Evaluation of response using FDG-PET/CT and diffusion weighted MRI after radiochemotherapy of pancreatic cancer: a non-randomized, monocentric phase II clinical trial—PaCa-DD-041 (Eudra-CT 2009-011968-11)

• Published in: Strahlentherapie und Onkologie Vol. 197; no. 1; pp. 19 - 26
• Main Authors: Zimmermann, Carolin, Distler, Marius, Jentsch, Christina, Blum, Sophia, Folprecht, Gunnar, Zöphel, Klaus, Polster, Heike, Troost, Esther G. C., Abolmaali, Nasreddin, Weitz, Jürgen, Baumann, Michael, Saeger, Hans-Detlev, Grützmann, Robert
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.01.2021; Springer Nature B.V
• Subjects: Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer; Cancer therapies; Carcinoma, Pancreatic Ductal - diagnostic imaging; Carcinoma, Pancreatic Ductal - therapy; Chemoradiotherapy; Chemotherapy; Chemotherapy, Adjuvant; Clinical trials; Computed tomography; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Diffusion; Diffusion coefficient; Diffusion Magnetic Resonance Imaging; Evaluation; Female; Fluorine Radioisotopes; Fluorodeoxyglucose F18; Health services; Humans; Imaging techniques; Kaplan-Meier Estimate; Magnetic resonance imaging; Male; Medical imaging; Medicine; Medicine & Public Health; Middle Aged; Neoadjuvant Therapy; Oncology; Original; Original Article; Oxaliplatin - administration & dosage; Palliative Care; Pancreatectomy; Pancreatic cancer; Pancreatic Neoplasms - diagnostic imaging; Pancreatic Neoplasms - therapy; Positron emission; Positron Emission Tomography Computed Tomography; Radiopharmaceuticals; Radiotherapy; Surgery; Survival; Tomography; Tumors; PDAC; Neoadjuvant radio-/chemotherapy; Surgery; Imaging; Downstaging; Pancreas cancer; Pancreatic adenocarcinoma
• ISSN: 0179-7158; 1439-099X
• DOI: 10.1007/s00066-020-01654-4

Background Pancreatic cancer is a devastating disease with a 5-year survival rate of 20–25%. As approximately only 20% of patients diagnosed with pancreatic cancer are initially staged as resectable, it is necessary to evaluate new therapeutic approaches. Hence, neoadjuvant (radio)chemotherapy is a promising therapeutic option, especially in patients with a borderline resectable tumor. The aim of this non-randomized, monocentric, prospective, phase II clinical study was to assess the prognostic value of functional imaging techniques, i.e., [ 18 F]2-fluoro-2-deoxy- d -glucose positron emission tomography/computed tomography (FDG-PET/CT) and diffusion weighted magnetic resonance imaging (DW-MRI), prior to and during neoadjuvant radiochemotherapy. Methods Patients with histologically proven resectable, borderline resectable or unresectable non-metastatic pancreatic adenocarcinoma received induction chemotherapy followed by neoadjuvant radiochemotherapy. Patients underwent FDG-PET/CT and DW-MRI including T1- and T2-weighted sequences prior to and after neoadjuvant chemotherapy as well as following induction radiochemotherapy. The primary endpoint was the evaluation of the response as quantified by the standardized uptake value (SUV) measured with FDG-PET. Response to treatment was evaluated by FDG-PET and DW-MRI during and after the neoadjuvant course. Morphologic staging was performed using contrast-enhanced CT and contrast-enhanced MRI to decide inclusion of patients and resectability after neoadjuvant therapy. In those patients undergoing subsequent surgery, imaging findings were correlated with those of the pathologic resection specimen. Results A total of 25 patients were enrolled in the study. The response rate measured by FDG-PET was 85% with a statistically significant decrease of the maximal SUV (SUV max ) during therapy ( p  < 0.001). Using the mean apparent diffusion coefficient (ADC), response was not detectable with DW-MRI. After neoadjuvant treatment 16 patients underwent surgery. In 12 (48%) patients tumor resection could be performed. The median overall survival of all patients was 25 months (range: 7–38 months). Conclusion Based on these limited patient numbers, it was possible to show that this trial design is feasible and that the neoadjuvant therapy regime was well tolerated. FDG-PET/CT may be a reliable method to evaluate response to the combined therapy. In contrast, when evaluating the response using mean ADC, DW-MRI did not show conclusive results.