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Showing 801 - 850FDA Issues New Draft Guidance to Industry for Developing Plans to Enroll Participants From Underrepresented Racial and Ethnic Populations
Recently, the U.S. Food and Drug Administration (FDA) issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the United States into clinical trials—expanding on the agency’s previous guidances for industry to...
Accounting for Genetic Factors That Cause Normal Variations in PSA Levels May Improve the Accuracy of Prostate Cancer Detection
The accuracy of prostate-specific antigen (PSA) screening for prostate cancer could be improved by accounting for genetic factors that cause changes in PSA levels not associated with cancer, according to data presented by Kachuri et al during the American Association for Cancer Research (AACR)...
Pediatric Patients With Cancer in Lower- and Middle-Income Countries Faced a Significantly Higher Mortality Risk During the COVID-19 Pandemic
During the first 9 months of the COVID-19 pandemic, patients with pediatric cancer from lower- and middle-income countries faced a higher risk of all-cause mortality than those in high-income countries, according to data presented by Elhadi et al at the American Association for Cancer Research...
Recurrent Noninvasive Breast Tumors May Not Always Be Related to the Primary Lesion
More than 10% of cases of recurrent ductal carcinoma in situ (DCIS) of the breast were de novo tumors that occurred independently of the primary lesion and had distinct genetic alterations, according to data presented by Kader et al during the American Association for Cancer Research (AACR) Annual...
An AI Model May Predict Elevated Pancreatic Cancer Risk Using Electronic Health Records
An artificial intelligence (AI) model trained using sequential health information derived from electronic health records identified a subset of individuals with a 25-fold risk of developing pancreatic cancer within 3 to 36 months, according to results presented by Placido et al at the American...
Reflections on the Evolution of Clinical Care Since the Passage of the National Cancer Act of 1971
Recently, I had the honor of coauthoring a chapter with Eric P. Winer, MD, President-Elect of ASCO, on the evolution of clinical cancer care since the enactment of the National Care Act of 1971 for the book A New Deal for Cancer: Lessons From a 50-Year War, by Abbe R. Gluck and Charles S. Fuchs,...
Conundrums of SARS–CoV-2 Infection in Cancer Care
The ASCO Post is pleased to present the Hematology Expert Review, an occasional feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib, Kröger, and Mikulska focus on the challenges of providing cancer care amid the COVID-19 pandemic. Here they present two...
Screening Platform May Contribute to Detection of Early-Stage Pancreatic Cancers, Other Malignancies
A novel screening platform flagged more than 95% of stage I pancreatic cancers, in addition to other early-stage malignancies, according to a pilot study published by Hinestrosa et al in Nature Communications Medicine. If validated by future studies, the approach may offer a new way to detect the...
Protecting the Immunocompromised From COVID-19: Practical Information for Physicians
COVID-19 may have caught the world off guard in 2020, but in the 2 years since the pandemic began, several effective monoclonal antibodies and antiviral drugs have emerged to protect the most vulnerable patients. The ASCO Post spoke with Gunjan L. Shah, MD, a hematologic oncologist at Memorial...
FDA Approves Alpelisib for PIK3CA-Related Overgrowth Spectrum
On April 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to alpelisib (Vijoice) for adult and pediatric patients aged 2 years and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. PROS encompasses a group of rare...
Anetumab Ravtansine vs Vinorelbine in Relapsed Mesothelin-Positive Advanced Malignant Pleural Mesothelioma
In the phase II ARCS-M trial reported in The Lancet Oncology, Hedy L. Kindler, MD, FASCO, and colleagues found that the antimesothelin antibody–tubulin inhibitor conjugate anetumab ravtansine did not improve progression-free survival vs vinorelbine as second-line treatment for patients with...
Combined BCMA and CD19 CAR T Cells in Relapsed or Refractory Multiple Myeloma: Long-Term Follow-up
In a long-term follow-up of a Chinese phase II study reported in the Journal of Clinical Oncology, Wang et al found that the combination of anti–B-cell maturation antigen (BCMA) and anti-CD19 chimeric antigen receptor (CAR) T cells produced durable responses and favorable survival outcomes in...
Study Finds AI Ultrasound Platform Can Predict Thyroid Malignancy, Pathologic Stage, and BRAF Mutation Status
An artificial intelligence (AI) ultrasound platform that incorporates multiple methods of machine learning can accurately predict thyroid malignancy as well as pathologic and genomic outcomes, according to data presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.1 Findings from...
Several Studies Evaluate Agents in the First-Line, Second-Line, and Later Treatment of 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,...
Effect of Traditional Eligibility Criteria on Enrollment of Black Patients in Pancreatic Cancer Clinical Trials
In a single-center study reported in the Journal of Clinical Oncology, Riner et al found that traditional eligibility criteria for clinical trials in pancreatic ductal adenocarcinoma excluded a higher proportion of Black vs White patients and identified factors that commonly led to exclusion. As...
ARIEL4 Trial: Rucaparib vs Chemotherapy in Patients With Relapsed Ovarian Cancer and Deleterious BRCA1 or BRCA2 Mutations
As reported in The Lancet Oncology by Rebecca Kristeleit, MD, and colleagues, the phase III ARIEL4 trial has shown a statistically significant improvement in progression-free survival with rucaparib vs chemotherapy in patients with relapsed ovarian cancer and deleterious BRCA1/2 mutations. Study...
Transportation Barriers to Health Care Among Cancer Survivors in the United States
In a study reported in a research letter in JAMA Oncology, Changchuan Jiang, MD, MPH, and colleagues found that U.S. cancer survivors were more likely to report delays in health care due to transportation barriers than persons without a history of cancer, with the difference driven by barriers...
Emerging Endocrine Therapies for the Management of Breast Cancer
Novel hormonal therapies for breast cancer could provide additional therapeutic options for patients with hormone receptor–positive breast cancer. The emerging landscape for these new agents was described at the 2022 Miami Breast Cancer Conference, sponsored by PER, by Aditya Bardia, MD, MPH,...
Study Finds Black Patients With Cancer Diagnosed With COVID-19 Have Worse Outcomes Than White Patients
Black patients with cancer experienced significantly worse outcomes after a COVID-19 diagnosis than non-Hispanic White patients, according to findings published by Fu et al in JAMA Network Open. Investigators from the COVID-19 and Cancer Consortium (CCC19) studied the electronic health records of...
PD-1 Inhibition in Patients With Classic or Endemic Kaposi Sarcoma
In a French phase II study reported in The Lancet Oncology, Delyon et al found that pembrolizumab produced a high response rate in patients with classic or endemic Kaposi sarcoma with progressive cutaneous extension requiring systemic treatment. As stated by the investigators, “Although the...
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...
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 ...
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...
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 ...
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...
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,...
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%,...
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,...
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...
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...
Outcomes and Toxicity With Single-Agent Immune Checkpoint Inhibitor Treatment in Geriatric Patients With Cancer
In a multicenter international retrospective cohort study reported in JAMA Oncology, Caroline A. Nebhan, MD, PhD, of Vanderbilt University Medical Center, and colleagues found that single-agent immune checkpoint inhibitor therapy in patients with cancer aged 80 and older appeared to be effective...
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...
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...
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 ...
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...
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...
Study Reports Modest Gain in Progression-Free Survival With Continued Enzalutamide in Advanced Prostate Cancer
Enzalutamide is a common first-line choice for patients with metastatic castration-resistant prostate cancer, but response in some patients eventually wanes and then patients are switched to a different treatment. According to the phase IIIb PRESIDE trial, reported at the 2022 ASCO Genitourinary...
Triplet Combination Improves Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer
Triplet therapy with the oral androgen receptor inhibitor darolutamide plus docetaxel plus androgen-deprivation therapy significantly improved overall survival in patients with metastatic hormone-sensitive prostate cancer vs docetaxel plus androgen-deprivation therapy, according to results of the...
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,...
Olaparib With or Without Cediranib vs Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer
As reported in the Journal of Clinical Oncology by Joyce F. Liu, MD, and colleagues, the phase III NRG-GY004 trial has shown no significant improvement in progression-free survival with olaparib/cediranib vs platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian 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...
HRR Mutational Status May Be Prognostic of Survival Outcomes for Women With Recurrent Platinum-Sensitive Ovarian Cancer
Results of a biomarker analysis of the NRG Oncology NRG-GY004 trial were presented during the Society for Gynecologic Oncology’s (SGO) Annual Meeting on Women’s Cancer. The analysis, which occurred as part of a preplanned translational endpoint for the study, concluded that homologous recombination ...
Younger Patients With Appendicitis May Be at Increased Risk for Appendiceal Cancer
Although appendectomy is still the most effective treatment for acute appendicitis, nonoperative management is increasingly common, as recent studies—such as one published in November 2020 in The New England Journal of Medicine and a second published in December 2021 in the same journal—have shown...
How Do Lifestyle and Cardiovascular Risk Factors Relate to Heart Failure Subtypes in Postmenopausal Breast Cancer Survivors?
In an analysis from the Women’s Health Initiative reported in JACC: CardioOncology, Kerryn W. Reding, PhD, MPH, RN, and colleagues identified the incidence of hospitalization for heart failure among postmenopausal breast cancer survivors, finding that both incidence of hospitalization and risk of...
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...
Researchers Identify Trends in Treatment for Retroperitoneal Soft-Tissue Sarcoma
Researchers have published an analysis of strategies for treating retroperitoneal soft-tissue sarcoma, which has historically been understudied due to its rarity. The researchers say the trends they identified—particularly the convergence of certain treatments across centers—will help guide the way ...
Perioperative Dose-Dense MVAC vs Gemcitabine/Cisplatin in Nonmetastatic Muscle-Invasive Bladder Cancer
As reported in the Journal of Clinical Oncology by Pfister et al, the French phase III GETUG-AFU V05 VESPER trial showed a nonsignificant improvement in 3-year progression-free survival with dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd- MVAC) vs gemcitabine/cisplatin given...
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...
Half of Patients With Cancer and Survivors Report Incurring Cancer-Related Medical Debt
The cost of cancer care is substantially impacting the lives of patients with cancer and survivors, forcing them to make significant lifestyle changes and causing some to incur long-term medical debt. According to a new Survivor Views survey from the American Cancer Society Cancer Action Network...
Study Reports Modest Gain in Progression-Free Survival With Continued Enzalutamide in Advanced Prostate Cancer
Enzalutamide is a common first-line choice for patients with metastatic castration-resistant prostate cancer, but response in some patients eventually wanes and then patients are switched to a different treatment. According to the phase IIIb PRESIDE trial, reported at the 2022 ASCO Genitourinary...
