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Intermediate-Risk Meningioma: Initial Outcomes from NRG Oncology/RTOG-0539
L. Rogers1, P. Zhang2, M. A. Vogelbaum3, A. Perry4, L. Ashby5, J. Modi6, A. Alleman7, J. M. Galvin8, D. Brachman9, J. M. Jenrette10, J. DeGroot11, J. A. Bovi12, M. Werner-Wasik13,
J. P. S. Knisely14, and M. P. Mehta15
1Virginia Commonwealth University, Richmond, VA, 2NRG Oncology Statistics and Data Management Center, Philadelphia, PA, 3Cleveland Clinic, Cleveland, OH, 4University of California, San Francisco, San Francisco, CA, 5Barrow Neurological Institute, Phoenix, AZ, 6Yale University, New Haven, CT, 7University of Oklahoma, Oklahoma City, OK, 8IROC Philadelphia RT, Philadelphia, PA, 9St. Joseph's Hospital and
Medical Center accruals for Arizona Oncology Services Foundation, Phoenix, AZ, 10Medical University of South Carolina, Charleston, SC, 11MD Anderson Cancer Center, Houston, TX, 12Medical College of
Wisconsin, Milwaukee, WI, 13Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, 14Hofstra North Shore-LIJ School of Medicine, Lake Success, NY, 15University of Maryland School of
Medicine, Baltimore, MD
MethodsPhase II Trial of Observation for Low-Risk Meningiomas, and of Radiotherapy for Intermediate and High-Risk Meningiomas
Opened June 19, 2009
Required Sample Size: 16555 for each Group
Patients enrolled:Group 1 65 CLOSED 9.29.10Group 2 56 CLOSED 5.12.11 Group 3 57 CLOSED 8.24.12
Average Monthly Accrual:Group 1 4.2Group 2 2.5Group 3 1.5
3D-CRT or IMRT 54 Gy / 30 Strata
ObservationGroup 1
Group 2
Group 3IMRT 60Gy / 30
Group 1 (Low Risk): New WHO Grade 1, GTR or STR
Group 2 (Interim Risk): Recurrent Grade 1, GTR or STRNew WHO Grade 2, GTR
Group 3 (High Risk): Any WHO Grade 3, GTR or STRRecurrent Grade 2, GTR or STRNew Grade 2, STR
Results• There was no difference in PFS between the subgroups (p=.503), validating our co-grouping of these entities into 1 prognostic category
• 3y PFS 96.0%
• 3y local control 98.0%
• 3y overall survival 96.0%
• According to the pre-specified analysis, AEs (definitely, probably or possibly related to protocol treatment) were limited to grade 1 or 2*, with no grade 3 events. Among 44 receiving IMRT, 4 (9%) developed grade 2* acute AEs, and 11 (25%) grade 2 late Aes.
*CTCAE grade 2: “moderate;; minimal, local or noninvasive intervention indicated.”http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
ResultsPrimary Endpoint 3y PFS:Progression-Free Survival
!Patients at risk
Years after registration
96%
Overall Survival
!
96%
Overall Survival
After 3 years, 2 additional patients progressed, 1 recurrent WHO I and 1 WHO II. Both remain alive.
ResultsAtypical Meningioma - 3y PFS / LC
0%10%20%30%40%50%60%70%80%90%100% 75%* 72%* 68%* 90%1* 89%* 68%* 65%2
0%10%20%30%40%50%60%70%80%90%100% 100% 100% 100%* 71%* 100% 98%1
GTR Alone GTR + EBRT
* taken from graph1 convexity only, 90% 3y retreatment-free surv2 crude 4-year
* taken from graph1 96% if morality is counted against PFS
NRG Oncology / Phase III Proposal
*GTR: gross total resection (Simpson grade 1-3)Stratify: pHH3 mitotic index 0-4 vs >5
RANDOMI ZE
Observation
RT (IMRT or Protons)59.4 Gy (1.8 Gy x 33)
Surgery GTR* WHO Grade IINewly Diagnosed Only
NRG Oncology / RTOG-0539 Accrual
! !
!
Group 1 Group 2
Group 3
Conclusions• This is the 1st completed cooperative group meningioma trial
• The 1st NRG/RTOG brain trial with protocol-specific IMRT parameters
• Patients with intermediate-risk meningioma (new WHO II with GTR or recurrent WHO I) treated with RT experienced 3y PFS of 96.0%, and 3y local control 98.0%
• Such treatment (54Gy/30) is well tolerated, with no acute or late AEs >2
• Path concordance is favorable (equal or superior to gliomas), at least among NRG institutions. If your WHO II percentages are <20-25%, inquire
• This study confirms that NRG can accrue meningioma patients well, and can mount a phase III trial
• We are planning a randomized trial of observation versus adjuvant RT for gross totally resected (Simpson grade 1-3) atypical meningioma
A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized
Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma
and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma
T. E. Merchant1, A. E. Bendel2, N. Sabin1, P. C. Burger3, S. Wu1, and J. M. Boyett1
1St. Jude Children's Research Hospital, Memphis, TN, 2Children's Hospitals and Clinics of Minnesota -Minneapolis, Minneapolis, MN, 3Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, MD
Study Design
Eligibility: Age ≥ 12 months, < 56 days from initial surgery, intracranial primary
ACNS0121 Study Dates: 8/25/2003 – 11/21/2007
Participants
ACNS0121 Children’s Oncology Group
ResultsEvent-Free Survival by Strata
ResultsEFS – Stratum 3+4 by Tumor Grade
ResultsEFS and OS – Stratum 3+4 by Age
Involved-Field Irradiation vs Elective Nodal Irradiation for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma: A Comparative Interim Analysis of Clinical
Outcomes and Toxicities (NCT01551589, CSWOG RTOG002)
T. Li1, A. Yisikandaer2, X. Zhang3, X. Wang4, Y. Ma5, L. Chen6, B. Lu7, H. Chen8, J. Yang9, J. Lv1, and J. Lang1
1Sichuan Cancer Hospital and Institute, Chengdu, China, 2The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China, 3The First Affiliated Hospital of XI'AN Jiaotong University, Xi An, China, 4Gansu Cancer Hospital, Lanzhou, China, 5Gansu Wu Wei Tumor hospital, Wu Wei, China, 6Guangxi Tumor
Hospital, The Affiliated Hospital of Guangxi Medical University, nanning, China, 7Guizhou Cancer Hospital, Guiyang, China, 8Kunming General Hospital Of Chengdu Military Region, kunming, China, 9Xinjiang
Renming Hospital, Xinjiang, China
Background• Esophageal carcinoma is a common disease with high mortality worldwide, especially in China.
• Chemoradiotherapy has become the most common treatment modality for LA-ESCC, but the definition of nodal irradiation volume is still a controversial topic.
• Elective Nodal Irradiation (ENI) practice is being widely adopted as a standard treatment regimen. However, ENI increased irradiation volume of the esophagus which presented as the major factor with possible complications of chemoradiotherapy.
• The aim of this study was to investigate the feasibility of reducing the nodal irradiation volume while maintaining the reasonable loco-regional lymph nodal control rate.
Study Design
Objective• Primary Endpoints:
o Toxicity
o Loco-regional lymph nodal recurrence (in-field, out-field)
• Secondary Endpoints:o Overall Survival (OS)
o Progression-free Survival (PFS)
Results
• IFI significantly decreased radiation pneumonitis and radiation esophagitis compared to ENI
• IFI didn't increase loco-regional lymph nodes recurrence especially the out-field recurrence rates compared to ENI
• They had similar Overall Survival and Progressive Free Survival
For patients with LA-ESCC treated with IFI compared to ENI group
Conclusions• Our study has preliminarily established the advantage of IFI in the radiotherapy of esophageal carcinoma.
• The results will dramatically alter the nodal irradiation volume significantly in future practice.
• It will also decrease the radiation pneumonitis and radiation esophagitis and obtain the same treatment effect accordingly.
• This could bring great benefit to the esophageal cancer patients.
Q & A
Questions?Contact ASTRO’s Press Officein San Antonio, Oct. 18-21
Slides, photos, and a link to the recording will be available following the briefing in ASTRO’s online press room:www.astro.org/AMPress
