Cancer最新文献

The weekly, self-injected peptide hepcidin mimetic rusfertide significantly reduced the mean number of phlebotomies (PHLs) and improved hematocrit control in patients with polycythemia vera (PV) receiving standard-of-care treatment according to results of the phase 3 VERIFY study.¹

“Based on these data, rusfertide represents a potential new treatment option for PV,” said Andrew Kuykendall, MD, an assistant member of the Department of Malignant Hematology in the Moffitt Cancer Center in Tampa, Florida, who presented the trial results at the 2025 ASCO annual meeting.

The VERIFY trial comprised two parts. In Part 1a, 293 patients with PV who required frequent PHLs with or without stable cytoreductive therapy (CRT) were randomly assigned to once weekly rusfertide or a placebo. Approximately half of the patients in both study arms received concurrent CRT. All patients completing the 32 weeks of Part 1a could continue on open-label rusfertide in Part 1b (Weeks 32–53).

The primary efficacy endpoint was the proportion of patients with a clinical response, which was defined as an absence of PHL eligibility and no PHLs from Week 20 to Week 32. A clinical response was achieved in 76.9% of the patients assigned to rusfertide but in 32.9% of the patients assigned to the placebo (p < .0001). The mean number of PHLs was 0.5 with rusfertide but 1.8 with the placebo (p < .0001).

“The exciting results of this phase 3 VERIFY study might be practice changing for patients with PV,” says Lucia Masarova, MD, an assistant professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, Texas. “The study confirmed findings previously seen in the phase 2 study of rusfertide (REVIVE); rusfertide, as the first-in-class hepcidin mimetics, consistently showed superior control of hematocrit and phlebotomy independence in patients with PV irrespectively of baseline risk or required cytoreductive therapy.”

In addition to meeting all primary and secondary endpoints, patients assigned to rusfertide had meaningful symptom control with favorable tolerance. Rusfertide demonstrated a manageable safety profile consistent with prior studies. The most common adverse events with rusfertide were localized injection site reactions (55.9%) and anemia (15.9%). Discontinuation due to treatment-related adverse events occurred in 5.5% of the patients assigned to rusfertide and in 2.7% of the patients assigned to the placebo.

In discussing the limitations of the study, Dr Kuykendall said that the heterogeneous patient population limited the interpretability of some of VERIFY’s secondary endpoints. Included patients had different cytoreductive strategies, different baseline symptom burdens, and different durations of disease.

“The placebo-controlled portion of VERIFY was only 32 weeks long,” Dr Kuykendall said during his presentation. “Given this chronic malignancy, we a

Adjuvant nivolumab added to the standard-of-care cisplatin radiotherapy (CRT) significantly improved disease-free survival (DFS) compared with the standard of care alone in patients with resected locally advanced head and neck squamous cell carcinoma (HNSCC) regardless of PD-L1 status according to results of the NIVOPOSTOP trial.¹

According to the improvements seen in this trial, postoperative nivolumab added to standard-of-care CRT “could be proposed as a new standard treatment,” said Jean Bourhis, MD, PhD, a radiation oncologist at the Lausanne University Hospital in Switzerland, who presented the results at the 2025 American Society of Clinical Oncology annual meeting.

The NIVOPOSTOP trial included 680 patients with resected locally advanced HNSCC who were at high risk for relapse, which was defined as the presence of nodal extracapsular extension and/or positive tumor margins, the involvement of four or more nodes, or multiple perineural invasion. Patients randomly were assigned after surgery to the standard-of-care treatment with 66 Gy of radiotherapy plus cisplatin or 240 mg of nivolumab followed by standard-of-care CRT with three cycles of 360 mg of nivolumab every 3 weeks followed by six cycles of 480 mg of nivolumab every 4 weeks. The primary endpoint was DFS.

Overall survival data are not yet mature. There was a slight to moderate increase in grade 4 adverse events in patients assigned to nivolumab (9.3% vs. 5.2%), with no increase in treatment-related deaths.

With a median follow-up of 30.3 months, the 3-year DFS rate was 63.1% with nivolumab plus CRT and 52.5% with CRT alone (stratified hazard ratio, 0.76; 95% CI, 0.60–0.98; p = .034).

“In this study, there was no selection of the patients based on the CPS [combined positive score] and PD-L1 expression, and the benefit of nivolumab was seen in all comers,” Dr Bourhis said in his presentation. “The CPS did not appear strongly correlated with DFS.”

The benefit of nivolumab was consistent across a variety of subgroups of patients who were categorized by age, gender, tumor site, pathological stage, and human papillomavirus p16 status.

“These results are clinically significant,” says Nabil F. Saba, MD, a professor and vice chair in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia, “as cisplatin-radiotherapy has been the standard of care for these patients since the early 1990s.”

Dr Saba notes that clinicians should remember that the patient population included in NIVOPOSTOP is different from the patients included in the KEYNOTE-689 trial, which showed that adding neoadjuvant and adjuvant pembrolizumab to the standard of care significantly improved event-free survival in patients with locally advanced squamous cell carcinoma of the head and neck.²

“There may be patients who are not eligible for the NIVOPOSTOP regimen who

Patients with estrogen receptor (ER)–positive, HER2-negative breast cancer who developed an ESR1 mutation during treatment with an aromatase inhibitor (AI) plus a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor benefited from switching to the next-generation oral selective ER degrader camizestrant in place of the AI during first-line therapy according to the results from the SERENA-6 study.

“The findings from SERENA-6 have the potential to become a new treatment strategy in oncology to optimize first-line patient outcomes,” said Nicholas Turner, MD, PhD, a professor of molecular oncology at the Royal Marsden Hospital and Institute of Cancer Research in London, United Kingdom, when he presented the results at the 2025 American Society of Clinical Oncology annual neeting.¹ The results were published simultaneously in The New England Journal of Medicine.²

An ESR1 mutation is a common mechanism of resistance to treatment with an AI plus a CDK4/6 inhibitor for advanced breast cancer. In the SERENA-6 trial, 3256 patients with ER-positive, HER2-negative breast cancer underwent testing for an ESR1 mutation in circulating tumor DNA once every 2–3 months.

The 315 patients without progression who were found to have an ESR1 mutation were randomly assigned either to switch to the regimen of camizestrant, a CDK4/6 inhibitor, and a placebo (157 patients) or to continue the regimen of an AI, a CDK4/6 inhibitor, and a placebo (158 patients).

“Camizestrant almost doubled progression-free survival when given with a CDK 4/6 inhibitor compared to continuing an aromatase inhibitor,” says Ruth O’Regan, MD, the chair of medicine at the University of Rochester in New York.

An interim analysis showed that camizestrant reduced the risk of progression or death by 56% compared with an AI (hazard ratio, 0.44; 95% CI, 0.31–0.60). The median progression-free survival was 16.0 months with camizestrant and 9.2 months with an AI (p < .0001).

“Overall survival has not as yet been reported,” Dr O’Regan says, “so it remains unclear whether switching therapies prior to overt disease progression is superior to standard approach.”

Overall, camizestrant was well tolerated with a low rate of treatment discontinuations. The most common adverse event was any grade of neutropenia. Grade 3 or higher adverse events were reported in 60.0% of the patients assigned to camizestrant and in 45.8% of the patients assigned to the AI.

Serious adverse events leading to death occurred in three patients assigned to camizestrant; two of these events were considered unrelated to the study drug, and one was considered possibly related. One patient assigned to the AI died because of a serious event that was considered possibly related to the AI.

Cancer-related symptoms are detrimental to the quality of life of people with cancer. This review systematically evaluates phase 3 randomized clinical trials (RCTs) assessing the effectiveness and safety of traditional Chinese medicine (TCM) interventions in managing cancer-related symptoms throughout the cancer care trajectory. A comprehensive literature search was conducted of PubMed, Embase, and the Cochrane Library until April 27, 2025, to further identify eligible RCTs involving patients with cancer or survivors and assessing TCM interventions against valid control arms. Data extraction and quality assessments were conducted in accordance with Cochrane standards and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Nineteen phase 3 RCTs involving 5387 participants (female, 3321; primarily breast, gastrointestinal, and lung cancers) from six countries or regions were included. Nonpharmacological interventions, namely acupuncture and Tai Chi, significantly reduced pain, fatigue, insomnia, radiation-induced xerostomia, and hormonal therapy–related hot flashes compared to usual care (UC). Their effects on preventing chemotherapy- and radiotherapy-induced nausea and vomiting were mixed, which depended on control arms and outcome measures. Conversely, evidence for pharmacological interventions was limited, with inconclusive results regarding chemotherapy-induced peripheral neuropathy and hematologic toxicities, although promising outcomes were noted for preventing chemoradiotherapy-induced mucositis, reducing colorectal adenoma recurrence, and enhancing chemotherapy completion rates compared to placebo or UC. Safety data suggested similar adverse event profiles across groups. These findings show strong evidence for the inclusion of nonpharmacological interventions in oncology practice. However, pharmacological interventions require more high-quality, multicenter research to fully understand their effectiveness and safety. Implementing rigorous safety assessments and standardized adverse event reporting protocols is crucial to enhance clinical confidence in TCM modalities.