The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Elizabeth Gore - One of the best experts on this subject based on the ideXlab platform.
-
randomized phase ii study comparing Prophylactic Cranial Irradiation alone to Prophylactic Cranial Irradiation and consolidative extraCranial Irradiation for extensive disease small cell lung cancer ed sclc nrg oncology rtog 0937
Journal of Thoracic Oncology, 2017Co-Authors: Elizabeth Gore, Maria Wernerwasik, Alexander Y Sun, Daniel F Grimm, Suresh S Ramalingam, Neal Dunlap, Kristin A Higgins, Aaron M Allen, Puneeth Iyengar, Gregory M M VideticAbstract:Abstract Introduction NRG Oncology RTOG 0937 is a randomized phase II trial evaluating 1-year overall survival (OS) with Prophylactic Cranial Irradiation (PCI) or PCI plus consolidative radiation therapy (PCI+cRT) to intrathoracic disease and extraCranial metastases for extensive-disease SCLC. Methods Patients with one to four extraCranial metastases were eligible after a complete response or partial response to chemotherapy. Randomization was to PCI or PCI+cRT to the thorax and metastases. Original stratification included partial response versus complete response after chemotherapy and one versus two to four metastases; age younger than 65 years versus 65 years or older was added after an observed imbalance. PCI consisted of 25 Gy in 10 fractions. cRT consisted of 45 Gy in 15 fractions. To detect an improvement in OS from 30% to 45% with a 34% hazard reduction (hazard ratio = 0.66) under a 0.1 type 1 error (one sided) and 80% power, 154 patients were required. Results A total of 97 patients were randomized between March 2010 and February 2015. Eleven patients were ineligible (nine in the PCI group and two in the PCI+cRT group), leaving 42 randomized to receive PCI and 44 to receive PCI+cRT. At planned interim analysis, the study crossed the futility boundary for OS and was closed before meeting the accrual target. Median follow-up was 9 months. The 1-year OS was not different between the groups: 60.1% (95% confidence interval [CI]: 41.2–74.7) for PCI and 50.8% (95% CI: 34.0–65.3) for PCI+cRT ( p = 0.21). The 3- and 12-month rates of progression were 53.3% and 79.6% for PCI and 14.5% and 75% for PCI+cRT, respectively. Time to progression favored PCI+cRT (hazard ratio = 0.53, 95% CI: 0.32–0.87, p = 0.01). One patient in each arm had grade 4 therapy-related toxicity and one had grade 5 therapy-related pneumonitis with PCI+cRT. Conclusions OS exceeded predictions for both arms. cRT delayed progression but did not improve 1-year OS.
-
Prophylactic Cranial Irradiation for patients with lung cancer
Lancet Oncology, 2016Co-Authors: Cecile Le Pechoux, A Sun, Ben J Slotman, Dirk De Ruysscher, J Belderbos, Elizabeth GoreAbstract:The incidence of brain metastases in patients with lung cancer has increased as a result of improved local and systemic control and better diagnosis from advances in brain imaging. Because brain metastases are responsible for life-threatening symptoms and serious impairment of quality of life, resulting in shortened survival, Prophylactic Cranial Irradiation has been proposed in both small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC) to try to improve incidence of brain metastasis, survival, and eventually quality of life. Findings from randomised controlled trials and a meta-analysis have shown that Prophylactic Cranial Irradiation not only reduces the incidence of brain metastases in patients with SCLC and with non-metastatic NSCLC, but also improves overall survival in patients with SCLC who respond to first-line treatment. Although Prophylactic Cranial Irradiation is potentially associated with neurocognitive decline, this risk needs to be balanced against the potential benefit in terms of brain metastases incidence and survival. Several strategies to reduce neurotoxicity are being investigated.
-
nrg oncology rtog 0937 randomized phase 2 study comparing Prophylactic Cranial Irradiation pci alone to pci and consolidative extraCranial Irradiation for extensive disease small cell lung cancer ed sclc
International Journal of Radiation Oncology Biology Physics, 2016Co-Authors: Elizabeth Gore, Maria Wernerwasik, A Sun, Daniel F Grimm, Suresh S Ramalingam, Neal Dunlap, Aaron M Allen, Puneeth Iyengar, Kristin Higgins, Gregory M M VideticAbstract:NRG Oncology/RTOG 0937: Randomized Phase 2 Study Comparing Prophylactic Cranial Irradiation (PCI) Alone to PCI and Consolidative ExtraCranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) E.M. Gore, C. Hu, A. Sun, D. Grimm, S. Ramalingam, N.E. Dunlap, K.A. Higgins, M. Werner-Wasik, A.M. Allen, P. Iyengar, G.M. Videtic, R.K. Hales, R.C. McGarry, J.J. Urbanic, A.T. Pu, C. Johnstone, J.N. Atkins, and J.D. Bradley; Medical College of Wisconsin, Milwaukee, WI, NRG Oncology, Philadelphia, PA, Princess Margaret Hospital, Toronto, ON, Canada, Emory University, Atlanta, GA, United States, University of Louisville, Louisville, KY, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, Rabin Medical Center, Petah Tikva, Israel, University of Texas Southwestern Medical Center, DALLAS, TX, Cleveland Clinic, Cleveland, OH, Johns Hopkins University, Baltimore, MD, United States, University of Kentucky, Lexington, KY, University of California, San Diego, La Jolla, CA, Sutter Medical Group Radiological Associates of Sacramento, Sacramento, CA, Southeast Cancer Consortium-Upstate NCORP, Goldsboro, NC, Washington University School of Medicine, St. Louis, MO
-
decline in tested and self reported cognitive functioning after Prophylactic Cranial Irradiation for lung cancer pooled secondary analysis of radiation therapy oncology group randomized trials 0212 and 0214
International Journal of Radiation Oncology Biology Physics, 2013Co-Authors: Rebecca Paulus, Deborah Watkins Bruner, Elizabeth Gore, Aaron H Wolfson, Maria Wernerwasik, Christina A. Meyers, Vinai Gondi, Hak Choy, Benjamin MovsasAbstract:Purpose To assess the impact of Prophylactic Cranial Irradiation (PCI) on self-reported cognitive functioning (SRCF), a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Methods and Materials Radiation Therapy Oncology Group (RTOG) protocol 0214 randomized patients with locally advanced non-small cell lung cancer to PCI or observation; RTOG 0212 randomized patients with limited-disease small cell lung cancer to high- or standard-dose PCI. In both trials, Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline (after locoregional therapy but before PCI or observation) and at 6 and 12 months. Patients developing brain relapse before follow-up evaluation were excluded. Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling. Fisher's exact test correlated decline in SRCF with HVLT decline. Results Of the eligible patients pooled from RTOG 0212 and RTOG 0214, 410 (93%) receiving PCI and 173 (96%) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis. Prophylactic Cranial Irradiation was associated with a higher risk of decline in SRCF at 6 months (odds ratio 3.60, 95% confidence interval 2.34-6.37, P P P =.002 and P =.002, respectively) but was not closely correlated with decline in SRCF at the same time points ( P =.05 and P =.86, respectively). Conclusions In lung cancer patients who do not develop brain relapse, PCI is associated with decline in HVLT-tested and self-reported cognitive functioning. Decline in HVLT and decline in SRCF are not closely correlated, suggesting that they may represent distinct elements of the cognitive spectrum.
-
phase iii trial of Prophylactic Cranial Irradiation compared with observation in patients with locally advanced non small cell lung cancer neurocognitive and quality of life analysis
Journal of Clinical Oncology, 2011Co-Authors: Elizabeth Gore, Benjamin Movsas, Maria Wernerwasik, Christina A. Meyers, Steven E Schild, Stuart J Wong, James A Bonner, Laurie E Gaspar, Jeffery A Bogart, Hak ChoyAbstract:Purpose There are scant data regarding the effects of Prophylactic Cranial Irradiation (PCI) on neurocognitive function (NCF) and quality of life (QOL). Radiation Therapy Oncology Group trial 0214 showed no overall survival (OS) benefit for PCI in stage III non–small-cell lung cancer (NSCLC) at 1 year. However, there was a significant decrease in brain metastases (BM). This analysis focuses on the impact of PCI on NCF and QOL. Patients and Methods Patients with stage III NSCLC who completed definitive therapy without progression were randomly assigned to PCI or observation. NCF was assessed with Mini-Mental Status Examination (MMSE), Activities of Daily Living Scale (ADLS), and Hopkins Verbal Learning Test (HVLT). QOL was assessed with the European Organisation for Research and Treatment of Cancer (EORTC) core tool (QOL Questionnaire-QLQC30) and brain module (QLQBN20). Results There were no statistically significant differences at 1 year between the two arms in any component of the EORTC-QLQC30 or QLQBN20...
Steven E Schild - One of the best experts on this subject based on the ideXlab platform.
-
Prophylactic Cranial Irradiation for extensive small cell lung cancer
Journal of Oncology Practice, 2017Co-Authors: Steven E Schild, Terence T Sio, Thomas B Daniels, Stephen G Chun, Dirk RadesAbstract:Small-cell lung cancer (SCLC) has a high predilection for metastasizing to the brain after chemotherapy. This has been blamed on the blood-brain barrier, which prevents chemotherapy from penetrating into the brain, thus creating a sanctuary site. It has been estimated that up to three quarters of patients with SCLC will eventually develop brain metastases. This led investigators to administer Prophylactic Cranial Irradiation (PCI) to decrease this risk. Several trials were performed in patients with SCLC after initial therapy (chemotherapy with or without thoracic radiotherapy) that compared the outcomes of PCI versus no PCI. Early trials generally found that PCI significantly decreased the risk of brain metastases but did not significantly improve survival. These trials were re-evaluated in two larger meta-analyses that included patients with either limited-stage SCLC or extensive-stage SCLC (ESCLC). Both meta-analyses reported that PCI significantly decreased brain metastases and improved survival in patients who had a complete response following initial therapy. These studies were performed before the advent of modern imaging with computed tomography or magnetic resonance imaging (MRI). There have been two modern trials of PCI versus no PCI in patients with ESCLC and both found that PCI decreases brain metastases. The first did not include brain MRI before registration and found that PCI improved survival, whereas the second study did include MRI before registration and at frequent intervals thereafter. That trial found that PCI did not confer a survival advantage. This review will examine the evidence and provide recommendations regarding the role of PCI for patients with ESCLC.
-
Prophylactic Cranial Irradiation following surgical resection of early stage small cell lung cancer a review of the literature
Frontiers in Oncology, 2017Co-Authors: Brooke C Bloom, Steven E Schild, Ritsuko Komaki, Alexander Augustyn, Boris Sepesi, Sunil M Patel, Shalin J Shah, Stephen G ChunAbstract:With increasing use of low-dose screening CT-scans, the diagnosis of early-stage small cell lung cancer (SCLC) without evidence of mediastinal nodal or distant metastasis is likely to become more common, but the role of adjuvant therapies such as Prophylactic Cranial Irradiation (PCI) are not well understood in this population. We performed a review of the literature pertaining to the impact of PCI in patients who underwent surgical resection of early-stage SCLC. Three studies were identified that were pertinent including three single-institution retrospective analyses and a National Cancer Database analysis. Based upon these studies, we estimate the rate of brain metastases to be 10-15% for Stage I and 15-25% for Stage II disease without PCI. However, the impact of PCI on the development of brain metastases and its ultimate impact on overall survival were not consistent across these studies. In summary, there is sparse evidence to guide recommendations for PCI following resection of early-stage SCLC. While it may be reasonable to offer PCI to maximize likelihood of cure, alternative strategies such as observation with close imaging follow-up can also be considered for the appropriate patient given the known neurocognitive side effects of PCI.
-
Prophylactic Cranial Irradiation in elderly patients with small cell lung cancer findings from a north central cancer treatment group pooled analysis
Journal of Geriatric Oncology, 2015Co-Authors: William G Rule, Nathan R Foster, Jeffrey P Meyers, Yolanda I Garces, Jonathan B Ashman, Sujay A Vora, Timothy F Kozelsky, James J Urbanic, Joseph K Salama, Steven E SchildAbstract:Abstract Objectives To examine the efficacy of Prophylactic Cranial Irradiation (PCI) in elderly patients with small cell lung cancer (SCLC) (≥70years of age) from a pooled analysis of four prospective trials. Materials & Methods One hundred fifty-five patients with SCLC (limited stage, LSCLC, and extensive stage, ESCLC) participated in four phase II or III trials. Ninety-one patients received PCI (30Gy/15 or 25Gy/10) and 64 patients did not receive PCI. Survival was compared in a landmark analysis that included only patients who had stable disease or better in response to primary therapy. Results Patients who received PCI had better survival than patients who did not receive PCI (median survival 12.0months vs. 7.6months, 3-year overall survival 13.2% vs. 3.1%, HR=0.53 [95% CI 0.36–0.78], p =0.001). On multivariate analysis of the entire cohort, the only factor that remained significant for survival was stage (ESCLC vs. LSCLC, p =0.0072). In contrast, the multivariate analysis of patients who had ESCLC revealed that PCI was the sole factor associated with a survival advantage (HR=0.47 [95% CI 0.24–0.93], p =0.03). Grade 3 or higher adverse events (AEs) were significantly greater in patients who received PCI (71.4% vs. 47.5%, p =0.0031), with non-neuro and non-heme being the specific AE categories most strongly correlated with PCI delivery. Conclusions PCI was associated with a significant improvement in survival for our entire elderly SCLC patient cohort on univariate analysis. Multivariate analysis suggested that the survival advantage remained significant in patients with ESCLC. PCI was also associated with a modest increase in grade 3 or higher AEs.
-
Prophylactic Cranial Irradiation in small cell lung cancer findings from a north central cancer treatment group pooled analysis
Annals of Oncology, 2012Co-Authors: Steven E Schild, Nathan R Foster, Jeffrey P Meyers, Helen J Ross, P J Stella, Yolanda I Garces, Kenneth R Olivier, Julian R Molina, L R Past, A A AdjeiAbstract:Background: This pooled analysis evaluated the outcomes of Prophylactic Cranial Irradiation (PCI) in 739 small-cell lung cancer (SCLC patients with stable disease (SD) or better following chemotherapy ± thoracic radiation therapy (TRT) to examine the potential advantage of PCI in a wider spectrum of patients than generally participate in PCI trials. Patients and methods: Three hundred eighteen patients with extensive SCLC (ESCLC) and 421 patients with limited SCLC (LSCLC) participated in four phase II or III trials. Four hundred fifty-nine patients received PCI (30 Gy/15 or 25 Gy/10) and 280 did not. Survival and adverse events (AEs) were compared. Results: PCI patients survived significantly longer than non-PCI patients {hazard ratio [HR] = 0.61 [95% confidence interval (CI): 0.52–0.72]; P< 0.0001}. The 1- and 3-year survival rates were 56% and 18% for PCI patients versus 32% and 5% for non-PCI patients. PCI was still significant after adjusting for age, performance status, gender, stage, complete response, and number of metastatic sites (HR = 0.82, P = 0.04). PCI patients had significantly more grade 3+ AEs (64%) compared with non-PCI patients (50%) (P= 0.0004). AEs associated with PCI included alopecia and lethargy. Dose fractionation could be compared only for LSCLC patients and 25 Gy/10 was associated with significantly better survival compared with 30 Gy/15 (HR = 0.67, P = 0.018). Conclusions: PCI was associated with a significant survival benefit for both ESCLC and LSCLC patients who had SD or a better response to chemotherapy ± TRT. Dose fractionation appears important. PCI was associated with an increase in overall and specific grade 3+ AE rates.
-
phase iii trial of Prophylactic Cranial Irradiation compared with observation in patients with locally advanced non small cell lung cancer neurocognitive and quality of life analysis
Journal of Clinical Oncology, 2011Co-Authors: Elizabeth Gore, Benjamin Movsas, Maria Wernerwasik, Christina A. Meyers, Steven E Schild, Stuart J Wong, James A Bonner, Laurie E Gaspar, Jeffery A Bogart, Hak ChoyAbstract:Purpose There are scant data regarding the effects of Prophylactic Cranial Irradiation (PCI) on neurocognitive function (NCF) and quality of life (QOL). Radiation Therapy Oncology Group trial 0214 showed no overall survival (OS) benefit for PCI in stage III non–small-cell lung cancer (NSCLC) at 1 year. However, there was a significant decrease in brain metastases (BM). This analysis focuses on the impact of PCI on NCF and QOL. Patients and Methods Patients with stage III NSCLC who completed definitive therapy without progression were randomly assigned to PCI or observation. NCF was assessed with Mini-Mental Status Examination (MMSE), Activities of Daily Living Scale (ADLS), and Hopkins Verbal Learning Test (HVLT). QOL was assessed with the European Organisation for Research and Treatment of Cancer (EORTC) core tool (QOL Questionnaire-QLQC30) and brain module (QLQBN20). Results There were no statistically significant differences at 1 year between the two arms in any component of the EORTC-QLQC30 or QLQBN20...
Maria Wernerwasik - One of the best experts on this subject based on the ideXlab platform.
-
randomized phase ii study comparing Prophylactic Cranial Irradiation alone to Prophylactic Cranial Irradiation and consolidative extraCranial Irradiation for extensive disease small cell lung cancer ed sclc nrg oncology rtog 0937
Journal of Thoracic Oncology, 2017Co-Authors: Elizabeth Gore, Maria Wernerwasik, Alexander Y Sun, Daniel F Grimm, Suresh S Ramalingam, Neal Dunlap, Kristin A Higgins, Aaron M Allen, Puneeth Iyengar, Gregory M M VideticAbstract:Abstract Introduction NRG Oncology RTOG 0937 is a randomized phase II trial evaluating 1-year overall survival (OS) with Prophylactic Cranial Irradiation (PCI) or PCI plus consolidative radiation therapy (PCI+cRT) to intrathoracic disease and extraCranial metastases for extensive-disease SCLC. Methods Patients with one to four extraCranial metastases were eligible after a complete response or partial response to chemotherapy. Randomization was to PCI or PCI+cRT to the thorax and metastases. Original stratification included partial response versus complete response after chemotherapy and one versus two to four metastases; age younger than 65 years versus 65 years or older was added after an observed imbalance. PCI consisted of 25 Gy in 10 fractions. cRT consisted of 45 Gy in 15 fractions. To detect an improvement in OS from 30% to 45% with a 34% hazard reduction (hazard ratio = 0.66) under a 0.1 type 1 error (one sided) and 80% power, 154 patients were required. Results A total of 97 patients were randomized between March 2010 and February 2015. Eleven patients were ineligible (nine in the PCI group and two in the PCI+cRT group), leaving 42 randomized to receive PCI and 44 to receive PCI+cRT. At planned interim analysis, the study crossed the futility boundary for OS and was closed before meeting the accrual target. Median follow-up was 9 months. The 1-year OS was not different between the groups: 60.1% (95% confidence interval [CI]: 41.2–74.7) for PCI and 50.8% (95% CI: 34.0–65.3) for PCI+cRT ( p = 0.21). The 3- and 12-month rates of progression were 53.3% and 79.6% for PCI and 14.5% and 75% for PCI+cRT, respectively. Time to progression favored PCI+cRT (hazard ratio = 0.53, 95% CI: 0.32–0.87, p = 0.01). One patient in each arm had grade 4 therapy-related toxicity and one had grade 5 therapy-related pneumonitis with PCI+cRT. Conclusions OS exceeded predictions for both arms. cRT delayed progression but did not improve 1-year OS.
-
nrg oncology rtog 0937 randomized phase 2 study comparing Prophylactic Cranial Irradiation pci alone to pci and consolidative extraCranial Irradiation for extensive disease small cell lung cancer ed sclc
International Journal of Radiation Oncology Biology Physics, 2016Co-Authors: Elizabeth Gore, Maria Wernerwasik, A Sun, Daniel F Grimm, Suresh S Ramalingam, Neal Dunlap, Aaron M Allen, Puneeth Iyengar, Kristin Higgins, Gregory M M VideticAbstract:NRG Oncology/RTOG 0937: Randomized Phase 2 Study Comparing Prophylactic Cranial Irradiation (PCI) Alone to PCI and Consolidative ExtraCranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) E.M. Gore, C. Hu, A. Sun, D. Grimm, S. Ramalingam, N.E. Dunlap, K.A. Higgins, M. Werner-Wasik, A.M. Allen, P. Iyengar, G.M. Videtic, R.K. Hales, R.C. McGarry, J.J. Urbanic, A.T. Pu, C. Johnstone, J.N. Atkins, and J.D. Bradley; Medical College of Wisconsin, Milwaukee, WI, NRG Oncology, Philadelphia, PA, Princess Margaret Hospital, Toronto, ON, Canada, Emory University, Atlanta, GA, United States, University of Louisville, Louisville, KY, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, Rabin Medical Center, Petah Tikva, Israel, University of Texas Southwestern Medical Center, DALLAS, TX, Cleveland Clinic, Cleveland, OH, Johns Hopkins University, Baltimore, MD, United States, University of Kentucky, Lexington, KY, University of California, San Diego, La Jolla, CA, Sutter Medical Group Radiological Associates of Sacramento, Sacramento, CA, Southeast Cancer Consortium-Upstate NCORP, Goldsboro, NC, Washington University School of Medicine, St. Louis, MO
-
decline in tested and self reported cognitive functioning after Prophylactic Cranial Irradiation for lung cancer pooled secondary analysis of radiation therapy oncology group randomized trials 0212 and 0214
International Journal of Radiation Oncology Biology Physics, 2013Co-Authors: Rebecca Paulus, Deborah Watkins Bruner, Elizabeth Gore, Aaron H Wolfson, Maria Wernerwasik, Christina A. Meyers, Vinai Gondi, Hak Choy, Benjamin MovsasAbstract:Purpose To assess the impact of Prophylactic Cranial Irradiation (PCI) on self-reported cognitive functioning (SRCF), a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Methods and Materials Radiation Therapy Oncology Group (RTOG) protocol 0214 randomized patients with locally advanced non-small cell lung cancer to PCI or observation; RTOG 0212 randomized patients with limited-disease small cell lung cancer to high- or standard-dose PCI. In both trials, Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline (after locoregional therapy but before PCI or observation) and at 6 and 12 months. Patients developing brain relapse before follow-up evaluation were excluded. Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling. Fisher's exact test correlated decline in SRCF with HVLT decline. Results Of the eligible patients pooled from RTOG 0212 and RTOG 0214, 410 (93%) receiving PCI and 173 (96%) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis. Prophylactic Cranial Irradiation was associated with a higher risk of decline in SRCF at 6 months (odds ratio 3.60, 95% confidence interval 2.34-6.37, P P P =.002 and P =.002, respectively) but was not closely correlated with decline in SRCF at the same time points ( P =.05 and P =.86, respectively). Conclusions In lung cancer patients who do not develop brain relapse, PCI is associated with decline in HVLT-tested and self-reported cognitive functioning. Decline in HVLT and decline in SRCF are not closely correlated, suggesting that they may represent distinct elements of the cognitive spectrum.
-
phase iii trial of Prophylactic Cranial Irradiation compared with observation in patients with locally advanced non small cell lung cancer neurocognitive and quality of life analysis
Journal of Clinical Oncology, 2011Co-Authors: Elizabeth Gore, Benjamin Movsas, Maria Wernerwasik, Christina A. Meyers, Steven E Schild, Stuart J Wong, James A Bonner, Laurie E Gaspar, Jeffery A Bogart, Hak ChoyAbstract:Purpose There are scant data regarding the effects of Prophylactic Cranial Irradiation (PCI) on neurocognitive function (NCF) and quality of life (QOL). Radiation Therapy Oncology Group trial 0214 showed no overall survival (OS) benefit for PCI in stage III non–small-cell lung cancer (NSCLC) at 1 year. However, there was a significant decrease in brain metastases (BM). This analysis focuses on the impact of PCI on NCF and QOL. Patients and Methods Patients with stage III NSCLC who completed definitive therapy without progression were randomly assigned to PCI or observation. NCF was assessed with Mini-Mental Status Examination (MMSE), Activities of Daily Living Scale (ADLS), and Hopkins Verbal Learning Test (HVLT). QOL was assessed with the European Organisation for Research and Treatment of Cancer (EORTC) core tool (QOL Questionnaire-QLQC30) and brain module (QLQBN20). Results There were no statistically significant differences at 1 year between the two arms in any component of the EORTC-QLQC30 or QLQBN20...
-
phase iii comparison of Prophylactic Cranial Irradiation versus observation in patients with locally advanced non small cell lung cancer primary analysis of radiation therapy oncology group study rtog 0214
Journal of Clinical Oncology, 2011Co-Authors: Elizabeth Gore, Maria Wernerwasik, A Sun, Steven E Schild, Stuart J Wong, James A Bonner, Laurie E Gaspar, Jeffery A Bogart, Kyounghwa Bae, Hak ChoyAbstract:Purpose This study was conducted to determine if Prophylactic Cranial Irradiation (PCI) improves survival in locally advanced non–small-cell lung cancer (LA-NSCLC). Patients and Methods Patients with stage III NSCLC without disease progression after treatment with surgery and/or radiation therapy (RT) with or without chemotherapy were eligible. Participants were stratified by stage (IIIA v IIIB), histology (nonsquamous v squamous), and therapy (surgery v none) and were randomly assigned to PCI or observation. PCI was delivered to 30 Gy in 15 fractions. The primary end point of the study was overall survival (OS). Secondary end points were disease-free survival (DFS), neurocognitive function (NCF), and quality of life. Kaplan-Meier and log-rank analyses were used for OS and DFS. The incidence of brain metastasis (BM) was evaluated with the logistic regression model. Results Overall, 356 patients were accrued of the targeted 1,058. The study was closed early because of slow accrual; 340 of the 356 patients ...
Hak Choy - One of the best experts on this subject based on the ideXlab platform.
-
decline in tested and self reported cognitive functioning after Prophylactic Cranial Irradiation for lung cancer pooled secondary analysis of radiation therapy oncology group randomized trials 0212 and 0214
International Journal of Radiation Oncology Biology Physics, 2013Co-Authors: Rebecca Paulus, Deborah Watkins Bruner, Elizabeth Gore, Aaron H Wolfson, Maria Wernerwasik, Christina A. Meyers, Vinai Gondi, Hak Choy, Benjamin MovsasAbstract:Purpose To assess the impact of Prophylactic Cranial Irradiation (PCI) on self-reported cognitive functioning (SRCF), a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Methods and Materials Radiation Therapy Oncology Group (RTOG) protocol 0214 randomized patients with locally advanced non-small cell lung cancer to PCI or observation; RTOG 0212 randomized patients with limited-disease small cell lung cancer to high- or standard-dose PCI. In both trials, Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline (after locoregional therapy but before PCI or observation) and at 6 and 12 months. Patients developing brain relapse before follow-up evaluation were excluded. Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling. Fisher's exact test correlated decline in SRCF with HVLT decline. Results Of the eligible patients pooled from RTOG 0212 and RTOG 0214, 410 (93%) receiving PCI and 173 (96%) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis. Prophylactic Cranial Irradiation was associated with a higher risk of decline in SRCF at 6 months (odds ratio 3.60, 95% confidence interval 2.34-6.37, P P P =.002 and P =.002, respectively) but was not closely correlated with decline in SRCF at the same time points ( P =.05 and P =.86, respectively). Conclusions In lung cancer patients who do not develop brain relapse, PCI is associated with decline in HVLT-tested and self-reported cognitive functioning. Decline in HVLT and decline in SRCF are not closely correlated, suggesting that they may represent distinct elements of the cognitive spectrum.
-
phase iii trial of Prophylactic Cranial Irradiation compared with observation in patients with locally advanced non small cell lung cancer neurocognitive and quality of life analysis
Journal of Clinical Oncology, 2011Co-Authors: Elizabeth Gore, Benjamin Movsas, Maria Wernerwasik, Christina A. Meyers, Steven E Schild, Stuart J Wong, James A Bonner, Laurie E Gaspar, Jeffery A Bogart, Hak ChoyAbstract:Purpose There are scant data regarding the effects of Prophylactic Cranial Irradiation (PCI) on neurocognitive function (NCF) and quality of life (QOL). Radiation Therapy Oncology Group trial 0214 showed no overall survival (OS) benefit for PCI in stage III non–small-cell lung cancer (NSCLC) at 1 year. However, there was a significant decrease in brain metastases (BM). This analysis focuses on the impact of PCI on NCF and QOL. Patients and Methods Patients with stage III NSCLC who completed definitive therapy without progression were randomly assigned to PCI or observation. NCF was assessed with Mini-Mental Status Examination (MMSE), Activities of Daily Living Scale (ADLS), and Hopkins Verbal Learning Test (HVLT). QOL was assessed with the European Organisation for Research and Treatment of Cancer (EORTC) core tool (QOL Questionnaire-QLQC30) and brain module (QLQBN20). Results There were no statistically significant differences at 1 year between the two arms in any component of the EORTC-QLQC30 or QLQBN20...
-
phase iii comparison of Prophylactic Cranial Irradiation versus observation in patients with locally advanced non small cell lung cancer primary analysis of radiation therapy oncology group study rtog 0214
Journal of Clinical Oncology, 2011Co-Authors: Elizabeth Gore, Maria Wernerwasik, A Sun, Steven E Schild, Stuart J Wong, James A Bonner, Laurie E Gaspar, Jeffery A Bogart, Kyounghwa Bae, Hak ChoyAbstract:Purpose This study was conducted to determine if Prophylactic Cranial Irradiation (PCI) improves survival in locally advanced non–small-cell lung cancer (LA-NSCLC). Patients and Methods Patients with stage III NSCLC without disease progression after treatment with surgery and/or radiation therapy (RT) with or without chemotherapy were eligible. Participants were stratified by stage (IIIA v IIIB), histology (nonsquamous v squamous), and therapy (surgery v none) and were randomly assigned to PCI or observation. PCI was delivered to 30 Gy in 15 fractions. The primary end point of the study was overall survival (OS). Secondary end points were disease-free survival (DFS), neurocognitive function (NCF), and quality of life. Kaplan-Meier and log-rank analyses were used for OS and DFS. The incidence of brain metastasis (BM) was evaluated with the logistic regression model. Results Overall, 356 patients were accrued of the targeted 1,058. The study was closed early because of slow accrual; 340 of the 356 patients ...
Ritsuko Komaki - One of the best experts on this subject based on the ideXlab platform.
-
rates of overall survival and intraCranial control in the magnetic resonance imaging era for patients with limited stage small cell lung cancer with and without Prophylactic Cranial Irradiation
JAMA network open, 2020Co-Authors: Todd A Pezzi, Penny Fang, Olsi Gjyshi, Lei Feng, Ritsuko KomakiAbstract:Importance Historical data suggest that there is an overall survival benefit associated with Prophylactic Cranial Irradiation (PCI) in patients with small cell lung cancer (SCLC). However, as the fidelity of magnetic resonance imaging (MRI) of the brain continues to improve, this idea is now being questioned, with recent research showing no survival benefit associated with PCI in extensive-stage SCLC; however, the role for PCI is not clear in patients with limited-stage SCLC (LS-SCLC). Objective To report the overall survival and rates of intraCranial control for patients with LS-SCLC, all staged with MRI, who either did or did not undergo PCI. Design, Setting, and Participants This cohort study included 297 patients with LS-SCLC at a large US academic cancer center. Patients were treated with thoracic radiation; 205 also underwent PCI and 92 did not. All patients underwent at least baseline MRI, with restaging brain MRI and/or computed tomography; they did not have disease progression after thoracic radiation treatment. A propensity score–matching analysis was undertaken in an attempt to adjust for potential bias. Of the 297 patients who met the inclusion criteria, the propensity score was calculated for 295 patients, using patient, tumor, and treatment characteristics. Data were analyzed in October 2019. Intervention Prophylactic Cranial Irradiation in patients with LS-SCLC. Main Outcomes and Measures The rate of overall survival and intraCranial control. Results Of the 297 patients, 162 (54.5%) were men. The median age was 62.2 years (range, 27.0-85.0 years) for patients who underwent PCI and 68.6 years (range, 40.0-86.0 years) for those who did not undergo PCI. The 3-year cumulative incidence rate of brain metastases was higher in the no-PCI group vs the PCI group, when counting death as a competing risk, but the difference was not statistically significant (20.40% [95% CI, 12.45%-29.67%] vs 11.20% [95% CI, 5.40%-19.20%];P = .10). The use of PCI was not associated with a difference in overall survival between the patient groups (hazard ratio, 0.844; 95% CI, 0.604-1.180;P = .32). Conclusions and Relevance These findings suggest that patients with LS-SCLC staged with MRI who undergo PCI after thoracic radiation treatment were not associated with a decreased risk of developing new brain metastases compared with patients who do not undergo PCI. The use of PCI was not associated with an overall survival benefit for such patients.
-
is Prophylactic Cranial Irradiation indicated for patients with extensive stage small cell lung cancer with a complete response to first line treatment
Radiotherapy and Oncology, 2018Co-Authors: Ryoko Suzuki, Ritsuko KomakiAbstract:Prophylactic Cranial Irradiation (PCI) has been considered standard of care for patients with limited-stage small-cell lung cancer who achieve complete response to definitive treatment after a meta-analysis revealed its favorable effects on survival. In a European trial, PCI was also shown to confer a survival advantage for patients with extensive-stage (ES) SCLC who experienced any positive response after initial chemotherapy, leading to PCI also being considered a standard treatment for these patients as well. However, a recent Japanese trial investigating PCI for patients with ES-SCLC was stopped early when an interim analysis failed to confirm a survival benefit. This finding has motivated the thoracic oncology community to rethink the role of PCI in ES-SCLC.
-
Prophylactic Cranial Irradiation following surgical resection of early stage small cell lung cancer a review of the literature
Frontiers in Oncology, 2017Co-Authors: Brooke C Bloom, Steven E Schild, Ritsuko Komaki, Alexander Augustyn, Boris Sepesi, Sunil M Patel, Shalin J Shah, Stephen G ChunAbstract:With increasing use of low-dose screening CT-scans, the diagnosis of early-stage small cell lung cancer (SCLC) without evidence of mediastinal nodal or distant metastasis is likely to become more common, but the role of adjuvant therapies such as Prophylactic Cranial Irradiation (PCI) are not well understood in this population. We performed a review of the literature pertaining to the impact of PCI in patients who underwent surgical resection of early-stage SCLC. Three studies were identified that were pertinent including three single-institution retrospective analyses and a National Cancer Database analysis. Based upon these studies, we estimate the rate of brain metastases to be 10-15% for Stage I and 15-25% for Stage II disease without PCI. However, the impact of PCI on the development of brain metastases and its ultimate impact on overall survival were not consistent across these studies. In summary, there is sparse evidence to guide recommendations for PCI following resection of early-stage SCLC. While it may be reasonable to offer PCI to maximize likelihood of cure, alternative strategies such as observation with close imaging follow-up can also be considered for the appropriate patient given the known neurocognitive side effects of PCI.
-
Prophylactic Cranial Irradiation after definitive chemoradiotherapy for limited stage small cell lung cancer do all patients benefit
Radiotherapy and Oncology, 2017Co-Authors: Ahsan Farooqi, Emma B Holliday, Pamela K Allen, X Wei, James D Cox, Ritsuko KomakiAbstract:Abstract Purpose Prophylactic Cranial Irradiation (PCI) can improve overall survival (OS) and suppress brain metastases (BM) in patients with limited-stage small cell lung cancer (LS-SCLC) after complete response to primary therapy. However, PCI can be toxic. We sought to identify characteristics of patients who may not benefit from PCI. Methods We identified 658 patients who received chemoradiotherapy at MD Anderson in 1986–2012; 364 received PCI and 294 did not. Median follow-up time was 21.2months (range 1.2–240.8months). Cox proportional hazards regression, competing-risk regression, and Kaplan–Meier analyses were used to identify factors influencing OS and BM. Results PCI reduced risks of death [HR 0.73, 95% CI 0.61–0.88, P =0.001] and BM [HR 0.54, 95% CI 0.39–0.76, P P =0.002] but not death [HR 1.16, 95% CI 0.96–1.40, P =0.114]. Among patients ⩾70years with ⩾5-cm tumors, PCI did not improve OS [2-year rates 39.4% vs 40.9%, P =0.739]. Conclusions PCI remains standard therapy after complete response to chemoradiotherapy for LS-SCLC. However, older patients may be at risk from comorbidity or extraCranial disease. Further work is warranted to identify patients who may not benefit from PCI.
-
neurocognitive function in patients with small cell lung cancer effect of Prophylactic Cranial Irradiation
Cancer, 2008Co-Authors: David R Grosshans, Christina A. Meyers, Pamela K Allen, Samuel D Davenport, Ritsuko KomakiAbstract:BACKGROUND. The use of Prophylactic Cranial Irradiation (PCI) in patients with small cell lung cancer (SCLC) has been tempered by fears of detrimental effects on cognitive function. Neuropsychologic testing was prospectively conducted before and after PCI to evaluate its effects on cognitive function in patients with SCLC. METHODS. Ninety-six patients who completely or partially responded to initial therapy underwent formal neurocognitive testing before PCI. Three patients who had central nervous system metastasis were excluded. Of the remaining patients, 69 received PCI (mean dose, 25 grays [Gy] in 10 fractions). Repeat testing was performed on 37 patients (median follow-up, 23 months; range, 6–120 months). RESULTS. Baseline impairment was defined as ≥1.5 standard deviations below the normative mean. Before undergoing PCI, 47% of patients had evidence of impaired cognitive function. After PCI, univariate analysis revealed significant transient declines in executive function (pre-PCI mean, 15.6 ± 11.5; post-PCI, 27.1 ± 17.6 [P = .008]) and language (pre-PCI mean, 33.8 ± 9.9; post-PCI, 31.0 ± 9.0 [P = .049]) at early timepoints. Controlling for noncentral nervous system disease progression the deficit in executive function was no longer significant. Moreover, these deficits were not sustained, and significant improvements in language and motor coordination were recorded. On multivariate analysis, no significant differences before and after PCI were found. CONCLUSIONS. Neurocognitive testing demonstrated that a substantial portion of patients with SCLC had impaired brain functioning at baseline. Persistent declines in cognitive function were not observed after Cranial Irradiation. These data do not favor the omission of PCI on the basis of fears of neurotoxic effects. Cancer 2008. © 2007 American Cancer Society.
