Neoadjuvant and Adjuvant Treatments for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma: The Current Status of Pancreatic Ductal Adenocarcinoma Treatment in Japan
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Resection is the only curative treatment for pancreatic ductal adenocarcinoma (PDAC). Although the outcome of technically resectable PDAC has improved with advances in surgery and adjuvant therapy, the 5-year survival rate remains low at 20% to 40%. More effective therapy is needed. Almost 15 years ago, the National Comprehensive Cancer Network guidelines proposed a resectability classification of PDAC based on preoperative imaging. Since then, treatment strategies for PDAC have been devised based on resectability. The standard of care for resectable PDAC is adjuvant chemotherapy after R0 resection, as shown by the results of pivotal clinical trials. With regard to neoadjuvant treatment, several recent clinical trials comparing neoadjuvant treatment with upfront resection have been conducted on resectable PDAC and borderline resectable PDAC, and the benefits and efficacy of neoadjuvant treatment for pancreatic cancer has become clearer. The significance of neoadjuvant treatment for resectable PDAC remains controversial, but in borderline resectable PDAC the efficacy of neoadjuvant treatment has been further recognised, although the standard of care has not yet been established. Several promising clinical trials for PDAC are ongoing. This review presents previous and ongoing trials of perioperative treatment for resectable and borderline resectable PDAC, focusing on the difference between Asian and Western countries.
Abstract
Resection is the only curative treatment for pancreatic ductal adenocarcinoma (PDAC). Although the outcome of technically resectable PDAC has improved with advances in surgery and adjuvant therapy, the 5-year survival rate remains low at 20% to 40%. More effective therapy is needed. Almost 15 years ago, the National Comprehensive Cancer Network guidelines proposed a resectability classification of PDAC based on preoperative imaging. Since then, treatment strategies for PDAC have been devised based on resectability. The standard of care for resectable PDAC is adjuvant chemotherapy after R0 resection, as shown by the results of pivotal clinical trials. With regard to neoadjuvant treatment, several recent clinical trials comparing neoadjuvant treatment with upfront resection have been conducted on resectable PDAC and borderline resectable PDAC, and the benefits and efficacy of neoadjuvant treatment for pancreatic cancer has become clearer. The significance of neoadjuvant treatment for resectable PDAC remains controversial, but in borderline resectable PDAC the efficacy of neoadjuvant treatment has been further recognised, although the standard of care has not yet been established. Several promising clinical trials for PDAC are ongoing. This review presents previous and ongoing trials of perioperative treatment for resectable and borderline resectable PDAC, focusing on the difference between Asian and Western countries.
참고문헌 (101)
- Neoptolemos JP, "Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer : a randomised controlled trial", Lancet, 358, pp.1576~1585 (2001)
- Oettle H, "Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer : the CONKO-001randomized trial", JAMA, 310, pp.1473~1481 (2013)
- "NCCN guidelines: pancreatic adenocarcinoma" (2021)[URL]
- Japan Pancreas Society, "General rules for the study of pancreatic cancer" (2016), Kanehara & Co., Ltd
- Murakami Y, "National Comprehensive Cancer Network resectability status for pancreatic carcinoma predicts overall survival", World J Surg, 39, pp.2306~2314 (2015)
- Kubo H, "The association between neoadjuvant therapy and pathological outcomes in pancreatic cancer patients after resection : prognostic significance of microscopic venous invasion", Ann Surg Oncol, 29, pp.4992~5002 (2022)
- Russo S, "The role of neoadjuvant therapy in pancreatic cancer : a review", Future Oncol, 12, pp.669~685 (2016)
- Neoptolemos JP, "A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer", N Engl J Med, 350, pp.1200~1210 (2004)
- Oettle H, "Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer : a randomized controlled trial", JAMA, 297, pp.267~277 (2007)
- Ueno H, "A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer : Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer", Br J Cancer, 101, pp.908~915 (2009)
- Neoptolemos JP, "Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection : a randomized controlled trial", JAMA, 304, pp.1073~1081 (2010)
- Uesaka K, "Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer : a phase 3, open-label, randomised, non-inferiority trial(JASPAC 01)", Lancet, 388, pp.248~257 (2016)
- Neoptolemos JP, "Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer(ESPAC-4) : a multicentre, open-label, randomised, phase 3trial", Lancet, 389, pp.1011~1024 (2017)
- Conroy T, "FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic cancer", N Engl J Med, 379, pp.2395~2406 (2018)
- Tempero MA, "Phase III, international, multicenter, randomized, open-label trial of adjuvant nab-paclitaxel plus gemcitabine(nab-P", G)vs gemcitabine(G)alone for surgically resected pancreatic adenocarcinoma(APACT) : subgroup analyses, 2019, pp.30, v259~v260
- "Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04)" (2010)[URL]
- Hamada T, "Interstitial lung disease associated with gemcitabine : a Japanese retrospective cohort study", Respirology, 21, pp.338~343 (2016)
- Ioka T, "Safety and effectiveness of gemcitabine in 855 patients with pancreatic cancer under Japanese clinical practice based on post-marketing surveillance in Japan", Jpn J Clin Oncol, 43, pp.139~145 (2013)
- Müller S, "Hemolytic uremic syndrome following prolonged gemcitabine therapy : report of four cases from a single institution", Ann Hematol, 84, pp.110~114 (2005)
- Fung MC, "A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy", Cancer, 85, pp.2023~2032 (1999)
- Abrams RA, "Results of the NRG oncology", RTOG 0848 adjuvant chemotherapy questionerlotinib+gemcitabine for resected cancer of the pancreatic head : a phase II randomized clinical trial, 2020, pp.43, 173~179
- Sinn M, "CONKO-005 : adjuvant chemotherapy with gemcitabine plus erlotinib versus gemcitabine alone in patients after R0 resection of pancreatic cancer : a multicenter randomized phase III trial", J Clin Oncol, 35, pp.3330~3337 (2017)
- van Groeningen CJ, "Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors", J Clin Oncol, 18, pp.2772~2779 (2000)
- Chuah B, "Comparison of the pharmacokinetics and pharmacodynamics of S-1 between Caucasian and East Asian patients", Cancer Sci, 102, pp.478~483 (2011)
- Ajani JA, "Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma", J Clin Oncol, 23, pp.6957~6965 (2005)
- Ajani JA, "Multicenter phase III comparison of cisplatin", S-1 with cisplatin, J Clin Oncol, pp.2010, 28[DOI]
- Smeenk HG, "Adjuvant 5-FUbased chemoradiotherapy for patients undergoing R-1", R-2resections for pancreatic cancer, 2005, pp.22, 321~328
- Hsu CC, "Adjuvant chemoradiation for pancreatic adenocarcinoma : the Johns Hopkins Hospital-Mayo Clinic collaborative study", Ann Surg Oncol, 17, pp.981~990 (2010)
- Merchant NB, "Adjuvant chemoradiation therapy for pancreatic adenocarcinoma : who really benefits?", J Am Coll Surg, 208, pp.829~841 (2009)
- Corsini MM, "Adjuvant radiotherapy and chemotherapy for pancreatic carcinoma : the Mayo Clinic experience(1975-2005)", J Clin Oncol, 26, pp.3511~3516 (2008)
- Gastrointestinal Tumor Study Group, "Further evidence of effective adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer", Cancer, 59, pp.2006~2010 (1987)
- The Gastrointestinal Tumor Study Group, "A multi-institutional comparative trial of radiation therapy alone and in combination with 5-fluorouracil for locally unresectable pancreatic carcinoma", Ann Surg, 189, pp.205~208 (1979)
- Yeo CJ, "Pancreaticoduodenectomy for pancreatic adenocarcinoma : postoperative adjuvant chemoradiation improves survival : a prospective, single-institution experience", Ann Surg, 225, pp.621~636 (1997)
- You DD, "Prognostic factors and adjuvant chemoradiation therapy after pancreaticoduodenectomy for pancreatic adenocarcinoma", J Gastrointest Surg, 13, pp.1699~1706 (2009)
- Yang R, "Survival effects of adjuvant chemoradiotherapy after resection for pancreatic carcinoma", Arch Surg, 145, pp.49~56 (2010)
- Van Laethem JL, "Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer : a randomized EORTC-40013-22012", FFCD-9203, J Clin Oncol, pp.2010, 28[DOI]
- Sainato A, "Adjuvant chemoradiotherapy(gemcitabine-based)in pancreatic adenocarcinoma : the Pisa University experience", Tumori, 103, pp.577~582 (2017)
- Abrams RA, "Failure to adhere to protocol specified radiation therapy guidelines was associated with decreased survival in RTOG 9704 : a phase III trial of adjuvant chemotherapy and chemoradiotherapy for patients with resected adenocarcinoma of the pancreas", Int J Radiat Oncol Biol Phys, 82, pp.809~816 (2012)
- Ozkok S, "Postoperative gemcitabine alone and concurrent with radiation therapy in locally advanced pancreatic carcinoma", Tumori, 96, pp.560~567 (2010)
- Herman JM, "Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer", Int J Radiat Oncol Biol Phys, 86, pp.678~685 (2013)
- Stocken DD, "Meta-analysis of randomised adjuvant therapy trials for pancreatic cancer", Br J Cancer, 92, pp.1372~1381 (2005)
- Japan Pancreas Society, "Clinical Practice Guidelines for Pancreatic Cancer 2019" (2019), Kanahara & Co, Ltd
- Bakkevold KE, "Adjuvant combination chemotherapy (AMF) following radical resection of carcinoma of the pancreas and papilla of Vater:results of a controlled, prospective, randomised multicentre study", Eur J Cancer, 29A, pp.698~703 (1993)
- Morak MJ, "Adjuvant intra-arterial chemotherapy and radiotherapy versus surgery alone in resectable pancreatic and periampullary cancer : a prospective randomized controlled trial", Ann Surg, 248, pp.1031~1041 (2008)
- Klinkenbijl JH, "Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region : phase III trial of the EORTC gastrointestinal tract cancer cooperative group", Ann Surg, 230, pp.776~784 (1999)
- Kalser MH, "Pancreatic cancer : adjuvant combined radiation and chemotherapy following curative resection", Arch Surg, 120, pp.899~903 (1985)
- Takadate T, "Staging laparoscopy is mandatory for the treatment of pancreatic cancer to avoid missing radiologically negative metastases", Surg Today, 51, pp.686~694 (2021)
- Jang JY, "Oncological benefits of neoadjuvant chemoradiation with gemcitabine versus upfront surgery in patients with borderline resectable pancreatic cancer : a prospective, randomized, open-label, multicenter phase 2", 3 trial, 2018, pp.268, 215~222
- Unno M, "Randomized phase II", III trial of neoadjuvant chemotherapy with gemcitabine and S-1 versus upfront surgery for resectable pancreatic cancer(Prep-02, J Clin Oncol, pp.2019, 37(4_suppl)[DOI]
- Motoi F, "Randomized phase II", III trial of neoadjuvant chemotherapy with gemcitabine and S-1 versus upfront surgery for resectable pancreatic cancer(Prep-02, Jpn J Clin Oncol, pp.2019, 49[DOI]
- Satoi S, "The effect of neoadjuvant chemotherapy with gemcitabine and S-1 for resectable pancreatic cancer(randomized phase II", III trial; Prep-02, J Clin Oncol, pp.2019, 37(15_suppl)[DOI]
- Versteijne E, "Preoperative chemoradiotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer : results of the Dutch Randomized Phase III PREOPANC Trial", J Clin Oncol, 38, pp.1763~1773 (2020)
- Versteijne E, "Neoadjuvant chemoradiotherapy versus upfront surgery for resectable and borderline resectable pancreatic cancer : long-term results of the Dutch Randomized PREOPANC Trial", J Clin Oncol, 40, pp.1220~1230 (2022)
- Takahashi S, "Neoadjuvant S-1with concurrent radiotherapy followed by surgery for borderline resectable pancreatic cancer : a phase II openlabel multicenter prospective trial(JASPAC05)", Ann Surg, 276, pp.e510~e517 (2022)
- Yamaguchi J, "Results of a phase II study on the use of neoadjuvant chemotherapy(FOLFIRINOX or GEM", nab-PTX)for borderline-resectable pancreatic cancer(NUPAT-01), 2022, pp.275, 1043~1049
- Katz MH, "Efficacy of preoperative mFOLFIRINOX vs mFOLFIRINOX plus hypofractionated radiotherapy for borderline resectable adenocarcinoma of the pancreas : the A021501 phase 2 randomized clinical trial", JAMA Oncol, 8, pp.1263~1270 (2022)
- Golcher H, "Neoadjuvant chemoradiation therapy with gemcitabine", cisplatin and surgery versus immediate surgery in resectable pancreatic cancer : results of the first prospective randomized phase II trial, 2015, pp.191, 7~16
- Casadei R, "Neoadjuvant chemoradiotherapy and surgery versus surgery alone in resectable pancreatic cancer : a single-center prospective, randomized, controlled trial which failed to achieve accrual targets", J Gastrointest Surg, 19, pp.1802~1812 (2015)
- Heinrich S, "Adjuvant gemcitabine versus NEOadjuvant gemcitabine", oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer : a randomized multicenter phase III study(NEOPAC Study), 2011, pp.11, 346~
- Tachezy M, "Sequential neoadjuvant chemoradiotherapy(CRT)followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma : NEOPA : a randomized multicenter phase III study(NCT01900327, DRKS00003893, ISRCTN82191749)", BMC Cancer, 14, pp.411~ (2014)
- Al-Batran SE, "Randomized multicenter phase II", III study with adjuvant gemcitabine versus neoadjuvant, J Clin Oncol, pp.2021, 39(3_suppl)[DOI]
- Hozaeel W, "Randomized multicenter phase II", III study with adjuvant gemcitabine versus neoadjuvant, J Clin Oncol, pp.2015, 33(15_suppl)[DOI]
- Ahmad SA, "Surgical outcome results from SWOG S1505 : a randomized clinical trial of mFOLFIRINOX versus gemcitabine", nab-paclitaxel for perioperative treatment of resectable pancreatic ductal adenocarcinoma, 2020, pp.272, 481~486
- Sohal D, "SWOG S1505 : results of perioperative chemotherapy(peri-op CTx)with mfolfirinox versus gemcitabine", nab-paclitaxel(Gem, J Clin Oncol, pp.2020, 38(15_suppl)[DOI]
- Kato H, "Clinical features and treatment outcome of borderline resectable pancreatic head", body cancer : a multi-institutional survey by the Japanese Society of Pancreatic Surgery, 2013, pp.20, 601~610
- Fujii T, "Inverse probability of treatment weighting analysis of upfront surgery versus neoadjuvant chemoradiotherapy followed by surgery for pancreatic adenocarcinoma with arterial abutment", Medicine(Baltimore), 94, pp.e1647~ (2015)
- Hirono S, "Treatment strategy for borderline resectable pancreatic cancer with radiographic artery involvement", Pancreas, 45, pp.1438~1446 (2016)
- Ielpo B, "A comparative study of neoadjuvant treatment with gemcitabine plus nab-paclitaxel versus surgery first for pancreatic adenocarcinoma", Surg Oncol, 26, pp.402~410 (2017)
- Murakami Y, "Survival impact of neoadjuvant gemcitabine plus S-1 chemotherapy for patients with borderline resectable pancreatic carcinoma with arterial contact", Cancer Chemother Pharmacol, 79, pp.37~47 (2017)
- Nagakawa Y, "Clinical impact of neoadjuvant chemotherapy and chemoradiotherapy in borderline resectable pancreatic cancer : analysis of 884 patients at facilities specializing in pancreatic surgery", Ann Surg Oncol, 26, pp.1629~1636 (2019)
- Inoue Y, "Neoadjuvant gemcitabine and nab-paclitaxel for borderline resectable pancreatic cancers : intention-to-treat analysis compared with upfront surgery", J Hepatobiliary Pancreat Sci, 28, pp.143~155 (2021)
- Michelakos T, "Predictors of resectability and survival in patients with borderline and locally advanced pancreatic cancer who underwent neoadjuvant treatment with FOLFIRINOX", Ann Surg, 269, pp.733~740 (2019)
- Labori KJ, "Neoadjuvant chemotherapy versus surgery first for resectable pancreatic cancer(Norwegian Pancreatic Cancer Trial-1(NorPACT-1)) : study protocol for a national multicentre randomized controlled trial", BMC Surg, 17, pp.94~ (2017)
- Schwarz L, "Resectable pancreatic adenocarcinoma neo-adjuvant FOLF(IRIN)OX-based chemotherapy : a multicenter, non-comparative, randomized, phase II trial(PANACHE01-PRODIGE48 Study)", BMC Cancer, 18, pp.762~ (2018)
- "Testing the use of the usual chemotherapy before and after surgery for removable pancreatic cancer. Identifier No. NCT04340141"[URL]
- "Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer (PREOPANC-3). Identifier No. NCT04927780"[URL]
- Janssen QP, "Total neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy and adjuvant gemcitabine for resectable and borderline resectable pancreatic cancer(PREOPANC-2Trial) : study protocol for a nationwide multicenter randomized controlled trial", BMC Cancer, 21, pp.300~ (2021)
- Grose DB, "PRIMUS-002: a multicentre, open-label, phase II study examining FOLFOX and nab-paclitaxel (FA) and nab-paclitaxel and gemcitabine (AG)as neoadjuvant therapy for (borderline) resectable pancreatic cancer (PC), focusing on biomarker and liquid biopsy development", J Clin Oncol, 37(15_suppl), pp.TPS4166~ (2019)
- "Phase I/II study of gemcitabine and S-1 (GS therapy)as neoadjuvant chemoradiationtherapy for borderline resectable pancreatic cancer (Prep-03/NS014-1)" (2014)[URL]
- Okada KI, "Effect of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival in patients with borderline resectable pancreatic cancer : a prospective multicenter phase II trial(NAC-GA Trial)", Oncology, 93, pp.343~346 (2017)
- "Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer (GABARNANCE Trial)" (2019)[URL]
- Sanford M, "S-1(TeysunoⓇ) : a review of its use in advanced gastric cancer in non-Asian populations", Drugs, 73, pp.845~855 (2013)
- Franck C, "Neoadjuvant treatment with cisplatin and S-1 in elderly patients with oesophagogastric adenocarcinoma and locoregional disease : two case reports and review of the literature", Mol Clin Oncol, 7, pp.1069~1072 (2017)
- Lenz HJ, "Extended safety and efficacy data on S-1 plus cisplatin in patients with untreated, advanced gastric carcinoma in a multicenter phase II study", Cancer, 109, pp.33~40 (2007)
- Schultheis B, "Results of a phase II trial of S-1 as first-line treatment of metastatic pancreatic cancer(CESAR-study group)", Invest New Drugs, 30, pp.1184~1192 (2012)
- Winther SB, "S-1(Teysuno)and gemcitabine in Caucasian patients with unresectable pancreatic adenocarcinoma", Cancer Chemother Pharmacol, 81, pp.573~578 (2018)
- Cui J, "Chinese Society of Clinical Oncology(CSCO) : clinical guidelines for the diagnosis and treatment of pancreatic cancer", J Natl Cancer Cent, 2, pp.205~215 (2022)
- Conroy T, "FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer", N Engl J Med, 364, pp.1817~1825 (2011)
- Von Hoff DD, "Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine", N Engl J Med, 369, pp.1691~1703 (2013)
- Teng MW, "Classifying cancers based on T-cell infiltration and PD-L1", Cancer Res, 75, pp.2139~2145 (2015)
- Gajiwala S, "Combination immunotherapy and radiation therapy strategies for pancreatic cancer-targeting multiple steps in the cancer immunity cycle", J Gastrointest Oncol, 9, pp.1014~1026 (2018)
- Bockhorn M, "Borderline resectable pancreatic cancer : a consensus statement by the International Study Group of Pancreatic Surgery(ISGPS)", Surgery, 155, pp.977~988 (2014)
- Tjensvoll K, "Circulating tumor cells in pancreatic cancer patients : methods of detection and clinical implications", Int J Cancer, 134, pp.1~8 (2014)
- Chen J, "A combination of circulating tumor cells and CA199 improves the diagnosis of pancreatic cancer", J Clin Lab Anal, 36, pp.e24341~ (2022)
- Isaji S, "International consensus on definition and criteria of borderline resectable pancreatic ductal adenocarcinoma 2017", Pancreatology, 18, pp.2~11 (2018)
- Macgregor-Das A, "Detection of circulating tumor DNA in patients with pancreatic cancer using digital next-generation sequencing", J Mol Diagn, 22, pp.748~756 (2020)
- Affolter KE, "Detection of circulating tumor DNA without a tumor-informed search using next-generation sequencing is a prognostic biomarker in pancreatic ductal adenocarcinoma", Neoplasia, 23, pp.859~869 (2021)
- Yamada S, "Evaluation and proposal of novel resectability criteria for pancreatic cancer established by the Japan Pancreas Society", Surgery, 162, pp.784~791 (2017)
- Fujii T, "Clinical benefits of neoadjuvant chemoradiotherapy for adenocarcinoma of the pancreatic head : an observational study using inverse probability of treatment weighting", J Gastroenterol, 52, pp.81~93 (2017)
- Yoshida K, "A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer", Oncotarget, 8, pp.111346~111355 (2017)
- Kondo N, "A phase II study of gemcitabine", nab-paclitaxel, Eur J Cancer, pp.2021, 159[DOI]
