judgment," he said. "Some things are easy to see as offering substantial clinical improvement and others are not." Tina Shih of the MD Anderson Cancer Center asked Hartstein why Medicare reimburses intensity-modulated radiotherapy (IMRT)
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Dignam said that the common notion that new technologies are better than old ones, compounded by easy access to these technologies, results in frequent failures of clinical trials due to lack of accrual. He gave the example of a trial of SBRT versus surgery for lung cancer, in which not enough patients were willing to be randomized to receive one or the other treatment, perceiving SBRT as a much better alternative.
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For example, Dignam wanted to compare the outcomes for PBRT versus standard radiation therapy for the brain cancer glioblastoma. But not all cancer centers have PBRT, and
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She suggested creating a platform for these data that is interconnected, while carefully ensuring privacy of the individual patients contributing to these data. Smith noted recent open-access data efforts in which patients participating in clinical trials volunteer to have their data stored in a centralized database and then disseminated to other researchers wishing to conduct additional studies beyond the clinical trial in which the patients originally participated.
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"There's no way to get prostate cancer mortality data quickly from randomized trials," Kessler said. "We need to gather that long-term data by pushing coverage with evidence development at the national and state level," as well as having private insurers cover new technologies while ensuring data are gathered on long-term outcomes akin to the Massachusetts Blue Cross/Blue Shield effort, which is described further in Box 8.
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He added that registries may be more comprehensive because they often include data that are not collected in clinical trials. He suggested that if high-quality statistical analyses are
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He added that the council of radiation oncologists convened by Blue Cross/Blue Shield in Massachusetts continues to meet to update their IMRT guidelines and to discuss creating guidelines for other advanced technologies, such as stereotactic radiation techniques and proton beam radiation therapy (PBRT)
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Evolving Technology and Expertise Evolving expertise regarding new technologies as well as evolution in the technologies themselves that make them a moving target also hamper retrospective data-mining studies of comparative effectiveness, several participants said. These changes over time can also affect the reliability of clinical trial results.
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Others noted the difficulty in conducting double-blind studies of surgical procedures. "In surgery it's very hard to have a double-blind study because you know what is being applied," said John Gardenier, who is retired from the Centers for Disease Control and Prevention, adding "you cannot have a placebo effect by not treating patients." In addition, surgeons may be reluctant to test the effectiveness of new techniques that many view as adaptations of current procedures.
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. STUDY DESIGNS A portion of the workshop was devoted to discussion of the advantages and limitations of data-mining and observational studies versus RCTs, as well as ways to design studies that can more easily and reliably assess the effectiveness or comparative effectiveness of new technologies.
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Yu noted that previous IOM reports recommended that clinical investigators use other methods in addition to RCTs for evidence generation because of the high costs of clinical trials and the rapidly changing nature of technology, though appropriate judgment is needed to assess the loss of information against the gains in technical and economic feasibility (IOM, 1979, 2013)
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The results seen had nothing to do with the actual therapy that was delivered," Carlson stressed. "There are important clues and information we can get from nonrandomized, high-quality registry data, but we have to be very cautious that we don't get fundamentally misled and follow a pathway that has nothing to do with the effectiveness of treatment, but everything to do with the biases of physicians." Mohler responded by pointing out that "we are overly obsessed with randomized clinical trials." He noted that often such trials for advanced prostate cancer show that new agents extend survival between 2.4 and 5 months.
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Dignam suggested taking an observational-randomized controlled clinical trial approach in which a trial is embedded within a registry that captures all the data needed. This would be more expensive to do than typical clinical trials, but worth doing, he said.
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With such a trial, researchers may be able to collect valuable outcomes data that are similar to those collected in a standard RCT, he said. Kessler added that investigators are increasingly using stepped-wedge studies in comparative effectiveness research.
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Efstathiou noted that in his study of prostate cancer treatment, he is collecting information on patients who do not accept randomization for treatment and those who volunteer to enroll in the study, but then withdraw for lack of insurance coverage of the treatment under investigation. Clinically Meaningful Studies There was some discussion about how studies should be designed to ensure that the results are not only reliable but also applicable to the clinical populations who will ultimately be treated with the intervention studied.
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Ron Kline, Medical Officer for the Patient Care Models Group at the CMS Center for Medicare & Medicaid Innovation, said that a five-fold variation in the complication rate of prostatectomies has been noted even at a large and well-respected, high-volume institution, so "If you just simply monitor the surgeons and improve their quality, you would have a much greater effect on health care in prostatectomy in the United States than anything a robot has been able to achieve." Miller agreed, saying, "Ultimately it is the surgeons who are doing the operations and not the robots." Hu also noted that injuries and death that occur during robotic surgery are largely due to the inexperience of the surgeons that use the robots. Concerns have also been raised about whether surgeons who have been trained primarily using robotic technology have the skills to convert to open surgical procedures should the need arise due to complications encountered during surgery.
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Most specialties have a set of core privileges usually acquired during residency as well as advanced privileges, the latter being surgical procedures done so infrequently that training in residency is insufficient and candidates need additional oversight before they can perform these procedures on their own. The Joint Commission recommends a focused practice performance evaluation that is applied to new staff members during their first 6 months and ideally requires another physician closely overseeing their care.
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He also stressed that there is a difference in being able to confidently perform an operation versus being proficient and mastering the technique. He said many surgical procedures have long learning curves, and a growing body of data show that skills for surgical procedures continue to improve until surgeons reach their 50s, after which they start to decline.
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Ashley concurred and noted that there is an increasing number of institutions developing skill centers and making large investments in training programs. He noted that Methodist Hospital is trying to position itself as "the place surgeons come from all over Texas to get credentialed, r ecredentialed, work in a skills lab, or get proctored to do robotic surgery," and the American College of Surgeons is currently accrediting such education institutes.
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This led to an increased complication rate initially for certain laparoscopic surgeries. Currently there are no standards for what is considered "new" in surgery and there is no national review process for new procedures, Ashley reported.
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"We realize that no one is wise enough to do robotic surgery alone. It's a team enterprise and we always test drive in the porcine lab anything that's new, whether that's a procedure, surgeon, or assistant." He mentioned that he had not done a robotic surgery in 3 weeks, and plans to use the simulation lab "to warm up and make sure that I can do justice to the person sitting in front of me," he said.
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Miller noted a study by Hu which found that video review of surgical residents' robotic prostatectomy procedures combined with performance feedback from peers on a social media site was linked to residents feeling more comfortable with robotic surgery and more satisfied with the learning experience (Carter et al., 2015)
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. Ashley noted that at Brigham and Women's Hospital, privileges for gynecologic robotic surgery require the surgeon to take a validated skills course, show proof of robotic proficiency, and then undergo a preceptorship with an expert robotic surgery proctor for a minimum of three cases.
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PAYMENT MODELS Several speakers described payment models and related approaches that could encourage evidence gathering on new treatments, and help to ensure they are being applied appropriately. Topics discussed included • coverage with evidence development; • accountable care organizations; • new pricing schemes and price transparency; and • delivery system innovation.
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Bekelman also noted the numerous challenges in determining how to price treatments in a bundled care payment system for radiation therapies, given the multimodality field of radiation oncology and the fact that radiation oncologists are not responsible for much of the care that cancer patients 12 See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ACO/index. html (accessed October 15, 2015)
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Patient advocate Gwen Darien, executive vice president of programs and services at the Cancer Support Community, noted that although some cancer patients may opt not to pursue a very expensive treatment if they thought the costs were so much greater than the potential benefits, others will want to do anything possible to treat their cancers. But another cancer survivor, Thomas Farrington, stressed that if patients knew not just the costs but the values of new technologies, they could make better decisions and foster the proper adoption and de-adoption of new treatments.
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But he added that the model may not be feasible given the long time frames needed to conduct the cancer clinical trials to acquire the comparative effectiveness evidence. Steinberg also advocated for a value-based payment model in which higher prices are paid for treatments showing better treatment outcomes because he said it incentivizes the triple aim of improved patient experience, improved health for populations, and lower per capita cost.
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Bekelman said that "each rung on the ladder can be experimented on to determine whether it will work, and we already know in some cases it does work." But he added that there could also be unintended consequences with this approach. Utilization management can slow clinical care, and patients with real indications may not be able to access certain treatments with limited evidence, such as PBRT, he said.
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Robotic surgery enhances 3D visualization and instrument rotation, and may limit the incision size and shorten the length of a hospital stay, but there is mixed evidence regarding how it affects functional outcome and cancer control, she noted. Shih said there are relatively fewer resources to conduct clinical trials of medical technologies compared to drugs, and noted that reimbursement practices can facilitate or hinder accrual to clinical trials that evaluate new technologies.
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2013. Multidisciplinary care and management selection in prostate cancer.
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2015. Video-based peer feedback through social networking for robotic surgery simulation: A multicenter randomized controlled trial.
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2010. Integrated prostate cancer centers and over-utilization of IMRT: A close look at fee-for-service medicine in radiation oncology.
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2010. Comparative effectiveness of prostate cancer treatments: Evaluating statistical adjustments for confounding in observational data.
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2012. Proton versus intensity-modulated radiotherapy for prostate cancer: Patterns of care and early toxicity.
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2011. Cost implications of the rapid adoption of newer technologies for treating prostate cancer.
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2015. Dissemination of new technologies: Cost and temporal trends in curative therapy for prostate cancer, edited by Y
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2012. Intensity-modulated radiation therapy, proton therapy, or conformal radiation therapy and morbidity and disease control in localized prostate cancer.
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2013. Proton versus intensity-modulated radiotherapy for prostate cancer: patterns of care and early toxicity.
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