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Expert Point of View: Ana Oaknin, MD, PhD

Ana Oaknin, MD, PhD, Head of the Gynecologic Cancer Program at Vall d’Hebron Institute of Oncology, Barcelona, discussed the PRIMA/ENGOT-OV26/GOG-3012 trial along with the results of the phase III PAOLA-1/ENGOT-ov25 trial of olaparib plus bevacizumab maintenance. All three trials—PRIMA, PAOLA-1,...

gynecologic cancers

ESMO 2019: PRIMA Trial Reports Benefit With Niraparib Across Ovarian Cancer Subsets

In women with advanced ovarian cancer responding to first-line chemotherapy, maintenance therapy with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib significantly reduced the risk of disease progression by 38% overall and by 60% in women with BRCA mutations. Even patients without a...

gynecologic cancers

Novel Drug Approvals and New Indications for Gynecologic Cancers

A number of new drugs and novel indications were added to the treatment armamentarium for gynecologic cancers over the past year. The U.S. Food and Drug Administration (FDA) approvals are noted here. Olaparib, PARP Inhibitor On May 8, 2020, the FDA expanded the indication of olaparib (Lynparza) to...

Expert Point of View: Thomas J. Herzog, MD

Thomas J. Herzog, MD, Deputy Director, University of Cincinnati Cancer Center, who presented a distillation of the PRIMA trial data along with updated results of the phase III PAOLA-1 trial of olaparib plus bevacizumab maintenance, called the data “practice-changing.” “We’ve suspected for a while...

gynecologic cancers

SGO 2020: Updated Data From PRIMA Trial: Niraparib as First-Line Maintenance Therapy for Advanced Ovarian Cancer

Making sense of maintenance therapy in advanced ovarian cancer has been a tall order since the publication of impressive data for not one but three poly (ADP-ribose) polymerase (PARP) inhibitors at the European Society for Medical Oncology (ESMO) 2019 Congress.1 The picture became a little clearer...

gynecologic cancers

Clinical Perspective on PAOLA-1: Maintenance Therapy for Advanced Ovarian Cancer

Based on multiple phase III prospective trials, there is evidence that both poly (ADP-ribose) polymerase (PARP) inhibitors and antiangiogenic therapies such as bevacizumab provide benefit when utilized in a maintenance strategy in the first-line treatment of advanced epithelial ovarian cancer (GOG...

gynecologic cancers

Addition of Olaparib to Bevacizumab Maintenance in Advanced Ovarian Cancer: PAOLA-1 Trial

As reported inThe New England Journal of Medicine by Isabelle Ray-Coquard, MD, PhD, of the Céntre Léon Berard, University Claude Bernard Lyon 1 and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), Paris, and colleagues, the phase III PAOLA-1 trial has shown a...

gynecologic cancers

Gynecologic Oncology Highlights 2019–2020 Almanac

Ovarian cancer is associated with the highest risk of mortality among the five most common gynecologic cancers (cervical, ovarian, uterine [endometrial], vaginal, and vulvar) in the United States; in 2020 in the United States, ovarian cancer will be diagnosed in an estimated 21,750 women, and...

skin cancer
immunotherapy

Adjuvant Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage IV Melanoma With No Evidence of Disease

In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected...

gynecologic cancers

Does Binimetinib Improve Progression-Free Survival in Recurrent or Persistent Low-Grade Serous Ovarian Carcinomas?

As reported in the Journal of Clinical Oncology by Bradley J. Monk, MD, and colleagues, the phase III MEK Inhibitor in Low-Grade Serous Ovarian Cancer (MILO)/ARRAY-162-311/ENGOT-ov11 trial showed that the MEK1/2 inhibitor binimetinib did not improve progression-free survival vs physician’s choice...

breast cancer

Addition of Veliparib to Carboplatin/Paclitaxel in Previously Treated Patients With BRCA-Mutated Advanced Breast Cancer: BROCADE3 Trial

As reported in The Lancet Oncology by Véronique Diéras, MD, and colleagues, the phase III BROCADE3 trial showed a significant improvement in progression-free survival with the addition of the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to carboplatin and paclitaxel in patients with...

leukemia

FDA Approves Oral Azacitidine as Maintenance Therapy for Adults With AML in First Remission

On September 1, the U.S. Food and Drug Administration (FDA) approved oral azacitidine (Onureg; also known as CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery...

lung cancer
immunotherapy

Is It Time to Add Checkpoint Inhibitors to the Treatment of Locally Advanced Lung Cancer?

After more than 20 years of failed strategies to improve survival rates for locally advanced lung cancers, checkpoint inhibitors have revolutionized therapy, but prognoses still lag behind other tumor types. During the ASCO20 Virtual Education Program, Mark G. Kris, MD, FASCO, a thoracic medical...

prostate cancer
cardio-oncology

Metastatic Prostate Cancer: Sorting Through the Treatment Maze

The message still needs to get out that metastatic castration-sensitive prostate cancer should be treated with both androgen-deprivation therapy (ADT) and either docetaxel or an androgen receptor pathway inhibitor. In spite of “overwhelming” support for ADT plus abiraterone/prednisone,...

lung cancer
immunotherapy

ORIENT-11 Trial Shows Sintilimab Plus Chemotherapy Improves Progression-Free Survival in Advanced NSCLC

The first-line setting for patients with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) now has become more complicated, according to data presented during the 2020 International Association for the Study of Lung Cancer’s World Conference on Lung Cancer Virtual...

leukemia

Addition of Nelarabine to Standard Therapy in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia

As reported in the Journal of Clinical Oncology by Dunsmore et al, the phase III Children’s Oncology Group AALL0434 trial has shown that the addition of nelarabine to standard therapy improved disease-free survival in children and young adults with newly diagnosed T-cell acute lymphoblastic...

lung cancer

Leora Horn, MD, on NSCLC: Ensartinib vs Crizotinib in ALK–Positive Disease

Leora Horn, MD, of Vanderbilt University, discusses phase III results from the eXalt3 trial, which suggest that ensartinib, a novel, next-generation ALK inhibitor, is superior to crizotinib in terms of progression-free survival as well as efficacy in central nervous system metastases for patients...

leukemia

Obinutuzumab, Ibrutinib, and Venetoclax in Treatment-Naive and Relapsed or Refractory Chronic Lymphocytic Leukemia

In a single-institution phase II trial reported in the Journal of Clinical Oncology, Rogers et al found that the combination of obinutuzumab, ibrutinib, and venetoclax produced high response rates in both treatment-naive and relapsed or refractory chronic lymphocytic leukemia. Study Details A total ...

leukemia
lymphoma

Final ASCEND Results Confirm Acalabrutinib as a Standard for Relapsed CLL

The Bruton’s tyrosine kinase (BTK) inhibitors have been one of the most exciting advances in the tre atment of chronic lymphocytic leukemia (CLL) and have led to the development of chemotherapy-free treatments for both treatment-naive as well as relapsed or refractory CLL based on studies where...

leukemia
lymphoma

Acalabrutinib Improves Progression-Free Survival vs Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory CLL

As reported in the Journal of Clinical Oncology by Paolo Ghia, MD, PhD, of the Università Vita-Salute San Raffaele, Milan, Italy, and colleagues, the phase III ASCEND trial showed significantly prolonged progression-free survival with acalabrutinib monotherapy vs the investigator’s choice of...

skin cancer

Adding Immunotherapy to BRAF/MEK Inhibition in BRAF V600–Mutant Melanoma: First Step on the Journey

As investigators, we were always determined to find the drug to work with BRAF/MEK inhibitor combination therapy. It had come on like a storm and showed us that we could help even those with the most advanced metastatic melanoma, as long as it harbored the magical BRAF V600E mutation.1...

skin cancer

Addition of Atezolizumab to Vemurafenib/Cobimetinib in Unresectable Advanced BRAF V600–Mutant Melanoma

As reported inThe Lancet by Ralf Gutzmer, MD, of Medizinische Hochschule Hannover, Germany, and colleagues, the phase III IMspire150 trial has shown that the addition of atezolizumab to BRAF and MEK inhibitor therapy with vemurafenib and cobimetinib improved progression-free survival in the...

covid-19

Repurposing Drugs for the Treatment of COVID-19

A vaccine for COVID-19 is currently the Holy Grail, but even if an effective vaccine were developed on a fast-track timetable, it may be effective in only a percentage of people, judging by existing flu vaccines, which show efficacy rates of approximately 45% and vary year by year. Until we have a...

gastrointestinal cancer

Switch Control Inhibitor for GISTs Harboring Drug-Resistance Mutations: The INVICTUS Trial

In May 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib for patients who have received prior treatment with three or more kinase inhibitors, including imatinib, for advanced gastrointestinal stromal tumors (GIST). The approval was largely based on the findings of the...

gastrointestinal cancer

Ripretinib Improves Progression-Free Survival vs Placebo in Previously Treated Advanced GIST

As reported inThe Lancet Oncology by Jean-Yves Blay, MD, of Centre Léon Bérard, Lyon, France, and colleagues, the phase III INVICTUS trial has shown that the oral KIT and PDGFRα tyrosine kinase inhibitor ripretinib significantly prolonged progression-free survival vs placebo in patients with...

lymphoma

Chemotherapy-Free Approaches in Follicular and Mantle Cell Lymphomas

As chemotherapy and chemoimmunotherapy regimens reach their maximal impact in follicular lymphoma and mantle cell lymphoma, clinicians are turning to chemotherapy-free approaches to achieve better control, less toxicity, and (hopefully) a cure. During the ASCO20 Virtual Education Program, Sonali M. ...

multiple myeloma
immunotherapy

FDA Approves Daratumumab Plus Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma

On August 20, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with carfilzomib (Kyprolis) and dexamethasone (DKd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy....

pancreatic cancer

ASCO Updates Metastatic Pancreatic Cancer Guideline

ASCO has released an update to its Metastatic Pancreatic Cancer Guideline that includes recommendations for second-line treatment, including early biomarker testing for actionable genomic alterations.1 Last updated in 2018, this new version was triggered by novel evidence related to targeted...

immunotherapy
lung cancer
cns cancers
leukemia
lymphoma

FDA Pipeline: Priority Reviews for Immunotherapy Dose Regimen, Small Cell Lung Cancer; Fast Track Designations in Brain Cancer and Leukemia

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for a novel dosing regimen for durvalumab as well as for trilaciclib in small cell lung cancer; granted Fast Track designations to treatments for glioblastoma and B-cell acute lymphoblastic leukemia; and issued reports...

leukemia

Sorafenib Maintenance After Stem Cell Transplant in FLT3-ITD–Positive Acute Myeloid Leukemia

In a Chinese phase III trial reported in The Lancet Oncology, Xuan et al found that sorafenib maintenance after allogeneic hematopoietic stem cell transplantation significantly reduced the risk of relapse vs no maintenance therapy in patients with FLT3–internal tandem duplication (ITD)–positive...

colorectal cancer

Effect of Muscle Mass and Radiodensity on Postoperative Complications and Outcomes of Colon Cancer Surgery

In a retrospective cohort study reported in JAMA Surgery, Xiao et al found that low skeletal muscle index and low skeletal muscle radiodensity were associated with an increased risk of complications and poor outcomes following surgery for colon cancer. Study Details The study involved data on...

immunotherapy

Meta-analysis of Overall Survival With Immunotherapy in Patients With Advanced Cancer According to Sex, Age, and Performance Status

In a systematic review and meta-analysis reported in JAMA Network Open, Yang et al found overall survival benefits with immune checkpoint inhibitor treatment vs non–immune checkpoint inhibitor treatment of advanced cancers irrespective of sex, age < 65 years vs ≥ 65 years, or Eastern Cooperative ...

breast cancer

Hypofractionated vs Conventionally Fractionated Radiotherapy After Breast-Conserving Surgery in Women With Breast Cancer

In a Chinese phase III trial reported in the Journal of Clinical Oncology, Wang et al found that hypofractionated radiotherapy (HFRT) and conventionally fractionated radiotherapy (CFRT) following breast-conserving surgery were associated with similar low 5-year local recurrence rates in women with...

leukemia

Addition of Venetoclax to Azacitidine in Previously Untreated Patients With AML Ineligible for Induction Therapy

In the phase III VIALE-A trial reported in The New England Journal of Medicine, Courtney D. DiNardo, MD, and colleagues found that venetoclax plus azacitidine significantly improved overall survival vs azacitidine alone in previously untreated patients with acute myeloid leukemia (AML) who were...

colorectal cancer
genomics/genetics

Molecular Testing in Metastatic Colorectal Cancer: Understanding How, When, and What to Profile

“In line with the emergence of targeted therapies, molecular biomarker testing in metastatic colorectal cancer has evolved over the past decade,” noted Jeanne Tie, MD, MBChB, FRACP, who acknowledged there is confusion about the best ways to use molecular testing in the clinic. Dr. Tie, who is...

lung cancer

Brigatinib vs Crizotinib in ALK Inhibitor–Naive Patients With ALK-Positive Advanced NSCLC

As reported in the Journal of Clinical Oncology by D. Ross Camidge, MD, PhD, and colleagues, a second prespecified interim analysis of the pivotal phase III ALTA-1L trial has shown maintained progression-free survival benefit with brigatinib vs crizotinib in ALK inhibitor–naive patients with...

lymphoma
immunotherapy

Early Rituximab Intensification in R-CHOP for Diffuse Large B-Cell Lymphoma

As reported in the Journal of Clinical Oncology by Pieternella Johanna Lugtenburg, MD, PhD, and colleagues, the phase III Haemato-Oncology Foundation for Adults in the Netherlands (HOVEN)/ Nordic Lymphoma Group HOVON-84 trial showed that early rituximab intensification in R-CHOP-14 (rituximab plus...

Expert Point of View: Amit Mahipal, MBBS, MPH

Amit Mahipal, MBBS, MPH, Consultant, Associate Professor of Oncology, Mayo College of Medicine, Rochester, put the findings for tremelimumab/durvalumab into context regarding other studies evaluating checkpoint inhibitors in advanced hepatocellular carcinoma. In the current study by Kelly et al, he ...

hepatobiliary cancer
immunotherapy

Novel Tremelimumab/Durvalumab Regimen Active in Advanced Hepatocelluar Carcinoma

A single priming dose of tremelimumab and durvalumab, followed by monthly durvalumab, showed clinical activity in a predominantly second-line advanced hepatocellular carcinoma population, in a study reported at the ESMO World Congress on Gastrointestinal Cancer Virtual 2020.1 In a study of 332...

immunotherapy

Subcutaneous Daratumumab Improves Outcomes for Patients With Light-Chain Amyloidosis, Study Finds

Patients with light-chain amyloidosis may soon have a new standard of care, according to data presented during the 25th European Hematology Association (EHA25) Virtual Annual Congress.1 Results of the phase III ANDROMEDA study have shown that adding subcutaneous daratumumab to the triplet...

prostate cancer

TITAN Trial: Apalutamide Adds to Options for Men With Metastatic Hormone-Sensitive Prostate Cancer

Androgen-deprivation therapy has been, and remains, the standard of care for patients with metastatic prostate cancer. Patients are often surprised to learn that was all we would do to control their disease and sometimes asked why they would not receive chemotherapy, as for other cancers. I would...

bladder cancer
immunotherapy

First-Line Atezolizumab Plus Platinum-Based Chemotherapy vs Chemotherapy Alone in Advanced Urothelial Cancer

As reported in The Lancet by Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, and colleagues, the phase III IMvigor130 trial has shown prolonged progression-free survival with first-line atezolizumab plus platinum-based chemotherapy vs...

Expert Point of View: Toni K. Choueiri, MD

At the Genitourinary Highlights session of the ASCO20 Virtual Scientific Program, Toni K. Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Boston, put the findings from KEYNOTE-426 into perspective. “This is an important update. The initial...

kidney cancer

Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma

Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented during the ASCO20 Virtual Scientific Program by Elizabeth R....

Expert Point of View: Philip J. Saylor, MD

Philip J. Saylor, MD, Attending Physician at Massachusetts General Hospital and Assistant Professor at Harvard Medical School, Boston, commented on this study. “The results presented are clearly exciting and cause us to look forward to a likely phase III study of this strategy. The high response...

bladder cancer
immunotherapy

Early Data Show Activity for Enfortumab Vedotin Plus Pembrolizumab in Advanced Bladder Cancer

It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if the results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin)...

prostate cancer

Many Choices Now for Men With Metastatic Hormone-Sensitive Prostate Cancer: How to Decide?

Based on the recently published ENZAMET, ARCHES, and TITAN trials,1-3 we now have several choices of systemic combination therapies for men with metastatic hormone-sensitive prostate cancer. Today, men are faced with decisions of androgen-deprivation therapy alone or combinations with abiraterone,...

bladder cancer
immunotherapy

Maintenance Avelumab Improves Survival in Advanced Bladder Cancer

Maintenance therapy with avelumab and best supportive care significantly prolonged overall survival vs best supportive care alone in patients with advanced urothelial carcinoma that did not progress on first-line platinum-based chemotherapy, according to an interim analysis of the phase III JAVELIN ...

kidney cancer
immunotherapy

First-Line Combination Treatments Improve Outcomes vs Sunitinib in Advanced Renal Cell Carcinoma

Two recently reported phase III trials have shown the benefits of combination therapy vs sunitinib in the first-line treatment of advanced renal cell carcinoma. As reported in The New England Journal of Medicine by Brian I. Rini, MD, of Cleveland Clinic Taussig Cancer Institute, and colleagues, the ...

prostate cancer

Enzalutamide Improves Survival vs Standard First-LineTreatment in Hormone-Sensitive Metastatic Prostate Cancer

As reported inThe New England Journal of Medicine by Ian D. Davis, MBBS, PhD, FRACP, FAChPM, of Monash University and Eastern Health in Melbourne, and colleagues, the phase III ENZAMET trial has shown that the androgen receptor inhibitor enzalutamide improved progression-free and overall survival...

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