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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...

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 chemotherapy, with fewer side effects (Abstract LBA4007).

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

2019 ASCO: Reduced Chemotherapy Dosages in Elderly Patients With Advanced Gastroesophageal Cancer

A phase III randomized clinical study evaluating the optimum dose of a combination chemotherapy regimen of oxaliplatin and capecitabine in the treatment of advanced gastroesophageal cancer in frail and elderly patients has found that the patients prescribed the lowest dose tested experienced less...

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...

gastroesophageal cancer

Paclitaxel or Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Cancer

In the Chinese phase III ESO-Shanghai 1 trial reported in the Journal of Clinical Oncology, Chen et al found that paclitaxel plus fluorouracil did not significantly prolong overall survival vs standard cisplatin plus fluorouracil in definitive concurrent chemoradiotherapy (dCRT) for locally...

Gastroesophageal Cancer

KEYNOTE-181: Pembrolizumab vs Chemotherapy in Second-Line Treatment of Advanced Esophageal Cancer

IN THE GLOBAL phase III KEYNOTE-181 trial, pembrolizumab as second-line therapy for advanced esophageal cancer did not improve overall survival in the whole population, vs chemotherapy, but did improve survival for patients with strong expression of programmed cell death ligand 1 (PD-L1),...

gastroesophageal cancer

AACR 2019: Small Study of Virotherapy Plus Radiotherapy for Patients With Esophageal Cancer Unable to Receive Standard Treatments

The experimental oncolytic adenovirus telomelysin in combination with radiotherapy was safe and showed early clinical efficacy in vulnerable patients with esophageal cancer, according to results from a phase I clinical trial presented by Fujiwara et al at the American Association for ...

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 junction...

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...

gastroesophageal cancer

Effectiveness of EsophaCap Tool in the Diagnosis of Barrett’s Esophagus

Barrett’s esophagus is the only known precursor of esophageal adenocarcinoma. Although endoscopy and biopsy are standard methods for diagnosing Barrett’s esophagus, their high cost and risk limit their use as a screening modality. Researchers sought to develop a screening method based...

gastroesophageal cancer
immunotherapy

Takashi Kojima, MD, on Esophageal Cancer: Results From the KEYNOTE-181 Trial on Immunotherapy vs Chemotherapy

Takashi Kojima, MD, of the National Cancer Center Hospital East, discusses phase III study findings on pembrolizumab vs chemotherapy as second-line treatment for advanced esophageal cancer (Abstract 2).

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).

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...

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...

gastroesophageal cancer

Hybrid Minimally Invasive Esophagectomy vs Open Esophagectomy in Esophageal Cancer

In a French phase III trial reported in The New England Journal of Medicine, Mariette et al found that a hybrid minimally invasive surgical procedure was associated with reduced postoperative complications vs transthoracic open esophagectomy in patients with resectable cancer of the middle or lower ...

gastroesophageal cancer

Pembrolizumab in Pretreated Advanced Esophageal Adenocarcinoma or Squamous Cell Carcinoma

As reported in JAMA Oncology by Shah et al, the phase II KEYNOTE-180 trial has shown that pembrolizumab produces durable responses in some patients with pretreated locally advanced or metastatic esophageal adenocarcinoma or squamous cell carcinoma. Study Details In the trial, 121 patients with...

gastroesophageal cancer

Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer

A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...

breast cancer
gynecologic cancer
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...

issues in oncology
gastroesophageal cancer
symptom management

ESMO 2018: Pooled Analysis of Influence of Sex on Chemotherapy Efficacy and Toxicity in Esophagogastric Cancer

In an analysis presented by Davidson et al at the European Society for Medical Oncology (ESMO) 2018 Congress (Abstract 619PD_PR), data were pooled from four UK randomized controlled clinical trials of first-line chemotherapy in esophagogastric cancer, finding significant differences in a...

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...

gastroesophageal cancer
immunotherapy

Immunotherapy in Advanced Esophagogastric Cancer

As reported in the Journal of Clinical Oncology by Janjigian et al, the phase I/II CheckMate-032 study has shown activity of nivolumab (Opdivo) and nivolumab plus ipilimumab (Yervoy) in advanced esophagogastric cancer. In the esophagogastric cohort of the multicohort study, 160 patients (who...

gastroesophageal cancer

Neoadjuvant Chemoradiotherapy in Locally Advanced Esophageal Cancer

In a Chinese phase III trial reported in the Journal of Clinical Oncology, Yang et al found that adding neoadjuvant chemoradiotherapy to surgery improved survival in locally advanced squamous cell carcinoma of the esophagus. Study Details In the open-label trial, 451 patients with potentially...

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...

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...

gastroesophageal cancer

2018 ASCO: Esomeprazole With Aspirin Offers Moderate Benefits in Patients With Barrett’s Esophagus

An updated analysis of a randomized phase III trial showed that taking a high dose of the acid-reducing medicine esomeprazole with low-dose aspirin for at least 7 years can moderately reduce the risk of developing high-grade dysplasia or esophageal cancer and delay death from any cause in people...

lung cancer
gastroesophageal cancer

ESTRO 37: Positioning for Radiotherapy and Impact on Survival in Patients With Lung or Esophageal Cancers

Very small differences in the way a patient lies during radiotherapy treatment for lung or esophageal cancer can have an impact on survival, according to research presented at the European Society for Radiotherapy & Oncology (ESTRO) 37 Conference (Abstract OC-0322). These differences of only a...

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...

gastroesophageal cancer

Possible Link Between Drinking Hot Tea and Increased Chance of Esophageal Cancer in High-Risk Individuals

Esophageal cancer is the eighth most common cancer worldwide, with an estimated 456,000 new cases in 2012, and the sixth most common cause of death from cancer with an estimated 400,000 deaths, according to data from GLOBOCAN, which provides statistics on the incidence and mortality of cancer...

gastroesophageal cancer

Patient Refusal of Esophagectomy and Long-Term Survival

Patients with esophageal cancer who refuse surgery when it is recommended are less likely to survive long term than similar groups of patients who undergo an operation, according to research presented by Ghaly et al at the 54th Annual Meeting of The Society of Thoracic Surgeons (P78). ...

breast cancer
colorectal cancer
gynecologic cancer
hepatobiliary cancer
lung cancer
pancreatic cancer
gastroesophageal cancer

Detecting and Localizing Eight Cancer Types With One Multianalyte Blood Test

Johns Hopkins Kimmel Cancer Center researchers developed a single blood test that screens for eight common cancer types and also helps identify the location of the cancer. The test, called CancerSEEK, is a unique noninvasive, multianalyte test that simultaneously evaluates levels of eight cancer...

gastroesophageal cancer

Abraham J. Wu, MD, on Esophageal Cancer: Impact of Lung and Heart Dose on Survival After Radiotherapy

Abraham J. Wu, MD, of Memorial Sloan Kettering Cancer Center, discusses his findings that suggest efforts to reduce lung dose, such as shrinking the treatment volumes or using proton therapy, may improve outcomes in esophageal cancer (Abstract 3).

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

Pieter van der Sluis, MD, PhD, on Esophageal Cancer: Results From a Surgical Treatment Trial

Pieter van der Sluis, MD, PhD, of the University Medical Center Utrecht, discusses study findings that compared robot-assisted minimally invasive thoracolaparoscopic esophagectomy vs open transthoracic esophagectomy for resectable esophageal cancer (Abstract 6).

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).

gastroesophageal cancer

David H. Ilson, MD, PhD, on Improving Esophageal Cancer Outcomes: Future Directions

David H. Ilson, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses the merits of preoperative chemotherapy vs chemoradiotherapy, the role of targeted agents, recent results from genomic profiling, and whether PET scans can guide neoadjuvant treatment.

gastroesophageal cancer

Basem Azab, MD, on Esophageal Cancer: Study Survival Results

Basem Azab, MD, of the Sylvester Comprehensive Cancer Center, University of Miami, discusses the impact on overall survival when more than 2 months elapse between finishing neoadjuvant therapy and undergoing esophagectomy (Abstract 2).

Gynecologic Cancers
Hepatobiliary Cancer
Gastroesophageal Cancer
Leukemia

Reports From the Journal of Clinical Oncology

Immunotherapy in PD-L1–Positive Advanced Cervical Cancer Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Jean-Sebastien Frenel, MD, of...

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

Oral Microbiota Indicates Possible Link Between Periodontal Disease and Esophageal Cancer

An analysis of bacteria present in the mouth showed that some types of bacteria that lead to periodontal disease were associated with higher risk of esophageal cancer, according to a study published by Peters et al in Cancer Research. Esophageal cancer is the eighth most common cancer and the...

gastroesophageal cancer

FDA Approves Biosimilar for the Treatment of Certain Breast and Stomach Cancers

The U.S. Food and Drug Administration (FDA) today approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The drug is the first...

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...

gastroesophageal cancer

Quality of Life With Neoadjuvant Chemoradiotherapy in Esophageal/Esophagogastric Junction Cancer

An analysis in the Dutch Chemoradiotherapy for Esophageal Cancer Followed by Surgery Study (CROSS) reported by Noordman et al in the Journal of Clinical Oncology showed no adverse effect of neoadjuvant chemoradiotherapy vs surgery alone on postsurgery health-related quality of life in patients with ...

gastroesophageal cancer

Immunotherapy in Advanced Esophageal Carcinoma

As reported in the Journal of Clinical Oncology by Doi et al, pembrolizumab (Keytruda) showed activity in patients with previously treated advanced esophageal carcinoma in the phase Ib multicohort KEYNOTE-028 study. Study Details In the study, eligible patients with squamous cell carcinoma or...

Solid Tumors
Gastrointestinal Cancer
Gastroesophageal Cancer

Metastatic Gastric Cancer: Dual HER2-Targeting Study Does Not Meet Primary Endpoint

Dual HER2 targeting in metastatic gastric and gastroesophageal junction cancers did not significantly improve outcomes over trastuzumab (Herceptin) alone—both in combination with chemotherapy—according to the results of the phase III JACOB study reported at the 2017 European Society for Medical...

gastroesophageal cancer

Adjuvant Chemotherapy vs Observation After Preoperative Chemoradiotherapy and Resection in Gastroesophageal Cancer

In a propensity score–matched analysis reported in JAMA Oncology, Mokdad et al found that adjuvant chemotherapy had a survival benefit vs observation after preoperative chemoradiotherapy and resection in patients with locally advanced gastroesophageal cancer. Study Details The study...

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