Clinical Practice Guidelines for Pancreatic Cancer 2022 from the Japan Pancreas Society: a synopsis

Abstract

Objectives: Clinical Practice Guidelines for Pancreatic Cancer was first published in 2006 by the Japan Pancreas Society, and revised in 2009, 2013, 2016, and 2019. In July 2022, Clinical Practice Guidelines for Pancreatic Cancer was newly revised in Japanese.

Methods: For this revision, we developed an entirely new guideline according to the Minds Manual for Guideline Development 2020, which includes the concepts of GRADE-Grading Recommendations Assessment, Development, and Evaluation, to enable a better understanding of the current guidelines. Patients and the public were actively involved in both the development and implementation of the guideline.

Results: The guideline includes algorithms for diagnosis, treatment, chemotherapy, and precision medicine of pancreatic cancer, and addresses 7 subjects: diagnosis, surgical therapy, adjuvant therapy, radiation therapy, chemotherapy, stent therapy, and supportive & palliative medical care. It includes 73 clinical questions and 112 statements. The statements correspond to the clinical questions, evidence levels, recommendation strengths, and agreement rates.

Conclusions: This guideline represents the most standard clinical and practical management guideline available until date in Japan. This is the English synopsis of the Clinical Practice Guidelines for Pancreatic Cancer 2022 in Japanese, and is an attempt to disseminate the Japanese guideline worldwide to introduce the Japanese approach to the clinical management of pancreatic cancer.

Keywords: Clinical guidelines; GRADE system; Japan Pancreas Society; Minds; Pancreatic cancer.

Fig. 1

Organizational structure for patient and public involvement in the development of the pancreatic cancer guideline

Fig. 2

Algorithm for the diagnosis of pancreatic cancer. ERCP: endoscopic retrograde cholangiopancreatography; EUS: endoscopic ultrasonography; MRI: magnetic resonance imaging; MRCP: magnetic resonance cholangiopancreatography; US: ultrasonography; ^*1Findings during health checkups, comprehensive medical examinations including ultrasonography, screening, and follow-up for other diseases. ^*2Note that the interpretations depend on proficiency of the attending technician and there is a limit to examining the entire pancreas. If other valuable diagnostic imagings are performed, it may be skipped. ^*3It is desirable for EUS to be performed at an institution where a high skill level for EUS is available. ^*4The diagnosis must be established, as much as possible, by histopathology. ^*5Dynamic CT, dynamic MRI, EUS, PET, and/or laparoscopic examination should be performed as needed

Fig. 3

Algorithm for the treatment of pancreatic cancer. Cancer stage classification and classification of the resectability are based on the General Rules for the Study of Pancreatic Cancer, Seventh Edition, Revised and Enlarged Version, the Japan Pancreas Society [12]. *¹Supportive care for pain, digestion and absorption disorders, pancreatic diabetes, and anxiety are required even from the early stages after diagnosis in patients with pancreatic cancer. For further details, please refer to the guidelines or the HP of the Japanese Society for Palliative Medicine (http://www.jspm.ne.jp/guidelines/index.html). *²Please refer to the algorithm for precision medicine. *³Stent therapy, bypass therapy, radiotherapy, supportive & palliative medicine, and/or surgical therapy are recommended according to individual patients’ conditions.

Fig. 4

Algorithm for chemotherapy of pancreatic cancer. GEM: gemcitabine; nab-PTX: nab-paclitaxel; FF: fluorouracil + calcium folinate; MSI-H: microsatellite instability-high; TMB-H: tumor mutational burden-high

Fig. 5

Algorithm for precision medicine of pancreatic cancer. ^*1Please refer to D4, ^*2 Genetic counseling is recommended. ^*3Surveillance to identify hereditary cancer is recommended for blood relatives of patients with pancreatic cancer, Surveillance to identify cancer(s) other than pancreatic cancer is proposed for patients with pancreatic cancer, ^*4Companion diagnostics (BRACAnalysis®), ^*5This testing before systemic chemotherapy is covered by health insurance in Japan, ^*6This testing is covered by health insurance in Japan after standard chemotherapy, ^*7Genetic counseling is recommended for patients who test positive for a pathogenic germline variant or somatic mutation suspected pathogenic germline variant, ^*8Standard chemotherapy is recommended independently of genomic findings, ^*9Maintenance therapy with olaparib is recommended for patients whose disease has not progressed for a certain period of time on a platinum-containing chemotherapy regimen, ^*10Cancer gene panel testing using blood samples is covered by health insurance in Japan if tumor tissue testing is not feasible or fails, ^*11 ‘POSITIVE FOR A DELETERIOUS MUTATION’ and ‘GENETIC VARIANT, SUSPECTED DELETERIOUS’ according to BRACAnalysis®