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Hematologic Malignancies
Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

FDA Pipeline: Designations for Treatments of Rare Blood Cancer, B-Cell Malignancies, and Gastric Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to an antibody-drug conjugate for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN); gave Fast Track designation to a novel chimeric antigen...

Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Elizabeth Smyth, MD

The overall survival benefit for PD-L1 CPS ≥ 5 tumors in CheckMate 649 is a game-changer. An oxaliplatin doublet plus chemotherapy should become a standard of care for these patients,” according to Elizabeth Smyth, MD, an oncology consultant at Cambridge University Hospital NHS Foundation Trust in...

Gastrointestinal Cancer
Immunotherapy

Nivolumab Plus Chemotherapy: New Standard of Care in Advanced Gastric Cancer?

As first-line treatment for advanced gastric cancer, nivolumab plus chemotherapy leads to significantly improved progression-free and overall survival over chemotherapy alone, investigators reported during a Presidential Symposium of the European Society for Medical Oncology (ESMO) Virtual Congress ...

Immunotherapy
Multiple Myeloma
Lymphoma
Gastroesophageal Cancer
Gastrointestinal Cancer
Breast Cancer

FDA Pipeline: Priority Review for Agents in Multiple Myeloma, Anaplastic Large Cell Lymphoma

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to therapies for pretreated patients with multiple myeloma and pediatric patients with ALK-positive anaplastic large cell lymphoma; granted Fast Track designation to novel agents in gastric/gastroesophageal junction...

Gastrointestinal Cancer

Long-Term Outcomes With Neoadjuvant Therapy Followed by Surgery in Rectal Adenocarcinoma: Focus on Pathologic Response

For patients with rectal adenocarcinoma treated with neoadjuvant therapy followed by operative resection, “achieving a pathologic complete response is associated with excellent long-term disease-free and overall survival,” according to the results of a study reported by Naomi M. Sell, MD, MHS, of...

Gastrointestinal Cancer
Genomics/Genetics

Genetic Testing May Be Cost-Effective for Newly Diagnosed Patients With GIST

In a paper published by Banerjee et al in JAMA Network Open, researchers reported that genetic testing is cost-effective and beneficial for newly diagnosed patients with metastatic gastrointestinal stromal tumors (GIST), a type of soft-tissue sarcoma that develops in specialized nerve cells in the...

Gastrointestinal Cancer

Avapritinib Produces High Response Rate in Advanced PDGFRA D842V–Mutant GIST

As reported inThe Lancet Oncology by Michael C. Heinrich, MD, of the VA Portland Health Care System and the Oregon Health & Science University Knight Cancer Institute, and colleagues, the phase I NAVIGATOR trial showed that the PDGFRA and KIT kinase inhibitor avapritinib produced a high...

Gastrointestinal Cancer

Is Infiltrating Tumor Border Configuration Linked to Poor Survival in Colon Adenocarcinoma?

Findings from a retrospective cohort study could fuel the debate over the use of adjuvant chemotherapy in stage II colon cancer, according to data presented during the virtual edition of the 2020 Society of Surgical Oncology (SSO) International Conference on Surgical Cancer Care.1 Results of the...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

First-Line PD-1 Inhibitor With or Without Chemotherapy vs Chemotherapy Alone in Advanced Gastric Cancer: KEYNOTE-062

As reported in JAMA Oncology by Kohei Shitara, MD, and colleagues, the phase III KEYNOTE-062 trial showed no significant improvement in overall or progression-free survival with first-line pembrolizumab with or without chemotherapy vs chemotherapy alone in patients with PD-L1–positive advanced...

Gastrointestinal Cancer

Switch Control Inhibitor for GISTs Harboring Drug-Resistance Mutations: The INVICTUS Trial

In May 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib for patients who have received prior treatment with three or more kinase inhibitors, including imatinib, for advanced gastrointestinal stromal tumors (GIST). The approval was largely based on the findings of the...

Gastrointestinal Cancer

Ripretinib Improves Progression-Free Survival vs Placebo in Previously Treated Advanced GIST

As reported inThe Lancet Oncology by Jean-Yves Blay, MD, of Centre Léon Bérard, Lyon, France, and colleagues, the phase III INVICTUS trial has shown that the oral KIT and PDGFRα tyrosine kinase inhibitor ripretinib significantly prolonged progression-free survival vs placebo in patients with...

Gastrointestinal Cancer

Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGFR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Milind Javle, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported that third- and later-line treatment with the selective fibroblast growth factor...

Gastrointestinal Cancer
Genomics/Genetics

NTRK Fusions in Gastrointestinal Cancers: Rare but Responsive to Treatment

Although NTRK gene fusions occur in less than 5% of gastrointestinal cancers, it looks like they can be targeted successfully with NTRK inhibitors. In a pooled analysis of three clinical trials, 50% of such patients responded to entrectinib, in an updated analysis presented during the 2020 virtual...

Gastrointestinal Cancer

First-Line S-1 Plus Leucovorin and Oxaliplatin vs S-1 Plus Cisplatin in Advanced Gastric Cancer

As reported in The Lancet Oncology by Kang et al, the Japanese-Korean phase III SOLAR trial showed that oral tegafur/gimeracil/oteracil, a combination known as S-1, plus leucovorin and oxaliplatin was associated with a modest but significant improvement in overall survival vs S-1 plus cisplatin in...

Gastrointestinal Cancer

Avapritinib in Advanced PDGFRA D842V–Mutant Gastrointestinal Stromal Tumors

As reported in The Lancet Oncology by Heinrich et al, the phase I NAVIGATOR trial showed that the PDGFRA and KIT kinase inhibitor avapritinib produced a response in patients with PDGFRA D842V–mutant gastrointestinal stromal tumors (GIST).   The study supported the January 2020 approval of...

Gastrointestinal Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab for Advanced Gastric Cancer

In the Japanese single-center phase II EPOC1706 trial reported in The Lancet Oncology, Kawazoe et al found high objective response among patients with advanced gastric cancer who received the combination of lenvatinib and pembrolizumab as first- or second-line treatment. Study Details The trial...

Gastrointestinal Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab for Advanced Gastric Cancer

In the Japanese single-center phase II EPOC1706 trial reported in The Lancet Oncology, Kawazoe et al found high objective response among patients with advanced gastric cancer who received the combination of lenvatinib and pembrolizumab as first- or second-line treatment. Study Details The trial...

Gastrointestinal Cancer

Ursodeoxycholic Acid for Preventing Gallstones After Gastrectomy for Gastric Cancer

In a Korean trial reported in JAMA Surgery, Lee et al found that treatment with ursodeoxycholic acid was successful in preventing gallstone formation in patients who had undergone gastrectomy for gastric cancer. Study Details In the multicenter double-blind trial, 465 evaluable patients undergoing...

Gastrointestinal Cancer

Long-Term Survival Outcomes With Different Durations of Adjuvant Imatinib for Gastrointestinal Stromal Tumors

In a 10-year follow-up of the phase III SSGXVIII/AIO trial reported in JAMA Oncology, Heikki Joensuu, MD, and colleagues found that 3 years vs 1 year of adjuvant treatment with imatinib was associated with superior overall survival among patients with high-risk gastrointestinal stromal tumors. The ...

Gastrointestinal Cancer

Ripretinib in Previously Treated Advanced Gastrointestinal Stromal Tumor

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 15, 2020, the receptor tyrosine kinase inhibitor...

Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Michael S. Lee, MD, and Autumn McRee, MD

DESTINY-CRC01 study discussant, Michael S. Lee, MD, Assistant Professor of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, called the findings “most promising” for the subsequent anti-HER2 treatment of HER2-positive metastatic colorectal cancer. The...

gastrointestinal cancer

Peter Reichardt, MD, PhD, on GIST: Adjuvant Imatinib for High-Risk Disease

Peter Reichardt, MD, PhD, of Helios Klinikum Berlin-Buch, discusses the 10-year survival analysis of 3 years vs 1 year of adjuvant imatinib for patients with high-risk gastrointestinal stromal tumor. The study found that about 50% of deaths can be avoided with longer imatinib treatment (Abstract 11503).

Colorectal Cancer
Pancreatic Cancer
Lymphoma
Hematologic Malignancies
Kidney Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer

FDA Pipeline: Fast Track Designations in Colorectal and Pancreatic Cancers, Lymphoplasmacytic Lymphoma/Waldenström’s Macroglobulinemia

Over the past month, the U.S. Food and Drug Administration has granted Fast Track designation to agents designed to treat colorectal and pancreatic cancers, in addition to lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia; accepted a new drug application for a treatment for relapsed or...

Gastrointestinal Cancer

Ripretinib in Previously Treated Patients With Advanced GIST: INVICTUS Trial

As reported in The Lancet Oncology by Jean-Yves Blay, MD, and colleagues, the phase III INVICTUS trial has shown that the oral KIT and PDGFRα tyrosine kinase inhibitor ripretinib prolonged progression-free survival vs placebo in patients with advanced gastrointestinal stromal tumors (GIST) whose...

Gastrointestinal Cancer
Immunotherapy

Trastuzumab Deruxtecan vs Chemotherapy for Previously Treated Patients With HER2-Positive Advanced Gastric Cancer

Results of the phase II DESTINY-Gastric01 study—reported at the ASCO20 Virtual Scientific Program (Abstract 4513) and published in The New England Journal of Medicine, by Kohei Shitara, MD, of the National Cancer Center Hospital East, Kashiwa, and colleagues—found that the antibody-drug conjugate...

Gastrointestinal Cancer
Lung Cancer
Leukemia
Hepatobiliary Cancer
Kidney Cancer
Immunotherapy

FDA Pipeline: Two Breakthrough Therapy Designations for Fam-Trastuzumab Deruxtecan-nxki, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designations for an antibody-drug conjugate in the treatment of gastric and lung cancers. The Agency has also issued Orphan Drug designations for agents being investigated in chronic myeloid...

Gastrointestinal Cancer

FDA Approves Ripretinib for Previously Treated Patients With Advanced Gastrointestinal Stromal Tumor

On May 15, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. INVICTUS Trial Efficacy was...

Colorectal Cancer
Gastrointestinal Cancer
Immunotherapy

Regorafenib Plus Nivolumab in Advanced Gastric and Colorectal Cancers

In a Japanese phase Ib/dose-expansion trial reported in the Journal of Clinical Oncology, Fukuoka et al found that the combination of regorafenib and nivolumab showed activity in patients with previously treated gastric cancer and colorectal cancer with microsatellite stable/mismatch...

Colorectal Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer
Pancreatic Cancer

Aspirin Use and Risk of Cancers of the Digestive Tract

Aspirin may be associated with a reduction in the risk of developing several cancers of the digestive tract. The largest and most comprehensive analysis to date of the link between aspirin and digestive tract cancers, published by Bosetti et al in Annals of Oncology, found reductions in the risk of ...

Gastrointestinal Cancer

Surgical Margins and Survival in Trial of Adjuvant Imatinib for Localized GIST

A post hoc observational study from the phase III EORTC 62024 trial of adjuvant imatinib in patients with localized gastrointestinal stromal tumors (GIST) showed that improvement in survival with R0 vs R1 resection was no longer evident when tumor rupture was excluded from the R1 category. The...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Trastuzumab Beyond Disease Progression in HER2‑Positive Advanced Gastric/Gastroesophageal Junction Cancer

In the Japanese phase II T-ACT study reported in the Journal of Clinical Oncology, Makiyama et al found no benefit of continued trastuzumab combined with paclitaxel after disease progression on first-line trastuzumab plus fluoropyrimidine/platinum chemotherapy in patients with HER2-positive...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Phase III JAVELIN Gastric 100 Trial Finds No Survival Benefit for Maintenance Avelumab

In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

Expert Point of View: Daniel V.T. Catenacci, MD

The analysis by Chao et al “highlights how well patients with MSI-H tumors do, compared to microsatellite-stable patients, and how much better they do in a randomized setting, being exposed to immunotherapy as compared to standard-of-care chemotherapy…The data also show that this is a...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Pembrolizumab in MSI-H and CPS ≥ 10 Advanced Gastric or Gastroesophageal Junction Cancer: Subanalysis of KEYNOTE-059, -061, and -062

The survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a combined positive score (CPS) ≥ 10 was established in post hoc subanalysis of three KEYNOTE trials. Findings were presented at the 2020...

Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Hepatobiliary Cancer
Pancreatic Cancer

Conference Highlights From the 2020 Gastrointestinal Cancers Symposium

This past January, the 2020 Gastrointestinal Cancers Symposium was held in San Francisco. More than 3,600 individuals attended and more than 900 abstracts and posters were presented. Among the highlights presented at the meeting and reported in the pages of The ASCO Post, several studies in...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

Expert Point of View: Daniel V.T. Catenacci, MD

Daniel V.T. Catenacci, MD, of the University of Chicago Medical Center and Biological Sciences, emphasized the value of the patient having microsatellite instability–high (MSI-H) status as a biomarker for immunotherapy. The analysis by Chao et al “highlights how well patients with MSI-H tumors do,...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

Survival Benefits Achieved With Pembrolizumab in MSI-H and CPS ≥ 10 Gastric/Gastroesophageal Junction Cancer

Post hoc subanalyses of three KEYNOTE trials established the survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 10 (ie, the number of...

Gastrointestinal Cancer
Genomics/Genetics

Avapritinib for Gastrointestinal Stromal Tumor With PDGFRA Exon 18 Mutation

On January 9, 2020, avapritinib was approved for treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.1,2 It is the first therapy approved for...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Daniel V.T. Catenacci, MD

Daniel V.T. Catenacci, MD, Associate Professor of Medicine and Director of the Gastrointestinal Oncology Program at the University of Chicago, was the JAVELIN Gastric 100 study’s invited discussant. After offering an extensive background on the use of immunotherapy in gastric or gastroesophageal...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

No Survival Benefit for Maintenance Avelumab in Advanced Gastric or Gastroesophageal Junction Cancer

In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...

Gastrointestinal Cancer

Expert Point of View: George A. Fisher, Jr, MD, PhD

George A. Fisher, Jr, MD, PhD, the Colleen Haas Chair in Medicine-Oncology at Stanford University School of Medicine, commented on the cell-free DNA methylation blood-based test from the Circulating Cell-Free Genome Atlas (CCGA) study. The findings presented by Dr. Wolpin, he said, “lead us to the ...

Gastrointestinal Cancer

Use of Cell-Free DNA Methylation–Based Blood Test in Detecting Gastrointestinal Cancers

A noninvasive, blood-based, cell-free DNA test focused on the presence of DNA methylation appears to be highly sensitive in detecting gastrointestinal cancers and may pinpoint the tissue of origin in the vast majority of these cancers.1 The assay was developed based on findings from the...

Lung Cancer
Lymphoma
Bladder Cancer
Head and Neck Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Lung Cancers, Lymphoma

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...

Lymphoma
Lung Cancer
Gastrointestinal Cancer
Breast Cancer
Head and Neck Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Lymphoma, Lung Cancer, GIST, and Breast Cancer

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents in lymphoma, lung cancer, gastrointestinal stromal tumors, and breast cancer, and granted Fast Track designation to a first-in-class radioenhancer hafnium oxide nanoparticle in head and neck cancer. Priority...

Gastrointestinal Cancer

Does Treating Individuals for H pylori Infection Reduce Gastric Cancer Risk in Those With a Family History of the Disease?

In a large Korean single-center study reported in The New England Journal of Medicine, Choi et al found that eradication of Helicobacter pylori infection was associated with a reduced risk of gastric cancer in individuals with a family history of gastric cancer in first-degree relatives. As stated ...

gastrointestinal cancer

Brian M. Wolpin, MD, on Performance of a Blood-Based Test for the Detection of Multiple Cancers

Brian M. Wolpin, MD, of Dana-Farber Cancer Institute, discusses a noninvasive blood test evaluating methylation of circulating free DNA. In his study, the blood test detected multiple gastrointestinal cancers at a sensitivity of approximately 81% and a prespecified specificity of > 99%. It also accurately localized the tissue of origin across more than 20 cancer types (Abstract 283).

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Zev A. Wainberg, MD, on PD-L1­–Positive Advanced Gastric Cancer: MSI and Combined Positive Score and Pembrolizumab vs Chemotherapy

Zev A. Wainberg, MD, of the UCLA Medical Center, discusses the first subset analysis of how a combined positive score in gastric and gastroesophageal junction cancers related to the efficacy of pembrolizumab in PD-L1–positive disease (Abstract 427).

Gastrointestinal Cancer
Palliative Care

2020 GI Cancers Symposium: Does Receipt of Palliative Care Increase Survival in Patients With Metastatic Esophageal Cancer Declining Chemotherapy?

Patients with metastatic esophageal cancer who declined chemotherapy but received palliative care had a numerically higher, but not statistically significant, difference in overall survival. These findings will be presented by Manguso et al at the 2020 Gastrointestinal Cancers Symposium (Abstract...

Gastrointestinal Cancer

Cancer No Longer Scares Me

Cancer was a disease I feared until 3 years ago, when I was diagnosed with gastric cancer. After receiving the diagnosis, I knew I didn’t have any time to indulge in fear; I had to take action if I was going to survive. In hindsight, symptoms of the cancer, including some fatigue and indigestion,...

Gastrointestinal Cancer

2020 GI Cancers Symposium: Detecting GI Tumors Using a Cell-Free DNA Test

A blood-based screening test using cell-free DNA to identify methylation signals of hard-to-detect gastrointestinal (GI) cancers could potentially help detect disease at earlier stages. This research will be presented by Brian M. Wolpin, MD, MPH, and colleagues at the 2020 Gastrointestinal Cancers...

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