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413 citation(s) found for "Da, Collins".

AAPM medical physics practice guideline 10.a.: Scope of practice for clinical medical physics
Clements, Jessica B., Baird, Christopher T., Boer, Steven F. de, Fairobent, Lynne, Fisher, Tyler, Goodwin, James, Johnson, Jennifer Lynn, Kolsky, K. L., Mageras, G , Marsh, Rebecca M., Martin, Melissa , Parker, Brent C. , Pavord, Daniel C. , Schell, Michael C., Seibert, J. Anthony , Stevens, Donna M., Tarver, Russell, Waite‐Jones, Christopher G., Wingreen, Nicholai, Milman, Rebecca , Kolsky, Kathryn L, Gress, Dustin A. , Wingreen, Nicholai E., Millman, Rebecca

Journal of Applied Clinical Medical Physics | October 19, 2018 | Volume: 19 | Issue: 6 | Pages: 11-25

10.1002/acm2.12469 | PMID 30338913 Get It

Abstract The American Association of Physicists in Medicine ( AAPM ) is a nonprofit professional society whose primary purposes are to advance the science, education, and professional practice of medical physics. The AAPM has more than 8000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline ( MPPG ) represents a policy statement by the AAPM , has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiation requires specific training, skills, and techniques as described in each document. As the review of the previous version of AAPM Professional Policy ( PP )‐17 (Scope of Practice) progressed, the writing group focused on one of the main goals: to have this document accepted by regulatory and accrediting bodies. After much discussion, it was decided that this goal would be better served through a MPPG . To further advance this goal, the text was updated to reflect the rationale and processes by which the activities in the scope of practice were identified and categorized. Lastly, the AAPM Professional Council believes that this document has benefitted from public comment which is part of the MPPG process but not the AAPM Professional Policy approval process. The following terms are used in the AAPM 's MPPG s: Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline. Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.
Cosmetic outcomes and quality of life in children with cardiac implantable electronic devices
Gist, Katja M. , Marino, Bradley S. , Palmer, Claire , Fish, Frank A. , Moore, Jeremy P. , Czosek, Richard J. , Cassedy, Amy , Law, Ian H. , Garnreiter, Jason M., Cannon, Bryan C. , Collins, Kathryn K. , Cannon, Bryan C , Law, Ian H , LaPage, Martin J

Pacing and Clinical Electrophysiology | October 18, 2018 | Volume: 42 | Issue: 1 | Pages: 46-57

10.1111/pace.13522 | PMID 30334588 Get It

AbstractBackgroundAxillary implant location is an alternative implant location in patients for cardiac implantable electronic devices (CIEDs) for the purposes of improved cosmetic outcome. The impact from the patient's perspective is unknown. The purpose of this study was to compare scar perception scores and quality of life (QOL) in pediatric patients with axillary CIED implant location versus the standard infraclavicular approach.MethodsThis is a multicenter prospective study conducted at eight pediatric centers and it includes patients aged from 8 to 18 years with a CIED. Patients with prior sternotomy were excluded. Scar perception and QOL outcomes were compared between the infraclavicular and axillary implant locations.ResultsA total of 141 patients (83 implantable cardioverter defibrillator [ICD]/58 pacemakers) were included, 55 with an axillary device and 86 with an infraclavicular device. Patients with an ICD in the axillary position had better perception of scar appearance and consciousness. Patients in the axillary group reported, on average, a total Pediatric QOL Inventory score that was 6 (1, 11) units higher than the infraclavicular group, after adjusting for sex and race (P = 0.02).ConclusionsQOL is significantly improved in axillary in comparison to the infraclavicular CIED position, regardless of device type. Scar perception is improved in patients with ICD in the axillary position.
PS02.107: OUTCOMES FOLLOWING DIFFERENT NEOADJUVANT CHEMORADIATION REGIMENS FOR LOCALLY ADVANCED ESOPHAGEAL CANCER
Collins, William, Yahn, Colten , Cassivi, Stephen D. , Nichols, Francis, Wigle, Dennis A. , Shen, Robert K. , Allen, Mark S. , Blackmon, Shanda , Nichols, Francis C.

Diseases of the Esophagus | September 16, 2018 | Volume: 31 | Issue: Supplement_1 | Pages: 151-151

10.1093/dote/doy089.ps02.107 Get It

Abstract Background The objective of this study was to analyze the induction therapy regimens employed since publication of CROSS Trial in patients treated with locally advanced EGJ cancer in terms of toxicity, complications, survival and recurrence. Methods Retrospective chart review all patients in single institution prospective database who had neoadjuvant CRT→Surgery 2012–2015. Complications during CRT and after surgery graded using National Cancer Institute CTCAE. Cox-proportion hazard ratios were used to compare the primary outcomes of overall survival (OS) and disease-free survival (DFS). Results 288 patients, 237 men and 51 women were identified. 246 were adenocarcinoma, 38 squamous cell carcinoma, and 4 had other histologic types. 4 distinct neoadjuvant regimens were observed: 50.4 Gy radiation with 5-fluorouracil and cisplatin (N = 22), CROSS regimen (41.4 Gy with carboplatin & paclitaxel) (N = 44), 50.4 Gy with carboplatin and paclitaxel (N = 152), and ‘Other’ which include 27 distinct regimens (N = 70). There were no differences in treatment related complications or postoperative complications between regimens. There was no difference in pathologic complete response rate, OS, or DFS between regimens. Conclusion Since the publication of the CROSS Trial, there is a significant heterogenity in the neoadjuvant chemoradiation treatment regimen employed for patients with locally advanced EGJ tumors. Does not appear to be any differences in treatment related complications or postoperative complications between regimens. There was also no difference in pCR, overall survival or disease-free survival. Disclosure All authors have declared no conflicts of interest.
A phase 2 study of a nivolumab (nivo)-containing regimen in patients (pts) with newly diagnosed classical Hodgkin lymphoma (cHL): Study 205 Cohort D.
Armand, Philippe , Ramchandren, Radhakrishnan , Timmerman, John M. , Sumbul, Anne, Ruisi, Mary, Kato, Kazunobu, Ansell, Stephen M. , Shipp, Margaret Ann , Kuruvilla, John , Collins, Graham P.

Journal of Clinical Oncology | September 6, 2018 | Volume: 34 | Issue: 15_suppl | Pages: TPS7573-TPS7573

10.1200/jco.2016.34.15_suppl.tps7573 Get It

Phase 1b/3 study of avelumab-based combination regimens in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Chen, Robert W., Ansell, Stephen M. , Vacirca, Jeffrey, López‐Guillermo, Armando , Hutchings, Martin , Offner, Fritz , Santoro, Armando , Salles, Gilles , Stypinski, Daria, Laird, Douglas, Pavlov, Dmitri, Andreola, Giovanna, Fly, Kolette D., Woolfson, Adrian , Salles, Gilles A , Santoro, Armando , Zinzani, Pier Luigi , Jurczak, Wojciech , Heß, Georg , Gouill, Steven Le , Collins, Graham P.

Journal of Clinical Oncology | September 6, 2018 | Volume: 35 | Issue: 15_suppl | Pages: TPS7575-TPS7575

10.1200/jco.2017.35.15_suppl.tps7575 Get It

TPS7575 Background: Approximately 50% of patients (pts) with advanced DLBCL are refractory to or relapse following first line R-CHOP therapy. Pts with R/R DLBCL have limited treatment options and a poor prognosis. This study assesses immunotherapy-based regimens containing avelumab (a fully human IgG1 anti–PD-L1 antibody) in combination with utomilumab (a novel 4-1BB agonist), azacitidine, rituximab, and/or conventional chemotherapy (CT; bendamustine) in pts with R/R DLBCL. Methods: JAVELIN DLBCL (NCT02951156) is a global, multicenter, randomized, open-label, 2-component(phase 1b followed by phase 3) study of avelumab-based combination regimens in R/R DLBCL. In phase 1b, up to 84 pts will be randomized 1:1:1 to receive avelumab/rituximab/utomilumab, or avelumab/azacitidine/utomilumab, or avelumab/rituximab/bendamustine. The primary phase 1b objectives are preliminary assessments of dose-limiting toxicities (n = 6 per arm) and efficacy (objective response [OR]; n = 28 per arm). One regimen from phase 1b will be selected for phase 3 evaluation in 220 additional pts randomized 1:1 to the chosen regimen or investigator’s choice CT (rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin). The primary phase 3 objective is to demonstrate progression-free survival (PFS) superiority of the avelumab-based regimen over CT. Overall survival is a key secondary endpoint. Eligible pts have completed up to 4 lines of prior rituximab/multiagent CT, and/or have failed autologous stem cell transplantation (ASCT), or are not eligible for intensive CT or ASCT. Other eligibility criteria include ECOG PS ≤1 and no prior therapy with a checkpoint inhibitor. Treatment with avelumab, utomilumab, and azacitidine will be continued until the pt no longer receives clinical benefit; rituximab and bendamustine are limited to 8 and 6 cycles, respectively. OR and PFS will be assessed per Lugano disease classification criteria. Other secondary efficacy endpoints include disease control, duration of response, time to response, and minimal residual disease burden. Safety, PK, immunogenicity, pt-reported outcomes, and biomarkers will also be evaluated. Clinical trial information: NCT02951156.
Relationship of bone marrow blast (BMBL) response to overall survival (OS) in a multicenter study of rigosertib (Rigo) in patients (pts) with myelodysplastic syndrome (MDS) with excess blasts progressing on or after treatment with a hypomethylating agent (
Al‐Kali, Aref , Baer, Maria R. , Greenberg, Peter L. , Collins, Robert H. , Shammo, Jamile M. , Seymour, John F. , Meyer, Wolfgang , Zbyszewski, Patrick S., Petrone, Michael E., Fruchtman, Steven, Garcia‐Manero, Guillermo , Silverman, Lewis R. , Hiwase, Devendra , Shortt, Jake , Steensma, David P. , Verma, Amit , Roboz, Gail J. , Ottmann, Oliver G. , Szer, Jeff , Meyer, Wolfgang

Journal of Clinical Oncology | September 6, 2018 | Volume: 35 | Issue: 15_suppl | Pages: 7056-7056

10.1200/jco.2017.35.15_suppl.7056 Get It

7056 Background: No therapies are approved for MDS after HMA failure. 04-24 was a single-arm study to evaluate best BMBL response as a potential surrogate for OS in higher-risk (HR) MDS pts who progressed on or after an HMA. Rigo is a Ras-mimetic that inhibits the RAS-RAF-MEK pathway, which is frequently activated in HR MDS (Athuluri-Divakar Cell 2016; Gil-Bazo Cancer Biol Ther 2016). Methods: Eligible MDS pts had 5-30% BMBL confirmed within 6 wks pre-study and progression per International Working Group (IWG) 2006 criteria on or after HMAs within 2 yrs. Rigo 1800 mg/24 hrs was continuously infused over 72 hrs q 2 wks × 8 cycles, then q 4 wks until progression or unacceptable toxicity. Primary endpoint was relationship of best BMBL IWG response to OS by Kaplan Meier method. Results: 64 pts were treated (median 5 cycles, range 1-32+), with 61% male, median age 73 (range 47-87), median prior HMA duration 10.8 mos (range 1.2-70.2). Revised International Prognostic Scoring System scores were low 2%, intermediate 11%, high 27%, very high 53%, and unknown 8%. ≥Grade 3 adverse events in ≥10% of pts were anemia 19%, thrombocytopenia 19%, and febrile neutropenia 16%. At the analysis time 40 pts (63%) had died. Best BMBL IWG response was marrow complete response (mCR) 14 pts (22%), stable disease (SD) 30 (47%), progressive disease (PD) 15 (23%), and failure (early death/withdrawal) 5 (8%); 2 mCR pts had transplant. Median OS was 7.0 mos (95% confidence interval 4.8-10.8). Landmark median OS (from day of best BMBL response) was mCR not reached; SD 6.3 mos; PD 3.3 mos. Median OS of mCR+SD was 8.5 mos, with log-rank p = 0.011 (mCR+SD OS to PD OS). Conclusions: BMBL response is a predictor of survival for MDS pts receiving Rigo after HMA failure, confirming findings in earlier Phase 1/2 studies (Silverman ASCO 2015 Abstr 7017). Based on earlier results identifying an MDS subset benefitting from Rigo (Garcia-Manero Lancet Oncol 2016; ASCO 2016 Abstr 165681), a randomized Phase 3 trial of Rigo vs physician’s choice (INSPIRE) is ongoing to determine if Rigo improves survival after HMA failure within 9 cycles. Clinical trial information: NCTO 1928537.
Evaluation of tumor and circulating cell free (cf) DNA mutations in women with hormone refractory metastatic breast cancer (MBC) enrolled in a phase I study of Z-endoxifen (MC093C).
Northfelt, Donald W. , Burhow, Sarah A., McGovern, Renee M., Dockter, Travis , Haddad, Tufia C. , Erlichman, Charles , Adjei, Alex A. , Visscher, Daniel W., Kipp, Benjamin R. , Hawse, John R. , Doroshow, James H. , Collins, Jerry M. , Streicher, Howard , Ames, Matthew M. , Liu, Minetta C. , Goetz, Matthew P. , Suman, Vera J. , Reid, Joel M. , Safgren, Stephanie L. , Ingle, James N.

Journal of Clinical Oncology | September 6, 2018 | Volume: 35 | Issue: 15_suppl | Pages: 1043-1043

10.1200/jco.2017.35.15_suppl.1043 Get It

1043 Background: In estrogen receptor (ER) positive MBC, mutations (e.g. ESR1), identified from tumor biopsies or cfDNA, confer resistance. The concordance between mutations observed in tumor and cfDNA and the implications for response to Z-endoxifen, a potent anti-estrogen, are unknown. Methods: We previously conducted a phase I trial of Z-endoxifen in endocrine refractory, ER positive MBC. Seven dose levels were considered ranging from 20 to 160 mg/day followed by expansion cohorts (EC) of 40, 80, and 100 mg/day. Pretreatment blood samples (all pts) and fresh tumor biopsies (EC) were collected prospectively. Tumor and cfDNA were evaluated by targeted NGS. Results: 41 pts (38 evaluable) were enrolled. Prior endocrine therapy included aromatase inhibitors (37/38, 97%), fulvestrant (22/38, 58%) and tamoxifen (26/38, 68%). Substantial endoxifen exposure without DLTs at doses above 80 mg/day led to a halt in dose escalation and opening of the EC. Overall clinical benefit (stable > 6 months [7 pts.] or partial response by RECIST criteria [3 pts.]) rate was 26.3% (95%CI: 13.4-43.1%). cfDNA was obtained from 36 pts and mutations were identified in 13 (36%) including ESR1 [ Y537N or D538G] (5), PIK3CA [ H1047R or E542K] (8), TP53 [ K132R, R248Q, R267Q, or H179Y] (4), AKT ( Q79K) (1), and KRAS ( G12D) (1). In 5 pts with cf ESR1 mutations, 4 had additional cfDNA mutations including PIK3CA (3), and TP53 (1). PFS was shorter in pts with cfDNA mutations relative to those without (median: 61 vs.132 days; log-rank p = 0.021). Discordance was observed between tumor and cfDNA mutations where 3/7 PIK3CA tumor mutations were detected by cfDNA, 1/2 TP53 tumor mutations were detected by cfDNA, and 0/1 AKT tumor mutations were detected by cfDNA. Conversely, 2 pts had cfDNA mutations (either ESR1, TP53 or AKT) undetected in tumor. Conclusions: The absence of cfDNA mutations in patients with endocrine resistant, MBC treated with Z-Endoxifen was associated with significantly longer PFS. Given the discordance between tumor and cfDNA sequence data, future studies must determine which approach maximizes prognosis and prediction of benefit for estrogen-targeted therapy. Clinical trial information: NCT01327781.
Checkmate 205: Nivolumab (nivo) in classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and brentuximab vedotin (BV)—A phase 2 study.
Younes, Anas , Santoro, Armando , Timmerman, John M. , Ansell, Stephen M. , Armand, Philippe , Fanale, Michelle A. , Ratanatharathorn, Voravit, Cohen, Jonathon B. , Kato, Kazunobu, Farsaci, Benedetto , Parker, Susan, Engert, Andreas , Santoro, Armando , Zinzani, Pier Luigi , Kuruvilla, John , Collins, Graham P. , Savage, Kerry J. , Trněný, Marek , Rodig, Scott J , Shipp, Margaret Ann

Journal of Clinical Oncology | September 6, 2018 | Volume: 34 | Issue: 15_suppl | Pages: 7535-7535

10.1200/jco.2016.34.15_suppl.7535 Get It

INSPIRE: A randomized phase III trial of intravenous rigosertib in patients with higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agents (HMAs)—Study design informed by subgroup analyses of ONTIME.
Garcia‐Manero, Guillermo , Al‐Kali, Aref , Baer, Maria R. , Collins, Robert H. , Shammo, Jamile M. , Raza, Azra , Silverman, Lewis R. , Azarnia, N., Fruchtman, Steven, Snyder, Barbara R, Fenaux, Pierre , Roboz, Gail J. , Platzbecker, Uwe , Kambhampati, Suman , Godley, Lucy A. , Santini, Valeria

Journal of Clinical Oncology | September 6, 2018 | Volume: 34 | Issue: 15_suppl | Pages: TPS7077-TPS7077

10.1200/jco.2016.34.15_suppl.tps7077 Get It

Brentuximab vedotin with chemotherapy for stage III or IV Hodgkin lymphoma (HL): Impact of cycle 2 PET result on modified progression-free survival (mPFS).
Chen, Robert W., Ansell, Stephen M. , Gallamini, Andrea , Grigg, Andrew , Sureda, Anna M., Feldman, Tatyana , Özdemir, Evren , Offner, Fritz , Engley, Gerald, Fenton, Keenan , Lee, Shih-Yuan, Jolin, Hina, Gautam, Ashish , Hutchings, Martin , Connors, Joseph M. , Savage, Kerry J. , Collins, Graham P. , Sureda, Anna , Ghosh, Nilanjan , Fosså, Alexander

Journal of Clinical Oncology | September 5, 2018 | Volume: 36 | Issue: 15_suppl | Pages: 7539-7539

10.1200/jco.2018.36.15_suppl.7539 Get It