Best of ASCO - 2014 Annual Meeting

 

Welcome

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

Randomized, open-label, perioperative phase II study evaluating nivolumab alone or nivolumab plus ipilimumab in patients with resectable HCC.

Sub-category:
Hepatobiliary Cancer

Category:
Gastrointestinal (Noncolorectal) Cancer

Meeting:
2019 ASCO Annual Meeting

Abstract No:
4098

Poster Board Number:
Poster Session (Board #203)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 4098)

Author(s): Ahmed Omar Kaseb, Roberto Carmagnani Pestana, Luis M. Vence, Jorge M. Blando, Shalini Singh, Naruhiko Ikoma, Kanwal Pratap Singh Raghav, Divya Sakamuri, Lauren Girard, Dongfeng Tan, Jean-Nicolas Vauthey, Ching-Wei David Tzeng, Thomas A. Aloia, Yun Shin Chun, James C. Yao, Robert A. Wolff, James Patrick Allison, Padmanee Sharma; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Texas MD Anderson Cancer Center, Houston, TX; Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX; Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; GI Medical Oncology Department, The University of Texas MD Anderson Cancer Center, Houston, TX; Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX; University of Kentucky, Lexington, KY; Department of GI Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX

Abstract Disclosures

Abstract:

Background: In HCC, surgical resection is associated with high recurrence rate, and no effective neoadjuvant or adjuvant therapies currently exist. On the basis of of previous reports on the efficacy and safety of anti–PD-1 (nivolumab) and anti–CTLA-4 (ipilimumab) antibodies against HCC, we initiated a randomized pilot trial of perioperative immunotherapy for resectable HCC. Methods: This is a randomized, phase II pilot trial of nivolumab (Arm A) or nivolumab + ipilimumab (Arm B) as pre-operative treatment for patients (pt) with HCC who are eligible for surgical resection. Pt are given nivolumab 240 mg every 2 weeks (wk) for a total of 6 wk. Pt in Arm B are treated concurrently with ipilimumab 1 mg/kg every 6 wk. Surgical resection occurs within 4 weeks after last cycle of therapy. Pt continue adjuvant immunotherapy for up to 2 years after resection. Primary objective is the safety and tolerability of nivolumab +/- ipilimumab. Secondary objectives include overall response rate, complete response rate and time to progression. Exploratory objectives include evaluating the pre- and post-treatment immunological changes in tumor tissues and peripheral blood. Results: 17 pt were enrolled at the time of interim analysis (8 in Arm A, 9 in Arm B) and 14 were evaluable. Most pt (53%) were 60-70yo, and males (70%). 6 pt were HCV-positive and 4 had chronic hepatitis B. 14 pt proceeded with resection as planned; surgery was aborted for 2 pt (1 for frozen abdomen and 1 for development of contralateral liver nodule). One is still receiving preoperative therapy. Pathologic complete response (pCR) was observed in 4/14 evaluable pt – 2 in Arm A and 2 Arm B (29% pCR rate). 4 pt in Arm B and 1 in Arm A experienced grade 3 or higher toxicity prior to surgery. Conclusions: We report a pCR rate of 29% in an interim analysis of a phase II pilot trial of perioperative immunotherapy for resectable HCC. Treatment was safe and surgical resection was not delayed. The study is ongoing and results may contribute to a paradigm shift in the perioperative treatment of HCC. Clinical trial information: NCT03222076

 
Other Abstracts in this Sub-Category:

 

1. A multicenter randomized controlled trial to evaluate the efficacy of surgery vs. radiofrequency ablation for small hepatocellular carcinoma (SURF trial).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4002 First Author: Namiki Izumi
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer

 

2. ABC-06 | A randomised phase III, multi-centre, open-label study of Active Symptom Control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4003 First Author: Angela Lamarca
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer

 

3. Nivolumab (NIVO) + ipilimumab (IPI) combination therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC): Results from CheckMate 040.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4012 First Author: Thomas Yau
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer

 

More...