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2019 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Oral Abstract Session

Time: Sunday June 2, 9:45 AM to 12:45 PM

Location: Arie Crown Theater

Prospective randomized phase II trial of pazopanib versus placebo in patients with progressive carcinoid tumors (CARC) (Alliance A021202).


Gastrointestinal (Noncolorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 4005)

Author(s): Emily K. Bergsland, Michelle R. Mahoney, Timothy R. Asmis, Nathan Hall, Priya Kumthekar, Michael L. Maitland, Donna Niedzwiecki, Andrew B. Nixon, Eileen Mary O'Reilly, Lawrence Howard Schwartz, Jonathan R. Strosberg, Jeffrey A. Meyerhardt; University of California San Francisco, San Francisco, CA; Mayo Clinic, Rochester, MN; Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; University of Pennsylvania, Philadelphia, PA; Northwestern Memorial Hospital, Chicago, IL; Inova Center for Personalized Health and University of Virginia, Falls Church, VA; Duke University Medical Center, Durham, NC; Memorial Sloan Kettering Cancer Center, New York, NY; Columbia University Medical Center, New York, NY; Moffitt Cancer Center, Tampa, FL; Dana-Farber Cancer Institute/Partners CancerCare, Boston, MA

Abstract Disclosures


Background: Patients (pts) with progressive advanced well-differentiated neuroendocrine tumors arising outside of the pancreas have limited systemic treatment options. Pazopanib (PZ) is an oral multi-kinase inhibitor with activity against VEGFR-2,-3, PDGFR-α, and β, and c-KIT, with initial data suggesting efficacy in CARC. Methods: This was a multicenter, randomized, double-blind, phase II study of PZ (800 mg/day) versus placebo (PL) in progressive CARC. Key eligibility: low-intermediate grade CARC, radiologic progressive disease (PD) < 12 months (mo), and adequate end-organ function. Prior somatostatin analog (SSA) mandated for midgut tumors. Concurrent SSA allowed if previous PD on SSA documented. Primary endpoint was progression-free survival (PFS), defined as time from randomization to PD by central review or death. Secondary endpoints included overall survival (OS), objective response rate (ORR) and safety. The trial had 85% power to detect a difference in median PFS of 14 v 9 mo (hazard ratio [HR] 0.64) at one-sided alpha = 0.1. A stratified log-rank test based on the intend-to-treat (ITT) principle was used. Unblinding and crossover were allowed if PD confirmed by central review. Results: 171 (97 PZ, 74 PL) pts were randomized between 6/2013-10/2015: median age 63; 56% female; 66% small bowel primary; 87% concurrent SSA. Median follow-up of 31 mo; 112 (56 PZ, 56 PL) PFS events observed. 6 pts (4 PZ, 2 PL) remain on initial treatment. Median PFS was 11.6 and 8.5 mo in PZ and PL, respectively (HR = 0.53, 1-sided 90% upper confidence limit [UCL] 0.69, p = 0.0005) which crossed the pre-specified protocol efficacy boundary. 49 PL pts received PZ after PD. Median OS was 41 and 42 mo in PZ and PL, respectively (HR = 1.13, 1-sided 90% UCL 1.51, p = 0.70). RR data will be presented. Notable grade 3+ adverse events were (PZ v. PL %) hypertension (35 v. 8), fatigue (11 v. 4), ALT (10 v. 0), AST (10 v. 0), and diarrhea (7 v. 4). Conclusions: PZ compared to PL was associated with significant improvement in PFS in patients with progressive CARC. The results confirm that VEGF signaling pathway is a valid target for therapy in CARC. Support: U10CA180821, U10CA180882 Clinical trial information: NCT01841736

Other Abstracts in this Sub-Category:


1. An open label, single-arm, two-stage, multicenter, phase II study to evaluate the efficacy and safety of TLC388 as second-line treatment in subjects with poorly differentiated neuroendocrine carcinomas (TCOGT1Z14).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4101 First Author: Ming-Huang Chen
Category: Gastrointestinal (Noncolorectal) Cancer - Neuroendocrine/Carcinoid


2. A phase I study of oncolytic immunotherapy of metastatic neuroendocrine tumors using intralesional rose bengal disodium: Cohort 1 results.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4102 First Author: Timothy Jay Price
Category: Gastrointestinal (Noncolorectal) Cancer - Neuroendocrine/Carcinoid


3. A phase II, open label, multicenter trial of avelumab in patients with advanced, metastatic high-grade neuroendocrine carcinomas NEC G3 (WHO 2010) progressive after first-line chemotherapy (AVENEC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4103 First Author: Christian Fottner
Category: Gastrointestinal (Noncolorectal) Cancer - Neuroendocrine/Carcinoid