scholarly journals Clinical Effects of Stereotactic Body Radiation Therapy Targeting the Primary Tumor of Liver-Only Oligometastatic Pancreatic Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Xiaoqin Ji ◽  
Yulu Zhao ◽  
Chenglong He ◽  
Siqi Han ◽  
Xixu Zhu ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Propensity Score ◽  
Primary Tumor ◽  
Performance Status ◽  
Clinical Effects ◽  
Metastatic Progression ◽  
Efficacy And Safety ◽  
Good Performance Status ◽  
Local Progression ◽  
Head Of Pancreas

AimTo investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) targeting the primary tumor for liver-only oligometastatic pancreatic cancer.MethodsWe compared the efficacy and safety of SBRT plus chemotherapy with chemotherapy alone in patients with liver-only oligometastatic pancreatic cancer. The populations were balanced by propensity score-weighted and propensity score-matched analyses based on baseline variables. The primary outcome was overall survival (OS). The secondary outcomes included progression free survival (PFS), local progression, metastatic progression and symptomatic local control.ResultsThis is a retrospective study of 89 pancreatic cancer patients with liver-only oligometastasis. Overall, 34 (38.2%) and 55 (61.8%) patients received SBRT plus chemotherapy and chemotherapy alone, respectively. After propensity score matching, 1-year OS rate was 34.0% (95%CI, 17.8-65.1%) in the SBRT plus chemotherapy group and 16.5% (95%CI, 5.9-46.1%) in chemotherapy alone group (P=0.115). The 6-month PFS rate was 29.4% (95%CI, 15.4-56.1) in SBRT plus chemotherapy and 20.6% (95%CI, 8.8-48.6) in chemotherapy alone group (P=0.468), respectively. Further subgroup analysis indicated that the addition of SBRT improved OS in patients with primary tumor located in the head of pancreas (stratified HR, 0.28; 95% CI, 0.09 to 0.90) or good performance status (stratified HR, 0.24; 95% CI, 0.07 to 0.86). In terms of disease control, SBRT delayed local progression of pancreas (P=0.008), but not distant metastatic progression (P=0.56). Besides, SBRT offered significant abdominal/back pain relief (P=0.016) with acceptable toxicities.ConclusionsThe addition of SBRT to chemotherapy in patients with liver-only oligometastatic pancreatic cancer improves the OS of those with primary tumor located in the head of pancreas or good performance status. In addition, it is a safe and effective method for local progression control and local symptomatic palliation in patients with metastatic pancreatic cancer.

Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group

2007 ◽  
Vol 25 (16) ◽  
pp. 2212-2217 ◽  
Author(s):  
Richard Herrmann ◽  
György Bodoky ◽  
Thomas Ruhstaller ◽  
Bengt Glimelius ◽  
Emilio Bajetta ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Karnofsky Performance Score ◽  
Phase Iii Trial ◽  
Good Performance Status ◽  
Grade 3

PurposeThis phase III trial compared the efficacy and safety of gemcitabine (Gem) plus capecitabine (GemCap) versus single-agent Gem in advanced/metastatic pancreatic cancer.Patients and MethodsPatients were randomly assigned to receive GemCap (oral capecitabine 650 mg/m2twice daily on days 1 to 14 plus Gem 1,000 mg/m2by 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2by 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks). Patients were stratified according to center, Karnofsky performance score (KPS), presence of pain, and disease extent.ResultsA total of 319 patients were enrolled between June 2001 and June 2004. Median overall survival (OS) time, the primary end point, was 8.4 and 7.2 months in the GemCap and Gem arms, respectively (P = .234). Post hoc analysis in patients with good KPS (score of 90 to 100) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm (10.1 v 7.4 months, respectively; P = .014). The overall frequency of grade 3 or 4 adverse events was similar in each arm. Neutropenia was the most frequent grade 3 or 4 adverse event in both arms.ConclusionGemCap failed to improve OS at a statistically significant level compared with standard Gem treatment. The safety of GemCap and Gem was similar. In the subgroup of patients with good performance status, median OS was improved significantly. GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status.

Modified FOLFIRINOX regimen in advanced biliary tract adenocarcinoma.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 484-484 ◽  
Author(s):  
Amit Rauthan ◽  
Poonam Patil
Keyword(s):  
Biliary Tract ◽  
Performance Status ◽  
Progression Free Survival ◽  
Complete Response ◽  
Tertiary Hospital ◽  
Efficacy And Safety ◽  
Good Performance Status ◽  
Pancreatic Cancers ◽  
Grade 3 ◽  
Dose Modifications

484 Background: The treatment of advanced biliary tract adenocarcinoma is based on chemotherapy with Gemcitabine with Cisplatin or Oxaliplatin in various combinations. After seeing the high efficacy of FOLFIRINOX regimen in advanced pancreatic cancers, we studied the efficacy and safety of a modified FOLFIRINOX regimen in advanced biliary tract adenocarcinoma. Methods: We retrospectively reviewed patient with advanced biliary tract adenocarcinoma who were treated with modified FOLFIRINOX regimen from April 2013 to March 2016 in a tertiary hospital. The schedule of modified FOLFIRINOX was - Oxaliplatin 85 mg/m2, Irinotecan 150 mg/ m2, Leucovorin 400 mg/m2, and 5 fluorouracil 2400 mg/m2given as a 46-hour continuous infusion, every 2 weeks. All patients received primary prophylactic growth factors. The objective was to evaluate the efficacy and safety of FOLFIRINOX regimen. Results: 20 patients with untreated advanced biliary tract adenocarcinoma were enrolled. The median age was 55 (range 31 to 66 years). All patients had good performance status. 2 patients had a complete response (10%), 8 patients had a partial response (40%), 5 patients had stable disease (25%) and 5 patients had progression (25%). The median progression free survival was 6 months and the median overall survival was 10 months. The major toxicities were grade 3/4 neutropenia (30%), oral mucositis (20%), fatigue (20%) and neuropathy (10%). Dose reduction was required in 30% patients. Conclusions: A modified FOLFIRINOX regimen is an effective regimen in good performance status patients with advanced biliary tract adenocarcinoma. Dose modifications are required to reduce toxicity of the regimen. It needs to be further studied in a phase 3 study in comparison to Gemcitabine based regimens.

scholarly journals Irreversible electroporation followed by chemotherapy vs. chemotherapy alone for locally advanced pancreatic cancer: A large cohort propensity score analysis.

2019 ◽  
Vol 5 (suppl) ◽  
pp. 117-117
Author(s):  
Chaobin He ◽  
Shengping Li
Keyword(s):  
Pancreatic Cancer ◽  
Propensity Score ◽  
Combination Therapy ◽  
Propensity Score Analysis ◽  
Locally Advanced ◽  
Irreversible Electroporation ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Combination Method ◽  
Local Progression

117 Background: Locally advanced pancreatic cancer (LAPC) has a dismal prognosis with the standard chemotherapy and the local progression contributed to nearly one-third of deaths of these patients. Irreversible electroporation (IRE) is a local destructive method which is feasible for the treatment of LAPC. The aim of this study was to evaluate IRE combined with chemotherapy as a new treatment and compared its efficacy with that of chemotherapy alone for LAPC patients. Methods: Data of LAPC patients who received chemotherapy combined IRE or not were extracted from database of the Surveillance, Epidemiology, and End Results (SEER) and Sun Yat-sen University Cancer Center (SYSUCC). The efficacy of these two treatments was compared based on data analyzed with propensity score matching (PSM) analysis. Results: In all, 3515 LAPC patients from SEER database were included, including 3348 patients received chemotherapy and 167 patients received combination therapy of IRE and chemotherapy. Additionally, 36 patients who received IRE plus chemotherapy and another 96 patients who received chemotherapy from the SYSUCC were included. After PSM, survival rates were compared between two groups. Patients in combination group achieved better survival than those in chemotherapy group [SEER: overall survival (OS), 16.0 months (95% CI, 12.0-21.0) vs 9.0 months (95% CI, 7.2-11.6), P < 0.001; SYSUCC: OS, 21.6 months (95% CI, 17.8-25.3) vs 7.1 months (95% CI, 5.4-9.5), P = 0.006]. Moreover, similar better results in terms of cancer-specific survival (CSS) and progression-free survival (PFS) were observed in patients who received combination therapy compared with chemotherapy alone. IRE combined with chemotherapy was shown as a favorable factor for OS, CSS and PFS in LAPC patients. Conclusions: Patients with LAPC who received IRE combined with chemotherapy had better survival compared with those after chemotherapy treatment alone. This combination method may be a more suitable way of treatment for patients with LAPC.

scholarly journals Portal-Mesenteric Vein Resection in Borderline Pancreatic Cancer; 33 Month-Survival in Patients with Good Performance Status

2019 ◽  
Vol 5 (1) ◽  
pp. 43-50 ◽  
Author(s):  
Gregory G. Tsiotos ◽  
Nikiforos Ballian ◽  
Theodoros Michelakos ◽  
Fotios Milas ◽  
Panoraia Ziogou ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Mesenteric Vein ◽  
Good Performance Status ◽  
Vein Resection ◽  
Borderline Pancreatic Cancer

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.

Phase II Study of Radiotherapy Employing Proton Beam for Hepatocellular Carcinoma

2005 ◽  
Vol 23 (9) ◽  
pp. 1839-1846 ◽  
Author(s):  
Mitsuhiko Kawashima ◽  
Junji Furuse ◽  
Teiji Nishio ◽  
Masaru Konishi ◽  
Hiroshi Ishii ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Cirrhosis ◽  
Proton Beam ◽  
Primary Tumor ◽  
Retention Rate ◽  
Performance Status ◽  
Tumor Diameter ◽  
Eligibility Criteria ◽  
Local Ablation ◽  
Local Progression

Purpose To evaluate the safety and efficacy of proton beam radiotherapy (PRT) for hepatocellular carcinoma. Patients and Methods Eligibility criteria for this study were: solitary hepatocellular carcinoma (HCC); no indication for surgery or local ablation therapy; no ascites; age ≥ 20 years; Zubrod performance status of 0 to 2; no serious comorbidities other than liver cirrhosis; written informed consent. PRT was administered in doses of 76 cobalt gray equivalent in 20 fractions for 5 weeks. No patients received transarterial chemoembolization or local ablation in combination with PRT. Results Thirty patients were enrolled between May 1999 and February 2003. There were 20 male and 10 female patients, with a median age of 70 years. Maximum tumor diameter ranged from 25 to 82 mm (median, 45 mm). All patients had liver cirrhosis, the degree of which was Child-Pugh class A in 20, and class B in 10 patients. Acute reactions of PRT were well tolerated, and PRT was completed as planned in all patients. Four patients died of hepatic insufficiency without tumor recurrence at 6 to 9 months. Three of these four patients had pretreatment indocyanine green retention rate at 15 minutes of more than 50%. After a median follow-up period of 31 months (16 to 54 months), only one patient experienced recurrence of the primary tumor, and 2-year actuarial local progression-free rate was 96% (95% CI, 88% to 100%). Actuarial overall survival rate at 2 years was 66% (48% to 84%). Conclusion PRT showed excellent control of the primary tumor, with minimal acute toxicity. Further study is warranted to scrutinize adequate patient selection in order to maximize survival benefit of this promising modality.

AGIG chemo-immunotherapy in patients with advanced pancreatic cancer: A single-arm, single-center, phase II study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 384-384
Author(s):  
Wangshu Dai ◽  
Xin Qiu ◽  
Changchang Lu ◽  
Zhengyun Zou ◽  
Huizi Sha ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Therapeutic Option ◽  
Performance Status ◽  
Interleukin 2 ◽  
Advanced Pancreatic Cancer ◽  
Efficacy And Safety ◽  
First Line ◽  
Gm Csf

384 Background: To date, chemotherapy remains the only effective treatment of unresectable pancreatic adenocarcinoma. In the last few years, the interest in the use of immunological anticancer strategies is greatly increased. AGIG is a novel chemo-immunotherapy regimen that combines nab-paclitaxel + gemcitabine chemotherapy with sequential recombinant interleukin-2 and granulocyte-macrophage colony stimulating factor (GM-CSF) therapy. We conducted a single-arm prospective phase II study to determine the efficacy and safety of the first-line treatment of advanced pancreatic cancer with AGIG regimen. Methods: Nab-paclitaxel (120 mg/m2) and gemcitabine (1000 mg/m2) were administered intravenously to all patients on days 1 and 8 triweekly, interleukin-2 and GM-CSF (100 µg) were administered subcutaneously on days 3-5 after chemotherapy. The primary end point was ORR by the Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary end points included safety profile, progression-free survival (PFS), overall survival (OS). Patients’ conditions and the efficacy and safety were assessed every 4 cycles. Results: Between 11/2018 and 01/2020, 64 patients were enrolled. In the 64 evaluable patients, the ORR and DCR were 43.75% and 76.6%, respectively. The median follow-up time was 12.1 (range 7.1–22.4) months, the median PFS was 5.7 (range 1.63–15.8) months, and the median OS was 14.2 (range 2.9–22.0) months. The most common adverse event was fever (75%). The incidence of grade 3/4 neutropenia was 4.69%. In subgroup analyses, we found that eosinophil count in the blood elevated three times higher than baseline level predicted a longer survival. Conclusions: The AGIG Chemo-immunotherapy regimen has presented encouraging ORR, OS, and manageable toxicities as first-line therapy for advanced pancreatic cancer. This regimen may be a novel reliable therapeutic option for patients with preserved performance status. The improvement of treatment efficiency may be related to the activation of non-specific immune response. Clinical trial information: NCT0376867. Research Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. [Table: see text]

scholarly journals AGIG Chemo-Immunotherapy in Patients With Advanced Pancreatic Cancer: A Single-Arm, Single-Center, Phase 2 Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Wangshu Dai ◽  
Xin Qiu ◽  
Changchang Lu ◽  
Zhengyun Zou ◽  
Huizi Sha ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Therapeutic Option ◽  
Performance Status ◽  
Interleukin 2 ◽  
Advanced Pancreatic Cancer ◽  
Common Adverse Event ◽  
Efficacy And Safety ◽  
First Line ◽  
Clinical Trial Registration ◽  
Gm Csf

BackgroundTo date, chemotherapy remains the only effective treatment of unresectable pancreatic adenocarcinoma. In the past few years, the interest in immunological anticancer therapy rises sharply. AGIG is a novel chemo-immunotherapy regimen that combines nab-paclitaxel + gemcitabine chemotherapy with sequential recombinant interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF) therapy. We conducted a single-arm prospective phase II study to determine the efficacy and safety of the first-line treatment of advanced pancreatic cancer with AGIG regimen.MethodsNab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) were administered intravenously to all patients on days 1 and 8 triweekly, interleukin-2 (1000000U) and GM-CSF (100 µg) were administered subcutaneously on days 3-5 after chemotherapy. The primary end point was ORR by the Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary end points included safety profile, progression-free survival (PFS), overall survival (OS). Patients’ conditions along with the efficacy and safety were assessed every two cycles.ResultsBetween 11/2018 and 01/2020, sixty-four patients were enrolled. In the sixty-four evaluable patients, the disease control rate (DCR) and overall response rate (ORR) were 76.6% and 43.75%, respectively. The median follow-up time was 12.1 (range 7.1–22.4) months. The median PFS was 5.7 (range 1.63–15.8) months. The median OS was 14.2 (range 2.9–22.0) months. The most common adverse event was fever (75%). The incidence of III/IV grade neutropenia was 4.69%. In subgroup analyses, we found that eosinophil count in the blood elevated three times higher than baseline level predicted a longer survival.ConclusionsThe AGIG chemo-immunotherapy regimen has presented favorable ORR, OS, and manageable toxicities as first-line therapeutic strategy of advanced pancreatic cancer treatment. This regimen may be a novel reliable therapeutic option for patients with preserved performance status. The improvement of treatment efficiency may be related to the activation of non-specific immune response.Clinical Trial Registrationhttps://clinicaltrials.gov/. identifier NCT03768687.

High C-reactive protein (CRP) level and leukocytosis as a prognostic factor for metastatic pancreatic cancer (MPC) patients with good performance status.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14677-e14677
Author(s):  
Masato Ozaka ◽  
Hiroshi Ishii ◽  
Seigo Yukisawa
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Prognostic Factor ◽  
Cancer Patients ◽  
Selection Criteria ◽  
Performance Status ◽  
Metastatic Pancreatic Cancer ◽  
Poor Overall Survival ◽  
Poor Prognostic Factor ◽  
Good Performance Status

e14677 Background: Prognostic factor for metastatic pancreatic cancer patients (pts) with good performance status has not been fully evaluated. The objective is to investigate the prognostic factor for metastatic pancreatic cancer patients with good performance status. Methods: Data was collected from the medical records of patients at our hospital. The selection criteria were as follows: 1) histologically proven MPC, 2) ECOG performance status 0 or 1, 3) inoperable or recurrent metastatic disease treated with systemic chemotherapy between Sep. 2007 and June 2011. Results: There were 123 pts who met selection criteria in this study. The median age was 65 years (range, 41-86); male/female, 70/53 pts; the metastatic site was liver/peritoneum/lung/lymph nodes/others in 75/31/15/10/ pts. Median overall survival was 9.5 months, respectively. Of the 123, 11 pts showed leukocytosis (WBC>10000) and 19 pts showed High CRP level (CRP>2.0). Pts with leukocytosis and high CRP level showed significantly poor overall survival (4.44 and 4.44 months). A multivariate analysis demonstrated that a leukocytosis and high CRP level were independent unfavorable prognostic factors. Conclusions: High CRP level and leukocytosis may be a poor prognostic factor for MPC patients with good performance status.

Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

2016 ◽  
Vol 34 (21) ◽  
pp. 2541-2556 ◽  
Author(s):  
Alok A. Khorana ◽  
Pamela B. Mangu ◽  
Jordan Berlin ◽  
Anitra Engebretson ◽  
Theodore S. Hong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Palliative Care ◽  
Adjuvant Chemotherapy ◽  
Primary Tumor ◽  
Performance Status ◽  
Disease Free Survival ◽  
Preoperative Therapy ◽  
Psychological Status ◽  
Free Survival

Purpose To provide evidence-based recommendations to oncologists and others on potentially curative therapy for patients with localized pancreatic cancer. Methods ASCO convened a panel of medical oncology, radiation oncology, surgical oncology, palliative care, and advocacy experts and conducted a systematic review of literature from January 2002 to June 2015. Outcomes included overall survival, disease-free survival, progression-free survival, and adverse events. Results Nine randomized controlled trials met the systematic review criteria. Recommendations A multiphase computed tomography scan of the abdomen and pelvis or magnetic resonance imaging should be performed for all patients to assess the anatomic relationships of the primary tumor and for the presence of intra-abdominal metastases. Baseline performance status, comorbidity profile, and goals of care should be evaluated and established. Primary surgical resection is recommended for all patients who have no metastases, appropriate performance and comorbidity profiles, and no radiographic interface between primary tumor and mesenteric vasculature. Preoperative therapy is recommended for patients who meet specific characteristics. All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of contraindications. Adjuvant chemoradiation may be offered to patients who did not receive preoperative therapy with microscopically positive margins (R1) after resection and/or who had node-positive disease after completion of 4 to 6 months of systemic adjuvant chemotherapy. Patients should have a full assessment of symptoms, psychological status, and social supports and should receive palliative care early. Patients who have completed treatment and have no evidence of disease should be monitored. Additional information is available at www.asco.org/guidelines/PCPC and www.asco.org/guidelineswiki .

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