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Article ; Online: Impact of a non-therapeutic laparotomy in patients with locally advanced pancreatic cancer treated with induction (m)FOLFIRINOX: Trans-Atlantic Pancreatic Surgery (TAPS) Consortium study.

Theijse, Rutger T / Stoop, Thomas F / Janssen, Quisette P / Prakash, Laura R / Katz, Matthew H G / Doppenberg, Deesje / Tzeng, Ching-Wei D / Wei, Alice C / Zureikat, Amer H / Groot Koerkamp, Bas / Besselink, Marc G

The British journal of surgery

2024 Volume 111, Issue 3

Abstract: Background: Surgery in selected patients with locally advanced pancreatic cancer after induction chemotherapy may have drawbacks related to surgical risks and breaks or delays in oncological treatment, in particular when curative intent resection is not ...

Abstract	Background: Surgery in selected patients with locally advanced pancreatic cancer after induction chemotherapy may have drawbacks related to surgical risks and breaks or delays in oncological treatment, in particular when curative intent resection is not possible (that is non-therapeutic laparotomy). The aim of this study was to assess the incidence and oncological impact of a non-therapeutic laparotomy in patients with locally advanced pancreatic cancer treated with induction (m)FOLFIRINOX chemotherapy. Methods: This was a retrospective international multicentre study including patients diagnosed with pathology-proven locally advanced pancreatic cancer treated with at least one cycle of (m)FOLFIRINOX (2012-2019). Patients undergoing a non-therapeutic laparotomy (group A) were compared with those not undergoing surgery (group B) and those undergoing resection (group C). Results: Overall, 663 patients with locally advanced pancreatic cancer were included (67 patients (10.1%) in group A, 425 patients (64.1%) in group B, and 171 patients (25.8%) in group C). A non-therapeutic laparotomy occurred in 28.2% of all explorations (67 of 238), with occult metastases in 30 patients (30 of 67, 44.8%) and a 90-day mortality rate of 3.0% (2 of 67). Administration of palliative therapy (65.9% versus 73.1%; P = 0.307) and median overall survival (20.4 [95% c.i. 15.9 to 27.3] versus 20.2 [95% c.i. 19.1 to 22.7] months; P = 0.752) did not differ between group A and group B respectively. The median overall survival in group C was 36.1 (95% c.i. 30.5 to 41.2) months. The 5-year overall survival rates were 11.4%, 8.7%, and 24.7% in group A, group B, and group C, respectively. Compared with group B, non-therapeutic laparotomy (group A) was not associated with reduced overall survival (HR = 0.88 [95% c.i. 0.61 to 1.27]). Conclusion: More than a quarter of surgically explored patients with locally advanced pancreatic cancer after induction (m)FOLFIRINOX did not undergo a resection. Such non-therapeutic laparotomy does not appear to substantially impact oncological outcomes.
MeSH term(s)	Humans ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/surgery ; Pancreatic Neoplasms/pathology ; Laparotomy ; Retrospective Studies ; Fluorouracil ; Leucovorin/therapeutic use ; Neoadjuvant Therapy ; Irinotecan ; Oxaliplatin
Chemical Substances	folfirinox ; Fluorouracil (U3P01618RT) ; Leucovorin (Q573I9DVLP) ; Irinotecan (7673326042) ; Oxaliplatin (04ZR38536J)
Language	English
Publishing date	2024-03-08
Publishing country	England
Document type	Multicenter Study ; Journal Article
ZDB-ID	2985-3
ISSN	1365-2168 ; 0263-1202 ; 0007-1323 ; 1355-7688
ISSN (online)	1365-2168
ISSN	0263-1202 ; 0007-1323 ; 1355-7688
DOI	10.1093/bjs/znae033
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Article ; Online: Serum CEA as a Prognostic Marker for Overall Survival in Patients with Localized Pancreatic Adenocarcinoma and Non-Elevated CA19-9 Levels Treated with FOLFIRINOX as Initial Treatment: A TAPS Consortium Study.

Doppenberg, Deesje / Stoop, Thomas F / van Dieren, Susan / Katz, Matthew H G / Janssen, Quisette P / Nasar, Naaz / Prakash, Laura R / Theijse, Rutger T / Tzeng, Ching-Wei D / Wei, Alice C / Zureikat, Amer H / Groot Koerkamp, Bas / Besselink, Marc G

Annals of surgical oncology

2024 Volume 31, Issue 3, Page(s) 1919–1932

Abstract: Introduction: About 25% of patients with localized pancreatic adenocarcinoma have non-elevated serum carbohydrate antigen (CA) 19-9 levels at baseline, hampering evaluation of response to preoperative treatment. Serum carcinoembryonic antigen (CEA) is a ...

Abstract	Introduction: About 25% of patients with localized pancreatic adenocarcinoma have non-elevated serum carbohydrate antigen (CA) 19-9 levels at baseline, hampering evaluation of response to preoperative treatment. Serum carcinoembryonic antigen (CEA) is a potential alternative. Methods: This retrospective cohort study from five referral centers included consecutive patients with localized pancreatic adenocarcinoma (2012-2019), treated with one or more cycles of (m)FOLFIRINOX, and non-elevated CA19-9 levels (i.e., < 37 U/mL) at baseline. Cox regression analyses were performed to assess prognostic factors for overall survival (OS), including CEA level at baseline, restaging, and dynamics. Results: Overall, 277 patients were included in this study. CEA at baseline was elevated (≥5 ng/mL) in 53 patients (33%) and normalized following preoperative therapy in 14 patients (26%). In patients with elevated CEA at baseline, median OS in patients with CEA normalization following preoperative therapy was 33 months versus 19 months in patients without CEA normalization (p = 0.088). At time of baseline, only elevated CEA was independently associated with (worse) OS (hazard ratio [HR] 1.44, 95% confidence interval [CI] 1.04-1.98). At time of restaging, elevated CEA at baseline was still the only independent predictor for (worse) OS (HR 1.44, 95% CI 1.04-1.98), whereas elevated CEA at restaging (HR 1.16, 95% CI 0.77-1.77) was not. Conclusions: Serum CEA was elevated in one-third of patients with localized pancreatic adenocarcinoma having non-elevated CA19-9 at baseline. At both time of baseline and time of restaging, elevated serum CEA measured at baseline was the only predictor for (worse) OS. Therefore, serum CEA may be a useful tool for decision making at both initial staging and time of restaging in patients with non-elevated CA19-9.
MeSH term(s)	Humans ; Pancreatic Neoplasms/surgery ; Carcinoembryonic Antigen ; CA-19-9 Antigen ; Antineoplastic Combined Chemotherapy Protocols ; Biomarkers, Tumor ; Prognosis ; Retrospective Studies ; Adenocarcinoma/surgery ; Irinotecan ; Oxaliplatin ; Leucovorin ; Fluorouracil
Chemical Substances	Carcinoembryonic Antigen ; CA-19-9 Antigen ; folfirinox ; Biomarkers, Tumor ; Irinotecan (7673326042) ; Oxaliplatin (04ZR38536J) ; Leucovorin (Q573I9DVLP) ; Fluorouracil (U3P01618RT)
Language	English
Publishing date	2024-01-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	1200469-8
ISSN	1534-4681 ; 1068-9265
ISSN (online)	1534-4681
ISSN	1068-9265
DOI	10.1245/s10434-023-14680-0
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Article: Neoadjuvant Treatment in Patients With Resectable and Borderline Resectable Pancreatic Cancer.

Janssen, Quisette P / O'Reilly, Eileen M / van Eijck, Casper H J / Groot Koerkamp, Bas

Frontiers in oncology

2020 Volume 10, Page(s) 41

Abstract: Approximately 20% of pancreatic ductal adenocarcinoma (PDAC) patients have (borderline) resectable pancreatic cancer [(B)RPC] at diagnosis. Upfront resection with adjuvant chemotherapy has long been the standard of care for these patients. However, ... ...

Abstract	Approximately 20% of pancreatic ductal adenocarcinoma (PDAC) patients have (borderline) resectable pancreatic cancer [(B)RPC] at diagnosis. Upfront resection with adjuvant chemotherapy has long been the standard of care for these patients. However, although surgical quality has improved, still about 50% of patients never receive adjuvant treatment. Therefore, recent developments have focused on a neoadjuvant approach. Directly comparing results from neoadjuvant and adjuvant regimens is challenging due to differences in patient populations that influence outcomes. Neoadjuvant trials include all patients who have (B)RPC on imaging, while adjuvant-only trials include patients who underwent a complete resection and recovered to a good performance status without any evidence of residual disease. Guidelines recommend neoadjuvant treatment for BRPC patients mainly to improve negative resection margin (R0) rates. For
Language	English
Publishing date	2020-01-31
Publishing country	Switzerland
Document type	Systematic Review
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2020.00041
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Article ; Online: Improved Clinical Staging System for Localized Pancreatic Cancer Using the ABC Factors: A TAPS Consortium Study.

Dekker, Esther N / van Dam, Jacob L / Janssen, Quisette P / Besselink, Marc G / DeSilva, Annissa / Doppenberg, Deesje / van Eijck, Casper H J / Nasar, Naaz / O'Reilly, Eileen M / Paniccia, Alessandro / Prakash, Laura R / Tzeng, Ching-Wei D / Verkolf, Eva M M / Wei, Alice C / Zureikat, Amer H / Katz, Matthew H G / Groot Koerkamp, Bas

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2024 Volume 42, Issue 12, Page(s) 1357–1367

Abstract: Purpose: Previous studies suggest that besides anatomy (A: resectable, borderline resectable [BR], or locally advanced [LA]) also biologic (B: carbohydrate antigen 19-9 [CA 19-9]) and conditional (C: performance status) factors should be considered when ...

Abstract	Purpose: Previous studies suggest that besides anatomy (A: resectable, borderline resectable [BR], or locally advanced [LA]) also biologic (B: carbohydrate antigen 19-9 [CA 19-9]) and conditional (C: performance status) factors should be considered when staging patients with localized pancreatic ductal adenocarcinoma (PDAC). The prognostic value of the combined ABC factors has not been quantitatively validated. Methods: In this retrospective cohort study, we evaluated patients with localized PDAC treated with initial (modified) fluorouracil with leucovorin, irinotecan, and oxaliplatin ([m]FOLFIRINOX) at five high-volume pancreatic cancer centers in the United States and the Netherlands (2012-2019). Multivariable Cox proportional hazards analysis was used to investigate the impact of the ABC factors for overall survival (OS). Results: Overall, 1,835 patients with localized PDAC were included. Tumor stage at diagnosis was potentially resectable in 346 (18.9%), BR in 531 (28.9%), and LA in 958 (52.2%) patients. The baseline CA 19-9 was >500 U/mL in 559 patients (32.5%). Performance status was ≥1 in 1,110 patients (60.7%). Independent poor prognostic factors for OS were BR disease (hazard ratio [HR], 1.26 [95% CI, 1.06 to 1.50]), LA disease (HR, 1.71 [95% CI, 1.45 to 2.02]), CA 19-9 >500 U/mL (HR, 1.36 [95% CI, 1.21 to 1.52]), and WHO performance status ≥1 (HR, 1.31 [95% CI, 1.16 to 1.47]). Patients were assigned 1 point for each poor ABC factor and 2 points for LA disease. The median OS for patients with score 0-4 was 49.7, 29.9, 22.0, 19.1, and 14.9 months with corresponding 5-year OS rates of 47.0%, 28.9%, 19.2%, 9.3%, and 4.8%, respectively. Conclusion: The ABC factors of tumor anatomy, CA 19-9, and performance status at diagnosis were independent prognostic factors for OS in patients with localized PDAC treated with initial (m)FOLFIRINOX. Staging of patients with localized PDAC at diagnosis should be based on anatomy, CA 19-9, and performance status.
MeSH term(s)	Humans ; Pancreatic Neoplasms/drug therapy ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Retrospective Studies ; Carcinoma, Pancreatic Ductal/drug therapy ; Fluorouracil/therapeutic use ; Leucovorin/therapeutic use ; Prognosis ; Neoadjuvant Therapy
Chemical Substances	Fluorouracil (U3P01618RT) ; Leucovorin (Q573I9DVLP)
Language	English
Publishing date	2024-02-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.23.01311
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Article ; Online: Alterations in Somatic Driver Genes Are Associated with Response to Neoadjuvant FOLFIRINOX in Patients with Localized Pancreatic Ductal Adenocarcinoma.

Ecker, Brett L / Court, Colin M / Janssen, Quisette P / Tao, Alice J / D'Angelica, Michael I / Drebin, Jeffrey A / Gonen, Mithat / O'Reilly, Eileen M / Jarnagin, William R / Wei, Alice C

Journal of the American College of Surgeons

2022 Volume 235, Issue 2, Page(s) 342–349

Abstract: Background: There is increased use of neoadjuvant fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in the management of localized pancreatic ductal adenocarcinoma (PDAC), yet there are few validated biomarkers of treatment response.: ...

Abstract	Background: There is increased use of neoadjuvant fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in the management of localized pancreatic ductal adenocarcinoma (PDAC), yet there are few validated biomarkers of treatment response. Study design: Consecutive patients (n = 196) with resectable, borderline resectable or locally advanced PDAC (2012-2019) receiving FOLFIRINOX as initial treatment and with targeted sequencing of a pretreatment biopsy were identified in a prospective institutional database. Genomic alterations were determined in the 4 driver mutations (KRAS, TP53, CDKN2A, SMAD4), and associations between genomic alterations and clinical outcomes were assessed. Results: Alterations in KRAS (n = 172, 87.8%) and TP53 (n = 131, 66.8%) were common; alterations in CDKN2A (n = 49, 25.0%) and SMAD4 (n = 36, 18.4%) were less frequently observed. A total of 105 patients (53.6%) were able to undergo resection, of whom 8 (7.6%) had a complete/near-complete pathologic response. There were no somatic alterations associated with major pathologic response. Alterations in SMAD4 were associated with a lower rate of surgical resection (27.8% vs 59.4%, p < 0.001); this was additionally observed in a multivariable regression model accounting for resectability status (OR 0.35, 95% confidence interval [CI] 0.15-0.85). Thirty-three patients (16.8%) developed metastatic disease while on neoadjuvant therapy. SMAD4 alterations were associated with a significant risk of metastatic progression on therapy when controlling for resectability status (OR 3.31, 95% CI 1.44-7.60). Conclusions: SMAD4 alterations are associated with more frequent development of metastasis during neoadjuvant FOLFIRINOX and lower probability of reaching surgical resection. Evaluation of alternative chemotherapy regimens in patients with SMAD4 alterations will be important to distinguish whether this represents a prognostic or predictive biomarker.
MeSH term(s)	Adenocarcinoma/drug therapy ; Adenocarcinoma/surgery ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Pancreatic Ductal/drug therapy ; Carcinoma, Pancreatic Ductal/genetics ; Fluorouracil/therapeutic use ; Humans ; Irinotecan/therapeutic use ; Leucovorin/therapeutic use ; Neoadjuvant Therapy ; Neoplasm Staging ; Oxaliplatin/therapeutic use ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/genetics ; Pancreatic Neoplasms/pathology ; Prospective Studies ; Proto-Oncogene Proteins p21(ras) ; Retrospective Studies ; Pancreatic Neoplasms
Chemical Substances	folfirinox ; Oxaliplatin (04ZR38536J) ; Irinotecan (7673326042) ; Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2) ; Leucovorin (Q573I9DVLP) ; Fluorouracil (U3P01618RT)
Language	English
Publishing date	2022-04-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	1181115-8
ISSN	1879-1190 ; 1072-7515
ISSN (online)	1879-1190
ISSN	1072-7515
DOI	10.1097/XCS.0000000000000212
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Article ; Online: Targeted next-generation sequencing has incremental value in the diagnostic work-up of patients with suspect pancreatic masses; a multi-center prospective cross sectional study.

PloS one

2023 Volume 18, Issue 1, Page(s) e0280939

Abstract: Background: The diagnostic process of patients with suspect pancreatic lesions is often lengthy and prone to repeated diagnostic procedures due to inconclusive results. Targeted Next-Generation Sequencing (NGS) performed on cytological material obtained ...

Abstract	Background: The diagnostic process of patients with suspect pancreatic lesions is often lengthy and prone to repeated diagnostic procedures due to inconclusive results. Targeted Next-Generation Sequencing (NGS) performed on cytological material obtained with fine needle aspiration (FNA) or biliary duct brushing can speed up this process. Here, we study the incremental value of NGS for establishing the correct diagnosis, and subsequent treatment plan in patients with inconclusive diagnosis after regular diagnostic work-up for suspect pancreatic lesions. Methods: In this prospective cross-sectional cohort study, patients were screened for inclusion in four hospitals. NGS was performed with AmpliSeq Cancer Hotspot Panel v2 and v4b in patients with inconclusive cytology results or with an uncertain diagnosis. Diagnostic results were evaluated by the oncology pancreatic multidisciplinary team. The added value of NGS was determined by comparing diagnosis (malignancy, cystic lesion or benign condition) and proposed treatment plan (exploration/resection, neoadjuvant chemotherapy, follow-up, palliation or repeated FNA) before and after integration of NGS results. Final histopathological analysis or a 6-month follow-up period were used as the reference standard in case of surgical intervention or non-invasive treatment, respectively. Results: In 50 of the 53 included patients, cytology material was sufficient for NGS analysis. Diagnosis before and after integration of NGS results differed in 24% of the patients. The treatment plan was changed in 32% and the diagnosis was substantiated by the NGS data in 44%. Repetition of FNA/brushing was prevented in 14% of patients. All changes in treatment plan were correctly made after integration of NGS. Integration of NGS increased overall diagnostic accuracy from 68% to 94%. Interpretation: This study demonstrates the incremental diagnostic value of NGS in patients with an initial inconclusive diagnosis. Integration of NGS results can prevent repeated EUS/FNA, and can also rigorously change the final diagnosis and treatment plan.
MeSH term(s)	Humans ; Cross-Sectional Studies ; Pancreatic Neoplasms/diagnosis ; Pancreatic Neoplasms/genetics ; Pancreatic Neoplasms/pathology ; Prospective Studies ; Pancreas/pathology ; High-Throughput Nucleotide Sequencing ; Endoscopic Ultrasound-Guided Fine Needle Aspiration
Language	English
Publishing date	2023-01-25
Publishing country	United States
Document type	Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0280939
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Article ; Online: Genomic Biomarkers Associated with Response to Induction Chemotherapy in Patients with Localized Pancreatic Ductal Adenocarcinoma.

Ecker, Brett L / Tao, Alice J / Janssen, Quisette P / Walch, Henry S / Court, Colin M / Balachandran, Vinod P / Crane, Christopher H / D'Angelica, Michael I / Drebin, Jeffrey A / Kingham, T Peter / Soares, Kevin C / Iacobuzio-Donahue, Christine A / Vakiani, Efsevia / Gonen, Mithat / O'Reilly, Eileen M / Varghese, Anna M / Jarnagin, William R / Wei, Alice C

Clinical cancer research : an official journal of the American Association for Cancer Research

2023 Volume 29, Issue 7, Page(s) 1368–1374

Abstract: Purpose: There is increasing use of neoadjuvant chemotherapy in the management of localized pancreatic ductal adenocarcinoma (PDAC), yet there are few validated biomarkers to guide therapy selection. We aimed to determine whether somatic genomic ... ...

Abstract	Purpose: There is increasing use of neoadjuvant chemotherapy in the management of localized pancreatic ductal adenocarcinoma (PDAC), yet there are few validated biomarkers to guide therapy selection. We aimed to determine whether somatic genomic biomarkers predict response to induction FOLFIRINOX or gemcitabine/nab-paclitaxel. Experimental design: This single-institution cohort study included consecutive patients (N = 322) with localized PDAC (2011-2020) who received at least one cycle of FOLFIRINOX (N = 271) or gemcitabine/nab-paclitaxel (N = 51) as initial treatment. We assessed somatic alterations in four driver genes (KRAS, TP53, CDKN2A, and SMAD4) by targeted next-generation sequencing, and determined associations between these alterations and (1) rate of metastatic progression during induction chemotherapy, (2) surgical resection, and (3) complete/major pathologic response. Results: The alteration rates in driver genes KRAS, TP53, CDKN2A, and SMAD4 were 87.0%, 65.5%, 26.7%, and 19.9%, respectively. For patients receiving first-line FOLFIRINOX, SMAD4 alterations were uniquely associated with metastatic progression (30.0% vs. 14.5%; P = 0.009) and decreased rate of surgical resection (37.1% vs. 66.7%; P < 0.001). For patients receiving induction gemcitabine/nab-paclitaxel, alterations in SMAD4 were not associated with metastatic progression (14.3% vs. 16.2%; P = 0.866) nor decreased rate of surgical resection (33.3% vs. 41.9%; P = 0.605). Major pathologic response was rare (6.3%) and not associated with type of chemotherapy regimen. Conclusions: SMAD4 alterations were associated with more frequent development of metastasis and lower probability of reaching surgical resection during neoadjuvant FOLFIRINOX but not gemcitabine/nab-paclitaxel. Confirmation in a larger, diverse patient cohort will be important before prospective evaluation of SMAD4 as a genomic biomarker to guide treatment selection.
MeSH term(s)	Humans ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/genetics ; Pancreatic Neoplasms/pathology ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Cohort Studies ; Induction Chemotherapy ; Proto-Oncogene Proteins p21(ras)/genetics ; Paclitaxel ; Deoxycytidine ; Carcinoma, Pancreatic Ductal/drug therapy ; Carcinoma, Pancreatic Ductal/genetics ; Carcinoma, Pancreatic Ductal/pathology ; Fluorouracil ; Genomics ; Albumins ; Pancreatic Neoplasms
Chemical Substances	Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2) ; Paclitaxel (P88XT4IS4D) ; Deoxycytidine (0W860991D6) ; Fluorouracil (U3P01618RT) ; Albumins
Language	English
Publishing date	2023-02-16
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-22-3089
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Article ; Online: FOLFIRINOX as Initial Treatment for Localized Pancreatic Adenocarcinoma: A Retrospective Analysis by the Trans-Atlantic Pancreatic Surgery Consortium.

Janssen, Quisette P / van Dam, Jacob L / Doppenberg, Deesje / Prakash, Laura R / van Eijck, Casper H J / Jarnagin, William R / O' Reilly, Eileen M / Paniccia, Alessandro / Besselink, Marc G / Katz, Matthew H G / Tzeng, Ching-Wei D / Wei, Alice C / Zureikat, Amer H / Groot Koerkamp, Bas

Journal of the National Cancer Institute

2022 Volume 114, Issue 5, Page(s) 695–703

Abstract: Background: Large pragmatic studies of patients who received 5-fluorouracil with leucovorin, irinotecan, and oxaliplatin ([m]FOLFIRINOX) as initial treatment for localized pancreatic ductal adenocarcinoma (PDAC) are lacking. This study aimed to provide ... ...

Abstract	Background: Large pragmatic studies of patients who received 5-fluorouracil with leucovorin, irinotecan, and oxaliplatin ([m]FOLFIRINOX) as initial treatment for localized pancreatic ductal adenocarcinoma (PDAC) are lacking. This study aimed to provide realistic estimates of oncologic outcomes in these patients. Methods: This international retrospective cohort study included all consecutive patients presenting with localized PDAC who received at least 1 cycle of (m)FOLFIRINOX as initial treatment in 5 referral centers from the United States and the Netherlands (2012-2019). Primary outcome was median overall survival (OS), calculated from the date of tissue diagnosis, assessed using Kaplan-Meier estimates. Log-rank test was used to compare OS between groups. A Cox proportional hazards regression model was used to assess prognostic baseline factors for OS. All statistical tests were 2-sided. Results: Overall, 1835 patients were included, of whom 958 (52.2%) had locally advanced (LA), 531 (28.9%) had borderline resectable (BR), and 346 (18.9%) had potentially resectable (PR) PDAC. The median number of (m)FOLFIRINOX cycles was 6 (interquartile range = 4-8). Subsequent treatment included second chemotherapy (12.9%), radiotherapy (49.0%), and resection (37.9%). The resection rate was 17.6% for LA, 53.1% for BR, and 70.5% for PR PDAC (P < .001). The margin-negative resection rate (>1 mm) was 55.2% for LA, 62.6% for BR, and 79.2% for PR PDAC (P < .001). The median OS was 18.7 months (95% confidence interval [CI] = 17.7 to 19.9 months) for LA, 23.2 months (95% CI = 21.0 to 25.7 months) for BR, and 31.2 months (95% CI = 26.2 to 36.6 months) for PR PDAC (P < .001). The median OS for 695 patients who underwent a resection was 38.3 months (95% CI = 36.1 to 42.0 months). Independent prognostic factors at baseline for worse OS were more advanced stage, worse performance status, baseline carbohydrate antigen (CA) 19-9 > 500 U/mL, and body mass index ≤18.5 kg/m2. Conclusions: This large international cohort study provides realistic estimates of resection rates and survival in patients with LA, BR, and PR PDAC who started (m)FOLFIRINOX treatment in PDAC referral centers.
MeSH term(s)	Adenocarcinoma/drug therapy ; Adenocarcinoma/surgery ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Pancreatic Ductal/drug therapy ; Carcinoma, Pancreatic Ductal/surgery ; Cohort Studies ; Fluorouracil/therapeutic use ; Humans ; Irinotecan/therapeutic use ; Leucovorin/therapeutic use ; Neoadjuvant Therapy ; Oxaliplatin/therapeutic use ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/surgery ; Retrospective Studies ; Pancreatic Neoplasms
Chemical Substances	folfirinox ; Oxaliplatin (04ZR38536J) ; Irinotecan (7673326042) ; Leucovorin (Q573I9DVLP) ; Fluorouracil (U3P01618RT)
Language	English
Publishing date	2022-02-14
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2992-0
ISSN	1460-2105 ; 0027-8874 ; 0198-0157
ISSN (online)	1460-2105
ISSN	0027-8874 ; 0198-0157
DOI	10.1093/jnci/djac018
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Article ; Online: Diagnostic performance of endoscopic tissue acquisition for pancreatic ductal adenocarcinoma in the PREOPANC and PREOPANC-2 trials.

Janssen, Quisette P / Quispel, Rutger / Besselink, Marc G / Bonsing, Bert A / Bruno, Marco J / Doukas, Michael / Sarasqueta, Arantza F / Homs, Marjolein Y V / van Hooft, Jeanin E / van Tienhoven, Geertjan / van Velthuysen, Marie-Louise F / Verheij, Joanne / Voermans, Rogier P / Wilmink, Johanna W / Groot Koerkamp, Bas / van Eijck, Casper H J / van Driel, Lydi M J W

HPB : the official journal of the International Hepato Pancreato Biliary Association

2023 Volume 25, Issue 10, Page(s) 1161–1168

Abstract: Background: Neoadjuvant treatment for pancreatic ductal adenocarcinoma (PDAC) has increased, necessitating histopathologic confirmation of cancer. This study evaluates the performance of endoscopic tissue acquisition (TA) procedures for borderline ... ...

Abstract	Background: Neoadjuvant treatment for pancreatic ductal adenocarcinoma (PDAC) has increased, necessitating histopathologic confirmation of cancer. This study evaluates the performance of endoscopic tissue acquisition (TA) procedures for borderline resectable and resectable PDAC. Methods: Pathology reports of patients included in two nationwide randomized controlled trials (PREOPANC and PREOPANC-2) were reviewed. The primary outcome was sensitivity for malignancy (SFM), considering both "suspicious for" and "malignant" as positive. Secondary outcomes were rate of adequate sampling (RAS) and diagnoses other than PDAC. Results: Overall, 892 endoscopic procedures were performed in 617 patients, including endoscopic ultrasonography (EUS)-guided TA in 550 (89.1%), endoscopic retrograde cholangiopancreatography (ERCP)-guided brush cytology in 188 (30.5%), and periampullary biopsies in 61 patients (9.9%). The SFM was 85.2% for EUS, 88.2% for repeat EUS, 52.7% for ERCP, and 37.7% for periampullary biopsies. The RAS ranged 94-100%. Diagnoses other than PDAC were other periampullary cancers in 24 (5.4%), premalignant disease in five (1.1%), and pancreatitis in three patients (0.7%). Conclusions: EUS-guided TA of patients with borderline resectable and resectable PDAC included in RCTs had an SFM above 85% for both first and repeat procedures, meeting international standards. Two percent had false positive result for malignancy and 5% had other (non-PDAC) periampullary cancers.
MeSH term(s)	Humans ; Pancreatic Neoplasms/diagnostic imaging ; Pancreatic Neoplasms/surgery ; Cholangiopancreatography, Endoscopic Retrograde/methods ; Pancreatic Ducts/pathology ; Carcinoma, Pancreatic Ductal/diagnostic imaging ; Carcinoma, Pancreatic Ductal/surgery ; Endosonography ; Endoscopic Ultrasound-Guided Fine Needle Aspiration ; Pancreatic Neoplasms
Language	English
Publishing date	2023-05-04
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2131251-5
ISSN	1477-2574 ; 1365-182X
ISSN (online)	1477-2574
ISSN	1365-182X
DOI	10.1016/j.hpb.2023.04.018
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Sensitivity of CT, MRI, and EUS-FNA/B in the preoperative workup of histologically proven left-sided pancreatic lesions.

Gorris, Myrte / Janssen, Quisette P / Besselink, Marc G / van den Broek, Bram L J / van Eijck, Casper H J / van Gils, Marjon J / Koerkamp, Bas Groot / Struik, Femke / van Driel, Lydi M J W / van Hooft, Jeanin E

Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.

2021 Volume 22, Issue 1, Page(s) 136–141

Abstract: Background and objectives: Left-sided pancreatic lesions are often treated surgically. Accurate diagnostic work-up is therefore essential to prevent futile major abdominal surgery. Large series focusing specifically on the preoperative work-up of left- ... ...

Abstract	Background and objectives: Left-sided pancreatic lesions are often treated surgically. Accurate diagnostic work-up is therefore essential to prevent futile major abdominal surgery. Large series focusing specifically on the preoperative work-up of left-sided pancreatic lesions are lacking. This surgical cohort analysis describes the sensitivity of CT, MRI, and EUS-FNA/B in the diagnostic work-up of left-sided pancreatic lesions. Methods: We performed a post-hoc analysis of patients who underwent surgery for a left-sided pancreatic lesion between April 2010 and August 2017 and participated in the randomized CPR trial. Primary outcome was the sensitivity of CT, MRI, and EUS-FNA/B. Sensitivity was determined as the most likely diagnosis of each modality compared with the postoperative histopathological diagnosis. Additionally, the change in sensitivity of EUS versus EUS-FNA/B (i.e., cyst fluid analysis, and/or tissue acquisition) was measured. Results: Overall, 181 patients were included (benign: 23%, premalignant: 27%, malignant: 50%). Most patients had solid lesions (65%). Preoperative imaging included CT (86%), MRI (41%), EUS (68%). Overall, CT and EUS-FNA/B reached a sensitivity of both 71%, compared with 66% for MRI. When EUS was combined with FNA/B, sensitivity rose from 64% to 71%. For solid lesions, CT reached the highest sensitivity (75%) when compared with MRI (70%) and EUS-FNA/B (69%). For cystic lesions, EUS-FNA/B reached the highest sensitivity (75%) when compared with CT and MRI (both 62%). Conclusions: CT is the most sensitive diagnostic modality for solid and EUS-FNA/B for cystic left-sided pancreatic lesions. EUS-FNA/B was associated with an increased sensitivity when compared to EUS alone.
MeSH term(s)	Aged ; Endoscopic Ultrasound-Guided Fine Needle Aspiration ; Endosonography ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Pancreatic Cyst/diagnostic imaging ; Pancreatic Neoplasms/diagnostic imaging ; Pancreatic Neoplasms/surgery ; Preoperative Care ; Sensitivity and Specificity ; Tomography, X-Ray Computed
Language	English
Publishing date	2021-11-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2056680-3
ISSN	1424-3911 ; 1424-3903
ISSN (online)	1424-3911
ISSN	1424-3903
DOI	10.1016/j.pan.2021.11.008
Database	MEDical Literature Analysis and Retrieval System OnLINE

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