scholarly journals Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer

2010 ◽  
Vol 28 (12) ◽  
pp. 2058-2063 ◽  
Author(s):  
John A. Chabot ◽  
Wei-Yann Tsai ◽  
Robert L. Fine ◽  
Chunxia Chen ◽  
Carolyn K. Kumah ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Median Survival ◽  
Proteolytic Enzyme ◽  
Phase Iii ◽  
Enzyme Treatment ◽  
Enzyme Therapy ◽  
Treatment Groups ◽  
Chemotherapy Group

Purpose Conventional medicine has had little to offer patients with inoperable pancreatic adenocarcinoma; thus, many patients seek alternative treatments. The National Cancer Institute, in 1998, sponsored a randomized, phase III, controlled trial of proteolytic enzyme therapy versus chemotherapy. Because most eligible patients refused random assignment, the trial was changed in 2001 to a controlled, observational study. Methods All patients were seen by one of the investigators at Columbia University, and patients who received enzyme therapy were seen by the participating alternative practitioner. Of 55 patients who had inoperable pancreatic cancer, 23 elected gemcitabine-based chemotherapy, and 32 elected enzyme treatment, which included pancreatic enzymes, nutritional supplements, detoxification, and an organic diet. Primary and secondary outcomes were overall survival and quality of life, respectively. Results At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P < .001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P < .01). Conclusion Among patients who have pancreatic cancer, those who chose gemcitabine-based chemotherapy survived more than three times as long (14.0 v 4.3 months) and had better quality of life than those who chose proteolytic enzyme treatment.

scholarly journals Health-Related Quality of Life as Measured by the 12-Item Short-Form Survey Among Adults With Community-Acquired Bacterial Pneumonia who Received Either Lefamulin or Moxifloxacin in 2 Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials

2020 ◽  
Vol 7 (6) ◽  
Author(s):  
Thomas P Lodise ◽  
Sam Colman ◽  
Elizabeth Alexander ◽  
Daniel S Stein ◽  
David Fitts ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bacterial Pneumonia ◽  
Short Form ◽  
The United States ◽  
Phase Iii ◽  
Health Related Quality ◽  
Treatment Groups ◽  
Related Quality ◽  
Health Related

Abstract Background Interest in patient-reported outcomes (PROs) as part of benefit–risk assessment for new drug approvals is increasing. Lefamulin is the first intravenous (IV) and oral pleuromutilin antibiotic for treatment of adults with community-acquired bacterial pneumonia (CABP). Assessment of health-related quality of life (HRQoL) was prospectively incorporated in its CABP trials (Lefamulin Evaluation Against Pneumonia [LEAP] 1 and 2) via the 12-Item Short-Form Survey (SF-12), a widely used PRO that measures general health status in 8 domains. Methods HRQoL was evaluated by SF-12 at baseline and test of cure (TOC; 5–10 days after the last study drug dose) in patients who received lefamulin or moxifloxacin in LEAP 1 (IV/oral treatment) and LEAP 2 (oral-only treatment). SF-12 outcomes included the 8 domains, physical component and mental component summary scores, and the Short-Form Six-Dimension health utility score. Results Analysis included 1215 patients (lefamulin: n = 607; moxifloxacin: n = 608). At baseline, all mean SF-12 scores in both treatment groups were well below the United States reference mean. Clinically meaningful and significant improvements from baseline to TOC were observed in all SF-12 scores. No significant differences in mean score improvements from baseline to TOC between treatment groups were observed. SF-12 score improvements at TOC across predefined subgroups were comparable between treatment groups. Conclusions Results indicate that adults with CABP experienced comparable HRQoL improvements with lefamulin relative to moxifloxacin, and treatment with either agent resulted in returns to population norm HRQoL levels. These data suggest that lefamulin is a potential alternative to moxifloxacin for treatment of adults with CABP.

A New Direction for Pancreatic Cancer Treatment: FOLFIRINOX in Context

2012 ◽  
pp. 232-237 ◽  
Author(s):  
Hedy Lee Kindler
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Biliary Stents ◽  
Borderline Resectable

Overview: Since 1996, the cornerstone of chemotherapy for advanced pancreatic cancer has been gemcitabine, which has a genuine, but modest effect on survival and quality of life. It has been remarkably difficult to improve on these outcomes. Many phase III studies of gemcitabine doublets have been uniformly negative, with the exception of a trial of gemctabine plus erlotinib, which provided only marginal benefit. In 2010, the FOLFIRINOX regimen (bolus and infusional 5-fluorouracil, irinotecan, and oxaliplatin) emerged as a major treatment advance for patients with metastatic pancreatic cancer. In a trial with 342 patients, FOLFIRINOX yielded a longer median overall survival (11.1 vs. 6.8 months, hazard ratio [HR] 0.57, p < 0.001), a superior progression-free survival (6.4 vs. 3.3 months, HR 0.47, p < 0.001), a higher objective response rate (31.6% vs. 9.4%, p < 0.001), and a significant increase in time until definitive deterioration in quality of life, compared with gemcitabine. FOLFIRINOX is also more cost-effective than gemcitabine. Because of higher rates of grade 3 to 4 neutropenia (46% vs. 21%), febrile neutropenia (5% vs. 1%), and diarrhea (13% vs. 2%) with FOLFIRINOX, vigilant patient selection, education, and monitoring are essential. Retrospective single-institution series confirm the substantial activity of FOLFIRINOX in metastatic, locally advanced, and previously-treated patients; demonstrate its safety in individuals with biliary stents; and elucidate how physicians routinely modify drug doses without clear evidence or guidelines. Ongoing and planned studies will prospectively evaluate FOLFIRINOX in the adjuvant, locally advanced, and borderline resectable settings, will add targeted agents to FOLFIRINOX, and will evaluate how to adjust doses to ameliorate toxicity.

scholarly journals Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Analysis of Quality of Life during a Phase III Study

2021 ◽  
pp. 1-8
Author(s):  
Alexander V. Karaulov ◽  
Natalia Nenasheva ◽  
Yury Smolkin ◽  
Aleksandr Maslakov ◽  
Luiz Lucio
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Triamcinolone Acetonide ◽  
Allergic Conjunctivitis ◽  
Phase Iii ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Previous Diagnosis ◽  
Post Hoc

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease that affects ≤24% of people in Russia, significantly impairing quality of life (QoL). Intranasal corticosteroids, such as triamcinolone acetonide (TAA), are considered effective drugs for treatment. A post hoc analysis of data (phase III NASANIF trial) examined weekly QoL changes in patients receiving TAA for the treatment of perennial AR (PAR). <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel group, multicenter, prospective, noninferiority, phase III clinical trial. Patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) for 4 weeks. Here, a post hoc analysis measures QoL using a shortened Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ). Differences in miniRQLQ score were evaluated using a mixed linear model and descriptive statistics. A subgroup analysis was performed in patients with a previous diagnosis of allergic conjunctivitis. <b><i>Results:</i></b> Of 260 patients eligible for randomization, 128 each completed treatment with TAA or FP. Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups: LS mean difference TAA: −30.92 (95% CI [−33.01 to −28.83]), <i>p</i> &#x3c; 0.001, and FP: −31.13 (−33.23 to −29.04), <i>p</i> &#x3c; 0.001. In both arms of the subgroup, there was a significant reduction in eye symptoms. There was no significant difference between the TAA and FP treatment groups in any analyses. <b><i>Conclusions:</i></b> TAA is effective in improving overall and individual domains of QoL in patients with PAR, over 4 weeks. Patients with a previous diagnosis of allergic conjunctivitis experienced significant improvements in QoL related to the resolution of these symptoms.

Significance of baseline quality of life scores in predicting clinical outcomes in an international phase III trial of advanced pancreatic cancer: NCIC CTG PA.3.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4053-4053
Author(s):  
Michael M. Vickers ◽  
Dongsheng Tu ◽  
Chee Lee ◽  
Paul Wheatley-Price ◽  
Wendy Parulekar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Adverse Events ◽  
Lower Risk ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Clinical Variables ◽  
Patient Reported ◽  
Grade 3

4053 Background: There is insufficient information regarding the prognostic significance of baseline Quality of life (QoL) scores on overall survival (OS) and adverse events (AEs) in advanced pancreatic cancer. Methods: QoL was assessed prospectively using the EORTC QLQ-C30 and AEs were graded using the NCI Common Toxicity Criteria version 2.0 as part of the PA.3 trial of gemcitabine + erlotinib (G+E) vs. gemcitabine + placebo (G+P). Relevant clinical variables, ECOG performance status (PS), and QoL scores at baseline were analyzed by Cox stepwise regression to determine predictors of OS and AEs. QoL scores were transformed by square root. Results: 222 of 285 patients (pts) (78%) treated with G+E and 220 of 284 pts (77%) treated with G+P completed baseline QoL assessments. In a multivariate Cox analysis (MVA) combining all pts, better QoL physical function (PF) score independently and incrementally predicted longer OS (HR 0.91; CI: 0.83-1.00), as did non-white race (HR 0.62; CI: 0.42-0.91), PS 0-1 (vs. PS 2 - HR 0.64; CI: 0.49-0.84), locally advanced pancreatic cancer (LAPC) (vs. metastatic - HR 0.54; CI: 0.42-0.69) and G+E (vs. G+P - HR 0.79; CI: 0.64-0.98). More financial difficulty (HR 0.92; CI: 0.87-0.98) and PS 0-1 (HR: 0.36; CI: 0.17-0.77) predicted a lower risk of grade 3 or higher AEs. In a MVA of pts treated with G+E, pain intensity <20 (vs. ≥ 20 - HR 0.68; CI:0.52-0.88) and LAPC (HR 0.67; CI: 0.48-0.91) were associated with longer OS, while better QoL cognitive (HR 0.71; CI: 0.50-1.00), worse constipation (HR 0.89; CI: 0.81-0.98) and worse financial scores (HR 0.86; CI: 0.78-0.94), better dyspnea score (HR 0.82; CI: 0.71-0.93) and PS 0-1 (HR 0.21; CI: 0.05-0.78) predicted for lower risk of AEs. In a MVA of pts treated with G+P, better global QoL score (HR 0.91; CI:0.85-0.98) and LAPC (HR 0.57; CI: 0.40-0.82) were predictors of longer OS while no variables predicted grade 3 or higher AEs. Conclusions: In addition to clinical variables (including physician assessed PS), patient reported QoL scores added incremental predictive information regarding survival and adverse events for advanced pancreatic cancer patients treated with systemic chemotherapy.

Multicenter Randomized Phase III Trial Comparing Protracted Venous Infusion (PVI) Fluorouracil (5-FU) With PVI 5-FU Plus Mitomycin in Inoperable Pancreatic Cancer

2002 ◽  
Vol 20 (14) ◽  
pp. 3130-3136 ◽  
Author(s):  
Nick Maisey ◽  
Ian Chau ◽  
David Cunningham ◽  
Andrew Norman ◽  
Matt Seymour ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Response Rate ◽  
Randomized Study ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Treatment Groups ◽  
Significant Difference ◽  
Uremic Syndrome ◽  
Venous Infusion

PURPOSE: To compare protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin (MMC) in patients with advanced pancreatic cancer in a multicenter, prospectively randomized study. PATIENTS AND METHODS: Two hundred eight patients were randomized to PVI 5-FU (300 mg/m2/d for a maximum of 24 weeks) or PVI 5-FU plus MMC (7 mg/m2 every 6 weeks for four courses). The major end points were tumor response, survival, toxicity, and quality of life (QOL). RESULTS: The two treatment groups were balanced for baseline demographic factors, and 62% had metastatic disease. The overall response rate was 8.4% (95% confidence interval [CI]) 3.2% to 13.7% for patients treated with PVI 5-FU alone compared with 17.6%; 95% CI 10.3% to 25.1% for PVI 5-FU plus MMC (P = .04). Median failure-free survival was 2.8 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC (P = .14). Median survival was 5.1 months for PVI 5-FU and 6.5 months for PVI 5-FU plus MMC (P = .34). Toxicities in both arms were mild. There was an increased incidence of neutropenia in the 5-FU plus MMC arm (P < .01), although no differences in infection were seen. No patients developed hemolytic uremic syndrome. Global QOL improved significantly after 24 weeks of treatment compared with baseline for patients receiving 5-FU plus MMC, although there was no statistically significant difference in QOL between arms. CONCLUSION: PVI 5-FU plus MMC resulted in a superior response rate in comparison with PVI 5-FU alone in advanced pancreatic cancer, but this did not translate into a survival advantage. These results emphasize the importance of chemotherapy in this setting and the continuing value of the fluoropyrimidines in pancreatic cancer.

Clinical Benefit and Quality of Life in Patients With Advanced Pancreatic Cancer Receiving Gemcitabine Plus Capecitabine Versus Gemcitabine Alone: A Randomized Multicenter Phase III Clinical Trial—SAKK 44/00–CECOG/PAN.1.3.001

2008 ◽  
Vol 26 (22) ◽  
pp. 3695-3701 ◽  
Author(s):  
Jürg Bernhard ◽  
Daniel Dietrich ◽  
Werner Scheithauer ◽  
Daniela Gerber ◽  
György Bodoky ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Treatment Failure ◽  
Clinical Benefit ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii

Purpose To compare clinical benefit response (CBR) and quality of life (QOL) in patients receiving gemcitabine (Gem) plus capecitabine (Cap) versus single-agent Gem for advanced/metastatic pancreatic cancer. Patients and Methods Patients were randomly assigned to receive GemCap (oral Cap 650 mg/m2 twice daily on days 1 through 14 plus Gem 1,000 mg/m2 in a 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2 in a 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks) for 24 weeks or until progression. CBR criteria and QOL indicators were assessed over this period. CBR was defined as improvement from baseline for ≥ 4 consecutive weeks in pain (pain intensity or analgesic consumption) and Karnofsky performance status, stability in one but improvement in the other, or stability in pain and performance status but improvement in weight. Results Of 319 patients, 19% treated with GemCap and 20% treated with Gem experienced a CBR, with a median duration of 9.5 and 6.5 weeks, respectively (P < .02); 54% of patients treated with GemCap and 60% treated with Gem had no CBR (remaining patients were not assessable). There was no treatment difference in QOL (n = 311). QOL indicators were improving under chemotherapy (P < .05). These changes differed by the time to failure, with a worsening 1 to 2 months before treatment failure (all P < .05). Conclusion There is no indication of a difference in CBR or QOL between GemCap and Gem. Regardless of their initial condition, some patients experience an improvement in QOL on chemotherapy, followed by a worsening before treatment failure.

Systemic therapy with a loco-regional treatment in patients with locally advanced pancreatic cancer: The SMART study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS445-TPS445
Author(s):  
Shahid Ahmed ◽  
Osama Ahmed ◽  
Deborah Anderson ◽  
Gavin Beck ◽  
Haji I. Chalchal ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Cost Effectiveness ◽  
Disease Progression ◽  
Combination Chemotherapy ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Phase Iii

TPS445 Background: Pancreatic cancer is a major cause of cancer-related death. About 40% of patients with pancreatic cancer present with locally advanced disease and are not candidates for curative surgery. Most patients are treated with chemotherapy with a limited life expectancy. The role of local treatment such as radiation is not well defined. Other conventional ablative therapies, such as thermal or cryoablation have limited role due to the risk of collateral damage to the adjacent structures. Irreversible electroporation (IRE) is a novel non-thermal ablation technology that does not cause injury to nearby blood vessels, ducts, and bowel and has the potential to provide longer disease control and thereby better overall survival. We hypothesized that addition of IRE to combination chemotherapy in patients with locally advanced pancreatic cancer will improve their outcomes, and patients with undetectable 12-week post IRE circulating tumor cell DNA will have better prognoses. Methods: It is a prospective, multicenter, single-arm phase II study. The primary objective is to determine 12-month PFS rate of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE. Secondary objectives include identification of prognostic and predictive biomarkers, 24-months survival rate, quality of life of subjects, as well as cost-effectiveness and complication rates of IRE. Based on the assumption that treatment with IRE and chemotherapy would result in doubling of PFS versus chemotherapy alone a sample of n = 27 of patients with locally advanced pancreatic adenocarcinoma is estimated. Eligible patients will be recruited at the two major cancer centers in Saskatchewan. All IRE-eligible patients will receive 12 weeks of induction combination chemotherapy and will undergo IRE if there is no disease progression. An additional 12 weeks of chemotherapy will be recommended. Patients who are not eligible for IRE will receive chemotherapy at the discretion of treating oncologist until disease progression or until they become eligible for IRE. Circulating tumor DNA and a panel of genes will be examined using next-generation sequencing for their correlation with prognosis. Quality of life will be assessed, and cost-effectiveness analysis of IRE will be performed.The results of this study will be used to develop a future multicenter, national phase III trial. Clinical trial information: NCT04276857.

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