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Терапия эрлотинибом в сочетании с гемцитабином при распространенном и/или метастатическом раке поджелудочной железы
Терапия эрлотинибом в сочетании с гемцитабином при распространенном и/или метастатическом раке поджелудочной железы
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Аннотация
Несмотря на достижения, связанные со снижением смертности от ряда злокачественных новообразований, до сих пор не получен прогресс в лечении рака поджелудочной железы. Смертность от этой локализации стоит на восьмом месте в мире у мужчин и на девятом – у женщин. Соотношение смертности и заболеваемости составляет 0,98, что свидетельствует о быстром и фатальном течении заболевания. Диагноз устанавливается на поздних стадиях, а медиана выживаемости составляет около 4,5–6 мес. Даже на ранних стадиях болезни 5-летняя выживаемость – всего 20% после оперативного лечения. Эрлотиниб утвержден FDA для применения в повседневной практике на основании результатов исследования (PA.3), которые продемонстрировали достоверное увеличение общей выживаемости. Схема «гемцитабин + эрлотиниб» считается стандартом лечения. Необходимо отметить, что данная комбинация должна использоваться в практической онкологии при местнораспространенном или диссеминированном раке поджелудочной железы.
Ключевые слова: рак поджелудочной железы, эрлотиниб.
Key words: pancreatic cancer, erlotinib.
Ключевые слова: рак поджелудочной железы, эрлотиниб.
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Key words: pancreatic cancer, erlotinib.
Полный текст
Список литературы
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2. Kamangar F, Dores GM, Anderson WF et al. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 2006; 24: 2137–50.
3. Burris HA 3rd, Moore MJ, Andersen J et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15: 2403–13.
4. Moore MJ, Goldstein D, Hamm J et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007; 25: 1960–6.
5. Li D, Xie K, Wolff R, Abbruzzese JL. Pancreatic cancer. Lancet 2004; 363: 1049–57.
6. Burris HA 3rd, Moore MJ, Andersen J et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15: 2403–13.
7. Stathis A, Moore MJ. Advanced pancreatic carcinoma: current treatment and future challenges. Nat Rev Clin Oncol 2010; 7: 163–72.
8. Poplin E, Feng Y, Rothenberg ML et al. Phase III trial of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2009; 27 (34): p. 5859.
9. Kindler HL, Niedzwiecki D, Hollis D et al. A double-blind, placebo-controlled, randomized phase III trial of gemcitabine (G) plus bevacizumab (B) versus gemcitabine plus placebo (P) in patients (pts) with advanced pancreatic cancer (PC): a preliminary analysis of Cancer and Leukemia Group B (CALGB) 80303. J Clin Oncol 2007; 25 (18). Abstr. 4508.
10. Philip PA, Benedetti J, Fenoglio-Preiser C et al. Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. J Clin Oncol 2007; 25 (18). Abstr LBA 4509.
11. Durkin AJ, Bloomston PM, Rosemurgy AS et al. Defining the role of the epidermal growth factor receptor in pancreatic cancer grown in vitro. Am J Surg 2003; 186 (5): 431–6.
12. Neuhaus P, Riess H, Post S et al. CONKO-001: final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). J Clin Oncol 2008; 26 (15). Abstr. LBA 4504.
13. Neoptolemos JP, Stocken DD, Friess H et al. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 2004; 350: 1200–10.
14. Chang BW, Saif MW. Combining Epidermal Growth Factor Receptor Inhibitors and Radiation Therapy in Pancreatic Cancer: Small Step or Giant Leap, JOP. J Pancreas (Online) 2009; 10 (3): 231–6.
15. Bilimoria KY, Bentrem DJ, Ko CY et al. Multimodality therapy for pancreatic cancer in the US: utilization, outcomes, and the effect of hospital volume. Cancer 2007; 110 (6): 1227–34.
16. Van Laethem J, Van Cutsem E, Hammel P et al. Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer: feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). J Clin Oncol 2008; 26 (15). Abstr. 4514.
17. Ko AH, Quivey JM, Venook AP et al. A phase II study of fixed-dose rate gemcitabine plus low-dose cisplatin followed by consolidative chemoradiation for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys 2007; 68 (3): 809–16.
18. Huguet F, Thierry A, Hammel P et al. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol 2007; 25 (3): 326–31.
19. Bao PQ, Ramanathan RK, Moser AJ et al. Phase II trial of adjuvant gemcitabine and erlotinib for resected pancreatic cancer. ASCO Gastrointestinal Cancers Symposium 2010. Abstr. 224.
20. Iannitti D, Dipetrillo T, Akerman P et al. Erlotinib and chemoradiation followed by maintenance erlotinib for locally advanced pancreatic cancer: a phase I study. Am J Clin Oncol 2005; 28 (6): 570–5.
21. Duffy A, Kortmansky J, Schwartz GK et al. A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma. Ann Oncol 2008; 19: 86–91.
22. Cardenes HR, Chiorean EG, Perkins S et al. Neoadjuvant gemcitabine, erlotinib and hypofractionated radiation therapy for potentially resectable pancreatic cancer: a pilot study. J Clin Oncol 2008; 26 (15): p. 15578. ASCO Annual Meeting.
23. Ma W, Herman JM, Laheru D et al. A phase I tolerability and pharmacokinetic study of adjuvant erlotinib (E) and capecitabine (Cap) with concurrent radiation (RT) in resected pancreatic cancer (PanCa) patients. ASCO Gastrointestinal Cancers Symposium 2008. Abstr. 217.
24. Robertson JM, Hardy MM, Ballouz S et al. Conformal radiation therapy with concurrent full-dose gemcitabine and erlotinib for unresected pancreas cancer: a phase I trial. Int J Radiat Oncol Biol Phys 2008; 72 (1) Suppl. 1: s275.
25. Van Cutsem E, Vervenne WL, Bennouna J et al. Rash as a marker for the efficacy of gemcitabine plus erlotinib-based therapy in pancreatic cancer: results from the AViTA study. J Clin Oncol 2009; 27 (15). Abstr. 4532.
26. Li J, Merl MY, Saif MW. Any Second-Line Therapy for Advanced Pancreatic Cancer? Highlights from the 2010 ASCO Gastrointestinal Cancers Symposium. Orlando FL USA 2010; JOP. J Pancreas (Online) 2010; 11 (2): 151–3.
2. Kamangar F, Dores GM, Anderson WF et al. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 2006; 24: 2137–50.
3. Burris HA 3rd, Moore MJ, Andersen J et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15: 2403–13.
4. Moore MJ, Goldstein D, Hamm J et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007; 25: 1960–6.
5. Li D, Xie K, Wolff R, Abbruzzese JL. Pancreatic cancer. Lancet 2004; 363: 1049–57.
6. Burris HA 3rd, Moore MJ, Andersen J et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15: 2403–13.
7. Stathis A, Moore MJ. Advanced pancreatic carcinoma: current treatment and future challenges. Nat Rev Clin Oncol 2010; 7: 163–72.
8. Poplin E, Feng Y, Rothenberg ML et al. Phase III trial of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2009; 27 (34): p. 5859.
9. Kindler HL, Niedzwiecki D, Hollis D et al. A double-blind, placebo-controlled, randomized phase III trial of gemcitabine (G) plus bevacizumab (B) versus gemcitabine plus placebo (P) in patients (pts) with advanced pancreatic cancer (PC): a preliminary analysis of Cancer and Leukemia Group B (CALGB) 80303. J Clin Oncol 2007; 25 (18). Abstr. 4508.
10. Philip PA, Benedetti J, Fenoglio-Preiser C et al. Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. J Clin Oncol 2007; 25 (18). Abstr LBA 4509.
11. Durkin AJ, Bloomston PM, Rosemurgy AS et al. Defining the role of the epidermal growth factor receptor in pancreatic cancer grown in vitro. Am J Surg 2003; 186 (5): 431–6.
12. Neuhaus P, Riess H, Post S et al. CONKO-001: final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). J Clin Oncol 2008; 26 (15). Abstr. LBA 4504.
13. Neoptolemos JP, Stocken DD, Friess H et al. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 2004; 350: 1200–10.
14. Chang BW, Saif MW. Combining Epidermal Growth Factor Receptor Inhibitors and Radiation Therapy in Pancreatic Cancer: Small Step or Giant Leap, JOP. J Pancreas (Online) 2009; 10 (3): 231–6.
15. Bilimoria KY, Bentrem DJ, Ko CY et al. Multimodality therapy for pancreatic cancer in the US: utilization, outcomes, and the effect of hospital volume. Cancer 2007; 110 (6): 1227–34.
16. Van Laethem J, Van Cutsem E, Hammel P et al. Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer: feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). J Clin Oncol 2008; 26 (15). Abstr. 4514.
17. Ko AH, Quivey JM, Venook AP et al. A phase II study of fixed-dose rate gemcitabine plus low-dose cisplatin followed by consolidative chemoradiation for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys 2007; 68 (3): 809–16.
18. Huguet F, Thierry A, Hammel P et al. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol 2007; 25 (3): 326–31.
19. Bao PQ, Ramanathan RK, Moser AJ et al. Phase II trial of adjuvant gemcitabine and erlotinib for resected pancreatic cancer. ASCO Gastrointestinal Cancers Symposium 2010. Abstr. 224.
20. Iannitti D, Dipetrillo T, Akerman P et al. Erlotinib and chemoradiation followed by maintenance erlotinib for locally advanced pancreatic cancer: a phase I study. Am J Clin Oncol 2005; 28 (6): 570–5.
21. Duffy A, Kortmansky J, Schwartz GK et al. A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma. Ann Oncol 2008; 19: 86–91.
22. Cardenes HR, Chiorean EG, Perkins S et al. Neoadjuvant gemcitabine, erlotinib and hypofractionated radiation therapy for potentially resectable pancreatic cancer: a pilot study. J Clin Oncol 2008; 26 (15): p. 15578. ASCO Annual Meeting.
23. Ma W, Herman JM, Laheru D et al. A phase I tolerability and pharmacokinetic study of adjuvant erlotinib (E) and capecitabine (Cap) with concurrent radiation (RT) in resected pancreatic cancer (PanCa) patients. ASCO Gastrointestinal Cancers Symposium 2008. Abstr. 217.
24. Robertson JM, Hardy MM, Ballouz S et al. Conformal radiation therapy with concurrent full-dose gemcitabine and erlotinib for unresected pancreas cancer: a phase I trial. Int J Radiat Oncol Biol Phys 2008; 72 (1) Suppl. 1: s275.
25. Van Cutsem E, Vervenne WL, Bennouna J et al. Rash as a marker for the efficacy of gemcitabine plus erlotinib-based therapy in pancreatic cancer: results from the AViTA study. J Clin Oncol 2009; 27 (15). Abstr. 4532.
26. Li J, Merl MY, Saif MW. Any Second-Line Therapy for Advanced Pancreatic Cancer? Highlights from the 2010 ASCO Gastrointestinal Cancers Symposium. Orlando FL USA 2010; JOP. J Pancreas (Online) 2010; 11 (2): 151–3.
Авторы
Э.К.Возный1, А.Ю.Попов2, М.М.Галкин1, Т.А.Астраханкина1, А.А.Овсянников1, Г.Э.Поливанов1
1 Городская клиническая больница №57, Москва
2 ФГУ ФНКЦ Детской гематологии, онкологии и иммунологии Росздрава
1 City Clinical Hospital Fifty-Seven, Moscow;
2 Federal Research and Clinical Center of Pediatric Hematology, Oncology, and Immunology, Russian Agency for Health Care
1 Городская клиническая больница №57, Москва
2 ФГУ ФНКЦ Детской гематологии, онкологии и иммунологии Росздрава
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1 City Clinical Hospital Fifty-Seven, Moscow;
2 Federal Research and Clinical Center of Pediatric Hematology, Oncology, and Immunology, Russian Agency for Health Care
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