Adjuvant Chemotherapy Advances Boost Outcomes in GI Malignancies

Jason Harris
Published: Monday, Jun 18, 2018
Diane Reidy-Lagunes, MD
Diane Reidy-Lagunes, MD
Improved chemotherapy combination regimens are enhancing outcomes for patients across a range of gastrointestinal (GI) cancers, according to Diane Reidy-Lagunes, MD, who reviewed practice-changing findings during a presentation at the 3rd Annual School of Gastrointestinal Oncology™ (SOGO®).

“The landscape is changing,” said Reidy-Lagunes, associate deputy physician in chief of clinical operations at Memorial Sloan Kettering Cancer Center in New York, New York. “We are making strides to [improve both] the quantity and quality of life.”

Reidy-Lagunes outlined the current state-of-the-art GI care during her presentation at SOGO®, which Physicians’ Education Resource® hosted April 28 in New York City. She detailed findings from pivotal studies in gastric, pancreatic, biliary, and colorectal cancers to give her audience an overview of the field.

Evolving Options in Gastric Cancer

In gastric cancer, results from the FLOT4 clinical trial suggest that the FLOT (fluorouracil/leucovorin, oxaliplatin, and docetaxel [Taxotere]) regimen should be the adjuvant treatment of choice in gastric cancer over epirubicin/cisplatin/fluorouracil (ECF) or epirubicin/cisplatin/oxaliplatin (ECX).1

“FLOT is now the standard of care,” Reidy-Lagunes said. “ECF and ECX...should go in the waste bin of oncologic history. We no longer use epirubicin-based therapies for preoperative treatment in gastric cancer.”

In the randomized, multicenter, phase III trial, patients with resectable gastric cancer or adenocarcinoma of the gastroesophageal junction type I to III were assigned to FLOT (n = 356) or ECF/ ECX (n = 360). ECF was the previous standard of care based on results from the MAGIC trial, which was published in 2006.

In FLOT4, overall survival (OS) was superior for patients assigned to FLOT compared with ECF/ ECX (50 vs 35 months; HR, 0.77; 95% CI, 0.63- 0.94; log-rank P = .012). OS rates in the FLOT arm are projected to be superior at 2 years (68% vs 59%), 3 years (57% vs 48%), and 5 years (45% vs 36%). “OS unquestionably was improved on the FLOT arm,” Reidy-Lagunes said. “All the way out to 5 years, you could still see that difference.”

Grade 3/4 diarrhea, infections, and neutropenia occurred more frequently in the FLOT arm, but the ECF/ECX arm had higher rates of grade 3/4 vomiting (2% vs 8%) and nausea (7% vs 16%). The 2 groups had nearly identical rates of serious adverse events (AEs), serious AEs related to treatment, and toxic deaths.

There was no difference in operative morbidity/mortality between the treatment groups, Reidy-Lagunes added. Furthermore, there were no differences in terms of complications, death at 30 or 90 days, or number of hospitalization days.

New Standard in Pancreatic Setting

The 5-year survival rate for stage Ia pancreatic cancer is 14%, dropping to 3% for stage III disease and about 1% for stage IV, according to the American Cancer Society. The disease accounts for 3% of all cancers but 7% of cancer deaths.2

That does not mean there is no hope for these patients, Reidy-Lagunes said—gemcitabine has been the backbone for both metastatic and adjuvant treatment since the 1990s. The advent of FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) gave patients with metastatic disease who had a good performance status a new option, and results published in 2017 did the same in the adjuvant setting.

“We have a lot more work to do in the world of pancreas cancer, but ESPAC4—at least incrementally—improved the overall survival,” Reidy-Lagunes said. This phase III, open-label, randomized trial was conducted at 92 hospitals in Europe and the United Kingdom. Adult patients who underwent complete macroscopic resection for ductal adenocarcinoma of the pancreas were randomly assigned to receive either 1000 mg/m2 of gemcitabine once weekly for 3 weeks of a 4-week cycle (n = 366) or 1000 mg/m2 of gemcitabine on days 1, 8, and 15 plus 1660 mg/m2 of oral capecitabine (Xeloda) administered daily for 21 days followed by 7 days off (n = 362). Patients were treated for up to 6 cycles.3

The median OS for gemcitabine alone was 25.5 months (95% CI, 22.7-27.9) versus 28.0 months (95% CI, 23.5-31.5) for the combination (HR, 0.82; 95% CI, 0.68-0.98; P = .032).

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Navigating Treatment Decisions in Pancreatic Cancer: Key QuestionsJun 29, 20191.5
Oncology Briefings™: Individualizing Treatment After Second-Line Therapy for Patients With mCRCAug 29, 20191.0
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