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Attend this session at the
2019 ASCO Annual Meeting!


Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A


Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Discussion Session

Time: Monday June 3, 3:00 PM to 4:30 PM

Location: Arie Crown Theater

Rivaroxaban thromboprohylaxis in ambulatory patients with pancreatic cancer: Results from a prespecified subgroup analysis of the CASSINI study.

Sub-category:
Pancreatic Cancer

Category:
Gastrointestinal (Noncolorectal) Cancer

Meeting:
2019 ASCO Annual Meeting

Abstract No:
4016

Poster Board Number:
Poster Discussion Session (Board #121)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 4016)

Author(s): Saroj Vadhan-Raj, Mairead Geraldine McNamara, Marino Venerito, Hanno Riess, Eileen Mary O'Reilly, Michael J. Overman, Xiao Zhou, Ujjwala Vijapurkar, Simrati Kaul, Peter Wildgoose, Alok A. Khorana; The University of Texas MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom; Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum, Magdeburg, Germany; Charité Universitätsmedizin Berlin, Berlin, Germany; Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY; The University of Texas MD Anderson Cancer Center, Houston, TX; Janssen Research & Development, Raritan, NJ; Janssen Scientific Affairs, LLC, Titusville, NJ; Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH

Abstract Disclosures

Abstract:

Background: Rivaroxaban thromboprophylaxis has been shown to reduce venous thromboembolism (VTE) on-treatment in ambulatory cancer patients in a recent randomized trial. Pancreatic cancer patients are at substantial risk for VTE; value of thromboprophylaxis has not been definitively established. Methods: CASSINI was a double-blind placebo-controlled trial of cancer patients initiating a new regimen, at high risk for VTE (Khorana score ≥2), randomized to rivaroxaban 10 mg daily or placebo up to 180 days. Patients were stratified by presence or absence of pancreatic cancer. Patients had screening ultrasound and blood drawn at baseline and every 8 wks. Primary efficacy endpoint was a composite of symptomatic DVT, asymptomatic proximal DVT, any PE and VTE-related death. Primary safety endpoint was International Society on Thrombosis and Hemostasis (ISTH)-defined major bleeding. Results: Of 1080 patients enrolled, 49 (4.5%) failed screening due to baseline VTE, with even higher rates [24/362 (6.6%)] in patients with pancreatic cancer. Of 841 randomized patients, 273 (32.6%) had pancreatic cancer with median age 66 y; 57% male and 155/273 (57% in each arm) completing the double-blind period. During intervention (on-treatment) period, 5/135 (3.7%) pancreatic cancer patients in the rivaroxaban arm and 14/138 (10.1%) in placebo arm had primary endpoint events [HR 0.35; 95%CI (0.13, 0.97), p = 0.03; number needed to treat, NNT = 16]. Major bleeding was not increased, occurring in 2 (1.5%) patients in rivaroxaban arm and 3 (2.3%) in placebo arm. Further benefit with rivaroxaban was observed when including primary and secondary endpoints (arterial/visceral events): 6/135 (4%) events in rivaroxaban vs 17/138 (12%) in placebo [HR, 0.34; 95%CI (0.14, 0.87), P = 0.02; NNT = 13]. Correlative biomarker studies demonstrated significant decline in D-dimer values over time (weeks 8 and 16) in patients without VTE randomized to rivaroxaban prophylaxis compared to placebo (P < 0.01), supporting clinical findings. Conclusions: Rivaroxaban substantially reduced VTE in pancreatic cancer patients during intervention period. Given no increase in major bleeding, our findings suggest benefit to rivaroxaban thromboprophylaxis in pancreatic cancer patients initiating systemic therapy. Clinical trial information: NCT02555878

 
Other Abstracts in this Sub-Category:

 

1. Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial.

Meeting: 2019 ASCO Annual Meeting Abstract No: LBA4 First Author: Hedy L. Kindler
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer

 

2. APACT: phase III, multicenter, international, open-label, randomized trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) for surgically resected pancreatic adenocarcinoma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4000 First Author: Margaret A. Tempero
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer

 

3. Randomized phase II study of second-line modified FOLFIRI with PARP inhibitor ABT-888 (Veliparib) (NSC-737664) versus FOLFIRI in metastatic pancreatic cancer (mPC): SWOG S1513.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4014 First Author: E. Gabriela Chiorean
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer

 

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