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Исходы неоадъювантной химиотерапии резектабельного, погранично резектабельного и местно-распространенного рака поджелудочной железы
Исходы неоадъювантной химиотерапии резектабельного, погранично резектабельного и местно-распространенного рака поджелудочной железы
Далгатов К.Д., Семенов Н.Н., Козодаева М.В. Исходы неоадъювантной химиотерапии резектабельного, погранично резектабельного и местно-распространенного рака поджелудочной железы. Современная Онкология. 2021; 23 (2): 300–306. DOI: 10.26442/18151434.2021.2.200869
DOI: 10.26442/18151434.2021.2.200869
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DOI: 10.26442/18151434.2021.2.200869
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Аннотация
Обоснование. Проблема неоадьювантного лечения местно-распространенного (МРРПЖ), погранично резектабельного (ПРРПЖ) и резектабельного рака поджелудочной железы (РРПЖ) активно обсуждается в настоящее время, хотя показания к его применению до конца не определены. В нашей работе мы хотим обсудить исходы применения неоадъювантной химиотерапии (НАХТ) в этих клинических ситуациях.
Материалы и методы. С 2016 по 2020 г. в клинике наблюдали 85 больных раком поджелудочной железы – РПЖ (37 пациентов с МРРПЖ, 15 – с ПРРПЖ и 33 – с РРПЖ), из них мужчины – 33 (38,8%), женщины – 52 (61,2%). Средний возраст составил 64 (31–83) года. Во всех группах применялись режимы GEMOX (гемцитабин/оксалиплатин) – 41,2% и FOLFIRINOX (фторурацил/лейковорин/иринотекан/оксалиплатин) – 58,8%. Повышение СА 19-9 выше нормы имели в группе МРРПЖ – 21 (56,6%), в группе ПРРПЖ – 9 (60%), в резектабельной группе – 26 (78,8%) пациентов. Проводилось от 3 до 6 курсов НАХТ с последующим компьютерно-томографическим контролем и принятием решения о тактике лечения.
Результаты. В группе с МРРПЖ использовались режимы GEMOX (n=15) и FOLFIRINOX (n=22). При оценке результатов после одного контрольного обследования через 2,5 мес установлено: 2 больных умерли; прогрессирование – 14 (37,8%) больных; остались неоперабельными 16 (43,2%) больных, из которых 9 проведена лучевая терапия. Удаление первичной опухоли выполнено у 5 (13,9%) больных. Средняя ОВ в этой группе составила 15 мес. С погранично резектабельными опухолями поджелудочной железы наблюдались 15 больных. НАХТ проводилась теми же режимами – GEMOX (n=7) и FOLFIRINOX (n=8) – в течение 2,5 мес. При оценке результатов после одного контрольного обследования через 2,5 мес установлено: 1 (7,7%) больная умерла; прогрессирование отмечено у 6 (40%) больных; у 1 (7,7%) больного хирургическое лечение не выполнено вследствие выраженных сопутствующих заболеваний. Хирургическое лечение выполнено 7 (46,7%) больным. НАХТ при РРПЖ назначена 33 больным. Основным критерием назначения НАХТ при формально операбельном РПЖ были высокий уровень СА 19-9>100 МЕ/мл (n=26, 75%) и большой размер первичной опухоли (n=7, 25%). Все больные получали те же режимы в течение 3,3 мес до первого контроля. При оценке результатов были получены следующие результаты: 1 (3%) больной умер; 3 (9,3%) – не оперированы в связи с отказом от хирургического лечения; 7 (21,9%) – не оперированы в связи с прогрессированием. Хирургическое лечение выполнено 22 (66,7%) больным в объеме панкреато-дуоденальной резекции у 17 больных, дистальной резекции у 3 больных, панкреатэктомии у 2 больных. При этом отмечена полная морфологическая ремиссия у 2 (9%) больных, R0-резекция – 19 (86%), R1 – 1 (4,5%) больного. Медиана выживаемости оперированных больных составила 20,2 мес (доверительный интервал 13,2–27,2 мес). Большинство пациентов (65,9%) имели высокий уровень СА 19-9, который исследовался в динамике и использовался как маркер биологической активности опухоли.
Заключение. Таким образом, можно определенно сказать, что НАХТ абсолютно показана всем пациентам с МРРПЖ и ПРРПЖ, и роль ее в селекции наиболее благоприятных в отношении прогноза пациентов бесспорна. Проведение периоперационной химиотерапии у больных РРПЖ дискутабельно, однако экстраполируя результаты в группах с МРРПЖ и ПРРПЖ и данные литературы, смеем предположить, что это вопрос времени и будущих рандомизированных исследований. И здесь важную роль может играть показатель СА 19-9, характеризующий биологически агрессивную опухоль, но требуются проспективные рандомизированные исследования для более детального изучения данного вопроса.
Ключевые слова: рак поджелудочной железы, неоадъювантная химиотерапия
Materials and methods. From 2016 to 2020, 85 patients with pancreatic cancer were observed in the clinic (37 patients with LA cancer of the pancreas; 15 with BR cancer of the pancreas and 33 with RPC). Of these, men – 33 (38.8%), women – 52 (61.2%). The average age was 64 (31–83) years. All groups had GEMOX (41.2%) and FOLFIRINOX (58.8%) regimens. Increased CA 19-9 above normal had, in the LA group – 21 (56.6%); in the BR group – 9 (60%); and in the resectable group 26 (78.8%). From 3 to 6 courses of NACT were carried out, followed by computer tomography control and decision-making on treatment tactics.
Results. In the LA group, the GEMOX (n=15) and FOLFIRINOX (n=22) modes were used. When evaluating the results after 1 follow-up examination after 2.5 months. found: 2 patients died; progression – 14 patients (37.8%); remained inoperable – 16 patients (43.2%), of whom 9 received radiation therapy. Removal of the primary tumor was performed in 5 patients (13.9%). The average OS in this group was 15 months. Fifteen patients with BR pancreatic tumors were observed. NACT was carried out with the same regimens – GEMOX (n=7) and FOLFIRINOX (n=8) – for 2.5 months. When evaluating the results after 1 follow-up examination after 2.5 months was found: 1 (7.7%) patient died; progression was noted in 6 (40%) patients; in 1 (7.7%) patient, surgical treatment was not performed due to pronounced concomitant diseases. Surgical treatment was performed in 7 (46.7%) patients. 33 patients were prescribed NACT for RPC. The main criteria for prescribing NACT for formally resectable pancreatic cancer were a high CA 19-9 level (>100 IU/ml) [n=26 (75%)] and a large primary tumor [n=7 (25%)]. All patients received the same regimens for 3.3 months. up to 1 control. When evaluating the results, the following results were obtained: 1 (3%) patient died; 3 (9.3%) patients were not operated on due to refusal from surgical treatment; 7 patients (21.9%) were not operated on due to progression. Surgical treatment was performed in 22 (66.7%) patients; Whipple procedure in 17 patients, distal resection in 3 patients, total pancreatoduodenectomy in 2 patients. At the same time, complete morphological responce was noted in 2 (9%) patients, R0 resection in 19 (86%) patients, R1 – in 1 patient (4.5%). The median survival rate of the operated patients was 20.2 months (CI 13.2–27.2 months). Most patients (65.9%) had a high level of CA 19-9, which was studied in dynamics and used as a marker of the biological activity of the tumor.
Conclusion. Thus, we can claim that NACT is absolutely indicated for all patients with LA and BR pancreatic cancer, and its role in the selection of the most favorable in relation to the prognosis of patients is indisputable. Perioperative chemotherapy in patients with RPC is still controversial; however, having in mind the results in groups with LA and BR pancreatic cancer and the literature data, we dare to assume that for this issue it is a matter of time and future randomized trials. And here an important role can be played by the CA 19-9 level, which characterizes a biologically aggressive tumor, but again, prospective randomized studies are required to study this issue in more detail.
Keywords: pancreatic cancer, neoadjuvant chemotherapy
Материалы и методы. С 2016 по 2020 г. в клинике наблюдали 85 больных раком поджелудочной железы – РПЖ (37 пациентов с МРРПЖ, 15 – с ПРРПЖ и 33 – с РРПЖ), из них мужчины – 33 (38,8%), женщины – 52 (61,2%). Средний возраст составил 64 (31–83) года. Во всех группах применялись режимы GEMOX (гемцитабин/оксалиплатин) – 41,2% и FOLFIRINOX (фторурацил/лейковорин/иринотекан/оксалиплатин) – 58,8%. Повышение СА 19-9 выше нормы имели в группе МРРПЖ – 21 (56,6%), в группе ПРРПЖ – 9 (60%), в резектабельной группе – 26 (78,8%) пациентов. Проводилось от 3 до 6 курсов НАХТ с последующим компьютерно-томографическим контролем и принятием решения о тактике лечения.
Результаты. В группе с МРРПЖ использовались режимы GEMOX (n=15) и FOLFIRINOX (n=22). При оценке результатов после одного контрольного обследования через 2,5 мес установлено: 2 больных умерли; прогрессирование – 14 (37,8%) больных; остались неоперабельными 16 (43,2%) больных, из которых 9 проведена лучевая терапия. Удаление первичной опухоли выполнено у 5 (13,9%) больных. Средняя ОВ в этой группе составила 15 мес. С погранично резектабельными опухолями поджелудочной железы наблюдались 15 больных. НАХТ проводилась теми же режимами – GEMOX (n=7) и FOLFIRINOX (n=8) – в течение 2,5 мес. При оценке результатов после одного контрольного обследования через 2,5 мес установлено: 1 (7,7%) больная умерла; прогрессирование отмечено у 6 (40%) больных; у 1 (7,7%) больного хирургическое лечение не выполнено вследствие выраженных сопутствующих заболеваний. Хирургическое лечение выполнено 7 (46,7%) больным. НАХТ при РРПЖ назначена 33 больным. Основным критерием назначения НАХТ при формально операбельном РПЖ были высокий уровень СА 19-9>100 МЕ/мл (n=26, 75%) и большой размер первичной опухоли (n=7, 25%). Все больные получали те же режимы в течение 3,3 мес до первого контроля. При оценке результатов были получены следующие результаты: 1 (3%) больной умер; 3 (9,3%) – не оперированы в связи с отказом от хирургического лечения; 7 (21,9%) – не оперированы в связи с прогрессированием. Хирургическое лечение выполнено 22 (66,7%) больным в объеме панкреато-дуоденальной резекции у 17 больных, дистальной резекции у 3 больных, панкреатэктомии у 2 больных. При этом отмечена полная морфологическая ремиссия у 2 (9%) больных, R0-резекция – 19 (86%), R1 – 1 (4,5%) больного. Медиана выживаемости оперированных больных составила 20,2 мес (доверительный интервал 13,2–27,2 мес). Большинство пациентов (65,9%) имели высокий уровень СА 19-9, который исследовался в динамике и использовался как маркер биологической активности опухоли.
Заключение. Таким образом, можно определенно сказать, что НАХТ абсолютно показана всем пациентам с МРРПЖ и ПРРПЖ, и роль ее в селекции наиболее благоприятных в отношении прогноза пациентов бесспорна. Проведение периоперационной химиотерапии у больных РРПЖ дискутабельно, однако экстраполируя результаты в группах с МРРПЖ и ПРРПЖ и данные литературы, смеем предположить, что это вопрос времени и будущих рандомизированных исследований. И здесь важную роль может играть показатель СА 19-9, характеризующий биологически агрессивную опухоль, но требуются проспективные рандомизированные исследования для более детального изучения данного вопроса.
Ключевые слова: рак поджелудочной железы, неоадъювантная химиотерапия
________________________________________________
Materials and methods. From 2016 to 2020, 85 patients with pancreatic cancer were observed in the clinic (37 patients with LA cancer of the pancreas; 15 with BR cancer of the pancreas and 33 with RPC). Of these, men – 33 (38.8%), women – 52 (61.2%). The average age was 64 (31–83) years. All groups had GEMOX (41.2%) and FOLFIRINOX (58.8%) regimens. Increased CA 19-9 above normal had, in the LA group – 21 (56.6%); in the BR group – 9 (60%); and in the resectable group 26 (78.8%). From 3 to 6 courses of NACT were carried out, followed by computer tomography control and decision-making on treatment tactics.
Results. In the LA group, the GEMOX (n=15) and FOLFIRINOX (n=22) modes were used. When evaluating the results after 1 follow-up examination after 2.5 months. found: 2 patients died; progression – 14 patients (37.8%); remained inoperable – 16 patients (43.2%), of whom 9 received radiation therapy. Removal of the primary tumor was performed in 5 patients (13.9%). The average OS in this group was 15 months. Fifteen patients with BR pancreatic tumors were observed. NACT was carried out with the same regimens – GEMOX (n=7) and FOLFIRINOX (n=8) – for 2.5 months. When evaluating the results after 1 follow-up examination after 2.5 months was found: 1 (7.7%) patient died; progression was noted in 6 (40%) patients; in 1 (7.7%) patient, surgical treatment was not performed due to pronounced concomitant diseases. Surgical treatment was performed in 7 (46.7%) patients. 33 patients were prescribed NACT for RPC. The main criteria for prescribing NACT for formally resectable pancreatic cancer were a high CA 19-9 level (>100 IU/ml) [n=26 (75%)] and a large primary tumor [n=7 (25%)]. All patients received the same regimens for 3.3 months. up to 1 control. When evaluating the results, the following results were obtained: 1 (3%) patient died; 3 (9.3%) patients were not operated on due to refusal from surgical treatment; 7 patients (21.9%) were not operated on due to progression. Surgical treatment was performed in 22 (66.7%) patients; Whipple procedure in 17 patients, distal resection in 3 patients, total pancreatoduodenectomy in 2 patients. At the same time, complete morphological responce was noted in 2 (9%) patients, R0 resection in 19 (86%) patients, R1 – in 1 patient (4.5%). The median survival rate of the operated patients was 20.2 months (CI 13.2–27.2 months). Most patients (65.9%) had a high level of CA 19-9, which was studied in dynamics and used as a marker of the biological activity of the tumor.
Conclusion. Thus, we can claim that NACT is absolutely indicated for all patients with LA and BR pancreatic cancer, and its role in the selection of the most favorable in relation to the prognosis of patients is indisputable. Perioperative chemotherapy in patients with RPC is still controversial; however, having in mind the results in groups with LA and BR pancreatic cancer and the literature data, we dare to assume that for this issue it is a matter of time and future randomized trials. And here an important role can be played by the CA 19-9 level, which characterizes a biologically aggressive tumor, but again, prospective randomized studies are required to study this issue in more detail.
Keywords: pancreatic cancer, neoadjuvant chemotherapy
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30. Yamada S, Fujii T, Sugimoto H, et al. Aggressive surgery for borderline resectable pancreatic cancer: Evaluation of National Comprehensive Cancer Network guidelines. Pancreas. 2013;42:1004-10.
31. Laurence JM, Tran PD, Morarji K, et al. A systematic review and meta-analysis of survival and surgical outcomes following neoadjuvant chemoradiotherapy for pancreatic cancer. J Gastrointest Surg. 2011;15(11):2059-69.
32. Mirkin KA, Hollenbeak CS, Wong JJ. Prognostic impact of carbohydrate antigen 19-9 level at diagnosis in resected stage I-III pancreatic adenocarcinoma: a U.S. population study. Gastrointest Oncol. 2017;8(5):778-88. DOI:10.21037/jgo.2017.07.04
2. Khushman M, Dempsey N, Maldonado JC, et al. Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma. Pancreatology. 2015;15(6):667-73. DOI:10.1016/j.pan.2015.08.010
3. Sahora K, Kuehrer I, Eisenhut A, et al. NeoGemOx: Gemcitabine and oxaliplatin as neoadjuvant treatment for locally advanced, nonmetastasized pancreatic cancer. Surgery. 2011;149(3):311-20. DOI:10.1016/j.surg.2010.07.048
4. Li X, Guo Ch, Li Q, et al. Association of Modified-FOLFIRINOX-Regimen-Based Neoadjuvant Therapy with Outcomes of Locally Advanced Pancreatic Cancer in Chinese Population. Оncologist. 2019;24(3):301-e93. DOI:10.1634/theoncologist.2018-0696
5. Hammel P, Huguet F, van Laethem J-L, et al. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib. The LAP07 Randomized Clinical Trial. JAMA. 2016;315(17):1844-53. DOI:10.1001/jama.2016.4324
6. Vogel JA, Rombouts SJ, de Rooij T, et al. Induction Chemotherapy Followed by Resection or Irreversible Electroporation in Locally Advanced Pancreatic Cancer (IMPALA): A Prospective Cohort Study. Ann Surg Oncol. 2017;24(9):2734-43. DOI:10.1245/s10434-017-5900-9
7. Stein SM, James ES, Deng Y, et al. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. Br J Cancer. 2016;114(7):737-43. DOI: 10.1038/bjc.2016.45
8. Blazer M, Wu C, Goldberg RM, et al. Neoadjuvant Modified (m) FOLFIRINOX for Locally Advanced Unresectable (LAPC) and Borderline Resectable (BRPC) Adenocarcinoma of the Pancreas. Ann Surg Oncol. 2015;22(4):1153-9. DOI:10.1245/s10434-014-4225-1
9. Barenboim А, Lahat G, Geva R, et al. Neoadjuvant FOLFIRINOX for locally advanced and borderline resectable pancreatic cancer: An intention to treat analysis. Eur J Surg Oncol. 2018;44(10):1619-23. DOI:10.1016/j.ejso.2018.07.057
10. Chan G, Pua U. Irreversible Electroporation of the Pancreas. Semin Intervent Radiol. 2019;36(3):213-20. DOI:10.1055/s-0039-1693980
11. Sadot E, Doussot A, O'Reilly EM, et al. FOLFIRINOX Induction Therapy for Stage 3 Pancreatic Adenocarcinoma. Ann Surg Oncol. 2015;22(11):3512-21. DOI:10.1245/s10434-015-4647-4
12. Marthey L, Sa-Cunha A, Blanc JF, et al. FOLFIRINOX for locally advanced pancreatic adenocarcinoma: results of an AGEO multicenter prospective observational cohort. Ann Surg Oncol. 2015;22(1):295-301. DOI:10.1245/s10434-014-3898-9
13. Versteijne E, Vogel JA, Besselink MG, et al. Meta-analysis comparing upfront surgery with neoadjuvant treatment in patients with resectable or borderline resectable pancreatic cancer. Br J Surg. 2018;105:946-58. DOI:10.1002/bjs.10870
14. Yoo C, Kang J, Kim K-P, et al. Efficacy and safety of neoadjuvant FOLFIRINOX for borderline resectable pancreatic adenocarcinoma: improved efficacy compared with gemcitabine-based regimen. Oncotarget. 2017;8(28):46337-47. DOI:10.18632/oncotarget.17940
15. Javed AA, Wright MJ, Siddique A, et al. Outcome of Patients with Borderline Resectable Pancreatic Cancer in the Contemporary Era of Neoadjuvant Chemotherapy. J Gastrointest Surg. 2019;23(1):112-21. DOI:10.1007/s11605-018-3966-8
16. O'Reilly EM, Perelshteyn A, Jarnagin WR, et al. A Single-Arm, Non-Randomized Phase II Trial of Neoadjuvant Gemcitabine and Oxaliplatin in patients with Resectable Pancreas Adenocarcinoma. Ann Surg. 2014;260(1):142-8. DOI:10.1097/SLA.0000000000000251
17. Versteijne E, Suker M, Groothuis K, et al. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020;38(16):1763-73.
18. Ghaneh P, Palmer DH, Cicconi S, et al. ESPAC-5F: Four-arm, prospective, multicenter, international randomized phase II trial of immediate surgery compared with neoadjuvant gemcitabine plus capecitabine (GEMCAP) or FOLFIRINOX or chemoradiotherapy (CRT) in patients with borderline resectable pancreatic cancer. J Clin Oncol. 2020;38(15;suppl.;abstr 4505). DOI:10.1200/JCO.2020.38.15_suppl.4505
19. Sohal D, Duong MT, Ahmad SA, et al. SWOG S1505: Results of perioperative chemotherapy (peri-op CTx) with mfolfirinox versus gemcitabine/nab-paclitaxel (Gem/nabP) for resectable pancreatic ductal adenocarcinoma (PDA). J Clin Oncol. 2020;38(15;suppl;abstr 4504). DOI:10.1200/JCO.2020.38.15_suppl.4504
20. Heinrich S, Pestalozzi BC, Schäfer M, et al. Prospective phase II trial of neoadjuvant chemotherapy with gemcitabine and cisplatin for resectable adenocarcinoma of the pancreatic head. J Clin Oncol. 2008;26(15):2526-31. DOI:10.1200/JCO.2007.15.5556
21. Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017;389:1011-24. DOI:10.1016/S0140-6736(16)32409-6
22. Conroy T, Hammel P, Hebbar M, et al. Unicancer GI PRODIGE 24/CCTG PA.6 trial: A multicenter international randomized phase III trial of adjuvant mFOLFIRINOX versus gemcitabine (gem) in patients with resected pancreatic ductal adenocarcinomas. J Clin Oncol. 2018;36(Suppl.;abstr LBA4001). DOI:10.1200/JCO.2018.36.18_suppl.LBA4001
23. Ferrone CR, Finkelstein DM, Thayer SP, et al. Perioperative CA19-9 levels can predict stage and survival in patients with resectable pancreatic adenocarcinoma. J Clin Oncol. 2006;24(18):2897-902.
24. Kim YC, Kim HJ, Park JH, et al. Can preoperative CA19-9 and CEA levels predict the resectability of patients with pancreatic adenocarcinoma? J Gastroenterol Hepatol. 2009;24(12):1869-75.
25. Ballehaninna UK, Chamberlain RS. The clinical utility of serum CA 19-9 in the diagnosis, prognosis and management of pancreatic adenocarcinoma: An evidence based appraisal. J Gastrointest Oncol. 2012;3(2):105-19.
26. Hartwig W, Strobel O, Hinz U, et al. CA19-9 in potentially resectable pancreatic cancer: perspective to adjust surgical and perioperative therapy. Ann Surg Oncol. 2013;20(7):2188-96.
27. Piagnerelli R, Marrelli D, Roviello G, et al. Clinical value and impact on prognosis of peri-operative CA 19-9 serum levels in stage I and II adenocarcinoma of the pancreas. Tumour Biol. 2016;37(2):1959-66.
28. Yamamoto Y, Ikoma H, Morimura R, et al. Optimal duration of the early and late recurrence of pancreatic cancer after pancreatectomy based on the difference in the prognosis. Pancreatology. 2014;14(6):524-9.
29. Bergquist JR, Puig CA, Shubert ChR, et al. Carbohydrate Antigen 19-9 Elevation in Anatomically Resectable, Early Stage Pancreatic Cancer Is Independently Associated with Decreased Overall Survival and an Indication for Neoadjuvant Therapy: A National Cancer Database Study. J Am Coll Surg. 2016;223(1):52-65. DOI:10.1016/j.jamcollsurg.2016.02.009
30. Yamada S, Fujii T, Sugimoto H, et al. Aggressive surgery for borderline resectable pancreatic cancer: Evaluation of National Comprehensive Cancer Network guidelines. Pancreas. 2013;42:1004-10.
31. Laurence JM, Tran PD, Morarji K, et al. A systematic review and meta-analysis of survival and surgical outcomes following neoadjuvant chemoradiotherapy for pancreatic cancer. J Gastrointest Surg. 2011;15(11):2059-69.
32. Mirkin KA, Hollenbeak CS, Wong JJ. Prognostic impact of carbohydrate antigen 19-9 level at diagnosis in resected stage I-III pancreatic adenocarcinoma: a U.S. population study. Gastrointest Oncol. 2017;8(5):778-88. DOI:10.21037/jgo.2017.07.04
2. Khushman M, Dempsey N, Maldonado JC, et al. Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma. Pancreatology. 2015;15(6):667-73. DOI:10.1016/j.pan.2015.08.010
3. Sahora K, Kuehrer I, Eisenhut A, et al. NeoGemOx: Gemcitabine and oxaliplatin as neoadjuvant treatment for locally advanced, nonmetastasized pancreatic cancer. Surgery. 2011;149(3):311-20. DOI:10.1016/j.surg.2010.07.048
4. Li X, Guo Ch, Li Q, et al. Association of Modified-FOLFIRINOX-Regimen-Based Neoadjuvant Therapy with Outcomes of Locally Advanced Pancreatic Cancer in Chinese Population. Оncologist. 2019;24(3):301-e93. DOI:10.1634/theoncologist.2018-0696
5. Hammel P, Huguet F, van Laethem J-L, et al. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib. The LAP07 Randomized Clinical Trial. JAMA. 2016;315(17):1844-53. DOI:10.1001/jama.2016.4324
6. Vogel JA, Rombouts SJ, de Rooij T, et al. Induction Chemotherapy Followed by Resection or Irreversible Electroporation in Locally Advanced Pancreatic Cancer (IMPALA): A Prospective Cohort Study. Ann Surg Oncol. 2017;24(9):2734-43. DOI:10.1245/s10434-017-5900-9
7. Stein SM, James ES, Deng Y, et al. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. Br J Cancer. 2016;114(7):737-43. DOI: 10.1038/bjc.2016.45
8. Blazer M, Wu C, Goldberg RM, et al. Neoadjuvant Modified (m) FOLFIRINOX for Locally Advanced Unresectable (LAPC) and Borderline Resectable (BRPC) Adenocarcinoma of the Pancreas. Ann Surg Oncol. 2015;22(4):1153-9. DOI:10.1245/s10434-014-4225-1
9. Barenboim А, Lahat G, Geva R, et al. Neoadjuvant FOLFIRINOX for locally advanced and borderline resectable pancreatic cancer: An intention to treat analysis. Eur J Surg Oncol. 2018;44(10):1619-23. DOI:10.1016/j.ejso.2018.07.057
10. Chan G, Pua U. Irreversible Electroporation of the Pancreas. Semin Intervent Radiol. 2019;36(3):213-20. DOI:10.1055/s-0039-1693980
11. Sadot E, Doussot A, O'Reilly EM, et al. FOLFIRINOX Induction Therapy for Stage 3 Pancreatic Adenocarcinoma. Ann Surg Oncol. 2015;22(11):3512-21. DOI:10.1245/s10434-015-4647-4
12. Marthey L, Sa-Cunha A, Blanc JF, et al. FOLFIRINOX for locally advanced pancreatic adenocarcinoma: results of an AGEO multicenter prospective observational cohort. Ann Surg Oncol. 2015;22(1):295-301. DOI:10.1245/s10434-014-3898-9
13. Versteijne E, Vogel JA, Besselink MG, et al. Meta-analysis comparing upfront surgery with neoadjuvant treatment in patients with resectable or borderline resectable pancreatic cancer. Br J Surg. 2018;105:946-58. DOI:10.1002/bjs.10870
14. Yoo C, Kang J, Kim K-P, et al. Efficacy and safety of neoadjuvant FOLFIRINOX for borderline resectable pancreatic adenocarcinoma: improved efficacy compared with gemcitabine-based regimen. Oncotarget. 2017;8(28):46337-47. DOI:10.18632/oncotarget.17940
15. Javed AA, Wright MJ, Siddique A, et al. Outcome of Patients with Borderline Resectable Pancreatic Cancer in the Contemporary Era of Neoadjuvant Chemotherapy. J Gastrointest Surg. 2019;23(1):112-21. DOI:10.1007/s11605-018-3966-8
16. O'Reilly EM, Perelshteyn A, Jarnagin WR, et al. A Single-Arm, Non-Randomized Phase II Trial of Neoadjuvant Gemcitabine and Oxaliplatin in patients with Resectable Pancreas Adenocarcinoma. Ann Surg. 2014;260(1):142-8. DOI:10.1097/SLA.0000000000000251
17. Versteijne E, Suker M, Groothuis K, et al. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020;38(16):1763-73.
18. Ghaneh P, Palmer DH, Cicconi S, et al. ESPAC-5F: Four-arm, prospective, multicenter, international randomized phase II trial of immediate surgery compared with neoadjuvant gemcitabine plus capecitabine (GEMCAP) or FOLFIRINOX or chemoradiotherapy (CRT) in patients with borderline resectable pancreatic cancer. J Clin Oncol. 2020;38(15;suppl.;abstr 4505). DOI:10.1200/JCO.2020.38.15_suppl.4505
19. Sohal D, Duong MT, Ahmad SA, et al. SWOG S1505: Results of perioperative chemotherapy (peri-op CTx) with mfolfirinox versus gemcitabine/nab-paclitaxel (Gem/nabP) for resectable pancreatic ductal adenocarcinoma (PDA). J Clin Oncol. 2020;38(15;suppl;abstr 4504). DOI:10.1200/JCO.2020.38.15_suppl.4504
20. Heinrich S, Pestalozzi BC, Schäfer M, et al. Prospective phase II trial of neoadjuvant chemotherapy with gemcitabine and cisplatin for resectable adenocarcinoma of the pancreatic head. J Clin Oncol. 2008;26(15):2526-31. DOI:10.1200/JCO.2007.15.5556
21. Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017;389:1011-24. DOI:10.1016/S0140-6736(16)32409-6
22. Conroy T, Hammel P, Hebbar M, et al. Unicancer GI PRODIGE 24/CCTG PA.6 trial: A multicenter international randomized phase III trial of adjuvant mFOLFIRINOX versus gemcitabine (gem) in patients with resected pancreatic ductal adenocarcinomas. J Clin Oncol. 2018;36(Suppl.;abstr LBA4001). DOI:10.1200/JCO.2018.36.18_suppl.LBA4001
23. Ferrone CR, Finkelstein DM, Thayer SP, et al. Perioperative CA19-9 levels can predict stage and survival in patients with resectable pancreatic adenocarcinoma. J Clin Oncol. 2006;24(18):2897-902.
24. Kim YC, Kim HJ, Park JH, et al. Can preoperative CA19-9 and CEA levels predict the resectability of patients with pancreatic adenocarcinoma? J Gastroenterol Hepatol. 2009;24(12):1869-75.
25. Ballehaninna UK, Chamberlain RS. The clinical utility of serum CA 19-9 in the diagnosis, prognosis and management of pancreatic adenocarcinoma: An evidence based appraisal. J Gastrointest Oncol. 2012;3(2):105-19.
26. Hartwig W, Strobel O, Hinz U, et al. CA19-9 in potentially resectable pancreatic cancer: perspective to adjust surgical and perioperative therapy. Ann Surg Oncol. 2013;20(7):2188-96.
27. Piagnerelli R, Marrelli D, Roviello G, et al. Clinical value and impact on prognosis of peri-operative CA 19-9 serum levels in stage I and II adenocarcinoma of the pancreas. Tumour Biol. 2016;37(2):1959-66.
28. Yamamoto Y, Ikoma H, Morimura R, et al. Optimal duration of the early and late recurrence of pancreatic cancer after pancreatectomy based on the difference in the prognosis. Pancreatology. 2014;14(6):524-9.
29. Bergquist JR, Puig CA, Shubert ChR, et al. Carbohydrate Antigen 19-9 Elevation in Anatomically Resectable, Early Stage Pancreatic Cancer Is Independently Associated with Decreased Overall Survival and an Indication for Neoadjuvant Therapy: A National Cancer Database Study. J Am Coll Surg. 2016;223(1):52-65. DOI:10.1016/j.jamcollsurg.2016.02.009
30. Yamada S, Fujii T, Sugimoto H, et al. Aggressive surgery for borderline resectable pancreatic cancer: Evaluation of National Comprehensive Cancer Network guidelines. Pancreas. 2013;42:1004-10.
31. Laurence JM, Tran PD, Morarji K, et al. A systematic review and meta-analysis of survival and surgical outcomes following neoadjuvant chemoradiotherapy for pancreatic cancer. J Gastrointest Surg. 2011;15(11):2059-69.
32. Mirkin KA, Hollenbeak CS, Wong JJ. Prognostic impact of carbohydrate antigen 19-9 level at diagnosis in resected stage I-III pancreatic adenocarcinoma: a U.S. population study. Gastrointest Oncol. 2017;8(5):778-88. DOI:10.21037/jgo.2017.07.04
________________________________________________
2. Khushman M, Dempsey N, Maldonado JC, et al. Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma. Pancreatology. 2015;15(6):667-73. DOI:10.1016/j.pan.2015.08.010
3. Sahora K, Kuehrer I, Eisenhut A, et al. NeoGemOx: Gemcitabine and oxaliplatin as neoadjuvant treatment for locally advanced, nonmetastasized pancreatic cancer. Surgery. 2011;149(3):311-20. DOI:10.1016/j.surg.2010.07.048
4. Li X, Guo Ch, Li Q, et al. Association of Modified-FOLFIRINOX-Regimen-Based Neoadjuvant Therapy with Outcomes of Locally Advanced Pancreatic Cancer in Chinese Population. Оncologist. 2019;24(3):301-e93. DOI:10.1634/theoncologist.2018-0696
5. Hammel P, Huguet F, van Laethem J-L, et al. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib. The LAP07 Randomized Clinical Trial. JAMA. 2016;315(17):1844-53. DOI:10.1001/jama.2016.4324
6. Vogel JA, Rombouts SJ, de Rooij T, et al. Induction Chemotherapy Followed by Resection or Irreversible Electroporation in Locally Advanced Pancreatic Cancer (IMPALA): A Prospective Cohort Study. Ann Surg Oncol. 2017;24(9):2734-43. DOI:10.1245/s10434-017-5900-9
7. Stein SM, James ES, Deng Y, et al. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. Br J Cancer. 2016;114(7):737-43. DOI: 10.1038/bjc.2016.45
8. Blazer M, Wu C, Goldberg RM, et al. Neoadjuvant Modified (m) FOLFIRINOX for Locally Advanced Unresectable (LAPC) and Borderline Resectable (BRPC) Adenocarcinoma of the Pancreas. Ann Surg Oncol. 2015;22(4):1153-9. DOI:10.1245/s10434-014-4225-1
9. Barenboim А, Lahat G, Geva R, et al. Neoadjuvant FOLFIRINOX for locally advanced and borderline resectable pancreatic cancer: An intention to treat analysis. Eur J Surg Oncol. 2018;44(10):1619-23. DOI:10.1016/j.ejso.2018.07.057
10. Chan G, Pua U. Irreversible Electroporation of the Pancreas. Semin Intervent Radiol. 2019;36(3):213-20. DOI:10.1055/s-0039-1693980
11. Sadot E, Doussot A, O'Reilly EM, et al. FOLFIRINOX Induction Therapy for Stage 3 Pancreatic Adenocarcinoma. Ann Surg Oncol. 2015;22(11):3512-21. DOI:10.1245/s10434-015-4647-4
12. Marthey L, Sa-Cunha A, Blanc JF, et al. FOLFIRINOX for locally advanced pancreatic adenocarcinoma: results of an AGEO multicenter prospective observational cohort. Ann Surg Oncol. 2015;22(1):295-301. DOI:10.1245/s10434-014-3898-9
13. Versteijne E, Vogel JA, Besselink MG, et al. Meta-analysis comparing upfront surgery with neoadjuvant treatment in patients with resectable or borderline resectable pancreatic cancer. Br J Surg. 2018;105:946-58. DOI:10.1002/bjs.10870
14. Yoo C, Kang J, Kim K-P, et al. Efficacy and safety of neoadjuvant FOLFIRINOX for borderline resectable pancreatic adenocarcinoma: improved efficacy compared with gemcitabine-based regimen. Oncotarget. 2017;8(28):46337-47. DOI:10.18632/oncotarget.17940
15. Javed AA, Wright MJ, Siddique A, et al. Outcome of Patients with Borderline Resectable Pancreatic Cancer in the Contemporary Era of Neoadjuvant Chemotherapy. J Gastrointest Surg. 2019;23(1):112-21. DOI:10.1007/s11605-018-3966-8
16. O'Reilly EM, Perelshteyn A, Jarnagin WR, et al. A Single-Arm, Non-Randomized Phase II Trial of Neoadjuvant Gemcitabine and Oxaliplatin in patients with Resectable Pancreas Adenocarcinoma. Ann Surg. 2014;260(1):142-8. DOI:10.1097/SLA.0000000000000251
17. Versteijne E, Suker M, Groothuis K, et al. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020;38(16):1763-73.
18. Ghaneh P, Palmer DH, Cicconi S, et al. ESPAC-5F: Four-arm, prospective, multicenter, international randomized phase II trial of immediate surgery compared with neoadjuvant gemcitabine plus capecitabine (GEMCAP) or FOLFIRINOX or chemoradiotherapy (CRT) in patients with borderline resectable pancreatic cancer. J Clin Oncol. 2020;38(15;suppl.;abstr 4505). DOI:10.1200/JCO.2020.38.15_suppl.4505
19. Sohal D, Duong MT, Ahmad SA, et al. SWOG S1505: Results of perioperative chemotherapy (peri-op CTx) with mfolfirinox versus gemcitabine/nab-paclitaxel (Gem/nabP) for resectable pancreatic ductal adenocarcinoma (PDA). J Clin Oncol. 2020;38(15;suppl;abstr 4504). DOI:10.1200/JCO.2020.38.15_suppl.4504
20. Heinrich S, Pestalozzi BC, Schäfer M, et al. Prospective phase II trial of neoadjuvant chemotherapy with gemcitabine and cisplatin for resectable adenocarcinoma of the pancreatic head. J Clin Oncol. 2008;26(15):2526-31. DOI:10.1200/JCO.2007.15.5556
21. Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017;389:1011-24. DOI:10.1016/S0140-6736(16)32409-6
22. Conroy T, Hammel P, Hebbar M, et al. Unicancer GI PRODIGE 24/CCTG PA.6 trial: A multicenter international randomized phase III trial of adjuvant mFOLFIRINOX versus gemcitabine (gem) in patients with resected pancreatic ductal adenocarcinomas. J Clin Oncol. 2018;36(Suppl.;abstr LBA4001). DOI:10.1200/JCO.2018.36.18_suppl.LBA4001
23. Ferrone CR, Finkelstein DM, Thayer SP, et al. Perioperative CA19-9 levels can predict stage and survival in patients with resectable pancreatic adenocarcinoma. J Clin Oncol. 2006;24(18):2897-902.
24. Kim YC, Kim HJ, Park JH, et al. Can preoperative CA19-9 and CEA levels predict the resectability of patients with pancreatic adenocarcinoma? J Gastroenterol Hepatol. 2009;24(12):1869-75.
25. Ballehaninna UK, Chamberlain RS. The clinical utility of serum CA 19-9 in the diagnosis, prognosis and management of pancreatic adenocarcinoma: An evidence based appraisal. J Gastrointest Oncol. 2012;3(2):105-19.
26. Hartwig W, Strobel O, Hinz U, et al. CA19-9 in potentially resectable pancreatic cancer: perspective to adjust surgical and perioperative therapy. Ann Surg Oncol. 2013;20(7):2188-96.
27. Piagnerelli R, Marrelli D, Roviello G, et al. Clinical value and impact on prognosis of peri-operative CA 19-9 serum levels in stage I and II adenocarcinoma of the pancreas. Tumour Biol. 2016;37(2):1959-66.
28. Yamamoto Y, Ikoma H, Morimura R, et al. Optimal duration of the early and late recurrence of pancreatic cancer after pancreatectomy based on the difference in the prognosis. Pancreatology. 2014;14(6):524-9.
29. Bergquist JR, Puig CA, Shubert ChR, et al. Carbohydrate Antigen 19-9 Elevation in Anatomically Resectable, Early Stage Pancreatic Cancer Is Independently Associated with Decreased Overall Survival and an Indication for Neoadjuvant Therapy: A National Cancer Database Study. J Am Coll Surg. 2016;223(1):52-65. DOI:10.1016/j.jamcollsurg.2016.02.009
30. Yamada S, Fujii T, Sugimoto H, et al. Aggressive surgery for borderline resectable pancreatic cancer: Evaluation of National Comprehensive Cancer Network guidelines. Pancreas. 2013;42:1004-10.
31. Laurence JM, Tran PD, Morarji K, et al. A systematic review and meta-analysis of survival and surgical outcomes following neoadjuvant chemoradiotherapy for pancreatic cancer. J Gastrointest Surg. 2011;15(11):2059-69.
32. Mirkin KA, Hollenbeak CS, Wong JJ. Prognostic impact of carbohydrate antigen 19-9 level at diagnosis in resected stage I-III pancreatic adenocarcinoma: a U.S. population study. Gastrointest Oncol. 2017;8(5):778-88. DOI:10.21037/jgo.2017.07.04
Авторы
К.Д. Далгатов*1,2, Н.Н. Семенов1,2, М.В. Козодаева2
1 ФГБОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия;
2 ГБУЗ «Городская клиническая больница №1 им. Н.И. Пирогова» Департамента здравоохранения г. Москвы, Москва, Россия
1 Pirogov Russian National Research Medical University, Moscow, Russia;
2 Pirogov City Clinical Hospital №1, Moscow, Russia
1 ФГБОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия;
2 ГБУЗ «Городская клиническая больница №1 им. Н.И. Пирогова» Департамента здравоохранения г. Москвы, Москва, Россия
________________________________________________
1 Pirogov Russian National Research Medical University, Moscow, Russia;
2 Pirogov City Clinical Hospital №1, Moscow, Russia
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