OCE Insights is an occasional department 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, the OCE’s Steven Clark Cunningham, MD, MLA, FACS, Clinical Reviewer on the Gastrointestinal Cancers Team, ...
In 2023, the World Health Organization (WHO) declared that “no level of alcohol consumption is safe for our health.”1 The warning came decades after the International Agency for Research on Cancer classified alcohol as a Group 1 carcinogen, which is the highest risk group, and also includes...
On September 23, 2024, the U.S. House of Representatives passed the Seniors’ Access to Critical Medications Act of 2024 (H.R. 5526), which would make permanent a waiver put in place during the COVID-19 pandemic that allowed Medicare patients to receive medications dispensed by in-office pharmacies...
In an analysis of two clinical trials reported in the Journal of Clinical Oncology, Weber et al identified “cure rates” with adjuvant nivolumab, ipilimumab, and placebo in patients with resected stage III/IV melanoma. Study Details The analysis used mixture cure models (MCMs) to estimate cure rates ...
In the Canadian phase II OPAR trial reported in the Journal of Clinical Oncology, Kim et al found no difference in adverse cosmesis with partial breast irradiation (PBI) in five daily fractions of 30 Gy vs 27.5 Gy given over 1 week in patients with early breast cancer. The aim of the trial was to...
The multicenter phase III CARMEN-LC03 trial did not meet its dual primary endpoints of progression-free and overall survival with the CEACAM5-directed antibody-drug conjugate tusamitamab ravtansine vs standard chemotherapy with docetaxel in previously treated patients with advanced nonsquamous...
Investigators have highlighted a critical connection between heart failure and cancer, demonstrating how shared mechanisms may contribute to the incidence and progression of both diseases, according to a recent scientific statement published by Bloom et al in the Journal of Cardiac Failure....
Listening to music may accelerate postsurgical recovery, according to recent findings presented by Raees et al at the American College of Surgeons (ACS) Clinical Congress 2024. Background “When patients wake up after surgery, sometimes they feel really scared and don’t know where they are,”...
An examination of patient-level data from the phase III CheckMate 816 and CheckMate 77T trials supports the perioperative use of the PD-1 inhibitor nivolumab plus chemotherapy, as compared with the neoadjuvant use of nivolumab plus chemotherapy without adjuvant therapy, in resectable non–small...
Two novel oral HER2 tyrosine kinase inhibitors have demonstrated promising efficacy in patients with HER2-mutant non–small cell lung cancer (NSCLC), potentially transforming the treatment landscape for this rare but challenging subset of lung cancer cases. According to data presented at the...
The combination of the EGFR tyrosine kinase inhibitor osimertinib and the MET inhibitor savolitinib has demonstrated clinically meaningful improvements compared with osimertinib alone as a first-line treatment of patients with de novo MET-aberrant, EGFR-mutant advanced non–small cell lung cancer...
Implementing the American College of Surgeons (ACS) Geriatric Surgery Verification program may reduce rates of postsurgical mortality and increase the proportion of patients with documentation standards such as advanced care directives, according to two new studies presented by Horattas et al and...
Researchers have found that financial fallout can follow patients with cancer and their families as financial bankruptcy, lower credit scores, and other types of financial challenges in the years following a cancer diagnosis, according to two new studies presented by Gomez-Mayorga et al and...
As reported in the Journal of Clinical Oncology by Pavlakis et al, the phase III INTEGRATE IIa study showed improved overall survival with regorafenib plus best supportive care vs placebo vs best supportive care in patients with refractory advanced gastric/esophagogastric junction cancer. Study...
My dad agreed to receive hospice on a technicality. It happened after weeks of trying to get him home oxygen. My brother drove him to the oncologist’s office, and I helped him get into the wheelchair. He did not complain, but just asked me to hold his coffee mug, smiling because I snuck him a...
Younger adults with colon cancer tend to be diagnosed at a later stage and have more aggressive types of tumors. Additionally, young patients living with colorectal cancer have long-term, adverse consequences on their lives, which are different from the impact the disease has on older adults,...
The Society of Thoracic Surgeons (STS) announced the introduction of two new risk calculators to inform physician-patient decision-making in thoracic surgery. Engineered using contemporary data from the STS General Thoracic Surgery Database, the interactive tools may provide surgeons with accurate, ...
Researchers have found that the combination of nivolumab plus doxorubicin, vinblastine, and dacarbazine (AVD) may reduce the risk of cancer progression and mortality in patients with Hodgkin lymphoma compared with standard treatment, according to a recent study published by Herrera et al in The New ...
Among most members of the health-care and oncology workforces, the lofty goals of the organizational framework of diversity, equity, and inclusion (DEI) seem to be clear and indisputable: to promote the fair treatment and full participation of all people, particularly groups who have historically...
On October 15, 2024, Novocure announced the U.S. Food and Drug Administration (FDA) approval of Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) who have experienced disease progression on or after...
Neoadjuvant therapy for patients with resectable stage III melanoma has recently emerged as a better approach than resection plus adjuvant therapy. At the European Society for Medical Oncology (ESMO) Congress 2024, updates of pivotal neoadjuvant studies demonstrated the long-standing benefit of...
Updated results of a Swedish screening study (GOTEBORG-2), reported in The New England Journal of Medicine by Hugosson et al, indicate that omitting biopsy among individuals with negative magnetic resonance imaging (MRI) results eliminated a high proportion of diagnoses of clinically insignificant...
The Society of Hematologic Oncology (SOHO) 2024 Annual Meeting showcased several groundbreaking studies in the field of hematologic oncology, including key findings in childhood acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). The ASCO...
Researchers found that a higher dosage of radioembolization treatment using yttrium (Y)-90 microspheres than previously recommended may benefit patients with hepatocellular carcinoma, according to a recent study published by Chen et al in Liver Cancer. The findings could be practice-changing....
For women with early-stage triple-negative breast cancer, KEYNOTE-522 changed the treatment paradigm several years ago. Support for neoadjuvant use of the PD-1 inhibitor pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, was bolstered by the positive overall survival analysis...
In a Chinese phase II trial (INOVA) reported in The Lancet Oncology, Peng et al found that the combination of sintilimab and bevacizumab showed activity in patients with relapsed or persistent ovarian clear cell carcinoma. Study Details In the multicenter trial, 37 evaluable patients with exposure...
Despite considerable progress in the discovery and development of new cancer drugs between 1990 and 2022, there may be disparities in both the availability and timeliness of these treatment options globally, particularly among lower-income countries, according to a recent study published by Li et...
Researchers at Case Western Reserve University and Vanderbilt University have received a $3.7 million grant from the National Cancer Institute to pioneer a novel approach to prostate cancer surgery that combines advanced robotics and low-field magnetic resonance imaging (MRI) technology. Overview...
A recent study found that measuring circulating tumor cells (CTCs) is a reliable way to predict later treatment response and survival prospects in men when metastatic prostate cancer is first diagnosed. The test may help providers to decide which patients should receive standard treatment vs who...
Canadian vaccination programs may switch to a one-dose, gender-neutral human papillomavirus (HPV) vaccination approach to eliminate cervical cancer, according to a recent study published by Drolet et al in the Canadian Medical Association Journal. Background HPV is known to cause cervical cancer...
Investigators have uncovered that during the Patient Protection and Affordable Care Act’s (ACA) first decade, the survival rates of Dependent Coverage Expansion–eligible young adult patients with cancer may have improved, according to a recent study published by Roth et al in Cancer. The federal...
Three years ago, it had become clear that I needed to be tested for the BRCA1/2 mutation. I knew my family history of cancer was not good. My paternal grandmother died of breast cancer when she was just 41, and her mother had likely died of cervical cancer when she was in her 50s. More recently,...
The 2024 Nobel Prize in Physiology or Medicine has been awarded jointly to two U.S. scientists: Victor Ambros, PhD, and Gary Ruvkun, PhD, for the discovery of microRNA and its role in post-transcriptional gene regulation. The recipients were named in a news release issued by The Nobel Assembly at ...
Initial analysis from the PEACE-3 trial suggests that the addition of radium-223 dichloride to enzalutamide could offer a promising new first-line treatment option for patients with metastatic castration-resistant prostate cancer, according to data presented by lead study author, Silke Gillessen,...
In the field of radiology, where a correct diagnosis is critical to ensure proper patient care, large language models such as ChatGPT may improve accuracy or offer a second opinion in assessing brain tumor magnetic response imaging (MRI) reports, according to a recent study published by Mitsuyama...
Late-breaking findings from the phase IIIb/IV, open-label DESTINY-Breast12 trial support the use of the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-positive metastatic breast cancer and brain metastases who have experienced disease progression on at least...
In the multiarm phase II NeoCOAST-2 trial, neoadjuvant treatment with datopotamab deruxtecan (Dato-DXd) plus the monoclonal antibody durvalumab and single-agent platinum chemotherapy led to promising rates of pathologic complete and major pathologic responses in patients with early-stage non–small...
As reported in the Journal of Clinical Oncology by González-Martín et al, a phase III trial (ENGOT-OV41/GEICO 69-O/ANITA) has shown no progression-free survival benefit with the addition of atezolizumab to a carboplatin doublet and maintenance niraparib in patients with recurrent ovarian cancer...
Spiritual beliefs and a historically based distrust of clinical research may influence Black patients’ decisions about whether to participate in cancer trials, according to new findings presented by Gomez et al at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract...
In an analysis reported in the Journal of Clinical Oncology, Tournilhac et al identified 7-year outcomes of the phase III AATT trial evaluating autologous vs allogeneic transplantation in younger patients with peripheral T-cell lymphoma. Study Details In the trial, 103 patients (aged 18–60) from...
A substantial number of patients with brain metastases who experience cognitive side effects after radiation therapy may fully regain cognitive function, according to recent findings presented by Cherng et al at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 150). ...
OCE Insights is an occasional department 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, the OCE’s Steven Clark Cunningham, MD, MLA, FACS, Clinical Reviewer on the Gastrointestinal Cancers Team, ...
It is not often that the oncology community looks to the Supreme Court to forecast its future. In 2024, two decisions seemingly unrelated to health care were issued that are likely to have a monumental impact on oncology care delivery. The Court’s rulings—on June 28, Loper Bright Enterprises et ...
An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...
As reported in The Lancet by Choueiri et al, the phase III TiNivo-2 trial has shown that immune checkpoint inhibitor rechallenge with nivolumab plus tivozanib did not improve progression-free survival vs tivozanib alone in patients with metastatic renal cell carcinoma following immune checkpoint...
Two types of contemporary radiation therapy—proton-beam therapy or intensity-modulated radiation therapy—may provide comparable rates of tumor control with no differences in patient-reported quality of life among patients with low- and intermediate-risk prostate cancer, according to new findings...
Findings of a multi-institutional phase III trial indicated that people with limited-stage small cell lung cancer may benefit from the addition of immunotherapy to chemoradiotherapy, but not if both treatments are given simultaneously, new research finds. The results suggest that the timing of when ...
Adding the immune checkpoint inhibitor durvalumab, with or without the monoclonal antibody oleclumab, to neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT) significantly improved pathologic complete response rates in patients with high-risk hormone receptor (HR)-positive breast ...
Investigators have uncovered a higher risk for strokes, heart attacks, and hospital admissions for heart failure in older cancer survivors, according to a recent study published by Muhandiramge et al in Cancer. Background Although advances in cancer treatment have led to decreased mortality rates...
As reported in The Lancet Oncology by Iliopoulos et al, updated findings from the phase II LITESPARK-004 trial support the efficacy of belzutifan in patients with von Hippel-Lindau (VHL) disease–associated CNS hemangioblastomas. Study Details In the study, 50 patients with CNS hemangioblastomas...