Abstract
CONSCIENCE-BASED MEDICINE: NEW APPROACHES TO THE MANAGEMENT OF PROSTATE CANCER PATIENTS
Lisovy V.N.1, Pilipenko I.N.2, Pilipenko N.I.1
1Kharkiv National Medical University, 2Grigoriev Institute for Medical Radiology of NAMSU, Ukraine
Abstract. Almost half of prostate men cancer, the disease is benign and not life threatening. However, some patients with aggressive tumors have manifestations that can lead to death if not treated. Now the problem concerns to predict the nature of its course. This will prevent useless severe treatment when most patients the tumor can be controlled minimal therapeutic intervention or even just to keep the patient under regular diagnostic control. At present there are real possibilities to confidently enough differentiate the cases where a radical medical aid to the patient is needed and where either only minimal therapeutic support or even just regular periodic examinations and consultations would suffice. What is respectfully acknowledged at major meetings and in editorials is not being applied to patients. The explanations are complex and rooted in a conflict between knowledge and belief with disturbing undertones of economic self-interest. It is time to practice conscience-based medicine.
Keywords: prostate cancer, management of patients, conscience-based medicine.
МЕДИЦИНА ЗАСНОВАНА НА СОВІСТІ: НОВІ ПІДХОДИ ДО ВЕДЕННЯ ХВОРИХ НА РАК ПРОСТАТИ
Лісовой В.М.1, Пилипенко М.І.2, Пилипенко І.М.1
1Харківський національний медичний університет, 2Інститут медичної радіології ім. С.П.Григор'єва, Україна
Реферат. Майже у половини хворих на рак простати, хвороба протікає доброякісно і не загрожує життю. Але у деяких пацієнтів пухлини бувають з агресивними проявами і можуть призвести до смерті,якщо не лікуються. Таким чином, наразі ставиться проблема прогнозувати характер її перебігу. Це дасть можливість запобігти марного тяжкого лікування у випадках, коли у більшості хворих пухлину можна контролювати мінімальним терапевтичним втручанням або навіть вести хворого лише під регулярним діагностичним контролем. Наразі існують реальні можливості достатньо впевнено диференціювати випадки захворювання, коли не обхідна радикальна лікувальна допомога хворому від тих, що потребують або мінімальну терапевтичну підтримку, або ж лише регулярний періодичний огляд і консультацію. Але те, що з повагою визнано на великих нарадах та в редакційних статтях, не стало повсякденною клінічною реальністю. Поясненняє складним і йде корінням у конфлікт між знанням і вірою з тривожним відтінком економічних інтересів. Настав час медицини, заснованої на сумлінні.
Ключові слова: рак простати, ведення хворого, сумлінна медицина
МЕДИЦИНА ОСНОВАННАЯ НА СОВЕСТИ: НОВЫЕ ПОДХОДЫ К ВЕДЕНИЮ БОЛЬНЫХ РАКОМ ПРОСТАТЫ
Лесовой В.Н.1, Пилипенко Н.И.2, Пилипенко И.Н.1
1Харьковский национальный медицинский университет, 2Институт медицинской радиологии им. С.П.Григорьева, Украина
Реферат. Примерно у половины заболевших раком простаты болезнь протекает доброкачественно и не угрожает жизни. Но у некоторых пациентов опухоль имеет агрессивное течение и может привести к смерти, если не лечить. Следовательно, ныне проблема состоит в прогнозировании характера заболевания. Это дает возможность избежать для большинства больных тяжкого лечения, контролируя опухоль только минимальными средствами, или даже ведя больного лишь под регулярным активным наблюдением. Ныне существуют возможности достаточно уверенно дифференцировать случаи заболевания, когда действительно не обходима радикальная лечебная помощь больному, от тех, когда нужна минимальная терапевтическая поддержка или даже всего лишь регулярное периодическое обследование и консультации. Тем не менее, то, что признано на широких совещаниях специалистов и в редакционных статьях, не стало широкой клинической реальностью. Найти объяснение этому явлению сложно, и уходит оно корнями, вероятно, в конфликт между знанием и верой с тревожным оттенком экономических интересов. Пришло время медицины совести.
Ключевые слова: рак простаты, ведение больного, основанная на совести медицина.
References
Jemal A., Siegel R., Xu J., Ward E. Cancer statistics, 2010. CA Cancer J Clin, 2010, vol. 60, pp. 277–300.
American Cancer Society. Cancer facts and figures, 2007. Atlanta, GA: ACS; 2007.
Jemal A., Siegel R., Ward E., et al. Cancer statistics, 2007. CA Cancer J Clin, 2007, vol. 57, pp. 43–66.
Canadian Cancer Society / National Cancer Institute of Canada, National Cancer Institute of Canada. In: Canadian cancer statistics. Toronto: National Institute of Cancer; 2008.
Jemal A., Siegel R., Xu J., Ward E. Cancer statistics, 2010. CA Cancer J Clin, 2010, vol. 60, P. 277–300. [Published correction appears in CA Cancer J Clin, 2011, vol. 61, pp. 133–134.]
Franks L.M. Proceedings: Etiology, epidemiology, and pathology of prostatic cancer. Cancer, 1973, vol. 32, pp. 1092–1095.
Hølund B. Latent prostatic cancer in a consecutive autopsy series. Scand J Urol Nephrol, 1980, vol. 14, pp. 29-35.
Sakr WA, Grignon DJ, Haas GP, et al. Epidemiology of high grade prostatic intraepithelial neoplasia. Pathol Res Pract, 1995; vol. 191, pp. 838–841.
Walsh P.C., DeWeese T.L., Eisenberger M.A. Clinical practice: localized prostate cancer. N Engl J Med, 2007; vol. 357, pp. 2696–2705.
American Cancer Society. Prostate cancer. Atlanta, Ga: American Cancer Society, 1999.
McNaughton-Collins M., Ransohoff D.F., Barry M.J. Early detection of prostate cancer: serendipity strikes again., 1997, vol. 278, pp. 1516–1519.
Choo R., Klotz L., Danjoux C., et al: Feasibility study: Watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression. J Urol, 2002, vol. 167, pp. 1664–1669.
Klotz L: Active surveillance for prostate cancer: For whom? J Clin Oncol, 2005, vol. 23, pp. 8165–8169.
Vargas H. A., Wassberg C., Akin O., Hricak H. MR Imaging of Treated Prostate Cancer. Radiology, 2012; vol. 262, pp. 26 –42.
Schroder F.H., Hugosson J., Roobol M.J., et al: Screening and prostate-cancer mortality in a randomized European study. N Engl J Med, 2009, vol. 360, pp. 1320– 1328.
Draisma G., Boer R., Otto S.J., et al. Lead times and overdetection due to prostatespecific antigen screening: estimates from the European Randomized Study of Screening for Prostate Cancer. J Natl Cancer Inst, 2003, vol. 95, pp. 868–878.
Kvеle R., Mшller B., Wahlqvist R., et al. Concordance between Gleason scores of needle biopsies and radical prostatectomy specimens: a population-based study. BJU Int, 2009, vol. 103, pp. 1647–1654.
Divrik R.T., Eroglu A., Sahin A., Zorlu F., Ozen H. Increasing the number of biopsies increases the concordance of Gleason scores of needle biopsies and prostatectomy specimens. Urol Oncol, 2007, vol. 25, pp. 376–382.
Tomioka S., Nakatsu H., Suzuki N., Murakami S., Matsuzaki O., Shimazaki J. Comparison of Gleason grade and score between preoperative biopsy and prostatectomy specimens in prostate cancer. Int J Urol, 2006, vol. 13, pp. 555–559.
Rajinikanth A., Manoharan M., Soloway C.T., Civantos F.J., Soloway M. S. Trends in Gleason score: concordance between biopsy and prostatectomy over 15 years. Urology, 2008, vol. 72, pp. 177–182.
Kilpelainen T.P., Tammela T.L.J., Maattanen L., et al. False-positive screening results in the Finnish prostate cancer screening trial. British Journal of Cancer, 2010, vol. 102, pp. 469–474.
Benson M.C., McMahon D.J., Cooner W.H., Olsson C.A. An algorithm for prostate cancer detection in a patient population using prostate specific antigen and prostate specific antigen density. World J Urol, 1993, vol. 11, pp. 206–213.
Lee F., Torp-Pedersen S.T., Siders D.B., et al. Transrectal ultrasound in the diagnosis and staging of prostatic carcinoma. Radiology, 1989, vol. 170, pp. 609–615.
Lee F., Littrup P.J., Torp-Pedersen S.T., et al. Prostate cancer: comparison of transrectal US and digital rectal examination for screening. Radiology, 1988, vol. 168, pp. 389–394.
Lee F., Littrup P.J., Loft-Christensen L., et al. Predicted prostate specific antigen results using transrectal ultrasound gland volume: differentiation of benign prostatic hyperplasia and prostate cancer. Cancer, 1992, vol. 70, pp. 211–220.
Lee F., Littrup P.J. The role of digital rectal examination, transrectal ultrasound, and prostate specific antigen for the detection of confined and clinically relevant prostate cancer. J Cell Biochem Suppl, 1992, vol. 16, pp. 69–73.
D’Amico A.V., Chen M., Roehl K., et al: Preoperative PSA velocity and the risk of death from prostate cancer after radical prostatectomy. N Engl J Med, 2005, vol. 351, pp. 125–135.
Sengupta S., Myers R.P., Slezak J.M., et al: Preoperative prostate-specific antigen doubling time and velocity are strong and independent predictors of outcomes following radical prostatectomy. J Urol, 2005, vol. 174, pp. 2191–2196.
Patel D.A., Presti J.C., McNBeal J.E., et al: Preoperative PSA velocity is an independent prognostic factor for relapse after radical prostatectomy. J Clin Oncol, 2005, vol. 23, pp. 6157–6162.
D’Amico A.V., Renshaw A.A., Sussman B., et al: Pretreatment PSA velocity and risk of death from prostate cancer following external beam radiation therapy. JAMA, 2005, vol. 294, pp. 440–447.
Cornud F., Belin X., Piron D., et al. Color Doppler-guided prostate biopsies in 591 patients with an elevated serum PSA level: impact on Gleason score for non-palpable lesions. Urology, 1997, vol. 49, pp. 709–715.
Halpern E. J., Rosenberg M., Gomella L. G. Prostate Cancer: Contrastenhanced US for Detection. Radiology, 2001, vol. 219, pp. 219–225.
Lawton C. A., Grignon D., Newhouse J. H., et al. Prostatic Carcinoma. RadioGraphics, 1999, vol. 19, pp. 185–203.
Perrotti M., Kaufman R.P., Jennings T.A., et al. Endo-rectal coil magnetic resonance imaging in clinically localized prostate cancer: is it accurate? J Urol, 1996, vol. 156, pp.106–109.
Huch Boni R.A., Boner J.A., Debatin J.F., et al. Optimization of prostate carcinoma staging: comparison of imaging and clinical methods. Clin Radiol, 1995, vol. 50, pp. 593–600.
Giri P.G., Walsh J.W., Hazra T.A., Texter J.H., Koontz W.W. Role of computed tomography in the evaluation and management of carcinoma of the prostate. Int J Radiat Oncol Biol Phys, 1982, vol. 8, pp. 283–287.
Chelsky M.J., Schnall M.D., Seidmon E.J., Pollack H.M. Use of endorectal surface coil magnetic resonance imaging for local staging of prostate cancer. J Urol, 1993; vol. 150, pp. 391–395.
Jager G.J, Barentsz J.O., de la Rosette J.J., Rosenbusch G. Preliminary results of endorectal surface coil magnetic resonance imaging for local staging of prostate cancer. Radiology, 1994, vol. 34, pp. 129–133.
McSherry S.A., Levy F., Schiebler M.L., Keefe B., Dent G.A., Mohler J.L. Preoperative prediction of pathological tumor volume and stage in clinically localized prostate cancer: comparison of digital rectal examination, transrectal ultrasonography, and magnetic resonance imaging. J Urol, 1991, vol. 146, pp. 85–89.
Chefchaouni M.C., Flam T., Cornud F., et al. Results of endorectal MRI in local staging of prostatic cancer: correlation with specimens from prostatectomy — apropos of 47 cases. J Urol, 1996, vol. 102, pp. 51–55.
Bartolozzi C., Menchi I., Lencioni R., et al. Local staging of prostate carcinoma with endorectal coil MRI: correlation with whole-mount radical prostatectomy specimens. Eur Radiol, 1996, vol. 6, pp. 339–345.
Bates T.S., Cavanagh P.M., Speakman M., Gillatt D.A. Endorectal MRI using a 0.5 T mid-field system in the staging of localized prostate cancer. Clin Radiol, 1996, vol. 51, pp. 550–553.
Kuligowska E., Barish M. A., Fenlon H. M., Blake M.. Predictors of Prostate Carcinoma: Accuracy of Gray-Scale and Color Doppler US and Serum Markers. Radiology, 2001, vol. 220, pp. 757–764.
Claus F. G., Hricak H., Hattery R. R.. Pretreatment Evaluation of Prostate Cancer: Role of MR Imaging and 1HMR Spectroscopy. RadioGraphics, 2004, vol. 24, S167–S180.
Cooperberg M.R., Broering J.M., Carroll P.R. Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol, 2010, vol. 28, pp. 1117– 1123.
Potters L., Klein E.A., Kattan M.W., et al. Monotherapy for stage T1-T2 prostate cancer: Radical prostatectomy, external beam radiotherapy, or permanent seed implantation. Radiother Oncol, 2004, vol. 71, pp. 29–33.
Ciezki J.P., Klein E.A., Angermeier K., et al. A retrospective comparison of androgen deprivation (AD) vs. no AD among lowrisk and intermediate-risk prostate cancer patients treated with brachytherapy, external beam radiation therapy, or radical prostatectomy. Int J Radiat Oncol Biol Phys, 2004, vol. 60, pp. 1347–1350.
Roemeling S., Roobol M.J., Postma R., et al. Management and survival of screen-detected prostate cancer patients who might have been suitable for active surveillance. Eur Urol, 2006, vol. 50, pp. 475–482.
Bracarda S., de Cobelli O., Greco C., et al. Cancer of the prostate. Crit Rev Oncol Hematol., 2005, vol. 56, pp. 379–396.
Bill-Axelson A., Holmberg L., Ruutu M., et al. Radical prostatectomy versus watchful waiting in early CaP. N Engl J Med, 2005, vol. 352, pp. 1977–1984.
Steineck G., Helgesen F., Adolfsson J., et al. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med, 2002, vol. 347, pp. 790–796.
Zhou E. H., Ellis R. J., Cherullo E., Colussi V., Fang Xu, Wei-Dong Chen et al. Radiotherapy and survival in prostate cancer patients: a population-based study. Int. J. Radiation Oncology Biol. Phys., 2009, vol. 73, pp. 15–23.
Thompson I., Thrasher J.B., Aus G., et al. Guideline for the management of clinically localized prostate cancer: 2007 update. J Urol, 2007, vol. 177, pp. 2106–2131.
Wilt T.J., Macdonald R., Rutks I., et al. Systematic review: The comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med., 2008, vol. 148, pp. 435–448.
D’Amico A.V., Whittington R., Malkowicz S.B., et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA, 1998, vol. 280, pp. 969–974.
Bolla M., Collette L., Blank L., et al. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): A phase III randomised trial. Lancet, 2002, vol. 360, pp. 103–106.
Hanks G.E., Pajak T.F., Porter A., et al. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: The radiation therapy oncology group protocol 92-02. J Clin Oncol, 2003, vol. 21, pp. 3972–3978.
Sylvester J.E., Blasko J.C., Grimm P.D., et al. Ten year biochemical relapse-free survival after external beam radiation and brachytherapy for localized prostate cancer: The Seattle experience. Int J Radiat Oncol Biol Phys, 2003, vol. 57, pp. 944– 952.
Potters L., Morgenstern C., Calugaru E., et al. 12-year outcomes following permanent prostate brachytherapy in patients with clinically localized prostate cancer. J Urol, 2005, vol. 173, pp. 1562–1566.
Zelefsky M.J., Yamada Y., Fuks Z., et al. Long-term results of conformal radiotherapy for prostate cancer: Impact of dose escalation on biochemical tumor control and distant metastasesfree survival outcomes. Int J Radiat Oncol Biol Phys, 2008, vol. 71, pp. 1028–1033.
Pervez N., Small C., Mackenzie M., et al. Acute toxicity in high risk prostate cancer patients treated with androgen suppression and hypofractionated intensity-modulated radiotherapy. Int. J. Radiation Oncology Biol. Phys., 2010, vol. 76, pp. 57–64.
King C. R., Kapp D. S. Radiotherapy after prostatectomy: is the evidence for dose escalation out there? Int. J. Radiation Oncology Biol Phys, 2008, vol. 71, pp. 346– 350.
Bolla M., van Poppel H., Collette L., et al. Postoperative radiotherapy after radical prostatectomy: A randomized controlled trial (EORTC trial 22911). Lancet, 2005, vol. 366, pp. 572–578.
Thompson I. M., Tangen C. M., Paradelo J., et al. Adjuvant radiotherapy for pathologically advanced prostate cancer: A randomized trial. JAMA, 2006, vol. 296, pp. 2329–2335.
Stephenson A. J., Scardino P. T., Kattan M. W., et al. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol, 2007, vol. 25, pp. 2035–2041.
Hayes S. B., Pollack A. Parameters for treatment decisions for salvage radiation therapy. J Clin Oncol, 2005, vol. 23, pp. 8204–8211.
Cox J. D., Gallagher M. J., Hammond E. H., et al. for the ASTRO Consensus Panel. Consensus statement on radiation therapy of prostate cancer: Guidelines for prostate re-biopsy after radiation and for radiation therapy with rising PSA levels after radical prostatectomy. J Clin Oncol, 1999, vol. 17, pp. 1155–1163.
Pollack A., Zagars G. K., Starkschall G., et al. Prostate cancer radiation dose–response: Results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys, 2002, vol. 53, pp. 1097–1105.
Zietman A. L., DeSilvio M. L., Slater J. D., et al. Comparison of conventional dose vs high dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: A randomized controlled trial. JAMA, 2005, vol. 294, pp. 1233–1239.
Eade T. N., Hanlon A. L., Horwitz E. M., et al. What dose of external beam radiation is high enough for prostate cancer? Int J Radiat Oncol Biol Phys, 2007, vol. 68: pp. 682–689.
Zelefsky M. J., Leibel S. A., Gaudin P. B., et al. Dose-escalation with three-dimensional conformal radiation therapy affects the outcome in prostate cancer. Int J Radiat Oncol Biol Phys, 1998, vol. 41, pp. 491–500.
Valicenti R. K., Gomella L. G., Ismail M., et al. Effect of higher radiation dose on biochemical control after radical prostatectomy for pT3N0 prostate cancer. Int J Radiat Oncol Biol Phys, 1998, vol. 42, pp. 501–506.
Anscher M. S., Clough R., Dodge R. Radiotherapy for a rising PSA after radical prostatectomy: The first 10 years. Int J Radiat Oncol Biol Phys, 2000, vol. 48, pp. 369–375.
Cheng J. C., Schultheiss T. E., Nguyen K. H., Wong J. Y. C.. Acute toxicity in definitive versus postprostatectomy image-guided radiotherapy for prostate cancer. Int. J. Radiation Oncology Biol Phys, 2008, vol. 71, pp. 351–357.
Kupelian P.A., Potters L., Khuntia D., et al. Radical prostatectomy, external beam radiotherapy <72 Gy, external beam radiotherapy > or =72 Gy, permanent seed implantation, or combined seeds/external beam radiotherapy for stage T1-T2 prostate cancer. Int J Radiat Oncol Biol Phys, 2004, vol. 58, pp.25–33.
Swanson G.P., Hussey M.A., Tangen C.M., et al. Predominant treatment failure in postprostatectomy patients is local: Analysis of patterns of treatment failure in SWOG 8794. J Clin Oncol, 2007, vol. 25, pp. 2225–2229.
Bolla M., van Poppel H., Collette L., et al. Postoperative radiotherapyafter radical prostatectomy: A randomised controlled trial (EORTC trial 22911). Lancet, 2005, vol. 366, pp. 572–578.
Skwarchuk M.W., Jackson A., Zelefsky M.J., et al. Late rectal toxicity after conformal radiotherapy of prostate cancer (I): Multivariate analysis and dose-response. Int J Radiat Oncol Biol Phys, 2000, vol. 47, pp. 103–113.
Kupelian P.A., Reddy C.A., Carlson T.P., et al. Dose/volume relationship of late rectal bleeding after external beam radiotherapy for localized prostate cancer: Absolute or relative rectal volume? Cancer J, 2002, vol. 8, pp. 62–66.
O’Brien P.C., Franklin C.I., Poulsen M.G. et al., for the Trans-Tasman Radiation Oncology Group. Acute symptoms, not rectally administered sucralfate, predict for late radiation proctitis: Longer term follow-up of a phase III trial. Int J Radiat Oncol Biol Phys, 2002, vol. 54, pp. 442–449.
De Meerleer G., Vakaet L., Meersschout S., et al. Intensitymodulated radiotherapy as primary treatment for prostate cancer: Acute toxicity in 114 patients. Int J Radiat Oncol Biol Phys, 2004, vol. 60, pp. 777–787.
Schultheiss T.E., Lee W.R., Hunt M.A., et al. Late GI and GU complications in the treatment of prostate cancer. Int J Radiat Oncol Biol Phys, 1997, vol. 37, pp. 3– 11.
Yeoh E.E., Botten R., Russo A., et al. Chronic effects of therapeutic irradiation for localized prostatic carcinoma on anorectal function. Int J Radiat Oncol Biol Phys, 2000, vol. 47, pp. 915–924.
Stone N. N., Stock R. G., Cesaretti J. A., Unger P.. Local control following permanent prostate brachytherapy: effect of high biologically effective dose on biopsy results and oncologic outcomes. Int. J. Radiation Oncology Biol Phys, 2010, vol. 76, pp. 355–360.
Stone N.N., Stock R.G., Unger P. Intermediate-term biochemical and local control following I-125 brachytherapy for prostate cancer. J Urol, 2005, vol. 173: pp. 803–807.
Stock R.G., Cahlon O., Cesaretti J., et al. Combined modality treatment in the management of high risk prostate cancer. Int J Radiat Oncol Biol Phys, 2004; vol. 59: pp. 1352–1359.
Cox J.D, Grignon D.J, Kaplan R.S. Consensus statement: guidelines for PSA following radiation therapy. Int J Radiat Oncol Biol Phys, 1997, vol. 37, pp. 1035–1041.
Zietman A. Evidence-Based Medicine, Conscience-Based Medicine, and the Management of Low-Risk Prostate Cancer. J. clin oncology, 2009, vol. 24, pp. 4935– 4936.
Andriole G.L., Crawford E.D., Grubb R.L., et al: Mortality results from a randomized prostate cancer screening trial. N Engl J Med, 2009, vol. 360, pp. 1310– 1319.
Cooperberg M. R., Lubeck D.P., Meng M.V., et al: The changing face of low-risk prostate cancer: Trends in clinical presentation and primary management. J Clin Oncol, 2004, vol. 22, pp. 2141–2149.
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14. Co-authors have the right to control their personal non-property rights by familiarizing themselves with the text (content) and form of the Work before its publication on the University's website, when transferring it to a printing company for reproduction or when using the Work in other ways.
15. The Co-authors, in addition to the property rights not transferred under this Agreement and taking into account the non-exclusive nature of the rights transferred under this Agreement, retain the property rights to finalize the Work and to use certain parts of the Work in other works created by the Co-authors.
16. The Co-authors are obliged to notify the Editorial Board of all errors in the Work, discovered by them independently after the publication of the Work, and to take all measures to eliminate such errors as soon as possible.
17. The University undertakes to indicate the names of the Co-authors on all copies of the Work during any public use of the Work. The list of Co-authors may be shortened according to the rules for the formation of bibliographic descriptions determined by the University or third parties.
18. The University undertakes not to violate the integrity of the Work, to agree with the Corresponding Author on all changes made to the Work during processing and editing.
19. In case of violation of their obligations under this Agreement, its parties bear the responsibility defined by this Agreement and the current legislation of Ukraine. All disputes under the Agreement are resolved through negotiations, and if the negotiations do not resolve the dispute – in the courts of the city of Kharkiv.
20. The parties are not responsible for the violation of their obligations under this Agreement, if it occurred through no fault of theirs. The party is considered innocent if it proves that it has taken all measures dependent on it for the proper fulfillment of the obligation.
21. The Co-authors are responsible for the truthfulness of the facts, quotes, references to legislative and regulatory acts, other official documentation, the scientific validity of the Work, all types of responsibility to third parties who have claimed their rights to the Work. The co-authors reimburse the University for all costs caused by claims of third parties for infringement of copyright and other rights to the Work, as well as additional material costs related to the elimination of identified defects.