Just In... Meeting News
Key news updates and reports from the latest meetings in oncology and hematology.
Monday, November 23, 2015
BY PEGGY EASTMAN
WASHINGTON—As cancer care shifts toward diagnosis and treatment based on molecular biology, care delivery is rapidly becoming more complex and challenging. For this reason, the nonprofit ECRI Institute and the federal National Cancer Institute co-sponsored a conference here to probe how the changing field of oncology is meeting the demands of treating a graying U.S. population, at least one-third of whom will develop cancer during their lifetimes.
ECRI, which provides information and consulting services on health care technology assessment and cost effectiveness, chose to spotlight cancer care delivery because of “a confluence of issues that are going to create change now,” ECRI President and CEO Jeffrey C. Lerner, PhD, explained.
Among the questions discussed at the meeting:
- Are the technologies for precision medicine really more effective than the alternatives or are they over-hyped?
- Are some health systems truly patient-centered, considering patients active participants in cancer care delivery?
- Is cancer care becoming more tailored and coordinated, and is there adequate quality measurement to assess cancer care? and
- What is the state of public and private-sector value-based payment initiatives for cancer care?
“We represent the interface between biology and patient care; we have to live at that interface,” said Larry Norton, MD, Deputy Physician-in-Chief for Breast Cancer Programs; Medical Director of the Evelyn H. Lauder Breast Center; and the Norma S. Sarofim Chair in Clinical Oncology at Memorial Sloan Kettering Cancer Center.
“The key now is that biology is driving treatment,” added Roy S. Herbst, MD, PhD, Ensign Professor of Medicine (medical oncology) and Professor of Pharmacology; Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven; Associate Director for Translational Research at Yale Cancer Center; and Translational Working Group Leader for the Thoracic Oncology Program at Yale Cancer Center.
Lack of Uniformity
But unfortunately the changes occurring in oncology are not being applied uniformly across the United States in cancer care, Herbst said. For example, in his specialty, lung cancer, “there are things you really want to know,” such as the patient’s EGFR, ALK, and ROS1 status, but not all patients are tested for these markers.
There are a handful of markers that are so well characterized that they inform first-line treatment, agreed Gaurav Singal, MD, Director of the Innovations Unit for Foundation Medicine, Inc. However, tests for these biomarkers are being ordered only about 40 to 50 percent of the time, he said, attributing this low rate of test ordering to a lack of education.
“I’m actually shocked” by the fact that only about half of lung cancer patients are getting tests that determine their treatment, Norton commented.
Such statistics are not that surprising, said several speakers: “Despite a lot of what you’ve heard about personalized medicine, it’s really in its infancy,” said James Zwiebel, MD, Chief of NCI’s Investigational Drug Branch.
Even though there have been dramatic advances in targeted approaches to cancer treatment, long and durable responses are still few in precision medicine, he cautioned. “The biology of these cancer cells is much more complicated than at first glance.” For example, two cancer types with mutated BRAF may respond differently to treatments targeting that mutation. Melanoma patients tend to respond much better to treatments targeting a BRAF mutation than do patients with colorectal cancer.
Management of toxicities can also be a problem in targeted therapy: “Combining these agents has attendant toxicities, which sometimes overlap,” Zwiebel noted.
‘Expectations Way Too High’
Herbst agreed. “Expectations are way too high,” he said. “The complexity of this is huge… we’ve got to be careful--Cancer care in the era of molecular biology is much more complex than simply finding a mutation and treating it.”
The shift toward cancer diagnosis and treatment based on molecular biology has had a major effect on the clinical trial process, speakers emphasized. Herbst is co-principal investigator of Lung-MAP, the multi-drug, multi-substudy, biomarker-driven clinical trial of squamous cell lung cancer that uses genomic profiling to match study participants to treatment substudies targeting specific mutations.
‘Slicing and Dicing’
There’s no question that we’re slicing and dicing cancer into these infinitesimally small groups,” Zwiebel said. He noted that the NCI-MATCH (Molecular Analysis for Therapy Choice) trial, which analyzes patients’ cancerous tumors to identify an actionable mutation--and treats that mutation, if present--has had a wildly popular enrollment: “We thought we’d have a wave; we had a tsunami,” he told OT. In fact, he said, trial enrollment (which is aiming for 3,000 subjects) has been so rapid since the trial opened last August that enrollment has temporarily closed while trial administrators catch up.
“This is a full-court press operation; it’s an enormous effort. We’ve never done anything like this before.” Asked why he thinks the NCI trial is so popular, Zwiebel attributed the flood of enrollment to high interest in precision medicine, fueled in part by last January’s announcement of the President’s Precision Medicine Initiative. NCI-MATCH, which uses an advanced DNA sequencing test, will have at least 10 arms; the trial plans to test more than 20 drugs.
Asked if he thinks expectations for NCI-MATCH are too high, he said, “The goal is not to oversell what we can do, but to learn from what is being discovered. We’re learning as we go; there may be opportunities to open up new arms.”
FDA Breakthrough Therapy Designation
In oncology, the Breakthrough Therapy designation of the U.S. Food and Drug Administration, signed into law in 2012, has meant that the clinical trials process has picked up pace to speed true therapeutic advances to cancer patients more rapidly, said Gideon Blumenthal, MD, Clinical Team Leader for Thoracic and Head/Neck Oncology at the agency’s Center for Drug Evaluation and Research. “The lines between Phase I, Phase II, and Phase III are blurring.”
He noted that about 40 percent of new drug applications in oncology are in the Breakthrough Therapy category, and about 30 percent of these are granted. “The pace has continued,” he said.
Speakers stressed that in the rush to better and more targeted diagnostics and treatments, caution must be exercised to ensure that new technologies are thoroughly evaluated. An example is proton therapy in radiation oncology. Adoption of this technology has been rapid, but evidence generation to prove its superiority over other types of external-beam radiotherapy has been lacking, noted Justin Bekelman, MD, Associate Professor of Radiation Oncology in the University of Pennsylvania’s Abramson Cancer Center, Perelman School of Medicine.
Because proton therapy is deposited over a narrow range (thus causing less damage to healthy tissue), there are suggestions that it may cause fewer long-term side effects, especially for children and for treatment of cancers in the chest and brain. Bekelman noted that the American Society for Radiation Oncology has “very responsibly” called for clinical trials of proton therapy: “This is an opportunity for the radiation device industry to invest in evidence generation,” he said.
Asked by OT if he thinks there has been some premature adoption of proton therapy, Bekelman said, “It’s not a surprise that medical centers have adopted proton therapy,” given the competition in health care delivery today. But, he said, it is “a little too soon” to say that U.S. adoption has been too rapid, since there are only about 24 proton therapy centers, compared with about 2400 linear accelerator centers delivering other forms of radiotherapy. Patients at his center, he said, receive detailed information from physicians on the pros and cons of proton therapy.
“There are some theoretical benefits to proton therapy that have not been demonstrated clinically,” he said. These include whether the radiation dose can be increased while maintaining the same toxicity level and whether toxicity can be decreased.
Several speakers discussed efforts to include patients more deliberately in cancer care through shared decision-making. “Shared decision-making is a new concept for Medicare coverage,” said Joseph Chin, MD, MS, Acting Director of the Coverage and Analysis Group at the Centers for Medicare & Medicaid Services (CMS).
He described a new CMS Medicare coverage decision that will reimburse providers for a shared decision-making discussion on lung cancer low-dose CT screening for eligible beneficiaries performed at specified radiology centers: “It’s something new; we’re just getting involved in it at this point,” he said.
Speakers at the conference also focused on the importance of quality assessment in the changing landscape of cancer care delivery. For more than a decade, it has been known that there are large performance differences in cancer care quality, said Peter B. Bach, MD, MAPP, Director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. A new study he coauthored showed that cancer patients on Medicare treated at freestanding U.S. hospitals exempt from the Medicare prospective payment system (PPS) had a 10 percent lower chance of dying in the first year than patients treated at other non-teaching U.S. hospitals (JAMA Oncology: Pfister et al: Risk Adjusting Survival Outcomes in Hospitals that Treat Patients with Cancer without Information on Cancer Stage.
The study found that Medicare claims data, irrespective of tumor stage, were enough to calculate long-term survival. Bach called the 10 percent one-year survival gap “substantial.”
The study authors said their findings are in line with Institute of Medicine reports concluding that U.S. cancer care is inconsistent and should be improved. Asked by OT what some of the causes for the gap might be, Bach said that identifying them is the researchers’ next step. Some potential reasons could include the volume of procedures; readmissions; mortality rates following surgery; and/or severe side effects in some patients that prevent them from finishing their chemotherapy regimens.
Sunday, November 22, 2015
BY ROBERT H. CARLSON
SAN ANTONIO--A potential synergy between radiotherapy and immunotherapy in the treatment of advanced melanoma was described here at the American Society for Radiation Oncology Annual Meeting.
In the Phase II trial (Abstract 215), a combination of the systemic anti-CTLA-4 agent ipilimumab with local radiotherapy produced higher response rates than seen with ipilimumab alone.
The researchers, led by Susan Hiniker, MD, an instructor in the Department of Radiation Oncology at Stanford University School of Medicine, explained that although checkpoint inhibitors such as ipilimumab are an innovative and promising approach to cancer immunotherapy, they have yet to produce high rates of response on their own and have been associated with immune-related toxicities.
The trial, designed to investigate whether use of radiation could potentiate the immune response, included 22 patients with stage IV melanoma treated with palliative radiotherapy and intravenous ipilimumab (3 mg/kg) every three weeks, for a total of four treatment cycles. One or two metastatic sites were treated with radiotherapy within five days of the initial immunotherapy treatment, and all the patients had at least one non-irradiated metastatic site that was at least 1.5 cm for assessment of response.
Speaking at a news conference highlighting “Novel Clinical Paradigms,” Hiniker said the primary objective was safety, with tumor response as a secondary assessment. Tumors were assessed at two to four weeks following the fourth cycle of ipilimumab, and then every three months thereafter until disease progression was detected. Patients also had blood drawn during and after treatment for evidence of immune response to therapy.
Initial Response Rate off 50 Percent
Hiniker reported that 11 of the patients (50 percent) had an initial response to therapy, including complete and partial, as well as and stable disease, at a median follow-up of 38 weeks.
Three of those patients (14%) have an ongoing systemic complete response to the combination therapy at a median of 55 weeks follow-up; three patients (14%) had an initial partial response for a median of 40 weeks; and five patients (23%) initially had stable disease following treatment, without progression for a median of 39 weeks.
Eleven patients had progressive disease on the first post-treatment scan. Hiniker noted that these responses compare with the results in previous trials in metastatic melanoma, where ipilimumab alone produced response rates of five to percent, with durable responses and a few rare complete responses.
She noted that an earlier prospective study of 22 patients treated with ipilimumab and radiotherapy showed an overall response rate of 18 percent, with no significant added toxicity (Twyman-Saint Victor et al. Nature 2015;520:373-377).
No Added Toxicities
Hiniker said patients in this new trial showed no significant added toxicity from combination therapy, and no apparent exacerbation of either radiation or ipilimumab-associated toxicities: “That is meaningful, because ipilimumab on its own has a quite high rate of grade 3 to 4 toxicity--generally on the order of 20 percent.”
She explained that ipilimumab blocks the CTLA-4 co-inhibitory receptor on T cells, blocking its interaction with B-7 on antigen-presenting cells, and therefore blocks an inhibitory signal on T cells, promoting the adaptive immune response. “Multiple trials have shown ipilimumab response rates of approximately 15 percent. The responses can be quite durable, but rarely are they complete responses, on the order of two to three percent--New methods of potentiating ipilimumab-induced immune responses are therefore needed.”
Local irradiation can modulate the local tumor environment and promote immune responses in several ways, she continued—for example:
· Through the upregulation of pro-inflammatory cytokines such as MCP-1, MIG, and IP-10, and there may be a relationship between elevated CD8-activated T cells and response; and
· Tumor antigens and neoantigens may also be released, dendritic cells activated, and cross-presentation of tumor antigens enhanced.
The next step will be to determine which patients will respond to the combination treatment, Hiniker added, noting that there was an interesting correlation between responders and grade 2 and 3 hypophysitis, an autoimmune endocrinopathy in the pituitary. This may reflect a more effective immune response in those patients, she said.
“More important will be biomarkers, and we did find higher levels of IL-2 during pre-treatment and treatment, as well as higher levels of CD8 central memory T cells, in patients who had good response.”
Future Radiotherapy Studies with PD-1 Inhibitors
At the news conference, Hiniker was asked to comment on the fact that ipilimumab is reported to be replaced by PD-1 checkpoint inhibitors, which are more efficacious and less toxic: “Ipilimumab is sort of on its way out, although recent studies support the combination of a PD-1 checkpoint inhibitor plus ipilimumab,” she said.
A multicenter Phase II trial by Stanford and Memorial Sloan Kettering Cancer Center as well as other institutions is under consideration that would combine radiation with anti-PD-1 agents, which may or may not also include ipilimumab, Hiniker said.
“When we opened this trial [with ipilimumab] there was much less data on PD-1 inhibitors, but the next stop will involve PD-1 inhibitors plus radiation. There is not much information on that combination yet, but there is exciting preclinical data from the Penn group in mouse models that found non-redundant mechanisms.”
The moderator of the news conference, Catherine Park, MD, Professor and Chair of the Department of Radiation Oncology at the University of California, San Francisco, called the combination of checkpoint inhibition and radiotherapy very promising: “We don't see that type of remarkable eradication [as in the Stanford trial] with radiation therapy alone--I think the response is quite striking. And there will be more to come, this study scratches the surface.”
Friday, November 20, 2015
SAN ANTONIO--This year’s Annual Meeting of the American Society for Radiation Oncology brought together more than 11,000 radiation oncologists, radiation therapists, medical physicists, dosimetrists, oncology nurses, and cancer center administrators. Nearly 3,000 abstracts were submitted for presentation at this meeting which is the largest of its kind serving the international radiation oncology community. The theme this year was “Technology Meets Patient Care.”
The benefits of the advanced technology behind intensity modulated radiation therapy (IMRT) were highlighted in several clinical trials. Despite the fact that IMRT was used to treat larger and less favorable non-small cell lung tumors in the phase III RTOG 0617 trial, IMRT was associated with a reduced rate of severe pneumonitis and an improved likelihood of patients being able to receive full doses of consolidative chemotherapy. Use of IMRT was also able to reduce the doses to the heart that had been previously been shown to be highly prognostic for survival.
Similarly in cervical cancer, interim results of an Indian phase III study of postoperative IMRT versus conventional 3D-conformal radiation suggested a reduction in the rates of grade 3 or greater bowel toxicity at two years. Disease-specific outcomes are still pending.
Combining the technology of brachytherapy and external beam therapy proved beneficial in the Canadian phase III trial ASCENDE-RT. In this trial, patients with intermediate and high risk prostate cancer were treated with a year of androgen deprivation, and received radiation to the whole pelvis eight months after the initiation of androgen deprivation. The randomized use of a low-dose rate iodine-125 seed implant as a focused boost to the prostate cut the incidence of a PSA relapse in half compared with the use of an external beam boost to the prostate at 6.5 years. This came at the cost however, of worse bodily pain, general health, sexual function, and urinary function quality of life.
Combined RT + Checkpoint Inhibitors
Combining the latest in radiation therapy with immune checkpoint inhibitors was also highlighted. A single-institution phase I trial was able to safely unite the use of a CTLA4 antibody for metastatic melanoma with escalating doses of radiation in three fractions to a single index lesion. Major tumor regressions were observed in patients. In parallel mouse studies, even with dual checkpoint blockade with anti-PD-L1 and anti-CTLA4 inhibitors, omission of radiation resulted in higher rates of relapse.
However, therapy de-escalation was also emphasized. Results from a prospective phase III trial in China showed that in esophageal cancer, treatment volumes could be reduced to only lymph nodes involved at diagnosis rather than the conventional treatment of elective nodal regions. This reduced toxicity without compromising loco-regional recurrence, distant metastasis, and overall survival.
The phase III Dutch HYPRO trial in intermediate and high risk prostate cancer patients attempted to cut the number of radiation treatments in half, from 39 fractions of 2 Gy to 19 fractions of 3.4 Gy. Two thirds of patients received androgen deprivation. With a median follow-up of five years, relapse-free survival and overall survival did not differ. There was no difference in late urinary or gastrointestinal toxicity, though there was worse acute gastrointestinal toxicity with the shorter regimen. Lower Gleason scores and greater than one year of androgen deprivation were associated with better disease outcomes.
Similarly in low risk prostate cancer, the results of RTOG 0415 showed no difference at five years in disease-free survival and biochemical PSA recurrence between 41 fractions of 1.8 Gy over 8.2 weeks versus 28 fractions of 2.5 Gy over 5.6 weeks. Physician-reported late but not acute grade 2 toxicity was slightly worse with the shorter regimen, however.
ESTRO Study of APBI
ESTRO, the European counterpart to ASTRO, showed that one week of accelerated partial breast irradiation using interstitial multicatheter brachytherapy resulted in no difference in the approximately 1% local recurrence rate when compared with six weeks of conventional whole breast external beam radiation with a boost.
Nodal, distant, and contralateral breast recurrences were also not significant and each risk of similar magnitude. Their trial enrolled over 1,000 women over 40 years of age with less than 3 cm of ductal carcinoma in-situ or invasive breast carcinoma with clear 2 mm resection margins and no more than microscopic nodal metastases. These encouraging results of this technically difficult partial breast method beat those shown in randomized trials of intra-operative partial breast radiation. Long term outcomes and cosmetic outcomes were not reported.
Magnetic Resonance Image-Guided Therapy
The emerging use of magnetic resonance image guided therapy received special attention at this meeting. The ability to track the motion of the pharyngeal airway and tumors of the liver was highlighted. The technique’s novel ability to adapt therapy with each fraction of stereotactic treatment of thoracic and abdominal primary malignancies and oligometastases was also demonstrated.
Lower-technology interventions were also presented, with analyses showing improved outcomes when hyperglycemia is controlled in patients with advanced cervical cancer and when patients quit smoking after stereotactic radiation treatment of early lung cancers.
NCIC CTG SC.23 showed that compared with placebo, the simple intervention of 8 mg of dexamethasone given once daily for five days significantly reduced the rate of radiation-induced pain flares from 30 to 20 percent. Radiation was given in a single fraction of 8 Gy to 1-2 metastases from a solid tumor. This reduction in the pain flare occurred in the first five days after treatment.
After 10 days, patients showed significant improvements in nausea, appetite, and patient function. No difference in response to radiation, toxicity, and death was observed. No hyperglycemia requiring hospitalization occurred.
‘We Are Doctors First’
The meeting’s presidential address, entitled “We are doctors first,” was delivered by Bruce Minsky, MD, FASTRO. “Remarkable advances in technology have led to advances in the design, delivery, and overall results of radiation therapy for the treatment of cancer,” he said. At the same time, he emphasized that the responsibility to be a skilled and compassionate physician is equally important: “Technology and outstanding patient care are complementary, not competitive with technology.”
MICHAEL C. ROACH, MD, is Chief Resident, and
CLIFF G. ROBINSON, is Associate Professor in the Department of Radiation Oncology at Washington University School of Medicine in Saint Louis.
Tuesday, November 17, 2015
BY ROBERT H. CARLSON
SAN ANTONIO--A European trial has moved a step closer to answering the question of which radiotherapy technique should be standard for women after breast-conserving surgery for early-stage breast cancer—external-beam whole-breast irradiation or accelerated partial-breast irradiation with brachytherapy.
As reported here at the American Society for Radiation Oncology Annual Meeting, the randomized Phase III GEC-ESTRO trial with 1,184 women showed equivalent five-year local control and survival rates for the two modalities (Abstract LBA 7).
The paper was also published online in The Lancet (doi.org/10.1016/S0140-6736(15)00471-7) immediately after the presentation by Vratislav Strnad, MD, PhD, Professor in the Department of Radiation Oncology at University Hospital Erlangen in Germany.
“This is the first Phase III study proving non-inferiority of APBI in comparison to whole-breast irradiation for selected early-stage breast cancer patients,” he and his colleagues concluded.
In the GEC-ESTRO (Groupe Européen de Curiethérapie of the European Society for Radiotherapy & Oncology) trial, conducted in 16 institutions across Europe, a total of 633 women were randomly selected to receive accelerated partial-breast irradiation with multi-catheter brachytherapy, and 551, to whole-breast radiation with boost.
The study, which was sponsored by the German Cancer Aid (Deutsche Krebshilfe) agency, was conducted from April 2004 to July 2009; patients were age 40 or older with stage 0, I, or IIA tumors.
Whole-breast irradiation consisted of 50 Gy with a boost to the tumor bed of 10 Gy for approximately seven weeks. Accelerated partia-breast irradiation used interstitial multi-catheter brachytherapy for five days.
Median Follow-up of 6.6 Years
After a median follow-up of 6.6 years, the overall rate of local regional recurrence was very low in both study arms: 1.4 percent for accelerated partial-breast irradiation and 0.92 percent for whole-breast irradiation; the rate of second primary breast cancers was 0.49 percent versus 0.75 percent, respectively; and regional recurrence rates were 0.49 and 0.56 percent, respectively.
The researchers concluded that adjuvant accelerated partial-breast irradiation using multi-catheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to five-year local control, disease-free survival, and overall survival.
The equivalence of local recurrence rates was evident in all age groups and in all tumor types, independent of additional drug therapy including chemotherapy and anti-hormonal therapy, Strnad said.
“The results were not totally surprising, because as we were preparing our Phase III trial, the first long-term results of several smaller Phase II trials were published showing low recurrence rates after breast-conserving treatment and accelerated partial-breast irradiation compared with whole-breast irradiation. What is surprising, however, is how clear the results are.”
A total of 92 percent of patients indicated that they were satisfied with cosmesis after brachytherapy, Strnad reported.
He noted that current guidelines state that patients should be at least age 50 (ESTRO) or 60 (ASTRO) in order to receive accelerated partial-breast irradiation.
This study, though, demonstrates excellent results in all participant age groups, including those aged 40 and older, he said.
Corroborates Earlier Findings
The Discussant for the study, which was presented at a plenary session, Julia White, MD, Professor of Radiation Oncology at Ohio State University Comprehensive Cancer Center, said the trial corroborates results of two earlier Phase III trials which reported similar results but were underpowered for their endpoints:
· Researchers at the University of Florence reported a 1.5 percent rate of local recurrence for accelerated partial-breast irradiation versus 1.4 percent for whole-breast irradiation at five years of follow-up (Livi et al: Eur J Ca 2015;4:451-463); and
· The NIO Budapest trial reported local recurrences at 10.2 years of follow-up of 5.5 and 4.6 percent, respectively (Polgar et al: Rad & Onc 2013;108:197-202).
White noted that these three Phase III adjuvant accelerated partial-breast irradiation trials all included similar populations—post-lumpectomy patients with negative margins, almost nearly uniformly over age 50 and ER/PR-positive, tumors less than 1 cm in size, and either grade 1 or 2 tumors.
She said radiation oncologists are very familiar with this study population, which is consistent with the current ASTRO consensus statement for accelerated partial-breast irradiation--which includes tumors less than 2 cm in size, negative margins, positive ER/PR receptors, and being pathologically node negative.
“While the current consensus lists age over 60 years, there is an updated ASTRO consensus statement on accelerated partial-breast irradiation currently under review, which will reduce this age to 50 years,” White said.
She said the study is also confirmation of low-risk pathologic features that are the likely reason for the fewer local recurrences seen in this trial compared with the intraoperative partial-breast irradiation in the ELIOT study (Veronesi et al: Lancet Oncol 2013;14:1269-1277) and TARGIT study (Vaidya et al: Lancet 2014;383:603-613).
GEC-ESTRO reported a 1.9 percent locoregional recurrence rate for partial-breast irradiation, versus 4.4 percent in ELIOT and 3.3 percent in TARGIT, she noted.
Potential Barrier to Adoption
The GEC-ESTRO trial used a complex and technically difficult accelerated partial-breast irradiation method, White said, which is potentially the main barrier to its widespread adoption: “While the 16 institutions in this study successfully completed multi-catheter accelerated partial-breast irradiation, in the U.S. this is the method least often used.”
In addition, White noted that the researchers used a novel accelerated partial-breast irradiation target definition of 2 cm around the tumor including both the surgical and radiotherapy margin, which they previously reported (Strnad et al: Rad & Onc 2015;115:342-348), a target definition that will have to be confirmed in terms of reproducibility.
White pointed to two clear conclusions from this new trial:
· A low-risk population can be identified post-lumpectomy using standard clinical pathologic criteria of nodal stage, tumor size, grade, ER status, and age; and
· Irradiation confined to the high-risk region around the post-lumpectomy cavity yields outcomes that are not inferior to treatment of the entire breast.
“The results of this trial are a large step forward, but caution is still needed,” she said. “The cosmetic outcome for these patients, undeniably an important outcome, is unknown although it will soon be reported.”
In addition, low-risk breast cancer can have late local recurrences, and there were very few events in this study to determine non-inferiority in that respect.
Finally, “these results cannot be applied to cases with higher-risk clinical pathologic features of the patients you see in your clinic when you go back to work.”
Meanwhile, the optimal delivery method of accelerated partial-breast irradiation continues to evolve: “There are numerous additional Phase III trials that will build on these current findings,” White said, listing the NSABP B-39/RTOG 0413, RAPID OCOG, IMPORT Low MRC, IRMA, and SHARE trials--“These trials will have more than 14,000 women to answer these questions.”
Friday, November 13, 2015
BY ROBERT H. CARLSON
SAN ANTONIO--For head and neck cancer patients at high-risk for adverse events after chemoradiotherapy, more frequent follow-up appointments in an outpatient clinic led by advanced practice nurses (APNs) resulted in fewer post-treatment emergency room visits and hospital admissions compared with patients receiving standard follow-up care.
That was the conclusion of a study reported here at the American Society for Radiation Oncology Annual Meeting (Abstract 3169).
In the study, six of the 25 patients (25%) receiving care in an APN clinic visited the emergency room and/or were admitted to the hospital after chemoradiotherapy, versus 12 of the 24 patients (50%) receiving standard follow-up care.
“This study illustrates an important role for APNs in radiation oncology,” the lead study author, Bridgett Harr, CNP, of the Department of Radiation Oncology at Cleveland Clinic, explained in a news release.
“APNs are in a unique position to provide more intensive follow-up care, allowing them to better manage the post-treatment symptoms of high-risk head and neck cancer patients.”
Not only is there greater patient satisfaction when being managed in an outpatient setting, Harr said, but it is also more cost-effective to avoid emergency room or hospital admissions.
“The APN’s ability to provide high-quality, cost-effective care will play an increasingly vital role in the future of radiation oncology and health care.”
APNs have post-graduate education in nursing, often in a specific role and/or patient population, allowing them to diagnose and treat illnesses and prescribe medication.
Many Common Treatment-Related Side Effects
The side effects of radiation therapy and chemoradiation therapy for patients with head and neck cancer include short- and long-term pain, difficulty swallowing, tooth decay, bone pain, nausea, fatigue, mouth sores, and/or sore throat, resulting in infection risks and complications that may require unplanned visits to the emergency department or hospital admissions in the immediate post-treatment months, Harr explained.
The study—which received ASTRO’s Annual Meeting Nurses Abstract Award, which honors the highest-rated abstract with a nursing designation--compared the incidence of adverse events--defined as unplanned emergency department visits and/or hospital admissions within 90 days of the completion of radiation--in 25 high-risk head and neck cancer patients who received post-treatment care at an APN-led, acute-rehabilitation-focused clinic with the incidence in another group of 24 head and neck cancer patients who received standard follow-up treatment.
The award included $1,000, along with a certificate and complimentary Annual Meeting registration.
Patients in the standard follow-up group were identified using an approved institutional review board database. Patients were considered high risk if they had limited social support, lived in a nursing home, required multiple hydrations during treatment, received a second course of stereotactic body radiation therapy (SBRT), and/or had a feeding tube.
Ninety percent of the patients overall had stage IV or recurrent cancer. All patients were treated with intensity-modulated radiation therapy (IMRT) or SBRT techniques. Radiation therapy alone was given to 22 patients (45%), and the other 27 (55%) had radiation therapy with concurrent chemotherapy using either cisplatin or cetuximab.
Seen Twice as Often
Patients in the APN clinic group were seen twice as often as those in the standard follow-up group (1.2 vs. 2.0 visits): Standard follow-up patients were seen at four to six weeks post-treatment, and then at three months post-treatment. Patients in the APN clinic group were seen at two to four weeks post-treatment and every two to four weeks thereafter until any symptoms stabilized.
Of the 49 patients studied, 18 had adverse events a total of 26 times. Of the 18 who visited the emergency department or were admitted to the hospital, six (33%) were receiving frequent follow-up through the APN-led clinic.
Patients treated with radiation therapy alone who were in the APN clinic group had the most significant decrease in complications: only about 17 percent had adverse effects, compared with 60 percent in the standard follow-up group.
Harr said no difference in the incidence of adverse events was found between patients in either group treated with chemoradiation therapy--most likely due to the intensive post-radiation follow-up also provided by medical oncology.
“Ms. Harr’s abstract exemplifies the best in the nursing abstracts submitted this year for ASTRO’s Annual Meeting,” said Bruce D. Minsky, MD, FASTRO, ASTRO President at the time of the meeting and now Chair of the Board of Directors. “Every year we select an abstract that highlights research showing how nursing can benefit patient care.”
Organized Team-Based Approach
The moderator of a news conference at the meeting that featured studies illustrating “Improving Value and Elevating the Patient Care,” Brian Kavanagh, MD, Interim Chair of the Department of Radiation Oncology at the University of Colorado School of Medicine—and President-elect of ASTRO’s Board of Directors--said the study was an exercise in establishing an organized team-based approach to cancer care, one of the themes of the Annual Meeting.
“The better we can integrate the members of the cancer team, the better we can treat our patients and have good results, “ he said. “When we can anticipate a certain number of side effects [from our therapies], if we can jump ahead of the curve in that regard, we can avoid hospitalizations and avoid very costly emergency room visits.”
At the news conference, Harr was asked how her study might have an impact on the future roles of advanced practice nurses and other health care providers in radiation oncology: “This study showed how consistent symptom management in the post-recovery period can help decrease emergency room visits and hospitalization,” she said.
Harr’s coauthors for the study, all from Cleveland Clinic, were J. Hamker, N.P. Joshi, M.C. Ward, J. Bodmann, D.
Ives, M. Rahe, T. Nwizu, D.J. Adelstein, J.F. Greskovich Jr., and S. Koyfman..
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