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Showing 2801 - 2850FDA Pipeline: Reviews and Designations in Hematology
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a gene therapy for patients with β-thalassemia, and Fast Track designation to a SETD2 inhibitor for patients with relapsed or refractory diffuse large B-cell lymphoma. Priority Review: Betibeglogene Autotemcel for...
Pembrolizumab Plus Chemotherapy With or Without Bevacizumab in First-Line Treatment of Advanced Cervical Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 13, 2021, pembrolizumab in combination with...
Novel Therapies Under Study in Acute Myeloid Leukemia
Newly identified genetic abnormalities in acute myeloid leukemia (AML), as well as therapies that can target some of those abnormalities, are now available as the landscape for treatment continues to evolve. During the 2021 National Comprehensive Cancer Network (NCCN) Annual Congress: Hematologic...
Expert Point of View: Steven J. Chmura, MD, PhD
At a press conference at the 2021 ASTRO Annual Meeting, Steven J. Chmura, MD, PhD, Professor of Radiation Oncology and Scientific Director of the Cancer Clinical Trials Office, University of Chicago, commented on the CURB study results. “Most trials of stereotactic body radiation therapy (SBRT)...
NETTER-1 Trial: Final Overall Survival Analysis of Lu-177 Dotatate Plus Long-Acting Octreotide vs High-Dose Long-Acting Octreotide for Midgut Neuroendocrine Tumors
As reported in The Lancet Oncology by Jonathan R. Strosberg, MD, and colleagues, the final overall survival analysis of the pivotal phase III NETTER-1 trial has shown an approximate 12-month benefit with the addition of lutetium-177 (Lu-177) dotatate to long-acting octreotide in patients with...
Expert Point of View: Elizabeth Nichols, MD
Invited discussant Elizabeth Nichols, MD, of the University of Maryland, School of Medicine, Baltimore, commented on both the phase II TRIUMPH-T and the phase III MC1635 trials. “There are multiple techniques in use for accelerated partial breast irradiation. Optimal dose and fractionation are...
Accelerated Radiation Therapies Move Forward in Early Breast Cancer
Two studies reported at the 2021 American Society for Radiation Oncology (ASTRO) Annual Meeting provide evidence in support of the use of accelerated radiation therapies as safe alternatives to standard radiotherapy options following breast-conserving surgery. The phase III MC1635 trial showed...
Shorter-Course Radiation Therapy: A New Practice Standard After Prostatectomy?
Hypofractionated radiotherapy to the prostate bed proved to be noninferior to conventionally fractionated radiotherapy after prostatectomy regarding gastrointestinal and genitourinary side effects, according to the results of the phase III NRG Oncology GU003 trial, presented at the 2021 American...
Novel Therapies Under Study in Acute Myeloid Leukemia
Newly identified genetic abnormalities in AML have led to novel therapies that can target some of them, as the landscape for treatment continues to evolve. During the 2021 National Comprehensive Cancer Network (NCCN) Annual Congress: Hematologic Malignancies, Alice S. Mims MD, presented updates in...
Early Study Examines Potential Benefits of a Fasting-Mimicking Diet in Patients With Cancer
A severely calorie-restricted, low-carbohydrate, low-protein, 5-day dietary regimen that mimics fasting was shown to be safe and feasible, and it resulted in a decrease of blood glucose and growth factor concentration, a reduction in peripheral blood immunosuppressive cells, and enhanced intratumor ...
Newer Agents on the Horizon for Refractory or Relapsed DLBCL
Although treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) remains challenging, some newer therapies on the horizon offer promise, including bispecific antibodies, anti-CD47 antibodies, antibody-drug conjugates, and chimeric antigen receptor (CAR) T-cell therapy,...
Yongbae Kim, MD, on Elective Internal Mammary Node Irradiation in Women With Node-Positive Breast Cancer: Results of a Randomized Phase III Trial
Yongbae Kim, MD, of the Yonsei Cancer Center and Yonsei University College of Medicine, discusses findings that showed the use of internal mammary area irradiation (IMNI) in regional nodal irradiation did not significantly improve disease-free survival for women with node-positive breast cancer....
Brain Substructure–Informed Radiotherapy Planning May Improve Neurocognitive Outcomes in Pediatric Patients With Medulloblastoma
In an analysis from the single-institution phase III SJMB03 trial reported in the Journal of Clinical Oncology, Acharya et al found that increasing radiation doses to the corpus callosum, frontal white matter, and hippocampus were associated with neurocognitive impairment in pediatric patients...
Immunotherapy Followed by Targeted Therapy Yields Greater Overall Survival in Patients With BRAF V600–Mutated Advanced Melanoma
Patients with BRAF V600–mutated advanced melanoma who received an immunotherapy regimen of nivolumab/ipilimumab followed by targeted therapy with dabrafenib/trametinib experienced greater overall survival (72%) compared with patients receiving the converse sequence (52%). According to the study...
Thomas Gruenberger, MD, Shares Thoughts on Radiotherapy for Colorectal Liver Metastases
Invited discussant of the phase III EPOCH trial, Thomas Gruenberger, MD, a surgical oncologist at the Clinic Favoriten, Health Network Vienna, noted that the trial’s “intention was fulfilled,” thus making it the “first positive phase III trial that prolonged both progression-free and hepatic...
For Liver Metastases, Transarterial Radioembolization With Yttrium-90 Plus Chemotherapy May Delay Disease Progression
In the international phase III EPOCH trial, patients with colorectal liver metastases who experienced disease progression on first-line therapy derived significant benefit from treatment with transarterial yttrium Y-90 radioembolization in combination with systemic chemotherapy, according to Mary...
Treatment Adherence, Toxicity, and Outcomes With Adjuvant Fluoropyrimidine Plus Oxaliplatin in Early-Onset Colorectal Cancer
In an analysis of data from the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) database reported in the Journal of Clinical Oncology, Fontana et al found a greater risk of relapse and cancer-specific mortality after adjuvant fluoropyrimidine/oxaliplatin chemotherapy in patients...
Numerous Regimens Proposed for Relapsed or Refractory Myeloma
Although patients with multiple myeloma can respond to initial treatment, once a patient has had three or four different types of therapy, and the disease is deemed relapsed or refractory, treatment becomes more complicated. This is related to both clinical characteristics, as patients may develop...
Use of Genomic Classifier Score May Help to Personalize Therapy for Men With High-Risk Prostate Cancer
A 22-genomic classifier (the Decipher score) was able to predict the course of disease in men with high-risk prostate cancer, according to a patient-level meta-analysis of three randomized clinical trials presented at the 2021 American Society for Radiation Oncology (ASTRO) Annual Meeting.1 Use of...
Novel Drug Combination May Help Children With Acute Promyelocytic Leukemia Avoid Conventional Chemotherapy
A clinical trial recently published by Kutny et al in JAMA Oncology found that the combination of all-trans retinoic acid and arsenic trioxide was highly effective in children with standard- and high-risk acute promyelocytic leukemia (APL). Nearly all patients in the trial survived for 2 years...
Study Examines Immunotherapy Outcomes in Patients With Solid Tumors Who Are Ineligible for Clinical Trials
Patients with solid tumors who are ineligible for clinical trials receive immune checkpoint inhibitors at greater rates than patients who are eligible, despite no survival benefit, according to a recent study by researchers at the Perelman School of Medicine at the University of Pennsylvania. The...
Rituximab Maintenance vs Response-Adapted Postinduction Strategy in Advanced Follicular Lymphoma
In an Italian phase III trial (FOLL12) reported in the Journal of Clinical Oncology, Luminari et al found that a response-adapted postinduction strategy resulted in poorer progression-free survival vs standard rituximab maintenance in patients with previously untreated advanced follicular lymphoma...
De-escalation of Radiation Therapy for HPV-Positive, Intermediate-Risk Oropharyngeal Cancer
De-escalated adjuvant radiotherapy appears to be safe in patients with surgically resectable, human papillomavirus (HPV)--positive oropharyngeal cancers, particularly in patients without extranodal extension or pN2 disease by American Joint Committee on Cancer (AJCC) 8th edition. These findings...
No Survival Benefit but Improved Secondary Endpoints With Radiotherapy Plus Androgen Suppression in Intermediate-Risk Prostate Cancer
Both dose-escalated radiation therapy and short-course androgen-deprivation therapy have been shown to improve outcomes in intermediate-risk prostate cancer, but it is not clear whether giving both modalities upfront to newly diagnosed patients is of benefit. The phase III RTOG 0815 study presented ...
CheckMate 214: Longer Treatment-Free Survival With Immunotherapy vs Targeted Therapy in Patients With Advanced Renal Cell Carcinoma
Patients with advanced renal cell carcinoma receiving first-line therapy with a checkpoint inhibitor combination of nivolumab plus ipilimumab experienced over twice as long treatment-free survival without toxicity compared with patients receiving the targeted therapy sunitinib, according to data...
David Morse Livingston, MD, Scientist and Esteemed Mentor, Dies at 80
David Morse Livingston, MD, formerly the Charles A. Dana Chair in Human Cancer Genetics at Dana-Farber and the Emil Frei III Distinguished Professor of Medicine at Harvard Medical School, died unexpectedly on October 17, 2021. He was Deputy Director of the Dana-Farber/Harvard Cancer Center (DF/HCC) ...
BrighTNess: Neoadjuvant Carboplatin Improves Event-Free Survival in Triple-Negative Breast Cancer
In patients with early resectable triple-negative breast cancer, not only did the addition of carboplatin to standard neoadjuvant chemotherapy improve pathologic complete response rates, it also improved 4-year event-free survival, regardless of BRCA status, according to the latest analysis of the...
Sidney Kimmel Cancer Center–Jefferson Health Welcomes Marcia Brose, MD, PhD, FASCO
The Sidney Kimmel Cancer Center–Jefferson Health (SKCC) has named Marcia Brose, MD, PhD, FASCO, as Vice Chair of Medical Oncology and SKCC Regional Chief of Cancer Services at Jefferson Torresdale Hospital in Northeast Philadelphia. Dr. Brose’s areas of expertise include thyroid cancer, rare...
CDK4/6 Inhibitors Combined With Fulvestrant for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer: FDA Analysis of Overall Survival
In an exploratory U.S. Food and Drug Administration (FDA) pooled analysis reported in The Lancet Oncology, Jennifer J. Gao, MD, and colleagues found that the addition of CDK4/6 inhibitor treatment to fulvestrant resulted in a consistent overall survival benefit vs placebo plus fulvestrant in...
IMpower010: Adjuvant Atezolizumab Improves Disease-Free Survival and NSCLC Relapse in Patients Whose Tumors Express PD-L1
Adjuvant immunotherapy with atezolizumab after standard chemotherapy improved disease-free survival and time to locoregional and distant relapse compared with best supportive care in prespecified subgroups of patients with stage II to IIIA non–small cell lung cancer (NSCLC), according to an...
Health-Related Quality of Life With Pembrolizumab vs Chemotherapy for Advanced Esophageal Cancer
In a study reported in the Journal of Clinical Oncology, Adenis et al found that health-related quality of life was maintained with both pembrolizumab and chemotherapy in the pivotal phase III KEYNOTE-181 trial, which included patients with advanced esophageal cancer who had received previous...
Optimizing Adjuvant Therapy for Women With Estrogen Receptor–Positive, Node-Positive Breast Cancer
“Nodal status remains the single most important prognostic marker in outcomes for women with estrogen receptor–positive, HER2-negative breast cancer. For that reason, it makes sense to think about optimizing adjuvant therapy, including endocrine treatments, chemotherapy, and targeted therapy,”...
Adjuvant Gefitinib vs Cisplatin/Vinorelbine for Completely Resected EGFR-Mutant Stage II to IIIA NSCLC
In the Japanese phase III IMPACT trial reported in the Journal of Clinical Oncology, Tada et al found that adjuvant gefitinib did not improve disease-free survival vs cisplatin/vinorelbine in patients with completely resected stage II to IIIA EGFR-mutant non–small cell lung cancer (NSCLC). In the...
Ibrutinib Plus R-CHOP for Younger Patients With DLBCL
New evidence suggests that adding the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib to a standard chemotherapy regimen may improve survival among younger people with a specific form of diffuse large B-cell lymphoma (DLBCL). The findings, published by Wyndham Wilson, MD, PhD, in Cancer Cell,...
Adjuvant Internal Mammary Node Irradiation in Node-Positive Breast Cancer
In a Korean phase III trial reported in JAMA Oncology, Kim et al found that the addition of internal mammary node irradiation to adjuvant regional nodal irradiation did not improve 7-year disease-free survival in women with node-positive breast cancer. In an ad hoc analysis, however, benefit was...
Retrospective Study Examines Real-World Survival in U.S. Women Treated for Early-Stage Breast Cancer
In a retrospective cohort study reported in JCO Oncology Practice, Gidwani et al found that among U.S. patients treated for early-stage breast cancer, those who were considered to be unrepresented in clinical trials have significantly poorer survival than those categorized as well represented....
Amar U. Kishan, MD, on Prostate Cancer: Impact of Androgen-Deprivation Therapy With Radiotherapy
Amar U. Kishan, MD, of the University of California, Los Angeles, discusses findings from a meta-analysis of clinical trials in patients with localized prostate cancer. The phase III results suggest that the use of androgen-deprivation therapy (ADT) or prolonged adjuvant ADT with radiotherapy may...
Study Finds Type I Interferon May Enhance the Antileukemia Effect of Allogeneic Transplantation
In a study published by Magenau et al in the journal Blood Advances, researchers found that patients with high-risk acute myeloid leukemia (AML) who received a form of type I interferon after allogeneic hematopoietic stem cell transplant experienced reduced rates of disease relapse. Additionally,...
FDA Pipeline: Novel Treatments in Lymphoma, Nasopharyngeal Cancer, Solid Tumors, and More
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for several kinds of lymphoma, as well as nasopharyngeal cancer; a Breakthrough Therapy designation for a treatment for patients with NTRK-positive advanced solid tumors; and Fast Track designation for...
Mark K. Buyyounouski, MD, MS, on Prostate Cancer: Hypofractionated vs Conventional Radiotherapy After Surgery
Mark K. Buyyounouski, MD, MS, of Stanford University, discusses phase III results from the NRG Oncology GU003 trial, which showed that, post-prostatectomy, using fewer—but higher—doses of radiation does not appear to increase long-term side effects or reduce quality of life when compared with...
Five-Year Follow-up of Olaparib Maintenance for Newly Diagnosed Patients With Advanced BRCA-Mutant Ovarian Cancer
As reported in The Lancet Oncology by Susana Banerjee, MBBS, PhD, and colleagues, 5-year follow-up of the pivotal phase III SOLO-1/GOG 3004 trial has shown a median progression-free survival of 56 months with maintenance olaparib following response to platinum-based chemotherapy in newly diagnosed...
Modified FOLFIRINOX vs Cisplatin/Gemcitabine for Advanced Biliary Tract Cancer
In the phase II portion of a French phase II/III trial (PRODIGE 38 AMEBICA) reported in the Journal of Clinical Oncology, Phelip et al found that modified (m) FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil) did not improve 6-month progression-free survival vs the combination of...
Overall Survival With Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer
As reported in JAMA Surgery by Huang et al, the Chinese phase III CLASS-01 trial has shown no difference in 5-year overall survival in patients with locally advanced gastric cancer who underwent laparoscopic vs open distal gastrectomy. The previously reported primary analysis of the trial showed no ...
Daniel J. Ma, MD, on HPV-Associated Oropharyngeal Squamous Cell Carcinoma: Comparing Longer and Shorter Courses of Radiotherapy
Daniel J. Ma, MD, of the Mayo Clinic Alix School of Medicine, discusses results from a phase III study of patients with HPV-associated oropharyngeal squamous cell carcinoma. Comparing a 2-week course of de-escalated adjuvant radiation therapy with the standard 6-week course, investigators found...
Hepatic Arterial Infusion of FOLFOX vs Transarterial Chemoembolization for Unresectable Large Hepatocellular Carcinoma
In a Chinese phase III trial reported in the Journal of Clinical Oncology, Li et al found that hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin; FOLFOX-HAIC) improved overall survival vs transarterial chemoembolization (TACE) as first-line treatment for...
Hypofractionated Postoperative Prostate Bed Radiotherapy Does Not Increase Patient-Reported Toxicity for Men With Prostate Cancer
A primary endpoint analysis of the NRG Oncology phase III NRG-GU003 clinical trial, which compared hypofractionated postoperative prostate bed radiotherapy (HYPORT) to conventional postprostatectomy radiotherapy (COPORT) for men with prostate cancer, determined that treatment with HYPORT yielded no ...
Nivolumab for Relapsed Malignant Mesothelioma: Improvements in Progression-Free and Overall Survival
In the phase III CONFIRM trial reported in The Lancet Oncology, Dean A. Fennell, FRCP, PhD, and colleagues found that nivolumab improved progression-free and overall survival vs placebo in patients with relapsed malignant mesothelioma. In October 2020, the combination of nivolumab and ipilimumab...
Phase III Trial Evaluates Efficacy of Total Androgen Suppression Plus Dose-Escalated Radiotherapy for Patients With Intermediate-Risk Prostate Cancer
Both dose-escalated radiation therapy and short-course androgen-deprivation therapy (SADT) have been shown to improve outcomes in patients with intermediate-risk prostate cancer. Researchers then posed a new question—is giving both modalities upfront to newly diagnosed patients of benefit? Findings ...
Addition of Vincristine, Topotecan, and Cyclophosphamide to Five-Drug Interval-Compressed Chemotherapy for Ewing Sarcoma
As reported in the Journal of Clinical Oncology by Leavey et al, the phase III Children’s Oncology Group AEWS1031 trial showed no improvement in event-free or overall survival with the addition of vincristine, topotecan, and cyclophosphamide (VTC) to standard five-drug interval-compressed...
Expert Point of View: Pierre Laurent-Puig, MD
The invited discussant of the FOCUS4-C trial was Pierre Laurent-Puig, MD, Professor of Medicine, Université de Paris, Institut du Cancer Paris CARPEM. According to Dr. Laurent-Puig, the “promising results” for the WEE1 inhibitor adavosertib in colorectal cancer in the FOCUS4-C trial could apply to ...
