or without IMC-RT in newly diagnosed Stage I and II breast cancers. ... Medical University, Syracuse, NY, 10UT Southwestern Medical Center at Dallas, Dallas, ...
Proceedings of the 51st Annual ASTRO Meeting
PLENARY
1
Ten-year Results of a Randomized Trial of Internal Mammary Chain Irradiation after Mastectomy
P. Romestaing1, A. Belot2, C. Hennequin3, J. Bosset4, P. Maingon5, J. Dubois6, N. Bossard2, J. Gerard7 Centre De Radiothe´rapie Charcot, Ste Foy Les Lyon, France, 2Service De Biostatistiques Des Hospices Civils De Lyon, Lyon Cedex, France, 3Service De Radiothe´rapie Hopital St. Louis, Hopitaux De Paris, France, 4Service De Radiothe´rapie, Besanc¸on, France, 5Service De Radiothe´rapie, Dijon, France, 6Service De Radiothe´rapie, Montpellier, France, 7Service De Radiothe´rapie, Nice, France 1
Purpose/Objective(s): To evaluate the impact of internal mammary chain irradiation (IMC-RT) on long-term survival in breast cancer patients treated with mastectomy. Materials/Methods: Multicentric randomized Phase III trial comparing chest wall, axillary, and supra-clavicular irradiation with or without IMC-RT in newly diagnosed Stage I and II breast cancers. Inclusion criteria: patients under 76-years-old with positive axillary nodes or internal/central tumor location whatever pN. Stratification was done by center, nodal status, and tumor location (internal/central vs. external). The IMC-RT consisted in a combination of photons (12.5 Gy in 5 fractions) and electrons (32.5 Gy in 13 fractions) over 5 weeks. The target field included the first five intercostal spaces. Adjuvant chemotherapy or hormonal treatment was at the discretion of the physician. We planned to include 1,200 patients that allowed us to detect 10% difference in 10-year overall survival. Results: A total of 1,334 patients have been randomized. Mean age was 56.5-years-old, 1,003 (75%) patients had positive lymph nodes. With a median follow-up of 10 years, we observed 535 deaths. Ten-year survival was 62.57% in case of IMC-RT and 59.55% without IMC-RT (p = 0.8762 by log–rank test). No difference was obtained in the different subgroups: positive or negative axillary nodes, external vs. central/internal tumors, or according to the different histologic subtypes, adjuvant chemotherapy, or hormonotherapy. Causes of death are known in 422 patients: most of these deaths were due to breast cancer (371); no increase in cardiac toxicity was observed in the IMC-RT group. Conclusions: Using IMC-RT did not improve overall survival in this large randomized study. Author Disclosure: P. Romestaing, None; A. Belot, None; C. Hennequin, None; J. Bosset, None; P. Maingon, None; J. Dubois, None; N. Bossard, None; J. Gerard, None.
PLENARY
2
Phase III Study of Prophylactic Cranial Irradiation vs. Observation in Patients with Stage III Non–small-cell Lung Cancer: Neurocognitive and Quality of Life Analysis of RTOG 0214
B. Movsas1, K. Bae2, C. Meyers3, E. Gore4, J. Bonner5, A. Sun6, S. Schild7, L. E. Gaspar8, J. Bogart9, H. Choy10 Henry Ford Hospital, Detroit, MI, 2Radiation Therapy Oncology Group, Philadelphia, PA, 3M. D. Anderson Cancer Center, Houston, TX, 4Medical College of Wisconsin, Milwaukee, WI, 5University of Alabama, Birmingham, AL, 6Ontario Cancer Institute, Toronto, ON, Canada, 7Mayo Clinic, Scottsdale, AZ, 8University of Colorado at Denver, Aurora, CO, 9SUNY Upstate Medical University, Syracuse, NY, 10UT Southwestern Medical Center at Dallas, Dallas, TX 1
Purpose/Objective(s): There are scant data from randomized trials regarding the effects of prophylactic cranial irradiation (PCI) on neurocognitive function (NF) and quality of life (QOL). The primary endpoint of RTOG 0214 showed no overall survival (OS) benefit for PCI in Stage III non–small-cell lung cancer (NSCLC). This analysis focuses on the secondary objectives to determine the impact of PCI on the incidence of central nervous system metastases (CNS mets), NF, and QOL. Materials/Methods: Patients with Stage III NSCLC who completed definitive therapy without progression were eligible. Patients were randomized to PCI (30 Gy at 2 Gy/fraction q/day) or observation. Mini-mental status exam (MMSE), activities of daily living scale (ADLS), and Hopkins Verbal Learning Test (HVLT) were used to assess NF. The EORTC QLQC30 and QLQBN20 were used to assess QOL. The Kaplan-Meier method with the log–rank test was used for OS and disease-free survival (DFS). The logistic regression model was used for the incidence of CNS mets. The p values from t test adjusted by Hommel’s stagewise rejective procedure were reported for NF and QOL tools. The cutoff of neurologic deterioration evaluated by MMSE and HVLT was calculated using reliable change index at 1 year from baseline. For QOL, a 10 point (of 100) change was considered clinically relevant. Results: This study opened in September 2002 and closed due to slow accrual in August 2007. Total accrual was 356 patients (of the targeted 1,058), of whom 340 were eligible. One-year OS (75.6% vs. 76.9%; p = 0.86) and 1 year DFS (56.4% vs. 51.2%; p = 0.11) for PCI vs. observation, respectively, were not significantly different. However, the incidence of CNS mets at 1 year was 7.7% vs. 18% for PCI vs. observation (p = 0.004). There were no significant differences at 1 year between the two arms in any component of the EORTC QLQC30 or QLQBN20 (all adjusted p values . 0.05), though a trend for greater decline in patient-reported cognitive functioning with PCI was noted. There were no differences in MMSE (p = 0.60) or ADLS (p = 0.88). However, for HVLT, there was greater decline in immediate recall (p = 0.03) and delayed recall (p = 0.008) in the PCI arm at 1 year. No clear differences at 1 year emerged in NF or QOL between patients \ = 60 or .60 years on either arm (all adjusted p values . 0.05). These results were the same when patients with and without CNS mets were compared. Conclusions: The PCI in Stage III NSCLC significantly decreases the risk of CNS mets without significant differences in OS or DFS. There were no significant differences in global cognitive function (on MMSE) or QOL following PCI, but there was a significant decline in memory (on HVLT). This study provides prospective data regarding the relative benefits and risks of PCI in this setting and the need to use sensitive cognitive assessments. Supported by grant numbers (RTOG U10 CA21661, CCOP U10 CA37422) from the NCI. Author Disclosure: B. Movsas, None; K. Bae, None; C. Meyers, None; E. Gore, None; J. Bonner, None; A. Sun, None; S. Schild, None; L.E. Gaspar, None; J. Bogart, None; H. Choy, None.
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