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865 results on '"Blanke, Charles"'

201. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES)

Author

Pinter, Tamás, primary, Klippel, Zandra, additional, Cesas, Alvydas, additional, Croitoru, Adina, additional, Decaestecker, Jochen, additional, Gibbs, Peter, additional, Hotko, Yevhen, additional, Jassem, Jacek, additional, Kurteva, Galina, additional, Novotny, Jan, additional, O'Reilly, Seamus, additional, Salek, Tomas, additional, Reiner, Maureen, additional, Morrow, Phuong Khanh, additional, Choi, Mi Rim, additional, Whittaker, Sadie, additional, and Blanke, Charles, additional

Published
2017
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203. Primary (1°) tumor location as an independent prognostic marker from molecular features for overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB / SWOG 80405 (Alliance).

Author

Venook, Alan P., primary, Ou, Fang-Shu, additional, Lenz, Heinz-Josef, additional, Kabbarah, Omar, additional, Qu, Xueping, additional, Niedzwiecki, Donna, additional, Zemla, Tyler, additional, Goldberg, Richard M., additional, Hochster, Howard S., additional, O'Neil, Bert H., additional, Sanoff, Hanna Kelly, additional, Mayer, Robert J., additional, Bertagnolli, Monica M., additional, Blanke, Charles David, additional, and Innocenti, Federico, additional

Published
2017
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204. Somatic DNA mutations, MSI status, mutational load (ML): Association with overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC) of CALGB/SWOG 80405 (Alliance).

Author

Innocenti, Federico, primary, Ou, Fang-Shu, additional, Zemla, Tyler, additional, Niedzwiecki, Donna, additional, Qu, Xueping, additional, Tam, Rachel, additional, Mahajan, Shilpi, additional, Goldberg, Richard M., additional, Mayer, Robert J., additional, Bertagnolli, Monica M., additional, Sanoff, Hanna Kelly, additional, Hochster, Howard S., additional, Blanke, Charles David, additional, Venook, Alan P., additional, Lenz, Heinz-Josef, additional, and Kabbarah, Omar, additional

Published
2017
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205. The scientific impact and value of large, NCI-sponsored randomized phase III cancer prevention trials.

Author

Unger, Joseph M., primary, Barlow, William E., additional, Tangen, Catherine M., additional, Ramsey, Scott David, additional, Thompson, Ian Murchie, additional, Klein, Eric A., additional, LeBlanc, Michael Leo, additional, Blanke, Charles David, additional, Goodman, Phyllis J., additional, Minasian, Lori M., additional, and Hershman, Dawn L., additional

Published
2017
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206. Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients With Advanced Carcinoid Tumors: SWOG S0518

Author

Yao, James C., primary, Guthrie, Katherine A., additional, Moran, Cesar, additional, Strosberg, Jonathan R., additional, Kulke, Matthew H., additional, Chan, Jennifer A., additional, LoConte, Noelle, additional, McWilliams, Robert R., additional, Wolin, Edward M., additional, Mattar, Bassam, additional, McDonough, Shannon, additional, Chen, Helen, additional, Blanke, Charles D., additional, and Hochster, Howard S., additional

Published
2017
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207. Impact of consensus molecular subtyping (CMS) on overall survival (OS) and progression free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405 (Alliance).

Author

Lenz, Heinz-Josef, primary, Ou, Fang-Shu, additional, Venook, Alan P., additional, Hochster, Howard S., additional, Niedzwiecki, Donna, additional, Goldberg, Richard M., additional, Mayer, Robert J., additional, Bertagnolli, Monica M., additional, Blanke, Charles David, additional, Zemla, Tyler, additional, Qu, Xueping, additional, Innocenti, Federico, additional, and Kabbarah, Omar, additional

Published
2017
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208. Effect of Selumetinib and MK-2206 vs Oxaliplatin and Fluorouracil in Patients With Metastatic Pancreatic Cancer After Prior Therapy

Author

Chung, Vincent, primary, McDonough, Shannon, additional, Philip, Philip A., additional, Cardin, Dana, additional, Wang-Gillam, Andrea, additional, Hui, Laifong, additional, Tejani, Mohamedtaki A., additional, Seery, Tara E., additional, Dy, Irene A., additional, Al Baghdadi, Tareq, additional, Hendifar, Andrew E., additional, Doyle, L. Austin, additional, Lowy, Andrew M., additional, Guthrie, Katherine A., additional, Blanke, Charles D., additional, and Hochster, Howard S., additional

Published
2017
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210. Associations of physical activity with survival and progression in metastatic colorectal cancer: Results from CALGB 80405 (Alliance).

Author

Guercio, Brendan John, primary, Venook, Alan P., additional, Niedzwiecki, Donna, additional, Zhang, Sui, additional, Sato, Kaori, additional, Fuchs, Charles S., additional, Lenz, Heinz-Josef, additional, Innocenti, Federico, additional, Fruth, Briant, additional, Van Blarigan, Erin, additional, O'Neil, Bert H., additional, Shaw, James Edward, additional, Polite, Blase N., additional, Hochster, Howard S., additional, Atkins, James Norman, additional, Goldberg, Richard M., additional, Mayer, Robert J., additional, Bertagnolli, Monica M., additional, Blanke, Charles David, additional, and Meyerhardt, Jeffrey A., additional

Published
2017
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211. P2.03b-053 Role of KRAS Mutation Status in NSCLC Patients Treated on SWOG S0819, a Phase III Trial of Chemotherapy with or without Cetuximab

Author

Mack, Philipp, primary, Moon, James, additional, Herbst, Roy, additional, Kim, Edward, additional, Semrad, Thomas, additional, Redman, Mary, additional, Tsai, Rebekah, additional, Solis, Leslie, additional, Gregg, Jeffrey, additional, Hatcher, Sandra, additional, Varella-Garcia, Marileila, additional, Hirsch, Fred R., additional, Blanke, Charles, additional, Kelly, Karen, additional, and Gandara, David R., additional

Published
2017
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212. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial

Author

Christen, William G, Glynn, Robert J, Gaziano, J Michael, Darke, Amy K, Crowley, John J, Goodman, Phyllis J, Lippman, Scott M, Lad, Thomas E, Bearden, James D, Goodman, Gary E, Minasian, Lori M, Thompson, Ian M, Blanke, Charles D, and Klein, Eric A

Subjects
Male, Aging, and promotion of well-being, Endpoint Determination, Clinical Trials and Supportive Activities, Cataract Extraction, Ophthalmology & Optometry, Cataract, Antioxidants, Double-Blind Method, Risk Factors, Clinical Research, Opthalmology and Optometry, Surveys and Questionnaires, Complementary and Integrative Health, Humans, Vitamin E, Selenomethionine, 3.3 Nutrition and chemoprevention, Eye Disease and Disorders of Vision, Proportional Hazards Models, Aged, Nutrition, Cancer, Incidence, Prevention, Prostatic Neoplasms, Evaluation of treatments and therapeutic interventions, Middle Aged, Prevention of disease and conditions, Drug Combinations, 6.1 Pharmaceuticals
Abstract

ImportanceObservational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention. However, the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium.ObjectiveTo test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men.Design, setting, and participantsThe Selenium and Vitamin E Cancer Prevention Trial (SELECT) Eye Endpoints Study was an ancillary study of the Southwest Oncology Group-coordinated SELECT, a randomized placebo-controlled 4-arm trial of selenium and vitamin E conducted among 35,533 men, 50 years and older for African American participants and 55 years and older for all other men, at 427 participating sites in the United States, Canada, and Puerto Rico. A total of 11,267 SELECT participants from 128 SELECT sites participated in the SELECT Eye Endpoints ancillary study.InterventionsIndividual supplements of selenium (200 μg per day from L-selenomethionine) and vitamin E (400 IU per day of all rac-α-tocopheryl acetate).Main outcomes and measuresIncident cataract was defined as a lens opacity, age related in origin, and responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review. Cataract extraction was defined as the surgical removal of an incident cataract.ResultsDuring a mean (SD) of 5.6 (1.2) years of treatment and follow-up, 389 cases of cataract were documented. There were 185 cataracts in the selenium group and 204 in the no selenium group (hazard ratio, 0.91; 95 % CI, 0.75-1.11; P = .37). For vitamin E, there were 197 cases in the treated group and 192 in the placebo group (hazard ratio, 1.02; 95 % CI, 0.84-1.25; P = .81). Similar results were observed for cataract extraction.Conclusions and relevanceThese data from a large cohort of apparently healthy men indicate that long-term daily supplementation with selenium and/or vitamin E is unlikely to have a large beneficial effect on age-related cataract.Trial registrationClinicalTrials.gov Identifier: NCT00784225.

Published
2015

213. Age-related Cataract in a Randomized Trial of Selenium and Vitamin E in Men: The SELECT Eye Endpoints (SEE) Study

Author

Christen, William G., Glynn, Robert J., Gaziano, J. Michael, Darke, Amy K., Crowley, John J., Goodman, Phyllis J., Lippman, Scott M., Lad, Thomas E., Bearden, James D., Goodman, Gary E., Minasian, Lori M., Thompson, Ian M., Blanke, Charles D., and Klein, Eric A.

Subjects
Male, Aging, Endpoint Determination, Incidence, Prostatic Neoplasms, Cataract Extraction, Middle Aged, Article, Antioxidants, Cataract, Drug Combinations, Double-Blind Method, Risk Factors, Surveys and Questionnaires, Humans, Vitamin E, Selenomethionine, Aged, Proportional Hazards Models
Abstract

Observational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention. However, the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium.To test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men.The Selenium and Vitamin E Cancer Prevention Trial (SELECT) Eye Endpoints Study was an ancillary study of the Southwest Oncology Group-coordinated SELECT, a randomized placebo-controlled 4-arm trial of selenium and vitamin E conducted among 35,533 men, 50 years and older for African American participants and 55 years and older for all other men, at 427 participating sites in the United States, Canada, and Puerto Rico. A total of 11,267 SELECT participants from 128 SELECT sites participated in the SELECT Eye Endpoints ancillary study.Individual supplements of selenium (200 μg per day from L-selenomethionine) and vitamin E (400 IU per day of all rac-α-tocopheryl acetate).Incident cataract was defined as a lens opacity, age related in origin, and responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review. Cataract extraction was defined as the surgical removal of an incident cataract.During a mean (SD) of 5.6 (1.2) years of treatment and follow-up, 389 cases of cataract were documented. There were 185 cataracts in the selenium group and 204 in the no selenium group (hazard ratio, 0.91; 95 % CI, 0.75-1.11; P = .37). For vitamin E, there were 197 cases in the treated group and 192 in the placebo group (hazard ratio, 1.02; 95 % CI, 0.84-1.25; P = .81). Similar results were observed for cataract extraction.These data from a large cohort of apparently healthy men indicate that long-term daily supplementation with selenium and/or vitamin E is unlikely to have a large beneficial effect on age-related cataract.ClinicalTrials.gov Identifier: NCT00784225.

Published
2015

214. Associations of Physical Activity With Survival and Progression in Metastatic Colorectal Cancer: Results From Cancer and Leukemia Group B (Alliance)/SWOG 80405.

Author

Guercio, Brendan J., Zhang, Sui, Ou, Fang-Shu, Venook, Alan P., Niedzwiecki, Donna, Lenz, Heinz-Josef, Innocenti, Federico, O'Neil, Bert H., Shaw, James E., Polite, Blase N., Hochster, Howard S., Atkins, James N., Goldberg, Richard M., Sato, Kaori, Ng, Kimmie, Van Blarigan, Erin, Mayer, Robert J., Blanke, Charles D., O'Reilly, Eileen M., and Fuchs, Charles S.

Published
2019
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215. Current Activities of the Coalition of Cancer Cooperative Groups.

Author

Bertagnolli, Monica M, Blaney, Susan M, Blanke, Charles D, Curran, Walter J, Dancey, Janet, Mannel, Robert S, O'Dwyer, Peter J, Schnall, Mitchell D, Wolmark, Norman, Groups, Coalition of Cancer Cooperative, and Coalition of Cancer Cooperative Groups

Subjects
CANCER associations, CLINICAL trials, LEADERSHIP, CANCER research, THERAPEUTICS
Abstract

The Coalition of Cancer Cooperative Groups is an organization representing the interests of patients and researchers who conduct research through the National Cancer Institute-supported National Clinical Trials Network (NCTN). The NCTN provides a crucial mechanism for executing practice-changing cancer clinical research to achieve both cancer control and development of new therapeutic agents or modality approaches. Public funding, largely through the National Cancer Institute, ensures that the work of the NCTN achieves important research that would not otherwise be accomplished in the private sector. In fall 2017, the Coalition of Cancer Cooperative Groups convened a Scientific Leadership Council to review the current state of the network with regard to research capabilities and to develop a list of research questions to be prioritized by the network. This report presents the results of this meeting, detailing a roadmap for future work by the NCTN. [ABSTRACT FROM AUTHOR]

Published
2019
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219. To the Editor.

Author

Blanke, Charles D.

Subjects
*ASSISTED suicide laws, *EUTHANASIA laws, *HOSPICE care, *HUMAN rights, *PATIENT advocacy, *AUTONOMY (Psychology), *PEOPLE with disabilities, *PALLIATIVE treatment
Published
2023
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220. Dual blockade of epidermal growth factor receptor (EGFR) and insulin-like growth factor receptor-1 (IGF-1R) signaling in metastatic pancreatic cancer: phase Ib and randomized phase II trial of gemcitabine, erlotinib, and cixutumumab versus gemcitabine plus erlotinib (SWOG S0727)

Author

Philip, Philip A., Goldman, Bryan, Ramanathan, Ramesh K., Lenz, Heinz-Josef, Lowy, Andrew M., Whitehead, Robert P., Wakatsuki, Takeru, Iqbal, Syma, Gaur, Rakesh, Benedetti, Jacqueline K., and Blanke, Charles D.

Subjects
Adult, Male, Antibodies, Monoclonal, Kaplan-Meier Estimate, Adenocarcinoma, Middle Aged, Antibodies, Monoclonal, Humanized, Deoxycytidine, Gemcitabine, Article, Disease-Free Survival, Drug Administration Schedule, ErbB Receptors, Pancreatic Neoplasms, Erlotinib Hydrochloride, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols, Quinazolines, Humans, Female, Insulin-Like Growth Factor I, Aged, Signal Transduction
Abstract

Targeting a single pathway in pancreatic adenocarcinoma (PC) is unlikely to affect its natural history. We tested the hypothesis that simulataneous targeting of the epidermal growth factor receptor (EGFR) and insulin-like growth factor receptor-1 (IGF-1R) pathways would significantly improve progression-free survival (PFS) by abrogating reciprocal signaling that promote drug resistanceThis was a phase Ib/II study testing cixutumumab, combined with erlotinib and gemcitabine (G) in patients with untreated metastatic PC. The control arm was erlotinib plus G. The primary end point was PFS. Eligibility included performance status 0/1 and normal fasting blood glucose. Polymorphisms in genes involved in G metabolism and in the EGFR pathway were also studiedThe phase I results (n = 10) established the safety of cixutumumab 6 mg/kg/week intravenously, erlotinib 100 mg/day orally, and G 1000 mg/m(2) intravenously on days 1, 8, and 15 of a 28-day cycle. In the RP2 portion (116 eligible patients; median age, 63), the median PFS and overall survival (OS) were 3.6 and 7.0 months, respectively, on the cixutumumab arm, and 3.6 and 6.7 months, respecively, on the control arm. Major grades 3 and 4 toxicities with cixutumumab and control were elevation of transaminases, 12% and 6%, respectively; fatigue, 16% and 12%, respectively; gastrointestinal, 35% and 28%, respectively; neutropenia, 21% and 10%, respectively; and thrombocytopenia, 16% and 7%, respecively. Grade 3/4 hyperglycemia was seen in 16% of patients on cixutumumab. Grade 3 or 4 skin toxicity was similar in both arms of the study (5%). No significant differences in PFS by genotype were seen for any of the polymorphisms.Adding the IGF-1R inhibitor cixutumumab to erlotinib and G did not lead to longer PFS or OS in metastatic PC.

Published
2014

221. Perioperative treatment of gastrointestinal stromal tumors

Author

Fernandes, Gustavo dos Santos, Blanke, Charles D., Freitas, Daniela, Guedes, Rodrigo, and Hoff, Paulo M.

Subjects
Enzyme inhibitors -- Dosage and administration, Gastrointestinal tumors -- Diagnosis, Gastrointestinal tumors -- Care and treatment, Gastrointestinal tumors -- Patient outcomes, Cancer -- Care and treatment, Cancer -- Health aspects, Cancer -- Patient outcomes
Abstract

This review describes the current multidisciplinary management of gastrointestinal stromal tumor (GIST), which is the most common sarcoma of the gastrointestinal tract. Before 2001, surgery was the only effective therapy for GIST. The discovery of the central role of KIT proto-oncogene mutations in the pathogenesis of this tumor, and the development of specific inhibitors of KIT tyrosine kinase (TK) function, has changed the paradigm of treatment for GISTs. Imatinib and sunitinib are TK inhibitors with activity against GISTs. Their major established role in GIST is in the treatment of advanced disease. A growing body of literature and clinical experience support the potential perioperative use of these drugs. The adjuvant use of imatinib is based on retrospective series and limited prospective studies demonstrating that imatinib reduces the risk of recurrence. Ongoing studies are further defining the length of adjuvant therapy, as well as identifying the patients that could achieve the best results. Neoadjuvant treatment often decreases the tumor size, allowing a less morbid surgery, appears to be safe and beneficial for some patients, and therefore deserves further study., Gastrointestinal stromal tumors (GISTs) originate from the interstitial cells of Cajal or a precursor and are the most common mesenchymal neoplasms of the gastrointestinal (GI) tract. [1] Although GISTs often [...]

Published
2009

228. Impact of primary (1º) tumor location on overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405 (Alliance).

Author

Venook, Alan P., primary, Niedzwiecki, Donna, additional, Innocenti, Federico, additional, Fruth, Briant, additional, Greene, Claire, additional, O'Neil, Bert H., additional, Shaw, James Edward, additional, Atkins, James Norman, additional, Horvath, Laura E., additional, Polite, Blase N., additional, Meyerhardt, Jeffrey A., additional, O'Reilly, Eileen Mary, additional, Goldberg, Richard M., additional, Hochster, Howard S., additional, Blanke, Charles David, additional, Schilsky, Richard L., additional, Mayer, Robert J., additional, Bertagnolli, Monica M., additional, and Lenz, Heinz-Josef, additional

Published
2016
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229. Outcomes for patients treated with or without bevacizumab on SWOG S0819: A randomized, phase III study comparing carboplatin/Paclitaxel or carboplatin/Paclitaxel/bevacizumab with or without concurrent cetuximab in patients with advanced non-small cell lung cancer (NSCLC).

Author

Semrad, Thomas John, primary, Redman, Mary Weber, additional, Herbst, Roy S., additional, Kim, Edward S., additional, Bazhenova, Lyudmila, additional, Masters, Gregory A., additional, Oettel, Kurt R., additional, Guaglianone, Perry, additional, Reynolds, Christopher M., additional, Karnad, Anand B., additional, Arnold, Susanne M., additional, Varella-Garcia, Marileila, additional, Moon, James, additional, Mack, Philip C., additional, Blanke, Charles David, additional, Hirsch, Fred R., additional, Kelly, Karen, additional, and Gandara, David R., additional

Published
2016
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230. Biomarker-enriched efficacy of cetuximab-based therapy: Squamous subset analysis from S0819, a phase III trial of chemotherapy with or without cetuximab in advanced NSCLC.

Author

Hirsch, Fred R., primary, Redman, Mary Weber, additional, Herbst, Roy S., additional, Kim, Edward S., additional, Semrad, Thomas John, additional, Bazhenova, Lyudmila, additional, Masters, Gregory A., additional, Oettel, Kurt R., additional, Guaglianone, Perry, additional, Reynolds, Christopher M., additional, Karnad, Anand B., additional, Arnold, Susanne M., additional, Varella-Garcia, Marileila, additional, Moon, James, additional, Mack, Philip C., additional, Blanke, Charles David, additional, Kelly, Karen, additional, and Gandara, David R., additional

Published
2016
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232. Next steps for adolescent and young adult oncology workshop: An update on progress and recommendations for the future

Author

Smith, Ashley Wilder, primary, Seibel, Nita L., additional, Lewis, Denise R., additional, Albritton, Karen H., additional, Blair, Donald F., additional, Blanke, Charles D., additional, Bleyer, W. Archie, additional, Freyer, David R., additional, Geiger, Ann M., additional, Hayes-Lattin, Brandon, additional, Tricoli, James V., additional, Wagner, Lynne I., additional, and Zebrack, Bradley J., additional

Published
2016
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233. In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs.

Author

Tefferi, Ayalew, Tefferi, Ayalew, Kantarjian, Hagop, Rajkumar, S Vincent, Baker, Lawrence H, Abkowitz, Jan L, Adamson, John W, Advani, Ranjana Hira, Allison, James, Antman, Karen H, Bast, Robert C, Bennett, John M, Benz, Edward J, Berliner, Nancy, Bertino, Joseph, Bhatia, Ravi, Bhatia, Smita, Bhojwani, Deepa, Blanke, Charles D, Bloomfield, Clara D, Bosserman, Linda, Broxmeyer, Hal E, Byrd, John C, Cabanillas, Fernando, Canellos, George Peter, Chabner, Bruce A, Chanan-Khan, Asher, Cheson, Bruce, Clarkson, Bayard, Cohn, Susan L, Colon-Otero, Gerardo, Cortes, Jorge, Coutre, Steven, Cristofanilli, Massimo, Curran, Walter J, Daley, George Q, DeAngelo, Daniel J, Deeg, H Joachim, Einhorn, Lawrence H, Erba, Harry P, Esteva, Francisco J, Estey, Elihu, Fidler, Isaiah J, Foran, James, Forman, Stephen, Freireich, Emil, Fuchs, Charles, George, James N, Gertz, Morie A, Giralt, Sergio, Golomb, Harvey, Greenberg, Peter, Gutterman, Jordan, Handin, Robert I, Hellman, Samuel, Hoff, Paulo Marcelo, Hoffman, Ronald, Hong, Waun Ki, Horowitz, Mary, Hortobagyi, Gabriel N, Hudis, Clifford, Issa, Jean Pierre, Johnson, Bruce Evan, Kantoff, Philip W, Kaushansky, Kenneth, Khayat, David, Khuri, Fadlo R, Kipps, Thomas J, Kripke, Margaret, Kyle, Robert A, Larson, Richard A, Lawrence, Theodore S, Levine, Ross, Link, Michael P, Lippman, Scott M, Lonial, Sagar, Lyman, Gary H, Markman, Maurie, Mendelsohn, John, Meropol, Neal J, Messinger, Yoav, Mulvey, Therese M, O'Brien, Susan, Perez-Soler, Roman, Pollock, Raphael, Prchal, Josef, Press, Oliver, Radich, Jerald, Rai, Kanti, Rosenberg, Saul A, Rowe, Jacob M, Rugo, Hope, Runowicz, Carolyn D, Sandmaier, Brenda M, Saven, Alan, Schafer, Andrew I, Schiffer, Charles, Sekeres, Mikkael A, Silver, Richard T, Siu, Lillian L, Steensma, David P, Tefferi, Ayalew, Tefferi, Ayalew, Kantarjian, Hagop, Rajkumar, S Vincent, Baker, Lawrence H, Abkowitz, Jan L, Adamson, John W, Advani, Ranjana Hira, Allison, James, Antman, Karen H, Bast, Robert C, Bennett, John M, Benz, Edward J, Berliner, Nancy, Bertino, Joseph, Bhatia, Ravi, Bhatia, Smita, Bhojwani, Deepa, Blanke, Charles D, Bloomfield, Clara D, Bosserman, Linda, Broxmeyer, Hal E, Byrd, John C, Cabanillas, Fernando, Canellos, George Peter, Chabner, Bruce A, Chanan-Khan, Asher, Cheson, Bruce, Clarkson, Bayard, Cohn, Susan L, Colon-Otero, Gerardo, Cortes, Jorge, Coutre, Steven, Cristofanilli, Massimo, Curran, Walter J, Daley, George Q, DeAngelo, Daniel J, Deeg, H Joachim, Einhorn, Lawrence H, Erba, Harry P, Esteva, Francisco J, Estey, Elihu, Fidler, Isaiah J, Foran, James, Forman, Stephen, Freireich, Emil, Fuchs, Charles, George, James N, Gertz, Morie A, Giralt, Sergio, Golomb, Harvey, Greenberg, Peter, Gutterman, Jordan, Handin, Robert I, Hellman, Samuel, Hoff, Paulo Marcelo, Hoffman, Ronald, Hong, Waun Ki, Horowitz, Mary, Hortobagyi, Gabriel N, Hudis, Clifford, Issa, Jean Pierre, Johnson, Bruce Evan, Kantoff, Philip W, Kaushansky, Kenneth, Khayat, David, Khuri, Fadlo R, Kipps, Thomas J, Kripke, Margaret, Kyle, Robert A, Larson, Richard A, Lawrence, Theodore S, Levine, Ross, Link, Michael P, Lippman, Scott M, Lonial, Sagar, Lyman, Gary H, Markman, Maurie, Mendelsohn, John, Meropol, Neal J, Messinger, Yoav, Mulvey, Therese M, O'Brien, Susan, Perez-Soler, Roman, Pollock, Raphael, Prchal, Josef, Press, Oliver, Radich, Jerald, Rai, Kanti, Rosenberg, Saul A, Rowe, Jacob M, Rugo, Hope, Runowicz, Carolyn D, Sandmaier, Brenda M, Saven, Alan, Schafer, Andrew I, Schiffer, Charles, Sekeres, Mikkael A, Silver, Richard T, Siu, Lillian L, and Steensma, David P

Published
2015

234. Phase I trial of sorafenib following liver transplantation in patients with high-risk hepatocellular carcinoma.

Author

Siegel, Abby B, Siegel, Abby B, El-Khoueiry, Anthony B, Finn, Richard S, Guthrie, Katherine A, Goyal, Abhishek, Venook, Alan P, Blanke, Charles D, Verna, Elizabeth C, Dove, Lorna, Emond, Jean, Kato, Tomoaki, Samstein, Benjamin, Busuttil, Ronald, Remotti, Helen, Coffey, Amy, Brown, Robert S, Siegel, Abby B, Siegel, Abby B, El-Khoueiry, Anthony B, Finn, Richard S, Guthrie, Katherine A, Goyal, Abhishek, Venook, Alan P, Blanke, Charles D, Verna, Elizabeth C, Dove, Lorna, Emond, Jean, Kato, Tomoaki, Samstein, Benjamin, Busuttil, Ronald, Remotti, Helen, Coffey, Amy, and Brown, Robert S

Abstract

Liver transplantation offers excellent long-term survival for hepatocellular carcinoma (HCC) patients who fall within established criteria. For those outside such criteria, or with high-risk pathologic features in the explant, HCC recurrence rates are higher. We conducted a multicenter phase I trial of sorafenib in liver transplantation patients with high-risk HCC. Subjects had HCC outside the Milan criteria (pre- or post-transplant), poorly differentiated tumors, or vascular invasion. We used a standard 3+3 phase I design with a planned duration of treatment of 24 weeks. Correlative studies included the number of circulating endothelial cells (CECs), plasma biomarkers, and tumor expression of p-Erk, p-Akt, and c-Met in tissue micro-arrays. We enrolled 14 patients with a median age of 63 years. Of these, 93% were men and 71% had underlying hepatitis C virus (HCV) and 21% had HBV. The maximum tolerated dose of sorafenib was 200 mg BID. Grade 3-4 toxicities seen in >10% of subjects included leukopenia (21%), elevated gamma-glutamyl transferase (21%), hypertension (14%), hand-foot syndrome (14%) and diarrhea (14%). Over a median follow-up of 953 days, one patient died and four recurred. The mean CEC number at baseline was 21 cells/4 ml for those who recurred, and 80 cells/4 ml for those who did not (p=0.10). Mean soluble vascular endothelial growth factor receptor-2 levels decreased after 1 month on sorafenib (p=0.09), but did not correlate with recurrence. There was a trend for tumor c-Met expression to correlate with increased risk of recurrence. Post-transplant sorafenib was found to be feasible and tolerable at 200 mg PO BID. The effect of post-transplant sorafenib on recurrence-free survival is potentially promising but needs further validation in a larger study.

Published
2015

235. Pharmacogenetic Analysis of INT 0144 Trial: Association of Polymorphisms with Survival and Toxicity in Rectal Cancer Patients Treated with 5-FU and Radiation

Author

Bohanes, Pierre, Rankin, Cathryn J, Blanke, Charles D, Winder, Thomas; https://orcid.org/0000-0003-4651-5758, Ulrich, Cornelia M, Smalley, Stephen R, Rich, Tyvin A, Martensen, James A, Benson III, Al B, Mayer, Robert J, Cripps, Christine M, Danenberg, Kathleen, Makar, Karen W, Zhang, Wu, Benedetti, Jacqueline K, Lenz, Heinz-Josef, Bohanes, Pierre, Rankin, Cathryn J, Blanke, Charles D, Winder, Thomas; https://orcid.org/0000-0003-4651-5758, Ulrich, Cornelia M, Smalley, Stephen R, Rich, Tyvin A, Martensen, James A, Benson III, Al B, Mayer, Robert J, Cripps, Christine M, Danenberg, Kathleen, Makar, Karen W, Zhang, Wu, Benedetti, Jacqueline K, and Lenz, Heinz-Josef

Abstract

PURPOSE We tested whether 18 polymorphisms in 16 genes (GSTP1, COX2, IL10, EGFR, EGF, FGFR4, CCDN1, VEGFR2, VEGF, CXCR2, IL8, MMP3, ICAM1, ERCC1, RAD51, and XRCC3) would predict disease-free survival (DFS), overall survival (OS), and toxicity in the INT0144 trial, which was designed to investigate different postoperative regimens of 5-fluorouracil (5-FU)-based chemoradiation (CRT) in locally advanced rectal cancers: Arm 1 consisted of bolus 5-FU followed by 5-FU protracted venous infusion (PVI) with radiotherapy; arm 2 was induction and concomitant PVI 5-FU with radiotherapy and arm 3 was induction and concomitant bolus 5-FU with radiotherapy. EXPERIMENTAL DESIGN DNA from 746 stage II/III rectal patients enrolled in the Southwest Oncology Group (SWOG) S9304 phase III trial was analyzed. Genomic DNA was extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue. The polymorphisms were analyzed using direct DNA-sequencing or polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). RESULTS GSTP1-Ile105Val (rs1695) was significantly associated with DFS and OS and its effect did not vary by treatment arm. The five-year DFS and OS were 53% and 58%, respectively, for G/G, 66% and 72% for G/A, and 57% and 66% for A/A patients. In arm 2, IL8-251A/A genotype (rs4073) was associated with a lower risk of toxicities (P = 0.04). The VEGFR2 H472Q Q/Q genotype (rs1870377) was associated with a higher risk of grade 3-5 proximal upper gastrointestinal tract (PUGIT) mucositis (P = 0.04) in arm 2. However, in arm 1, this genotype was associated with a lower risk of PUGIT mucositis (P = 0.004). CONCLUSION rs1695 may be prognostic in patients with rectal cancer treated with adjuvant CRT. rs4073 and rs1870377 may exhibit different associations with toxicity, according to the 5-FU schedule.

Published
2015

236. Comparison of dietary and lifestyle habits among stage III and metastatic colorectal cancer patients: findings from CALGB 89803 and CALGB 80405

Author

Van Loon, Katherine, Wigler, Devin, Niedzwiecki, Donna, Venook, Alan P, Fuchs, Charles, Blanke, Charles, Saltz, Leonard, Goldberg, Richard M, and Meyerhardt, Jeffrey A

Subjects
Alcohol Drinking, Behavioral patterns, Health Behavior, Oncology and Carcinogenesis, Motor Activity, Oral and gastrointestinal, Nutrition Policy, Cohort Studies, Clinical Research, Surveys and Questionnaires, Behavioral and Social Science, Prevalence, Humans, Chemotherapy, Obesity, Oncology & Carcinogenesis, Neoplasm Metastasis, Vitamin D, Life Style, Exercise, Neoplasm Staging, Nutrition, Cancer, Prevention, Smoking, Vitamins, Feeding Behavior, Colo-Rectal Cancer, Colon cancer, Good Health and Well Being, Dietary Supplements, Colorectal Neoplasms, Digestive Diseases
Abstract

UnlabelledSelf-administered questionnaires were completed by patients undergoing chemotherapy for stage III colon cancer (n=1095) and metastatic colorectal cancer (n=875). We describe the prevalence of a wide-range of health-related dietary patterns and lifestyle behaviors among colorectal cancer patients with stage III and metastatic disease and report notable similarities in these 2 cohorts.BackgroundCancer patients often pursue lifestyle and dietary changes with the aim to improve outcomes. Using data from 2 large National Cancer Institute-sponsored clinical trials, we report on the dietary and lifestyle practices of patients receiving therapy for stage III colon or metastatic colorectal cancer.Patients and methodsSelf-administered questionnaires were completed by patients undergoing chemotherapy for stage III colon cancer (n=1095) and metastatic colorectal cancer (n=875). Descriptive statistical analyses were performed to evaluate anthropometrics, diet, and lifestyle in each cohort.ResultsMedian body mass index was comparable for stage III and metastatic patients (27.3 vs. 26.5 kg/m2). Stage III patients reported a modestly higher median level of physical activity than metastatic patients (4.6 vs. 3.4 metabolic equivalent task-hours per week). Ten percent of stage III and 9% of metastatic patients reported ongoing cigarette use. Avoidance of alcohol was reported by 47% of stage III and 43% of metastatic patients. Dietary patterns for both groups were comparable with more than 80% of stage III and metastatic patients failing to meet the recommended daily intake of vegetables, fruits, and milk products. Usage of at least 2 multivitamins per week was reported by 49% of stage III and 40% of metastatic patients. Two percent of stage III and 5% of metastatic patients reported vitamin D supplement use.ConclusionsWe observed notable similarities in dietary and lifestyle behaviors between stage III colon and metastatic colorectal cancer patients actively receiving chemotherapy. Future research should aim to elucidate the effect of these behaviors on patient outcomes.

Published
2013

237. Phase II open label pilot trial of aprepitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic FOLFOX chemotherapy for the treatment of colorectal cancer.

Author

Bubalo, Joseph S., Palumbo, Alison, Blanke, Charles, Lopez, Charles D., Herrington, Jon D., Takemoto, Marc, Willman, Patricia, Edwards, Michael S., Williams, Casey, Fisher, Alan, and Chen, Eric

Subjects
COLON cancer treatment, NAUSEA -- Risk factors, FLUOROURACIL, OXALIPLATIN, FOLINIC acid, ANTIEMETICS, CHEMOTHERAPY complications, THERAPEUTICS, VOMITING prevention, HETEROCYCLIC compounds, DEXAMETHASONE, ANTINEOPLASTIC agents, CLINICAL trials, COLON tumors, COMPARATIVE studies, RESEARCH methodology, MEDICAL cooperation, NAUSEA, ORGANOPLATINUM compounds, RECTUM tumors, RESEARCH, VOMITING, PILOT projects, EVALUATION research, PREVENTION
Abstract

Purpose: Chemotherapy-induced nausea and vomiting (CINV) causes significant morbidity among colorectal cancer patients, receiving fluorouracil, oxaliplatin, and leucovorin (FOLFOX) chemotherapy even with standard antiemetic prophylaxis. The purpose of this study is to determine if the addition of aprepitant to standard antiemetic therapy improves CINV in these patients.Methods: Patients receiving FOLFOX for colorectal cancer were given antiemetic prophylaxis with aprepitant 125 mg orally on day 1 and 80 mg on days 2 and 3. Palonosetron 0.25 mg was given IV push on day 1 only. Dexamethasone 12 mg was administered orally on day 1 and 8 mg each morning on days 2 through 4. Assessments including emetic events, rescue doses, nutritional intake, and appetite were recorded in a patient diary which was returned to study personnel in the following cycle.Results: Of the 53 patients screened, 50 were evaluable and had a complete dataset for cycle 1. For the first cycle, 74% of patients achieved a complete response (CR), 22% achieved a major response and 4% experienced treatment failure. The percentage of patients achieving a CR remained high throughout each cycle at 83, 83, and 86% for cycles 2, 3, and 4, respectively. Appetite and nutritional status remained largely unchanged throughout treatment. Adverse events occurring in more than 10% of patients included diarrhea (13.6%), fatigue (12.6%), and neutropenia (11%).Conclusions: Aprepitant added to standard antiemetic therapy appears to be an effective and safe regimen for prevention of CINV in patients receiving FOLFOX. [ABSTRACT FROM AUTHOR]

Published
2018
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239. SWOG S1823/CCTG GCC1: Translational observational investigational study of the liquid biomarker microRNA 371a-3p in newly diagnosed germ cell tumours—Real-world trial design, rapid accrual, and robust secondary use of data opportunities.

Author

Morin Coulombe, Antoine, Ozgun, Guliz, Johnson, Rebecca, Lewis, Mark Andrew, Adra, Nabil, Eggener, Scott E., Roth, Bruce J., Ryan, Christopher W., Porter, Christopher, Millard, Fred, Jang, Thomas, Hamilton, Robert James, Einhorn, Lawrence H., Kollmannsberger, Christian K., Arnold, Kathryn B., Blanke, Charles David, Daneshmand, Siamak, Nichols, Craig R., Nappi, Lucia, and Harzstark, Andrea

Published
2023
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240. A phase II basket trial of dual anti–CTLA-4 and anti–PD-1 blockade in rare tumors (DART SWOG 1609) in patients with refractory gallbladder cancer (cohort 48).

Author

Patel, Sandip Pravin, Guadarrama, Elizabeth, Chae, Young Kwang, Liao, Chih-Yi, Kasi, Anup, Tarabay, Grace R., George, Thomas J., Chung, Liam, Lopez, Gabby, McLeod, Christine, Othus, Megan, Chen, Helen X., Sharon, Elad, Streicher, Howard, Ryan, Christopher W., Blanke, Charles David, and Kurzrock, Razelle

Published
2023
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244. The Globalization of Cooperative Groups

Author

Valdivieso, Manuel, primary, Corn, Benjamin W., additional, Dancey, Janet E., additional, Wickerham, D. Lawrence, additional, Horvath, L. Elise, additional, Perez, Edith A., additional, Urton, Alison, additional, Cronin, Walter M., additional, Field, Erica, additional, Lackey, Evonne, additional, and Blanke, Charles D., additional

Published
2015
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246. SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Author

Ben-Josef, Edgar, primary, Guthrie, Katherine A., additional, El-Khoueiry, Anthony B., additional, Corless, Christopher L., additional, Zalupski, Mark M., additional, Lowy, Andrew M., additional, Thomas, Charles R., additional, Alberts, Steven R., additional, Dawson, Laura A., additional, Micetich, Kenneth C., additional, Thomas, Melanie B., additional, Siegel, Abby B., additional, and Blanke, Charles D., additional

Published
2015
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247. In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs

Author

Tefferi, Ayalew, primary, Kantarjian, Hagop, additional, Rajkumar, S. Vincent, additional, Baker, Lawrence H., additional, Abkowitz, Jan L., additional, Adamson, John W., additional, Advani, Ranjana Hira, additional, Allison, James, additional, Antman, Karen H., additional, Bast, Robert C., additional, Bennett, John M., additional, Benz, Edward J., additional, Berliner, Nancy, additional, Bertino, Joseph, additional, Bhatia, Ravi, additional, Bhatia, Smita, additional, Bhojwani, Deepa, additional, Blanke, Charles D., additional, Bloomfield, Clara D., additional, Bosserman, Linda, additional, Broxmeyer, Hal E., additional, Byrd, John C., additional, Cabanillas, Fernando, additional, Canellos, George Peter, additional, Chabner, Bruce A., additional, Chanan-Khan, Asher, additional, Cheson, Bruce, additional, Clarkson, Bayard, additional, Cohn, Susan L., additional, Colon-Otero, Gerardo, additional, Cortes, Jorge, additional, Coutre, Steven, additional, Cristofanilli, Massimo, additional, Curran, Walter J., additional, Daley, George Q., additional, DeAngelo, Daniel J., additional, Deeg, H. Joachim, additional, Einhorn, Lawrence H., additional, Erba, Harry P., additional, Esteva, Francisco J., additional, Estey, Elihu, additional, Fidler, Isaiah J., additional, Foran, James, additional, Forman, Stephen, additional, Freireich, Emil, additional, Fuchs, Charles, additional, George, James N., additional, Gertz, Morie A., additional, Giralt, Sergio, additional, Golomb, Harvey, additional, Greenberg, Peter, additional, Gutterman, Jordan, additional, Handin, Robert I., additional, Hellman, Samuel, additional, Hoff, Paulo Marcelo, additional, Hoffman, Ronald, additional, Hong, Waun Ki, additional, Horowitz, Mary, additional, Hortobagyi, Gabriel N., additional, Hudis, Clifford, additional, Issa, Jean Pierre, additional, Johnson, Bruce Evan, additional, Kantoff, Philip W., additional, Kaushansky, Kenneth, additional, Khayat, David, additional, Khuri, Fadlo R., additional, Kipps, Thomas J., additional, Kripke, Margaret, additional, Kyle, Robert A., additional, Larson, Richard A., additional, Lawrence, Theodore S., additional, Levine, Ross, additional, Link, Michael P., additional, Lippman, Scott M., additional, Lonial, Sagar, additional, Lyman, Gary H., additional, Markman, Maurie, additional, Mendelsohn, John, additional, Meropol, Neal J., additional, Messinger, Yoav, additional, Mulvey, Therese M., additional, O’Brien, Susan, additional, Perez-Soler, Roman, additional, Pollock, Raphael, additional, Prchal, Josef, additional, Press, Oliver, additional, Radich, Jerald, additional, Rai, Kanti, additional, Rosenberg, Saul A., additional, Rowe, Jacob M., additional, Rugo, Hope, additional, Runowicz, Carolyn D., additional, Sandmaier, Brenda M., additional, Saven, Alan, additional, Schafer, Andrew I., additional, Schiffer, Charles, additional, Sekeres, Mikkael A., additional, Silver, Richard T., additional, Siu, Lillian L., additional, Steensma, David P., additional, Stewart, F. Marc, additional, Stock, Wendy, additional, Stone, Richard, additional, Storb, Rainer, additional, Strong, Louise C., additional, Tallman, Martin S., additional, Thompson, Michael, additional, Ueno, Naoto T., additional, Van Etten, Richard A., additional, Vose, Julie M., additional, Wiernik, Peter H., additional, Winer, Eric P., additional, Younes, Anas, additional, Zelenetz, Andrew D., additional, and LeMaistre, Charles A., additional

Published
2015
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248. SWOG S1115: Randomized phase II trial of selumetinib (AZD6244; ARRY 142886) hydrogen sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in pretreated patients (Pts) with metastatic pancreatic cancer.

Author

Chung, Vincent M., primary, McDonough, Shannon L, additional, Philip, Philip Agop, additional, Cardin, Dana Backlund, additional, Wang-Gillam, Andrea, additional, Hui, Laifong, additional, Lowy, Andrew M., additional, Guthrie, Katherine, additional, Blanke, Charles David, additional, and Hochster, Howard S., additional

Published
2015
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250. A genome-wide association study (GWAS) of overall survival (OS) in 609 metastatic colorectal cancer (mCRC) patients treated with chemotherapy and biologics in CALGB 80405.

Author

Innocenti, Federico, primary, Owzar, Kouros, additional, Jiang, Chen, additional, Sibley, Alexander, additional, Niedzwiecki, Donna, additional, Lenz, Heinz-Josef, additional, Bertagnolli, Monica M., additional, Friedman, Paula N., additional, Furukawa, Yoichi, additional, Kubo, Michiaki, additional, Ratain, Mark J., additional, Blanke, Charles David, additional, Venook, Alan P., additional, and McLeod, Howard L., additional

Published
2015
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