scholarly journals FOLFIRINOX in borderline resectable and locally advanced unresectable pancreatic adenocarcinoma

2020 ◽  
Vol 12 ◽  
pp. 175883592095329
Author(s):  
Changhoon Yoo ◽  
Inhwan Hwang ◽  
Tae Jun Song ◽  
Sang Soo Lee ◽  
Jae Ho Jeong ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Significant Proportion ◽  
Progression Free Survival ◽  
Conversion Surgery ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Curative Intent ◽  
Free Survival

Background: Despite the scarcity of data based on randomized trials, FOLFIRINOX is widely used in the management of borderline resectable pancreatic cancer (BRPC) and locally advanced unresectable pancreatic cancer (LAPC). We investigated the clinical outcomes of neoadjuvant FOLFIRINOX in patients with BRPC and LAPC. Methods: This single-center retrospective analysis included a total of 199 consecutive patients with BRPC or LAPC who received conventional or modified FOLFIRINOX between February 2013 and January 2017. An independent radiologist reviewed all baseline computed tomography or magnetic resonance imaging scans were reviewed for vascular invasion status. Results: With median follow-up duration of 40.3 months [95% confidence interval (CI), 36.7–43.8] in surviving patients, median progression-free survival (PFS) and overall survival (OS) were 10.6 (95% CI, 9.5–11.7) and 18.1 (95% CI, 16.0–20.3) months, respectively. The 1-year PFS rate was 66.0% (95% CI, 65.3–66.7%), and the 2-year OS rate was 37.2% (95% CI, 36.5–37.9%). PFS and OS did not differ between BRPC and LAPC groups [median PFS, 11.1 months (95% CI, 8.8–13.5) versus 10.1 months (95% CI, 8.4–11.8), p = 0.47; median OS, 18.4 months (95% CI, 16.1–20.8) versus 17.1 months (95% CI, 13.2–20.9), p = 0.50]. Curative-intent conversion surgery (R0/R1) was performed in 63 patients (31.7%). C•A 19-9 response, objective tumor response to FOLFIRINOX, and conversion surgery were independent prognostic factors for OS. Conclusion: FOLFIRINOX was effective for management of BRPC and LAPC. Given the potential for cure, a significant proportion of patients can undergo conversion curative-intent surgery following FOLFIRINOX.

scholarly journals Neoadjuvant treatment for locally advanced unresectable and borderline resectable pancreatic cancer: oncological outcomes at a single academic centre

ESMO Open ◽  
2020 ◽  
Vol 5 (6) ◽  
pp. e000929
Author(s):  
Susana Roselló ◽  
Claudio Pizzo ◽  
Marisol Huerta ◽  
Elena Muñoz ◽  
Roberto Aliaga ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Progression Free Survival ◽  
Rank Test ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Curative Intent ◽  
Kaplan Meier ◽  
Dismal Prognosis

IntroductionPancreatic cancer (PC), even in the absence of metastatic disease, has a dismal prognosis. One-third of them are borderline resectable (BRPC) or locally advanced unresectable PC (LAUPC) at diagnosis. There are limited prospective data supporting the best approach on these tumours. Neoadjuvant chemotherapy (ChT) is being increasingly used in this setting.MethodsThis is a retrospective series of consecutive patients staged as BRPC or LAUPC after discussion in the multidisciplinary board (MDB) at an academic centre. All received neoadjuvant ChT, followed by chemoradiation (ChRT) in some cases, and those achieving enough downstaging had a curative-intent surgery. Descriptive data about patient’s characteristics, neoadjuvant treatments, toxicities, curative resections, postoperative complications, pathology reports and adjuvant treatment were collected. Overall survival (OS) and progression-free survival was calculated with Kaplan-Meier method and log-rank test.ResultsBetween August 2011 and July 2019, 49 patients fulfilled the inclusion criteria, and all of them received neoadjuvant ChT. Fluorouracil+folinic acid, irinotecan and oxaliplatin was the most frequently used scheme (77%). The most prevalent grade 3 or 4 toxicities were neutropenia (26.5%), neurotoxicity (12.2%), diarrhoea (8.2%) and nausea (8.2%). 18 patients (36.7%) received ChRT thereafter. In total, 22 patients (44,9%) became potentially resectable and 19 of them had an R0 or R1 pancreatic resection. One was found to be unresectable at surgery and two refused surgery. A vascular resection was required in 7 (35%). No postoperative deaths were observed. Postoperative ChT was given to 12 (66.7%) of resected patients. Median OS of the whole cohort was 24,9 months (95% CI 14.1 to 35.7), with 30.6 months for resected and 13.1 months for non-resected patients, respectively (p<0.001).ConclusionA neoadjuvant approach in BRPC and LAUPC was well tolerated and allowed a curative resection in 38.8% of them with a potential improvement on OS.

Modified gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer (MPC): A single-institution experience.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 366-366 ◽  
Author(s):  
Kavya Krishna ◽  
Marlo A. Blazer ◽  
Lai Wei ◽  
Daniel H. Ahn ◽  
Christina Sing-Ying Wu ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Cost Savings ◽  
Progression Free Survival ◽  
Borderline Resectable ◽  
Free Survival ◽  
Kaplan Meier ◽  
Grade 3 ◽  
Cost Of Drugs

366 Background: The combination of gemcitabine and nab-paclitaxel (GA) in first line treatment (tx) of MPC has a modest survival advantage over gemcitabine (gem) alone, but adds significant toxicities (tox) and increased cost. Based on data suggesting that biweekly administration (adm) of gem-based combinations preserves efficacy and improves tox profile, our institution adopted a modified regimen of GA (mGA). Methods: This is a retrospective analysis of a prospectively maintained database of patients (pts) with pancreatic cancer treated with gem (1000 mg/m2) and nab-paclitaxel (125 mg/m2) on days 1 and 15 of a 28-day cycle. Survival curves were estimated using Kaplan-Meier method, with alive pts censored at time of last follow-up. Cost of tx includes cost of drugs, adm, and tox. Results: Of total 69 pts treated with mGA for MPC, locally advanced, or borderline resectable disease, 63 pts were evaluable for tox (table 1). A total of 49 pts (47 evaluable for response) received mGA for previously untreated MPC, with median progression free survival of 4.8 months(mo) (95% CI 2.6,7.4) and overall survival of 11.1 mo (95% CI 5.3,not reached). Overall, 27% of pts experienced neurotoxicity with rate of grade 3 tox of < 2%, and 8% required growth factors (GF). Average cost savings was $5500/pt/month with mGA compared to standard GA, excluding GF cost which was lower with mGA. Conclusions: A less intense regimen of GA maintains efficacy while significantly improving tox profile and cost in pts with MPC. [Table: see text]

Efficacy and safety of mFOLFIRINOX in patients with borderline resectable and locally advanced unresectable pancreatic cancer: Intention-to-treat population analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 720-720
Author(s):  
Inhwan Hwang ◽  
Changhoon Yoo ◽  
Kyu-Pyo Kim ◽  
Jae Ho Byun ◽  
Jae Ho Jeong ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Objective Response ◽  
Locally Advanced ◽  
Significant Proportion ◽  
Phase Iii ◽  
Unresectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Curative Intent ◽  
Primary Tumor Site ◽  
Free Survival

720 Background: Borderline resectable pancreatic cancer (BRPC) and locally advanced unresectable pancreatic cancer (LAUPC) are heterogeneous disease entity with various prognosis. Based on the phase III PRODIGE trial, (m)FOLFIRINOX has been widely used for the management of patients with BRPC and LAUPC. Considering the lack of large phase 3 trial of (m)FOLFIRINOX for BRPC and LAUPC, real-life evidences of (m)FOLFIRINOX are needed. Methods: In this retrospective analysis, 199 patients who received at least one dose of (m)FOLFIRINOX between February 2013 and January 2017 were included. Endpoints of this study were objective response rates (ORR), surgical resection rate, progression-free survival (PFS) and overall survival (OS). Results: Median age was 60 years (range, 33-79) and 62.3% of patients were male. Pancreas head (n=112, 56.3%) was the most common primary tumor site, followed by body (n=42, 21.1%) and multifocal (n=34, 17.1%). By an independent radiology review, patients were classified to BRPC (n=75, 37.7%) and LAUPC (n=124, 62.3%). With median 40.3 months (95% CI, 36.7-43.8) of follow-up duration in surviving patients, ORR was 26.6% (n=53), median PFS and OS were 10.6 months (95% CI, 9.5-11.7) and 17.1 months (95% CI, 13.2-20.9), respectively. There was no difference in PFS and OS between BRPC and LAUPC (median PFS, 11.1 months [95% CI, 8.8-13.5] vs. 10.1 months [95% CI, 8.4-11.8], p=0.47); (median OS, 18.4 months [95% CI, 16.1-20.8] vs. 17.1 months [95% CI, 13.2-20.9], p=0.50). Curative-intent surgery (R0 and R1) was done in 63 patients (33.2%, 49 for R0 and 14 for R1) after treatment with (m)FOLFIRINOX. Resection rates were 58.2% in BRPC patients and 19.4% in LAUPC patients (p<0.001). In patients who underwent curative-intent surgery, median disease-free survival since surgery was 10.4 months (95% CI, 8.3-12.5 ) and there was no difference according to the baseline disease extent (BRPC vs. LAUPC): 10.0 months (95% CI, 7.5-12.5) vs. 12.0 months (95% CI, 3.7-20.3), p=0.37. Conclusions: (m)FOLFIRINOX is effective therapy for BRPC and LAUPC patients. Significant proportion of patients could receive curative-intent surgery.

scholarly journals Chemoradiotherapy (Gemox Plus Helical Tomotherapy) for Unresectable Locally Advanced Pancreatic Cancer: A Phase II Study

Cancers ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 663 ◽  
Author(s):  
Alessandro Passardi ◽  
Emanuela Scarpi ◽  
Elisa Neri ◽  
Elisabetta Parisi ◽  
Giulia Ghigi ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Locally Advanced Pancreatic Cancer ◽  
R0 Resection ◽  
Resection Rate ◽  
Free Survival ◽  
Moderate Nausea

The aim of the study was to evaluate the safety and efficacy of a new chemo-radiotherapy regimen for patients with locally advanced pancreatic cancer (LAPC). Patients were treated as follows: gemcitabine 1000 mg/m2 on day 1, and oxaliplatin 100 mg/m2 on day 2, every two weeks (GEMOX regimen) for 4 cycles, 15 days off, hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days), 15 days off, 4 additional cycles of GEMOX, restaging. From April 2011 to August 2016, a total of 42 patients with non resectable LAPC were enrolled. Median age was 67 years (range 41–75). Radiotherapy was well tolerated and the most frequently encountered adverse events were mild to moderate nausea and vomiting, abdominal pain and fatigue. In total, 9 patients underwent surgical laparotomy (5 radical pancreatic resection 1 thermoablation and 3 explorative laparotomy), 1 patient became operable but refused surgery. The overall resectability rate was 25%, while the R0 resection rate was 12.5%. At a median follow-up of 50 months, the median progression-free survival and overall survival were 9.3 (95% CI 6.2–14.9) and 15.8 (95% CI 8.2–23.4) months, respectively. The results demonstrate the feasibility of a new chemo-radiotherapy regimen as a potential treatment for unresectable LAPC.

scholarly journals AGITG MASTERPLAN: a randomised phase II study of modified FOLFIRINOX alone or in combination with stereotactic body radiotherapy for patients with high-risk and locally advanced pancreatic cancer

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Andrew Oar ◽  
Mark Lee ◽  
Hien Le ◽  
Kate Wilson ◽  
Chris Aiken ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
New Zealand ◽  
High Risk ◽  
Phase Ii ◽  
Stereotactic Body Radiotherapy ◽  
Locally Advanced ◽  
Borderline Resectable ◽  
Free Survival

Abstract Background Among patients with non-metastatic pancreatic cancer, 80% have high-risk, borderline resectable or locally advanced cancer, with a 5-year overall survival of 12%. MASTERPLAN evaluates the safety and activity of stereotactic body radiotherapy (SBRT) in addition to chemotherapy in these patients. Methods and design MASTERPLAN is a multi-centre randomised phase II trial of 120 patients with histologically confirmed potentially operable pancreatic cancer (POPC) or inoperable pancreatic cancer (IPC). POPC includes patients with borderline resectable or high-risk tumours; IPC is defined as locally advanced or medically inoperable pancreatic cancer. Randomisation is 2:1 to chemotherapy + SBRT (investigational arm) or chemotherapy alone (control arm) by minimisation and stratified by patient cohort (POPC v IPC), planned induction chemotherapy and institution. Chemotherapy can have been commenced ≤28 days prior to randomisation. Both arms receive 6 × 2 weekly cycles of modified FOLFIRINOX (oxaliplatin (85 mg/m2 IV), irinotecan (150 mg/m2), 5-fluorouracil (2400 mg/m2 CIV), leucovorin (50 mg IV bolus)) plus SBRT in the investigational arm. Gemcitabine+nab-paclitaxel is permitted for patients unsuitable for mFOLFIRINOX. SBRT is 40Gy in five fractions with planning quality assurance to occur in real time. Following initial chemotherapy ± SBRT, resectability will be evaluated. For resected patients, adjuvant chemotherapy is six cycles of mFOLFIRINOX. Where gemcitabine+nab-paclitaxel was used initially, the adjuvant treatment is 12 weeks of gemcitabine and capecitabine or mFOLFIRINOX. Unresectable or medically inoperable patients with stable/responding disease will continue with a further six cycles of mFOLFIRINOX or three cycles of gemcitabine+nab-paclitaxel, whatever was used initially. The primary endpoint is 12-month locoregional control. Secondary endpoints are safety, surgical morbidity and mortality, radiological response rates, progression-free survival, pathological response rates, surgical resection rates, R0 resection rate, quality of life, deterioration-free survival and overall survival. Tertiary/correlative objectives are radiological measures of nutrition and sarcopenia, and serial tissue, blood and microbiome samples to be assessed for associations between clinical endpoints and potential predictive/prognostic biomarkers. Interim analysis will review rates of locoregional recurrence, distant failure and death after 40 patients complete 12 months follow-up. Fifteen Australian and New Zealand sites will recruit over a 4-year period, with minimum follow-up period of 12 months. Discussion MASTERPLAN evaluates SBRT in both resectable and unresectable patients with pancreatic ductal adenocarcinoma. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12619000409178, 13/03/2019. Protocol version: 2.0, 19 May 2019

scholarly journals Neoadjuvant FOLFIRINOX in Patients With Borderline Resectable Pancreatic Cancer: A Systematic Review and Patient-Level Meta-Analysis

2019 ◽  
Vol 111 (8) ◽  
pp. 782-794 ◽  
Author(s):  
Quisette P Janssen ◽  
Stefan Buettner ◽  
Mustafa Suker ◽  
Berend R Beumer ◽  
Pietro Addeo ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
R0 Resection ◽  
Resection Rate ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Free Survival ◽  
Patient Level ◽  
Grade Iii

Abstract Background FOLFIRINOX is a standard treatment for metastatic pancreatic cancer patients. The effectiveness of neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer (BRPC) remains debated. Methods We performed a systematic review and patient-level meta-analysis on neoadjuvant FOLFIRINOX in patients with BRPC. Studies with BRPC patients who received FOLFIRINOX as first-line neoadjuvant treatment were included. The primary endpoint was overall survival (OS), and secondary endpoints were progression-free survival, resection rate, R0 resection rate, and grade III–IV adverse events. Patient-level survival outcomes were obtained from authors of the included studies and analyzed using the Kaplan-Meier method. Results We included 24 studies (8 prospective, 16 retrospective), comprising 313 (38.1%) BRPC patients treated with FOLFIRINOX. Most studies (n = 20) presented intention-to-treat results. The median number of administered neoadjuvant FOLFIRINOX cycles ranged from 4 to 9. The resection rate was 67.8% (95% confidence interval [CI] = 60.1% to 74.6%), and the R0-resection rate was 83.9% (95% CI = 76.8% to 89.1%). The median OS varied from 11.0 to 34.2 months across studies. Patient-level survival data were obtained for 20 studies representing 283 BRPC patients. The patient-level median OS was 22.2 months (95% CI = 18.8 to 25.6 months), and patient-level median progression-free survival was 18.0 months (95% CI = 14.5 to 21.5 months). Pooled event rates for grade III–IV adverse events were highest for neutropenia (17.5 per 100 patients, 95% CI = 10.3% to 28.3%), diarrhea (11.1 per 100 patients, 95% CI = 8.6 to 14.3), and fatigue (10.8 per 100 patients, 95% CI = 8.1 to 14.2). No deaths were attributed to FOLFIRINOX. Conclusions This patient-level meta-analysis of BRPC patients treated with neoadjuvant FOLFIRINOX showed a favorable median OS, resection rate, and R0-resection rate. These results need to be assessed in a randomized trial.

scholarly journals Clinical Outcomes of Conversion Surgery after Neoadjuvant Chemotherapy in Patients with Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer: A Single-Center, Retrospective Analysis

Cancers ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 278 ◽  
Author(s):  
Changhoon Yoo ◽  
Sang Shin ◽  
Kyu-pyo Kim ◽  
Jae Jeong ◽  
Heung-Moon Chang ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Clinical Outcomes ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Exploratory Analysis ◽  
Unresectable Pancreatic Cancer ◽  
Conversion Surgery ◽  
Borderline Resectable ◽  
Free Survival

The clinical benefit and potential risks of conversion surgery after neoadjuvant chemotherapy (NACT) have not been fully investigated in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced unresectable pancreatic cancer (LAPC). Therefore, this has been evaluated in a retrospective, prospective cohort-based analysis. Between October 2005 and April 2017, 135 patients (65 with BRPC and 70 with LAPC) received conversion surgery after NACT. Exploratory analysis to assess clinical outcomes in comparison with patients who underwent upfront surgery in the same time period (n = 359) was also conducted. NACT with gemcitabine-based regimens (including gemcitabine monotherapy, gemcitabine-capecitabine combination, and gemcitabine-erlotinib combination) was used in 69 patients (51%) and FOLFIRINOX in 66 patients (49%). The median overall survival (OS) and disease-free survival (DFS) from the time of surgery was 25.4 months (95% CI, 18.6–32.2 months) and 9.0 months (95% CI, 6.8–11.2 months), respectively. The median OS and progression-free survival from the initiation of NACT was 29.7 months (95% CI, 22.5–36.8 months) and 13.4 months (95% CI, 12.5–14.4 months), respectively. In the exploratory analysis, conversion surgery after NACT was associated with a better median OS and DFS than upfront surgery (vs. 17.1 months; 95% CI, 15.5–18.7 months; p = 0.001 and vs. 7.1 months; 95% CI, 6.4–7.8 months; p = 0.005, respectively). There was no difference in length of hospital stay between the two groups, and conversion surgery after NACT showed a significantly lower incidence of postoperative complications than upfront surgery (38% vs. 27%, p = 0.03). Conversion surgery after NACT is a feasible and effective therapeutic strategy for the treatment of patients with BRPC and LAPC. Further clinical trials investigating optimal therapeutic strategies for BRPC and LAPC are warranted.

scholarly journals Outcomes of neoadjuvant chemotherapy in resectable, borderline resectable and locally advanced pancreatic cancer

2021 ◽  
Vol 23 (2) ◽  
pp. 300-306
Author(s):  
Kamil D. Dalgatov ◽  
Nikolai N. Semenov ◽  
Margarita V. Kozodaeva
Keyword(s):  
Pancreatic Cancer ◽  
Surgical Treatment ◽  
Neoadjuvant Chemotherapy ◽  
Primary Tumor ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Cancer Of The Pancreas

Background. The problem of neoadjuvant treatment of locally advanced (LA), borderline resectable (BR) and resectable pancreatic cancer (RPC) is being actively discussed at the present time, although the indications for its use have not been fully determined. In our work, we want to discuss the outcomes of using neoadjuvant chemotherapy (NACT) in these patients. Materials and methods. From 2016 to 2020, 85 patients with pancreatic cancer were observed in the clinic (37 patients with LA cancer of the pancreas; 15 with BR cancer of the pancreas and 33 with RPC). Of these, men 33 (38.8%), women 52 (61.2%). The average age was 64 (3183) years. All groups had GEMOX (41.2%) and FOLFIRINOX (58.8%) regimens. Increased CA 19-9 above normal had, in the LA group 21 (56.6%); in the BR group 9 (60%); and in the resectable group 26 (78.8%). From 3 to 6 courses of NACT were carried out, followed by computer tomography control and decision-making on treatment tactics. Results. In the LA group, the GEMOX (n=15) and FOLFIRINOX (n=22) modes were used. When evaluating the results after 1 follow-up examination after 2.5 months. found: 2 patients died; progression 14 patients (37.8%); remained inoperable 16 patients (43.2%), of whom 9 received radiation therapy. Removal of the primary tumor was performed in 5 patients (13.9%). The average OS in this group was 15 months. Fifteen patients with BR pancreatic tumors were observed. NACT was carried out with the same regimens GEMOX (n=7) and FOLFIRINOX (n=8) for 2.5 months. When evaluating the results after 1 follow-up examination after 2.5 months was found: 1 (7.7%) patient died; progression was noted in 6 (40%) patients; in 1 (7.7%) patient, surgical treatment was not performed due to pronounced concomitant diseases. Surgical treatment was performed in 7 (46.7%) patients. 33 patients were prescribed NACT for RPC. The main criteria for prescribing NACT for formally resectable pancreatic cancer were a high CA 19-9 level (100 IU/ml) [n=26 (75%)] and a large primary tumor [n=7 (25%)]. All patients received the same regimens for 3.3 months. up to 1 control. When evaluating the results, the following results were obtained: 1 (3%) patient died; 3 (9.3%) patients were not operated on due to refusal from surgical treatment; 7 patients (21.9%) were not operated on due to progression. Surgical treatment was performed in 22 (66.7%) patients; Whipple procedure in 17 patients, distal resection in 3 patients, total pancreatoduodenectomy in 2 patients. At the same time, complete morphological responce was noted in 2 (9%) patients, R0 resection in 19 (86%) patients, R1 in 1 patient (4.5%). The median survival rate of the operated patients was 20.2 months (CI 13.227.2 months). Most patients (65.9%) had a high level of CA 19-9, which was studied in dynamics and used as a marker of the biological activity of the tumor. Conclusion. Thus, we can claim that NACT is absolutely indicated for all patients with LA and BR pancreatic cancer, and its role in the selection of the most favorable in relation to the prognosis of patients is indisputable. Perioperative chemotherapy in patients with RPC is still controversial; however, having in mind the results in groups with LA and BR pancreatic cancer and the literature data, we dare to assume that for this issue it is a matter of time and future randomized trials. And here an important role can be played by the CA 19-9 level, which characterizes a biologically aggressive tumor, but again, prospective randomized studies are required to study this issue in more detail.

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