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Первые результаты многоцентрового нерандомизированного проспективного исследования II фазы изучения эффективности и безопасности индукционной терапии пембролизумабом, цисплатином и 5-фторурацилом у пациентов с нерезектабельным плоскоклеточным раком
Первые результаты многоцентрового нерандомизированного проспективного исследования II фазы изучения эффективности и безопасности индукционной терапии пембролизумабом, цисплатином и 5-фторурацилом у пациентов с нерезектабельным плоскоклеточным раком
Стативко О.А., Покатаев И.А., Кравцов С.А., Жукова Л.Г., Строяковский Д.Л., Сабитов Э.Р., Кузьмина Е.С., Феоктистова П.С., Антонова Т.Г., Лядова М.А., Носова М.В., Сыдыкова Р.С., Лисицына К.Н., Стрельникова Т.Б., Ализаде Г.Р., Партс С.А., Долов М.М., Тедеева А.Х., Галкин В.Н. Первые результаты многоцентрового нерандомизированного проспективного исследования II фазы изучения эффективности и безопасности индукционной терапии пембролизумабом, цисплатином и 5-фторурацилом у пациентов с нерезектабельным плоскоклеточным раком ротоглотки, гортаноглотки и гортани. Современная Онкология. 2024;26(4):447–453. DOI: 10.26442/18151434.2024.4.203019
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
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Аннотация
Обоснование. Высокая токсичность стандартного режима индукционной химиотерапии DCF может компрометировать проведение последующей (химио-) лучевой терапии у пациентов с нерезектабельным плоскоклеточным раком головы и шеи, ухудшая их выживаемость.
Цель. Изучить эффективность и переносимость индукционной иммунохимиотерапии по схеме пембролизумаб + производное платины + 5-фторурацил у пациентов с местно-распространенным плоскоклеточным раком ротоглотки, гортаноглотки или гортани.
Материалы и методы. В проспективное многоцентровое нерандомизированное исследование включались пациенты с PD-L1 – позитивными опухолями III-IVA стадии, ECOG 0-2 и адекватными показателями общего и биохимического анализов крови. После трех циклов индукционной терапии по схеме пембролизумаб + цисплатин + 5-фторурацил пациентам назначалось выполнение II этапа – лучевой или химиолучевой терапии.
Результаты. Всего с января 2022 г. включены 120 пациентов. Средний возраст составил 60 (35–75) лет, большинство – мужчины (105; 87,5%). Объективные ответы оценены у 116 из 120 пациентов. Частота объективного ответа на индукционной фазе составила 62,9% (n=73), в том числе 16,4% (n=19) полных ответов. Среднее изменение таргетных очагов составило -55% (от -100 до 65%). В настоящее время только 7 пациентам по разным причинам вовремя не начата (химио-) лучевая терапия – из-за прогрессирования заболевания (4 пациента) или отказа от дальнейшего лечения (3 пациента). Среди 95 больных, завершивших лучевую терапию, 94,7% получили дозу облучения ≥66 Гр. Частота нежелательных явлений 3–4-й степени составила 30,8%, необходимость госпитализации ввиду токсичности – лишь 5%. Летальности, связанной с токсичностью на фоне индукции, не отмечено. Наиболее часто встречалась гематологическая токсичность в виде нейтропении 3–4-й степени у 28 (23,3%) больных. Иммуноопосредованная токсичность отмечалась редко: у 2 (1,7%) больных – кожная сыпь, у 1 (0,8%) – гипотиреоз. Применение высоких доз цисплатина приводило к тенденции к снижению скорости клубочковой фильтрации (среднее снижение составило 10,5% от исходного уровня), хотя ни одному пациенту не потребовался гемодиализ.
Заключение. Индукционная терапия пембролизумабом в сочетании с цисплатином и 5-фторурацилом обеспечила значимую частоту объективного ответа и приемлемый профиль безопасности при местно-распространенном плоскоклеточном раке ротоглотки, гортаноглотки и гортани. Это практически не влияло на частоту пропуска последующей лучевой терапии. Для оценки долгосрочной эффективности необходимо дальнейшее наблюдение.
Ключевые слова: индукционная химиотерапия, иммунохимиотерапия, нерезектабельный рак головы и шеи, пембролизумаб, распространенный плоскоклеточный рак, рак ротоглотки, рак гортаноглотки, рак гортани
Materials and methods. The inclusion criteria were: unresectable stage III–IVA cancer of larynx, oropharynx, hypopharynx, PD-L1-positive (CPS≥1) squamous cell cancer, ECOG 0-2. Included pts received 3 cycles of pembrolizumab 200 mg d1+ cisplatin 100 mg/m2 d1 + 5-fluorouracil 1000 mg/m2/day 1-4 d followed by (chemo-) radiation.
Results. Since January 2022 a total of 120 pts were included. Median age was 60 (35–75), the majority were male (105; 87.5%). Objective responses were assessed in 116 of 120 pts. ORR on induction phase was 62.9% (n=73), including 16.4% (n=19) of complete responses. Median change of target lesions was -55% (from -100% to 65%). To date, only 7 pts did not start (chemo)radiation in time due to disease progression (4 pts) or refuse of consent (3 pts). Among 95 pts who completed radiation therapy 94.7% received radiation dose ≥66Gy. The incidence of grade 3-4 adverse events was 30,8%, in 6 (5%) pts it required hospitalization. No grade 5 adverse events were observed. The most common toxicity was hematological with neutropenia grade 3-4 in 28 (23.3%) pts. There was mild immune-related toxicity: 2 (1.7%) pts had skin rash and 1 (0.8%) – hypothyroidism. The use of high dose of cisplatin resulted in a trend to decline glomerular filtration rate (median decrease was 10.5% from baseline) although none of pts required hemodialysis.
Conclusion. Induction therapy with pembrolizumab plus cisplatin and 5-fluorouracil provided meaningful ORR and acceptable safety profile in locally advanced HNSCC. It almost did not influence the following radiation therapy omission rate. Further follow-up is needed to assess long-term efficacy.
Keywords: induction chemotherapy, immunochemotherapy, unresectable head and neck cancer, pembrolizumab, advanced squamous cell carcinoma, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer
Цель. Изучить эффективность и переносимость индукционной иммунохимиотерапии по схеме пембролизумаб + производное платины + 5-фторурацил у пациентов с местно-распространенным плоскоклеточным раком ротоглотки, гортаноглотки или гортани.
Материалы и методы. В проспективное многоцентровое нерандомизированное исследование включались пациенты с PD-L1 – позитивными опухолями III-IVA стадии, ECOG 0-2 и адекватными показателями общего и биохимического анализов крови. После трех циклов индукционной терапии по схеме пембролизумаб + цисплатин + 5-фторурацил пациентам назначалось выполнение II этапа – лучевой или химиолучевой терапии.
Результаты. Всего с января 2022 г. включены 120 пациентов. Средний возраст составил 60 (35–75) лет, большинство – мужчины (105; 87,5%). Объективные ответы оценены у 116 из 120 пациентов. Частота объективного ответа на индукционной фазе составила 62,9% (n=73), в том числе 16,4% (n=19) полных ответов. Среднее изменение таргетных очагов составило -55% (от -100 до 65%). В настоящее время только 7 пациентам по разным причинам вовремя не начата (химио-) лучевая терапия – из-за прогрессирования заболевания (4 пациента) или отказа от дальнейшего лечения (3 пациента). Среди 95 больных, завершивших лучевую терапию, 94,7% получили дозу облучения ≥66 Гр. Частота нежелательных явлений 3–4-й степени составила 30,8%, необходимость госпитализации ввиду токсичности – лишь 5%. Летальности, связанной с токсичностью на фоне индукции, не отмечено. Наиболее часто встречалась гематологическая токсичность в виде нейтропении 3–4-й степени у 28 (23,3%) больных. Иммуноопосредованная токсичность отмечалась редко: у 2 (1,7%) больных – кожная сыпь, у 1 (0,8%) – гипотиреоз. Применение высоких доз цисплатина приводило к тенденции к снижению скорости клубочковой фильтрации (среднее снижение составило 10,5% от исходного уровня), хотя ни одному пациенту не потребовался гемодиализ.
Заключение. Индукционная терапия пембролизумабом в сочетании с цисплатином и 5-фторурацилом обеспечила значимую частоту объективного ответа и приемлемый профиль безопасности при местно-распространенном плоскоклеточном раке ротоглотки, гортаноглотки и гортани. Это практически не влияло на частоту пропуска последующей лучевой терапии. Для оценки долгосрочной эффективности необходимо дальнейшее наблюдение.
Ключевые слова: индукционная химиотерапия, иммунохимиотерапия, нерезектабельный рак головы и шеи, пембролизумаб, распространенный плоскоклеточный рак, рак ротоглотки, рак гортаноглотки, рак гортани
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Materials and methods. The inclusion criteria were: unresectable stage III–IVA cancer of larynx, oropharynx, hypopharynx, PD-L1-positive (CPS≥1) squamous cell cancer, ECOG 0-2. Included pts received 3 cycles of pembrolizumab 200 mg d1+ cisplatin 100 mg/m2 d1 + 5-fluorouracil 1000 mg/m2/day 1-4 d followed by (chemo-) radiation.
Results. Since January 2022 a total of 120 pts were included. Median age was 60 (35–75), the majority were male (105; 87.5%). Objective responses were assessed in 116 of 120 pts. ORR on induction phase was 62.9% (n=73), including 16.4% (n=19) of complete responses. Median change of target lesions was -55% (from -100% to 65%). To date, only 7 pts did not start (chemo)radiation in time due to disease progression (4 pts) or refuse of consent (3 pts). Among 95 pts who completed radiation therapy 94.7% received radiation dose ≥66Gy. The incidence of grade 3-4 adverse events was 30,8%, in 6 (5%) pts it required hospitalization. No grade 5 adverse events were observed. The most common toxicity was hematological with neutropenia grade 3-4 in 28 (23.3%) pts. There was mild immune-related toxicity: 2 (1.7%) pts had skin rash and 1 (0.8%) – hypothyroidism. The use of high dose of cisplatin resulted in a trend to decline glomerular filtration rate (median decrease was 10.5% from baseline) although none of pts required hemodialysis.
Conclusion. Induction therapy with pembrolizumab plus cisplatin and 5-fluorouracil provided meaningful ORR and acceptable safety profile in locally advanced HNSCC. It almost did not influence the following radiation therapy omission rate. Further follow-up is needed to assess long-term efficacy.
Keywords: induction chemotherapy, immunochemotherapy, unresectable head and neck cancer, pembrolizumab, advanced squamous cell carcinoma, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer
Полный текст
Список литературы
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9. Hitt R, López-Pousa A, Martínez-Trufero J, et al. Phase III Study Comparing Cisplatin Plus Fluorouracil to Paclitaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2005;23(34):8636-45.
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12. Paccagnella A, Orlando A, Marchiori C, et al. Phase III Trial of Initial Chemotherapy in Stage III or IV Head and Neck Cancers: a Study by the Gruppo di Studio sui Tumori della Testa e del Collo. JNCI J Nat Cancer Inst. 1994;86(4):265-72.
13. Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and Fluorouracil Alone or with Docetaxel in Head and Neck Cancer. New Engl J Med. 2007;357(17):1705-15.
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15. Bernadach M, Lapeyre M, Dillies AF, et al. Predictive factors of toxicity of TPF induction chemotherapy for locally advanced head and neck cancers. BMC Cancer. 2021;21(1):360.
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17. Fayette J, Fontaine-Delaruelle C, Ambrun A, et al. Neoadjuvant modified TPF (docetaxel, cisplatin, fluorouracil) for patients unfit to standard TPF in locally advanced head and neck squamous cell carcinoma: a study of 48 patients. Oncotarget. 2016;7(24):37297-304.
18. Inhestern J, Schmalenberg H, Dietz A, et al. A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). Ann Oncol. 2017;28(8):1917-22. DOI:10.1093/annonc/mdx20
19. Lee KW, Koh Y, Kim SB, et al. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015;20(10):1119-20.
20. Dietz A, Wichmann G, Flentje M, et al. Final results of the randomized phase II DeLOS-II trial: Induction chemotherapy (IC) followed by radiotherapy (R) vs. cetuximab (E) plus IC and R for functional larynx preservation in resectable laryngeal and hypopharyngeal cancer (LHSCC). J Clin Oncol. 2016;34(Suppl. 15):6025. DOI:10.1200/JCO.2016.34.15_suppl.6025
21. Vermorken JB, Remenar E, van Herpen C, et al.; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007;357(17):1695-704. DOI:10.1056/NEJMoa071028
22. Harrington KJ, Burtness D, Greil R, et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023;41(4):790-802.
23. Machiels JP, Tao Y, Licitra L, et al. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2024;25(5):572-87.
24. Spicer JD, Garassino MC, Wakelee H, et al. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;404(10459):1240-52.
25. Wu D, Li Y, Xu P, et al. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Communicat. 2024;15(1):2177.
2. Bolotina LV, Vladimirova LIu, Dengina NV. Prakticheskiie rekomendatsii po lekarstvennomu lecheniiu opukholei golovy i shei. Zlokachestvennyie Opukholi. 2022;12(3s2-1):94-112 (in Russian).
3. Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly Cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: A retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncologica. 2008;47(8):1513-8.
4. Strojan P, Vermorken JB, Beitler JJ, et al. Cumulative cisplatin dose in concurrent chemoradiotherapy for head and neck cancer: A systematic review. Head Neck. 2016;38(Suppl. 1):E2151-8. DOI:10.1002/hed.24026
5. Machiels JP, René Leemans C, Golusinski W, et al.; EHNS Executive Board; ESMO Guidelines Committee; ESTRO Executive Board. Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS–ESMO–ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(11):1462-75. DOI:10.1016/j.annonc.2020.07.011
6. Ghi MG, Paccagnella A, Ferrari D, et al. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II–III trial. Ann Oncol. 2017;28(9):2206-12.
7. Kramer HJ, Jaar BJ, Choi MJ, et al. An Endorsement of the Removal of Race From GFR Estimation Equations: A Position Statement From the National Kidney Foundation Kidney Disease Outcomes Quality Initiative. Am J Kidney Dis. 2022;80(6):691-6.
8. Domenge C, Hill C, Lefebvre JL, et al. Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. Br J Cancer. 2000;83(12):1594-8.
9. Hitt R, López-Pousa A, Martínez-Trufero J, et al. Phase III Study Comparing Cisplatin Plus Fluorouracil to Paclitaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2005;23(34):8636-45.
10. Iocca O, Farcomeni A, Di Rocco A, et al. Locally advanced squamous cell carcinoma of the head and neck: A systematic review and Bayesian network meta-analysis of the currently available treatment options. Oral Oncol. 2018;80:40-51.
11. Lorch JH, Goloubeva O, Haddad RI, et al. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011;12(2):153-9.
12. Paccagnella A, Orlando A, Marchiori C, et al. Phase III Trial of Initial Chemotherapy in Stage III or IV Head and Neck Cancers: a Study by the Gruppo di Studio sui Tumori della Testa e del Collo. JNCI J Nat Cancer Inst. 1994;86(4):265-72.
13. Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and Fluorouracil Alone or with Docetaxel in Head and Neck Cancer. New Engl J Med. 2007;357(17):1705-15.
14. Ferrari D, Ghi MG, Franzese C, et al. The Slippery Role of Induction Chemotherapy in Head and Neck Cancer: Myth and Reality. Front Oncol. 2020;10:7. DOI:10.3389/fonc.2020.00007
15. Bernadach M, Lapeyre M, Dillies AF, et al. Predictive factors of toxicity of TPF induction chemotherapy for locally advanced head and neck cancers. BMC Cancer. 2021;21(1):360.
16. Ko EC, Genden EM, Misiukiewicz K, et al. Toxicity profile and clinical outcomes in locally advanced head and neck cancer patients treated with induction chemotherapy prior to concurrent chemoradiation. Oncol Rep. 2012;27(2):467-74. DOI:10.3892/or.2011.1512
17. Fayette J, Fontaine-Delaruelle C, Ambrun A, et al. Neoadjuvant modified TPF (docetaxel, cisplatin, fluorouracil) for patients unfit to standard TPF in locally advanced head and neck squamous cell carcinoma: a study of 48 patients. Oncotarget. 2016;7(24):37297-304.
18. Inhestern J, Schmalenberg H, Dietz A, et al. A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). Ann Oncol. 2017;28(8):1917-22. DOI:10.1093/annonc/mdx20
19. Lee KW, Koh Y, Kim SB, et al. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015;20(10):1119-20.
20. Dietz A, Wichmann G, Flentje M, et al. Final results of the randomized phase II DeLOS-II trial: Induction chemotherapy (IC) followed by radiotherapy (R) vs. cetuximab (E) plus IC and R for functional larynx preservation in resectable laryngeal and hypopharyngeal cancer (LHSCC). J Clin Oncol. 2016;34(Suppl. 15):6025. DOI:10.1200/JCO.2016.34.15_suppl.6025
21. Vermorken JB, Remenar E, van Herpen C, et al.; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007;357(17):1695-704. DOI:10.1056/NEJMoa071028
22. Harrington KJ, Burtness D, Greil R, et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023;41(4):790-802.
23. Machiels JP, Tao Y, Licitra L, et al. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2024;25(5):572-87.
24. Spicer JD, Garassino MC, Wakelee H, et al. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;404(10459):1240-52.
25. Wu D, Li Y, Xu P, et al. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Communicat. 2024;15(1):2177.
2. Болотина Л.В., Владимирова Л.Ю., Деньгина Н.В. Практические рекомендации по лекарственному лечению опухолей головы и шеи. Злокачественные опухоли. 2022;12(3s2-1):94-112 [Bolotina LV, Vladimirova LIu, Dengina NV. Prakticheskiie rekomendatsii po lekarstvennomu lecheniiu opukholei golovy i shei. Zlokachestvennyie Opukholi. 2022;12(3s2-1):94-112 (in Russian)].
3. Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly Cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: A retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncologica. 2008;47(8):1513-8.
4. Strojan P, Vermorken JB, Beitler JJ, et al. Cumulative cisplatin dose in concurrent chemoradiotherapy for head and neck cancer: A systematic review. Head Neck. 2016;38(Suppl. 1):E2151-8. DOI:10.1002/hed.24026
5. Machiels JP, René Leemans C, Golusinski W, et al.; EHNS Executive Board; ESMO Guidelines Committee; ESTRO Executive Board. Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS–ESMO–ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(11):1462-75. DOI:10.1016/j.annonc.2020.07.011
6. Ghi MG, Paccagnella A, Ferrari D, et al. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II–III trial. Ann Oncol. 2017;28(9):2206-12.
7. Kramer HJ, Jaar BJ, Choi MJ, et al. An Endorsement of the Removal of Race From GFR Estimation Equations: A Position Statement From the National Kidney Foundation Kidney Disease Outcomes Quality Initiative. Am J Kidney Dis. 2022;80(6):691-6.
8. Domenge C, Hill C, Lefebvre JL, et al. Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. Br J Cancer. 2000;83(12):1594-8.
9. Hitt R, López-Pousa A, Martínez-Trufero J, et al. Phase III Study Comparing Cisplatin Plus Fluorouracil to Paclitaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2005;23(34):8636-45.
10. Iocca O, Farcomeni A, Di Rocco A, et al. Locally advanced squamous cell carcinoma of the head and neck: A systematic review and Bayesian network meta-analysis of the currently available treatment options. Oral Oncol. 2018;80:40-51.
11. Lorch JH, Goloubeva O, Haddad RI, et al. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011;12(2):153-9.
12. Paccagnella A, Orlando A, Marchiori C, et al. Phase III Trial of Initial Chemotherapy in Stage III or IV Head and Neck Cancers: a Study by the Gruppo di Studio sui Tumori della Testa e del Collo. JNCI J Nat Cancer Inst. 1994;86(4):265-72.
13. Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and Fluorouracil Alone or with Docetaxel in Head and Neck Cancer. New Engl J Med. 2007;357(17):1705-15.
14. Ferrari D, Ghi MG, Franzese C, et al. The Slippery Role of Induction Chemotherapy in Head and Neck Cancer: Myth and Reality. Front Oncol. 2020;10:7. DOI:10.3389/fonc.2020.00007
15. Bernadach M, Lapeyre M, Dillies AF, et al. Predictive factors of toxicity of TPF induction chemotherapy for locally advanced head and neck cancers. BMC Cancer. 2021;21(1):360.
16. Ko EC, Genden EM, Misiukiewicz K, et al. Toxicity profile and clinical outcomes in locally advanced head and neck cancer patients treated with induction chemotherapy prior to concurrent chemoradiation. Oncol Rep. 2012;27(2):467-74. DOI:10.3892/or.2011.1512
17. Fayette J, Fontaine-Delaruelle C, Ambrun A, et al. Neoadjuvant modified TPF (docetaxel, cisplatin, fluorouracil) for patients unfit to standard TPF in locally advanced head and neck squamous cell carcinoma: a study of 48 patients. Oncotarget. 2016;7(24):37297-304.
18. Inhestern J, Schmalenberg H, Dietz A, et al. A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). Ann Oncol. 2017;28(8):1917-22. DOI:10.1093/annonc/mdx20
19. Lee KW, Koh Y, Kim SB, et al. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015;20(10):1119-20.
20. Dietz A, Wichmann G, Flentje M, et al. Final results of the randomized phase II DeLOS-II trial: Induction chemotherapy (IC) followed by radiotherapy (R) vs. cetuximab (E) plus IC and R for functional larynx preservation in resectable laryngeal and hypopharyngeal cancer (LHSCC). J Clin Oncol. 2016;34(Suppl. 15):6025. DOI:10.1200/JCO.2016.34.15_suppl.6025
21. Vermorken JB, Remenar E, van Herpen C, et al.; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007;357(17):1695-704. DOI:10.1056/NEJMoa071028
22. Harrington KJ, Burtness D, Greil R, et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023;41(4):790-802.
23. Machiels JP, Tao Y, Licitra L, et al. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2024;25(5):572-87.
24. Spicer JD, Garassino MC, Wakelee H, et al. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;404(10459):1240-52.
25. Wu D, Li Y, Xu P, et al. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Communicat. 2024;15(1):2177.
________________________________________________
2. Bolotina LV, Vladimirova LIu, Dengina NV. Prakticheskiie rekomendatsii po lekarstvennomu lecheniiu opukholei golovy i shei. Zlokachestvennyie Opukholi. 2022;12(3s2-1):94-112 (in Russian).
3. Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly Cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: A retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncologica. 2008;47(8):1513-8.
4. Strojan P, Vermorken JB, Beitler JJ, et al. Cumulative cisplatin dose in concurrent chemoradiotherapy for head and neck cancer: A systematic review. Head Neck. 2016;38(Suppl. 1):E2151-8. DOI:10.1002/hed.24026
5. Machiels JP, René Leemans C, Golusinski W, et al.; EHNS Executive Board; ESMO Guidelines Committee; ESTRO Executive Board. Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS–ESMO–ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(11):1462-75. DOI:10.1016/j.annonc.2020.07.011
6. Ghi MG, Paccagnella A, Ferrari D, et al. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II–III trial. Ann Oncol. 2017;28(9):2206-12.
7. Kramer HJ, Jaar BJ, Choi MJ, et al. An Endorsement of the Removal of Race From GFR Estimation Equations: A Position Statement From the National Kidney Foundation Kidney Disease Outcomes Quality Initiative. Am J Kidney Dis. 2022;80(6):691-6.
8. Domenge C, Hill C, Lefebvre JL, et al. Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. Br J Cancer. 2000;83(12):1594-8.
9. Hitt R, López-Pousa A, Martínez-Trufero J, et al. Phase III Study Comparing Cisplatin Plus Fluorouracil to Paclitaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2005;23(34):8636-45.
10. Iocca O, Farcomeni A, Di Rocco A, et al. Locally advanced squamous cell carcinoma of the head and neck: A systematic review and Bayesian network meta-analysis of the currently available treatment options. Oral Oncol. 2018;80:40-51.
11. Lorch JH, Goloubeva O, Haddad RI, et al. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011;12(2):153-9.
12. Paccagnella A, Orlando A, Marchiori C, et al. Phase III Trial of Initial Chemotherapy in Stage III or IV Head and Neck Cancers: a Study by the Gruppo di Studio sui Tumori della Testa e del Collo. JNCI J Nat Cancer Inst. 1994;86(4):265-72.
13. Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and Fluorouracil Alone or with Docetaxel in Head and Neck Cancer. New Engl J Med. 2007;357(17):1705-15.
14. Ferrari D, Ghi MG, Franzese C, et al. The Slippery Role of Induction Chemotherapy in Head and Neck Cancer: Myth and Reality. Front Oncol. 2020;10:7. DOI:10.3389/fonc.2020.00007
15. Bernadach M, Lapeyre M, Dillies AF, et al. Predictive factors of toxicity of TPF induction chemotherapy for locally advanced head and neck cancers. BMC Cancer. 2021;21(1):360.
16. Ko EC, Genden EM, Misiukiewicz K, et al. Toxicity profile and clinical outcomes in locally advanced head and neck cancer patients treated with induction chemotherapy prior to concurrent chemoradiation. Oncol Rep. 2012;27(2):467-74. DOI:10.3892/or.2011.1512
17. Fayette J, Fontaine-Delaruelle C, Ambrun A, et al. Neoadjuvant modified TPF (docetaxel, cisplatin, fluorouracil) for patients unfit to standard TPF in locally advanced head and neck squamous cell carcinoma: a study of 48 patients. Oncotarget. 2016;7(24):37297-304.
18. Inhestern J, Schmalenberg H, Dietz A, et al. A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). Ann Oncol. 2017;28(8):1917-22. DOI:10.1093/annonc/mdx20
19. Lee KW, Koh Y, Kim SB, et al. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015;20(10):1119-20.
20. Dietz A, Wichmann G, Flentje M, et al. Final results of the randomized phase II DeLOS-II trial: Induction chemotherapy (IC) followed by radiotherapy (R) vs. cetuximab (E) plus IC and R for functional larynx preservation in resectable laryngeal and hypopharyngeal cancer (LHSCC). J Clin Oncol. 2016;34(Suppl. 15):6025. DOI:10.1200/JCO.2016.34.15_suppl.6025
21. Vermorken JB, Remenar E, van Herpen C, et al.; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007;357(17):1695-704. DOI:10.1056/NEJMoa071028
22. Harrington KJ, Burtness D, Greil R, et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023;41(4):790-802.
23. Machiels JP, Tao Y, Licitra L, et al. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2024;25(5):572-87.
24. Spicer JD, Garassino MC, Wakelee H, et al. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;404(10459):1240-52.
25. Wu D, Li Y, Xu P, et al. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Communicat. 2024;15(1):2177.
Авторы
О.А. Стативко*1, И.А. Покатаев1, С.А. Кравцов1, Л.Г. Жукова2, Д.Л. Строяковский3, Э.Р. Сабитов1, Е.С. Кузьмина1, П.С. Феоктистова2, Т.Г. Антонова1, М.А. Лядова1,4, М.В. Носова1, Р.С. Сыдыкова1, К.Н. Лисицына1, Т.Б. Стрельникова3, Г.Р. Ализаде2, С.А. Партс1, М.М. Долов5, А.Х. Тедеева5, В.Н. Галкин1,6
1ГБУЗ «Городская клиническая больница им. С.С. Юдина» Департамента здравоохранения г. Москвы, Москва, Россия;
2ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова» Департамента здравоохранения г. Москвы, Москва, Россия;
3ГБУЗ «Московская городская онкологическая больница №62» Департамента здравоохранения г. Москвы, Москва, Россия;
4Новокузнецкий государственный институт усовершенствования врачей – филиал ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Новокузнецк, Россия;
5Московский международный онкологический центр, Москва, Россия;
6ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*olesya_stativko@mail.ru
1Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department, Moscow, Russia;
2Loginov Moscow Clinical Scientific Center, Moscow, Russia;
3Moscow City Oncology Hospital №62, Moscow, Russia;
4Novokuznetsk State Institute for Further Training of Physicians – Branch of the Russian Medical Academy of Continuous Professional Education, Novokuznetsk, Russia;
5Moscow International Cancer Center, Moscow, Russia;
6Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*olesya_stativko@mail.ru
1ГБУЗ «Городская клиническая больница им. С.С. Юдина» Департамента здравоохранения г. Москвы, Москва, Россия;
2ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова» Департамента здравоохранения г. Москвы, Москва, Россия;
3ГБУЗ «Московская городская онкологическая больница №62» Департамента здравоохранения г. Москвы, Москва, Россия;
4Новокузнецкий государственный институт усовершенствования врачей – филиал ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Новокузнецк, Россия;
5Московский международный онкологический центр, Москва, Россия;
6ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*olesya_stativko@mail.ru
________________________________________________
1Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department, Moscow, Russia;
2Loginov Moscow Clinical Scientific Center, Moscow, Russia;
3Moscow City Oncology Hospital №62, Moscow, Russia;
4Novokuznetsk State Institute for Further Training of Physicians – Branch of the Russian Medical Academy of Continuous Professional Education, Novokuznetsk, Russia;
5Moscow International Cancer Center, Moscow, Russia;
6Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*olesya_stativko@mail.ru
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