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4. P-103 Associations between quality-of-life, symptom burden, and demographic characteristics in long-term esophageal and gastroesophageal junction cancer survivors

Author

McGillivray, E., primary, Jain, R., additional, Ramamurthy, C., additional, Sheng, J., additional, Granina, E., additional, Yu, D., additional, Lu, X., additional, Abbas, A., additional, Dotan, E., additional, Meyer, J., additional, Fang, C., additional, and Denlinger, C., additional

Published
2021
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8. OA01.06 Safety, Efficacy, and Pharmacokinetics of AMG 510, a Novel KRASG12C Inhibitor, in Patients with Non-Small Cell Lung Cancer

Author

Govindan, R., primary, Fakih, M., additional, Price, T., additional, Falchook, G., additional, Desai, J., additional, Kuo, J., additional, Strickler, J., additional, Krauss, J., additional, Li, B., additional, Denlinger, C., additional, Durm, G., additional, Ngang, J., additional, Henary, H., additional, Ngarmchamnanrith, G., additional, Rasmussen, E., additional, Morrow, P.K., additional, and Hong, D., additional

Published
2019
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9. OA02.02 Phase 1 Study of Safety, Tolerability, PK and Efficacy of AMG 510, a Novel KRASG12C Inhibitor, Evaluated in NSCLC

Author

Govindan, R., primary, Fakih, M., additional, Price, T., additional, Falchook, G., additional, Desai, J., additional, Kuo, J., additional, Strickler, J., additional, Krauss, J., additional, Li, B., additional, Denlinger, C., additional, Durm, G., additional, Ngang, J., additional, Henary, H., additional, Ngarmchamnanrith, G., additional, Rasmussen, E., additional, Morrow, P., additional, and Hong, D., additional

Published
2019
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13. Quality-of-life (QoL) results from RAINFALL: A randomized, double-blind, placebo (PL)-controlled phase III study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy for metastatic gastric or gastroesophageal junction (G-GEJ) cancer

Author

Chau, I., primary, Al-Batran, S.-E., additional, Luft, A., additional, Kowalyszyn, R.D., additional, Hernandez, C.A., additional, Pfeiffer, P., additional, Wojcik, E., additional, Bodoky, G., additional, Madi, A., additional, Brenner, B., additional, De Vita, F., additional, Folprecht, G., additional, Peltola, K., additional, Lorenzen, S., additional, Denlinger, C., additional, Liepa, A., additional, Das, M., additional, Wei, R., additional, and Fuchs, C.S., additional

Published
2018
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14. Worldwide Esophageal Cancer Collaboration: pathologic staging data

Author

Rice, T. W., Chen, L.-Q., Hofstetter, W. L., Smithers, B.M., Rusch, V. W., Wijnhoven, B. P. L., Chen, K. L., Davies, A. R., D’Journo, X. B., Kesler, K. A., Luketich, J. D., Ferguson, M. K., Räsänen, J. V., van Hillegersberg, R., Fang, W., Durand, L., Cecconello, I., Allum, W. H., Cerfolio, R. J., Pera, M., Griffin, S. M., Burger, R., Liu, J.-F, Allen, M. S., Law, S., Watson, T. J., Darling, G. E., Scott, W. J., Duranceau, A., Denlinger, C. E., Schipper, P. H., Lerut, T. E. M. R., Orringer, M. B., Ishwaran, H., Apperson-Hansen, C., DiPaola, L. M., Semple, M. E., Blackstone, E. H., and Surgery

Subjects
Ablation Techniques, Adult, Male, Esophageal Neoplasms, Carcinoma, Middle Aged, Prognosis, Risk Assessment, Article, Esophagectomy, SDG 3 - Good Health and Well-being, Humans, Female, Esophagogastric Junction, Intersectoral Collaboration, Aged, Neoplasm Staging
Abstract

We report data-simple descriptions of patient characteristics, cancer categories, and non-risk-adjusted survival-for patients with pathologically staged cancer of the esophagus and esophagogastric junction after resection or ablation with no preoperative therapy from the Worldwide Esophageal Cancer Collaboration (WECC). Thirty-three institutions from six continents submitted de-identified data using standard definitions: demographics, comorbidities, clinical cancer categories, and all-cause mortality from first management decision. Of 13,300 patients, 5,631 had squamous cell carcinoma, 7,558 adenocarcinoma, 85 adenosquamous carcinoma, and 26 undifferentiated carcinoma. Patients were older (62 years) men (80%) with normal body mass index (51%), little weight loss (1.8 kg), 0-2 ECOG performance status (83%), and a history of smoking (70%). Cancers were pT1 (24%), pT2 (15%), pT3 (50%), pN0 (52%), pM0 (93%), and pG2-G3 (78%); most involved distal esophagus (71%). Non-risk-adjusted survival for both squamous cell carcinoma and adenocarcinoma was monotonic and distinctive across pTNM. Survival was more distinctive for adenocarcinoma than squamous cell carcinoma when pT was ordered by pN. Survival for pTis-1 adenocarcinoma was better than for squamous cell carcinoma, although monotonic and distinctive for both. WECC pathologic staging data is improved over that of the 7th edition, with more patients studied and patient and cancer variables collected. These data will be the basis for the 8th edition cancer staging manuals following risk adjustment for patient, cancer, and treatment characteristics, and should direct 9th edition data collection. However, the role of pure pathologic staging as the principal point of reference for esophageal cancer staging is waning.

Published
2016

15. Worldwide Esophageal Cancer Collaboration : clinical staging data

Author

Rice, T. W., Apperson-Hansen, C., DiPaola, L. M., Semple, M. E., Lerut, T. E. M. R., Orringer, M. B., Chen, L.-Q., Hofstetter, W. L., Smithers, B. M., Rusch, V. W., Wijnhoven, B. P. L., Chen, K. N., Davies, A. R., D’Journo, X. B., Kesler, K. A., Luketich, J. D., Ferguson, M. K., Räsänen, J. V., van Hillegersberg, R., Fang, W., Durand, L., Allum, W. H., Cecconello, I., Cerfolio, R. J., Pera, M., Griffin, S. M., Burger, R., Liu, J.-F, Allen, M. S., Law, S., Watson, T. J., Darling, G. E., Scott, W. J., Duranceau, A., Denlinger, C. E., Schipper, P. H., Ishwaran, H., Blackstone, E. H., III kirurgian klinikka, Clinicum, Department of Surgery, and Surgery

Subjects
Adult, Male, Esophageal Neoplasms, Carcinoma, education, 3122 Cancers, Middle Aged, Prognosis, 3126 Surgery, anesthesiology, intensive care, radiology, Risk Assessment, Article, Esophagectomy, SDG 3 - Good Health and Well-being, Humans, Female, Intersectoral Collaboration, Aged, Neoplasm Staging
Abstract

To address uncertainty of whether clinical stage groupings (cTNM) for esophageal cancer share prognostic implications with pathologic groupings after esophagectomy alone (pTNM), we report data—simple descriptions of patient characteristics, cancer categories, and non-risk-adjusted survival—for clinically staged patients from the Worldwide Esophageal Cancer Collaboration (WECC). Thirty-three institutions from six continents submitted data using variables with standard definitions: demographics, comorbidities, clinical cancer categories, and all-cause mortality from first management decision. Of 22,123 clinically staged patients, 8,156 had squamous cell carcinoma, 13,814 adenocarcinoma, 116 adenosquamous carcinoma, and 37 undifferentiated carcinoma. Patients were older (62 years) men (80%) with normal body mass index (18.5–25 mg/kg2, 47%), little weight loss (2.4 ± 7.8 kg), 0–1 ECOG performance status (67%), and history of smoking (67%). Cancers were cT1 (12%), cT2 (22%), cT3 (56%), cNO (44%), cMO (95%), and cG2–G3 (89%); most involved the distal esophagus (73%). Non-risk-adjusted survival for squamous cell carcinoma was not distinctive for early cT or cN; for adenocarcinoma, it was distinctive for early versus advanced cT and for cNO versus cN+. Patients with early cancers had worse survival and those with advanced cancers better survival than expected from equivalent pathologic categories based on prior WECC pathologic data. Thus, clinical and pathologic categories do not share prognostic implications. This makes clinically based treatment decisions difficult and pre-treatment prognostication inaccurate. These data will be the basis for the 8th edition cancer staging manuals following risk adjustment for patient characteristics, cancer categories, and treatment characteristics and should direct 9th edition data collection.

Published
2016

17. Phase 1b study of WNT inhibitor vantictumab (VAN, human monoclonal antibody) with nab-paclitaxel (Nab-P) and gemcitabine (G) in patients (pts) with previously untreated stage IV pancreatic cancer (PC)

Author

Messersmith, W., primary, Cohen, S., additional, Shahda, S., additional, Lenz, H.-J., additional, Weekes, C., additional, Dotan, E., additional, Denlinger, C., additional, O'Neil, B., additional, Kapoun, A., additional, Zhang, C., additional, Henner, R., additional, Cattaruzza, F., additional, Xu, L., additional, Dupont, J., additional, Brachmann, R., additional, Uttamsingh, S., additional, Farooki, A., additional, and Berlin, J., additional

Published
2016
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18. Worldwide Esophageal Cancer Collaboration: neoadjuvant pathologic staging data

Author

Rice, T. W., primary, Lerut, T. E. M. R., additional, Orringer, M. B., additional, Chen, L.-Q., additional, Hofstetter, W. L., additional, Smithers, B. M., additional, Rusch, V. W., additional, van Lanschot, J., additional, Chen, K. N., additional, Davies, A. R., additional, D'Journo, X. B., additional, Kesler, K. A., additional, Luketich, J. D., additional, Ferguson, M. K., additional, Räsänen, J. V., additional, van Hillegersberg, R., additional, Fang, W., additional, Durand, L., additional, Allum, W. H., additional, Cecconello, I., additional, Cerfolio, R. J., additional, Pera, M., additional, Griffin, S. M., additional, Burger, R., additional, Liu, J.-F., additional, Allen, M. S., additional, Law, S., additional, Watson, T. J., additional, Darling, G. E., additional, Scott, W. J., additional, Duranceau, A., additional, Denlinger, C. E., additional, Schipper, P. H., additional, Ishwaran, H., additional, Apperson-Hansen, C., additional, DiPaola, L. M., additional, Semple, M. E., additional, and Blackstone, E. H., additional

Published
2016
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19. 616PD - Quality-of-life (QoL) results from RAINFALL: A randomized, double-blind, placebo (PL)-controlled phase III study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy for metastatic gastric or gastroesophageal junction (G-GEJ) cancer

Author

Chau, I., Al-Batran, S.-E., Luft, A., Kowalyszyn, R.D., Hernandez, C.A., Pfeiffer, P., Wojcik, E., Bodoky, G., Madi, A., Brenner, B., De Vita, F., Folprecht, G., Peltola, K., Lorenzen, S., Denlinger, C., Liepa, A., Das, M., Wei, R., and Fuchs, C.S.

Published
2018
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26. Safety, tolerability, and pharmacokinetics of TAK-701, a humanized anti-hepatocyte growth factor (HGF) monoclonal antibody, in patients with advanced nonhematologic malignancies: First-in-human phase I dose-escalation study.

Author

Jones, S. F., primary, Cohen, R. B., additional, Bendell, J. C., additional, Denlinger, C. S., additional, Harvey, R. D., additional, Parasuraman, S., additional, Chi, X., additional, Scholz, C., additional, Wyant, T., additional, and Kauh, J., additional

Published
2010
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34. ANNOTATED BIBLIOGRAPHY.

Author

Robson, M. E., Carey, L. A., Melisko, M. E., Denlinger, C. S., Goldstein, L. J., Hershman, D. L., Recht, A., Glück, S., Nagtegaal, I. D., Allred, D. C., Ma, C. X., Ellis, M. J., Swaby, R. F., Brufsky, A. M., Elledge, R. M., Hillner, B. E., and Loprinzi, C. L.

Subjects
DRUG therapy, BRCA genes, BREAST cancer, HORMONE therapy, PROTO-oncogenes
Abstract

The article presents abstracts on medical topics which include acute chemotherapy-related toxicity in BRCA1 and BRCA2 mutation carriers treated for breast cancer in Great Britain, neoadjuvant endocrine therapy for locally advanced breast cancer, and human epidermal growth factor receptor positivity for the development of brain metastasis after newly diagnosed breast cancer.

Published
2007

35. CHEMOTHERAPY.

Author

Buzdar, A. U., Oktay, K., Dang, C., Patil, S., Denlinger, C. S., and Goldstein, L. J.

Subjects
DRUG therapy, BREAST cancer, HER2 protein, ESTROGEN replacement therapy
Abstract

The article presents abstracts on medical topics which include estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer, therapeutic use of doxetaxel, cisplastin and trastuzumab for human epidermal growth factor receptor 2-positive locally advanced breast cancer.

Published
2007

38. NCCN guidelines® insights survivorship, version 1.2016 featured updates to the NCCN Guidelines

Author

Denlinger, C. S., Ligibel, J. A., Are, M., Baker, K. S., Broderick, G., Demark-Wahnefried, W., Friedman, D. L., Goldman, M., Jones, L. W., King, A., Ku, G. H., Kvale, E., Langbaum, T. S., Mccabe, M. S., Melisko, M., Montoya, J. G., Mooney, K., Morgan, M. A., Moslehi, J. J., O Connor, T., Overholser, L., Paskett, E. D., Peppercorn, J., Rodriguez, M. A., Ruddy, K. J., Sanft, T., Silverman, P., Sophia Smith, Syrjala, K. L., Urba, S. G., Wakabayashi, M. T., Zee, P., Mcmillian, N. R., and Freedman-Cass, D. A.

39. Survivorship: Introduction and definition: Clinical practice guidelines in oncology

Author

Denlinger, C. S., Carlson, R. W., Are, M., Baker, K. S., Davis, E., Edge, S. B., Friedman, D. L., Goldman, M., Jones, L., Allison King, Kvale, E., Langbaum, T. S., Ligibel, J. A., Mccabe, M. S., Mcvary, K. T., Melisko, M., Montoya, J. G., Mooney, K., Morgan, M. A., O Connor, T., Paskett, E. D., Raza, M., Syrjala, K. L., Urba, S. G., Wakabayashi, M. T., Zee, P., Mcmillian, N., and Freedman-Cass, D.

Subjects
Adult, Survival Rate, Neoplasms, Humans, Guidelines as Topic, Survivors, humanities, Article
Abstract

Many cancer survivors experience physical and/or psychosocial side effects, which can be severe, debilitating, and sometimes permanent. These NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for common consequences of cancer and cancer treatment for health care professionals who work with survivors of adult-onset cancer in the posttreatment period. These introductory sections of the guidelines include the panel's definition of cancer survivors, a discussion of the effects of cancer and its treatment, general principles and standards for survivorship care, and guidance regarding screening for problems that require further assessment.

40. Occult primary

Author

Ettinger, D. S., Agulnik, M., Justin Cates, Cristea, M., Denlinger, C. S., Eaton, K. D., Fidias, P. M., Gierada, D., Gockerman, J. P., Handorf, C. R., Iyer, R., Lenzi, R., Phay, J., Rashid, A., Saltz, L., Shulman, L. N., Smerage, J. B., Varadhachary, G. R., Zager, J. S., and Zhen, W.

44. Polychemotherapy for Early Breast Cancer: Results from the International Adjuvant Breast Cancer Chemotherapy Randomized Trial.

Author

Denlinger, C. S. and Goldstein, L. J.

Subjects
BREAST cancer, COMBINATION drug therapy, CANCER chemotherapy, TAMOXIFEN, CANCER patients
Abstract

The article discusses research being done on the use of polychemotherapy in patients diagnosed with early breast cancer. It references a study published in the 2007 issue of the "Journal of National Cancer Institute." The study included 1,991 women from Great Britain and other European countries with breast cancer. It illustrated the benefits of polychemotherapy with tamoxifen. A comment on the study is also offered.

Published
2008
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46. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors.

Author

Hong, D. S., Fakih, M. G., Strickler, J. H., Desai, J., Durm, G. A., Shapiro, G. I., Falchook, G. S., Price, T. J., Sacher, A., Denlinger, C. S., Bang, Y.-J., Dy, G. K., Krauss, J. C., Kuboki, Y., Kuo, J. C., Coveier, A. L., Park, K., Kim, T. W., Bariesi, F., and Munster, P. N.

Subjects
*NON-small-cell lung carcinoma, *PROGRESSION-free survival, *TUMORS, *COLON cancer
Abstract

BACKGROUND No therapies for targeting KRAS mutations in cancer have been approved. The KRAS p.G12C mutation occurs in 13% of non-small-cell lung cancers (NSCLCs) and in 1 to 3% of colorectal cancers and other cancers. Sotorasib is a small molecule that selectively and irreversibly targets KRASG12C. METHODS We conducted a phase 1 trial of sotorasib in patients with advanced solid tumors harboring the KRAS p.G12C mutation. Patients received sotorasib orally once daily. The primary end point was safety. Key secondary end points were pharmacokinetics and objective response, as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. RESULTS A total of 129 patients (59 with NSCLC, 42 with colorectal cancer, and 28 with other tumors) were included in dose escalation and expansion cohorts. Patients had received a median of 3 (range, 0 to 11) previous lines of anticancer therapies for metastatic disease. No dose-limiting toxic effects or treatment-related deaths were observed. A total of 73 patients (56.6%) had treatment-related adverse events; 15 patients (11.6%) had grade 3 or 4 events. In the subgroup with NSCLC, 32.2% (19 patients) had a confirmed objective response (complete or partial response) and 88.1% (52 patients) had disease control (objective response or stable disease); the median progression-free survival was 6.3 months (range, 0.0+ to 14.9 [with + indicating that the value includes patient data that were censored at data cutoffl). In the subgroup with colorectal cancer, 7.1% (3 patients) had a confirmed response, and 73.8% (31 patients) had disease control; the median progression-free survival was 4.0 months (range, 0.0+ to 11.1+). Responses were also observed in patients with pancreatic, endometrial, and appendiceal cancers and melanoma. CONCLUSIONS Sotorasib showed encouraging anticancer activity in patients with heavily pretreated advanced solid tumors harboring the KRAS p.G12C mutation. Grade 3 or 4 treatment-related toxic effects occurred in 11.6% of the patients. (Funded by Amgen and others; CodeBreaKlOO ClinicalTrials.gov number, NCT03600883). [ABSTRACT FROM AUTHOR]

Published
2020
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47. Phase I study of PF-03446962, a fully human monoclonal antibody against activin receptor-like kinase-1, in patients with hepatocellular carcinoma.

Author

Simonelli, M., Zucali, P., Santoro, A., Thomas, M. B., de Braud, F. G., Borghaei, H., Berlin, J., Denlinger, C. S., Noberasco, C., Rimassa, L., Kim, T.-Y., English, P. A., Abbattista, A., Stampino, C. Gallo, Carpentieri, M., and Williams, J. A.

Subjects
*LIVER cancer, *MONOCLONAL antibodies, *ACTIVIN receptor-like kinase 1, *MEDICATION safety, *DRUG tolerance
Abstract

Background: This expansion cohort of a multicenter, dose-escalation, phase I study (NCT00557856) evaluated safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamic effects of the anti-activin receptor-like kinase-1 (ALK-1) monoclonal antibody PF-03446962 in advanced hepatocellular carcinoma (HCC). Patients and methods: Patients with HCC and disease progression after prior antiangiogenic therapy or intolerance to treatment received PF-03446962 7 mg/kg intravenously biweekly, as recommended in the dose-escalation part of the study. Results: Twenty-four patients received PF-03446962. The most frequent treatment-related adverse events (AEs) were thrombocytopenia (33.3%), asthenia (29.2), and chills (16.7%). Two patients experienced treatment-related telangiectasia, suggesting an in vivo knockout of ALK-1 function through ALK-1 pathway inhibition. Overall, treatment-related grade 3-4 AEs were reported in eight patients (33.3%). Treatment-related grade 3-4 thrombocytopenia was noted in four patients. No complete or partial responses were reported. Twelve (50%) patients achieved stable disease, which lasted ≥12 weeks in seven (29.2%) patients. The median time to progression was 3 months. Biomarker analyses showed higher mean tumor expression of c-tumor mesenchymal-epithelial transition factor and higher mean serum levels of bone morphogenetic protein-9 in patients with disease control (DC) for ≥12 weeks versus patients with disease progression. Conversely, lower mean serum transforming growth factor-β and vascular endothelial growth factor receptor-3 levels were detected in patients with DC versus patients with progression. Conclusions: The observed safety, tolerability, pharmacokinetic profile, and clinical activity support further evaluation of PF-03446962 in patients with HCC and other solid malignancies, as single agent or in combination with other antiangiogenic, chemotherapeutic, or immunotherapeutic agents. [ABSTRACT FROM AUTHOR]

Published
2016
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48. NCCN Policy Summit: Cancer Across Geography.

Author

McCarson ST, Schatz A, Hood V, Orr A, Bailey A, Plascak J, Brown-Glaberman U, Rodriguez EM, Carter T, and Denlinger C

Subjects
Humans, Healthcare Disparities, Health Policy, Geography, Neoplasms therapy, Neoplasms epidemiology, Neoplasms diagnosis, Health Services Accessibility standards
Abstract

Geographic location of a patient directly impacts access to care, including preventive screenings and early detection. Although there is a higher prevalence of the most common cancers in urban areas, mortality rates are higher in rural communities. Notably, indigenous communities residing on tribal lands often experience heightened access issues and environmental exposure to known and probable human carcinogens. The burdens associated with a cancer diagnosis can be exacerbated by various barriers to accessing quality care; however, there are emerging best practices to overcome these barriers. Understanding the interplay between geography and a patient's access to cancer care services is crucial for addressing existing disparities and ensuring equitable health care provision across regions. By leveraging innovative policy and practice solutions, communities can begin to close care gaps and establish bidirectional trust between patients and providers across the care continuum, which is necessary to enact meaningful reforms. To advance the conversation on geographic disparities and strategies that mitigate associated barriers to care, NCCN hosted the Policy Summit "Cancer Across Geography" on June 15, 2023, at the National Press Club in Washington, DC. Through keynote addresses and multistakeholder panel discussions, this hybrid event explored care imbalances across geography, recent policy and technology advancements, and current challenges associated with cancer care. This created a forum for a diverse group of attendees to thoughtfully discuss policies and practices to advance high-quality, effective, efficient, equitable, and accessible cancer care for all. Speakers and attendees featured multidisciplinary clinicians, epidemiologists, community oncologists, researchers, payers, patient advocates, industry, providers, policymakers, and leaders representing underserved communities, among others.

Published
2024
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