Real-life results from the prospective QoliXane trial of the platform for outcome, quality of life, and translational research on pancreatic cancer (PARAGON) registry.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4625-4625
Author(s):  
Salah-Eddin Al-Batran ◽  
Ralf Dieter Hofheinz ◽  
Alexander Reichart ◽  
Claudia Pauligk ◽  
Rudolf Schlag ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Cox Regression ◽  
Real Life ◽  
Progression Free Survival ◽  
Response Analysis ◽  
First Line ◽  
Cox Regression Analysis ◽  
First Line Therapy

4625 Background: Gemcitabine and nab-paclitaxel (NPG) is standard first-line therapy for metastatic pancreatic cancer (mPC), but the pivotal study did not include quality of life (QoL) analyses. Methods: The QOLIXANE-PARAGON study started as a prospective, non-interventional, multicenter study conducted in Germany and transitioned into a permanent registry for pancreatic cancer patients (pts) considering all types of treatments. This report focuses on the pts enrolled into the QOLIXANE portion of the study. Pts were recruited from 95 German centers. QoL was prospectively measured via EORTC-C30 questionnaires (prior to and every month thereafter): therapy and efficacy parameters were prospectively collected. QoL and efficacy endpoints were analyzed in the intention-to-treat population (ITT). The primary endpoint was the rate of pts without deterioration of QoL/Global Health Score (QoL/GHS) at 3 months. Results: 600 pts were enrolled. Mean GHS/QoL score at baseline was low and was 46.2 (SD 22.8). Median progression-free survival was 5.85 months (95% CI, 5.23 to 6.25). Median overall survival (OS) was 8.91 months (95% CI, 7.89 to 10.19). The KM-analysis showed that 61% and 41% of pts had maintained QoL/GHS after 3 and 6 months, respectively. Median time to deterioration of QoL/GHS was 4.68 months (95% CI, 4.04 to 5.59). Mean QoL/GHS improved from 46.1 (SD 22.7) at baseline to 52.8 (SD 21.3) after 6 months. In the QoL response analysis, 34.6%, 37.4% and 28% of evaluable pts had improved, stable and worse QoL/GHS after 3 months, respectively. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a HR of 0.86 (p < 0.0001). Conclusions: QoliXane the largest study on QoL of mPC. It shows that time to deterioration of QoL is short but that a relevant group of mPC in first line have improved or maintained QoL after 3 and 6 months and that QoL is a predictor of pts outcome. Clinical trial information: NCT02691052 .

Bevacizumab associated calcifications might be a prognostic marker in patients with metastatic colorectal cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16108-e16108
Author(s):  
Yuwen Zhou ◽  
Qiu Meng
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Prognostic Marker ◽  
Cox Regression ◽  
Objective Response ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
First Line ◽  
Cox Regression Analysis ◽  
First Line Therapy

e16108 Background: Cetuximab associated calcifications is a positive predictive factor in metastatic colorectal cancer (mCRC). In patients with glioblastoma, bevacizumab-induced calcifications are also related to a better prognosis. However, tumor calcifications are rarely recognized in mCRC patients treated with bevacizumab. This study was to investigate the correlation between clinical outcome and calcification in mCRC who received bevacizumab and chemotherapy as the first-line treatment. Methods: A single retrospective cohort study was conducted with all diagnosed mCRC cases who received bevacizumab and chemotherapy as the first-line therapy in our hospital from January 2016 to January 2019. Clinical variables were retrieved from medical records and tumor calcification were evaluated independently by radiologists on the basis of computed tomography scans. A univariate and multivariate COX regression analysis was performed to evaluate the association between calcification and outcome. Results: 159 patients with an average age of 59.0 years were included. Median follow-up was 29.6 months. Among all enrolled patients, 31 had tumor calcification [31/159 (19.5%)]. The median overall survival (OS) and progression-free survival (PFS) was significantly better in patients with calcification than those without calcification (28.0 vs. 24.9 months, p= 0.024; 12.0 vs. 10.0 months, p= 0.026). A higher objective response rate (61.3% vs. 50.0%) was also observed in calcification group. On multivariate analysis, tumor calcification was independently associated with OS (hazard ratio 1.799, 95% CI 1.002–3.230) and PFS (hazard ratio 1.609, 95% CI 1.013–2.557). Conclusions: Tumor calcification was independently associated with improved prognosis in colorectal cancer. It might be a potential prognostic marker.

Oral maintenance capecitabine versus active monitoring for patients with metastatic colorectal cancer (mCRC) who are stable or responding after 16 weeks of first-line treatment: Results from the randomized FOCUS4-N trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3504-3504
Author(s):  
Richard Adams ◽  
David Fisher ◽  
Janet Graham ◽  
Jenny F. Seligmann ◽  
Matthew Seymour ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cox Regression ◽  
Final Analysis ◽  
Line Treatment ◽  
First Line ◽  
Active Monitoring ◽  
Intention To Treat ◽  
First Line Therapy ◽  
First Line Treatment

3504 Background: There is extensive randomised evidence supporting the use of treatment breaks in mCRC, but breaks from treatment are not universally offered to patients despite reductions in toxicity, without detriment to OS. Prior trials have shown that the combination of Cp and bevacizumab extend PFS but not OS. FOCUS4-N explores oral maintenance Cp monotherapy in patients with disease control on first line therapy. Methods: FOCUS4 was a molecularly stratified trial programme registering patients with newly diagnosed mCRC from 88 hospitals in the UK. Whilst undergoing 16 wks of first line treatment, a sample of tumour was sent for laboratory testing to stratify their disease into molecular subtypes: MSI, BRAF, PIK3CA, TP53 and RAS mutations. For some molecular groups, a targeted therapy subtrial was available but entry into the FOCUS4-N trial was offered to those in whom a targeted subtrial was unavailable. Patients were randomised 1:1 between maintenance Cp therapy or AM. The primary outcome was PFS assessed using 8-wkly RECIST reported CT scans with quality of life (using EQ5D 8 weekly) and OS as secondary outcomes. Toxicity and tolerability were assessed 4-wkly. On progression, from the nadir, patients recommenced first line treatment. Cox regression was used to assess efficacy by intention-to-treat (ITT) with adjustment for tumour location, WHO status, metastatic burden, first line treatment and biomarker subtype. Results: Between March 2014 and March 2020, 254 patients were randomised (127 to Cp and 127 to AM). Baseline characteristics were balanced between groups but event rates were higher than anticipated in the AM group and the final analysis was triggered early as a result of the COVID-19 pandemic halting recruitment. The table presents results for PFS and OS. Compliance with treatment was good with per-protocol analysis results very similar to ITT (PFS HR=0.38 (95% CI 0.28-0.51)). Toxicity from Cp v AM was as expected with G≥2 fatigue (25% v 12%), diarrhoea (23% v 13%) and hand-foot syndrome (26% v 3%). Quality of life showed no statistically significant differences between the two arms. Conclusions: Despite strong evidence of prolongation of PFS with maintenance therapy, OS remains unaffected and FOCUS4-N provides additional evidence to support the use of treatment breaks as a safe management alternative for patients who are stable or responding well to first line treatment for mCRC. Cp without bevacizumab may be used to extend PFS, in the interval after 16 weeks of combination therapy. Clinical trial information: ISRCTN#90061546. [Table: see text]

Clinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1049-1049
Author(s):  
Mark Jesus Mendoza Magbanua ◽  
Oleksandr Oleksandr Savenkov ◽  
Erik Asmus ◽  
Karla V. Ballman ◽  
Janet H Scott ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Predictive Value ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
First Line ◽  
Cox Regression Analysis ◽  
First Line Therapy ◽  
Study Results

1049 Background: CALGB 40503 randomized HR+ MBC postmenopausal pts to Let alone or Let+Bev as first-line therapy. Adding Bev to Let prolonged progression-free survival (PFS) but not overall survival (OS) (Dickler JCO 2016). We performed a correlative study to assess prognostic and predictive value of CTCs in this population. Methods: Blood was collected prior to initiation of treatment. CTCs were enumerated using US FDA-cleared CellSearch assay; samples with ≥5 CTCs per 7.5 mLs of blood were considered CTC-positive (CTC+). Correlation of CTCs with PFS and OS was assessed using Cox regression analysis. Median follow-up was 39 months (mo). Results: Of 343 pts treated, 294 had CTC data and were included in this analysis. Original study results that showed improved PFS (HR = 0.75; 95% CI: 0.59-0.96) but not OS (HR = 0.87; 95% CI: 0.65-1.18) in pts receiving Let+Bev compared to Let were recapitulated in this subset. In multivariable analysis, CTC+ pts (31%) had significantly reduced PFS (HR = 1.49; 95% CI: 1.12-1.97) and OS (HR = 2.08; 95% CI: 1.49-2.93) compared to CTC- pts. Moreover, CTC+ pts who did not receive Bev had worse PFS (HR = 2.31; 95% CI: 1.54-3.47) and OS (HR = 2.64; 95% CI: 1.59-4.40) (Table). CTC+ pts who received Bev had numerically longer median PFS (18.0 vs. 7.0 mo) and OS (33.6 vs. 27.1 mo) compared to CTC+ pts with no Bev; however, tests for interaction between CTC status and Bev (yes vs. no) were not statistically significant for PFS (p=0.70) or OS (p=0.84). Conclusions: CTCs were highly prognostic in this study involving addition of Bev to first-line Let in postmenopausal HR+ MBC. Further research to determine the potential predictive value of CTCs in the setting of both metastatic disease and early breast cancer is warranted. Support: U10CA180821, U10CA180882; Genentech; https://acknowledgments.alliancefound.org ; NCT00601900. Survival in HR+ MBC pts receiving Let or Let+Bev stratified by CTC status. Clinical trial information: NCT00601900. [Table: see text]

Efficacy of sorafenib in heavily pretreated adult patients with metastatic osteosarcoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e23511-e23511
Author(s):  
Nail Paksoy ◽  
Izzet Dogan ◽  
Meltem Ekenel ◽  
Mert Basaran
Keyword(s):  
Treatment Option ◽  
Rare Variants ◽  
Cox Regression ◽  
Real Life ◽  
Palliative Radiotherapy ◽  
Progression Free Survival ◽  
Adult Patients ◽  
Cox Regression Analysis ◽  
Metastatic Osteosarcoma ◽  
Heavily Pretreated

e23511 Background: Osteosarcoma is a rare tumor and is commonly seen in young people. It arises from bone and rarely from soft tissue. Surgery is the primary treatment option for osteosarcoma. Osteosarcoma is radioresistant, except for rare variants. The choices of chemotherapy are limited in the treatment of metastatic osteosarcoma. The efficiency data of targetted therapies in metastatic osteosarcoma is limited. This study aimed to evaluate sorafenib's efficacy in adult patients with heavily pretreated metastatic osteosarcoma. Methods: We evaluated the patients aged over 18 years with metastatic osteosarcoma retrospectively. The clinical, pathological, and treatment data of the patients were recorded. We used SPSS 25. version for statistical analysis. Kaplan-Meier and Cox-regression analysis were used for survival analysis. Results: Fifteen patients were included in the study. Ten (66.7%) of the patients were male, and the median age was 25 (range,19-64). The primary localization of the tumor was the lower extremity (53.4%), head and neck (20%), upper extremity (13.3%), and other sites (13.3%), respectively. The most common metastatic sites were lung (93.3%), bone (46.7%,) and other (33.3%), respectively. Before sorafenib, fourteen (93.3%) patients had received at least two different cytotoxic chemotherapy regimens, six (40%) patients palliative radiotherapy. In addition, metastasectomy had performed on eight (53.3%) patients. The median progression-free survival was 5.5 (95% CI, 1.3-9.7) months with sorafenib. The stable response was observed in 8 (50%) patients and progressive disease 8 (50%) patients. Grade 1-2 toxicities were observed in 50% of the patients, and grade 3-4 toxicities in 14.3% of the patients. Conclusions: In the study, we showed real-life outcomes of sorafenib for disease control in heavily pretreated adult patients with metastatic osteosarcoma. Sorafenib was effective and well-tolerated in the patients. Sorafenib may be considered as a treatment option after chemotherapy in patients with metastatic osteosarcoma.

scholarly journals 1533P Real-life data from the platform for outcome, quality of life and translational research on pancreatic cancer - PARAGON

2020 ◽  
Vol 31 ◽  
pp. S943
Author(s):  
S-E. Al-Batran ◽  
W. Blau ◽  
R. Liersch ◽  
S. Mahlmann ◽  
A. Lueck ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Translational Research ◽  
Real Life ◽  
Outcome Quality ◽  
Life Data ◽  
Real Life Data

scholarly journals Long-Term Outcomes in Patients with Stroke after in-Hospital Treatment—Study Protocol of the Prospective Stroke Cohort Augsburg (SCHANA Study)

Medicina ◽  
2020 ◽  
Vol 56 (6) ◽  
pp. 280
Author(s):  
Michael Ertl ◽  
Christa Meisinger ◽  
Jakob Linseisen ◽  
Sebastian-Edgar Baumeister ◽  
Philipp Zickler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Recurrent Events ◽  
Cox Regression ◽  
University Hospital ◽  
Hospital Treatment ◽  
Invasive Treatment ◽  
Cox Regression Analysis ◽  
Relative Risks

Introduction: In Germany, stroke is the third leading cause of death, with more than 60,000 fatalities out of approximately 260,000 cases (first-ever and recurrent strokes) each year. So far, there are only a few long-term studies investigating determinants of the natural course of the disease, especially in the era of mechanical thrombectomy. Materials and Methods: The prospective single-center stroke cohort Augsburg (SCHANA) study will include about 1000 patients treated for stroke in the University Hospital of Augsburg. Patients aged 18 years or older with a confirmed diagnosis of ischemic or hemorrhagic stroke are included in the study. Information on demographic characteristics, onset of symptoms, etiologic factors, comorbidities, quality of life, invasive and non-invasive treatment, complications, and laboratory parameters are collected during a personal interview conducted during the patients’ hospital stay and via a medical chart review. About 30 mL of blood is collected from each patient, and after processing and aliquoting, all blood specimens are frozen at −80° C. The study participants will be followed-up via postal questionnaires at three and 12 months after discharge from the hospital. Furthermore, mortality follow-ups will be conducted. Cox-regression analysis will be used to estimate relative risks. Conclusion: The SCHANA study will generate comprehensive data on the long-term course of the disease. In addition to the main outcomes, recurrent events and survival, patient-oriented outcomes such as health-related quality of life and depression are the focus of the study.

Sign in / Sign up

Export Citation Format

Share Document