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Borderline resectable pancreatic cancer
Abstracts / Pancreatology 16 (2016) S1eS192
Patients and methods: 310 patients with IPMN underwent pancreatic resection at Aichi Cancer Center Hospital, Wakayama Medical University, or Teine-Keijinkai Hospital between 1996 and March 2011. Among them, 100 patients with BD-IPMN were enrolled this study. Preoperative laboratory and imaging findings were analyzed in logistic regression analyses. Endoscopic ultrasonography (EUS) measurements were essential for the size of mural nodules, and computed tomography (CT) for the diameter of MPD and cyst size of BPDs. In this study, BD-IPMN was defined as cases with cystic dilatation of BPD and the MPD diameter was considered <5 mm (International Consensus Guidelines 2012). According to the WHO histological classification of IPMN (2000), pathological diagnosis is classified as adenoma (IPMA), borderline (IPMB), and noninvasive and invasive carcinoma (IPMC). A central review was conducted for pathological diagnosis. Patients were categorized as benign (IPMA and IPMB) or malignant (IPMC). Results: Pathological diagnosis was benign IPMN in 64 cases and malignant in 36. In univariate analysis CA19-9, the sizes of mural nodules and BPD cysts were significant factors. In multivariate analyses, size of mural nodules (p <0.0001) and CA19-9 (p¼0.0420) were independent predictors of malignancy, and in ROC analysis AUC for these factors was 0.83 and 0.56, respectively. With 7 mm taken as the cutoff value for the size of mural nodules, the diagnosis of malignant IPMN had sensitivity of 72%, specificity of 81% and accuracy of 78%. Carcinoma without nodules was present in 4 patients (4/36¼11%). Pathological findings of these 4 patients were noninvasive carcinoma. Conclusions: The size of mural nodules measured with EUS showed high predictive ability in BD-IPMN. However, about 10% of carcinoma patients did not have nodules, and the handling of the diagnosis in such cases is a problem for the future.
IC4-KL. Borderline resectable pancreatic cancer: Need for standardization and quality control in clinical treatment trials Matthew H.G. Katz Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, USA Chemotherapy and/or chemoradiation is often recommended to patients with borderline resectable pancreatic cancer prior to planned pancreatectomy, but methodological limitations of prior clinical studies have prevented a complete understanding of the role of preoperative therapy in this setting. Existing studies of multimodality therapy are typically small, retrospective, single-institution series confounded by both pre-existing biases and heterogeneity in staging definitions, in the metrics used to characterize response to preoperative therapy, and in the criteria used to select patients for surgical resection. The rigorous standards of clinical trial design incorporated into clinical trials of other disease stages must be adopted in future studies of borderline resectable pancreatic cancer. In this presentation, we will review prior studies and emphasize the research infrastructure that is critical to making progress in this important problem.
IC4-1. Borderline resectable pancreatic cancer Thilo Hackert, Oliver Strobel, Markus W. Büchler Department of Surgery, University of Heidelberg, Germany Background: Surgery followed by adjuvant chemotherapy remains the only treatment option for pancreatic ductal adenocarcinoma (PDAC) with the chance of long-term survival rates of 20-25%. Pancreatic surgery has significantly changed during the past years with resection approaches beyond standard procedures, including vascular and multivisceral resections. Consequently, borderline resectable pancreatic cancer (BR-PDAC), has become a controversial issue with
S9
regard to upfront resection vs. neoadjuvant treatment and sequential resection. Methods: Overview of the current definitions, management strategies and outcomes in BR-PDAC. Results: Four definitions of BR-PDAC are currently used, published by the AHPBA/SSO/SSAT, the M.D. Anderson group, the NCCN and the ISGPS. All definitions focus on vascular involvement. Preoperative diagnostic accuracy to define resectability of PDAC is a keypoint for decision making and is achieved by MD-CT scan as the gold standard. Venous resections of the superior mesenteric/portal vein should be performed in an upfront setting, whenever technically possible. Patients with arterial involvement should be considered for neoadjuvant therapy, the FOLFIRINOX regimen seems to be the most efficient scheme in this setting with secondary resection rates of up to 65% and long-term survival comparable to primary resection outcomes.
IC4-2. Borderline resectable pancreatic cancer: The role of neoadjuvant chemotherapy to improve surgical outcome Claudio Bassi Surgical and Oncological Department, University of Verona, Italy Background: The involvement of the vascular structures at the time of diagnosis is a common feature in patients suffering from pancreatic ductal adenocarcinoma (PDAC). In absence of distant metastases, resectability is established depending on the degree of vascular involvement, diagnosed at radiological imaging. When upfront surgery cannot be accomplished, patients should undertake neoadjuvant treatments and then reconsidered for surgical exploration. In the last years different schemes of neoadjuvant treatment have been suggested and particularly FOLFIRINOX have showed its effectiveness in the preoperative setting. More recently also the association gemcitabine/nab-paclitaxel have been introduced, with encouraging results. Methods: We retrospectively analyzed all patients who underwent surgical exploration from January 2013 to December 2015 and had previously received neoadjuvant chemotherapy, due to local extension or distant metastases at diagnosis. The type of neoadjuvant treatment was at personal choice of the oncologist. Clinical data were retrieved from prospective maintained databases. Accordingly with ISGPS and NCCN classifications, we defined as borderline resectable (BR) those patients with venous involvement of the superior mesenteric vein (SMV) or portal vein (PV) with distortion or narrowing of the vein or occlusion of the vein, with suitable vessel proximal and distal, allowing for safe resection and replacement; gastroduodenal encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery (HA) without extension to the celiac axis (CA); tumor abutment of the SMA not to exceed 180 of the circumference of the vessel wall. Patients were considered as locally advanced (LA), when involvement of the mesenteric/ portal vein prevented safe vascular reconstruction, when more than 2/3 of the SMA was wrapped, or in case of involvement of the celiac trunk or inferior vena cava. Results: During the study period 162 surgical explorations following neoadjuvant chemo- or chemo-radiotherapy were performed. Of them, 113 patients (69.8%) were BR, 25 patients (15.4%) were LA and 24 patients (14.8%) were metastatic at diagnosis. Mean age was 61.28 years (±9.28 SD). FOLFIRINOX was given to 96 patients (59.3%), 24 patients (14.8%) received the association gemcitabine/nab-paclitaxel, 28 patients (17.3%) gemcitabine-oxaliplatinum, 28 patients (17.3%) gemcitabine alone and 11 patients (6.8%) platinum-based CT-schemes. In 104 patients (64.2%) surgical exploration was followed by resection; 75 patients (46.3%) underwent pancreatoduodenectomy (PD), 23 (14.2%) distal pancreatectomy (DP) and 6 (3.7%) total pancreatectomy (TP). In 26 patients (16.0%) an intraoperative ablative therapy was performed (IRE/ RFTA), while in 32 cases (19.8%) intraoperative findings discouraged curative treatments. At pathology R0 was achieved in 67 (63.8%) out of 104 resected patients.
Patients and methods: 310 patients with IPMN underwent pancreatic resection at Aichi Cancer Center Hospital, Wakayama Medical University, or Teine-Keijinkai Hospital between 1996 and March 2011. Among them, 100 patients with BD-IPMN were enrolled this study. Preoperative laboratory and imaging findings were analyzed in logistic regression analyses. Endoscopic ultrasonography (EUS) measurements were essential for the size of mural nodules, and computed tomography (CT) for the diameter of MPD and cyst size of BPDs. In this study, BD-IPMN was defined as cases with cystic dilatation of BPD and the MPD diameter was considered <5 mm (International Consensus Guidelines 2012). According to the WHO histological classification of IPMN (2000), pathological diagnosis is classified as adenoma (IPMA), borderline (IPMB), and noninvasive and invasive carcinoma (IPMC). A central review was conducted for pathological diagnosis. Patients were categorized as benign (IPMA and IPMB) or malignant (IPMC). Results: Pathological diagnosis was benign IPMN in 64 cases and malignant in 36. In univariate analysis CA19-9, the sizes of mural nodules and BPD cysts were significant factors. In multivariate analyses, size of mural nodules (p <0.0001) and CA19-9 (p¼0.0420) were independent predictors of malignancy, and in ROC analysis AUC for these factors was 0.83 and 0.56, respectively. With 7 mm taken as the cutoff value for the size of mural nodules, the diagnosis of malignant IPMN had sensitivity of 72%, specificity of 81% and accuracy of 78%. Carcinoma without nodules was present in 4 patients (4/36¼11%). Pathological findings of these 4 patients were noninvasive carcinoma. Conclusions: The size of mural nodules measured with EUS showed high predictive ability in BD-IPMN. However, about 10% of carcinoma patients did not have nodules, and the handling of the diagnosis in such cases is a problem for the future.
IC4-KL. Borderline resectable pancreatic cancer: Need for standardization and quality control in clinical treatment trials Matthew H.G. Katz Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, USA Chemotherapy and/or chemoradiation is often recommended to patients with borderline resectable pancreatic cancer prior to planned pancreatectomy, but methodological limitations of prior clinical studies have prevented a complete understanding of the role of preoperative therapy in this setting. Existing studies of multimodality therapy are typically small, retrospective, single-institution series confounded by both pre-existing biases and heterogeneity in staging definitions, in the metrics used to characterize response to preoperative therapy, and in the criteria used to select patients for surgical resection. The rigorous standards of clinical trial design incorporated into clinical trials of other disease stages must be adopted in future studies of borderline resectable pancreatic cancer. In this presentation, we will review prior studies and emphasize the research infrastructure that is critical to making progress in this important problem.
IC4-1. Borderline resectable pancreatic cancer Thilo Hackert, Oliver Strobel, Markus W. Büchler Department of Surgery, University of Heidelberg, Germany Background: Surgery followed by adjuvant chemotherapy remains the only treatment option for pancreatic ductal adenocarcinoma (PDAC) with the chance of long-term survival rates of 20-25%. Pancreatic surgery has significantly changed during the past years with resection approaches beyond standard procedures, including vascular and multivisceral resections. Consequently, borderline resectable pancreatic cancer (BR-PDAC), has become a controversial issue with
S9
regard to upfront resection vs. neoadjuvant treatment and sequential resection. Methods: Overview of the current definitions, management strategies and outcomes in BR-PDAC. Results: Four definitions of BR-PDAC are currently used, published by the AHPBA/SSO/SSAT, the M.D. Anderson group, the NCCN and the ISGPS. All definitions focus on vascular involvement. Preoperative diagnostic accuracy to define resectability of PDAC is a keypoint for decision making and is achieved by MD-CT scan as the gold standard. Venous resections of the superior mesenteric/portal vein should be performed in an upfront setting, whenever technically possible. Patients with arterial involvement should be considered for neoadjuvant therapy, the FOLFIRINOX regimen seems to be the most efficient scheme in this setting with secondary resection rates of up to 65% and long-term survival comparable to primary resection outcomes.
IC4-2. Borderline resectable pancreatic cancer: The role of neoadjuvant chemotherapy to improve surgical outcome Claudio Bassi Surgical and Oncological Department, University of Verona, Italy Background: The involvement of the vascular structures at the time of diagnosis is a common feature in patients suffering from pancreatic ductal adenocarcinoma (PDAC). In absence of distant metastases, resectability is established depending on the degree of vascular involvement, diagnosed at radiological imaging. When upfront surgery cannot be accomplished, patients should undertake neoadjuvant treatments and then reconsidered for surgical exploration. In the last years different schemes of neoadjuvant treatment have been suggested and particularly FOLFIRINOX have showed its effectiveness in the preoperative setting. More recently also the association gemcitabine/nab-paclitaxel have been introduced, with encouraging results. Methods: We retrospectively analyzed all patients who underwent surgical exploration from January 2013 to December 2015 and had previously received neoadjuvant chemotherapy, due to local extension or distant metastases at diagnosis. The type of neoadjuvant treatment was at personal choice of the oncologist. Clinical data were retrieved from prospective maintained databases. Accordingly with ISGPS and NCCN classifications, we defined as borderline resectable (BR) those patients with venous involvement of the superior mesenteric vein (SMV) or portal vein (PV) with distortion or narrowing of the vein or occlusion of the vein, with suitable vessel proximal and distal, allowing for safe resection and replacement; gastroduodenal encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery (HA) without extension to the celiac axis (CA); tumor abutment of the SMA not to exceed 180 of the circumference of the vessel wall. Patients were considered as locally advanced (LA), when involvement of the mesenteric/ portal vein prevented safe vascular reconstruction, when more than 2/3 of the SMA was wrapped, or in case of involvement of the celiac trunk or inferior vena cava. Results: During the study period 162 surgical explorations following neoadjuvant chemo- or chemo-radiotherapy were performed. Of them, 113 patients (69.8%) were BR, 25 patients (15.4%) were LA and 24 patients (14.8%) were metastatic at diagnosis. Mean age was 61.28 years (±9.28 SD). FOLFIRINOX was given to 96 patients (59.3%), 24 patients (14.8%) received the association gemcitabine/nab-paclitaxel, 28 patients (17.3%) gemcitabine-oxaliplatinum, 28 patients (17.3%) gemcitabine alone and 11 patients (6.8%) platinum-based CT-schemes. In 104 patients (64.2%) surgical exploration was followed by resection; 75 patients (46.3%) underwent pancreatoduodenectomy (PD), 23 (14.2%) distal pancreatectomy (DP) and 6 (3.7%) total pancreatectomy (TP). In 26 patients (16.0%) an intraoperative ablative therapy was performed (IRE/ RFTA), while in 32 cases (19.8%) intraoperative findings discouraged curative treatments. At pathology R0 was achieved in 67 (63.8%) out of 104 resected patients.