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leukemia
prostate cancer
gastrointestinal cancer

FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance

Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...

lung cancer
gastroesophageal cancer
bladder cancer
gastrointestinal cancer
immunotherapy

Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma

Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...

issues in oncology
gastrointestinal cancer

ESMO World GI 2019: Incidence of Gastric Cancer in Younger Individuals

The incidence of gastric cancer has been increasing in younger individuals, and those under 40 with chronic digestive symptoms should be more actively investigated. These findings follow new data from a retrospective, observational study in Mexico, which showed that 1 in 7 of over 2,000...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

FDA Approves New Trastuzumab Biosimilar

Today, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...

gastrointestinal cancer

Does Adding HIPEC to Cytoreductive Surgery Improve Outcomes in Patients With Gastric Cancer and Peritoneal Metastases?

In a propensity score analysis reported in the Journal of Clinical Oncology, Bonnot et al found that the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery improved outcomes among patients with gastric cancer with peritoneal metastases. The study included 277...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Josep Tabernero, MD, PhD, on Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: Pembrolizumab With or Without Chemotherapy vs Chemotherapy

Josep Tabernero, MD, PhD, of the Vall d’Hebron Institute of Oncology, discusses phase III findings of the KEYNOTE-062 study showing that, for some patients with advanced gastric or gastroesophageal junction cancer, pembrolizumab may improve survival and may be an effective alternative to...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

2019 ASCO: KEYNOTE-062: Pembrolizumab With or Without Chemotherapy vs Chemotherapy in Advanced Gastric or GEJ Adenocarcinoma

The randomized, phase III KEYNOTE-062 trial achieved its primary endpoint, showing that for patients with programmed cell death ligand 1 (PD-L1)-positive, HER2-negative, advanced gastric or gastroesophageal junction (GEJ) cancer, initial therapy with pembrolizumab resulted in noninferior overall...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

Trastuzumab Deruxtecan in Advanced HER2-Positive Gastric and Breast Cancers

Two phase I studies reported in The Lancet Oncology indicate activity of the antibody-drug conjugate trastuzumab deruxtecan in advanced HER2-positive gastric cancer and advanced HER2-positive breast cancer previously treated with trastuzumab emtansine (T-DM1). Trastuzumab deruxtecan (DS-8201a) is a ...

gastroesophageal cancer
gastrointestinal cancer

Perioperative Therapy With FLOT vs ECF/ECX in Locally Advanced Gastric Adenocarcinoma

In the German phase II/III FLOT4 trial reported in The Lancet, Al-Batran et al found that perioperative therapy with the docetaxel-based triplet FLOT (fluorouracil [5-FU]/leucovorin, oxaliplatin, and docetaxel) was associated with improved overall survival vs ECF/ECX (epirubicin and cisplatin plus...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

FDA Approves Trastuzumab-qyyp in HER2-Overexpressing Breast and Gastric Cancers

The U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...

gastroesophageal cancer
gastrointestinal cancer

FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma

On February 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Addition of First-Line Ramucirumab to Cisplatin and Fluoropyrimidine in Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

In the phase III RAINFALL trial reported in The Lancet Oncology, Fuchs et al found no apparent benefit of the addition of the VEGFR-2 inhibitor ramucirumab to first-line cisplatin and fluoropyrimidine treatment in metastatic gastric or gastroesophageal junction adenocarcinoma. Study Details The...

gastrointestinal cancer

Rongbo Lin, MD, on Gastric Cancer: Results From the FNF-004 Trial

Rongbo Lin, MD, of Fujian Cancer Hospital, discusses phase II study findings on FOLFOX alone vs paclitaxel plus FOLFOX vs intraperitoneal paclitaxel plus FOLFOX as a first-line treatment in advanced gastric cancer (Abstract 6).

gastroesophageal cancer
gastrointestinal cancer

Manish A. Shah, MD, on Gastric Cancer: Results From the GAMMA-1 Study on First-Line Combination Therapy

Manish A. Shah, MD, of NewYork–Presbyterian/Weill Cornell Medical Center, discusses phase III data on the efficacy and safety of andecaliximab combined with mFOLFOX6 as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma (Abstract 4).

gastrointestinal cancer

David H. Ilson, MD, PhD, on Gastric Cancer: Results From the TAGS Study on Third-Line Trifluridine/Tipiracil

David H. Ilson, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses findings on the efficacy and safety of third-line trifluridine/tipiracil in patients with metastatic gastric cancer with or without prior gastrectomy (Abstract 3).

breast cancer
gastroesophageal cancer
gastrointestinal cancer

FDA Approves Biosimilar Trastuzumab-dttb

On January 18, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab, across all eligible indications—namely, adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or...

head and neck cancer
gastrointestinal cancer
immunotherapy

2019 GI Cancers Symposium: Pembrolizumab in Second-Line Therapy for Advanced Esophageal Cancer

Pembrolizumab significantly improved overall survival in the second-line setting of advanced esophageal cancer in patients whose tumors tested positive for programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) of 10 or greater. This was compared to investigator’s choice...

gastrointestinal cancer

2019 GI Cancers Symposium: Safety, Efficacy of Trifluridine/Tipiracil in Metastatic Gastric Cancer With or Without Gastrectomy

In a poster session earlier today David Ilson, MD, of Memorial Sloan Kettering Cancer Center, and colleagues reported on a preplanned subgroup analysis of the double-blind phase III TAGS study looking at the safety and efficacy of the oral agent trifluridine/tipiracil (FTP/TPI) in heavily...

gastroesophageal cancer
gastrointestinal cancer

2019 GI Cancers Symposium: Addition of Andecaliximab to mFOLFOX6 in Treatment-Naive Advanced Gastric or GEJ Adenocarcinoma

A phase I/Ib study found that the addition of andecaliximab, a monoclonal antibody that inhibits matrix metalloproteinase 9, to modified fluorouracil (5-FU), leucovorin, and oxaliplatin (mFOLFOX6) showed activity in gastric and or gastroesophageal junction (GEJ) carcinoma. Based on these...

hepatobiliary cancer
gastrointestinal cancer

EORTC-NCI-AACR: Dabrafenib Plus Trametinib Active in Some BRAF V600E–Mutated Gastrointestinal Cancers

In a late-breaking presentation at the 30th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Zev Wainberg, MD, reported on results from a phase II international clinical trial of dabrafenib (Tafinlar) plus trametinib (Mekinist), which showed some activity in 36 patients ...

breast cancer
gynecologic cancers
lymphoma
pancreatic cancer
gastroesophageal cancer
bladder cancer
symptom management
gastrointestinal cancer

FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...

gastrointestinal cancer

PERSIST-5: 5-Year Adjuvant Imatinib in Resected Intermediate- or High-Risk Primary Gastrointestinal Stromal Tumor

In the phase II PERSIST-5 study reported in JAMA Oncology, Raut et al found that 5 years of adjuvant imatinib therapy was associated with little risk of recurrence in patients with resected intermediate- or high-risk primary gastrointestinal stromal tumor (GIST). As noted by the investigators, 3...

gastrointestinal cancer

Trifluridine/Tipiracil in Heavily Pretreated Metastatic Gastric Cancer

In the phase III TAGS trial reported in The Lancet Oncology, Shitara et al found that trifluridine/tipiracil (Lonsurf) significantly improved overall survival vs placebo in patients with heavily pretreated metastatic gastric cancer. In the double-blind trial, 507 patients with nonresectable...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Pertuzumab and Trastuzumab Plus Chemotherapy in HER2-Positive, Metastatic Gastric or Gastroesophageal Junction Cancer

As reported in The Lancet Oncology by Tabernero et al, the phase III JACOB trial showed no significant overall survival benefit of adding pertuzumab (Perjeta) to trastuzumab (Herceptin) plus chemotherapy in first-line treatment of HER2-positive metastatic gastric or gastroesophageal junction...

gastrointestinal cancer

MUC16 Mutation, Tumor Mutation Load, and Prognosis in Gastric Cancer

In a study reported in JAMA Oncology, Li et al found that MUC16 mutation was associated with increased tumor mutation load and improved prognosis in gastric cancer. The study involved analysis of genomic data from 437 gastric cancer samples from The Cancer Genome Atlas (TCGA; discovery set) and...

breast cancer
gastroesophageal cancer
gastrointestinal cancer
immunotherapy

European Commission Approves Trastuzumab Biosimilar

The European Commission (EC) has approved Trazimera, a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor (HER2)–overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval...

gastrointestinal cancer
immunotherapy

Ability of Assay to Predict Response to Immunotherapy in Patients With Advanced Gastric Cancer

Researchers from Samsung Medical Center and Guardant Health, Inc have demonstrated the feasibility of determining a measure analogous to tumor mutation burden, a promising biomarker that may predict patient response to certain immunotherapies, utilizing the Guardant360 assay, a...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Second-Line Pembrolizumab vs Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...

gastrointestinal cancer

Risk of Gastrointestinal Cancers in Patients With Cystic Fibrosis

In a meta-analysis reported in The Lancet Oncology, Yamada et al found that patients with cystic fibrosis are at increased risk of gastrointestinal (GI) cancers vs the general population. Improved management of cystic fibrosis has led to increased life expectancy and increased incidence of...

gastroesophageal cancer
gastrointestinal cancer

Postoperative Chemotherapy vs Chemoradiotherapy in Resectable Gastric Cancer

In the Scandinavian phase III CRITICS trial reported in The Lancet Oncology, Cats et al found no benefit of postoperative chemoradiotherapy vs chemotherapy among patients with gastric cancer who had received neoadjuvant chemotherapy. Compliance with postoperative regimens was poor in both groups....

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Anti–PD-1 Immunotherapy in Previously Treated Gastric Cancer

As reported in JAMA Oncology by Fuchs et al, pembrolizumab (Keytruda) showed activity in patients with previously treated advanced gastric and gastroesophageal junction cancer in the phase II KEYNOTE-059 trial. Study Details In the study, 259 patients from sites in 16 countries who had disease...

gastrointestinal cancer

Antibiotic Therapy for Helicobacter pylori Infection and Prevention of Metachronous Gastric Cancer

In a Korean study reported in The New England Journal of Medicine, Choi et al found that antibiotic treatment for Helicobacter pylori was associated with a significant reduction in metachronous gastric cancer in patients who had undergone endoscopic resection of early gastric cancer or high-grade...

gastrointestinal cancer

SSO 2018: Improved Survival With Nodal Downstaging in Gastric Cancer if ypN0 Is Achieved

A team of researchers led by Naruihiko Ikoma, MD, MS, of The University of Texas MD Anderson Cancer Center in Houston, analyzed outcomes in 316 patients with gastric cancer to determine whether patients who had clinically positive nodal disease before preoperative therapy have...

issues in oncology
gastrointestinal cancer

Rehospitalization Patterns After Gastrointestinal Cancer Hospitalizations

In a study reported in the Journal of Oncology Practice, Manzano et al found that unplanned rehospitalization within 30 days after gastrointestinal (GI) cancer hospitalization was more likely after medical vs surgical index hospitalizations among older patients. Some risk factors for...

gastrointestinal cancer

Incidence of Noncardia Gastric Cancer Increasing Among Americans Under 50

A type of cancer that occurs in the lower stomach has been increasing among some Americans under the age of 50, even though in the general population, the incidence of all stomach cancers has been declining for decades. These findings were published by Anderson et al in the Journal of the National...

pancreatic cancer
gastrointestinal cancer

FDA Approves Lutetium Lu-177 Dotatate for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

On January 26, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs. Lu-177 dotatate is...

gastroesophageal cancer
gastrointestinal cancer

Maria Svensson, MD, PhD Candidate, on Esophageal and Gastric Cancers: Significance of PD-1 and PD-L1 Expression

Maria Svensson, MD, PhD Candidate, of Lund University, discusses high expression of PD-1 and PD-L1 in chemotherapy-naive esophageal and gastric adenocarcinomas, the implications for survival, and the link to a deficiency in mismatched repair genes (Abstract 9).

gastroesophageal cancer
gastrointestinal cancer

Manish A. Shah, MD, on Gastric Cancer: Results From the RAINFALL Trial

Manish A. Shah, MD, of Weill Cornell Medicine, discusses phase III study findings on cisplatin plus capecitabine or fluorouracil with or without ramucirumab as first-line therapy in patients with metastatic gastric or gastroesophageal junction adenocarcinoma (Abstract 5).

gastrointestinal cancer
immunotherapy

Florian Lordick, MD, on Gastric Cancer: Final Results From the AIO Trial

Florian Lordick, MD, of the University Medicine Leipzig, discusses study findings on intraperitoneal immunotherapy with the antibody catumaxomab for patients with peritoneal carcinomatosis from gastric cancer (Abstract 4).

gastrointestinal cancer

Khaldoun Almhanna, MD, MPH, on Gastric Cancer: Results From the CCOG 1102 Trial

Khaldoun Almhanna, MD, MPH, of the H. Lee Moffitt Cancer Center, discusses the long-term outcome of a phase III study that explored the significance of extensive intraoperative peritoneal lavage in addition to standard treatment for ≥ T3 resectable gastric cancer (Abstract 1).

gastrointestinal cancer

2018 GI CANCERS SYMPOSIUM: First-Line Ramucirumab in Gastric Cancer Improves Progression-Free but Not Overall Survival

The monoclonal antibody ramucirumab (Cyramza) was evaluated as first-line therapy for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma in the international phase III RAINFALL trial. Charles Fuchs, MD, of Yale New Haven Health in Connecticut, presented findings...

gastrointestinal cancer

2018 GI CANCERS SYMPOSIUM: Cabozantinib Demonstrates Significant Overall Survival Benefit in Patients With Previously Treated Advanced HCC

Detailed results of the phase III CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC) were presented in a late-breaking oral session by Abou-Alfa et al at the 2018 ASCO Gastrointestinal (GI) Cancers Symposium (Abstract 207). Study Findings In CELESTIAL,...

gastrointestinal cancer
immunotherapy

2018 GI CANCERS SYMPOSIUM: KEYNOTE-224 Trial: Pembrolizumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

Findings from the phase II KEYNOTE-224 trial investigating the use of pembrolizumab (Keytruda) in patients with advanced hepatocellular carcinoma who were previously treated with sorafenib (Nexavar) were presented by Zhu et al at the 2018 Gastrointestinal (GI) Cancers Symposium in San Francisco...

breast cancer
skin cancer
issues in oncology
gastrointestinal cancer

Study Finds Increased Risk in Common Cancers in Female Night Shift Workers

In 2007, the International Agency for Research on Cancer classified shift work with circadian disruption or chronodisruption as a probable human carcinogen. Now, a meta-analysis investigating whether long-term shift work increases the risks of common cancers in women has found that, overall, night...

gastroesophageal cancer
gastrointestinal cancer

Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma

The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...

gastroesophageal cancer
gastrointestinal cancer

Update on Phase III JAVELIN Gastric 300 Trial of Avelumab in Pretreated Advanced Gastric Cancer

On November 28, Merck KGaA and Pfizer announced that the phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival with single-agent avelumab (Bavencio) compared with physician's choice of chemotherapy. The trial investigated avelumab as a third-line...

gastrointestinal cancer

Adding Targeted Agent to Chemotherapy in Second-Line Treatment of Advanced Gastric Cancer

In the Asian phase III GOLD trial reported in The Lancet Oncology, Bang et al found that the addition of olaparib (Lynparza) to paclitaxel did not significantly improve overall survival among patients with previously treated advanced gastric cancer, including those with...

gastrointestinal cancer

Survival in Patients Treated With Adjuvant Chemoradiotherapy After Resection of Gastric Cancer

In the CALGB 80101/Alliance trial, no difference in overall survival was found for adjuvant chemoradiotherapy with epirubicin, cisplatin, and fluorouracil (ECF) vs fluorouracil and leucovorin (5-FU/LV) after curative resection of gastric cancer. The findings were reported in the Journal of Clinical ...

gastrointestinal cancer

Immunotherapy for Previously Treated Advanced Gastric Cancer

In an Asian phase III trial (ONO-4538-12, ATTRACTION-2) reported in The Lancet, Kang et al found that nivolumab (Opdivo) produced an improvement in overall survival vs placebo in patients with advanced gastric or gastroesophageal junction cancer who had disease refractory to or who were intolerant...

gastrointestinal cancer

Nivolumab Approved in Japan for Unresectable Advanced or Recurrent Gastric Cancer That Has Progressed After Chemotherapy

On September 22, Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved nivolumab (Opdivo) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. This approval was based on the phase III ...

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