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Pancreatic Neoplasms: HELP
Articles by Paolo Passoni
Based on 15 articles published since 2010
(Why 15 articles?)
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Between 2010 and 2020, P. Passoni wrote the following 15 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Clinical Trial A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. 2018

Reni, Michele / Zanon, Silvia / Balzano, Gianpaolo / Passoni, Paolo / Pircher, Chiara / Chiaravalli, Marta / Fugazza, Clara / Ceraulo, Domenica / Nicoletti, Roberto / Arcidiacono, Paolo Giorgio / Macchini, Marina / Peretti, Umberto / Castoldi, Renato / Doglioni, Claudio / Falconi, Massimo / Partelli, Stefano / Gianni, Luca. ·Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. Electronic address: reni.michele@hsr.it. · Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Department of Radiotherapy, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Department of Radiology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Pancreato-Biliary Endoscopy and Endosonography Division, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Pathology Unit, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy; Università Vita e Salute, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy; Università Vita e Salute, Milan, Italy. ·Eur J Cancer · Pubmed #30149366.

ABSTRACT: BACKGROUND: The current trial assessed whether the addition of cisplatin and capecitabine to the nab-paclitaxel-gemcitabine backbone is feasible and active against borderline and locally advanced pancreatic adenocarcinoma (PDAC). METHOD: Fifty-four chemo-naive patients, aged between 18 and 75 years, with a pathological diagnosis of locally advanced or borderline resectable PDAC were randomised to receive either nab-paclitaxel, gemcitabine, cisplatin and oral capecitabine (PAXG; arm A; N = 26) or nab-paclitaxel followed by gemcitabine (AG; arm B; N = 28). The primary end-point was the tumour resection rate. If at least four such resections were performed, the treatment was considered as active. The secondary end-points were progression-free survival (PFS), overall survival (OS), Response Evaluation Criteria in Solid Tumours response rate, Hartman's pathologic response, carbohydrate antigen 19.9 response rate and toxicity. RESULTS: Eight patients (31%) in the PAXG arm and nine (32%) in the AG arm underwent resection. PFS at 1-year was 58% in arm A and 39% in arm B. OS at 18-month was 69% in arm A and 54% in arm B. CONCLUSIONS: In this phase II study, the addition of cisplatin and capecitabine to the AG backbone was feasible and yielded promising results in terms of disease control without detrimental impact on tolerability. The approach warrants further investigation in a phase III study. TRIAL REGISTRATION: NCT01730222.

2 Clinical Trial Phase 1B trial of Nab-paclitaxel plus gemcitabine, capecitabine, and cisplatin (PAXG regimen) in patients with unresectable or borderline resectable pancreatic adenocarcinoma. 2016

Reni, Michele / Balzano, Gianpaolo / Zanon, Silvia / Passoni, Paolo / Nicoletti, Roberto / Arcidiacono, Paolo Giorgio / Pepe, Gino / Doglioni, Claudio / Fugazza, Clara / Ceraulo, Domenica / Falconi, Massimo / Gianni, Luca. ·Department of Medical Oncology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Surgery, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Radiotherapy, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Radiology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Gastroenterology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Nuclear Medicine Unit, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Pathology Unit, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. ·Br J Cancer · Pubmed #27404453.

ABSTRACT: BACKGROUND: Nab-paclitaxel-gemcitabine combination significantly improved overall survival over gemcitabine in metastatic pancreatic adenocarcinoma. A phase 1b trial was performed (ClinicalTrials.gov number, NCT01730222) to determine the recommended phase 2 dose (RP2D) of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine at fixed dose (800, 30, and 1250 mg m(-2) every 2 weeks, respectively; PAXG regimen). METHODS: Nab-paclitaxel doses were escalated from 100 (level one) to 125 (level two) and 150 mg m(-2) (level three) every 2 weeks in cohorts of 3-6 patients with pathologically confirmed unresectable or borderline resectable pancreatic adenocarcinoma. RESULTS: Between Dec 2012 and Apr 2014, 24 patients were enroled (3 at level one, 5 at level two, 16 at level three) and received 117 cycles of PAXG. No dose-limiting toxicity occurred and level three was the RP2D. At this dose, nab-paclitaxel dose-intensity was 91%. Worse per patient grade 3/4 toxicity were neutropenia 25/31%; fatigue 19%; anaemia and hand-foot syndrome 12%, nausea 6%, and febrile neutropenia 6%. A partial response (PR) was observed in 16 (67%) and stable disease (SD) in 8 patients (33%). Among 21 patients with a baseline positive positron emission tomography (PET) scan, a complete metabolic response was observed in 9 (43%), PR in 10 (48%), SD in 2. CA19-9 decreased by ⩾49% in all the 19 patients with elevated basal value. Six patients were resected after chemotherapy. Progression-free survival at 6 months (PFS-6) was 96%. CONCLUSIONS: The RP2D of nab-paclitaxel in the PAXG regimen was 150 mg m(-2) every 2 weeks. The preliminary results are promising and warrant further exploration.

3 Clinical Trial Hypofractionated image-guided IMRT in advanced pancreatic cancer with simultaneous integrated boost to infiltrated vessels concomitant with capecitabine: a phase I study. 2013

Passoni, Paolo / Reni, Michele / Cattaneo, Giovanni M / Slim, Najla / Cereda, Stefano / Balzano, Gianpaolo / Castoldi, Renato / Longobardi, Barbara / Bettinardi, Valentino / Gianolli, Luigi / Gusmini, Simone / Staudacher, Carlo / Calandrino, Riccardo / Di Muzio, Nadia. ·Department of Radiation Oncology, San Raffaele Scientific Institute, Milan, Italy. Electronic address: passoni.paolo@hsr.it. ·Int J Radiat Oncol Biol Phys · Pubmed #24267968.

ABSTRACT: PURPOSE: To determine the maximum tolerated radiation dose (MTD) of an integrated boost to the tumor subvolume infiltrating vessels, delivered simultaneously with radical dose to the whole tumor and concomitant capecitabine in patients with pretreated advanced pancreatic adenocarcinoma. METHODS AND MATERIALS: Patients with stage III or IV pancreatic adenocarcinoma without progressive disease after induction chemotherapy were eligible. Patients underwent simulated contrast-enhanced four-dimensional computed tomography and fluorodeoxyglucose-labeled positron emission tomography. Gross tumor volume 1 (GTV1), the tumor, and GTV2, the tumor subvolume 1 cm around the infiltrated vessels, were contoured. GTVs were fused to generate Internal Target Volume (ITV)1 and ITV2. Biological tumor volume (BTV) was fused with ITV1 to create the BTV+Internal Target Volume (ITV) 1. A margin of 5/5/7 mm (7 mm in cranium-caudal) was added to BTV+ITV1 and to ITV2 to create Planning Target Volume (PTV) 1 and PTV2, respectively. Radiation therapy was delivered with tomotherapy. PTV1 received a fixed dose of 44.25 Gy in 15 fractions, and PTV2 received a dose escalation from 48 to 58 Gy as simultaneous integrated boost (SIB) in consecutive groups of at least 3 patients. Concomitant chemotherapy was capecitabine, 1250 mg/m(2) daily. Dose-limiting toxicity (DLT) was defined as any treatment-related G3 nonhematological or G4 hematological toxicity occurring during the treatment or within 90 days from its completion. RESULTS: From June 2005 to February 2010, 25 patients were enrolled. The dose escalation on the SIB was stopped at 58 Gy without reaching the MTD. One patient in the 2(nd) dose level (50 Gy) had a DLT: G3 acute gastric ulcer. Three patients had G3 late adverse effects associated with gastric and/or duodenal mucosal damage. All patients received the planned dose of radiation. CONCLUSIONS: A dose of 44.25 Gy in 15 fractions to the whole tumor with an SIB of 58 Gy to small tumor subvolumes concomitant with capecitabine is feasible in chemotherapy-pretreated patients with advanced pancreatic cancer.

4 Clinical Trial Adjuvant PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) or gemcitabine followed by chemoradiation in pancreatic cancer: a randomized phase II trial. 2012

Reni, Michele / Balzano, Gianpaolo / Aprile, Giuseppe / Cereda, Stefano / Passoni, Paolo / Zerbi, Alessandro / Tronconi, Maria Chiara / Milandri, Carlo / Saletti, Piercarlo / Rognone, Alessia / Fugazza, Clara / Magli, Alessandro / Di Muzio, Nadia / Di Carlo, Valerio / Villa, Eugenio. ·Department of Oncology, S. Raffaele Scientific Institute, Milan, Italy. reni.michele@hsr.it ·Ann Surg Oncol · Pubmed #22237835.

ABSTRACT: BACKGROUND: Information from randomized trials on the role of combination chemotherapy in the adjuvant treatment of pancreatic adenocarcinoma is limited. This randomized phase II trial aimed to identify the most promising regimen warranting phase III evaluation. METHODS: Therapy-naive patients, age 18-75 years, Karnofsky Performance Status (KPS)>60, gross total resection of stage IB-III pancreatic adenocarcinoma, stratified for center and surgical margins, were randomly assigned to receive either gemcitabine 1 g/m2 weekly on days 1, 8, and 15 (arm A) or the PEFG regimen (cisplatin and epirubicin 40 mg/m2, day 1; gemcitabine 600 mg/m2, days 1, 8; 5-fluorouracil 200 mg/m2 daily, days 1-28) (arm B). Chemotherapy was administered every 4 weeks for 3 months and followed by irradiation concurrent to continuous infusion of 5-fluorouracil 250 mg/m2 daily. Primary endpoint was the probability of being disease-free at 1 year from surgery. Assuming P0=35% and P1=55%, α=.05 and β=.10, the study was to enroll 51 patients per arm. RESULTS: A total of 102 patients were randomized; 100 were eligible (arm A: 51; arm B: 49). Baseline characteristic (A/B) were: Median age was 61/60 years; 75% had KPS>80 75/76%; 36% grade 3 tumor 29/43%, 79% stage IIB/III 75/84%, 31% R1 resection 35/29%. Survival figures (A/B) were: Median disease-free survival was 11.7 and 15.2 months; 1-year disease-free survival 49.0% (95% confidence interval [95% CI] 35-63%) and 69.4% (95% CI 56-83%); median survival 24.8 and 28.9 months. Combination chemotherapy produced more hematological toxicity without relevant differences in nonhematological toxicities. CONCLUSIONS: The 4-drug regimen deserves further assessment in resectable pancreatic cancer.

5 Clinical Trial A randomized phase II trial of two different 4-drug combinations in advanced pancreatic adenocarcinoma: cisplatin, capecitabine, gemcitabine plus either epirubicin or docetaxel (PEXG or PDXG regimen). 2012

Reni, Michele / Cereda, Stefano / Rognone, Alessia / Belli, Carmen / Ghidini, Michele / Longoni, Simonetta / Fugazza, Clara / Rezzonico, Sara / Passoni, Paolo / Slim, Najla / Balzano, Giampaolo / Nicoletti, Roberto / Cappio, Stefano / Doglioni, Claudio / Villa, Eugenio. ·Department of Oncology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. reni.michele@hsr.it ·Cancer Chemother Pharmacol · Pubmed #21626049.

ABSTRACT: PURPOSE: PEFG regimen (P:cisplatin, E:epirubicin, F:5-fluorouracil, G:gemcitabine) significantly prolonged progression-free (PFS) and overall survival (OS) of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine. The current trial was aimed at assessing whether the replacement of E with docetaxel (D) may improve 6 months PFS (PFS6). METHODS: Chemo-naive patients with stage III or metastatic PA received P (30 mg/m(2) day 1 and 15), G (800 mg/m(2) day 1 and 15), and capecitabine (1,250 mg/m(2)/day days 1-28, without a break) and were randomized to receive either D at 25-30 mg/m(2) day 1 and 15 (arm A: PDXG regimen) or E at 30 mg/m(2) day 1 and 15 (arm B: PEXG regimen). Cycles were repeated every 28 days for a maximum of 6 months. The Fleming design was used to calculate the sample size on the probability of being PFS6. Assuming P0 = 40% and P1 = 60%, α = 0.05 and β = 0.10; the study was to enroll 52 patients per arm. RESULTS: Between July 2005 and September 2008, 105 patients were enrolled, stratified by stage and randomized. Patients' characteristics were (A/B) the following: median age 61/59, PS >70 92/88%, metastatic disease 66/65%. PFS6 was 58%, and median OS was 11 months in both arms. A partial response was observed in 60/37% of patients. Main per cycle G3-4 toxicity was the following: neutropenia 4/13%, thrombocytopenia 2/4%, anemia 4/4%, and fatigue 6/3%. CONCLUSIONS: The inclusion of D instead of E yielded more objective response and less G3-4 neutropenia but did not improve PFS and OS. The present trial confirms the relevant impact on outcome of advanced PA of 4-drug regimens.

6 Clinical Trial Planning design of locally advanced pancreatic carcinoma using 4DCT and IMRT/IGRT technologies. 2011

Sangalli, Giulia / Passoni, Paolo / Cattaneo, Giovanni M / Broggi, Sara / Bettinardi, Valentino / Reni, Michele / Slim, Najla / Muzio, Nadia Di / Calandrino, Riccardo. ·Medical Physics Department, San Raffaele Scientific Institute, Milan, Italy. ·Acta Oncol · Pubmed #20482224.

ABSTRACT: BACKGROUND AND PURPOSE: to study the impact of the 4DCT imaging technique on radiotherapy planning for pancreatic carcinoma. To evaluate the possibility of IMRT/IGRT to increase the dose to PTV subvolume. MATERIAL AND METHODS: contrast-enhanced 4DCT scans of 15 patients (PTs) with unresectable pancreatic cancer were acquired. A 4DCT based PTV (4D-PTV) was created by the convolution of contours and then expanded for geometric uncertainties; a standard PTV (STD-PTV) was derived from a single CTV plus conventional margins. Two 3D conformal treatment (3DCRT) plans and one Helical Tomotherapy (HT) plan were generated with a prescription of 60 Gy. Regarding the 3DCRT plans, the 4D-PTV was considered as the target volume for one, and the STD-PTV for the other; the HT plans were performed only for 4D-PTV. Twelve of 15 PTs were admitted to a Phase I hypofractionated study (15 fractions). The prescribed dose was 44.25 Gy to the 4D-PTV and the PTV subvolume around vascular involvement was boosted from 50 to 55 Gy; before treatment, daily patient position was corrected using MVCT. RESULTS: 4D-PTVs were smaller than STD-PTVs with a volume reduction equal to 37%. 3DCRT plans on 4D-PTV showed a significant sparing of most OARs, the use of IMRT allowed a further significant dose reduction. In the Phase I study the PTV subvolume received up to 55 Gy with modest increase in dose to OARs. CONCLUSIONS: the 4DCT procedure decreases the overlap between PTV and OARs. HT technique, compared with 3DCRT, allows efficient dose sparing in particular for the duodenum. The IMRT/IGRT approach allows a safe dose escalation to PTV subvolume.

7 Article Early variation of 18-fluorine-labelled fluorodeoxyglucose PET-derived parameters after chemoradiotherapy as predictors of survival in locally advanced pancreatic carcinoma patients. 2019

Incerti, Elena / Vanoli, Emilia G / Broggi, Sara / Gumina, Calogero / Passoni, Paolo / Slim, Najla / Fiorino, Claudio / Reni, Michele / Mapelli, Paola / Cattaneo, Mauro / Zanon, Silvia / Calandrino, Riccardo / Gianolli, Luigi / Di Muzio, Nadia / Picchio, Maria. ·Unit of Nuclear Medicine. · Unit of Medical Physics. · Unit of Radiotherapy. · Department of Oncology, IRCCS San Raffaele Scientific Institute. · Vita-Salute San Raffaele University, Milan, Italy. ·Nucl Med Commun · Pubmed #31365502.

ABSTRACT: OBJECTIVE: To investigate if early variation of PET-derived parameters after concomitant chemoradiotherapy (CRT) predicts overall survival (OS), local relapse free survival (LRFS), distant relapse free survival (DRFS) and progression free survival (PFS) in locally advanced pancreatic cancer (LAPC) patients. METHODS: Fifty-two LAPC patients (median age: 61 years; range: 35-85) with available FDG PET/CT before and after RT (2-6 months, median: 2) were enrolled from May 2005 to June 2015. The predictive value of the percentage variation of mean/maximum standard uptake value (ΔSUVmean/max), metabolic tumour volume (ΔMTV) and total lesion glycolysis (ΔTLG), estimated considering different uptake thresholds (40-50-60%), was investigated between pre- and post-RT PET. The percentage difference between gastrointestinal cancer-associated antigen (ΔGICA) levels measured at the time of PET was also considered. Log-rank test and Cox regression analysis were performed to assess the prognostic value of considered PET-derived parameters on survival outcomes. RESULTS: The median follow-up was 13 months (range: 4-130). At univariate analysis, ΔTLG50 showed borderline significance in predicting OS (P = 0.05) and was the most significant parameter correlated to LRFS and PFS (P = 0.001). Median LRFS was 4 and 33 months if ΔTLG50 was below or above 35% respectively (P = 0.0003); similarly, median PFS was 3 vs 6 months (P = 0.0009). No significant correlation was found between PET-derived parameters and DRFS, while the ΔGICA was the only borderline significant prognostic value for this endpoint (P = 0.05). CONCLUSION: PET-derived parameters predict survival in LAPC patients; in particular, ΔTLG50 is the strongest predictor. The combination of these biochemical and imaging biomarkers is promising in identifying patients at higher risk of earlier relapse.

8 Article Adjuvant chemoradiation in pancreatic cancer: impact of radiotherapy dose on survival. 2019

Morganti, Alessio G / Cellini, Francesco / Buwenge, Milly / Arcelli, Alessandra / Alfieri, Sergio / Calvo, Felipe A / Casadei, Riccardo / Cilla, Savino / Deodato, Francesco / Di Gioia, Giancarmine / Di Marco, Mariacristina / Fuccio, Lorenzo / Bertini, Federica / Guido, Alessandra / Herman, Joseph M / Macchia, Gabriella / Maidment, Bert W / Miller, Robert C / Minni, Francesco / Passoni, Paolo / Valentini, Chiara / Re, Alessia / Regine, William F / Reni, Michele / Falconi, Massimo / Valentini, Vincenzo / Mattiucci, Gian Carlo. ·Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, via Giuseppe Massarenti 9, 40138, Bologna, Italy. · UOC Radioterapia Oncologica, Dipartimento di Diagnostica per immagini, Radioterapia Oncologica ed Ematologia, Istituto di Radiologia, Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica Sacro Cuore, Roma, Italy. · Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, via Giuseppe Massarenti 9, 40138, Bologna, Italy. mbuwenge@gmail.com. · Istituto di Clinica Chirurgica, Fondazione Policlinico A. Gemelli IRCCS - Università Cattolica Sacro Cuore, Roma, Italy. · Department of Oncology, Hospital General Universitario Gregorio Marañón, Complutense University, Madrid, Spain. · Department of Medical and Surgical Sciences - DIMEC, University of Bologna, Bologna, Italy. · Unit of Medical Physics, Fondazione Giovanni Paolo II, Campobasso, Italy. · Radiotherapy Unit, Fondazione Giovanni Paolo II, Campobasso, Italy. · Department of Experimental, Diagnostic, and Specialty Medicine - DIMES, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. · Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. · Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA. · Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA. · IRCCS, Ospedale S. Raffaele, Milan, Italy. · Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. · Department of Radiation Oncology, University of Maryland Medical Center, Baltimore, MD, USA. · Pancreatic Surgery, Pancreas Translational & Clinical Research Center, San Raffaele Hospital, University "Vita e Salute", Milan, Italy. ·BMC Cancer · Pubmed #31185957.

ABSTRACT: BACKGROUND: To evaluate the impact of radiation dose on overall survival (OS) in patients treated with adjuvant chemoradiation (CRT) for pancreatic ductal adenocarcinoma (PDAC). METHODS: A multicenter retrospective analysis on 514 patients with PDAC (T1-4; N0-1; M0) treated with surgical resection with macroscopically negative margins (R0-1) followed by adjuvant CRT was performed. Patients were stratified into 4 groups based on radiotherapy doses (group 1: < 45 Gy, group 2: ≥ 45 and < 50 Gy, group 3: ≥ 50 and < 55 Gy, group 4: ≥ 55 Gy). Adjuvant chemotherapy was prescribed to 141 patients. Survival functions were plotted using the Kaplan-Meier method and compared through the log-rank test. RESULTS: Median follow-up was 35 months (range: 3-120 months). At univariate analysis, a worse OS was recorded in patients with higher preoperative Ca 19.9 levels (≥ 90 U/ml; p < 0.001), higher tumor grade (G3-4, p = 0.004), R1 resection (p = 0.004), higher pT stage (pT3-4, p = 0.002) and positive nodes (p < 0.001). Furthermore, patients receiving increasing doses of CRT showed a significantly improved OS. In groups 1, 2, 3, and 4, median OS was 13.0 months, 21.0 months, 22.0 months, and 28.0 months, respectively (p = 0.004). The significant impact of higher dose was confirmed by multivariate analysis. CONCLUSIONS: Increasing doses of CRT seems to favorably impact on OS in adjuvant setting. The conflicting results of randomized trials on adjuvant CRT in PDAC could be due to < 45 Gy dose generally used.

9 Article Quantifying the robustness of [ 2018

Belli, Maria Luisa / Mori, Martina / Broggi, Sara / Cattaneo, Giovanni Mauro / Bettinardi, Valentino / Dell'Oca, Italo / Fallanca, Federico / Passoni, Paolo / Vanoli, Emilia Giovanna / Calandrino, Riccardo / Di Muzio, Nadia / Picchio, Maria / Fiorino, Claudio. ·Medical Physics, San Raffaele Scientific Institute, Milano, Italy. · Nuclear Medicine, San Raffaele Scientific Institute, Milano, Italy. · Radiotherapy, San Raffaele Scientific Institute, Milano, Italy. · Medical Physics, San Raffaele Scientific Institute, Milano, Italy. Electronic address: fiorino.claudio@hsr.it. ·Phys Med · Pubmed #29866335.

ABSTRACT: PURPOSE: To investigate the robustness of PET radiomic features (RF) against tumour delineation uncertainty in two clinically relevant situations. METHODS: Twenty-five head-and-neck (HN) and 25 pancreatic cancer patients previously treated with RESULTS: A large disagreement between manual and SUV_max method was found for thresholds  ≥50%. Inter-observer variability showed median DICE values between 0.81 (HN-T) and 0.73 (pancreas). Volumes defined by PET_Edge were better consistent with the manual ones compared to SUV40%. Regarding RF, 19%/19%/47% of the features showed ICC < 0.80 between observers for HN-N/HN-T/pancreas, mostly in the Voxel-alignment matrix and in the intensity-size zone matrix families. RFs with ICC < 0.80 against manual delineation (taking the worst value) increased to 44%/36%/61% for PET_Edge and to 69%/53%/75% for SUV40%. CONCLUSIONS: About 80%/50% of 72 RF were consistent between observers for HN/pancreas patients. PET_edge was sufficiently robust against manual delineation while SUV40% showed a worse performance. This result suggests the possibility to replace manual with semi-automatic delineation of HN and pancreas tumours in studies including PET radiomic analyses.

10 Article Selecting patients for resection after primary chemotherapy for non-metastatic pancreatic adenocarcinoma. 2017

Reni, M / Zanon, S / Balzano, G / Nobile, S / Pircher, C C / Chiaravalli, M / Passoni, P / Arcidiacono, P G / Nicoletti, R / Crippa, S / Slim, N / Doglioni, C / Falconi, M / Gianni, L. ·Department of Oncology. Electronic address: reni.michele@hsr.it. · Department of Oncology. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center. · Department of Radiotherapy. · Department of Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute IRCCS. · Department of Radiology. · Department of Pathology, Pancreas Translational & Clinical Research Center, IRCCS Ospedale San Raffaele, Milan; Department of Vita-Salute San Raffaele University, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center; Department of Vita-Salute San Raffaele University, Milan, Italy. ·Ann Oncol · Pubmed #28945895.

ABSTRACT: Background: Patients with borderline (BL) or locally advanced (LA) pancreatic adenocarcinoma are usually treated with primary chemotherapy (CT), followed by resection when feasible. Scanty data are available about the criteria to candidate patients to resection after CT. Patients and methods: Between 2002 and 2016 overall 223 patients diagnosed with BL or LA pancreatic adenocarcinoma were primarily treated with Gemcitabine combination (4-drugs or nab-paclitaxel-gemcitabine) for 3-6 months followed by surgery and/or chemoradiation. Resection was carried out when radical resection could be predicted by imaging studies and intraoperative findings. The prognostic value of both pre-treatment factors and treatment response was retrospectively evaluated, searching for criteria that could improve the selection of patients for surgery. Results: Median survival (MS) for the whole population was 18.3 months. Surgical resection was carried out in 61 patients; MS in resected patients was significantly longer (30.0 months) as compared with 162 non-resected patients (16.5 months) (P < 0.00001). According to response criteria, 48% had a radiological partial response, 47% a stable disease and 5% a disease progression); CA19.9 response (reduction >50%) was obtained in 77.8% of patients. Among resected patients, neither pre-treatment factors, including BL/LA distinction, nor radiological response, were able to prognosticate survival differences. Survival of resected patients having no CA19.9 response was significantly lower as compared with responders (MS 15.0 versus 31.5 months, P = 0.04), and was similar to non-responders patients that did not undergo resection (MS 10.9 months, P= 0.25). Multivariate analysis carried out on the overall population, showed that Karnofsky performance status, T3-T4 status, resection and CA19.9 response were independent prognostic factors, while radiological response, BL/LA distinction and baseline CA19.9 had not significant influence on survival. Conclusions: CA19.9 response may allow a better selection of patients who will benefit from resection after primary CT for BL or LA pancreatic adenocarcinoma.

11 Article Dosimetric and clinical predictors of toxicity following combined chemotherapy and moderately hypofractionated rotational radiotherapy of locally advanced pancreatic adenocarcinoma. 2013

Cattaneo, Giovanni M / Passoni, Paolo / Longobardi, Barbara / Slim, Najla / Reni, Michele / Cereda, Stefano / di Muzio, Nadia / Calandrino, Riccardo. ·Medical Physics Department, San Raffaele Scientific Institute, Milan, Italy. cattaneo.mauro@hsr.it ·Radiother Oncol · Pubmed #23726116.

ABSTRACT: BACKGROUND AND PURPOSE: Hypofractionated radiotherapy (RT) of pancreatic adenocarcinoma is limited by the tolerance of adjacent normal tissues. A better understanding of the influence of dosimetric variables on the rate of toxicity after RT must be considered an important goal. METHODS AND MATERIALS: Sixty-one patients with histologically proven locally advanced disease (LAPD) were analyzed. The therapeutic strategy consisted of induction chemotherapy (ChT) followed by concurrent chemoradiotherapy (CRT). In 39 out of 61 patients the target volume was based on a four-dimensional CT (4D-CT) procedure. Delivered dose was 44.25Gy in 15 fractions to PTV2, which consisted of pancreatic tumor and regional lymph nodes considered radiologically involved; 23 out of 61 patients received a simultaneous integrated boost (SIB) to a tumor sub-volume infiltrating the great abdominal vessels (PTV1) with dose in the range of 48-58Gy. RT was delivered with Helical Tomotherapy. Dose-volume histograms (DVHs) of target volumes and organs at risk (OARs) were collected for analysis. The predictive value of clinical/dosimetric parameters was tested by univariate/multivariate analyses. RESULTS: The crude incidence of acute gastrointestinal (GI) grade 2 toxicity was 33%. The 12-month actuarial rate of "anatomical" (gastro-duodenal mucosa damage) toxicity was 13% (95% CI: 4-22%). On univariate analysis, several stomach and duodenum DVH endpoints are predictive of toxicity after moderately hypofractionated radiotherapy. Multivariate analysis confirmed that baseline performance status and the stomach V20[%] were strong independent predictors of acute GI grade ⩾2 toxicity. The high-dose region of duodenum DVH (V45[%]; V40[%]) was strongly correlated with grade ⩾2 "anatomical" toxicity; the best V40[%] and V45[%] cut-off values were 16% and 2.6% respectively. CONCLUSION: Regarding dosimetric indices, stomach V20[%] correlates with a higher rate of acute toxicity; more severe acute and late anatomical toxicities are related to the high dose region of duodenum DVH.

12 Article Role of PET/CT in the clinical management of locally advanced pancreatic cancer. 2012

Picchio, Maria / Giovannini, Elisabetta / Passoni, Paolo / Busnardo, Elena / Landoni, Claudio / Giovacchini, Giampiero / Bettinardi, Valentino / Crivellaro, Cinzia / Gianolli, Luigi / Di Muzio, Nadia / Messa, Cristina. ·Nuclear Medicine, San Raffaele Scientific Institute, Via Olgettina 60, Milan, Italy. picchio.maria@hsr.it ·Tumori · Pubmed #23235761.

ABSTRACT: AIM: To evaluate the role of 18F-fluorodeoxyglucose (FDG) PET/CT in: a) the selection of patients with locally advanced pancreatic cancer for helical tomotherapy with concurrent chemotherapy (HTT-ChT); b) monitoring HTT-ChT treatment efficacy in comparison with contrast-enhanced CT (c.e.CT). METHODS: Forty-two consecutive patients with unresectable locally advanced pancreatic cancer referred for HTT-ChT were enrolled in the study. All patients were pretreated with induction ChT. Before the beginning of HTT-ChT treatment patients underwent diagnostic c.e.CT (CT0) and FDG PET/CT (PET/CT0) for staging. After staging, patients received HTT-ChT. Three months after the end of HTT-ChT a control c.e.CT (CT1) was done. FDG PET/CT (PET/CT1) was repeated only in patients with positive PET/CT0. PET/CT1 and CT1 were compared with baseline imaging results to assess treatment efficacy. RESULTS: In 31/42 cases (74%) PET/CT0 documented pathological uptake in pancreatic lesions, while in the remaining 11/42 cases it showed no uptake. In 7/42 (17%) patients, PET/CT0 also detected distant metastases, prompting a change in the therapeutic approach. Compared to PET/CT0, PET/CT1 (n = 18) documented 3 complete metabolic responses, 9 partial metabolic responses, 2 instances of stable metabolic disease, and 4 instances of progressive metabolic disease. In the same group of 18 patients, CT1 showed 0 complete responses, 3 partial responses, 8 instances of stable disease, and 7 instances of progressive disease compared to CT0. Concordance between PET/CT and CT response was seen in 33% of cases. In 50% of cases, PET/CT1 documented a response to therapy that was not evident on CT. CONCLUSIONS: PET/CT influenced the treatment strategy by detecting distant metastases not documented by CT, thus accurately selecting patients for HTT-ChT after induction ChT. In monitoring treatment efficacy, PET/CT can detect a metabolic response to treatment not identified by CT.

13 Article XELIRI or FOLFIRI as salvage therapy in advanced pancreatic cancer. 2010

Cereda, Stefano / Reni, Michele / Rognone, Alessia / Ghidini, Michele / Belli, Carmen / Longoni, Simona / Fugazza, Clara / Brioschi, Matteo / Nicoletti, Roberto / Balzano, Gianpaolo / Passoni, Paolo / Villa, Eugenio. ·Department of Oncology, S Raffaele Scientific Institute, Milan, Italy. ·Anticancer Res · Pubmed #21115942.

ABSTRACT: BACKGROUND: More than half of patients with pancreatic adenocarcinoma (PA) are candidates for further treatment when they experience upfront treatment failure. PATIENTS AND METHODS: Patients with gemcitabine-resistant PA, age <76 years and Karnofski performance status (KPS) >50 were treated with a XELIRI or FOLFIRI regimen until progressive disease or a maximum of six months. As this was an observational study, no statistical design was performed. RESULTS: Between July 2007 and December 2009, 34 patients (median age 60 years; median KPS 90) were treated with XELIRI (26) or FOLFIRI (8) regimen. Grade >2 toxicity consisted of neutropenia in 9% of patients, anemia and fatigue in 3% and hand-foot syndrome in 12%. Median progression-free survival was two months (range 1-4). Maximum response was stable disease in four patients (12%). Median survival was 4.2 (range 1-15) months. CONCLUSION: Fluoropyrimidine and irinotecan combination does not seem to have any role in the treatment of gemcitabine-resistant PA.

14 Article Internal target volume defined by contrast-enhanced 4D-CT scan in unresectable pancreatic tumour: evaluation and reproducibility. 2010

Cattaneo, Giovanni Mauro / Passoni, Paolo / Sangalli, Giulia / Slim, Najla / Longobardi, Barbara / Mancosu, Pietro / Bettinardi, Valentino / Di Muzio, Nadia / Calandrino, Riccardo. ·Medical Physics Department, San Raffaele Scientific Institute, Milano, Italy. mauro.cattaneo@hsr.it ·Radiother Oncol · Pubmed #20826027.

ABSTRACT: We compared customized ITVs obtained with CE-4D-CT imaging (ITV(4D)) with a population-based (ITV(PBC)) in 29 patients (PTs) and evaluated the intra-observer ITV delineation reproducibility in 5 PTs with unresectable pancreatic ductal adenocarcinoma (PDA). The ITV(PBC) was quite different from the ITV(4D), with under/over estimation of volume. Intra-observer volume delineation variability on CE-4D-CT and on a single-phase CE-CT were similar (27.6% vs 24.9%).

15 Minor In reply to Ren et al. 2014

Passoni, Paolo / Reni, Michele / Cattaneo, Giovanni M / Slim, Najla / Cereda, Stefano. ·Department of Radiation Oncology, San Raffaele Scientific Institute, Milan, Italy. · Department of Medical Oncology, San Raffaele Scientific Institute, Milan, Italy. · Department of Medical Physics, San Raffaele Scientific Institute, Milan, Italy. ·Int J Radiat Oncol Biol Phys · Pubmed #24837892.

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