Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

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Howard Safran, Kathryn A. Winter, Dennis A. Wigle, et al. 
 
The abstract concludes: 
The addition of trastuzumab to trimodality treatment did not improve DFS for patients with HER2 overexpressing esophageal adenocarcinoma. Supported by NCI grants U10CA180868, UG1CA189867, U10CA180822 and Genentech. Clinical trial information: NCT01196390.
 
Read the comment in the ASCO DAILY NEWS:
 
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Salah-Eddin Al-Batran, Ralf Dieter Hofheinz, Harald Schmalenberg,et al. 
 
The abstract concludes: 
In this phase II trial, the addition of ramucirumab to perioperative FLOT significantly improved R0-resection rates without an impact on path response, mainly because more patients could proceed to operation. The FLOT-RAM is safe, when type I tumors are excluded. Clinical trial information: NCT02661971
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Ralf Dieter Hofheinz, Georg Martin Haag, Thomas Jens Ettrich, et al. 
 
The abstract concludes: 
The addition of tras/per to perioperative FLOT significantly improved pCR and nodal negativity rates in pts with Her2+ resectable esophagogastric adenocarcinoma at the price of higher rates of diarrhea and leukopenia. Clinical trial information: NCT02581462.
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This long-term analysis found that second-line pembrolizumab prolonged OS among patients with PD-L1–positive GC and led to fewer drug-related AEs vs paclitaxel. Clinical trial information: NCT02370498.
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Davendra Sohal, Mai T. Duong, Syed A. Ahmad, et al.
 
The abstract concludes: 
We have demonstrated: 1) two-year OS of 41.6% (median 22.4 months) with mFOLFIRINOX and 48.8% (median 23.6 months) with Gem/nabP for all eligible pts starting treatment for resectable PDA; 2) post-resection DFS of 10.9 months and 14.2 months, respectively; 3) adequate safety and high resectability rates with peri-op CTx; 4) little evidence that either regimen improves OS compared with the historical standard. Clinical trial information: NCT02562716.
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The abstract concludes: 
There was no difference in resection rate between arms, however neoadjuvant therapy had a significant survival benefit compared with immediate surgery. Clinical trial information: 89500674.
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Feng Bi, Shukui Qin, Shanzhi Gu, et al. 
 
The abstract concludes: 
Donafenib significantly improves OS over sorafenib with favourable safety and tolerability. Donafenib is a promising superior first-line therapy for advanced HCC. Funding: Zelgen. Clinical trial information: NCT02645981.
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Qiu Li, Shukui Qin, Shanzhi Gu, et al.
 
The abstract concludes: 
Apatinib significantly prolonged OS and PFS in Chinese pts with pretreated advanced HCC, and was well tolerated with a manageable safety profile. Clinical trial information: NCT02329860.
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Robin Kate Kelley, Bruno Sangro, William Proctor Harris, et al.
 
The abstract concludes: 
The encouraging clinical activity and tolerable safety profile suggest T300+D provides the best benefit-risk profile as opposed to T75+D or monotherapies. The unique pharmacodynamic activity of the T300+D regimen further supports its use in aHCC. T300+D and D are being evaluated in the ongoing phase III HIMALAYA study (NCT03298451) in first-line HCC vs sorafenib. Funding: AstraZeneca. Clinical trial information: NCT02519348.
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DISCUSSANT
Susan Tsai, MD, MHS | Medical College of Wisconsin and Clement J. Zablocki Veterans Affairs Medical Center
 
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POSTER ABSTRACTS
Ramon Jin, Haeseong Park, Andrea Wang-Gillam, et al.
 
The abstract concludes: 
FOLFIRINOX is a highly effective three-drug regimen for first-line treatment of advanced gastroesophageal cancer with expected, tolerable toxicities. Clinical trial information: NCT01928290.
 
Published simultaneously in JAMA Oncology:
FOLFIRINOX for the Treatment of Advanced Gastroesophageal Cancers: A Phase 2 Nonrandomized Clinical Trial
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Zev A. Wainberg, Tanios S. Bekaii-Saab, Richard Hubner, et al.
  • The primary endpoint is overall survival (OS).
  • Secondary endpoints (progression-free survival [PFS] and overall response rate assessed with Response Evaluation Criteria in Solid Tumors v1.1 criteria) will be compared only if the primary endpoint shows superiority for liposomal irinotecan + 5-FU/ LV + OX over nab-paclitaxel + gemcitabine.
Clinical trial information: NCT04083235
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4624 Liposomal irinotecan plus fluorouracil/leucovorin versus FOLFIRINOX as the second-line chemotherapy for patients with metastatic pancreatic cancer: Multicenter study of the Korean Cancer Study Group (KCSG).

Hongjae Chon, Hyung Soon Park, Beodeul Kang, et al.

The abstract concludes:

In second-line setting for mPC after progression on gemcitabine-based therapy, both nal-IRI/FL and FOLFIRINOX regimen showed comparable efficacy and acceptable safety outcomes. FOLFIRINOX regimen might be preferentially considered in patients with liver metastasis.

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Esther Pijnappel, Judith de Vos-Geelen, Teresa Macarulla Mercade, et al.
  • multi-center, open label, randomized phase II trial. Patients ≥ 18 years of age with histologically or cytologically confirmed PDAC, previously treated with gemcitabine (-based) therapy, or progression within 6 months of adjuvant gemcitabine-based treatment are eligible. After a safety run-in of the nal-IRI plus S-1 regimen, patients will be randomized between nal-IRI plus S-1 and nal-IRI plus 5-FU/LV.

Clinical trial information: NCT03986294.

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4634 A phase I study of nanoliposomal irinotecan and 5-fluorouracil/folinic acid in combination with interleukin-1-alpha antagonist for advanced pancreatic cancer patients with cachexia (OnFX).

Andrew Eugene Hendifar, Sungjin Kim, Mourad Tighiouart, et al.
 
The abstract concludes:
Bermekimab, nano-liposomal irinotecan and 5-fluorouracil in refractory pancreatic cancer patients with cachexia was well-tolerated with promising efficacy and improvements in patient performance. Clinical trial information: NCT03207724
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Kohei Shitara, Yung-Jue Bang, Satoru Iwasa, et al.
 
The abstract concludes:
 
T-DXd demonstrated statistically significant and clinically meaningful improvements in ORR and OS compared with standard chemotherapy (paclitaxel or irinotecan) in patients with HER2+ advanced gastric or GEJ adenocarcinoma. Clinical trial information: NCT03329690.
 

Published simultaneously in the NEJM:

Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer

K. Shitara and Others

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Poster Discussion Session
 
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Gastrointestinal (Abstracts #4500, 4504, 4508)
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