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FDA Approvals in Prostate and Endometrial Cancers

In this week’s episode, we are discussing two recent FDA approvals—one for prostate cancer, and the other for endometrial cancer. The radioconjugate lutetium Lu-177 vipivotide tetraxetan was approved for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic...

bladder cancer
immunotherapy

Study Evaluates Response-Based Immunotherapy Strategy in Patients With Advanced Urothelial Carcinoma

In a phase II study (TITAN-TCC) reported in the Journal of Clinical Oncology, Grimm et al found that a nivolumab/ipilimumab boost in patients with advanced urothelial cancer who did not respond to nivolumab monotherapy alone increased objective response rates, with the benefit being greatest in...

global cancer care

How ASCO, ECO, and WHO Are Marshalling Resources to Provide Care for Ukrainian Civilians and Refugees With Cancer

Since Russia invaded Ukraine on February 24, the number of attacks on health-care facilities continues to mount. According to the World Health Organization (WHO), as of March 16, there have been 43 attacks on health facilities, including 34 attacks that have directly impacted health facilities and...

pancreatic cancer
genomics/genetics

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, Durham, North Carolina, during the February ...

pancreatic cancer
genomics/genetics

KRYSTAL-1: Adagrasib Controls Disease in Gastrointestinal Malignancies Beyond Colorectal Cancer

A disease control rate of 100% was achieved in gastrointestinal cancers treated with the KRAS G12C inhibitor adagrasib in the phase II KRYSTAL-1 trial, presented at the 2022 ASCO Gastrointestinal Cancers Symposium.1 The population included primarily those with pancreatic cancer; other noncolorectal ...

hepatobiliary cancer
immunotherapy

Expert Point of View: Anthony El-Khoueiry, MD

Anthony El-Khoueiry, MD, Member of the Section of Gastrointestinal Cancers, Director of the phase I program, and Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and USC Norris Comprehensive Cancer Center, said the findings of the...

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

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

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...

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...

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...

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...

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...

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...

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...

head and neck cancer

Midtreatment Imaging De-escalates Therapy for Half of Study Patients With Oropharyngeal Cancer

Positron-emission tomography (PET) scans obtained before and midway through treatment may be used to de-escalate therapy for patients with oropharyngeal cancer, leading to fewer side effects, according to data presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.1 An interim...

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...

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...

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...

Expert Point of View: Hao G. Nguyen, MD, PhD

Invited discussant Hao G. Nguyen, MD, PhD, of the University of California, San Francisco, said: “New treatments are needed for advanced penile cancer. PERICLES is the first randomized trial for patients with stage IV penile cancer treated without chemotherapy. Although this prospective trial...

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,...

Expert Point of View: Guru P. Sonpavde, MD

Invited discussant Guru P. Sonpavde, MD, Director of the Bladder Cancer Program at Dana-Farber Cancer Institute, said: “Antibody-drug conjugates are a major weapon in the way forward in bladder cancer…. The EV-103 trial evaluated neoadjuvant therapy with enfortumab vedotin-ejfv, one of two...

Expert Point of View: Celestia S. Higano, MD

Formal discussant Celestia S. Higano, MD, Adjunct Professor in the Department of Urologic Sciences at the University of British Columbia, Vancouver, had the task of reviewing the results of both the MAGNITUDE and PROpel trials, which were presented at the same session. Of the two trials, PROpel...

prostate cancer

First-Line Olaparib Plus Abiraterone Extends Radiographic Progression-Free Survival in Men With Metastatic Castration-Resistant Prostate Cancer

The PARP inhibitor olaparib in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs current standard-of-care abiraterone as a first-line treatment for patients with metastatic castration-resistant...

prostate cancer

Xin Gao, MD, on Prostate Cancer: Early-Phase Results on Bavdegalutamide

Xin Gao, MD, of Massachusetts General Hospital, discusses phase I/II findings on bavdegalutamide, an androgen receptor protein degrader, which showed clinical activity in heavily pretreated patients with metastatic castration-resistant prostate cancer who received one to two prior novel hormonal...

kidney cancer

CheckMate 9ER: Final Results Support First-Line Regimen of Nivolumab Plus Cabozantinib in Advanced Kidney Cancer

The combination of nivolumab plus cabozantinib achieved a continued survival benefit compared with sunitinib in patients with untreated clear cell metastatic or advanced renal cell carcinoma, according to a final overall survival analysis of the phase III CheckMate 9ER trial.1 Additionally,...

survivorship
genomics/genetics

Study Identifies Genetic Variants That May Contribute to Accelerated Aging in Childhood Cancer Survivors

Scientists from St. Jude Children’s Research Hospital have identified variants in two genes that may be associated with accelerated aging in childhood cancer survivors. Their research looked at the difference between the survivors’ biologic age and chronologic age. The study, published by Dong et...

prostate cancer

FDA Approves Radioligand for Metastatic Castration-Resistant Prostate Cancer

On March 23, the U.S. Food and Drug Administration approved lutetium Lu-177 vipivotide tetraxetan (Pluvicto) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor...

gynecologic cancers
immunotherapy

Atezolizumab Plus Chemoradiation Is Safe, Demonstrates Signs of Immune Activation in Patients With Cervical Cancer

A phase I/Ib trial conducted by the National Cancer Institute’s National Clinical Trials Network group NRG Oncology, NRG-GY017, concluded that the addition of the immunotherapy atezolizumab prior to and concurrently given with chemoradiation was safe for women with node-positive, locally advanced...

gynecologic cancers

Abemaciclib/Letrozole in Patients With Recurrent ER-Positive Endometrial Cancer

A combination therapy caused tumors to shrink or stabilize in 75% of patients with recurrent or persistent estrogen receptor (ER)-positive endometrial cancer, results from a recent clinical trial show. Trial leaders from Dana-Farber Cancer Institute presented the findings at the Society of...

hepatobiliary cancer

Characteristics of Nonalcoholic Fatty Liver Disease–Related HCC vs HCC From Other Causes

In a meta-analysis reported in The Lancet Oncology, Tan et al found that patients with nonalcoholic fatty liver disease (NAFLD)-related hepatocellular carcinoma (HCC) were more likely to have metabolic/cardiovascular comorbidity, less likely to have cirrhosis, and less likely to undergo...

lymphoma
immunotherapy
symptom management

Early Intrathecal Therapy for High-Grade ICANS in Patients Receiving CAR T-Cell Therapy

In a single-institution retrospective review reported in JAMA Oncology, Zurko et al found that early intrathecal therapy with hydrocortisone with or without intrathecal chemotherapy was effective in treating grade ≥ 3 immune effector cell–associated neurotoxicity syndrome (ICANS) in patients...

colorectal cancer
immunotherapy

Temozolomide Followed by Low-Dose Ipilimumab/Nivolumab in MSS and MGMT-Silenced Metastatic Colorectal Cancer

In an Italian phase II study (MAYA) reported in the Journal of Clinical Oncology, Morano et al found that patients with microsatellite-stable (MSS) and O6-methylguanine–DNA methyltransferase (MGMT)-silenced metastatic colorectal cancer without disease progression on temozolomide derived benefit...

covid-19

Antibody Response to SARS–CoV-2 mRNA-1273 Vaccination in Patients With Cancer: Single-Institution Study

In a single-institution study reported in JAMA Oncology, Giuliano et al found that seroconversion after two doses of the SARS–CoV-2 mRNA-1273 (Moderna) vaccine in patients with cancer was lower among patients with hematologic malignancies vs solid tumors and differed according to cancer treatment...

prostate cancer

Expert Point of View: Celestia S. Higano, MD

MAGNITUDE is challenging from a statistical point of view,” said formal discussant Celestia S. Higano, MD, currently Adjunct Professor, Department of Urologic Sciences at the University of British Columbia, Vancouver, Canada, and formerly of Fred Hutchinson Cancer Research Center in Seattle....

prostate cancer

Addition of Ipatasertib to Abiraterone Plus Prednisolone Improves Radiographic Progression–Free Survival in Metastatic Castration-Resistant Prostate Cancer With PTEN Loss

In a phase III trial (IPATential150) reported in The Lancet, Christopher Sweeney, MD, of Dana-Farber Cancer Institute, and colleagues, found that the addition of the AKT inhibitor ipatasertib to abiraterone and prednisolone produced a significant improvement in radiographic progression-free...

prostate cancer

Shorter-Course Radiation Therapy: A New Practice Standard After Prostatectomy?

Hypofractionated radiotherapy to the prostate bed proved to be noninferior to conventionally fractionated radiotherapy after prostatectomy regarding gastrointestinal and genitourinary side effects, according to the results of the phase III NRG Oncology GU003 trial, presented at the 2021 American...

Expert Point of View: Eleni Efstathiou, MD

Invited discussant Eleni Efstathiou, MD, of Houston Methodist Cancer Center and Athens Medical Center, Greece, said that both the STAMPEDE meta-analysis1 and the PEACE-1 trial2 firmly establish the importance of introducing abiraterone acetate earlier in the course of treatment. “The STAMPEDE...

prostate cancer

STAMPEDE: In Nonmetastatic Castration-Sensitive Prostate Cancer, Abiraterone Added to Androgen-Deprivation Therapy Improves Survival

The addition of 2 years of abiraterone acetate plus prednisolone (AAP) to androgen-deprivation therapy improves metastasis-free survival and overall survival compared with androgen-deprivation therapy alone in men with nonmetastatic castration-sensitive prostate cancer, according to a primary...

prostate cancer

PEACE-1: Abiraterone Plus Androgen-Deprivation Therapy and Docetaxel Boosts Survival in Metastatic Castration-Sensitive Prostate Cancer

The addition of abiraterone acetate plus prednisone on top of androgen-deprivation therapy plus docetaxel improved survival in patients with de novo metastatic castration-sensitive prostate cancer vs androgen-deprivation therapy plus docetaxel alone. These results were from the phase III PEACE-1...

prostate cancer

VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer

Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...

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,...

kidney cancer
immunotherapy

KEYNOTE-564: Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma

Adjuvant pembrolizumab following surgery significantly improved disease-free survival compared with placebo among patients with high-risk clear cell renal cell carcinoma (RCC), according to the international phase III KEYNOTE-564 study presented at the Plenary session during the 2021 ASCO Annual...

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