Prognostic factors for patients with Ewing sarcoma (EWS) at first recurrence

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 10011-10011
Author(s):  
P. Leavey ◽  
L. Mascarenhas ◽  
N. Marina ◽  
Z. Chen ◽  
M. Krailo ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Disease Progression ◽  
Metastatic Disease ◽  
Ewing Sarcoma ◽  
Significant Risk ◽  
Female Gender ◽  
Initial Diagnosis ◽  
Phase Iii ◽  
Rank Test ◽  
First Recurrence

10011 Background: The prognosis for patients with recurrent Ewing sarcoma (EWS) is very poor with 5-year survival of 13%. Since 30–40% of patients with newly diagnosed, non-metastatic EWS develop recurrence, the Children's Oncology Group (COG) sought to evaluate prognostic factors for these patients. Data was derived from the phase III, multi-institutional study INT 0091. Methods: Between 1988 and 1994, five hundred and seventy-eight eligible patients with previously untreated EWS or PNET of bone were enrolled on INT 0091. Patients who experienced recurrence or disease progression as their first analytic event were considered. Survival was calculated from date of disease progression to death or last patient contact. Comparisons of the risk for death across groups were accomplished using the log-rank test. Survivor functions were estimated by the method of Kaplan and Meier. Results: Two hundred and sixty-two patients experienced disease progression or recurrence. The median time to first recurrence was 1.3 years (range 0–7.4 years) for all patients, 1.4 years (range 0 to 7.4 years) for patients with initially localized disease and 1 year (range 0 to 6 years) for patients with initially metastatic disease. Time to first recurrence from date of initial diagnosis was a predictor of post-recurrence survival (p<0.0001). Twenty-one percent of patients whose disease recurred or progressed experienced first recurrence 2 or more years from initial diagnosis and had an estimated 5 year post-recurrence survival of 30%. This compares with 7% for those whose first recurrence or progression was earlier. No statistical difference was detected when patients whose disease recurred < 12 months were compared with those whose recurrence was 12–24 months from initial diagnosis. Significant risk factors for death after recurrence included metastatic disease at initial diagnosis, elevated LDH at initial diagnosis and female gender. In patients non-metastatic at initial diagnosis pelvic primary site was also a risk factor for death after recurrence. Conclusions: Patients with longer time to first recurrence represent the subset of patients most likely to survive following recurrence. All patients with recurrent Ewing sarcoma would benefit from collaborative trials to investigate new therapeutic options. No significant financial relationships to disclose.

scholarly journals Age as a Prognostic Factor in Patients with Ewing Sarcoma—The Polish Sarcoma Group Experience

2021 ◽  
Vol 10 (16) ◽  
pp. 3627
Author(s):  
Paulina Jagodzińska-Mucha ◽  
Anna Raciborska ◽  
Hanna Koseła-Paterczyk ◽  
Katarzyna Kozak ◽  
Katarzyna Bilska ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Ewing Sarcoma ◽  
Cox Model ◽  
Multidisciplinary Treatment ◽  
Local Treatment ◽  
Age Groups ◽  
Female Gender ◽  
Rank Test ◽  
Treatment Results ◽  
Kaplan Meier

Ewing sarcoma (ES) is a rare and aggressive disease that requires multidisciplinary treatment with the use of chemotherapy, radiotherapy, and surgery. Our retrospective study aimed to analyze the prognostic factors and treatment results in different age groups of patients. Between 1998 and 2018, 569 patients with ES were treated in two referral centers. The patients were divided into four age groups (≤10 years; 11–18 years; 19–25, and >25). The treatment results and prognostic factors were assessed for each group. For statistical analyses, we used the Chi2 test, the Kaplan–Meier estimator with a log-rank test, and the multivariate Cox model. Five-year overall survival (OS) rate was 56%. In the age subgroups: ≤10 years, 11–18 years, 19–25 years, and >25 years, the 5-year OS rates were 75%, 58%, 41%, and 52%, respectively. Favorable prognostic factors: female gender (p = 0.024), non-axial localization (p = 0.005), VIDE regimen (p < 0.001), and surgery as a local treatment (p < 0.001) dominated in the group ≤10 years. In multivariate analysis, male (HR = 1.53), axial localization (HR = 1.46), M1 status at presentation (HR = 2.64), and age > 10 years (HR = 2.29) were associated with shorter OS. The treatment results in ES are significantly better in children aged ≤10 years; the challenge is to provide therapy for adolescents and young adults. The diagnostics and treatment of ES patients must be provided in referral centers.

scholarly journals Impact of early vs. delayed initiation of dutasteride/tamsulosin combination therapy on the risk of acute urinary retention or BPH-related surgery in LUTS/BPH patients with moderate-to-severe symptoms at risk of disease progression

2020 ◽  
Author(s):  
Salvatore D’Agate ◽  
Chandrashekhar Chavan ◽  
Michael Manyak ◽  
Juan Manuel Palacios-Moreno ◽  
Matthias Oelke ◽  
...  
Keyword(s):  
At Risk ◽  
Combination Therapy ◽  
Disease Progression ◽  
Urinary Retention ◽  
Acute Urinary Retention ◽  
Treatment Algorithm ◽  
Phase Iii ◽  
Rank Test ◽  
Survival Curves ◽  
Risk Of Disease

Abstract Purpose To evaluate the effect of delayed start of combination therapy (CT) with dutasteride 0.5 mg and tamsulosin 0.4 mg on the risk of acute urinary retention or benign prostatic hyperplasia (BPH)-related surgery (AUR/S) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) at risk of disease progression. Methods Using a time-to-event model based on pooled data from 10,238 patients from Phase III/IV dutasteride trials, clinical trial simulations (CTS) were performed to assess the risk of AUR/S up to 48 months in moderate-to-severe LUTS/BPH patients following immediate and delayed start of CT for those not responding to tamsulosin monotherapy. Simulation scenarios (1300 subjects/arm) were investigated, including immediate start (reference) and alternative delayed start (six scenarios 1–24 months). AUR/S incidence was described by Kaplan–Meier survival curves and analysed using log-rank test. The cumulative incidence of events as well as the relative and attributable risks were summarised stratified by treatment. Results Survival curves for patients starting CT at month 1 and 3 did not differ from those who initiated CT immediately. By contrast, significant differences (p < 0.001) were observed when switch to CT occurs ≥ 6 months from the initial treatment. At month 48, AUR/S incidence was 4.6% vs 9.5%, 11.0% and 11.3% in patients receiving immediate CT vs. switchers after 6, 12 and 24 months, respectively. Conclusions Start of CT before month 6 appears to significantly reduce the risk of AUR/S compared with delayed start by ≥ 6 months. This has implications for the treatment algorithm for men with LUTS/BPH at risk of disease progression.

Retrospective analysis of risk factors for fatigue in clinical trial patients (pts) with metastatic renal cell carcinoma (mRCC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15624-e15624
Author(s):  
Martin Eric Gore ◽  
Viktor Gruenwald ◽  
Robert John Motzer ◽  
David I. Quinn ◽  
Brian I. Rini ◽  
...  
Keyword(s):  
Risk Factors ◽  
Retrospective Analysis ◽  
Kinase Inhibitors ◽  
Significant Risk ◽  
Multivariate Logistic Regression Analysis ◽  
Female Gender ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Increased Risk ◽  
Ecog Ps

e15624 Background: Fatigue is a common toxicity in pts with mRCC, often associated with therapy, particularly with tyrosine kinase inhibitors (TKI). We performed a pooled retrospective analysis of pts with mRCC treated in clinical studies in order to explore predictors for fatigue. Methods: Data from pts treated in Pfizer mRCC trials (2003-2011) from phase III (NCT00083899, NCT00065468, NCT00678392) and phase II trials (NCT00054886, NCT00077974, NCT00083889, NCT00338884, NCT00137423) were included. Adverse event (CTCAE v3.0) terms of “fatigue” and “asthenia” were used. Hypothyroidism was defined as TSH>ULN or T4<LLN. A multivariate logistic regression analysis was performed to identify significant risk factors for grade (G) 2 (moderate or causing difficulty performing some ADL) or higher fatigue. Results: 2749 pts (71% male) with a median age 60 (33% ≥65) were treated (median 162 days) with axitinib (n=359), sunitinib (n=1059), temsirolimus (TEM) (n=208), interferon-alfa (IFN) (n=560), sorafenib (n=335), or TEM + IFN (n=208). Most pts had baseline ECOG PS of 0 (47%) or 1 (51%), clear cell histology (91%), and nephrectomy (84%). 553 (20%) pts reported fatigue prior to starting study therapy. During study, fatigue was reported in 1794 (65%) pts (21% G1, 26% G2, 17% G3, 1% G4); in 61% pts worst grade was reported within the first 2 months of therapy. Fatigue led to discontinuation in 2%, and dose interruption or adjustment in 8%. Of 1773 pts treated with TKIs, 42% had ≥G2 fatigue. Of pts treated with TEM, IFN or both, 39%, 50% and 50%, respectively, had ≥G2 fatigue. Baseline factors [Odds Ratio] associated (p < 0.05) with ≥G2 fatigue were pretreatment fatigue [1.7] or hypothyroidism [1.6], age ≥65 [1.6], time from diagnosis ≥1 yr [1.4], female gender [1.3], ECOG PS 0 [0.7], and Asian vs Caucasian race [0.5]. Baseline LDH, calcium, and anemia were not significant. Conclusions: Pt attributes and comorbidities at baseline, independent of therapy, are associated with increased risk of clinically significant fatigue in pts treated for mRCC, and can be used to generate a predictive model. Appropriate counseling and control of co-morbid conditions may be important in managing fatigue in pts on TKI therapy.

Is RECIST-defined progression free-survival a meaningful endpoint in the era of immunotherapy?

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 488-488 ◽  
Author(s):  
Sukhvinder Johal ◽  
Irene Santi ◽  
Justin Doan ◽  
Saby George
Keyword(s):  
Overall Survival ◽  
Disease Progression ◽  
Tumor Regression ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Rank Test ◽  
Apparent Lack ◽  
Free Survival ◽  
Treatment Beyond Progression ◽  
Significant Difference

488 Background: Progression-free survival (PFS) is often used as a primary endpoint in oncology clinical trials as a surrogate for overall survival. Traditionally, the Response Evaluation Criteria in Solid Tumors (RECIST) have defined disease progression as a significant increase in the size of tumor lesions and the development of new lesions. However, some patients starting immunotherapy have shown initial increased size of tumor lesions followed by tumor regression, due to the unique mechanism of action of immunotherapies. This initial “pseudo-progression” could be classified inaccurately as disease progression, as evidenced by benefit from the treatment beyond progression approach ( JAMA Oncol 2016). The phase III CheckMate 025 trial of nivolumab versus everolimus in patients with advanced renal cell carcinoma allowed treatment beyond progression if there was investigator-assessed clinical benefit and tolerability. The purpose of our study was to test if treatment duration for an immunotherapy was different from RECIST-defined PFS, and as such, could potentially explain the apparent lack of correlation between RECIST progression and overall survival shown in CheckMate 025. Methods: Using 1-year data from CheckMate 025, Kaplan–Meier methodology was used to estimate the median duration of PFS and time to treatment discontinuation (TTD). Stratified log-rank test was used to assess the difference in treatments. Results: For all patients, the median PFS with nivolumab was 4.6 months (95% CI, 3.7–5.4 months) and median TTD was 6.2 months (95% CI, 5.6–7.7 months). For everolimus, the median PFS was 4.4 months (95% CI, 3.7–5.5 months) and median TTD was 3.9 months (95% CI, 3.7–4.6 months). Conclusions: Patients in CheckMate 025 had significantly longer survival with nivolumab than with everolimus, but with similar PFS. Our analysis demonstrated that while PFS was similar to TTD with everolimus, there was a significant difference between the 2 measures for nivolumab, suggesting that RECIST-defined PFS may not be the proper endpoint to define progression for immunotherapies. Further evaluation of the association of TTD and other immune-related progression endpoints with overall survival is warranted. Clinical trial information: NCT01668784.

scholarly journals Prognostic factors for patients with Ewing sarcoma (EWS) at first recurrence following multi‐modality therapy: A report from the Children's Oncology Group

2008 ◽  
Vol 51 (3) ◽  
pp. 334-338 ◽  
Author(s):  
Patrick J. Leavey ◽  
Leo Mascarenhas ◽  
Neyssa Marina ◽  
Zhengjia Chen ◽  
Mark Krailo ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Ewing Sarcoma ◽  
Oncology Group ◽  
First Recurrence

scholarly journals Metastatic Pattern of Truncal and Extremity Leiomyosarcoma: Retrospective Analysis of Predictors, Outcomes, and Detection

2021 ◽  
Author(s):  
Seth Stravers Tigchelaar ◽  
Christopher Frey ◽  
Nicole A. Segovia ◽  
David G. Mohler ◽  
Robert J. Steffner ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Retrospective Analysis ◽  
Metastatic Disease ◽  
Significant Risk ◽  
Metastatic Potential ◽  
Primary Diagnosis ◽  
Metastatic Pattern ◽  
Heterogenous Group ◽  
Increased Risk ◽  
Survival Endpoints

Abstract BackgroundLeiomyosarcomas (LMS) are a heterogenous group of malignant mesenchymal neoplasms with smooth muscle origin and are classified as either non-uterine (NULMS) or uterine (ULMS). Metastatic pattern, prognostic factors, and ideal staging/surveillance studies for truncal and extremity LMS have not been defined.MethodsA retrospective analysis of patients diagnosed with histopathology-confirmed truncal or extremity LMS between 2009-2019 was conducted. Data collected included demographics, tumor characteristics, staging, surveillance, and survival endpoints. Primary site was defined as either 1. Extremity, 2. Flank/Pelvis, or 3. Chest wall/Spine.ResultsWe identified 73 patients, 23.3% of which had metastatic LMS at primary diagnosis, while 68.5% developed metastatic disease at any point. The mean metastatic-free survival from primary diagnosis of localized LMS was 3.0±2.8 years. Analysis of prognostic factors revealed that greater age (≥50 years) at initial diagnosis (OR=3.74, p=0.0003) and higher tumor grades II (OR=16, p=0.019) and III (OR=13, p=0.025) were significantly associated with metastases.ConclusionsTruncal and peripheral extremity LMS is an aggressive tumor with high metastatic potential. While there is a significant risk of metastases to lungs, extra-pulmonary tumors are relatively frequent. Older patients and patients with higher-grade (II/III) tumors carry an increased risk of developing metastatic disease.

Phase III trial comparing antibody-drug conjugate (ADC) SAR408701 with docetaxel in patients with metastatic non-squamous non-small cell lung cancer (NSQ NSCLC) failing chemotherapy and immunotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS9625-TPS9625
Author(s):  
Melissa Lynne Johnson ◽  
Mustapha Chadjaa ◽  
Semra Yoruk ◽  
Benjamin Besse
Keyword(s):  
Disease Progression ◽  
Tumor Cells ◽  
Objective Response ◽  
Human Study ◽  
Phase Iii ◽  
Rank Test ◽  
Type I ◽  
Cell Surface Glycoprotein ◽  
Platinum Based Chemotherapy ◽  
Eortc Qlq

TPS9625 Background: Despite recent advances in the treatment of NSQ NSCLC, including the integration of immune checkpoint inhibitors (ICI) into first-line treatment of all patients, novel therapies are necessary at disease progression. Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5), a cell-surface glycoprotein, is overexpressed in several tumor types, including NSQ NSCLC; ~20% of patients express high CEACAM5 levels. SAR408701 is an ADC combining a humanized antibody targeting CEACAM5 with the potent cytotoxic maytansinoid derivative DM4 and is expected to selectively deliver DM4 to CEACAM5-expressing cancer cells. In an interim analysis of a first-in-human study (NCT02187848) in patients with NSQ NSCLC and CEACAM5 expression in ≥50% of tumor cells, SAR408701 administered 100 mg/m² every 2 weeks showed an objective response rate (ORR) of 23% and a favorable safety profile (Gazzah A et al J Clin Oncol. 2019;37:15, 9072). Methods: In this randomized, open-label, phase 3 trial, patients receive either SAR408701 100 mg/m² IV every 2 weeks or the standard of care treatment docetaxel 75 mg/m² IV every 3 weeks. Randomization is stratified on ECOG performance status (PS), previous ICI treatment (sequential vs combination), and geographical region. Patients are ≥18 years with metastatic NSQ NSCLC after platinum-based chemotherapy and ICI treatment (anti-PD-1/PD-L1 monoclonal antibody), express CEACAM5 in ≥50% of tumor cells at ≥2+ intensity (central testing), and have ECOG PS 0–1. Exclusion criteria include untreated brain metastases, history of corneal disorders, and prior treatment with docetaxel, maytansinoid derivatives, or CEACAM5-targeting drugs. Tumor imaging occurs at baseline and every 8 weeks until disease progression. Primary endpoints are progression-free survival (PFS; RECIST v1.1 by independent blinded review committee) and overall survival (OS), both analyzed by Kaplan-Meier method, stratified log-rank test, and stratified Cox proportional hazard model. Study success is defined either on PFS or OS, with a strong type-I error control for multiple hypotheses. Secondary endpoints are ORR and duration of response (RECIST v1.1), health related quality of life (EORTC QLQ-C30 and EORTC QLQ-LC13), and safety (adverse events graded by NCI CTCAE v5). Approximately 554 randomized patients (277 per arm) is adequate to reach both PFS and OS events. The study opened in Nov 2019, and as of Feb 7, 2020, 20 sites in 8 countries are activated. Clinical trial information: NCT04154956 .

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.

Sentinel Lymphadenectomy Does Not Increase the Incidence of In-Transit Metastases in Primary Melanoma

2005 ◽  
Vol 23 (21) ◽  
pp. 4764-4770 ◽  
Author(s):  
John C. Kang ◽  
Leslie A. Wanek ◽  
Richard Essner ◽  
Mark B. Faries ◽  
Leland J. Foshag ◽  
...  
Keyword(s):  
Early Stage ◽  
Primary Melanoma ◽  
Phase Iii ◽  
Rank Test ◽  
Sentinel Lymphadenectomy ◽  
Treatment Groups ◽  
T Stage ◽  
Before And After ◽  
First Recurrence ◽  
In Transit

PurposeRecent reports by European investigators suggest that sentinel lymphadenectomy (SLND), a mainstay of melanoma diagnosis and treatment planning, increases the risk of in-transit metastasis (ITM) and should be abandoned. This study compared the incidence of ITM after wide local excision (WLE), WLE plus SLND (SLND), or WLE plus elective lymphadenectomy (ELND) for primary melanoma.Patients and MethodsReview of our prospective database identified 4,412 patients who underwent WLE (n = 2,771), SLND (n = 1,016), or ELND (n = 625) for stage I/II melanoma (1971 through 2002). The incidence of ITM overall and as a first recurrence was examined before and after computerized prognostic matching of treatment groups. Intergroup statistical comparisons used χ2analysis and log-rank test.ResultsThe incidence of ITM increased with Breslow depth, Clark level, and T stage. Although overall incidence of ITM was significantly higher (P = .0008) after ELND (6.56%) versus WLE (3.36%) or SLND (3.64%), the ELND group had higher risk primaries. Treatment groups matched by T stage (1,875 patients; 625 per group) or by age, sex, Breslow depth, and primary location (1,680 patients; 560 per group), showed no significant differences in ITM overall or as a first recurrence.ConclusionThere is no relationship between SLND and ITM. Recent reports to the contrary reflect analysis of significantly smaller cohorts not matched for confounding variables such as T stage. The phase III Multicenter Selective Lymphadenectomy Trial will definitively settle the issue; until then, use of SLND, the most accurate staging procedure for early-stage melanoma, should continue.

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.

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