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.

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.

PANOVA-3: A phase III study of tumor treating fields with nab-paclitaxel and gemcitabine for front-line treatment of locally advanced pancreatic adenocarcinoma (LAPC).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS792-TPS792
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

TPS792 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.

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 .

Clinical outcomes of gemcitabine plus nab-paclitaxel (GnP) in initially diagnosed locally advanced pancreatic cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 407-407 ◽  
Author(s):  
Yusuke Hashimoto ◽  
Hideaki Takahashi ◽  
Izumi Ohno ◽  
Hiroshi Imaoka ◽  
Mitsuhito Sasaki ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Median Time ◽  
Univariate Analysis ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Pancreatic Head ◽  
Tumor Board ◽  
Rank Test

407 Background: Gemcitabine plus nab-Paclitaxel has shown improved survival in patients with metastatic pancreatic cancer in MPACT. Many studies have been investigating the survival benefit of GnP in LACP patients. The aim of this study is to clinical outcome of GnP in initially diagnosed LAPC in our single tertiary institution. Methods: LACP patients who received GnP as initial chemotherapy were identified between December 2014. and December 2016 from our database retrospectively. Demographic characteristics, disease status, response, conversion to resection and survival was reviewed. Resectability was determined at our hepatobiliary pancreatic tumor board, reflecting Japanese guideline of pancreatic cancer. Results: We identified 55 LACP patients initially treated with GnP (median age: 67 year old, female was 49%, ECOG PS 0/1, 62%/38%, pancreatic head 58%, baseline tumor size: median 32mm (18-62), CA19-9: median 139ng/ml (3.9-12956)). Best objective response rate was 58% and median time to partial response was 60 days (40-212). Median overall survival (mOS) was 24.7 months (95%CI :15.5-not reached). Nine patients (16%:9/55) were re-evaluated as resectable with CT and normalized CA19-9/CEA and subsequently proceeded to conversion to resection. Seven patients (13%:7/55) achieved R0 resection and sequentially performed adjuvant six- month duration of GnP. Median time to resection from initial GnP administration was 5.2 months (4.0-7.3). LAPC patients who achieved conversion to resection was associated with better overall survival than non-resected LAPC in log-rank test (mOS: all alive :12.1-25.4months vs 21.5 months 95%Cl:15.5-, HR:0.493 range: NA, P = 0.043). Shrinking tumor minimal size from the baseline was the factor to successful conversion in univariate analysis (P = 0.006). Conclusions: GnP showed promising results of response and overall survival in uLAPC patients. Conversion to resection in carefully selected uLAPC currently suggests an early surgical benefit, but longer follow-up and more cases will be required to assess the potential long-term benefit of conversion therapy.

Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group

2007 ◽  
Vol 25 (15) ◽  
pp. 1960-1966 ◽  
Author(s):  
Malcolm J. Moore ◽  
David Goldstein ◽  
John Hamm ◽  
Arie Figer ◽  
Joel R. Hecht ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Pancreatic Tumors ◽  
Double Blind ◽  
Phase Iii Trial

PurposePatients with advanced pancreatic cancer have a poor prognosis and there have been no improvements in survival since the introduction of gemcitabine in 1996. Pancreatic tumors often overexpress human epidermal growth factor receptor type 1 (HER1/EGFR) and this is associated with a worse prognosis. We studied the effects of adding the HER1/EGFR-targeted agent erlotinib to gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer.Patients and MethodsPatients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib (100 or 150 mg/d orally) or gemcitabine plus placebo in a double-blind, international phase III trial. The primary end point was overall survival.ResultsA total of 569 patients were randomly assigned. Overall survival based on an intent-to-treat analysis was significantly prolonged on the erlotinib/gemcitabine arm with a hazard ratio (HR) of 0.82 (95% CI, 0.69 to 0.99; P = .038, adjusted for stratification factors; median 6.24 months v 5.91 months). One-year survival was also greater with erlotinib plus gemcitabine (23% v 17%; P = .023). Progression-free survival was significantly longer with erlotinib plus gemcitabine with an estimated HR of 0.77 (95% CI, 0.64 to 0.92; P = .004). Objective response rates were not significantly different between the arms, although more patients on erlotinib had disease stabilization. There was a higher incidence of some adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2.ConclusionTo our knowledge, this randomized phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine. The recommended dose of erlotinib with gemcitabine for this indication is 100 mg/d.

scholarly journals Gemcitabine plus nab-paclitaxel for locally advanced or borderline resectable pancreatic cancer

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Akiko Tsujimoto ◽  
Kentaro Sudo ◽  
Kazuyoshi Nakamura ◽  
Emiri Kita ◽  
Ryusuke Hara ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
First Line ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer

Abstract Overall survival in a phase III study for metastatic pancreatic cancer has significantly improved with gemcitabine (GEM) plus nab-paclitaxel. However, to date, there is limited data on the efficacy and safety of its use for patients with locally advanced (LA) or borderline resectable pancreatic cancer (BRPC). Here, we investigated the efficacy and safety of first-line GEM plus nab-paclitaxel for LA or BRPC. We retrospectively analysed consecutive patients with pathologically confirmed, untreated LA or BRPC who started receiving first-line GEM plus nab-paclitaxel. A total of 30 patients (LA, n = 22; BRPC, n = 8) were analysed. Twelve patients (40%) without distant metastasis received additional chemoradiotherapy using S-1. Laparotomy was performed on 8 patients and 6 (20%; LA, n = 3; BR, n = 3) achieved R0 resection. Objective response rate was 44.8%. For all patients, median progression-free survival and overall survival were 14.8 and 29.9 months, respectively. Median overall survival for LA was 24.1 months with a 2-year survival rate of 50.8%. The most frequently observed grade 3 or 4 toxicities were neutropenia (73%) and biliary infection (13%). First-line GEM plus nab-paclitaxel was well-tolerated and feasible with an encouraging survival for LA or BRPC.

Activity and survival benefit of second-line chemotherapy (2L-Ctx) in advanced pancreatic adenocarcinoma (APC): Pooled analysis of the literature.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15019-e15019 ◽  
Author(s):  
MinYuen Teo ◽  
Raymond S. McDermott
Keyword(s):  
Overall Survival ◽  
Phase Ii ◽  
Survival Benefit ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Line Setting ◽  
Line Chemotherapy

e15019 Background: Many clinicians adopt a nihilistic approach to the management of APC. Delivery of 2L-Ctx is relatively uncommon and no recognized standard exists. We sought to examine the published activity of chemotherapy in the 2nd line setting, and the rate of 2L-Ctx delivery and its influence on reported overall survival in 1st line trials. Methods: 1st and 2L-Ctx randomized trials published between 2000 and 2012 were identified from Pubmed, and manuscripts were obtained for data extraction. Pooled weighted objective response rates (ORR) and disease control rates (DCR) were calculated. For 1st line studies, the percentage of patients who received 2L-Ctx were extracted and plotted against reported median overall survival (OS) and post-progression survival (PPS), defined as arithmetic difference between median OS and progression-free survival. Spearman correlation and linear regression were performed. Results: Sixty nine 2L Ctx studies (77 arms, n=2859) were identified. Majority received prior gemcitabine-based chemotherapy. Pooled ORR was 6.6% (95% CI 5.6 – 7.6%) and DCR was 36.7% (34.5 – 38.0%). When only prospective studies were evaluated (42 studies, 48 arms, n=1546), ORR was 5.0% (3.8 – 6.2%) and DCR was 33.9% (31.0 – 36.9%). Exploratory analysis suggested that intensification of gemcitabine-based therapy (ORR: 10.0%; DCR: 54.7%) might be marginally more active than fluoropyrimidine (7.6%; 32.2%) or taxane based 2L-Ctx (5.2%; 33.6%). 28/52 identified 1st line studies (54%) reported the percentage of patients treated with second-line chemotherapy (11 phase II, 28 arms, n=1450; 17 phase III, 33 arms, n=5051). Percentage of 2L-Ctx delivery ranged from 14 – 68% and correlated with OS (r=.49 [.26 – .67], p<.01) and PPS (r=.57 [.36 – .72], p<.01). When phase II studies were excluded, correlation was improved for OS (r=.63 [.35 – .81], p<.01) and PPS (r=.79 [.59 – .89], p<.01). Percentage of locally advanced disease did not correlate with OS/PPS nor affect prior analysis. Conclusions: Whilst awaiting further advancement in the 1st line setting, increased delivery of 2L-Ctx to patients with APC and maintained performance status may offer a survival benefit.

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.

Phase III Randomized Comparison of Gemcitabine Versus Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic Cancer

2009 ◽  
Vol 27 (33) ◽  
pp. 5513-5518 ◽  
Author(s):  
David Cunningham ◽  
Ian Chau ◽  
Deborah D. Stocken ◽  
Juan W. Valle ◽  
David Smith ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Meta Analysis ◽  
Performance Status ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Open Label

PurposeBoth gemcitabine (GEM) and fluoropyrimidines are valuable treatment for advanced pancreatic cancer. This open-label study was designed to compare the overall survival (OS) of patients randomly assigned to GEM alone or GEM plus capecitabine (GEM-CAP).Patients and MethodsPatients with previously untreated histologically or cytologically proven locally advanced or metastatic carcinoma of the pancreas with a performance status ≤ 2 were recruited. Patients were randomly assigned to GEM or GEM-CAP. The primary outcome measure was survival. Meta-analysis of published studies was also conducted.ResultsBetween May 2002 and January 2005, 533 patients were randomly assigned to GEM (n = 266) and GEM-CAP (n = 267) arms. GEM-CAP significantly improved objective response rate (19.1% v 12.4%; P = .034) and progression-free survival (hazard ratio [HR], 0.78; 95% CI, 0.66 to 0.93; P = .004) and was associated with a trend toward improved OS (HR, 0.86; 95% CI, 0.72 to 1.02; P = .08) compared with GEM alone. This trend for OS benefit for GEM-CAP was consistent across different prognostic subgroups according to baseline stratification factors (stage and performance status) and remained after adjusting for these stratification factors (P = .077). Moreover, the meta-analysis of two additional studies involving 935 patients showed a significant survival benefit in favor of GEM-CAP (HR, 0.86; 95% CI, 0.75 to 0.98; P = .02) with no intertrial heterogeneity.ConclusionOn the basis of our trial and the meta-analysis, GEM-CAP should be considered as one of the standard first-line options in locally advanced and metastatic pancreatic cancer.

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