Startseite Kongressberichte & Archiv 2021 Gastrointestinal Cancers Symposium Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Oral Abstract & Rapid Abstract Session

Oral Abstract Session

Session Link
 
Final results from ClarIDHy, a global, phase III, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation.
 
Andrew X. Zhu, Teresa Macarulla, Milind M. Javle, et al.
 
The authors conclude:   
IVO was well tolerated and resulted in a favorable OS trend vs PBO despite a high rate of crossover. These data – coupled with statistical improvement in PFS, supportive quality of life data, and favorable safety profile – demonstrate the clinical benefit of IVO in advanced mIDH1 CCA.
 
Final results from a phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2gene fusion or rearrangement.
 
Milind M. Javle, Sameek Roychowdhury, Robin Kate K. Kelley, et al.
 
The authors conclude:   
Infigratinib is associated with promising anticancer activity and a manageable AE profile in patients with advanced, refractory CCA with an FGFR2 gene fusion or rearrangement. A phase III study of infigratinib versus gemcitabine/cisplatin is ongoing in the front-line setting (NCT03773302).
 

Alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX plus hypofractionated radiation therapy (RT) for borderline resectable (BR) adenocarcinoma of the pancreas.

Matthew H. Katz, Qian Shi, Jeffrey P. Meyers, et al. 

The authors conclude:   

Neoadjuvant mFOLFIRINOX was associated with favorable OS relative to historical data in pts with BL PDAC in this phase II NCTN trial. mFOLFIRINOX with hypofractionated RT did not improve OS compared to historical data. mFOLFIRINOX represents a reference regimen in this setting and a backbone on which to add novel agents. Support: U10CA180821, U10CA180882, U24CA196171; https://acknowledgments.alliancefound.org

A phase II/III randomized double-blind study of octreotide acetate with axitinib versus octreotide acetate with placebo in patients with advanced G1-G2 NETs of non-pancreatic origin (AXINET trial-GETNE-1107).
 
Rocio Garcia-Carbonero, Marta Benavent, Paula Jiménez Fonseca, et al.
 
The authors conclude:   
Although the study failed to demonstrate a significant PFS benefit per investigator assessment, axitinib in combination with octreotide LAR demonstrated activity and had a tolerable safety profile in patients with advanced G1-2 extra-pancreatic NETs. Data base cleaning and central blinded radiological PFS assessment are currently ongoing. Clinical trial information: NCT01744249
 
 

Rapid Abstract Session

Session Link
 
IMbrave150: Updated overall survival (OS) data from a global, randomized, open-label phase III study of atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor) in patients (pts) with unresectable hepatocellular carcinoma (HCC).
 
Richard S. Finn, Shukui Qin, Masafumi Ikeda, et al.
 
The authors conclude:   
IMbrave150 showed consistent clinically meaningful treatment benefit and safety with 12 mo of additional follow-up. The combination provides the longest survival seen in a front-line Phase III study in advanced HCC, confirming atezo + bev as a standard of care for previously untreated, unresectable HCC.
 
Overall survival from the phase 3 POLO trial: Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer.
 
Talia Golan, Pascal Hammel, Michele Reni, et al.
 
The authors conclude:   
Although HR for OS was in favor of maintenance O vs P among patients with a gBRCAm and mPaC whose disease had not progressed during PBC, there was no statistically significant difference. PFS2 showed a clear trend for treatment benefit beyond disease progression in favor of O, but was not alpha protected. Safety data were consistent with the primary analysis.
 
Pembrolizumab (pembro) vs placebo (pbo) in patients (pts) with advanced hepatocellular carcinoma (aHCC) previously treated with sorafenib: Updated data from the randomized, phase III KEYNOTE-240 study.
 
Philippe Merle, Julien Edeline, Mohamed Bouattour, et al.
 
The authors conclude:   
In previously treated pts with aHCC, improvement in OS and PFS was maintained over time with pembro vs pbo, and the safety profile remained consistent over time. These data support the benefit:risk profile of pembro.
 
COVID-19 infection in gastrointestinal (GI) cancer patients receiving systemic anticancer treatment (SACT) during the outbreak of the pandemic: The Guy's Cancer Centre experience.
 
Eirini Tsotra, Charalampos Gousis, Beth Russell, et al.
 
The authors conclude:   
The rate of COVID-19 infection in our population was relatively low (3.4%). Of the 14 COVID-19 positive patients, 57.1% had severe infection, 21.4% died (compared to 3.7% mortality in the non-infected group) and all but one were on chemotherapy. This prospective data, from a large UK comprehensive Cancer Centre, provides some evidence that continuing SACT through the pandemic is relatively safe. The risk of COVID-19 related infection and death must be off-set against the cancer-related morbidity and mortality associated with treatment delays.
 
Nivolumab (NIVO) plus ipilimumab (IPI) combination therapy in patients (Pts) with advanced hepatocellular carcinoma (aHCC): Long-term results from CheckMate 040.
 
Anthony B. El-Khoueiry, Thomas Yau, Yoon-Koo Kang, et al.
 
The authors conclude:   
At a minimum follow-up of 44 mo, second-line NIVO1+IPI3 continued to demonstrate clinically meaningful responses and long-term survival benefit in aHCC. The safety profile was manageable and no new safety signals were identified with longer follow-up.
 
TACTICS: Final overall survival (OS) data from a randomized, open label, multicenter, phase II trial of transcatheter arterial chemoembolization (TACE) therapy in combination with sorafenib as compared with TACE alone in patients (pts) with hepatocellular carcinoma (HCC).
 
AUTHOR(S)
Masatoshi Kudo, Kazuomi Ueshima, Masafumi Ikeda, et al.
 
The authors conclude:   
In TACTICS, TACE plus sorafenib did not show OS benefit as compared with TACE alone although significantly better PFS was consistently observed. OS in TACE plus sorafenib in TACTICS trial showed the longest OS (36.2 mo) with the longest ?OS (5.4 mo) as compared with the previous 5 TACE combination trials. The major reason for negative OS result was speculated that many post-trial active treatments were performed in control arm (76.3%), which implies that OS endpoint in TACE combination trial may not be feasible anymore in current era of sequential therapy with many active locoregional and systemic treatments.