Clinical Practice Guidelines for Pancreatic Cancer 2019 From the Japan Pancreas Society

Abstract

Objectives Clinical Practice Guidelines for Pancreatic Cancer were first published in 2006 by the Japan Pancreas Society, and they were revised in 2009, 2013, and 2016. In July 2019, the Clinical Practice Guidelines for Pancreatic Cancer 2019 were newly revised in Japanese. Methods For this version, we developed the new guidelines according to the Minds Manual for Guideline Development 2017, which includes the concepts of GRADE (Grading Recommendations Assessment, Development, and Evaluation), to enable a better understanding of the current guidelines. Results The guidelines show algorithms for the diagnosis, treatment, and chemotherapy of pancreatic cancer and address 7 subjects: diagnosis, surgical therapy, adjuvant therapy, radiation therapy, chemotherapy, stent therapy, and supportive and palliative medicine. They include 56 clinical questions and 84 statements. There are statements corresponding to clinical questions, evidence levels, recommendation strengths, and agreement rates. Conclusions These guidelines represent the most standard clinical and practical management guidelines at this time in Japan. This is the English synopsis of the Clinical Practice Guidelines for Pancreatic Cancer 2019 in Japanese and is an attempt to disseminate the Japanese guidelines worldwide for introducing the Japanese approach for clinical management of pancreatic cancer.

Recent advances in chemotherapy for pancreatic cancer: evidence from Japan and recommendations in guidelines

“…Prior to these two studies mentioned above, no phase III study had demonstrated the benefits of neoadjuvant therapy for patients with resectable pancreatic cancer [7,8]; therefore, Japanese guidelines had not recommended neoadjuvant therapy for patients with pancreatic cancer until recently [9,10]; the same is true of guidelines in other countries overseas, which still do not recommend neoadjuvant therapy as standard treatment for patients with resectable pancreatic cancer with exceptions for those with high-risk factors [11][12][13][14]. Based on the results of the Prep-02/JSAP-05 study, however, the latest Japanese guidelines (Clinical Practice Guidelines for Pancreatic Cancer 2019) recommend gemcitabine plus S-1 combination therapy (GS therapy) as a standard neoadjuvant therapy for patients with resectable pancreatic cancer [15,16]. Since the Prep-02/JSAP-05 study was conducted only in Japan and use of S-1 is not as feasible in Western populations, as mentioned later, until now, GS therapy is recognized as a standard therapy only in Japan and China [13,17,18].…”

“…For patients with borderline resectable pancreatic cancer, Japanese guidelines recommend neoadjuvant therapy, in general, but have refrained from recommending any specific regimens [15,16]. Although guidelines in many other countries also recommend neoadjuvant therapy for borderline resectable pancreatic cancer, no consensus on any standard regimens has been established in any country until date [11][12][13][14].…”

“…Since no clinical study has been conducted to compare S-1 alone with the combined gemcitabine plus capecitabine regimen and modified FOLFIRINOX regimen, and it is still not clear as to which of the three above regimes might be the optimal one for adjuvant therapy. In Japan and China, S-1 is frequently used as the standard treatment agent [13,15,16] because of its higher efficacy as compared to gemcitabine monotherapy (as suggested by the superior HR of 0.57) [32], its milder adverse effects in Asians, and its availability as an oral formulation, which can be expected to reduce the burden on the patients. On the other hand, S-1 has not been tested as adjuvant therapy in Western populations [12,17].…”

“…Locally advanced pancreatic cancer, defined as locally invasive pancreatic cancer without obvious distant metastases, is difficult to resect because of invasion of the major arteries. Both in Japan and other countries, guidelines recommend chemoradiotherapy or chemotherapy alone for locally advanced pancreatic cancer, although there is no consensus yet on which of the two might be preferable [11][12][13][14][15][16].…”

“…Induction chemotherapy is not a common practice in Japan. Therefore, Japanese guidelines do not recommend induction chemotherapy for patients with locally advanced pancreatic cancer [15,16].…”