Changing the Practice

Radiology research from the ACR Clinical Research Center takes center stage at this year's ASTRO meeting.changing the practice

Editor's Note: World-class research from RTOG® was spotlighted at the American Society for Radiation Oncology (ASTRO) 55th Annual Meeting in September. Twenty-two RTOG research presentations were featured during the meeting, which took place in Atlanta.

The meeting's focus on patient-centered care and the physician's role in improving the quality and safety of patient care provided an exceptional opportunity to showcase recent results. Particularly exciting was the program's plenary session comprised of four presentations reporting RTOG practice-changing science highlighted below.

Less is Sometimes More: RTOG 9910

Current practice trends show an increase in the duration of androgen suppression therapy (AST) for men with prostate cancer who are at intermediate risk for cancer recurrence after initial treatment. However, RTOG Principal Investigator Thomas M. Pisansky, MD, professor of radiation oncology at the Mayo Clinic in Rochester, Minn., reported results of the RTOG 9910 trial that confirm excellent outcomes with a short course of hormonal therapy. The phase-III randomized study evaluated whether the standard 16-week course of AST (eight weeks prior to radiation therapy [RT] followed by RT with eight additional weeks of AST [Arm 1]) would improve patient outcomes compared with extended AST (28 weeks prior to RT followed by RT with eight additional weeks of AST [Arm 2]).

Nearly 1,580 study participants with intermediate-risk prostate cancer were enrolled in the study at 152 research sites. Pisansky reported that the shorter course of AST is substantiated as the optimal treatment regimen by the end points evaluated in the study. These included, at 10 years study participant follow up, comparisons of the overall survival rate of participants in Arm 1 and Arm 2 (66 versus 67 percent), incidence of a rising prostate-specific antigen level (27 percent in both arms), locoregional prostate cancer recurrence (6 percent versus 4 percent), and cancer metastasis rates (6 percent in both arms).

"This evidence demonstrates that a short 16-week course of hormonal therapy provides excellent outcomes for patients with intermediate-risk prostate cancer without the increased side effects of longer hormonal therapy, which may include hot flashes and erectile dysfunction. It's also excellent news that we can reduce the cost of the medical therapy and yet not sacrifice patient outcomes," says Pisansky.

What do Patients Say? RTOG 0617

The RTOG 0617 phase-III randomized trial evaluated whether a higher dose of RT (74 Gy) with chemotherapy versus a standard dose of RT (60 Gy) with chemotherapy improved overall survival for patients with stage-III, non-small cell lung cancer. RTOG researchers previously reported the 74 Gy arm resulted in lower rates of patient survival, although no differences in provider-reported adverse events between the study arms were recorded. However, results of an RTOG 0617 quality of life (QOL) analysis presented by Benjamin Movsas, MD, FACR, chair of radiation oncology at Henry Ford Hospital in Detroit and the trial's QOL co-chair, showed a different picture.

Three months after treatment began, almost half of the patients who received the higher dose of RT with chemotherapy reported a clinically meaningful decline in quality of life, compared with less than a third of those who received a standard dose of RT with chemotherapy. "This speaks to the disconnect that can occur between the provider and patient perspective," says Movsas. "Provider-reported toxicities, while important, often do not capture the whole story. Analyzing QOL reports coming directly from the patients demonstrated more clearly clinically meaningful differences in how the patients were doing in each of this study's two arms."

Commenting on the finding that QOL results are predictive of patient survival, Movsas points out, "It's noteworthy that patients on the higher-dose RT arm had a lower quality of life at three months and, unfortunately, this arm also ended up having lower survival. It's intriguing that, when you add quality of life to the mix of prognostic variables, it becomes a critical and independent predictor of outcome."

The meeting's focus on patient-centered care and the physician's role in improving the quality and safety of patient care provided an exceptional opportunity to showcase recent results.

Preserving Memory: RTOG 0933

"Radiation oncologists often face the dilemma of weighing the therapeutic benefits of whole-brain radiotherapy (WBRT) against the treatment's known side effects," says Vinai Gondi, MD, co-director of the Cadence Health Brain Tumor Center and associate research director at the Cadence Health Proton Center. He cites, as an example, the use of WBRT in patients with multiple brain metastases and the associated memory loss that clearly impacts their quality of life.

"Preclinical and clinical evidence has suggested that the dose of radiation received by the hippocampus during WBRT may play a role in radiation-induced cognitive decline. That led us to develop the research study RTOG 0933, a single-arm, phase-II trial. The study was designed to determine if employing a hippocampal avoidance technique with intensity-modulated radiation therapy would achieve the therapeutic benefits of whole brain radiotherapy while still preserving memory function," explains Gondi, the trial's co-principal investigator, who presented the study results.

RTOG 0933 study participants with brain metastases in whom the hippocampal region was avoided during WBRT experienced, on average, a 7 percent memory score decline at 4 months post-treatment, as measured by the delayed recall scale of the Hopkins Verbal Learning Test. In comparison, a historical control group of patients with brain metastases who underwent conventional WBRT without avoiding the hippocampus had a 30 percent memory score decline. "Although we expected to observe some benefit, we were surprised and excited by results suggesting that, by minimizing radiation dose to the hippocampus during WBRT, patient memory function can essentially be preserved," says Gondi, who also notes that a 7 percent memory decline score is within the standard error of measurement for the delayed recall scale, suggesting that the hippocampal-avoidance WBRT technique resulted in minimal impact on patients' memory.changing the practice in textr

Effectively Screening Patients for Depression: RTOG 0841

RTOG 0841 Co-Principal Investigator William Small Jr., MD, FACR, chair of the Department of Radiation Oncology at the Stritch School of Medicine at Loyola University in Chicago, reported the trial's conclusions — patients undergoing RT in community-based radiation oncology practices can be screened for depression effectively using a two-item questionnaire administered by clinical staff. "It is particularly exciting to observe that, across the three screening approaches we evaluated, a very simple and easy-to-administer, two-item questionnaire proved to be effective for identifying patients who require further evaluation for depression," says Small.

Study participants enrolled in RTOG 0841 and about to undergo radiotherapy completed three depression screening questionnaires in the radiation oncology clinic: the Patient Health Questionnaire-9 Item (PHQ-9), which contains the Patient Health Questionnaire-2 Item (PHQ-2); the Hopkins Symptom Checklist (HSCL-25); and the single-item National Comprehensive Cancer Network® (NCCN) Distress Thermometer. Participants who screened positive for depression were contacted by a clinical psychologist who then administered the Structured Clinical Interview for DSM-IV Disorders (SCID) Mood Disorder modules via a telephone interview.

"We used the SCID, a well-recognized gold standard for diagnosing mood disorders, including depression, to determine how accurately the screening questionnaires identified clinically depressed patients," says RTOG 0841 Principal Investigator Lynne Wagner, PhD, an associate professor in the Department of Medical Social Sciences at the Northwestern University Feinberg School of Medicine in Chicago. "Our data show that the PHQ-2 accurately identifies patients for whom further assessment is indicated. We also established that the widely used NCCN Distress Thermometer, while effective at detecting anxiety, is not an adequate depression screening tool." She stressed that the results can be used by cancer programs to inform the development of effective distress screening programs, in light of the Commission on Cancer's accreditation requirements.


By Nancy Fredericks, MBA
Nancy Fredericks, MBA (This email address is being protected from spambots. You need JavaScript enabled to view it.), is communications director, ACR Clinical Research Center.

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