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lung cancer
genomics/genetics

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...

lymphoma

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,...

breast cancer

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...

breast cancer

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....

prostate cancer

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...

leukemia

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,...

lymphoma
head and neck cancer
solid tumors
genomics/genetics
gynecologic cancers
skin cancer
immunotherapy

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...

prostate cancer

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...

gynecologic cancers
genomics/genetics

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...

hepatobiliary cancer

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...

gastrointestinal cancer

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 ...

head and neck cancer

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...

hepatobiliary cancer

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...

prostate cancer

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 ...

lung cancer
immunotherapy

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...

prostate cancer

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 ...

sarcoma

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 ...

colorectal cancer

Expert Point of View: Federica Di Nicolantonio, MD, PhD

“KRAS G12C inhibitors as monotherapy yield a relatively low overall response rate, but when you combine them with an EGFR [epidermal growth factor receptor] inhibitor, the response rate is nearly double,” said ­Federica Di Nicolantonio, MD, PhD, Professor of Oncology at the University of Turin in...

colorectal cancer

KRAS G12C Inhibitor Adagrasib Shows Activity in Colorectal Cancer

Adagrasib, a covalent inhibitor of KRAS G12C, combined with cetuximab, showed activity in patients with metastatic colorectal cancer in the phase I/II KRYSTAL-1 trial, as presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2021 by Jared Weiss, MD,...

prostate cancer

22-Gene Classifier Score May Allow for Personalization of Therapy in Patients With High-Risk Prostate Cancer

A 22-gene genomic classifier (the Decipher score) may be 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 by Paul L. Nguyen, MD, at the 2021 American Society for Radiation Oncology...

multiple myeloma

Melphalan Flufenamide Withdrawn From the U.S. Market

On October 22, Oncopeptides announced its decision to withdraw melphalan flufenamide (Pepaxto), a first-in-class peptide-drug conjugate, from the market in the United States, following results from the phase III OCEAN study in patients with relapsed or refractory multiple myeloma. The decision to...

symptom management

Ruxolitinib for Chronic Graft-vs-Host Disease After Failure of Systemic Therapy

On September 22, 2021, ruxolitinib, a tyrosine kinase inhibitor of JAK1 and JAK2 was granted approval for treatment of chronic graft-vs-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged ≥ 12 years.1 Supporting Efficacy Data Approval was...

leukemia

Noninferior Progression-Free Survival and Reduced Cardiovascular Toxicity With Acalabrutinib vs Ibrutinib in Previously Treated CLL

As reported in the Journal of Clinical Oncology by John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, and colleagues, the phase III ELEVATE-RR trial has shown noninferior progression-free survival with the more-selective Bruton’s tyrosine kinase (BTK) inhibitor...

thyroid cancer

Cabozantinib for Previously Treated Advanced Differentiated Thyroid Cancer

On September 17, 2021, cabozantinib was approved for adult and pediatric patients aged ≥ 12 years with locally advanced or metastatic differentiated thyroid cancer progressing after ­VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.1 Cabozantinib inhibits the...

Expert Point of View: Bruna Pellini, MD

Study discussant Bruna Pellini, MD, of the Department of Thoracic Oncology, Moffitt Cancer Center, Florida, noted that, regardless of PD-L1 or tumor mutation burden status, the NADIM trial demonstrated improved progression-free and overall survival for patients with resectable, stage IIIA non–small ...

lung cancer

POSEIDON Trial: Dual Checkpoint Blockade Plus Chemotherapy Improves Survival in First-Line Metastatic NSCLC

The combination of dual checkpoint inhibition plus chemotherapy could be the new standard of care in first-line metastatic non–small cell lung cancer (NSCLC), according to data presented during the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer.1 ...

Expert Point of View: Eleni Efstathiou, MD

Invited discussant Eleni Efstathiou, MD, of Houston Methodist Cancer Center and Athens Medical Center, Greece, said that both the STAMPEDE meta-analysis1 and the PEACE-1 trial2 firmly establish the importance of introducing abiraterone acetate earlier in the course of treatment. “The STAMPEDE...

breast cancer
immunotherapy

Hope S. Rugo, MD, on Triple-Negative Breast Cancer: Treatment Findings From KEYNOTE-355 on Pembrolizumab and Chemotherapy

Hope S. Rugo, MD, of the University of California, San Francisco, discusses phase III results from the KEYNOTE-355 study of pembrolizumab plus chemotherapy, which improved overall survival vs chemotherapy alone in patients with previously untreated locally recurrent, inoperable, or metastatic...

prostate cancer

STAMPEDE: In Nonmetastatic Castration-Sensitive Prostate Cancer, Abiraterone Added to Androgen-Deprivation Therapy Improves Survival

The addition of 2 years of abiraterone acetate plus prednisolone (AAP) to androgen-deprivation therapy improves metastasis-free survival and overall survival compared with androgen-deprivation therapy alone in men with nonmetastatic castration-sensitive prostate cancer, according to a primary...

Expert Point of View: Florian Lordick, MD, PhD

Florian Lordick, MD, PhD, Professor of Oncology and Director of the University Cancer Center Leipzig, Germany, applauded the positive finding for nivolumab plus chemotherapy in CheckMate 6491 and questioned why nivolumab plus ipilimumab did not meet its endpoint. “I’m calling this a big step...

solid tumors

CheckMate 649: Long-Term Data Support Nivolumab Plus Chemotherapy but Not Nivolumab Plus Ipilimumab in Gastric Cancer

Longer follow-up data from the phase III CheckMate 649 trial support the use of nivolumab plus chemotherapy as a new standard first-line regimen in patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The findings were reported by Yelena Janjigian, ...

skin cancer
genomics/genetics
immunotherapy

Expert Point of View: Omid Hamid, MD

Commenting on the SECOMBIT trial was Omid Hamid, MD, Chief of Translational Research and Immunotherapy at The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate, and Co-Director, Cutaneous Malignancy Program, Cedars-Sinai Cancer. Dr. Hamid said SECOMBIT addresses an important...

Expert Point of View: Barbara Pistilli, MD

Barbara Pistilli, MD, of the Breast Cancer Group at Gustave Roussy Cancer Center, Villejuif, France, said the results of the TULIP trial, showing the progression-free survival benefit for vic-trastuzumab duocarmazine (SYD985), help to establish antibody-drug conjugates as key components of the...

breast cancer
immunotherapy

Another Antibody-Drug Conjugate Enters the Metastatic Breast Cancer Landscape

In the global phase III TULIP trial in metastatic HER2-positive breast cancer, treatment with the antibody-drug conjugate vic-trastuzumab duocarmazine (SYD985) significantly improved progression-free survival in comparison with standard chemotherapy in previously treated patients, making this a new ...

bladder cancer

Neoadjuvant dd-MVAC Improves Local Control and Progression-Free Survival in Patients With Muscle-Invasive Bladder Cancer

The VESPER phase III trial answers some key questions regarding the optimal management of muscle-invasive bladder cancer. The study found that the neoadjuvant regimen of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) was superior to standard gemcitabine/cisplatin in...

Expert Point of View: Gonzalo Gomez-Abuin, MD, and Gabriel N. Hortobagyi, MD, MACP, FASCO

The invited discussant of the MONALESSA-2 trial was Gonzalo Gomez-Abuin, MD, a medical oncologist who is Head of the Clinical Research Unit at Hospital Alemán in Buenos Aires. According to Dr. Gomez-Abuin, phase III trials of three different CDK4/6 inhibitors—ribociclib, palbociclib, and...

breast cancer

MONALEESA-2: Overall Survival Benefit With First-Line Ribociclib Plus Letrozole

Ribociclib plus hormonal therapy in the first-line setting boosted overall survival by more than 1 year, vs hormone therapy alone, in postmenopausal women with hormone receptor–positive HER2-negative advanced breast cancer, according to the latest findings from the MONALEESA-2 trial, reported at...

multiple myeloma
immunotherapy

Overall Survival in the MAIA Trial: Daratumumab, Lenalidomide, and Dexamethasone for Newly Diagnosed Transplant-Ineligible Patients With Multiple Myeloma

As reported in The Lancet Oncology by Thierry Facon, MD, and colleagues, an interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to lenalidomide/dexamethasone in newly diagnosed, transplant-ineligible patients with ...

neuroendocrine tumors

Dieter Hörsch, MD: For Patients With Bronchopulmonary Neuroendocrine Tumors, Lanreotide Autogel May Be Beneficial

Dieter Hörsch, MD, of Germany’s Central Clinic in Bad Berka, discusses phase III results from the SPINET trial, the largest prospective study to date of the somatostatin analog lanreotide autogel. The study suggests that this agent may prove to be an appropriate treatment option for patients with...

gynecologic cancers

PARP Rechallenge Slows Ovarian Cancer Progression in Platinum-Sensitive Disease

Rechallenge with the poly (ADP-­ribose) polymerase (PARP) inhibitor olaparib in patients with platinum-sensitive ovarian cancer led to significant improvement in progression-free survival, in patients with either BRCA1/2-mutated or nonmutated (ie, wild-type) disease compared with placebo, according ...

colorectal cancer

Primary Tumor Resection Followed by Systemic Treatment vs Systemic Treatment Alone in Metastatic Colorectal Cancer: 60-Day Mortality

As reported in JAMA Surgery by van der Kruijssen et al, 60-day post–random assignment mortality results in the Danish/Dutch phase III CAIRO4 trial showed higher rates of mortality in patients with metastatic colorectal cancer who received primary tumor resection plus systemic treatment vs those...

lymphoma

Final Analysis of iNNOVATE: Addition of Ibrutinib to Rituximab for Waldenström’s Macroglobulinemia

As reported in the Journal of Clinical Oncology by Buske et al, the final analysis of the pivotal phase III iNNOVATE trial has shown a continued progression-free survival benefit with the addition of ibrutinib to rituximab in patients with Waldenström’s macroglobulinemia after 50 months of...

prostate cancer
immunotherapy

Neeraj Agarwal, MD, on Advanced Prostate Cancer: Data on Cabozantinib Plus Atezolizumab

Neeraj Agarwal, MD, of Hunstman Cancer Institute at the University of Utah, discusses efficacy and safety results from the COSMIC-021 study, in which cabozantinib plus atezolizumab demonstrated clinically meaningful activity and a manageable safety profile in patients with metastatic...

breast cancer

Recent FDA Approvals in Breast Cancer

In the past year, the U.S. Food and Drug Administration (FDA) approved five treatment options for patients with breast cancer, which are summarized herein. Abemaciclib Combination On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase...

breast cancer

KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer

Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...

Expert Point of View: Melinda L. Telli, MD

EA1131 study discussant, Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, commented: “At this point, capecitabine remains preferred as...

breast cancer

EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer

In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...

breast cancer

Sacituzumab Govitecan-hziy Improves Survival vs Single-Agent Chemotherapy in Metastatic Triple-Negative Breast Cancer

As reported in The New England Journal of Medicine by Aditya Bardia, MD, of the Division of Medical Oncology, Massachusetts General Hospital Cancer Center, and colleagues, the phase III ASCENT trial has shown prolonged progression-free and overall survival with the Trop-2–directed antibody-drug...

Expert Point of View: Melinda L. Telli, MD

The invited discussant of GeparNuevo,1 Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University School of Medicine, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, welcomed the additional data...

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