The studies summarized below were reported online over the past month in The ASCO Post, generating a high number of visitors. For comprehensive news of these studies and more, visit ASCOPost.com.
Triple-Negative Breast Cancer: Phase III KEYNOTE-522
Peter Schmid, MD, PhD
The phase III KEYNOTE-522 trial has significantly changed the treatment landscape for early-stage triple-negative breast cancer by demonstrating the benefits of neoadjuvant pembrolizumab plus chemotherapy. At the ESMO Congress 2024, Peter Schmid, MD, PhD, announced a statistically significant overall survival advantage, with a hazard ratio of 0.66 and a 5% improvement in survival rates after 5 years (86.6% vs 81.7%). The trial involved 574 women, showing consistent benefits across various subgroups, regardless of tumor characteristics. Pembrolizumab was previously approved by the FDA for high-risk patients, validating its role in improving outcomes in this population.
WHO Study Reevaluates Carcinogenic Classification of Mobile Phones
A recent review commissioned by the World Health Organization (WHO) by Karipidis et al found no significant link between mobile phone use and an increased risk of brain cancer. The study analyzed 63 research papers from 1994 to 2022, focusing on radiofrequency exposure from various devices. Despite the rise in wireless technology, brain cancer rates did not increase. The findings suggest that prolonged mobile phone use does not elevate cancer risks. Consequently, the WHO may reevaluate the “possibly carcinogenic” classification of mobile phone radiation, last assessed in 2011, with new results expected in early 2025.
Renal Cell Carcinoma: Phase III TiNivo-2 Trial
The phase III TiNivo-2 trial reported in The Lancet by Choueiri et al found that rechallenging patients with metastatic renal cell carcinoma using nivolumab plus tivozanib did not enhance progression-free survival compared to tivozanib alone. Involving 343 patients across 16 countries, the study showed median progression-free survival of 5.7 months in the combination group vs 7.4 months with tivozanib alone. Adverse events were similar between groups, with 61% experiencing grade ≥ 3 events. The authors concluded that immune checkpoint inhibitor rechallenge is not recommended and emphasized the efficacy of tivozanib as monotherapy in post-checkpoint inhibitor treatment.
Colorectal Cancer: SOLARIS Trial
The SOLARIS trial (Alliance A021703) found that adding high-dose vitamin D3 to standard treatment did not improve progression-free survival in untreated metastatic colorectal cancer patients compared to standard-dose vitamin D3. Conducted by Ng et al at Dana-Farber Cancer Institute, the study included over 450 patients receiving chemotherapy and bevacizumab, with a median follow-up of 20 months. Although no additional side effects were noted, high-dose vitamin D3 did not delay cancer progression. However, potential benefits were suggested for patients with left-sided disease, warranting further investigation. Overall, high-dose vitamin D3 is not recommended for this patient group.
Breast Cancer Incidence Rising in Key Subgroups
The American Cancer Society’s 2024 Breast Cancer Statistics report reveals a 44% decline in breast cancer mortality rates since 1989, preventing around 517,900 deaths. However, disparities persist, particularly for American Indian and Alaska Native women, whose rates have stagnated. Breast cancer incidence has increased by 1% annually from 2012 to 2021, with the most significant rise in women under 50 and Asian American/Pacific Islander women. The report underscores the need for improved access to screening and treatment, particularly for marginalized groups, and highlights new initiatives like the VOICES of Black Women study to address disparities in outcomes.
Adjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma
In a retrospective cohort study published in the Journal of Clinical Oncology, Habib et al examined the role of adjuvant chemotherapy in patients with resected pancreatic ductal adenocarcinoma. Analyzing data from 1,031 patients, the study found that 63.5% received chemotherapy. Key findings revealed that patients with node-positive disease and elevated CA19-9 levels benefited from adjuvant therapy, showing a median overall survival improvement of 34.4 months. However, 18.1% were undertreated and 61.2% were overtreated, with no survival benefit for node-negative patients. The authors emphasized the need for randomized controlled trials to validate their findings.
African Men May Have Higher Risk of Developing Prostate Cancer Earlier
A study published by Janivara et al in Nature Genetics identified unique genetic risk factors for prostate cancer in African men, highlighting variations absent in European populations. Involving nearly 8,000 participants from five African countries, the researchers discovered three genetic loci linked to increased prostate cancer incidence, emphasizing the need for tailored screening and treatment approaches in Africa. This study is part of the Men of African Descent and Carcinoma of the Prostate network, which aims to improve cancer care by addressing the genetic diversity and specific risks in African populations, ultimately enhancing understanding and management of prostate cancer in these groups.
Puxitatug Samrotecan in First-in-Human Trial
The novel antibody-drug conjugate puxitatug samrotecan shows a manageable safety profile and initial efficacy in heavily pretreated patients with advanced or metastatic solid tumors, according to findings presented by Meric-Bernstam et al at the ESMO Congress 2024. Targeting the B7-H4 protein, which is linked to poor prognosis, the drug delivers a topoisomerase 1 inhibitor to disrupt DNA replication. In a phase I/II trial with 47 patients, 20.5% achieved partial responses. Although 91.5% experienced treatment-related adverse events, only two patients discontinued treatment due to toxicity, suggesting good tolerability. Ongoing trials are exploring its effectiveness in various cancers.
For more on these and other studies, visit ASCOPost.com.
