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Showing 3101 - 3150Neoadjuvant Durvalumab Improves Long-Term Outcomes in the GeparNuevo Trial
In the phase II GeparNuevo trial, patients with early triple-negative breast cancer receiving the PD-L1 inhibitor durvalumab in addition to chemotherapy as neoadjuvant therapy saw improvements in long-term outcomes. The results were presented at the 2021 ASCO Annual Meeting by Sibylle Loibl, MD,...
Expert Point of View: Giuseppe Curigliano, MD, PhD
Invited discussant Giuseppe Curigliano, MD, PhD, Associate Professor of Medical Oncology at the University of Milan, Italy, and Head of the Division of Early Drug Development at the European Institute of Oncology, said the “clear” findings of KEYNOTE-5221 are “practice-changing.” However, the ideal ...
KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer
The latest analysis of the phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III trial to ...
Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at the 38th Miami Breast Cancer Conference, held virtually this year, by Adam M....
Margetuximab-cmkb Plus Chemotherapy Prolongs Progression-Free Survival in Heavily Pretreated HER2 Positive Breast Cancer
As reported in JAMA Oncology by Hope S. Rugo, MD, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs...
Long-Term Analysis of Short-HER Trial of Adjuvant Trastuzumab
Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for recurrence. High-risk patients, however, derived considerably more...
Novel HER2-Targeted Therapies Pose Sequencing Challenges
With three new HER2-targeted therapies approved over the past year or two alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and...
RxPONDER: Many Postmenopausal Patients With Node-Positive Breast Cancer Can Avoid Chemotherapy
The SWOG S1007 RxPONDER trial evaluated the benefit of chemotherapy in women with early-stage hormone receptor–positive, HER2-negative breast cancer and node-positive disease.1 The data showed that many postmenopausal women can skip adjuvant chemotherapy, based on a 46% reduction in the risk of...
A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer
The primary outcome analysis of the phase III monarchE trial, an update of previous data, continued to show significant benefit for abemaciclib in the adjuvant setting, reducing the risk for invasive disease recurrence by 28.7%. Meanwhile, the first results of the phase III PENELOPE-B trial of...
Addition of Adjuvant Palbociclib to Ongoing Endocrine Therapy in HR-Positive, HER2-Negative Early Breast Cancer: PALLAS Trial
As reported in The Lancet Oncology by Erica L. Mayer, MD, and colleagues, the second interim analysis of the phase III PALLAS trial showed no improvement in invasive disease–free survival with the addition of adjuvant palbociclib to ongoing endocrine therapy in patients with hormone receptor...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
Beyond CDK4/6 Inhibitors in Metastatic Breast Cancer: What’s Next?
Because of their well-established efficacy, inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) are the standard of care in the treatment of hormone receptor–positive, HER2-negative metastatic breast cancer. The question now is this: After disease progresses on a CDK4/6 inhibitor and endocrine...
Breast Cancer 2020–2021 Almanac
The past decade has seen an explosion of novel agents for breast cancer across subtypes. Although each new advance improves therapeutic options for patients, it also brings forth a challenging question: Who needs what treatment? Not all cancers are created equally, and similarly not all patients...
Expert Point of View: Eleni Efstathiou, MD
Invited discussant of the PEACE-1 trial, Eleni Efstathiou, MD, of the Houston Methodist Cancer Center and Athens Medical Center, Greece, reminded listeners: “Androgen signaling inhibition is the prevailing therapeutic strategy in advanced prostate cancer, with reproducible outcomes. Many studies...
PEACE-1: Abiraterone Plus Androgen-Deprivation Therapy and Docetaxel Boosts Survival in Metastatic Castration-Sensitive Prostate Cancer
The addition of abiraterone acetate plus prednisone on top of androgen-deprivation therapy plus docetaxel improved survival in patients with de novo metastatic castration-sensitive prostate cancer vs androgen-deprivation therapy plus docetaxel alone. These results were from the phase III PEACE-1...
ACIS Trial: Addition of Apalutamide to Abiraterone Acetate/Prednisone for Metastatic Castration-Resistant Prostate Cancer
As reported in The Lancet Oncology by Fred Saad, MD, FRCS, and colleagues, the phase III ACIS trial has shown that the addition of apalutamide to abiraterone acetate and prednisone significantly prolonged radiographic progression–free survival in men with metastatic castration-resistant prostate...
New Certification Pilot Focuses on Patient-Centered Cancer Care, Equips Practices With Evidence-Based Approach to Value-Based Care Delivery
The Association for Clinical Oncology (the Association) launched the ASCO Patient-Centered Cancer Care Certification, a new pilot that certifies outpatient oncology group practices and health systems that meet a single set of comprehensive, expert-backed standards for patient-centered care...
Reduction in Ipsilateral Recurrence Risk With Radiotherapy vs Observation After Lumpectomy for Good-Risk DCIS
In an analysis of long-term outcomes from the phase III NRG/RTOG 9804 trial reported in the Journal of Clinical Oncology, Beryl McCormick, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that whole-breast irradiation vs observation was associated with a reduced risk of all and...
Cabozantinib Prolongs Progression-Free Survival in Previously Treated Radioiodine-Refractory Differentiated Thyroid Cancer
As reported in The Lancet Oncology by Marcia S. Brose, MD, Abramson Cancer Center, University of Pennsylvania, and colleagues, the phase III COSMIC-311 trial has shown that cabozantinib produced a numerically higher objective response rate and significantly prolonged progression-free survival vs...
Neoadjuvant Atezolizumab Under Study in Mesothelioma
Neoadjuvant atezolizumab combined with pemetrexed and cisplatin, with maintenance atezolizumab, proved to be safe and feasible, offering a hint of benefit in patients with resectable pleural mesothelioma, in a small multicenter study presented at the International Association for the Study of Lung...
Expert Point of View: Charles M. Rudin, MD, PhD
Charles M. Rudin, MD, PhD, Hassenfeld Professor and Chief of the Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, commented that although ATLANTIS1 “unfortunately joins the ranks of negative phase III studies in patients with recurrent small cell lung cancer,” there are “some...
Benefits Seen With Lurbinectedin Plus Doxorubicin in Small Cell Lung Cancer—but Primary Endpoint Missed
As a second-line treatment for patients with small cell lung cancer, lurbinectedin plus doxorubicin failed to improve overall survival in the multicenter ATLANTIS trial but did provide other benefits, including better tolerability, researchers reported at the 2021 World Conference on Lung Cancer,...
Adjuvant Pembrolizumab Shows Efficacy in High-Risk Stage II Melanoma in Adults and Children Older Than 12
Adjuvant pembrolizumab reduced the risk of recurrence in adults and children older than age 12 with high-risk stage II (AJCC 8th edition, stage IIB/IIC) melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial, presented during the European Society for...
Expert Point of View: Mansoor Raza Mirza, MD
“The standard of care [in advanced cervical cancer] has been the addition of bevacizumab to platinum-based chemotherapy since 2014. Even with the addition of bevacizumab, we still need to do better. There is a substantial unmet need for new therapies,” said invited discussant Mansoor Raza Mirza,...
Expert Point of View: Monica Arnedos, MD, PhD
Monica Arnedos, MD, PhD, Head of the Breast Cancer Research Program at the Institut Bergonié, Bordeaux, France, commented on the study findings on extended treatment with letrozole. “We cannot ignore the results of the GIM4 trial.1 It provides additional strong evidence to support extended...
Phase III Trial Supports Adjuvant Endocrine Therapy for 7 Years in Early-Stage Breast Cancer
For patients with early-stage hormone receptor–positive breast cancer, extending the duration of letrozole after tamoxifen—for up to 8 years of total endocrine therapy—significantly improved invasive disease–free survival over the standard 5 or so years, according to the final analysis of the...
Expert Point of View: Ichiro Yoshino, MD, PhD
Ichiro Yoshino, MD, PhD, Professor and Chairman of the Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, Japan, reviewed the finer details of the IMpower010 exploratory analysis.1 He maintained that atezolizumab’s benefit does, indeed, seem to favor some patient...
IMpower010: Benefits Observed With Atezolizumab Regardless of Stage, Type of Prior Treatment
In an exploratory analysis of the pivotal phase III IMpower010 trial in stage II–IIIA non–small cell lung cancer (NSCLC), continued treatment with the monoclonal antibody atezolizumab after surgery and chemotherapy improved disease-free survival regardless of the type of surgery or chemotherapy...
Expert Point of View: Shanu Modi, MD
Shanu Modi, MD, of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, New York, called the DESTINY-Breast03 results,1 which showed a highly significant benefit for fam-trastuzumab deruxtecan-nxki (T-DXd) over trastuzumab emtansine (T-DM1), “unprecedented.” She suggested they...
DESTINY Breast03 Trial Supports Second-Line Use of T-DXd in Metastatic HER2-Positive Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) may become a new option as a second-line treatment of patients with HER2-positive unresectable or metastatic breast cancer, based on results from the global phase III DESTINY-Breast03 trial. These findings were presented by Javier...
FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space
Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...
Effect of Chronic Stress on Treatment Completion and Survival Outcomes in Patients With Breast Cancer
Elevated allostatic load was associated with a lower likelihood of completing chemotherapy and a lower overall survival rate in patients with lymph node–positive or high-risk lymph node–negative HER2-negative breast cancer, according to results presented by Samilia Obeng-Gyasi, MD, MPH, at the 14th ...
ARAMIS Analysis: Darolutamide Shows Similar Benefits for Black Patients as Observed in the Overall Population
Black patients with prostate cancer who were treated with the androgen receptor inhibitor darolutamide had clinical outcomes similar to those observed in the overall clinical trial population, according to results from the phase III ARAMIS trial presented by Neal Shore, MD, at the 14th AACR...
Rates of Diagnosis of Gastrointestinal Cancers—and Stage at Diagnosis—Before and During the COVID-19 Pandemic in Japan
In a study reported in JAMA Network Open, Kuzuu et al found that the COVID-19 pandemic in Japan was associated with reduced rates of new diagnoses, as well as reduced rates of diagnosis at earlier stages, for some gastrointestinal cancers. Study Details The retrospective cohort study included data...
Study Finds Some Pancreatic Cancer Trial Eligibility Criteria Disproportionately Exclude Black Patients
Although lack of clinical trial participation is associated with worse survival outcomes in some malignancies, data show that Black patients with cancer represent just 7.3% of participants—and only 4.5% for such cancers as multiple myeloma—in cancer clinical trials, compared with 84.2% for White...
Study Finds Medicaid Expansion May Be Associated With Decrease in Early Lung Cancer Mortality
Medicare expansion under the Affordable Care Act may have improved outcomes for patients with lung cancer, the leading cause of cancer death in the United States, according to data presented at the 2021 ASCO Quality Care Symposium.1 The National Cancer Database analysis of nearly 12,000 patients...
Zanubrutinib for Waldenström’s Macroglobulinemia
On August 31, 2021, the Bruton’s tyrosine kinase inhibitor zanubrutinib was approved for treatment of adults with Waldenström’s macroglobulinemia.1 Supporting Efficacy Data Approval was based on findings in patients receiving zanubrutinib in the phase III open-label ASPEN trial (ClinicalTrials.gov...
Jyoti Patel, MD, Offers Thoughts on Maintenance Durvalumab Utilization
Study discussant Jyoti Patel, MD, Medical Director of Thoracic Oncology and Assistant Director for Clinical Research at the Lurie Cancer Center of Northwestern University, Chicago, called the research “important for many reasons.” Although the study analyzed data from both open and closed claims,...
Maintenance Durvalumab: Increased Utilization May Improve Outcomes in NSCLC
Maintenance durvalumab, the standard-of-care treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC), remains significantly underutilized, according to data presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung...
Adjuvant Atezolizumab Following Adjuvant Chemotherapy for Resected Stage IB to IIIA NSCLC
In the phase III IMpower010 trial reported in The Lancet, Enriqueta Felip, MD, and colleagues found that the use of adjuvant atezolizumab after adjuvant platinum-based chemotherapy significantly improved disease-free survival vs best supportive care in patients with resected stage II to IIIA...
Radioembolization Plus Second-Line Chemotherapy for Colorectal Liver Metastases
In the phase III EPOCH trial reported in the Journal of Clinical Oncology, Mary F. Mulcahy, MD, and colleagues found that the addition of transarterial yttrium-90 radioembolization (TARE) to second-line chemotherapy significantly prolonged progression-free survival and hepatic progression–free...
Ivosidenib vs Placebo for Previously Treated Advanced IDH1-Mutated Cholangiocarcinoma: Final Overall Survival Analysis of the ClarIDHy Trial
As reported in JAMA Oncology by Andrew X. Zhu, MD, PhD, and colleagues, the final overall survival analysis of the pivotal phase III ClarIDHy trial showed prolonged overall survival with ivosidenib vs placebo in previously treated patients with unresectable or metastatic cholangiocarcinoma and an...
Biomarker May Help to Predict Response to Gemcitabine for Patients With High-Grade Serous Ovarian Cancer
For more than 2 decades, the chemotherapy agent gemcitabine has been a mainstay treatment for several types of cancer. Now, scientists have uncovered genetic evidence of which patients with high-grade serous ovarian cancer are likely to benefit from the drug. In a study published by Panagiotis...
Ga-68 PSMA-11 PET for Detection of Pelvic Nodal Metastasis in Intermediate- to High-Risk Prostate Cancer
In a collaborative phase III trial reported in JAMA Oncology, Thomas A. Hope, MD, and colleagues found that gallium-68 prostate-specific membrane antigen–11 positron-emission tomography (Ga-68 PSMA-11 PET) had 40% sensitivity and 95% specificity in the detection of pelvic nodal metastases prior to...
Extended Adjuvant Letrozole After Tamoxifen in Postmenopausal Women With Early-Stage Breast Cancer: GIM4
In the Italian phase III GIM4 trial reported in The Lancet Oncology, Lucia Del Mastro, MD, and colleagues found that 5 years vs 2 to 3 years of adjuvant letrozole significantly prolonged invasive disease–free survival in postmenopausal women with early-stage breast cancer who had already completed...
Nasser K. Altorki, MD, on NSCLC: Adjuvant Atezolizumab for Stage IB–IIIA Disease
Nasser K. Altorki, MD, of Weill Medical College of Cornell University and NewYork-Presbyterian Hospital, discusses phase III data from the IMpower010 study, which showed that, compared with best supportive care, atezolizumab improved disease-free survival in patients with stage II–IIIA non–small...
CASSIOPEIA Part 2: Maintenance Daratumumab After Initial Therapy for Newly Diagnosed Multiple Myeloma
As reported in The Lancet Oncology by Philippe Moreau, MD, and colleagues, an interim analysis of part 2 of the phase III CASSIOPEIA trial has shown significantly prolonged progression-free survival with maintenance daratumumab vs observation following induction and consolidation with or without...
Hepatectomy With or Without Adjuvant mFOLFOX6 for Liver-Only Metastatic Colorectal Cancer: Disease-Free and Overall Survival
In the Japanese phase II/III JCOG0603 trial reported in the Journal of Clinical Oncology, Kanemitsu et al found that the addition of adjuvant mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to hepatectomy improved disease-free survival in patients with liver-only metastatic colorectal cancer;...
Overall Survival With the Bispecific Fusion Protein Tebentafusp for Metastatic Uveal Melanoma
In an interim analysis of the phase III IMCgp100-202 trial reported in The New England Journal of Medicine, Nathan et al found that tebentafusp, a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector, significantly improved overall survival vs...
New Study Aims to Measure Success of Phase III Oncology Trials
New research published by Shen et al in JNCCN—Journal of the National Comprehensive Cancer Network has found that more than 80% of therapies tested in phase III oncology trials did not achieve meaningful clinical benefit in prolonging survival. The researchers analyzed 362 industry-sponsored phase...
