ACCCBuzz

Senate Postpones Decision on SGR

U.S. Capitol By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

On Thursday, March 26, the U.S. House of Representatives passed H.R. 2, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.

Unfortunately, the Senate announced late Thursday evening that they will not consider the SGR repeal bill until they return from recess on April 13, 2015.  CMS has indicated it will hold claims for two weeks, through April 14.

ACCC urges members to contact your Senators in the next two weeks and ask them to support a permanent repeal of the SGR.

SGR Bill Heads to Senate—Contact Your Senators Today!

U.S. Capitol By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

On March 26, by a vote of 392-37 the U.S. House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.

Rep. Michael C. Burgess, MD, (R-Texas), the bill’s primary sponsor, said in a statement, “This is the work of a collaborative body. . . .It is time to end the SGR. Let us never speak of this issue again.”

On March 25, the White House expressed support for the bill.

The Senate is expected to vote on the bill March 27, before Congress recesses for two weeks.

ACCC urges members to contact your Senators and ask them to support a permanent repeal of the SGR. As an expert in cancer care, they need to hear from you!

Call to Action: Support Permanent Repeal of the SGR!

Posted in ACCC News, Advocacy, Cancer Care, Healthcare Reform, In and Around Washington, DC by ACCCBuzz on March 25, 2015

by Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

U.S. Capitol With another SGR deadline looming, leaders in the U.S. Senate and House are coming close to striking a bipartisan, bicameral deal to finally replace the broken Medicare Sustainable Growth Rate (SGR) formula.

On March 24, bipartisan leaders of the House Energy and Commerce and House Ways and Means Committees introduced H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), to permanently replace Medicare’s Sustainable Growth Rate (SGR). The agreement builds upon H.R. 1470, introduced last week.

H.R. 2 would create an improved physician payment system that rewards quality, efficiency, and innovation and put an end to the cycle of annual “doc fix” crises that have created uncertainty for millions of Medicare providers and beneficiaries for over a decade. As you well know, physicians need the assurance of predictable, appropriate payments in order to plan for the future and invest in the personnel and technologies that are essential to providing high-quality cancer care.

This is historic momentum on an issue that has plagued providers—and Congress— for years. This year’s compromise builds on last year’s efforts, and the window to get this bill across the finish line is narrowing. Join us in urging Congress to continue to work together to pass responsible legislation that appropriately reimburses patient care.

Contact your member of Congress to support a permanent repeal of the SGR. As an expert in cancer care, they need to hear from you!

CANCERSCAPE—ACA’s Impact on the Frontline of Care

Posted in ACCC News, Across the Nation, Advocacy, Healthcare Reform by ACCCBuzz on March 24, 2015

by Amanda Patton, ACCC Communications

March 23 marked t20150317_ACCC_41st_067-ForWebhe five-year anniversary of President Obama’s signing of the Affordable Care Act into law. Over the last five years, nearly 16.4 million Americans have gained health coverage under the ACA.

Last week, at ACCC’s Annual Meeting, CANCERSCAPE, in Arlington, Va., panelists Steven D’Amato, BSPharm, BCOP, executive director, New England Cancer Specialists; Wendy Andrews, BS, practice manager, Hematology/Oncology at the University of Arizona Cancer Center; and George Dahlman, executive vice president, Federal Affairs & Operations, National Patient Advocate Foundation, explored the impact of the ACA from the patient advocate and provider perspective, sharing the view from the frontlines of care delivery and patient advocacy. The discussion was moderated by ACCC Executive Director Christian Downs, JD, MHA.

One challenge panelists identified is meeting the increased demand for services driven by growing numbers of insured patients.

“In Maine we have an exchange, Maine Community Health Options. It’s been so successful that the challenge is having adequate staff to manage the program,” said Steven D’Amato. “The big challenge will be the workforce challenge as we have more insured patients.”

Wendy Andrews, who is a practice manager, noted that Arizona has expanded Medicaid, which has moved many patients from self-pay to Medicaid. While they are seeing more patients with insurance, these patients all tend to be underinsured.

Another challenge expressed by each of the panelists is the pressing need to help patients understand their insurance coverage and, especially, their out-of-pocket costs.

During the first year of the Marketplace in Arizona, those trying to help consumers with plan selection often had a lack of knowledge [about coverage] and patients were “actually given the wrong information,” Ms. Andrews said. Now, in the Marketplace’s second year, this problem continues.

From the patient advocate’s perspective, George Dahlman finds that the Marketplace experience is exposing consumers’ education gaps. “We have 200 case workers that help patients with insurance problems and copay programs. [This is exposing] the biggest education gaps for consumers. Most people look at the insurance premiums—not what’s included in the benefits program” when purchasing coverage.

Andrews agreed, finding that “ninety percent of all patients really, truly do not understand their insurance benefits.”

Providers and patient advocate organizations alike are challenged to help educate consumers about their coverage. “These are complicated insurance products, and you’re educating two patient populations: previously insured and those who’ve never had insurance before. It’s a brave new world for consumers,” said Dahlman. Patients need information about whether they can keep their current providers when considering insurance options, and what their out-of-pocket costs will be.

“In our practice, it’s essential that patients meet with a financial advocate first,” said D’Amato. Wendy Andrews agreed. “We pre-register all of our patients and verify their benefits.” Her practice requires that patients also verify that they’ve made premium payments. As a result, the front-end administrative burden for providers has increased.

Finally, the panel touched on the impact of narrow networks within marketplace plans. In a rural state, like Maine, “you always worry about access,” said D’Amato. “Creation of narrow networks creates inconvenience for patients.” In Arizona, Andrews said,“the problem we see the most is lack of providers being available in all the plans. What does a patient do when there isn’t a provider in their plan and they have to travel long distances [for care]?”

In summary, the panelists’ described three key challenges post-ACA implementation:

  • Access challenges, i.e., having enough providers to meet increased patient demand; narrow networks potentially limiting patient access to providers
  • Education challenges, i.e., increased need to help patients, both previously insured and those who are newly insured, understand their coverage and out-of-pocket costs, and
  • Front-end administrative burdens, i.e., verifying coverage, understanding patients’ insurance plan coverage, and helping identify resources for underinsured patients.

CANCERSCAPE Session on OCM Brings Insights

by Amanda Patton, ACCC Communications

20150317_ACCC_41st_190On Tuesday, March 17, at ACCC’s Annual Meeting, Ron Kline, MD, Medical Officer with the Center for Medicare and Medicaid Innovation (CMMI), and Kavita Patel, MD, MS, of the Brookings Institution helped bring a little more clarity to CMMI’s Medicare’s Oncology Care Model (OCM).

The OCM has been developed by CMMI to test new payment and service delivery models, as part of its overarching triple aim of better care, smarter spending, and healthier people. OCM goals center on care coordination; appropriateness of care; and access for beneficiaries going through chemotherapy, Dr. Kline said. Learn more here.

In his overview of the five-year pilot, Dr. Kline pointed to the multi-payer nature of the OCM. “Payers are encouraged to work as part of the model. The point is to leverage the OCM to bring in more and more payers and patients to this model.”

Finally, he stressed the OCM is not intended to be a one-size-fits-all model.

“Part of the point of OCM is that we don’t have all the right answers for all the parts of the country…and the best way to move forward is to learn best practices [through the model].”

CMMI plans to hold webinars, site visits, and meetings at ASCO and elsewhere to share OCM best practices, he said.

So, What’s Everyone Asking?

According to Dr. Patel, the top OCM hot topics are:

# 1 Eligibility. CMMI wants the OCM to “include everyone as much as possible as long as we adhere to the principles of the OCM, attribute, and benchmark appropriately,” said Dr. Kline.

“ACCC is exactly the audience the Oncology Care Model is tailored for—those providing ongoing services for cancer care,” said Dr. Patel.

#2 If you have a practice, can only some providers participate? The short answer is, if you participate, anyone in the practice who is prescribing chemotherapy would be automatically included in the OCM. This includes NPs or PAs who might be prescribing. Simply put: It’s an inclusive model.

#3 Data requirements. Participants need the administrative and technological resources to support these.

For those contemplating OCM participation Patel suggests the following steps:

  • Evaluate what infrastructure investment you will need to make.
  • Perform a serious “gut check” with providers on what OCM participation will mean.
  • Consider how you’ll get all those involved in the OCM to understand the model’s total cost of care framework. (This last item is likely the biggest organizational hurdle, Patel said.)
  • Finally, consider the staffing requirements for participation.

What components will be needed for OCM success? Dr. Patel identified three:

  • Bringing on primary care physicians
  • Learning how to do robust data exchange inside the practice, e.g., having an EMR able to deliver clinicians what they need at point of service
  • Being able to predict which patients in your population will need more intensive services (risk stratify).

Perhaps it’s not surprising that even during the OCM discussion, the SGR made a cameo appearance. Dr. Patel noted that details of an SGR fix currently being negotiated on Capitol Hill will likely include some provisions that will force doctors to enter into alternative payment models in the next five years.

ACCC on Capitol Hill

DSC_0545by Amanda Patton, ACCC Communications

ACCC’s 41st Annual Meeting, CANCERSCAPE, kicked off on March 16 with Capitol Hill Day. ACCC members from across the country fanned out across the Capitol for more than 70 scheduled meetings with legislators and key staff members from both the House and Senate.

With the current Sustainable Growth Rate (SGR) patch set to expire March 31, the timing was ripe for these advocates to speak up for a permanent fix to the SGR.

First time ACCC Hill Day participant Linda Gascoyne, patient advocate for medical oncology, East Maine Medical Center in Brewer, Maine, spent the day with the Maine delegation that met with Senator Susan Collins on Monday, afternoon. “I found her [Senator Collins] to be very empathetic as she listened and learned about what we were asking [from Congress],” Ms. Gascoyne said. In addition to the SGR, the Maine delegation talked with Senator Collins about the need for federal oral parity legislation and elimination of the prompt pay discount from the ASP calculation.

Donna Sulsenti, practice manager, South Shore Hematology Oncology and president of HOMNY was part of the New York delegation that had visits with four congressional offices. “It was extremely interesting speaking about issues with our legislators and getting something accomplished,” she said. She also finds it “satisfying to know that ACCC is working for us.”

Another first time ACCC Hill Day participant Monica Cfarku, nurse manager, Oregon Health & Science University, Knight Cancer Institute, said she “learned a lot” from her meetings with hill staff. In turn, she found staff engaged on the issues and interested in learning from her. “I felt like I offered them a different perspective as someone on the frontline of care delivery.” In fact, staff from a congressional office invited her to return later in the week to share more of her perspective.

Stay tuned for more from ACCC’s Annual Meeting, Cancerscape underway in Arlington, Va. Follow us on Twitter at #cancerscape15.

Bringing the Oncology Care Model into Focus

By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

imagesAs ACCC members are well aware, on February 12, the CMS Innovation Center (CMMI) released its much-anticipated Oncology Care Model (OCM) as part of the broader effort to lower healthcare costs and tie reimbursement to quality and value. ACCC has been conducting an in-depth analysis, and, overall, the OCM generally resembles the discussion draft we saw in August; while the model contains many positive elements, other areas still need clarification.

At its core, the OCM looks similar to a patient-centered oncology medical home or accountable care organization (ACO), with a target expenditure and shared savings component that encompasses the total cost of patient care during a particular period of treatment. The model is a voluntary, five-year program slated to begin in spring 2016. Physician group practices, hospital-based practices (except for PPS-exempt hospitals), and solo practitioners that furnish cancer chemotherapy are eligible to participate. Payments will be based on a six-month episode of chemotherapy treatment that is triggered by the administration of a pre-set list of chemotherapy drugs, and will take into account all Part A, Part B, and some Part D expenditures for that patient during the episode. In addition to a FFS payment, providers will receive a care coordination payment to improve quality of care ($160 per patient, per month during the episode) and a performance-based payment to incentivize lower costs that will be based on the difference between a risk-adjusted target price and actual expenditures during the episode. The payment arrangement is one-sided risk, with the option of converting to two-sided risk in the third year.

Importantly, the OCM is a multi-payer model in which commercial payers and state Medicaid agencies are encouraged to participate. Aligning financial incentives by engaging multiple payers will leverage the opportunity to transform oncology care across a broader population. During the selection process, CMMI will favor practices that participate with other payers in addition to Medicare. In addition, practices will have to meet certain quality metrics and undergo practice transformation requirements, including: effective use of electronic health records; 24-hour access to practitioners who can consult the patient’s medical record in real time; comprehensive patient care plans; patient navigators; and continuous quality improvement.

While we were pleased to see much of ACCC’s feedback incorporated in the final version, our dialogue with CMS is ongoing. Our members continue to have questions about the benchmarking methodology, specifics on the quality metrics and practice transformation requirements, eligibility to participate in the model, and more. ACCC will continue to seek answers to these questions, and will offer CMS feedback based on member input.

If your practice is interested in participating, or considering participation, we encourage you to submit a non-binding letter of intent to CMS by the deadline of April 23, 2015. We anticipate CMS will continue to provide additional guidance until the application deadline, which is June 18, 2015.

Join us at ACCC’s Annual Meeting CANCERSCAPE on March 17 and hear directly from Ron Kline, MD, Medical Officer with the Center for Medicare and Medicaid Innovation—an author of the Oncology Care Model, as he shares an insider’s perspective on New Payment and Delivery Models in Medicare.

Transformation ⇒ From Volume to Value

Centers_for_Medicare_and_Medicaid_Services_logoBy Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

This week the CMS Innovation Center announced the launch of the Oncology Care Model—the agency’s newest payment and service delivery model, described as a multi-payer, oncology practitioner-focused model designed to improve the quality of cancer care while lowering cost.

According to the CMS announcement, key facets of the model include:

  • Episode-based payment that targets chemotherapy and related care during a six-month period following the start of chemotherapy treatment.
  • Multi-payer design with Medicare fee-for-service and other payers working in tandem to promote care redesign for oncology patients.
  • Requiring physician practices to engage in practice transformation to improve quality and coordination of care.

This is the latest signal that the shift from volume-based reimbursement to payment for value and quality is gaining momentum. The interest in moving healthcare payment away from a system that incentivizes quantity has been reflected in every major healthcare law in recent years—from the Medicare Modernization Act (MMA) in 2003 to the Affordable Care Act (ACA) in 2010.

In fact, the ACA created the $10 billion Center for Medicare and Medicaid Innovation (CMMI) with the sole aim of developing and testing innovative ways to pay providers. And on Feb. 12 the Innovation Center provided its first model for oncology care.

The launch of this model is not unexpected given that in January 2015, for the first time in Medicare’s history, the Department of Health and Human Services (HHS) announced explicit goals for tying Medicare payments to alternative payment models and value-based payments. According to the HHS timeline, 30 percent of all fee-for-service (FFS) Medicare payments will be tied to alternative payment models by 2016—including, but not limited to, Accountable Care Organizations (ACOs), medical homes, and bundled payments for episodes of care. By 2018, 50 percent of payments will be tied to these models. CMS also set a goal of tying 85 percent of traditional Medicare payments to quality or value by 2016 and 90 percent by 2018 through such programs as the Hospital Value Based Purchasing or Hospital Readmissions Reduction programs.

Ambitious Goals

The initial benchmark of 2016 sets a laudable, but ambitious, goal. Certainly the announcement signals the Obama Administration is making this issue a priority, and we can expect to see an accelerated push to transition Medicare payments and, in turn, private payers.

This shift is a huge undertaking that will not only affect payments, but fundamentally change incentives for how providers deliver care. Implementation will take time, and will require the right balance of forward momentum and important safeguards to ensure that patients continue to receive the most appropriate, quality care. As HHS moves full steam ahead, the provider community must speak up and urge policymakers to:

  • continue to work to find consensus on appropriate quality measures,
  • establish a sound, fair methodology for calculating financial benchmarks and risk adjustment, and
  • allow providers the time, resources, and flexibility they need to implement these new payment models.

The just-announced Oncology Care Model (OCM) will test the bundling of payments for chemotherapy administration. But with other models, such as the Medicare Shared Savings Program (Medicare ACOs) that are primary care focused, it’s still unclear how oncologists will be included or even participate. Caring for cancer patients is complex and often expensive, leaving inherent challenges in how to account for cancer care in alternative models. How will high-cost drugs and innovative therapies be treated in the construct of an ACO? Will high-cost cancer patients be included in the financial benchmark? What is oncology’s role in shared risk and savings? ACCC and other organizations are continuing to work with CMS to answer these questions.

Call to Action

ACCC encourages the provider community to remain informed and active participants in the policy-making dialogue to ensure that we do, in fact, achieve meaningful, realistic payment reform. One of the best ways to get engaged is meeting with your legislators at ACCC’s upcoming Capitol Hill Day on March 16. The next day, at ACCC’s Annual Meeting, CANCERSCAPE on March 17, we’ll be hearing from Ron Kline, MD, Medical Officer with the Center for Medicare and Medicaid Innovation – an author of the Oncology Care Model. Now is the time to come to Washington D.C. – get your questions answered and voices heard at a pivotal moment for oncology care. Join us!

 

8 Strategies to Help Gastric Cancer Patients Cope with Nutrition Problems During Treatment

Posted in ACCC News, Cancer Care, Education by ACCCBuzz on February 2, 2015

ACCC’s Improving Care in Gastric/GE Junction Cancer project seeks to better the quality of care for gastric and GE cancer patients treated at community cancer programs. This guest post by Colleen Gill, MS, RD, CSO, is the final blog in a series on gastric and GE junction cancers. Colleen Gill is outpatient dietitian at the University of Colorado Cancer Center, and she serves on the Advisory Committee for ACCC’s Improving Care in Gastric/GE Junction Cancer initiative.

Gastric-GE JunctionBy Colleen Gill, MS, RD, CSO

More than 70 percent of patients with gastric cancer develop malnutrition, depleting muscle mass, slowing healing, and limiting the immune system.

The growth of any tumor within the stomach will limit intake and create problems with the digestion of food. Unfortunately, diagnosis of gastric cancer may be delayed due to symptoms—such as feeling extremely full after small amounts of food and abdominal pain or heartburn—that may be attributed to more common causes. As a result, malnutrition in gastric cancer patients can begin early. Nausea and vomiting are inevitable when there is tumor blocking either the gastro-esophageal junction or gastric outlet. Fatigue can result from iron deficiency anemia due to problems with iron absorption.

Patients with gastric cancer may undergo a combination of chemotherapy and radiation prior to surgery, and may be given adjuvant therapy after surgery as well. Treatment side effects may include inflammation, pain, nausea, and vomiting which can further affect a patient’s ability to eat and maintain weight.

Here are 8 strategies that may help the patient eat better, avoid excess loss of weight and muscle, and stay on treatment:

  • Schedule 5 – 6 times to eat each day. Because stomach capacity is reduced due to tumor and/or surgery, patients can try eating smaller amounts of food at intervals during the day. Scheduling a cell phone reminder to eat can be helpful. Without some type of reminder to eat every two and one-half to three hours, patients can easily miss these opportunities, and limited stomach capacity makes it impossible to make up their calorie intake at a later meal.
  • Choose softer foods. The stomach usually breaks down solid foods into smaller pieces through muscular contractions and acid secretion, but both functions may be limited by the cancer. Consider foods that are pre-processed, like shredded meats, and canned or cooked fruits and vegetables. Take advantage of foods that are already in soft “pureed” texture, like fish, refried beans, most dairy products, eggs, mashed potatoes, winter squash.
  • Make it slick. Moist foods, or those with gravies and sauces, spread taste through the mouth, increasing palatability. These foods also slide down more easily.
  • Make it easy. There are many prepared foods that will work for you, so tour the aisles of the grocery store with your goals in mind. Frozen/prepared pasta dishes, mini-quiches, and microwavable mashed potatoes, soups and breakfast dishes are available. Friends and family often offer their help which can be coordinated through websites like mealtrain.com or lotsofhelpinghands.com. Include liquid calories. They slip through narrow openings and are less likely to distend the walls of the stomach. Options include milk-like oral supplements, which are usually lactose free if that is a concern. Choose the “plus” versions for an extra 100 calories and higher protein levels. If milk is tolerated, many enjoy Carnation Instant Breakfast powder, stirred in, adding 130 calories. Scandishakes will add 440 calories and are well liked. Clear liquid drinks include Boost Breeze and Ensure Active, which some people also enjoy mixed with carbonated clear sodas. In the grocery store’s produce area, you’ll find fruit-based drinks such as those from Odwalla, Naked Juice, and Bolthouse that include versions with protein. All of these can be used as a base for smoothies, which should always include some source of protein.
  • Create a list. Coming up with ideas for what to eat on the spur of the moment can be stressful. Create a “go to” list of options for your refrigerator (or wallet). This can help you avoid falling back on the same things over and over, which can lead to “burning out” on particular foods. Including the “extras” that add calories on your list. These can help ensure that each bite counts. For example, add cheese when you warm up refried beans or scramble an egg, or add walnuts or peanut butter to oatmeal. Jot down ideas for days when you struggle, so you can always “go to” something from the list. Use the list when making shopping lists, so that foods are available to you when you want them.
  • Adjust your list by tolerance. Never cross something off your list until it has failed you more than twice. However, if you notice that higher fat or high fiber foods cause food to “sit” on the stomach for long periods of time, you may try lowering the content of fat/fiber in the food you eat and see if that is helpful. Journaling can help you see patterns.
  • Keep food safe. Many patients with gastric cancer will be on acid suppressive therapies or have less secretion of acid as the result of their cancer. Without acid in the stomach, you have less protection from bacterial contamination in food. Be careful to take precautions to keep food safe: avoid letting food sit at room temperature (keep it cold or hot), wash your hands frequently, and avoid cross contamination by keeping surfaces clean and using separate cutting boards for raw meats and foods that won’t be cooked. Be cautious with self-service salad bars and high-risk foods. Use leftovers within 48 hours.
  • Talk to your team about anything that is getting in the way of eating. They will have some solutions if you are having problems with nausea/vomiting, constipation, dehydration, sleeping, or anything else that is limiting your ability to eat. They can guide you about over the counter and prescription medications that may help, or schedule you for IV fluids or other procedures to deal with the problems. Waiting never resolves anything!

Read other blogs in this series here. Learn more about ACCC’s Improving Care in Gastric/GE Junction Cancer project here.

Optimal Treatment for Gastric Cancer—Two Multimodality Approaches

Posted in ACCC News, Cancer Care by ACCCBuzz on January 27, 2015

Gastric-GE JunctionACCC’s Improving Care in Gastric/GE Junction Cancers project seeks to better the quality of care for gastric and GE cancer patients treated at community cancer programs. This guest post on Optimal Treatment for Gastric Cancer — Two Multimodality Approaches is the fourth in a five-part blog series focused on gastric and GE junction cancers.

by Gurleen Dhami, MD; Veena Shankaran MD; Brant K. Oelschlager, MD; and Shilpen Patel, MD, FACRO

In 2013, there were approximately 21,600 cases of gastric cancers in the U.S. with 10,990 deaths. The incidence, however, is much higher worldwide, being the third most common cancer in the world and second leading cause of cancer-related death. Surgery has been the primary modality of treatment for early-stage gastric cancers. However, many gastric cancers are diagnosed at an advanced stage, leading investigators to find the optimal modality of treatment in this setting.

Two multimodality treatment approaches have been investigated in randomized clinical trials, both of which have been shown to improve survival beyond surgery alone. Perioperative chemotherapy (MAGIC trial) and postoperative chemoradiation therapy (INT 0116) have not been directly compared to each other. The findings and limitations of both key studies are discussed below.

MAGIC Trial

The landmark international phase III randomized MAGIC trial evaluated the role of perioperative chemotherapy in patients with resectable gastric cancers as well as GE junction tumors. The hope was for perioperative chemotherapy to improve the likelihood of a curative resection and to downstage the tumor at time of surgery. Five hundred and three patients with resectable gastric adenocarcinoma, GE junction, and lower esophageal cancers were randomized at the time of diagnosis to undergo either perioperative chemotherapy, entailing both pre- and post-operative chemotherapy, versus no additional treatment after surgery. Nearly three-quarters of the cases were gastric cancers. The chemotherapy arm consisted of three cycles of ECF (epirubicin, cisplatin, and 5-FU) before and after surgery. In terms of the surgical resection, the extent of lymph node dissection was determined by the surgeon. With a median follow-up of 4 years, only 42% of participants randomized to the chemotherapy arm actually completed the entire course. Despite this completion rate, patients who received perioperative chemotherapy had a statistically significant improvement in 5-year overall survival, 36% in the chemotherapy arm versus 23% in the surgery alone arm (p = 0.009). Progression-free survival also was improved in patients who underwent perioperative chemotherapy (HR 0.66, p<0.001). Additionally, perioperative chemotherapy decreased the tumor size, 3 versus 5 cm median maximal diameter at time of surgery (p<0.001), as well as increased proportion of stage T1 and T2 tumors at time of surgery (p=0.002). Postoperative complications were similar in both groups. The results of this study established that perioperative chemotherapy had superior survival outcomes in addition to shrinking the tumor at time of surgery. A major limitation of this study was the limited extent of lymph node dissection, with only 38% of patients undergoing a D2 resection. Resections were curative in 69% of the perioperative chemotherapy arm and 66% of the surgery alone arm. This stems from the design of the study as patients were randomized at time of diagnosis and prior to any treatment. Thus, approximately one-fourth of the patients actually had non-curative surgery. Another limitation of this trial was that laparoscopy to rule out occult metastasis was not required prior to randomization. Thus, disease burden could have been underestimated prior to enrollment.

INT 0116

Another hallmark study, the Macdonald trial (INT 0116), evaluated the role of postoperative treatment after a R0 resection in stage IB-IV adenocarcinoma of the stomach and GE junction tumors. Five hundred and fifty-six patients were randomized to two arms after surgery: chemoradiation therapy sandwiched with chemotherapy versus no further treatment. The treatment arm consisted of one cycle of chemotherapy (5-FU and leucovorin), followed by combined treatment of radiation to 45 Gy in 25 fractions with concurrent 5-FU and leucovorin which was then lastly followed by by two more cycles of 5 FU and leucovorin. With a median follow-up of 5 years, slightly longer than the MAGIC trial, there was a statistically significant survival advantage with postoperative treatment. Median survival increased from 27 months to 36 months with postoperative treatment (p=0.005). Three-year RFS increased from 21% in the observation arm to 48% in the adjuvant treatment arm (p=0.001). A major limitation of this study is the low rate of D2 resection with only 10% of patients having a D2 resection and with approximately half of patients with a D0 resection. Treatment toxicity was also another concern of this study with over 40% of patients in the chemoradiotherapy arm experiencing grade 3 toxic effects and approximately one-third having grade 4 toxicity. Approximately one-third did not complete treatment due to toxicity. While postoperative chemoradiotherapy has been shown to have high toxicity rates in clinical trials, this toxicity has decreased with modern methods of administering radiotherapy. A 10-year update showed that there was a persistent benefit to adjuvant chemoradiation in terms of overall survival and RFS.

Making a direct comparison between these two trials is difficult as the treatment regimen and timing differed. Both trials highlight the survival benefit of additional treatment for resected gastric cancers. Patients who received perioperative treatment in the MAGIC trial did having down-staging of their tumor with preoperative portion of treatment whereas the patients in the MacDonald trial treatment arm only received postoperative treatment. In order to be eligible for INT 0116, patients had to complete a R0 resection, as opposed to the MAGIC trial in which approximately one-quarter of patients had non-curative surgery. Worth noting is in the MAGIC study, the trial was limited by hetereogenous staging, including limited use of ultrasound for staging and the variable quality of surgery and pathology. In addition, two-year survivals in the Intergroup trial was 58% versus 48% in the MAGIC trial.

These studies do highlight the importance of a multidisciplinary approach for gastric cancers. Hopefully, future trials will be able to delineate the patient timing of adjuvant treatment for gastric cancers. Many in the oncology community are awaiting the Dutch CRITICS trial which will analyze the survival benefits of perioperative chemotherapy versus neoadjuvant chemotherapy plus adjuvant chemoradiotherapy.

The authors are all affiliated with the University of Washington and the Seattle Cancer Care Alliance.


 

References

National Comprehensive Cancer Network.  Gastric Cancer. Available at: http:www.nccn.org/professionals/physician_gls/pdf/gastric.pdf. Last accessed February 27, 2014.

Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20.

Sasson AR. Localized gastric cancer: chemoradiation is not always needed. Gastrointest Cancer Res. 2009 Mar;3(2 Suppl):S22-5.

Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30.

Smalley SR, Benedetti JK, Haller DG, et al. Updated analysis of SWOG-directed intergroup study 0116: a phase III trial of adjuvant radiochemotherapy versus observation after curative gastric cancer resection. J Clin Oncol. 2012 Jul 1;30(19):2327-33.

 

 

 

 

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