Showing papers by "Barbara Fisher published in 2020"
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Rush University Medical Center1, Rhode Island Hospital2, University of Colorado Boulder3, University of Maryland Marlene and Stewart Greenebaum Cancer Center4, Thomas Jefferson University Hospital5, University of Texas MD Anderson Cancer Center6, Wayne State University7, University of California, San Diego8, Memorial Sloan Kettering Cancer Center9, Tel Aviv Sourasky Medical Center10, Kaiser Permanente11, Mayo Clinic12, University of Rochester13, Spartanburg Regional Medical Center14, Duke University15
TL;DR: The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial and this manuscript reports the final analysis of these step 1 data.
Abstract: PURPOSE NRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data. METHODS Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm-6 cycles of gemcitabine. Gemcitabine+erlotinib arm-gemcitabine and erlotinib 100 mg/d. Two hundred deaths provided 90% power (1-sided α=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2. RESULTS From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ≤90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38). CONCLUSIONS The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.
33 citations
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Ohio State University1, Wake Forest University2, Thomas Jefferson University Hospital3, Henry Ford Hospital4, Université de Montréal5, University of Alabama at Birmingham6, Medical College of Wisconsin7, University of Wisconsin-Madison8, Mayo Clinic9, University of California, San Francisco10, University of Maryland, College Park11, University of Michigan12, Christiana Care Health System13
TL;DR: The long-term results confirmed the findings from the initial report for efficacy suggesting OS and PFS outcomes with the RT-TMZ regimen exceeding historical control control groups treated with radiation alone.
Abstract: Purpose To report the long-term outcomes of the RTOG 0424 study of a high-risk, low-grade glioma population treated with concurrent and adjuvant temozolomide (TMZ) and radiation therapy (RT). Methods and Materials For this single-arm, phase 2 study, patients with low-grade gliomas with ≥3 risk factors (age ≥40 years, astrocytoma, bihemispheric tumor, size ≥6 cm, or preoperative neurologic function status >1) received RT (54 Gy in 30 fractions) with TMZ and up to 12 cycles of post-RT TMZ. The initial primary endpoint P was overall survival (OS) at 3 years after registration. Secondary endpoints included progression-free survival (PFS) and the association of survival outcomes with methylation status. The initial 3-year report of this study was published in 2015. Results The study accrued 136 patients, of whom 129 were analyzable. The median follow-up for surviving patients was 9.0 years. The 3-year OS was 73.5% (95% confidence interval, 65.8%-81.1%), numerically superior to the 3-year OS historical control of 54% (P Conclusions The long-term results confirmed the findings from the initial report for efficacy, suggesting OS and PFS outcomes with the RT-TMZ regimen exceeded historical control groups treated with radiation alone. Toxicity was acceptable.
28 citations
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1 citations
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Ohio State University1, Wake Forest Baptist Medical Center2, University of Western Ontario3, Barrow Neurological Institute4, Ford Motor Company5, Thomas Jefferson University Hospital6, Mayo Clinic7, University of California, San Francisco8, University of Maryland Medical Center9, University of Wisconsin-Madison10, Baptist Hospital of Miami11
TL;DR: This study sought to evaluate the prognostic significance of the three WHO-defined molecular glioma subgroups (IDHwt, IDHmt/non-codel, and IDHMT/codel) in NRG Oncology/RTOG 0424.
Abstract: 2518Background: This study sought to evaluate the prognostic significance of the three WHO-defined molecular glioma subgroups (IDHwt, IDHmt/non-codel, and IDHmt/codel) in NRG Oncology/RTOG 0424, a ...
1 citations