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Bone Cancer

J. Sybil Biermann, Douglas R. Adkins, Robert S. Benjamin, Brian Brigman, Warren Chow, Ernest U. Conrad III, Deborah A. Frassica, Frank J. Frassica, Suzanne George, Kenneth R. Hande, Francis J. Hornicek, G. Douglas Letson, Joel Mayerson, Sean V. McGarry, Brian McGrath, Carol D. Morris, Richard J. O'Donnell, R. Lor Randall, Victor M. Santana, Robert L. Satcher, Herrick J. Siegel, Neeta Somaiah, and Alan W. Yasko

-up are necessary when considering the risk for recurrence and comorbidities associated with chemotherapy and radiation therapy (RT). Extended therapy and surveillance may be necessary for long-term survivors to address the potential side effects of

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Uterine Neoplasms

Benjamin E. Greer, Wui-Jin Koh, Nadeem Abu-Rustum, Michael A. Bookman, Robert E. Bristow, Susana M. Campos, Kathleen R. Cho, Larry Copeland, Marta Ann Crispens, Patricia J. Eifel, Warner K. Huh, Wainwright Jaggernauth, Daniel S. Kapp, John J. Kavanagh, John R. Lurain III, Mark Morgan, Robert J. Morgan Jr, C. Bethan Powell, Steven W. Remmenga, R. Kevin Reynolds, Angeles Alvarez Secord, William Small Jr, and Nelson Teng

. Carcinoma of the corpus uteri. FIGO 6th annual report on the Results of Treatment in Gynecological Cancer . Int J Gynaecol Obstet 2006 ; 95 ( Suppl 1 ): S105 – 143 . 21 Fishman DA Roberts KB Chambers JT . Radiation therapy as exclusive

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Survival in Patients With Severe Lymphopenia Following Treatment With Radiation and Chemotherapy for Newly Diagnosed Solid Tumors

Stuart A. Grossman, Susannah Ellsworth, Jian Campian, Aaron T. Wild, Joseph M. Herman, Dan Laheru, Malcolm Brock, Ani Balmanoukian, and Xiaobu Ye

but occurred rapidly after the initiation of radiation therapy. 21 Lymphocytes are the most radiosensitive cells in the body, and in vitro studies suggest that the dose required to kill 50% of the population (D 50 ) of lymphocytes is approximately 1

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Disparities in the Use of Neoadjuvant Therapy for Resectable Pancreatic Ductal Adenocarcinoma

Jordan M. Cloyd, Chengli Shen, Heena Santry, John Bridges, Mary Dillhoff, Aslam Ejaz, Timothy M. Pawlik, and Allan Tsung

greater number of patients will be unable to complete the intended course of adjuvant therapy for similar reasons. 7 , 8 The administration of chemotherapy with or without radiation therapy (RT) before surgical resection is an alternative strategy that

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CLO19-037: Reducing the Duration, Incidence and Severity of Mucosal Injury Due to Cancer Radiation therapy (RT); Positive Randomized Phase 2b Trial Results With GC4419 (Avasopasem Manganese), a Small Molecule Superoxide (SO) Dismutase (SOD) Mimetic

Jon T. Holmlund, Carryn M. Anderson, Stephen T. Sonis, Robert Beardsley, Dennis Riley, Jeffrey Mark Brill, Melissa Brookes, Kara Terry, and J. Mel Sorensen

Introduction: RT-induced SO contributes to initiation of mucosal injury; eg, oral mucositis (OM) and esophagitis. GC4419 specifically mimics SOD’s dismutation of SO to hydrogen peroxide (H2O2), interdicting OM initiation. GC4419 reduced RT-severe OM (SOM) in a hamster cheek pouch model, and protected mucosa and other normal tissues from radiation-induced injury in other animal models. In a published phase 1b/2a open-label trial (Anderson et al, IJROBP, 1 Feb 2018), GC4419 attenuated SOM in patients (Pts) receiving intensity-modulated RT (IMRT) plus concurrent cisplatin (CDDP) for locally advanced head & neck cancer (HNC). Objectives: Determine whether GC4419 reduces duration, incidence, & severity of SOM. Methods: Pts with locally advanced oral cavity or oropharyngeal cancer; definitive or postoperative intensity-modulated (IM)RT (approximately 70 Gy [>50 Gy to > 2 oral sites]) plus CDDP (weekly or q3wk) were randomized (stratification: tumor HPV status, CDDP schedule) to 30 or 90 mg of GC4419, or placebo (PBO), 60-minute IV infusion, M–F, ending <60 minutes before IMRT delivered in 35 fractions over 7 weeks. WHO grade OM was assessed by trained evaluators biw during IMRT & qwk for up to 8 wks after IMRT. Primary endpoint: duration of SOM. Efficacy was tested for each active dose vs PBO (ITT population) by a sequential, conditional approach (2-sided alpha, 0.05). Results: 223 pts (44 sites): 90 mg (n=76), 30 mg (n=73), or PBO (n=74). Baseline patient and tumor characteristics and treatment delivery were balanced. Efficacy: At 90 mg GC4419 vs PBO, duration of SOM was significantly reduced (median, 1.5 vs 19 d; P=.024). SOM incidence (43% vs 65%; P=.009), and grade 4 incidence (16% vs 30%; P=.045) also improved. There were intermediate improvements with 30 mg. Safety was comparable across arms; no significant GC4419-specific toxicity; other known toxicities of IMRT/CDDP were not increased. Conclusions: GC4419 demonstrated a significant, clinically meaningful reduction of SOM duration, and dose-dependent improvements in other SOM parameters, with acceptable safety. A confirmatory phase 3 trial (NCT03689712) is in progress. Clinical trials to reduce RT-related esophagitis are also planned.

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Squamous Cell Transformation of Primary Lung Adenocarcinoma in a Patient With EML4-ALK Fusion Variant 5 Refractory to ALK Inhibitors

Jay Gong, Jeffrey P. Gregg, Weijie Ma, Ken Yoneda, Elizabeth H. Moore, Megan E. Daly, Yanhong Zhang, Melissa J. Williams, and Tianhong Li

palliative whole-brain radiation therapy (WBRT) in 10 daily fractions; crizotinib for 13 months; 30 Gy of palliative external-beam RT (EBRT) to T11–L1 in 10 daily fractions; ceritinib for 10 months; alectinib for 7 months; 30 Gy of palliative EBRT to T4–T9 in

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Bladder Cancer

James E. Montie, Peter E. Clark, Mario A. Eisenberger, Rizk El-Galley, Richard E. Greenberg, Harry W. Herr, Gary R. Hudes, Deborah A. Kuban, Timothy M. Kuzel, Paul H. Lange, Subodh M. Lele, Jeffrey Michalski, Anthony Patterson, Kamal S. Pohar, Jerome P. Richie, Wade J. Sexton, William U. Shipley, Eric J. Small, Donald L. Trump, Phillip J. Walther, and Timothy G. Wilson

patients with invasive bladder cancer treated with selective bladder preservation by combined radiation therapy and chemotherapy: initial results of RTOG 89-03 . J Clin Oncol 1998 ; 16 : 3576 – 3583 . 39 Shipley WU Kaufman DS Zehr E

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Chemo- and Radiotherapy in Adjuvant Management of Optimally Debulked Endometrial Cancer

David Scott Miller, Gini Fleming, and Marcus E. Randall

-cell carcinoma of the endometrium: implications for adjuvant radiation therapy . Int J Radiat Oncol Biol Phys 2003 ; 55 : 1272 – 1276 . 7 McMeekin DS Lashbrook D Gold M . Analysis of FIGO Stage IIIc endometrial cancer patients . Gynecol Oncol

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Daniel G. Coit, Robert Andtbacka, Christopher J. Anker, Christopher K. Bichakjian, William E. Carson III, Adil Daud, Raza A. Dilawari, Dominick DiMaio, Valerie Guild, Allan C. Halpern, F. Stephen Hodi Jr., Mark C. Kelley, Nikhil I. Khushalani, Ragini R. Kudchadkar, Julie R. Lange, Anne Lind, Mary C. Martini, Anthony J. Olszanski, Scott K. Pruitt, Merrick I. Ross, Susan M. Swetter, Kenneth K. Tanabe, John A. Thompson, Vijay Trisal, and Marshall M. Urist

clinical and biologic significance of this observation remains unclear. Adjuvant Radiation Therapy Adjuvant RT is rarely necessary for excised local melanoma. One exception may be desmoplastic neurotropic melanoma (DNM), which tends to be locally

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Daniel G. Coit, Robert Andtbacka, Christopher K. Bichakjian, Raza A. Dilawari, Dominick DiMaio, Valerie Guild, Allan C. Halpern, F. Stephen Hodi, Mohammed Kashani-Sabet, Julie R. Lange, Anne Lind, Lainie Martin, Mary C. Martini, Scott K. Pruitt, Merrick I. Ross, Stephen F. Sener, Susan M. Swetter, Kenneth K. Tanabe, John A. Thompson, Vijay Trisal, Marshall M. Urist, Jeffrey Weber, and Michael K. Wong

melanoma of the head and neck . Cancer 2004 ; 100 : 383 – 389 . 86 Strom EA Ross MI . Adjuvant radiation therapy after axillary lymphadenectomy for metastatic melanoma: toxicity and local control . Ann Surg Oncol 1995 ; 2 : 445 – 449