Clinical outcomes of gemcitabine plus nab-paclitaxel (GnP) in initially diagnosed locally advanced pancreatic cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 407-407 ◽  
Author(s):  
Yusuke Hashimoto ◽  
Hideaki Takahashi ◽  
Izumi Ohno ◽  
Hiroshi Imaoka ◽  
Mitsuhito Sasaki ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Median Time ◽  
Univariate Analysis ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Pancreatic Head ◽  
Tumor Board ◽  
Rank Test

407 Background: Gemcitabine plus nab-Paclitaxel has shown improved survival in patients with metastatic pancreatic cancer in MPACT. Many studies have been investigating the survival benefit of GnP in LACP patients. The aim of this study is to clinical outcome of GnP in initially diagnosed LAPC in our single tertiary institution. Methods: LACP patients who received GnP as initial chemotherapy were identified between December 2014. and December 2016 from our database retrospectively. Demographic characteristics, disease status, response, conversion to resection and survival was reviewed. Resectability was determined at our hepatobiliary pancreatic tumor board, reflecting Japanese guideline of pancreatic cancer. Results: We identified 55 LACP patients initially treated with GnP (median age: 67 year old, female was 49%, ECOG PS 0/1, 62%/38%, pancreatic head 58%, baseline tumor size: median 32mm (18-62), CA19-9: median 139ng/ml (3.9-12956)). Best objective response rate was 58% and median time to partial response was 60 days (40-212). Median overall survival (mOS) was 24.7 months (95%CI :15.5-not reached). Nine patients (16%:9/55) were re-evaluated as resectable with CT and normalized CA19-9/CEA and subsequently proceeded to conversion to resection. Seven patients (13%:7/55) achieved R0 resection and sequentially performed adjuvant six- month duration of GnP. Median time to resection from initial GnP administration was 5.2 months (4.0-7.3). LAPC patients who achieved conversion to resection was associated with better overall survival than non-resected LAPC in log-rank test (mOS: all alive :12.1-25.4months vs 21.5 months 95%Cl:15.5-, HR:0.493 range: NA, P = 0.043). Shrinking tumor minimal size from the baseline was the factor to successful conversion in univariate analysis (P = 0.006). Conclusions: GnP showed promising results of response and overall survival in uLAPC patients. Conversion to resection in carefully selected uLAPC currently suggests an early surgical benefit, but longer follow-up and more cases will be required to assess the potential long-term benefit of conversion therapy.

FOLFIRINOX versus gemcitabine nab-paclitaxel for advanced pancreatic cancer: KU Cancer Center experience.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15744-e15744 ◽  
Author(s):  
Anup Kasi ◽  
Akshay Middinti ◽  
An Cao ◽  
Pratikkumar Vekaria ◽  
Devangi Patel ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Pancreatic Head ◽  
Cancer Center ◽  
Disease Rate ◽  
First Line ◽  
Significant Difference

e15744 Background: FOLFIRINOX (FFN) and Gemcitabine plus nab-paclitaxel (GN) have been established as first line chemotherapy in advanced pancreatic cancer (PC). But there is no head-to-head randomized trial data available to support preferable first line choice between these two regimens. Methods: We retrospectively evaluated 154 chemotherapy-naïve locally advanced and metastatic PC patients treated with FFN or GN at KU Cancer Center between January 2011 and November 2016. FFN consisted of Oxaliplatin 85mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 as a bolus and 2,400 mg/m2over 46 hour on days 1 and 15 every 4 weeks. GN consisted of Gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day1,8,15 every 4 weeks. We compared characteristics, efficacy and adverse events between FFN and GN. Results: 107 patients were treated with FFN and 47 patients with GN as first line therapy. Demographic and baseline characteristics (FFN/GN) were as follows: Median age 61/63 years, ECOG performance status (0-1): 90% / 83%, Gender (male): 57% / 54%, distant metastases: 52%/70%, biliary stenting: 41%/20%, locally advanced tumor: 48%/30%, pancreatic head tumors: 63%/55%, median number of cycles: 4/4 respectively. Objective response rate (13% vs. 10%), Stable disease rate (76% vs 82%) and disease control rate (89% vs. 92%, p = 0.5) were similar in FFN and in GN. Median PFS was 11.7 months (95% CI: 7.2-16.1) in FFN and 5.7 months (95% CI: 2.7-8.8) in GN [p = 0.07]. Median OS was 15.9 months (95% CI: 13.7-18.1) in FFN and 10.8 months (95% CI: 7.1 – 14.5) in GN [p = 0.17]. Incidences of grade 3 or higher adverse effects were neutropenia (33% vs. 17%), anemia (14% vs 31%), thrombocytopenia (28% vs 6%), elevated creatinine (2.8% vs 4%), elevated transminases (3.7% vs 6%), diarrhea (5% vs. 0%), and peripheral neuropathy (6% vs. 6%) respectively. Conclusions: Patients treated with FFN showed statistically better PFS compared to GN. However this difference in PFS did not translate into statistically significant difference in OS. Response rates were similar. Incidences of adverse events were relatively more with FFN compared to GN as expected.

A phase III trial of tumor-treating fields with nab-paclitaxel and gemcitabine for front-line treatment of locally-advanced pancreatic adenocarcinoma (LAPC): PANOVA-3.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS448-TPS448
Author(s):  
Vincent J. Picozzi ◽  
Teresa Macarulla ◽  
Philip Agop Philip ◽  
Carlos Roberto Becerra ◽  
Tomislav Dragovich
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Rank Test ◽  
Type I ◽  
Tumor Treating Fields ◽  
Local Disease

TPS448 Background: Tumor Treating Fields (TTFields) are a non-invasive, regional antimitotic treatment modality, which has been approved for the treatment of glioblastoma. TTFields at specific frequency (150-200 kHz) are delivered via transducer arrays placed on the skin in proximity to the tumor site. TTFields predominantly act by disrupting the formation of the mitotic spindle during metaphase. TTFields were effective in multiple preclinical models of pancreatic cancer. The phase 2 PANOVA study, the first trial testing TTFields in pancreatic cancer patients, demonstrated the safety and preliminary efficacy of TTFields when combined with nab-paclitaxel and gemcitabine in both metastatic and LAPC. The Phase 3 PANOVA-3 trial (NCT03377491) is designed to test the efficacy and safety of adding TTFields to nab-paclitaxel and gemcitabine combination in LAPC. Methods: Patients (N = 556) with unresectable, LAPC (per NCCN guidelines) will be enrolled in this prospective, randomized trial. Patients should have an ECOG score of 0-2 and no prior progression or treatment. Patients will be stratified based on their performance status and geographical region, and will be randomized 1:1 to TTFields plus nab-paclitaxel and gemcitabine or to nab-paclitaxel and gemcitabine alone. Chemotherapy will be administered at standard dose of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2 once weekly). TTFields (150 kHz) will be delivered at least 18 hours/day until local disease progression per RECIST Criteria V1.1. Follow up will be performed q8w, including a CT scan of the chest and abdomen. Following local disease progression, patients will be followed monthly for survival. Overall survival will be the primary endpoint and progression-free survival, objective response rate, rate of resectability, quality of life and toxicity will all be secondary endpoints. Sample size was calculated using a log-rank test comparing time to event in patients treated with TTFields plus chemotherapy with control patients on chemotherapy alone. PANOVA-3 is designed to detect a hazard ratio 0.75 in overall survival. Type I error is set to 0.05 (two-sided) and power to 80%. Clinical trial information: NCT03377491.

scholarly journals Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M. S. Walma ◽  
◽  
S. J. Rombouts ◽  
L. J. H. Brada ◽  
I. H. Borel Rinkes ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26–34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking. Methods The “Pancreatic Locally Advanced Unresectable Cancer Ablation” (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA. Discussion The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment. Trial registration Dutch Trial RegistryNL4997. Registered on December 29, 2015. ClinicalTrials.govNCT03690323. Retrospectively registered on October 1, 2018

PANOVA-3: A phase III study of tumor treating fields with nabpaclitaxel and gemcitabine for front-line treatment of locally advanced pancreatic adenocarcinoma (LAPC).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. TPS469-TPS469 ◽  
Author(s):  
Uri Weinberg ◽  
Moshe Giladi ◽  
Zeev Bomzon ◽  
Eilon David Kirson
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Rank Test ◽  
Type I ◽  
Tumor Treating Fields ◽  
Local Disease

TPS469 Background: Tumor Treating Fields (TTFields) are a non-invasive, regional antimitotic treatment modality, which has been approved for the treatment of patients with glioblastoma by the FDA. TTFields predominantly act by disrupting the formation of the mitotic spindle during metaphase. TTFields were effective in multiple preclinical models of pancreatic cancer. The Phase 2 PANOVA study was the first trial testing TTFields in pancreatic cancer patients, and demonstrated the safety of TTFields when combined with nab-paclitaxel and gemcitabine in both metastatic and LAPC. The Phase 3 PANOVA-3 trial (NCT03377491) is designed to test the efficacy of adding TTFields to nab-paclitaxel and gemcitabine combination in LAPC. Methods: Patients (N = 556) with unresectable, LAPC (per NCCN guidelines) will be enrolled in this prospective, randomized trial. Patients should have an ECOG score of 0-2 and no prior progression or treatment. Patients will be stratified based on their performance status and geographical region, and will be randomized 1:1 to TTFields plus nab-paclitaxel and gemcitabine or to nab-paclitaxel and gemcitabine alone. Chemotherapy will be administered at standard dose of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2 once weekly). TTFields (150kHz) will be deilvered at least 18 hours/day until local disease progression per RECIST Criteria V1.1. Follow up will be performed q8w, including a CT scan of the chest and abdomen. Following local disease progression, patients will be followed monthly for survival. Overall survival will be the primary endpoint and progression-free survival, objective response rate, rate of resectability, quality of life and toxicity will all be secondary endpoints. Sample size was calculated using a log-rank test comparing time to event in patients treated with TTFields plus chemotherapy with control patients on chemotherapy alone. PANOVA-3 is designed to detect a hazard ratio 0.75 in overall survival. Type I error is set to 0.05 (two-sided) and power to 80%. Clinical trial information: NCT03377491.

scholarly journals Irreversible electroporation for locally advanced pancreatic cancer

2018 ◽  
Vol 23 (2) ◽  
pp. 59-68
Author(s):  
D. A. Astakhov ◽  
D. N. Panchenkov ◽  
Yu. V. Ivanov ◽  
O. R. Shablovsky ◽  
A. G. Kedrova ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Locally Advanced ◽  
Irreversible Electroporation ◽  
Advanced Pancreatic Cancer ◽  
Pancreatic Head ◽  
Locally Advanced Pancreatic Cancer ◽  
Control Group ◽  
Recurrence Free Survival ◽  
Free Survival

Aim. To assess overall survival and recurrence-free period in patients with locally advanced pancreatic cancer who underwent irreversible electroporation of the tumor in combination with chemotherapy. Matherials and methods. It was performed a prospective analysis of overall survival in 23 patients who underwent irreversible electroporation of unresectable pancreatic cancer for the period from May 2012 to March 2017. Control group consisted of 35 patients with pancreatic cancer stage III who received standard chemotherapy alone. Results. Mean age of patients was 61 years (range 45–80). All procedures were successful. Fifteen patients had pancreatic head cancer, 8 – cancer of pancreatic body. Preoperative chemotherapy has been applied in 20 (86.9%) patients for 4 months prior to surgery on the average. Seventeen (73%) patients underwent chemotherapy after electroporation procedure. 90-day mortality was 4.3% (n = 1) in electroporation group. Surgery was followed by improved local recurrence-free survival (12 and 6 months, respectively, p = 0.01) and distant recurrence-free survival (15 and 8 months, respectively, p = 0.03). Overall survival was 18 and 11 months, respectively (p = 0.03). Conclusion. Irreversible electroporation of locally advanced pancreatic cancer is safe. Four-month chemotherapy followed by surgical procedure is associated with good local response and better overall survival compared with chemotherapy alone. These data will be validated in further multicenter study.

Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group

2007 ◽  
Vol 25 (15) ◽  
pp. 1960-1966 ◽  
Author(s):  
Malcolm J. Moore ◽  
David Goldstein ◽  
John Hamm ◽  
Arie Figer ◽  
Joel R. Hecht ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Pancreatic Tumors ◽  
Double Blind ◽  
Phase Iii Trial

PurposePatients with advanced pancreatic cancer have a poor prognosis and there have been no improvements in survival since the introduction of gemcitabine in 1996. Pancreatic tumors often overexpress human epidermal growth factor receptor type 1 (HER1/EGFR) and this is associated with a worse prognosis. We studied the effects of adding the HER1/EGFR-targeted agent erlotinib to gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer.Patients and MethodsPatients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib (100 or 150 mg/d orally) or gemcitabine plus placebo in a double-blind, international phase III trial. The primary end point was overall survival.ResultsA total of 569 patients were randomly assigned. Overall survival based on an intent-to-treat analysis was significantly prolonged on the erlotinib/gemcitabine arm with a hazard ratio (HR) of 0.82 (95% CI, 0.69 to 0.99; P = .038, adjusted for stratification factors; median 6.24 months v 5.91 months). One-year survival was also greater with erlotinib plus gemcitabine (23% v 17%; P = .023). Progression-free survival was significantly longer with erlotinib plus gemcitabine with an estimated HR of 0.77 (95% CI, 0.64 to 0.92; P = .004). Objective response rates were not significantly different between the arms, although more patients on erlotinib had disease stabilization. There was a higher incidence of some adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2.ConclusionTo our knowledge, this randomized phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine. The recommended dose of erlotinib with gemcitabine for this indication is 100 mg/d.

Neoadjuvant multimodal treatment of borderline resectable (BRPC) and locally advanced unresectable pancreatic cancer (LAPC) in Mexico.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 454-454
Author(s):  
Vanessa Rosas Camargo ◽  
Edgar Omar Martos Armedáriz ◽  
Miriam Heidi Cisneros Cordero ◽  
ZULEYMA NIETO GARCIA ◽  
Christian Haydeé Flores Balcázar ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Surgical Resection ◽  
Multimodal Treatment ◽  
Performance Status ◽  
Univariate Analysis ◽  
Single Agent ◽  
Locally Advanced ◽  
Pancreatic Head ◽  
Rank Test ◽  
R0 Resection

454 Background: Pancreatic cancer remains a highly lethal disease. There is no consensus on treatment sequences and chemotherapy (CT) regimen in BRPC and LAPC. Our aim was to describe the multimodal treatment and outcomes in our population. Methods: We retrospectively reviewed medical records of patients (pts) with BRPC/LAPC and histological diagnosis of adenocarcinoma evaluated at Instituto Nacional de Ciencias Médicas y Nutrición from January 2011-December 2016. Clinical and pathological variables at diagnosis and treatment were recorded. Overall survival (OS) was estimated using Kaplan-Meier method and compared by Log-rank test. Results: 69 pts were evaluated, 39% (27) did not receive treatment. We analyze 42 treated pts. BRPC 33%/LAPC 67%. Median age was 58.8 y/o, 54.8% were female. Symptoms at diagnosis: 79% abdominal pain, 76% weight loss, 55% jaundice. ECOG performance status (PS): 0 (17%), 1 (69%) and 2 (14%). Main location was pancreatic head (76%). Median laboratory values: total bilirubin 1.04 mg/dL (0.2-25), albumin 4.1 g/dL (2.4-5.1), CA 19.9 182.8 U/mL (0.8-4028). Laparotomy at diagnosis was performed in 21%. All pts received induction CT (iCT). FOLFIRINOX was the most common regimen (37%), followed by FOLFOX4 (34%). The best overall response with iCT was stable disease (62%), progressive disease was observed in 24%. iCT followed by chemoradiation (CRT) could be delivered to 48% (20/42). Capecitabine-based CRT was preferred (94%). Six pts (14%) underwent surgical resection after multimodal treatment (36% BRPC, 3.5% LAPC), 5 pts achieved R0 resection. The resection rate with single-agent iCT was 0% vs 20% with combination iCT. Median OS was 15.6 months (m): 14.4 m for BRPC and 15.5 m for LAPC. Median OS according iCT: gemcitabine 7.8 m, fluorouracil 13.7 m, FOLFOX4 15.5 m and FOLFIRINOX 24.6 m. Univariate analysis identified ECOG PS (0-1 vs 2, P = 0. 014) and age ( < 59 vs ³59, P = 0.002) as significantly associated with survival. Conclusions: Early administration of combination CT followed by CRT and/o surgical resection in selected pts improves oncological outcomes in pts with BRPC/LAPC. In pts with good PS, iCT with FOLFIRINOX is the preferred regimen given best results.

PANOVA-3: A phase III study of tumor treating fields with nab-paclitaxel and gemcitabine for front-line treatment of locally advanced pancreatic adenocarcinoma (LAPC).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS792-TPS792
Author(s):  
Vincent J. Picozzi ◽  
Teresa Macarulla ◽  
Philip Agop Philip ◽  
Carlos Roberto Becerra ◽  
Tomislav Dragovich
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Rank Test ◽  
Type I ◽  
Tumor Treating Fields ◽  
Local Disease

TPS792 Background: Tumor Treating Fields (TTFields) are a non-invasive, regional antimitotic treatment modality, which has been approved for the treatment of glioblastoma. TTFields at specific frequency (150-200 kHz) are delivered via transducer arrays placed on the skin in proximity to the tumor site. TTFields predominantly act by disrupting the formation of the mitotic spindle during metaphase. TTFields were effective in multiple preclinical models of pancreatic cancer. The Phase 2 PANOVA study, the first trial testing TTFields in pancreatic cancer patients, demonstrated the safety and preliminary efficacy of TTFields when combined with nab-paclitaxel and gemcitabine in both metastatic and LAPC. The Phase 3 PANOVA-3 trial (NCT03377491) is designed to test the efficacy and safety of adding TTFields to nab-paclitaxel and gemcitabine combination in LAPC. Methods: Patients (N = 556) with unresectable, LAPC (per NCCN guidelines) will be enrolled in this prospective, randomized trial. Patients should have an ECOG score of 0-2 and no prior progression or treatment. Patients will be stratified based on their performance status and geographical region, and will be randomized 1:1 to TTFields plus nab-paclitaxel and gemcitabine or to nab-paclitaxel and gemcitabine alone. Chemotherapy will be administered at standard dose of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2 once weekly). TTFields (150 kHz) will be delivered at least 18 hours/day until local disease progression per RECIST Criteria V1.1. Follow up will be performed q8w, including a CT scan of the chest and abdomen. Following local disease progression, patients will be followed monthly for survival. Overall survival will be the primary endpoint and progression-free survival, objective response rate, rate of resectability, quality of life and toxicity will all be secondary endpoints. Sample size was calculated using a log-rank test comparing time to event in patients treated with TTFields plus chemotherapy with control patients on chemotherapy alone. PANOVA-3 is designed to detect a hazard ratio 0.75 in overall survival. Type I error is set to 0.05 (two-sided) and power to 80%. Clinical trial information: NCT03377491.

Neoadjuvant chemotherapy improves outcomes of chemoradiation therapy for locally advanced pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4036-4036 ◽  
Author(s):  
V. Rana ◽  
S. Krishnan ◽  
J. L. Abbruzzese ◽  
H. Q. Xiong ◽  
G. R. Varadhachary ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Median Time ◽  
Induction Chemotherapy ◽  
Initial Treatment ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Chemoradiation Therapy ◽  
Locally Advanced Pancreatic Cancer

4036 Background: Two-thirds of all pancreatic cancer patients have radiographically detectable metastatic disease at the time of diagnosis. Most of the remaining patients have locally advanced, unresectable disease that is typically treated with either chemoradiation or chemotherapy alone. We explored the possible benefit of the use of consolidative chemoradiation after induction chemotherapy. Methods: Between December 1993 and October 2005, 318 patients with locally advanced, non-metastatic, pancreatic cancer were treated at our institution with concurrent chemoradiation therapy. All patients underwent CT staging and biopsy confirmed adenocarcinoma. 245 patients received chemoradiation (CR) as initial treatment while 73 patients received a median of 2.5 months of induction chemotherapy prior to chemoradiation (CCR). Radiosensitizers included 5FU (42%), gemcitabine (39%) and capecitabine (19%) and most patients (88%) received 30 Gy of radiation therapy. The most common induction chemotherapy regimens were gemcitabine and cisplatin (73%) and gemcitabine alone (15%). Results: All statistics are actuarial and calculated from date of initial treatment. Median follow-up was 5.5 months (range 1–63 months). For all patients, overall survival was 9.0 months and 2-year survival was 8%. Age, gender, histology, grade, radiation fractionation and concurrent chemotherapy regimen had no impact on outcomes on univariate analysis. However, overall survival was 8.5 months in the CR group and 11.9 months in the CCR group (p = 0.0004). Median time to local progression was 6.0 months in the CR group and 8.4 in the CCR group (p = 0.0055). Median time to distant progression was 5.8 months in the CR group and 9.5 months in the CCR group (p=0.0136). Conclusions: In one of the largest series of locally advanced pancreatic cancer patients, the use of induction chemotherapy followed by chemoradiation seems to prolong median survival over initial treatment with chemoradiation. By excluding patients who progress rapidly during induction chemotherapy, this approach presumably selects patients most likely to benefit from a local treatment modality. This strategy merits prospective evaluation. [Table: see text]

scholarly journals Induction Chemotherapy for Primarily Unresectable Locally Advanced Pancreatic Adenocarcinoma—Who Will Benefit from a Secondary Resection?

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 77
Author(s):  
Nathalie Rosumeck ◽  
Lea Timmermann ◽  
Fritz Klein ◽  
Marcus Bahra ◽  
Sebastian Stintzig ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Neoadjuvant Therapy ◽  
Induction Therapy ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Comprehensive Cancer Center ◽  
Secondary Resection ◽  
Number Of Patients

Background and Objectives: An increasing number of patients (pts) with locally advanced pancreatic cancer (LAPC) are treated with an intensive neoadjuvant therapy to obtain a secondary curative resection. Only a certain number of patients benefit from this intention. The aim of this investigation was to identify prognostic factors which may predict a benefit for secondary resection. Materials and Methods: Survival time and clinicopathological data of pts with pancreatic cancer were prospective and consecutively collected in our Comprehensive Cancer Center Database. For this investigation, we screened for pts with primarily unresectable pancreatic cancer who underwent a secondary resection after receiving induction therapy in the time between March 2017 and May 2019. Results: 40 pts had a sufficient database to carry out a reliable analysis. The carbohydrate-antigen 19-9 (CA 19-9) level of the pts treated with induction therapy decreased by 44.7% from 4358.3 U/mL to 138.5 U/mL (p = 0.001). The local cancer extension was significantly reduced (p < 0.001), and the Eastern Cooperative Oncology Group (ECOG) performance status was lowered (p = 0.03). The median overall survival (mOS) was 20 months (95% CI: 17.2–22.9). Pts who showed a normal CA 19-9 level (<37 U/mL) at diagnosis and after neoadjuvant therapy or had a Body Mass Index (BMI) below 25 kg/m2 after chemotherapy had a significant prolonged overall survival (29 vs. 19 months, p = 0.02; 26 vs. 18 months, p = 0.04; 15 vs. 24 months, p = 0.01). Pts who still presented elevated CA 19-9 levels >400 U/mL after induction therapy did not profit from a secondary resection (24 vs. 7 months, p < 0.001). Nodal negativity as well as the performance of an adjuvant therapy lead to better mOS (25 vs. 15 months, p = 0.003; 10 vs. 25 months, p < 0.001). Conclusion: The pts in our investigation had different benefits from the multimodal treatment. We identified the CA 19-9 level at time of diagnosis and after neoadjuvant therapy as well as the preoperative BMI as predictive factors for overall survival. Furthermore, diagnostics of presurgical nodal status should gain more importance as nodal negativity is associated with better outcome.

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