Real‑world treatment outcomes among patients with metastatic pancreatic cancer in Japan: The Tokushukai real‑world data project

1. Siegel RL, Miller KD, Fuchs HE and Jemal A: Cancer statistics,

2021. CA Cancer J Clin 71: 7‑33, 2021.

2. Cancer statistics. https://ganjoho.jp/reg_stat/statistics/data/dl/

en.html. Accessed June 30 2022 Cancer Information Service,

Natl Cancer Cntr, Japan. Vital Statistics of Japan Ministry of

Health, Labour and Welfare.

3. Ben Q, Xu M, Ning X, Liu J, Hong S, Huang W, Zhang H and Li Z:

Diabetes mellitus and risk of pancreatic cancer: A meta‑analysis

of cohort studies. Eur J Cancer 47: 1928‑1937, 2011.

4. Stolzenberg‑Solomon RZ, Adams K, Leitzmann M, Schairer C,

Michaud DS, Hollenbeck A, Schatzkin A and Silverman DT:

Adiposity, physical activity, and pancreatic cancer in the

National Institutes of Health‑AARP Diet and Health Cohort. Am

J Epidemiol 167: 586‑597, 2008.

5. Aune D, Greenwood DC, Chan DS, Vieira R, Vieira AR,

Navarro Rosenblatt DA, Cade JE, Burley VJ and Norat T: Body

mass index, abdominal fatness and pancreatic cancer risk: A

systematic review and non‑linear dose‑response meta‑analysis of

prospective studies. Ann Oncol 23: 843‑852, 2012.

6. Matsuo K, Ito H, Wakai K, Nagata C, Mizoue T, Tanaka K, Tsuji I,

Tamakoshi A, Sasazuki S, Inoue M, et al: Cigarette smoking and

pancreas cancer risk: An evaluation based on a systematic review

of epidemiologic evidence in the Japanese population. Jpn J Clin

Oncol 41: 1292‑1302, 2011.

7. Tramacere I, Scotti L, Jenab M, Bagnardi V, Bellocco R, Rota M,

Corrao G, Bravi F, Boffetta P and La Vecchia C: Alcohol drinking

and pancreatic cancer risk: A meta‑analysis of the dose‑risk rela‑

tion. Int J Cancer 126: 1474‑1486, 2010.

8. Raimondi S, Lowenfels AB, Morselli‑Labate AM, Maisonneuve P

and Pezzilli R: Pancreatic cancer in chronic pancreatitis;

aetiology, incidence, and early detection. Best Pract Res Clin

Gastroenterol 24: 349‑358, 2010.

9. Bur r is HA III, Moore MJ, Andersen J, Green M R,

Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK,

Storniolo AM, Tarassoff P, 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 15: 2403‑2413, 1997.

10. Ueno H, Okusaka T, Ikeda M, Takezako Y and Morizane C: An

early phase II study of S‑1 in patients with metastatic pancreatic

cancer. Oncology 68: 171‑178, 2005.

14

SHIMOYAMA et al: METASTATIC PANCREATIC CANCER OUTCOMES IN JAPAN

11. Okusaka T, Funakoshi A, Furuse J, Boku N, Yamao K, Ohkawa S

and Saito H: A late phase II study of S‑1 for metastatic pancreatic

cancer. Cancer Chemother Pharmacol 61: 615‑621, 2008.

12. Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S,

Au HJ, Murawa P, Walde D, Wolff RA, 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 25: 1960‑1966, 2007.

13. Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R,

Bécouarn Y, Adenis A, Raoul JL, Gourgou‑Bourgade S,

de la Fouchardière C, et al: Folfirinox versus gemcitabine for

metastatic pancreatic cancer. N Engl J Med 364: 1817‑1825, 2011.

14. Okusaka T, Ikeda M, Fukutomi A, Ioka T, Furuse J, Ohkawa S,

Isayama H and Boku N: Phase II study of FOLFIRINOX for

chemotherapy‑naïve Japanese patients with metastatic pancreatic

cancer. Cancer Sci 105: 1321‑1326, 2014.

15. Ozaka M, Ishii H, Sato T, Ueno M, Ikeda M, Uesugi K, Sata N,

Miyashita K, Mizuno N, Tsuji K, et al: A phase II study of modi‑

fied folfirinox for chemotherapy‑naïve patients with metastatic

pancreatic cancer. Cancer Chemother Pharmacol 81: 1017‑1023,

2018.

16. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J,

Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, et al:

Increased survival in pancreatic cancer with nab‑paclitaxel plus

gemcitabine. N Engl J Med 369: 1691‑1703, 2013.

17. Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N,

Fukutomi A, Sugimori K, Baba H, Yamao K, et al: Randomized

phase III study of gemcitabine plus S‑1, S‑1 alone, or gemcitabine

alone in patients with locally advanced and metastatic pancre‑

atic cancer in Japan and Taiwan: GEST study. J Clin Oncol 31:

1640‑1648, 2013.

18. National Comprehensive Cancer Network (NCCN): NCCN clin‑

ical practice guidelines in oncology pancreatic adenocarcinoma.

Version 1.2022. https://www.nccn.org/guidelines/category_1.

Accessed June 30, 2022.

19. Okusaka T, Nakamura M, Yoshida M, Kitano M, Uesaka K, Ito Y,

Furuse J, Hanada K and Okazaki K; Committee for Revision of

Clinical Guidelines for Pancreatic Cancer of the Japan Pancreas

Society: Clinical practice guidelines for pancreatic cancer 2019

from the Japan Pancreas Society: A synopsis. Pancreas 49:

326‑335, 2020.

20. Wang‑Gillam A, Hubner RA, Siveke JT, Von Hoff DD,

Belanger B, de Jong FA, Mirakhur B and Chen LT: NAPOLI‑1

phase 3 study of liposomal irinotecan in metastatic pancreatic

cancer: Final overall survival analysis and characteristics of

long‑term survivors. Eur J Cancer 108: 78‑87, 2019.

21. Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T,

Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, et al:

Maintenance olaparib for germline BRCA‑mutated metastatic

pancreatic cancer. N Engl J Med 381: 317‑327, 2019.

22. Averitt AJ, Weng C, Ryan P and Perotte A: Translating evidence

into practice: Eligibility criteria fail to eliminate clinically

significant differences between real‑world and study populations.

NPJ Digit Med 3: 67, 2020.

23. Hilgers RD, König F, Molenberghs G and Senn S: Design and

analysis of clinical trials for small rare disease populations.

J Rare Dis Res Treat 1: 53‑60, 2016.

24. Latimer NR: Survival analysis for economic evaluations

alongside clinical trials‑extrapolation with patient‑level data:

Inconsistencies, limitations, and a practical guide. Med Decis

Making 33: 743‑754, 2013.

25. Corrigan‑Curay J, Sacks L and Woodcock J: Real‑world evidence

and real‑world data for evaluating drug safety and effectiveness.

JAMA 320: 867‑868, 2018.

26. Katkade VB, Sanders KN and Zou KH: Real world data: An

opportunity to supplement existing evidence for the use of

long‑established medicines in health care decision making.

J Multidiscip Healthc 11: 295‑304, 2018.

27. Makady A, de Boer A, Hillege H, Klungel O and Goettsch W;

(on behalf of GetReal Work Package 1): What is real‑world data?

A review of definitions based on literature and stakeholder inter‑

views. Value Health 20: 858‑865, 2017.

28. Shimoyama R, Imamura Y, Uryu K, Mase T, Fujimura Y,

Hayashi M, Ohtaki M, Ohtani K, Shinozaki N and Minami H:

Real‑world outcomes of systemic therapy in Japanese patients

with cancer (Tokushukai REAl‑world Data project: TREAD):

Study protocol for a nationwide cohort study. Healthcare

(Basel) 10: 2146, 2022.

29. National Cancer Registry (Ministry of Health, Labour and

Welfare), tabulated by Cancer Information Service, National

Cancer Center, Japan. https://ganjoho.jp/med_pro/cancer_

control/can_reg/index.html. Accessed June 30, 2022.

30. Haj Mohammad N, Bernards N, Besselink MG, Busch OR,

Wilmink JW, Creemers GJ, De Hingh IH, Lemmens VE and

van Laarhoven HW: Volume matters in the systemic treatment

of metastatic pancreatic cancer: A population‑based study in the

Netherlands. J Cancer Res Clin Oncol 142: 1353‑1360, 2016.

31. Terashima T, Yamashita T, Sakai A, Ohta H, Hinoue Y, Toya D,

Kawai H, Yonejima M, Urabe T, Noda Y, et al: Treatment

patterns and outcomes of unresectable pancreatic cancer patients

in real‑life practice: A region‑wide analysis. Jpn J Clin Oncol 48:

966‑973, 2018.

32. Sasaki T, Kanata R, Yamada I, Matsuyama M, Ozaka M and

Sasahira N: Improvement of treatment outcomes for metastatic

pancreatic cancer: A real‑world data analysis. In Vivo 33:

271‑276, 2019.

33. Javed MA, Beyer G, Le N, Vinci A, Wong H, Palmer D,

Morgan RD, Lamarca A, Hubner RA, Valle JW, et al: Impact

of intensified chemotherapy in metastatic pancreatic ductal

adenocarcinoma (PDAC) in clinical routine in Europe.

Pancreatology 19: 97‑104, 2019.

34. Cho IR, Kang H, Jo JH, Lee HS, Chung MJ, Park JY,

Park SW, Song SY, An C, Park MS and Bang S: Folfirinox vs

gemcitabine/nab‑paclitaxel for treatment of metastatic pancre‑

atic cancer: Single‑center cohort study. World J Gastrointest

Oncol 12: 182‑194, 2020.

35. Chan KKW, Guo H, Cheng S, Beca JM, Redmond‑Misner R,

Isaranuwatchai W, Qiao L, Earle C, Berry SR, Biagi JJ, et al:

Real‑world outcomes of FOLFIRINOX vs gemcitabine and

nab‑paclitaxel in advanced pancreatic cancer: A popula‑

tion‑based propensity score‑weighted analysis. Cancer Med 9:

160‑169, 2020.

36. Franco F, Camara JC, Martín‑Valadés JI, López‑Alfonso A,

Marrupe D, Gutiérrez‑Abad D, Martínez‑Amores B, León A,

Juez I, Pérez M, et al: Clinical outcomes of folfirinox and

gemcitabine‑nab paclitaxel for metastatic pancreatic cancer in

the real world setting. Clin Transl Oncol 23: 812‑819, 2021.

37. Pijnappel EN, Dijksterhuis WPM, van der Geest LG,

de Vos‑Geelen J, de Groot JWB, Homs MYV, Creemers GJ,

Mohammad NH, Besselink MG, van Laarhoven HWM, et al:

First‑ and second‑line palliative systemic treatment outcomes in

a real‑world metastatic pancreatic cancer cohort. J Natl Compr

Canc Netw 20: 443‑450.e3, 2021.

38. Mizusawa J, Ohba A, Ozaka M, Katayama H, Okusaka T,

Kobayashi S, Ikeda M, Terashima T, Sasahira N, Okano N, et al:

Protocol of a randomized phase II/III study of gemcitabine

plus nab‑paclitaxel combination therapy versus modified

FOLFIRINOX versus S‑IROX for metastatic or recurrent pancre‑

atic cancer: JCOG1611 (GENERATE). Jpn J Clin Oncol 53:

80‑84, 2023.

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