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hepatobiliary cancer
immunotherapy

HIMALAYA Trial: First-Line Tremelimumab Plus Durvalumab Improves Overall Survival in Unresectable Hepatocellular Carcinoma

Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....

hepatobiliary cancer
immunotherapy

Expert Point of View: Ian Chau, MD

Invited discussant Ian Chau, MD, Consultant Medical Oncologist at The Royal Marsden Hospital in London and Surrey in the United Kingdom, said the findings from COSMIC-312 are not mature enough to establish cabozantinib/atezolizumab as a new front-line option for advanced hepatocellular carcinoma...

hepatobiliary cancer
immunotherapy

COSMIC-312: Cabozantinib Plus Atezolizumab Improves Progression-Free Survival in Advanced Hepatocellular Carcinoma

The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...

hepatobiliary cancer
immunotherapy

Expert Point of View: Chris Verslype, MD, PhD

The invited discussant of the RATIONALE 208 trial, Chris Verslype, MD, PhD, Professor of Medicine at University Hospitals Leuven in Belgium, said tislelizumab is an “active and safe” investigational PD-1 antibody, “comparable to other PD-1 agents.” In particular, he noted, the results of RATIONALE...

hepatobiliary cancer
immunotherapy

RATIONALE 208: ‘Durable Clinical Activity’ Reported With Tislelizumab in Advanced Liver Cancer

With the investigational checkpoint inhibitor tislelizumab, durable responses were achieved by some patients with previously treated advanced hepatocellular carcinoma, regardless of the number of prior lines of therapy, in the phase II RATIONALE 208 trial. These findings were presented during the...

hepatobiliary cancer
immunotherapy

Expert Point of View: Nilofer Azad, MD

Nilofer Azad, MD, Professor of Oncology at Johns Hopkins University School of Medicine and Co-Director of Cancer Genetics and Epigenetics at the Sidney Kimmel Comprehensive Cancer Center, Baltimore, was invited to discuss the results of the phase III TOPAZ-1 study, which found an overall survival...

hepatobiliary cancer
immunotherapy

TOPAZ-1: Overall Survival Prolonged With First-Line Immunotherapy Plus Chemotherapy in Biliary Tract Cancer

For the first time, a phase III study has shown an overall survival benefit for upfront treatment using immunotherapy plus chemotherapy in advanced biliary tract cancer. In the TOPAZ-1 trial, the addition of the anti–PD-L1 agent durvalumab to gemcitabine plus cisplatin significantly improved...

hepatobiliary cancer

Ivosidenib vs Placebo for Previously Treated Advanced IDH1-Mutated Cholangiocarcinoma: Final Overall Survival Analysis of the ClarIDHy Trial

As reported in JAMA Oncology by Andrew X. Zhu, MD, PhD, and colleagues, the final overall survival analysis of the pivotal phase III ClarIDHy trial showed prolonged overall survival with ivosidenib vs placebo in previously treated patients with unresectable or metastatic cholangiocarcinoma and an...

gastroesophageal cancer

Adjuvant Nivolumab Improves Disease-Free Survival vs Placebo in Resected Esophageal or Gastroesophageal Junction Cancer After Neoadjuvant Chemoradiotherapy

As reported in The New England Journal of Medicine by Ronan J. Kelly, MB BCh, MBA, of The Charles A. Sammons Cancer Center at Baylor University Medical Center, and colleagues, an interim analysis of the phase III CheckMate 577 trial has shown a significant improvement in disease-free survival with ...

Expert Point of View: Gabriel A. Brooks, MPH, MD

Gabriel A. Brooks, MPH, MD, Associate Professor of Medicine, Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, was invited to discuss the results of the ACCENT/IDEA database analysis of early treatment discontinuation in stage III colon cancer. Although the results confirm the...

colorectal cancer

Adjuvant Therapy for Colon Cancer: Impact of Stopping Treatment Early

For patients with stage III colon cancer, early discontinuation of adjuvant chemotherapy leads to worse outcomes—but early discontinuation of oxaliplatin did not. These findings, which came from an analysis of the large ACCENT and IDEA clinical trials databases, were presented at the 2022 ASCO...

Expert Point of View: Rona Yaeger, MD

Rona Yaeger, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, New York, offered her thoughts on the findings of Morris et al for the combination regimen of encorafenib, cetuximab, and nivolumab in microsatellite-stable BRAF V600E–mutated metastatic colorectal cancer...

colorectal cancer

High Response Rate Seen With Nivolumab Added to Encorafenib and Cetuximab in BRAF V600E–Mutated Metastatic Colorectal Cancer

The combination of encorafenib, cetuximab, and nivolumab produced responses in 50% of patients and disease control in 96% of patients with microsatellite-stable BRAF V600E–mutated metastatic colorectal cancer in a phase I/II trial reported at the 2022 ASCO Gastrointestinal Cancers Symposium. The...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

KEYNOTE-811: Pembrolizumab Plus Trastuzumab and Chemotherapy in Previously Untreated Advanced HER2-Positive Gastric Adenocarcinoma

As reported in Nature by Yelena Y. Janjigian, MD, of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, and colleagues, the first interim analysis of the phase III KEYNOTE-811 trial has shown a significantly higher objective response rate with the addition of...

colorectal cancer
hepatobiliary cancer
gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Recent FDA Approvals in Gastrointestinal Cancer

Over the past year, the U.S. Food and Drug Administration granted approval to several novel drugs and new indications for older therapeutic agents used in gastrointestinal oncology. Cetuximab Plus Encorafenib On September 28, 2021, cetuximab (Erbitux) was approved in combination with encorafenib...

Expert Point of View: Benoit Rousseau, MD, PhD

Benoit Rousseau, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, called the findings of the phase II GERCOR NIPICOL trial “interesting and convincing.” Long-term follow-up showed the 3-year progression-free survival rate to be 70% after 1 total year of treatment with nivolumab plus...

gastroesophageal cancer
immunotherapy

Expert Point of View: Samuel J. Klempner, MD

Samuel J. Klempner, MD, Associate Professor at Massachusetts General Hospital and Harvard Medical School, commented on the NEONIPIGA study for The ASCO Post. “This study was the first prospective data set to show what many have suspected—that neoadjuvant immune checkpoint blockade would lead to a...

colorectal cancer

NIPICOL Trial: Promising Outcomes With Shorter Duration of Checkpoint Inhibition in Metastatic Colorectal Cancer

The phase II GERCOR NIPICOL study evaluated 1 year of treatment with nivolumab plus ipilimumab in patients with chemotherapy-resistant metastatic colorectal cancer whose tumors were microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR). With this shortened treatment duration,...

colorectal cancer

Sotorasib in Previously Treated Patients With KRAS G12C–Mutant Colorectal Cancer

In a prespecified analysis of the phase II CodeBreaK100 trial reported in The Lancet Oncology, Marwan Fakih, MD, and colleagues found that the KRAS G12C protein inhibitor sotorasib showed modest activity in patients with previously treated KRAS G12C–mutant colorectal cancer.1 Study Details The...

gastroesophageal cancer
immunotherapy

Neoadjuvant Checkpoint Inhibitor Doublet Yields Complete Responses in Gastroesophageal Cancers

In patients with resectable microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) gastric and gastroesophageal junction adenocarcinoma, dual checkpoint inhibition with ipilimumab and nivolumab given as neoadjuvant therapy led to a pathologic complete response rate of 58.6%,...

gastroesophageal cancer
immunotherapy

Adding Pembrolizumab to Chemotherapy Improves Overall and Progression-Free Survival in First-Line Treatment of Advanced Esophageal Cancer

As reported in The Lancet by Jong-Mu Sun, MD, of Samsung Medical Center, Sungkyunkwan University, Seoul, and colleagues, an interim analysis in the phase III KEYNOTE-590 trial has shown that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free...

Expert Point of View: Elena Élez, MD, PhD

Invited discussant of the two studies, Elena Élez, MD, PhD, of the Colon Cancer Program, Vall d’Hebron Institute of Oncology, Barcelona, Spain, discussed the challenge of treating BRAF-mutant colorectal cancer and what the new data bring to that effort. Dr. Élez noted: “BRAF V600E–mutant...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Adding First-Line Nivolumab to Chemotherapy Improves Survival in Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas

As reported in The Lancet by Yelena Y. Janjigian, MD, of the Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, and colleagues, the phase III CheckMate 649 trial has shown that the addition of first-line nivolumab to chemotherapy resulted in improved overall and...

colorectal cancer

BRAF-Mutant Colorectal Cancer: Latest Findings for Targeted Treatment

The phase II ANCHOR CRC study, the largest prospective study of BRAF inhibitor–based therapy as first-line treatment of metastatic colorectal cancer, has met its primary endpoint, with 47.8% of patients with metastatic colorectal cancer responding to first-line treatment with encorafenib,...

colorectal cancer

Addition of Neoadjuvant FOLFIRINOX to Preoperative Chemoradiotherapy in Locally Advanced Rectal Cancer

As reported in The Lancet Oncology by Thierry Conroy, MD, and colleagues, the French phase III UNICANCER-PRODIGE 23 trial has shown that intensification of preoperative therapy with FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, fluorouracil [5-FU]) prior to chemoradiotherapy resulted in...

solid tumors

New ASCO-SNO Guideline Addresses Treatment Recommendations Tailored to Glioma Subtypes

Reflecting recent significant classification changes and new data on the use of biomarkers to inform treatment for central nervous system tumors, a new guideline offers oncologists up-to-date recommendations for managing gliomas in adults with neurologic cancer.1 “Over the past decade, there have...

issues in oncology

Most Favored Nation Model’s Withdrawal Complete; ASCO Applauds Decision Preserving Access to Care

On December 29, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule rescinding the Most Favored Nation (MFN) model. MFN was originally proposed in November 2020 and scheduled to be implemented on January 1, 2021. ASCO and other groups strenuously opposed what would have ...

ASCO Provisional Clinical Opinion Offers Guidance for Using and Interpreting Genomic Testing in Patients With Advanced Cancer

Somatic genomic testing should be a routine part of clinical care for many patients with metastatic or advanced solid tumors, according to a new ASCO provisional clinical opinion.1 As reported in the Journal of Clinical Oncology, the expert panel found that genomic testing in oncology practice has...

solid tumors

Should Patients Aged 80 and Older Receive Single-Agent Immune Checkpoint Inhibitor Treatment?

The checkpoint inhibitors are among the most important advances in oncology in recent times. They have changed the natural history of many tumors, particularly melanoma. They have a favorable toxicity profile, which for most patients is manageable and tolerable. However, there are several...

Expert Point of View: Quynh-Thu Le, MD, FACR, FASTRO

According to Quynh-Thu Le, MD, FACR, FASTRO, Professor and Chair of Radiation Oncology at Stanford, these results suggest that monitoring circulating human papillomavirus (HPV) DNA may lead to the detection of relapse prior to imaging. In an interview with The ASCO Post, Dr. Le also noted that...

head and neck cancer

Blood Test Predicts Recurrence of HPV-Driven Oropharyngeal Cancer After Treatment

A blood-basedliquid biopsy may accurately predict recurrence of human papillomavirus (HPV)-driven oropharyngeal squamous cell carcinoma following treatment, according to data presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.1 Results of the large, multi-institutional study...

American Cancer Society Names Arif Kamal, MD, First Chief Patient Officer

The American Cancer Society (ACS) has named Arif Kamal, MD, MBA, MHS, FACP, ­FAAHPM, FASCO, as its first Chief Patient Officer to lead its patient support vision and strategic plans to improve the lives of patients with cancer and their families. Based in Chapel Hill, North Carolina, Dr. Kamal will ...

genomics/genetics

I Enrolled in the WISDOM Study and Learned I Am at High Risk for Cancer

I have always been interested in volunteering my services and helping others, so when I got an e-mail asking if I’d like to participate in the WISDOM (Women Informed to Screen Depending on Measures of Risk) study (www.thewisdomstudy.org) I signed on. The study plans to enroll 100,000 diverse women...

New Role for Raymond N. DuBois, MD, PhD, FAACR, at The Mark Foundation for Cancer Research

Raymond N. DuBois, MD, PhD, FAACR, was recently appointed Executive Chairman of the Board of The Mark Foundation for Cancer Research. Dr. DuBois is Director of the Medical University of South Carolina (MUSC) Hollings Cancer Center and Distinguished University Professor at MUSC. As The Mark...

Robert Otto Valdez, PhD, MHSA, Named Director of the AHRQ

Robert Otto Valdez, PhD, MHSA, was appointed Director of the Agency for Healthcare Research and Quality (AHRQ) in February 2022. He was previously the Robert Wood Johnson Foundation (RWJF) Professor Emeritus of Family & Community Medicine and Economics at the University of New Mexico (UNM). In...

Expert Point of View: Quynh-Thu Le, MD, FACR, FASTRO

In an interview with The ASCO Post, Quynh-Thu Le, MD, FACR, FASTRO, Professor and Chair of Radiation Oncology at Stanford Cancer Center, called this phase II de-escalation trial an “intriguing study” that heads in the right direction for treatment de-escalation. However, Dr. Le noted, the...

ACCC Appoints David R. Penberthy, MD, MBA, as New President

David R. Penberthy, MD, MBA, was recently named President of the Association of Community Cancer Centers (ACCC) at the organization’s 48th Annual Meeting and Cancer Center Business Summit. Oncology professionals from around the nation gathered at the conference to discuss the convergence of...

New Appointments for ECOG-ACRIN and NCI Committees

Janice Mehnert, MD, was recently named Co-Chair of the ECOG-ACRIN Melanoma Committee, replacing Craig L. Slingluff, MD. Dr. Mehnert is Associate Director for Clinical Research and Director, Melanoma and Cutaneous Medical Oncology at NYU Langone’s Perlmutter Cancer Center. She specializes in both...

hematologic malignancies
leukemia
lymphoma
myelodysplastic syndromes

Allogeneic Transplantation for Hematologic Neoplasms in Adults

“The value of experience is not in seeing much, but in seeing wisely.” —Sir William Osler To complement The ASCO Post’s continued comprehensive coverage of the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting...

Arul Chinnaiyan, MD, PhD, Awarded Sjöberg Prize for Cancer Research

The Royal Swedish Academy of Sciences, which also awards Nobel Prizes, has announced the winner of the 2022 Sjöberg Prize. Arul Chinnaiyan, MD, PhD, S.P. Hicks Professor of Pathology and Urology at Michigan Medicine, is being honored for the discovery of recurrent gene fusions in prostate cancer....

Expert Point of View: E. Gabriela Chiorean, MD

The invited discussant of the CodeBreaK 100 data, E. Gabriela Chiorean, MD, Professor of Medicine at the University of Washington and Fred Hutchinson Cancer Research Center, and Clinical Director of the Gastrointestinal Medical Oncology program at Seattle Cancer Care Alliance, found the efficacy...

neuroendocrine tumors

Peptide Receptor Radionuclide Therapy for Gastroenteropancreatic Neuroendocrine Tumors: Implications for Current Practice

The rising incidence and prevalence of gastroenteropancreatic endocrine tumors make them the second-most prevalent gastrointestinal cancer.1 Although most of these tumors are relatively slow growing, their histologic grade and differentiation are closely correlated with their clinical behavior.2,3...

ACCC Welcomes Matt Devino, MPH, as Director, Cancer Care Delivery and Health Policy

The Association of Community Cancer Centers (ACCC) announced that Matt ­Devino, MPH, has joined the organization as Director, Cancer Care Delivery and Health Policy. Mr. Devino will lead the organization’s initiatives to improve cancer care delivery and promote health equity across rural, urban,...

pancreatic cancer

CodeBreaK 100: Sotorasib Shows Activity in KRAS G12C–Mutated Pancreatic Cancer

Promising activity in metastatic pancreatic cancer was shown by sotorasib, an inhibitor of the KRAS G12C mutation, in the phase I/II CodeBreaK 100 study presented by John H. Strickler, MD, Associate Professor of Medicine at Duke University Medical Center in Durham, North Carolina, during the...

immunotherapy

Atezolizumab Induces Responses in Advanced Penile Cancer, but Biomarkers Needed to Improve Patient Selection

Use of the immune checkpoint inhibitor atezolizumab with or without radiotherapy showed antitumor activity in stage IV penile cancer in the phase II PERICLES trial, although the study failed to meet the primary endpoint of 1-year progression-free survival of at least 35%. The hints of activity were ...

immunotherapy

ARIES Trial: Avelumab Failed to Improve 1-Year Survival in PD-L1–Positive Advanced Urothelial Cancer

First-line treatment with the PD-L1 antibody avelumab failed to meet the primary endpoint of an improvement in overall survival at 1 year for patients with cisplatin-ineligible, PD-L1–positive advanced urothelial cancer. However, the objective response and disease control rates were favorable in...

B.J. Rimel, MD, Named Medical Director, Cancer Clinical Trials Office

Gynecologic oncologist and surgeon B.J. Rimel, MD, recently was named Medical Director of the Cedars-Sinai Cancer Clinical Trials Office. She will serve as a medical liaison between clinical trial principal investigators and Cedars-Sinai Cancer leadership to ensure the quality of services provided...

kidney cancer
immunotherapy

KEYNOTE-564 Update Supports Benefit of Adjuvant Pembrolizumab in High-Risk Renal Cell Carcinoma

An updated analysis of the phase III KEYNOTE-564 trial continues to support the use of adjuvant pembrolizumab vs placebo in patients with renal cell carcinoma at high risk of recurrence, according to a presentation at the 2022 ASCO Genitourinary Cancers Symposium.1 At 30 months of follow-up,...

prostate cancer

Expert Point of View: Elisabeth I. Heath, MD, FACP, and Oliver Sartor, MD

Formal discussant of the ARASENS trial, Elisabeth I. Heath, MD, FACP, Professor of Oncology and Associate Center Director, Translational Sciences, at Karmanos Cancer Institute in Detroit, commented on the changing paradigm in prostate cancer treatment. “The narrative is changing to triplet therapy, ...

bladder cancer

Neoadjuvant Enfortumab Vedotin-ejfv Shows Activity in Muscle-Invasive Bladder Cancer

Neoadjuvant treatment with the antibody-drug conjugate enfortumab vedotin-ejfv achieved notable antitumor activity in patients with muscle-invasive bladder cancer who are ineligible for treatment with cisplatin, according to preliminary results for cohort H of the EV-103 trial reported at the 2022...

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