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5. Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer

Author

Colombo, N, Huang, G, Scambia, G, Chalas, E, Pignata, S, Fiorica, J, Van Le, L, Ghamande, S, González-Santiago, S, Bover, I, Graña Suárez, B, Green, A, Huot-Marchand, P, Bourhis, Y, Karve, S, Blakeley, C, Colombo, Nicoletta, Huang, Gloria, Scambia, Giovanni, Chalas, Eva, Pignata, Sandro, Fiorica, James, Van Le, Linda, Ghamande, Sharad, González-Santiago, Santiago, Bover, Isabel, Graña Suárez, Begoña, Green, Andrew, Huot-Marchand, Philippe, Bourhis, Yann, Karve, Sudeep, Blakeley, Christopher, Colombo, N, Huang, G, Scambia, G, Chalas, E, Pignata, S, Fiorica, J, Van Le, L, Ghamande, S, González-Santiago, S, Bover, I, Graña Suárez, B, Green, A, Huot-Marchand, P, Bourhis, Y, Karve, S, Blakeley, C, Colombo, Nicoletta, Huang, Gloria, Scambia, Giovanni, Chalas, Eva, Pignata, Sandro, Fiorica, James, Van Le, Linda, Ghamande, Sharad, González-Santiago, Santiago, Bover, Isabel, Graña Suárez, Begoña, Green, Andrew, Huot-Marchand, Philippe, Bourhis, Yann, Karve, Sudeep, and Blakeley, Christopher

Abstract

Purpose There is a growing demand for BRCA1/2 mutation (BRCAm) testing in patients with ovarian cancer; however, the limited number of genetic counselors presents a potential barrier. To facilitate more widespread BRCAm testing in ovarian cancer, pretest counseling by the oncology team could shorten testing turnaround times and ease the pressure on genetic counselors. Patients and Methods The prospective, observational Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients With Ovarian Cancer (ENGAGE) study evaluated a streamlined, oncologist-led BRCAm testing pathway. The analysis population comprised 700 patients with ovarian cancer at 26 sites in the United States, Italy, and Spain. The primary objectives were to assess turnaround time and, using questionnaires, to evaluate stakeholder satisfaction (patients, oncologists, and geneticists or genetic counselors) with the oncologist-led BRCAm testing pathway. Results The median overall turnaround time was 9.1 weeks (range, 0.9 to 37.1 weeks), with median turnaround times in the United States, Italy, and Spain of 4.1 weeks (range, 0.9 to 37.1 weeks), 20.4 weeks (range, 2.9 to 35.4 weeks), and 12.0 weeks (range, 2.0 to 36.7 weeks), respectively. Patient satisfaction with the oncologist-led BRCAm testing pathway was high, with . 99% of patients expressing satisfaction with pre- and post-BRCAm test counseling. Oncologist satisfaction with the BRCAm testing pathway was also high, with . 80% agreeing that the process for performing BRCAm testing worked well and that counseling patients on BRCAm testing was an efficient use of their time. Oncologists expressed higher levels of satisfaction with the BRCAm testing pathway than did geneticists or genetic counselors. Conclusion The results of the ENGAGE study demonstrate that an oncologist-led BRCAm testing process is feasible in ovarian cancer. Development of local BRCAm testing guidelines similar to the one used in this study could allow faste

Published
2018

7. Common variants at 12p11, 12q24, 9p21, 9q31.2 and in ZNF365 are associated with breast cancer risk for BRCA1 and/or BRCA2 mutation carriers

Author

Antoniou, AC, Kuchenbaecker, KB, Soucy, P, Beesley, J, Chen, X, McGuffog, L, Lee, A, Barrowdale, D, Healey, S, Sinilnikova, OM, Caligo, MA, Loman, N, Harbst, K, Lindblom, A, Arver, B, Rosenquist, R, Karlsson, P, Nathanson, K, Domchek, S, Rebbeck, T, Jakubowska, A, Lubinski, J, Jaworska, K, Durda, K, Złowowcka-Perłowska, E, Osorio, A, Durán, M, Andrés, R, Benítez, J, Hamann, U, Hogervorst, FB, van Os, TA, Verhoef, S, Meijers-Heijboer, HE, Wijnen, J, Gómez Garcia, EB, Ligtenberg, MJ, Kriege, M, Collée, JM, Ausems, MG, Oosterwijk, JC, Peock, S, Frost, D, Ellis, SD, Platte, R, Fineberg, E, Evans, DG, Lalloo, F, Jacobs, C, Eeles, R, Adlard, J, Davidson, R, Cole, T, Cook, J, Paterson, J, Douglas, F, Brewer, C, Hodgson, S, Morrison, PJ, Walker, L, Rogers, MT, Donaldson, A, Dorkins, H, Godwin, AK, Bove, B, Stoppa-Lyonnet, D, Houdayer, C, Buecher, B, de Pauw, A, Mazoyer, S, Calender, A, Léoné, M, Bressac-de Paillerets, B, Caron, O, Sobol, H, Frenay, M, Prieur, F, Ferrer, SU, Mortemousque, I, Buys, S, Daly, M, Miron, A, Terry, MU, Hopper, JL, John, EM, Southey, M, Goldgar, D, Singer, CF, Fink-Retter, A, Tea, MK, Kaulich, DU, Hansen, TV, Nielsen, FC, Barkardottir, RB, Gaudet, M, Kirchhoff, T, Joseph, V, Dutra-Clarke, A, Offit, K, Piedmonte, M, Kirk, J, Cohn, D, Hurteau, J, Byron, J, Fiorica, J, Toland, AE, Montagna, M, Oliani, C, Imyanitov, E, Isaacs, C, Tihomirova, L, Blanco, I, Lazaro, C, Teulé, A, Valle, JD, Gayther, SA, Odunsi, K, Gross, J, Karlan, BY, Olah, E, Teo, SH, Ganz, PA, Beattie, MS, Dorfling, CM, van Rensburg, EU, Diez, O, Kwong, A, Schmutzler, RK, Wappenschmidt, B, Engel, C, Meindl, A, Ditsch, N, Arnold, N, Heidemann, S, Niederacher, D, Preisler-Adams, S, Gadzicki, D, Varon-Mateeva, R, Deissler, H, Gehrig, A, Sutter, C, Kast, K, Fiebig, B, Schäfer, D, Caldes, T, de la Hoya, M, Nevanlinna, H, Muranen, TA, Lespérance, B, Spurdle, AB, Neuhausen, SL, Ding, YC, Wang, X, Fredericksen, Z, Pankratz, VS, Lindor, NM, Peterlongo, P, Manoukian, S, Peissel, B, Zaffaroni, D, Bonanni, B, Bernard, L, Dolcetti, R, Papi, L, Ottini, L, Radice, P, Greene, MH, Loud, JT, Andrulis, IL, Ozcelik, H, Mulligan, AU, Glendon, G, Thomassen, M, Gerdes, AM, Jensen, UB, Skytte, AB, Kruse, TA, Chenevix-Trench, G, Couch, FJ, Simard, J, Easton, DF, CIMBA, SWE-BRCA, HEBON, EMBRACE, GEMO Collaborators Study, and kConFab Investigators

Subjects
skin and connective tissue diseases
Abstract

Several common alleles have been shown to be associated with breast and/or ovarian cancer risk for BRCA1 and BRCA2 mutation carriers. Recent genome-wide association studies of breast cancer have identified eight additional breast cancer susceptibility loci: rs1011970 (9p21, CDKN2A/B), rs10995190 (ZNF365), rs704010 (ZMIZ1), rs2380205 (10p15), rs614367 (11q13), rs1292011 (12q24), rs10771399 (12p11 near PTHLH) and rs865686 (9q31.2).

Published
2012

8. A parallel-arm phase I trial of the humanised anti-IGF-1R antibody dalotuzumab in combination with the AKT inhibitor MK-2206, the mTOR inhibitor ridaforolimus, or the NOTCH inhibitor MK-0752, in patients with advanced solid tumours

Author

Brana, I, primary, Berger, R, additional, Golan, T, additional, Haluska, P, additional, Edenfield, J, additional, Fiorica, J, additional, Stephenson, J, additional, Martin, L P, additional, Westin, S, additional, Hanjani, P, additional, Jones, M B, additional, Almhanna, K, additional, Wenham, R M, additional, Sullivan, D M, additional, Dalton, W S, additional, Gunchenko, A, additional, Cheng, J D, additional, Siu, L L, additional, and Gray, J E, additional

Published
2014
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30. Hormone replacement therapy and breast cancer risk in California.

Author

Coombs NJ, Taylor R, Wilcken N, Fiorica J, and Boyages J

Abstract

Numerous studies have documented increased breast cancer risks with hormone replacement therapy (HRT), but these do not give a woman her specific absolute risk for the remainder of her life. This article estimates the magnitude of the effect of HRT on breast cancer incidence in California and calculates a woman's cumulative risk of breast cancer with different formulations and durations of HRT use. The effects of HRT on the underlying breast cancer incidence were estimated using the attributable fraction method, applying HRT prevalence data from the 2001 California Health Interview Survey and published rates of higher relative risk (RR) from HRT use from the Women's Health Initiative (WHI) study and Million Women's Survey (MWS). The annual number of breast cancers potentially attributable to HRT in California was estimated, along with individual cumulative risk of breast cancer for various ages to 79 years according to HRT use, duration, and formulation. Using the WHI data, 829 of 19,000 breast cancers (4.3%) in California may be attributable to HRT. This figure increases to 3401 (17.4%) when the MWS RRs are applied. Use of estrogen-only HRT or short-term (approximately 5 years) use of combined HRT has a minimal effect on the cumulative risk calculated to the age of 79 years; application of the MWS data to a Californian woman commencing HRT at the age of 50 years (no HRT, 8.5%; estrogen only, 8.6%; combined, 9.1%). Prolonged (approximately 10 years) use of combined HRT increases the cumulative risk to 10.3%. This article demonstrates that HRT will generate a small additional risk of breast cancer in an individual. The reduction in perimenopausal symptoms may be considered sufficient to warrant this extra risk. However, this view needs to be balanced because the small increases in individual risk will be magnified, producing a noticeable change in population cancer caseload where HRT use is high. [ABSTRACT FROM AUTHOR]

Published
2005
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36. Endotoxin-induced atrial natriuretic factor release: in vivo and in vitro studies.

Author

Rao, Papineni S., Cavanagh, Denis, Graham, Lloyd B., Dietz, John R., Fiorica, James V., Hoffman, Mitchel S., Rao, P S, Cavanagh, D, Graham, D, Graham, L B, Dietz, J R, Fiorica, J V, and Hoffman, M S

Subjects
ENDOTOXINS, KIDNEYS, ANIMAL experimentation, BIOLOGICAL models, BIOTRANSFORMATION (Metabolism), BLOOD pressure, DOGS, ESCHERICHIA coli, HEART atrium, HEART beat, KIDNEY function tests, RATS, RENAL circulation, OSMOLAR concentration, LIPOPOLYSACCHARIDES, IN vitro studies
Abstract

Objective: We evaluated the effects of coliform endotoxin on the circulating levels of atrial natriuretic factor and renal function. To understand the direct effects of endotoxin in the release of atrial natriuretic factor by cardiac tissue, studies in isolated rat atria were performed.Study Design: In vivo studies were used. Anesthetized dogs were studied, with one group receiving isotonic saline solution (n = 6) and the other group receiving 50 microg/kg of coliform endotoxin (n = 7) as a continuous infusion over a 4-hour period. Cardiovascular parameters, renal function, and circulating levels of atrial natriuretic factor were measured at specified time intervals. In another set of experiments with in vitro studies left atria from Sprague-Dawley rats were isolated and perfused. In the control group (n = 9) the standard Krebs perfusate was used. In the endotoxin group (n = 9) coliform endotoxin was added at a concentration of 250 microg/mL to the standard perfusate. Atrial pressure was used as an index of stretch, and atrial natriuretic factor was measured from the perfusate.Results: Administration of endotoxin resulted in decreased blood pressure (P < .05) with a concomitant increase in heart rate. Renal artery flow, however, showed an increase (P < .05) initially followed by a return to its baseline value, with a sustained increase occurring in the saline solution control group. A significant (P < .05) and sustained increase in the circulating levels of atrial natriuretic factor after endotoxin infusion did not prevent the decrease in fractional sodium excretion (P < .05) and creatinine clearance despite an increase in the urinary output. Serum sodium, serum potassium, and osmolalities, however, remained relatively stable. The study pertaining to isolated atria showed that in the presence of low atrial pressures, addition of endotoxin had no significant effect on the release of atrial natriuretic factor. With the increase in atrial pressure atrial natriuretic factor release was significantly higher in the group directly exposed to endotoxin compared with the control group.Conclusions: These studies demonstrate that the slow infusion of coliform endotoxin results in increased circulating levels of atrial natriuretic factor. This increase is in part due to the direct effect of endotoxin on the heart as indicated by studies in isolated atria. Our data suggest that atrial natriuretic factor in endotoxemia acts in an integrative manner with other hormones on a variety of target organs to modulate cardiovascular function and fluid balance. [ABSTRACT FROM AUTHOR]

Published
1998
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43. Pudendal Thigh Fasciocutaneous Flaps for Vaginal Reconstruction in Gynecologic Oncology

Author

Gleeson, N. C., Baile, W., Roberts, W. S., Hoffman, M. S., Fiorica, J. V., Finan, M. A., and Cavanagh, D.

Abstract

The pudendal thigh is a sensate fasciocutaneous flap supplied by the posterior labial artery. We report on the results of pudendal thigh flaps used for vaginal reconstruction in eight patients at the time of pelvic exenteration (6) and radical vaginectomy (2). Patients were interviewed and results were assessed 5 to 19 months after surgery. The flaps were raised in the thigh creases just lateral to the hair bearing area of the labia majora and included skin, subcutaneous tissues, deep fascia of the thigh, and the epimysium of the adductor muscles. Flap sizes varied from 9 × 4 cm to 15 × 6 cm. Bilateral flaps were used in seven patients. The flaps were technically easy to perform. Partial (apical) flap necrosis occurred in four patients. One patient developed complete necrosis of bilateral flaps, followed by an enterovaginal fistula. One patient whose flaps did not necrose developed a rectovaginal fistula at the site of rectal reanastomosis. The functional results are disappointing. The only patient having successful vaginal intercourse had a unilateral flap reconstruction following lower vaginectomy in a nonirradiated pelvis. No patient with bilateral flaps or prior pelvic irradiation has had successful coitus. Other long-term sequelae include vulvar pain (2), chronic vaginal discharge (2), hair growth (4), and protrusion of the flaps (2). These vulvovaginal symptoms discourage patients and their partners from genital contact. Breaching the integrity of the vulva to construct a neovagina that is likely to be unsuitable for sexual intercourse may deprive women of their only potential for normal genital sexual responsiveness. Techniques of vaginoplasty require continued assessment. Copyright 1994, 1999 Academic Press

Published
1994
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44. Externalized Groshong Catheters and Hickman Ports for Central Venous Access in Gynecologic Oncology Patients

Author

Gleeson, N. C., Fiorica, J. V., Mark, J. E., Pinelli, D. M., Hoffman, M. S., Roberts, W. S., and Cavanagh, D.

Abstract

There is a demand on gynecologic oncology services for semi-permanent cannulization of central veins to improve the quality of life in cancer patients by circumventing the need for frequent peripheral venous punctures. Central venous thrombosis and sepsis are the major complications with these lines. We reviewed our experience with the externalized Groshong catheters and subcutaneously implanted Hickman ports in 104 gynecologic oncology patients requiring either chemotherapy (56), hyperalimentation (5), or supportive care (43). All devices were inserted under the supervision of one primary gynecologic oncologist. Groshong catheters and Hickman ports remained in place for a median of 68.5 and 210 days, respectively (P &lt; 0.001). Thrombosis occurred in association with 4.8% of catheters and was exclusive to the Groshong catheters. Line sepsis occurred in 32% of Groshong catheters and 16.2% of Hickman ports (P = 0.04). Infection rates were not higher in dual-lumen compared to single-lumen Groshong catheters. Staphylococcus epidermidis was the commonest isolate in line infections. The majority of lines were salvaged despite infectious complications. Malfunction of the catheter was equally common in both groups (10.5-13.5%), but was complete, necessitating replacement of only 2.9% of lines. The Groshong catheters took less time to insert (P &lt; 0.003). The externalized Groshong catheter remains a useful alternative to the subcutaneously implanted ports, especially when relatively short-term use is anticipated, but gynecologic oncologists should be aware that there is an increased frequency of complications with the externalized catheter. Copyright 1993, 1999 Academic Press

Published
1993
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46. Cervical cancer guidelines. Clinical practice guidelines in oncology

Author

Teng, N., Abu-Rustum, N. R., Bahador, A., Bookman, M. A., Bristow, R. E., Campos, S., Kathleen Cho, Copeland, L., Eifel, P., Fiorica, J., Greer, B. E., Kapp, D. S., Kavanagh, J., Koh, W. J., Kuettel, M., Lurain, J. R., Molpus, K. L., Nag, S., Partridge, E. E., Powell, C. B., Reynolds, R. K., Small Jr, W., Soper, J., and Tillmanns, T. D.

Subjects
Humans, Uterine Cervical Neoplasms, Female, Guidelines as Topic, Medical Oncology, Uterine Cervical Dysplasia, Algorithms, Neoplasm Staging

49. Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer

Author

Nicoletta Colombo, Isabel Bover, Linda Van Le, C. Blakeley, Gloria S. Huang, Sudeep Karve, Sharad A. Ghamande, Andrew Green, Yann Bourhis, Philippe Huot-Marchand, Eva Chalas, Santiago González-Santiago, Begoña Graña Suárez, James Fiorica, Sandro Pignata, Giovanni Scambia, Colombo, N, Huang, G, Scambia, G, Chalas, E, Pignata, S, Fiorica, J, Van Le, L, Ghamande, S, González-Santiago, S, Bover, I, Graña Suárez, B, Green, A, Huot-Marchand, P, Bourhis, Y, Karve, S, and Blakeley, C

Subjects
0301 basic medicine, Oncology, Counseling, Cancer Research, medicine.medical_specialty, Genetic counseling, Population, Turnaround time, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Surveys and Questionnaires, BRCA mutation, genetic counselors, ovarian cancer, questionnaires, medicine, Humans, Genetic Testing, Prospective Studies, Prospective cohort study, education, Genetic testing, BRCA2 Protein, Oncologists, Ovarian Neoplasms, education.field_of_study, medicine.diagnostic_test, business.industry, BRCA1 Protein, BRCA mutation, ORIGINAL REPORTS, Middle Aged, medicine.disease, United States, 030104 developmental biology, Italy, Spain, 030220 oncology & carcinogenesis, Mutation, Observational study, Female, business, Ovarian cancer, Program Evaluation
Abstract

Purpose There is a growing demand for BRCA1/ 2 mutation ( BRCAm) testing in patients with ovarian cancer; however, the limited number of genetic counselors presents a potential barrier. To facilitate more widespread BRCAm testing in ovarian cancer, pretest counseling by the oncology team could shorten testing turnaround times and ease the pressure on genetic counselors. Patients and Methods The prospective, observational Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients With Ovarian Cancer (ENGAGE) study evaluated a streamlined, oncologist-led BRCAm testing pathway. The analysis population comprised 700 patients with ovarian cancer at 26 sites in the United States, Italy, and Spain. The primary objectives were to assess turnaround time and, using questionnaires, to evaluate stakeholder satisfaction (patients, oncologists, and geneticists or genetic counselors) with the oncologist-led BRCAm testing pathway. Results The median overall turnaround time was 9.1 weeks (range, 0.9 to 37.1 weeks), with median turnaround times in the United States, Italy, and Spain of 4.1 weeks (range, 0.9 to 37.1 weeks), 20.4 weeks (range, 2.9 to 35.4 weeks), and 12.0 weeks (range, 2.0 to 36.7 weeks), respectively. Patient satisfaction with the oncologist-led BRCAm testing pathway was high, with > 99% of patients expressing satisfaction with pre- and post- BRCAm test counseling. Oncologist satisfaction with the BRCAm testing pathway was also high, with > 80% agreeing that the process for performing BRCAm testing worked well and that counseling patients on BRCAm testing was an efficient use of their time. Oncologists expressed higher levels of satisfaction with the BRCAm testing pathway than did geneticists or genetic counselors. Conclusion The results of the ENGAGE study demonstrate that an oncologist-led BRCAm testing process is feasible in ovarian cancer. Development of local BRCAm testing guidelines similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer.

Published
2018

50. Effectiveness of COVID-19 Convalescent Plasma Infusion Within 48 Hours of Hospitalization With SARS-CoV-2 Infection.

Author

Lattanzio N, Acosta-Diaz C, Villasmil RJ, Kirkland Z, Bass C, Yenari S, Conte J, Dawkins K, Fonseca T, Grimes C, Stewart A, Geary ME, Vore H, Hamad K, Wiese-Rometsch W, Fiorica J, Gordillo M, Mercado R, and Voelker K

Abstract

On January 30, 2020, the World Health Organization (WHO) declared the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic a worldwide emergency. Worldwide there have been 170 million cases of the resulting disease coronavirus 2019 (COVID-19), of those, 3.53 million have resulted in death. The Food and Drug Administration (FDA) with Mayo Clinic as the lead institution authorized COVID-19 convalescent plasma (CCP) for treatment of SARS-CoV-2 infection. Effective therapeutic window for CCP administration had yet to be defined. We addressed this gap by characterizing longitudinal biologic response and clinical outcomes of COVID-19 patients treated with CCP. Primary outcome was discharged to home/home health., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2021, Lattanzio et al.)

Published
2021
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