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Showing 3451 - 3500FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer
On March 11, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant...
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,...
Postoperative Weekly vs Every-3-Week Cisplatin in Chemoradiation for Locally Advanced Head and Neck Cancer
In a Japanese phase II/III trial (JCOG1008) reported in the Journal of Clinical Oncology, Kiyota et al found that overall survival with once-weekly cisplatin in postoperative chemoradiation was noninferior to every-3-week cisplatin for patients with high-risk locally advanced squamous cell...
New ASCO Report Clarifies Potential Value and Utility of Biosimilars in Oncology
A new report from an ASCO expert panel that addresses unanswered questions about biosimilars—licensed biologic products that are largely analogous to products approved by the U.S. Food and Drug Administration (FDA)—found that they may represent an affordable and effective alternative for cancer...
ASCO and Ontario Health Provide Updated Recommendations on Using Adjuvant Bone-Modifying Treatments in Nonmetastatic Breast Cancer
An update to a joint guideline from Cancer Care Ontario (now a division of Ontario Health) and ASCO provides revised recommendations for the use of adjuvant bone-modifying agents for patients with nonmetastatic breast cancer, with the overarching goal of improving relapse and survival rates.1,2...
Managing Long-Term Toxicity From Pelvic Radiation Therapy
Advances over the past 3 decades in improvements in cancer prevention and screening strategies and more effective diagnostics and therapies in cancer care have led to unprecedented declines in death rates from all cancers, including prostate, gynecologic, and colorectal/anal cancers. The fastest...
Project Confirm: An Initiative to Promote Transparency of the Accelerated Approval Program for Oncology Indications
OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Gautam U. Mehta, MD, Neurosurgical Oncologist and Clinical Reviewer, Division of Oncology 2; Fatima Rizvi,...
Time for a Radical Change in the Treatment of Endometrial Cancer: KEYNOTE-775 and Beyond
I had the privilege of sitting in a meeting on the treatment of endometrial cancer as a junior investigator in January 2015 where a representative from the U.S. Food and Drug Administration was present. The topic of the meeting was on how to design the next endometrial cancer trials. I remember...
Lenvatinib/Pembrolizumab Improves Progression-Free and Overall Survival vs Chemotherapy in Previously Treated Advanced Endometrial Cancer
As reported in The New England Journal of Medicine by Vicky Makker, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, the phase III Study 309/KEYNOTE-775 trial has shown prolonged progression-free and overall survival with lenvatinib plus pembrolizumab vs physician’s choice of...
Expert Point of View: Priyanka Sharma, MD
Priyanka Sharma, MD, of the University of Kansas Medical Center in Westwood, the invited discussant of the poster, noted that the DAISY study asked whether HER2-targeted antibody-drug conjugates—in this case, fam-trastuzumab deruxtecan-nxki (T-DXd)—have activity beyond the conventional...
T-DXd Shows Activity in HER2-Low, HER2-Undetectable Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has led to practice changes in previously treated HER2-positive metastatic breast cancer. Most notably, in the DESTINY-Breast03 trial, treatment with T-DXd produced a doubling in 12-month progression-free survival vs...
Clinical Trials Underway for T-DXd in Breast Cancer
The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...
ABC Sixth International Consensus Conference Updates Guidelines for Advanced Breast Cancer
New recommendations for treating advanced breast cancer, coming from a panel of experts at the Advanced Breast Cancer (ABC) Sixth International Consensus Conference (ABC6), were recently published.1 The report highlights advances that have resulted in robust improvements in overall survival for...
CHIP Mutations ‘Surprisingly’ Associated With Lower Risk of Alzheimer’s Disease
The presence of clonal hematopoiesis of indeterminate potential, or CHIP, increases the risk of developing a myeloid malignancy and also cardiovascular disease—which are well-established findings—but it may also protect against developing Alzheimer’s disease, according to findings reported at the...
Combinations Advance the Power of Pembrolizumab in Hodgkin Lymphoma
Pembrolizumab monotherapy is an established treatment strategy for relapsed or refractory classical Hodgkin lymphoma. In combination with chemotherapy, the checkpoint inhibitor is also showing value in the front-line setting and further boosting outcomes in the relapsed setting, according to...
American Cancer Society Reports Breast Cancer Is Now the Leading Cause of Cancer Mortality in Black Women
Breast cancer has surpassed lung cancer as the leading cause of cancer mortality among Black women as of 2019. This news is one of the key findings in Cancer Statistics for African American/Black People 2022, published recently in CA: A Cancer Journal for Clinicians and its consumer-friendly...
Expert Point of View: Stefano Cascinu, MD
Stefano Cascinu, MD, of the Comprehensive Cancer Center, Università Vita-Salute, IRCCS-Ospedale San Raffaele, Milan, Italy, was the invited discussant of KEYNOTE-5901 and CheckMate 649.2 “These landmark studies could change the treatment paradigm of advanced esophageal and gastric cancers. They...
Cancer in the Arab World: Addressing Challenges to Improve Outcomes
I returned home to the United Arab Emirates in 2017, following my oncology fellowship training and work experience in the United States. I immediately realized that I am now dealing with a considerably different cancer patient population in terms of age of onset, stage at presentation, awareness...
Checkpoint Inhibitors in Esophagogastric Cancer: Updates of Landmark Trials
Updates of landmark trials of immune checkpoint inhibitors as first-line therapy for advanced HER2-negative esophagogastric cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium. The studies upheld previous findings of an overall survival benefit when these agents are paired...
Report on COVID-19 Outlines the Pandemic’s Negative Impact on Patient Care and Clinical Research—and the Lessons Learned
Patients with cancer are not only at an increased risk for developing severe COVID-19, but also face cancer treatment delays and interruptions due to the pandemic, potentially worsening cancer outcomes, according to the AACR Report on the Impact of COVID-19 on Cancer Research and Patient Care. In...
Expert Point of View: Christopher Willett, MD
Christopher Willett, MD, Professor and Chair of the Department of Radiation Oncology at Duke University in Durham, North Carolina, shared his thoughts on the findings of the study by Lumish et al1 with The ASCO Post. He first noted the shift in recent years toward total neoadjuvant therapy in the...
Small Study Reports Neoadjuvant PD-1 Blockade Yields 100% Clinical Complete Response Rate in Locally Advanced Mismatch Repair–Deficient Rectal Cancer
In a small study of patients with locally advanced mismatch repair–deficient (dMMR) rectal cancer, treatment with the anti–PD-1 agent dostarlimab-gxly alone led to a clinical complete response rate of 100%. The findings of this study from Memorial Sloan Kettering Cancer Center (MSK) were reported...
Massage for Pain Management in the Cancer Population
Guest Editor’s Note: Pain is a debilitating symptom experienced by many patients with cancer that negatively impacts their quality of life. Massage therapy, historically used for relaxation and pain relief, plays an important supportive role in oncology settings. In this installment of The ASCO...
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...
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%,...
‘Potential for Curative Intent’
Findings from the international phase II KEYNOTE-158 trial of pembrolizumab among women with previously treated microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) endometrial tumors “suggest a long-term benefit to patients,” stated the trial’s lead author David M. O’Malley, ...
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 just 1 total year of treatment with nivolumab...
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,...
Robust and Durable Responses to Pembrolizumab in Patients With Previously Treated MSI-H/dMMR Endometrial Cancer
“Robust and clinically meaningfulantitumor activity,” with durable responses and “encouraging survival outcomes,” were reported among patients with previously treated microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) endometrial tumors who received pembrolizumab in the...
Petros Grivas, MD, PhD, on Urothelial Cancer: New Data on Sacituzumab Govitecan-hziy and Pembrolizumab
Petros Grivas, MD, PhD, of the University of Washington and Fred Hutchinson Cancer Research Center, discusses results from Cohort 3 of the TROPHY-U-01 study, which assessed sacituzumab govitecan-hziy in combination with pembrolizumab in patients with metastatic urothelial cancer who experienced...
Mihir Gupta, MD, and Ganesh M. Shankar, MD, PhD, Offer Commentary on the Use of ctDNA to Detect CNS Lymphoma
Mihir Gupta, MD, a neurosurgery resident at the University of California San Diego and postdoctoral fellow at Massachusetts General Hospital Department of Neurosurgery, and Ganesh M. Shankar, MD, PhD, Assistant Professor of Neurosurgery, Massachusetts General Hospital and Harvard Medical School,...
SBRT in Combination With Pembrolizumab/Trametinib vs Gemcitabine in Locally Recurrent Pancreatic Cancer
In a Chinese single-institution phase II trial reported in The Lancet Oncology, Zhu et al found that stereotactic body radiotherapy (SBRT) followed by pembrolizumab plus trametinib improved overall survival vs SBRT followed by gemcitabine in patients with postresection, KRAS-mutant, PD-L1–positive...
CAR T-Cell Therapy as Second-Line Treatment in Large B-Cell Lymphomas
“The mind is not a vessel to be filled but a fire to be kindled.” —Plutarch About 30% to 40% of patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) experience relapse, and 10% are refractory to the...
Comparison of Multiparametric Ultrasound and Multiparametric MRI for the Diagnosis of Prostate Cancer
In the prospective paired-cohort CADMUS study reported in The Lancet Oncology, Grey et al found that patients at risk of prostate cancer had a similar likelihood of being diagnosed with clinically significant cancer with the use of multiparametric ultrasound vs multiparametric magnetic resonance...
Updated Findings on T-DXd in Gastrointestinal Malignancies
Updates of phase II studies evaluating fam-trastuzumab deruxtecan-nxki (T-DXd) in gastrointestinal cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium, continuing to offer support for the antibody-drug conjugate in these malignancies. In HER2-expressing gastric cancer, T-DXd...
Risk of Major Adverse Cardiovascular Events With Combined Immune Checkpoint Inhibition and VEGFR Inhibition in Patients With Advanced RCC
As reported in the Journal of Clinical Oncology by Brian I. Rini, MD, and colleagues, prospective cardiovascular monitoring in the phase III JAVELIN Renal 101 trial in advanced renal cell carcinoma (RCC) showed that patients with higher baseline troponin T levels receiving the combination of the...
Elective Upper-Neck vs Whole-Neck Irradiation in Nasopharyngeal Carcinoma
In a Chinese phase III trial reported in The Lancet Oncology, Tang et al found that elective upper-neck irradiation sparing the uninvolved neck was noninferior in regional relapse–free survival vs standard whole-neck irradiation in previously untreated patients with nasopharyngeal carcinoma. Study...
(Epi)genetic Predisposing Factors in Wilms Tumor
In a Dutch study reported in the Journal of Clinical Oncology, Janna A. Hol, MD, and colleagues found that (epi)genetic predisposing factors could be identified in one-third of children diagnosed with Wilms tumor. As stated by the investigators, “Wilms tumor is associated with (epi)genetic...
FDA Approves Neoadjuvant Nivolumab and Platinum Doublet Chemotherapy for Early-Stage NSCLC
On March 4, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with platinum-doublet chemotherapy for adult patients with resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting. This represents the first FDA approval for neoadjuvant therapy for...
Patients With Merkel Cell Carcinoma Face 40% 5-Year Recurrence Rate, According to Recent Study
Patients treated for Merkel cell carcinoma face a 5-year recurrence rate of 40%—markedly higher than the recurrence rates for melanoma and other skin cancers, according to research published by McEvoy et al in JAMA Dermatology. Additionally, in the study cohort of more than 600 patients, 95% of...
Addition of Selumetinib to Adjuvant Radioactive Iodine in High-Risk Differentiated Thyroid Cancer
As reported in the Journal of Clinical Oncology by Ho et al, the phase III ASTRA trial showed no improvement in complete remission rate with the addition of selumetinib to adjuvant radioactive iodine (RAI) in patients with high-risk differentiated thyroid cancer. As stated by the investigators,...
Addition of BCL-XL/BCL-2 Inhibitor Navitoclax to Ongoing Ruxolitinib in Patients With Myelofibrosis With Disease Progression or Suboptimal Response
In a phase II trial reported in the Journal of Clinical Oncology, Harrison et al found that the BCL-XL/BCL-2 inhibitor navitoclax showed activity in patients with myelofibrosis with disease progression or suboptimal response during ongoing ruxolitinib treatment. As stated by the investigators,...
Upfront Peptide Receptor Radionuclide Therapy for Enteropancreatic Neuroendocrine Tumors
In an Italian retrospective cohort study reported in JAMA Network Open, Pusceddu et al found that upfront peptide receptor radionuclide therapy (PRRT) was associated with better progression-free survival vs upfront chemotherapy or targeted therapy in patients with advanced well-differentiated...
Minority Enrollment in U.S. Phase II and III Trials in Genitourinary Cancers
In a study reported in the Journal of Clinical Oncology, Owens-Walton et al found that minority populations are underrepresented in phase II and III trials targeting prostate, kidney, and bladder cancers taking place in the United States. Study Details In the analysis, the ClinicalTrials.gov...
Esophagus-Sparing vs Standard Palliative Radiation for Patients With Advanced Central NSCLC
As reported in JAMA Oncology by Louie et al, the Canadian phase III PROACTIVE trial showed that esophagus-sparing intensity-modulated radiotherapy (ES-IMRT) did not significantly improve esophageal quality of life vs standard radiotherapy in patients with advanced central non–small cell lung cancer ...
Effect of Screening Initiative on Disparity in Colorectal Cancer Mortality Between Black and White Patients
In an analysis reported in a letter to the editor in The New England Journal of Medicine, Doubeni et al found that a sustained Kaiser Permanente Northern California (KPNC) colorectal cancer screening initiative resulted in increased screening, increased identification of colorectal cancer, and a...
FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia
On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a...
FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...
Biomarker Test May Predict Recurrence of HPV-Driven Oropharyngeal Cancer
A large, multi-institutional study demonstrated that a blood test to detect circulating tumor DNA may accurately predict recurrence of human papillomavirus (HPV)-driven oropharyngeal cancer following treatment. Results also indicated that the biomarker test may detect recurrent disease earlier than ...
Axicabtagene Ciloleucel vs Standard of Care as Second-Line Treatment for Large B-cell Lymphoma
As reported in The New England Journal of Medicine by Frederick L. Locke, MD, and colleagues, the phase III ZUMA-7 trial of patients with large B-cell lymphoma has shown improved event-free survival with second-line axicabtagene ciloleucel vs chemoimmunotherapy with high-dose chemotherapy and...
