Options in First Line Management of Metastatic Pancreatic Cancer and the Determinative Role of ECOG Performance Status

2022 ◽  
Author(s):  
Ferhat Ekinci
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Metastatic Pancreatic Cancer ◽  
First Line ◽  
Ecog Performance Status ◽  
Line Management

Clinical outcome of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel as first line chemotherapy in metastatic pancreatic cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 438-438 ◽  
Author(s):  
Kazuo Watanabe ◽  
Yusuke Hashimoto ◽  
Kumiko Umemoto ◽  
Hideaki Takahashi ◽  
Mitsuhito Sasaki ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Performance Status ◽  
Objective Response ◽  
Metastatic Pancreatic Cancer ◽  
Cancer Center ◽  
First Line ◽  
Ecog Performance Status ◽  
Line Chemotherapy

438 Background: FOLFIRINOX and Gemcitabine plus nab-paclitaxel (GN) have been established as first line chemotherapy in metastatic pancreatic cancer (mPC). But few data support preferable first line choice of these two regimens in “real-world” clinical setting. Methods: We retrospectively enrolled 135 chemotherapy-naive mPC patients treated with modified FOLFIRINOX (mFFX) or GN at National Cancer Center Hospital East between December 2013 and September 2015. mFFX is a modified regimen of reduced dose of irinotecan 150mg/m2 and eliminated bolus 5-FU from original FFX. GN consists of gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day1,8,15 every 4 weeks. We compared characteristics, efficacy and adverse events between mFFX and GN. Results: Seventy patients were treated with mFFX and 65 patients with GN as first line therapy. Demographic and baseline characteristics (mFFX/GN) were similar as follows: ECOG performance status (0-1): 100% / 99%, Gender (male): 66% / 69%, liver metastasis: 56%/49%, peritoneal metastasis: 34% / 31%, prior biliary drainage: 21%/17%, median observation period: 330 / 265 days, respectively. The population of elderly patients ( > 75y) was smaller in mFFX than GN (4.3% vs. 12%, p = 0.05). Objective response rate (27% vs. 39%, p = 0.02) and disease control rate (79% vs. 92%, p = 0.02) were significantly lower in mFFX than in GN. Median OS was 11.5 months (95% CI: 9.7-16.8) in mFFX and 14.0 months (95% CI: 12.2 - not reached) in GN. Median PFS was 5.7 months (95% CI: 3.4-7.1) in mFFX and 6.5 months (95% CI: 6.1-7.9) in GN. One-year survival rate was significantly higher in GN than in mFFX (44% vs. 67%, p = 0.0006). Incidences of grade 3 or 4 neutropenia (47% vs. 45%), diarrhea (1.4% vs. 2.0%), and peripheral neuropathy (4.2% vs. 4.6%) were similar in each group. On the other hand, incidences of febrile neutropenia (8.5% vs. 2.0%, p = 0.06) and G-CSF use rate (21% vs. 0%, p < 0.0001), anorexia (13% vs. 3%, p = 0.03) were significantly higher in mFFX than those of GN. Conclusions: Patients treated with GN showed more favorable efficacy and survival. Incidences of most adverse events did not differ between mFFX and GN,whereas febrile neutropenia occurred more frequently in mFFX.

scholarly journals Early Tumor Shrinkage and Depth of Response Evaluation in Metastatic Pancreatic Cancer Treated with First Line Chemotherapy: An Observational Retrospective Cohort Study

Cancers ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 939 ◽  
Author(s):  
Caterina Vivaldi ◽  
Lorenzo Fornaro ◽  
Carla Cappelli ◽  
Irene Pecora ◽  
Silvia Catanese ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
Tumor Shrinkage ◽  
First Line ◽  
Free Survival ◽  
Depth Of Response ◽  
Early Tumor Shrinkage ◽  
Early Tumor

Early tumor shrinkage (ETS) and depth of response (DoR) predict favorable outcomes in metastatic colorectal cancer. We aim to evaluate their prognostic role in metastatic pancreatic cancer (PC) patients treated with first-line modified-FOLFIRINOX (FOLFOXIRI) or Gemcitabine + Nab-paclitaxel (GemNab). Hence, 138 patients were tested for ETS, defined as a ≥20% reduction in the sum of target lesions’ longest diameters (SLD) after 6–8 weeks from baseline, and DoR, i.e., the maximum percentage shrinkage in the SLD from baseline. Association of ETS and DoR with progression-free survival (PFS) and overall survival (OS) was assessed. ETS was reached in 49 patients (39.5% in the FOLFOXIRI, 29.8% in the GemNab group; p = 0.280). In the overall population, ETS was significantly associated with better PFS (8.0 vs. 4.8 months, p < 0.001) and OS (13.2 vs. 9.7 months, p = 0.001). Median DoR was −27.5% (−29.4% with FOLFOXIRI and −21.4% with GemNab, p = 0.016): DoR was significantly associated with better PFS (9.0 vs. 6.7 months, p < 0.001) and OS (14.3 vs. 11.1 months, p = 0.031). Multivariate analysis confirmed both ETS and DoR are independently associated with PFS and OS. In conclusion, our study added evidence on the role of ETS and DoR in the prediction of outcome of PC patients treated with first-line combination chemotherapy.

scholarly journals Patterns of care in metastatic pancreatic cancer: patient selection in clinical routine

2019 ◽  
Vol 12 ◽  
pp. 175628481987763 ◽  
Author(s):  
Werner Scheithauer ◽  
Paul Martin Putora ◽  
Birgit Grünberger ◽  
Wolfgang Eisterer ◽  
Ewald Wöll ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Decision Trees ◽  
Patient Selection ◽  
Performance Status ◽  
Treatment Options ◽  
Metastatic Pancreatic Cancer ◽  
Decision Criteria ◽  
First Line ◽  
Clinical Routine ◽  
Treatment Algorithms

Background: The management of patients with metastatic pancreatic cancer (mPC) is challenging, and the optimal treatment strategy is debated among experts. In an attempt to identify treatment decision criteria and to investigate variations in the first-line management of this disease, we performed an analysis of treatment algorithms among experts in the field of pancreatic cancer. The aim of this study was to identify relevant criteria in the complex process of patient selection and decision making for the management of mPC patients. Methods: Experts from the ABCSG (Austrian Breast and Colorectal Cancer Study Group) Pancreatic Cancer Club were contacted and agreed to participate in this analysis. Eight experts from seven centers in Austria provided their decision algorithms for the first-line treatment of patients with mPC. Their responses were converted into decision trees based on the objective consensus methodology. The decision trees were used to identify consensus and discrepancies. Results: The final treatment algorithms included four decision criteria (performance status, age, comorbidities, and symptomatic disease) and six treatment options: mFOLFIRINOX, gemcitabine + nab-paclitaxel, gemcitabine mono, 5-FU mono, gemcitabine/erlotinib, and best supportive care (BSC). Conclusions: We identified consensus for the treatment of young and fit patients with mFOLFIRINOX. With higher age and reduced performance status, gemcitabine + nab-paclitaxel was increasingly used. For patients with Eastern Co-operative Oncology Group Performance Status (ECOG PS) 4, BSC was the treatment of choice. Among experts, different decision criteria and treatment options are implemented in clinical routine. Despite multiple options in current recommendations, a consensus for specific recommendations was identified.

scholarly journals Folfirinox versus gemcitabine/nab-paclitaxel as first-line therapy in patients with metastatic pancreatic cancer: a comparative propensity score study

2019 ◽  
Vol 12 ◽  
pp. 175628481987866 ◽  
Author(s):  
Nicolas Williet ◽  
Angélique Saint ◽  
Anne-Laure Pointet ◽  
David Tougeron ◽  
Simon Pernot ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Propensity Score ◽  
Liver Metastases ◽  
Performance Status ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Reverse Sequence ◽  
Metastatic Sites

Background: Folfirinox (FFX) and gemcitabine/nab-paclitaxel (GN) are both standard first-line treatments in patients with metastatic pancreatic cancer (mPC). However, data comparing these two chemotherapeutic regimens and their sequential use remain scarce. Methods: Data from two independent cohorts enrolling patients treated with FFX ( n = 107) or GN ( n = 109) were retrospectively pooled. Primary endpoint was overall survival (OS). Progression-free survival (PFS) was the secondary endpoint. A propensity score based on age, gender, performance status (PS), and presence of liver metastases was used to make groups comparable. Results: In the whole study population, OS was significantly higher in FFX (14 months; 95% CI: 10–21) than in GN groups (9 months; 95% CI: 8–12) before ( p = 0.008) and after ( p = 0.021) adjusting for age, number of metastatic sites, liver metastases, peritoneal carcinomatosis and CA19.9 level at baseline. PFS tends to be higher in FFX (6 months) than GN groups (5 months; p = 0.053). After matching ( n = 49/group), patients were comparable for all baseline characteristics including PS. In the matched population, there was a trend toward greater OS in patients treated with FFX (HR = 0.67; p = 0.097). However, survival in each group was not solely a result of the first-line regimen. The proportion of patients who were fit for GN after FFX failure (FFX–GN sequence) was higher (46.9%) than the reverse sequence (20.4%; p = 0.01), which suggests a higher feasibility for the FFX–GN sequence. Corresponding median OS were 19 months versus 9.5 months, respectively ( p = 0.094). Conclusion: This study shows greater OS with FFX than with GN in patients with mPC. GN after FFX failure appears more feasible than the reverse sequence.

A phase II trial of weekly gemcitabine and bevacizumab in combination with abdominal radiation therapy in patients with localized pancreatic cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15043-15043 ◽  
Author(s):  
W. Small ◽  
M. Mulcahy ◽  
A. Benson ◽  
S. Gold ◽  
R. Bredesen ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Metastatic Pancreatic Cancer ◽  
Organ Function ◽  
Ecog Performance Status ◽  
Cross Sectional ◽  
Cross Sectional Imaging ◽  
The Mean ◽  
Grade 3

15043 Purpose: To evaluate the response rate, survival and toxicity of non-metastatic pancreatic cancer patients treated with a combination of, Gemcitabine, Bevacizumab and Radiotherapy. Materials and Methods: Eligibility included patients with non- metastatic pancreatic cancer, standard organ function and ECOG performance status of 0 or 1. The patients received three cycles of therapy. Cycle one was 21 days and consisted of Gemcitabine days 1 and 8 and Bevacizumab days 1 and 15. Cycle 2 was 28 days and consisted of Gemcitabine days 1, 8, and 15, Bevacizumab days 8 and 22 and Radiotherapy days 1–5, 8–12, and 15–19. Cycle three was 21 days and delivered Gemcitabine days 1 and 8, and Bevacizumab day 8. The Gemcitabine dose was 1,000 mg/m2, Bevacizumab at 10 mg/kg and Radiotherapy was delivered to the gross tumor volume only for a total dose of 36 Gy at 2.4 Gy/fraction. Response was determined on week ten with cross sectional imaging and CA 19–9. Toxicities were scored utilizing CTC version 3.0. Resectable patients were to undergo surgery 8 (currently amended to 6) weeks after the last dose of Bevacizumab. Results: Ninteen patients have been enrolled on study from 10/10/05 - 1/4/07. Twelve patients are evaluable for toxicity and response. Ten (83%) had a grade 3 toxicity. The grade 3 toxicities included cytopenias (9), DVT (2), Dehydration (2), hypotension (1), mucositis (1), increased LFT’s (2), Anorexia (1), nausea (1) and fatigue (1).There were no Grade 4 or 5 toxicities. All but one patient completed all three cycles. Radiographic response at 10 weeks was noted to be stable in 10 (83%) patients. Two patients progressed distantly (liver and abdomen). The mean CA 19–9 pre and post treatment CA 19–9 was 1519.56 and 356.09 respectively. One patient underwent surgical resection. The mean follow up is 4.83 months. At last follow up nine patients were alive. Conclusions: The combination of full dose Gemcitabine, Bevacizumab and Radiotherapy was generally well tolerated with no Grade 4 toxicities and the majority of Grade 3 toxicities hematologic. All but one patient completed all three cycles. Responses were limited to a reduction in CA 19–9. Nine patients remain alive. Accrual to the trial continues. No significant financial relationships to disclose.

Safety and efficacy of modified FOLFIRINOX in pancreatic cancer: A retrospective experience.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14614-e14614 ◽  
Author(s):  
Hemchandra Mahaseth ◽  
John S. Kauh ◽  
Edith Brutcher ◽  
Natalyn Nicole Hawk ◽  
Sungjin Kim ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
Clinical Activity ◽  
Ecog Performance Status ◽  
Emory University ◽  
Grade 3

e14614 Background: Conroy et al reported a significant improvement in overall survival of patients with metastatic pancreatic cancer treated with FOLFIRINOX compared to single agent gemcitabine. The regimen was associated with significant grade 3/ 4 toxicities, such as myelosuppression(46%), fatigue(24%), vomiting(15%) and diarrhea (13%). In order to improve the toxicity profile, we have modified FOLFIRINOX (mFOLFIRINOX) regimen by removing the bolus 5-FU and adding the routine use of growth factor prophylaxis. We present our experience with mFOLFIRINOX in patients with locally advanced or metastatic pancreatic cancer. Methods: After obtaining IRB approval, patients with a diagnosis of pancreatic cancer were identified from the Emory University tumor registry. Twenty eight patients who received at least one dose of mFOLFIRINOX (5-FU 2400 mg/m2 CIVI over 46 hours, leucovorin 400 mg/m2, oxaliplatin 85 mg/m2, irinotecan 180 mg/m2 and pegfilgrastim 6 mg every two weeks ) were selected and their charts were retrospectively reviewed for safety, response, and survival. Results: Of 28 patients, 14 (50%) were male, 18 (64%) white, 8 (29%) black and other 2(7%). Median age was 63 (50-75) and ECOG performance status 0-1. Nineteen (68%) patients had primary tumor located in head of pancreas. Eight patients (29%) experienced grade 3/4 toxicities, i.e., nausea/vomiting (11%), diarrhea (11%), fatigue (11%), neuropathy (4%), neutropenia (4%), thrombocytopenia(4%), and sepsis not-related to neutropenia (4%). No grade 3/4 anemia or febrile neutropenia was noted. mFOLFIRINOX controlled the disease in 20 patients (71%) with 2 CR, 4 PR and 14 SD. With a median follow up of 5.5 months, median overall or progression free survival is not reached. Two patients have died and six patients have progressed. Conclusions: Modified FOLFIRINOX is well tolerated in this US population. The clinical activity appears very promising with majority of patients being free of progression.

Abstract PO-029: Using treatment to determine ECOG performance status in metastatic pancreatic cancer

2020 ◽  
Author(s):  
Suvina Amin ◽  
Elisabetta Malangone-Monaco ◽  
Virginia Noxon ◽  
Seongiung Joo ◽  
Michael J. Pishvaian
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Metastatic Pancreatic Cancer ◽  
Ecog Performance Status

Potential role of chemoradiotherapy for metastatic pancreatic cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 344-344
Author(s):  
D. Y. Lee ◽  
J. M. Robertson ◽  
J. Huang ◽  
J. H. Margolis ◽  
S. Balaraman ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Cancer Patients ◽  
Performance Status ◽  
Metastatic Pancreatic Cancer ◽  
Categorical Variables ◽  
Ecog Performance Status ◽  
Term Survival ◽  
Kaplan Meier ◽  
Radiotherapy Dose

344 Background: Patients with metastatic pancreatic cancer have a poor outcome and the radiotherapy is typically only given to patients requiring palliation. We analyzed our institutional pancreas database to compare the outcome between chemotherapy alone vs. chemoradiotherapy. Methods: From January 2000 to December 2008, 199 metastatic pancreatic cancer patients were retrospectively analyzed. 13 (6.5%) patients received chemoradiotherapy and 186 (93.5%) patients received chemotherapy alone. Chemotherapy regimens consisted of 5-fluorouracil, gemcitabine, erlotinib, or cisplatin. The follow-up time was calculated from the time of diagnosis to the date of death or the last contact. Kaplan-Meier analysis was used to calculate the overall survival (OS). Results: Median OS was 5.3 months for all patients. Median OS was 4.9 months (0.4–27.0) for patients treated with chemotherapy alone and 7.8 months (0.6–44.1) for those treated with chemoradiotherapy (p = 0.013). Univariate survival analysis of categorical variables for patients treated with chemoradiotherapy revealed that age, race, gender, location of metastatic site, T stage (T3 v. T4) or nodal stage were not significant. However, ECOG performance status (1 v. 2/3) and the dose of radiation (<35 v. >35 Gy) received were associated with improved survival (p = 0.013, p=0.049). Median OS was 12.9 months for ECOG 1 vs. 5.6 months for ECOG 2/3. Median OS was 11.1 months for patients treated with radiotherapy dose > 35 Gy vs. 5.9 months for those who received less than 35 Gy. 3/13 (23%) patients who received chemoradiotherapy lived nearly two years or more. Conclusions: Metastatic pancreatic cancer patients with good performance score may benefit from chemoradiotherapy. Long-term survival was observed in this selected group. No significant financial relationships to disclose.

Randomized phase II trial of olaparib + pembrolizumab versus olaparib alone as maintenance therapy in metastatic pancreatic cancer patients with germline BRCA1 or BRCA2 (gBRCA1/2+) mutations: SWOG S2001.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS447-TPS447
Author(s):  
Vincent Chung ◽  
Katherine A Guthrie ◽  
Michael J. Pishvaian ◽  
Andrew M. Lowy ◽  
Elena Gabriela Chiorean ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Maintenance Therapy ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Progression Free Survival ◽  
Disease Status ◽  
Primary Objective ◽  
Metastatic Pancreatic Cancer ◽  
First Line ◽  
Platinum Chemotherapy

TPS447 Background: Olaparib was approved in 2019 as maintenance therapy for g BRCA1/2+ metastatic pancreatic cancer (mPDA) patients (pts). The POLO trial showed an improvement in median progression free survival (mPFS) with olaparib compared to placebo (7.4 versus 3.8 months) for g BRCA1/2+ mPDA pts following either stable disease/response on first-line platinum chemotherapy. Preclinical studies have demonstrated that PARP inhibitors modulate the immune microenvironment by increasing genomic instability, PD-L1 expression and activating the immune inflammatory stimulator of interferon genes (STING) pathway. Several clinical studies in solid tumors have shown preliminary efficacy with the combination of PARP plus immune checkpoint inhibitors. Based upon these data, SWOG S2001 aims to further improve the PFS of g BRCA1/2+ mPDA pts. Methods: S2001 was developed in collaboration with the Alliance and was activated in SWOG in October 2020. mPDA pts with gBRCA1/2 mutations identified with standard of care germline genetic testing will be eligibleif no progression after receiving 4 to 6 months of platinum chemotherapy (FOLFIRINOX, FOLFOX or gemcitabine/cisplatin). Zubrod performance status (PS) 0 or 1 pts are eligible. Pts will be stratified according to first line chemotherapy, PS 0 versus 1, and disease status after first-line treatment. The primary objective of this study is to evaluate the PFS of mPDA pts treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy. Based upon the POLO trial, we expect a mPFS of 7 months in the control arm. Targeting a mPFS of 11.7 months in the experimental arm (hazard ratio 0.6) and assuming 15 months follow-up, 80% power and a 1-sided alpha=0.10, this design requires 78 evaluable pts to be accrued over 3 years. Prospective serial blood samples will be collected to bank DNA and RNA for future correlative studies. Support:NIH/NCI grants U10CA180888 and U10CA180819. Clinical trial information: TBD.

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