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prostate cancer

Apalutamide Improves Survival Outcomes in Castration-Sensitive Metastatic Prostate Cancer in TITAN Trial

Adding apalutamide to androgen-deprivation therapy (ADT) significantly improved survival in men with metastatic castration-sensitive (also termed hormone-sensitive) prostate cancer, according to the results of the phase III TITAN trial, which were presented at the 2019 ASCO Annual Meeting and...

head and neck cancer
immunotherapy

FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma

On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was approved for...

pancreatic cancer

POLO Trial Shows Maintenance Olaparib Improves Progression-Free Survival in Metastatic Pancreatic Cancer

In patients with metastatic pancreatic cancer and germline mutations in BRCA1 or BRCA2, maintenance therapy with olaparib doubled the time to disease progression and the proportion of patients who were progression-free at 2 years, in the phase III POLO trial.1 “Maintenance olaparib provided a...

prostate cancer

ENZAMET Trial Shows Enzalutamide Improves Overall Survival in Hormone-Sensitive Metastatic Prostate Cancer

Agents that improve survival in metastatic castration-resistant prostate cancer when added to background androgen-deprivation therapy (ADT) are showing success in treating metastatic prostate cancer earlier while it is still hormone-sensitive. These agents include docetaxel (chemotherapy) and...

breast cancer

Denosumab Prevents Neither Breast Cancer Relapse Nor Death

The recently published report of Austrian Breast and Colorectal Cancer Study Group’s Study 18 (ABCSG-18)1 for the secondary endpoint of disease-free survival suggests that denosumab given in a low dose of 60 mg subcutaneously every 6 months during aromatase inhibitor adjuvant therapy is...

leukemia

EHA 2019: CLL12 Trial Investigates Ibrutinib in Previously Untreated, Asymptomatic Early-Stage CLL

At the 24th Annual Congress of the European Hematology Association (EHA), Langerbeins et al presented findings from the phase III CLL12 trial, which evaluated whether ibrutinib prolongs event-free survival in patients with previously untreated, Binet stage A chronic lymphocytic leukemia (CLL)...

multiple myeloma

EHA 2019: BELLINI Trial Evaluates Addition of Venetoclax to Bortezomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma

The phase III BELLINI trial—reported by Kumar et al at the 24th Annual Congress of the European Hematology Association (EHA; Abstract LB2601) investigated the efficacy and safety of venetoclax/bortezomib/dexamethasone vs bortezomib/dexamethasone in patients with relapsed or refractory...

gynecologic cancers

2019 ASCO: Paclitaxel/Carboplatin vs Paclitaxel/Ifosfamide in Carcinosarcoma of the Uterus or Ovary

Results from the phase III NRG Oncology clinical trial GOG 0261 comparing paclitaxel plus carboplatin to paclitaxel plus ifosfamide in women with stage I–IV recurrent carcinosarcoma of the uterus or ovary found that treatment with paclitaxel/carboplatin was not inferior to...

colorectal cancer

2019 ASCO: Addition of Veliparib to Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Results from an experimental arm of the phase II NRG-GI002 trial using veliparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, as part of total neoadjuvant therapy (induction chemotherapy followed by chemoradiotherapy and surgery) in patients with locally advanced rectal adenocarcinoma were...

cns cancers
immunotherapy

2019 ASCO: Combination Therapy With SurVaxM in Newly Diagnosed Glioblastoma

Ahluwalia et al shared research results on SurVaxM at the 2019 ASCO Annual Meeting, reporting that combination therapy with the immunotherapy vaccine was more effective than standard therapy for nearly all patients with newly diagnosed glioblastoma in a phase II trial (Abstract 2016). SurVaxM...

cns cancers

2019 ASCO: Subgroups of Patients With Low-Grade Glioma May Benefit From PCV Chemotherapy Plus Radiotherapy

A recent, updated predictive analysis of the three World Health Organization (WHO)-defined molecular subgroups based on IDH mutation status and 1p/19q codeletion status represented in the high-risk treatment arms of a phase III trial found that both IDH-mutant subgroups may derive benefit ...

head and neck cancer
immunotherapy

FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma

On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was...

cns cancers

As My Outside World Became Smaller, My Family Focus Became Larger

As I write this, I think I’m making sense but am not 100% sure. My brain is a little scrambled after nearly 4 years of treatment for grade 4 glioblastoma multiforme, but I think the essence of my humor and humanity is still intact. When I experienced my first partial seizure while riding my...

From Leeches to Liquid Biopsy: Uncovering the Mysteries of Blood

BOOKMARK Title: Nine Pints: A Journey Through the Money, Medicine, and Mysteries of BloodAuthor: Rose GeorgePublisher: Metropolitan BooksPublication date: October 2018Price: $27.00, hardcover, 368 pages Blood has been mythologized and misunderstood since the earliest records of humankind and still ...

bladder cancer
immunotherapy

Adverse Events and Outcomes in Patients Receiving Anti–PD-1/PD-L1 Antibody Treatment for Advanced Urothelial Cancer

In an analysis reported in the Journal of Clinical Oncology, Maher et al found that treatment-related adverse events of special interest and immune-mediated adverse events were more common among patients with advanced urothelial cancer with vs without response to anti–programmed cell death...

lung cancer
immunotherapy

2019 ASCO: NEOSTAR: Neoadjuvant Nivolumab Plus Ipilimumab in Early-Stage, Resectable NSCLC

Neoadjuvant treatment with nivolumab plus ipilimumab resulted in an overall major pathologic response rate of 33% of treated patients with early-stage, resectable non–small cell lung cancer (NSCLC). With these results, the combination immunotherapy met the prespecified trial...

breast cancer
supportive care

Using Bioimpedance Spectroscopy to Prevent Progression of Lymphedema

Surveillance of women at risk for breast cancer–related lymphedema using bioimpedance spectroscopy was more effective in preventing lymphedema progression than traditional measurement of arm circumference, when each is combined with immediate compression therapy. These findings came from the...

immunotherapy
head and neck cancer

Head and Neck Cancer Immunotherapy in Locally Advanced Disease: Clinical Trial Updates

Programmed cell death protein 1 (PD-1) inhibitors are approved for the second-line treatment of head and neck cancer and likely will be soon in the first-line treatment of locally advanced disease. According to Robert L. Ferris, MD, PhD, developments in immunotherapy for this population should be...

Ruxolitinib Approved for Acute Graft-vs-Host Disease

On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on the REACH1 trial/Study INCB 18424-271, an open-label, single-arm, multicenter...

head and neck cancer

NovoTTF-100L System in Combination With Chemotherapy Approved for Malignant Pleural Mesothelioma

On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive,...

breast cancer

MONALEESA-7 Shows Overall Survival Benefit for Ribociclib/Endocrine Therapy

The first statistically significant overall survival benefit has been shown for a cyclin-dependent kinase (CDK) 4/6 inhibitor plus endocrine therapy as first-line treatment of advanced breast cancer. The results are from the phase III MONALEESA-7 trial, which evaluated ribociclib plus endocrine...

bladder cancer
immunotherapy

2019 ASCO: Enfortumab Vedotin Shows Activity in Previously Treated, Locally Advanced or Metastatic Urothelial Cancer

The single-arm, phase II EV-201 trial showed treatment with enfortumab vedotin—an agent targeting Nectin-4, a protein found in 97% of urothelial cancers—produced responses in 44% of patients with locally advanced or metastatic forms of urothelial cancer. Patients had previously been...

breast cancer

2019 ASCO: MONALEESA-7: Addition of Ribociclib to Endocrine Therapy in Premenopausal Women With HR-Positive, HER2-Negative Breast Cancer

The international, randomized phase III MONALEESA-7 trial found that the addition of ribociclib to standard-of-care endocrine therapy significantly improved overall survival for premenopausal women with advanced hormone receptor (HR)-positive, HER2-negative breast cancer compared with endocrine...

sarcoma

2019 ASCO: Vincristine and Irinotecan With or Without Temozolomide in Relapsed or Refractory Rhabdomyosarcoma

In the European phase II VIT-091 trial, researchers examined the efficacy of the combination of vincristine and irinotecan with or without the addition of temozolomide in children and adults with relapsed or refractory rhabdomyosarcoma. Their results were presented by Defachelles et al at the 2019...

leukemia

FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory FLT3-Mutated AML

On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved...

New Data on Improving Access to Cancer Care, Advances in Precision Medicine Highlighted at 2019 ASCO Annual Meeting

As this special edition of The ASCO Post goes to press, more than 32,000 cancer experts from around the world have convened in Chicago to share the latest clinical cancer research impacting patient care at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). Advances in...

Cancer Researcher Continues to Push the Envelope in Immunotherapy to Help Patients Live Longer

Nationally regarded cancer immunologist Padmanee Sharma, MD, PhD, was born and reared in Georgetown, Guyana, on South America’s North Atlantic coast, noted for being the only South American country in which English is the official language. Her parents were descendants of indentured immigrants...

lymphoma

FDA Approves Lenalidomide in Combination for Previously Treated Follicular and Marginal Zone Lymphomas

Today, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid) in combination with a rituximab product for previously treated follicular and marginal zone lymphoma. AUGMENT and MAGNIFY Trials Approval was based on two clinical trials: AUGMENT and MAGNIFY. In AUGMENT, 358...

lung cancer

FDA Approves the NovoTTF-100L System in Combination With Chemotherapy for Malignant Pleural Mesothelioma

On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive,...

symptom management

FDA Approves Ruxolitinib for Acute Graft-vs-Host Disease

On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. REACH1/Study INCB 18424-271 Approval was based on the REACH1 trial/Study INCB 18424-271, an...

pancreatic cancer

Lifestyle Modifications and Screening of Patients at High Risk Can Reduce Deaths From Pancreatic Cancer

After disclosing that he had been diagnosed with stage IV pancreatic cancer, Alex Trebek, longtime host of the popular television game show Jeopardy!, vowed that he would beat the disease despite the low associated survival rate. His statement has brought pancreatic cancer back into the public...

Teen Cancer America Announces New Advisory Council

Teen Cancer America (TCA), the national nonprofit organization founded by rock artists Roger Daltrey and Pete Townshend of The Who, recently announced appointments to its newly formed Advisory Council. Based in Los Angeles, TCA develops specialized facilities as well as treatment- and age-specific...

solid tumors
bladder cancer

Erdafitinib for Metastatic Urothelial Carcinoma

On April 12, 2019, erdafitinib was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations, when the disease has progressed during or following platinum-containing...

hematologic malignancies
leukemia
lymphoma

FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL

On May 15, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on the CLL14...

lung cancer

FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting

On April 14, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....

hematologic malignancies
leukemia

FDA Approves First-Line Ivosidenib for IDH1-Mutated AML

On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...

hematologic malignancies
lymphoma

Combination Immunotherapy With Lenalidomide Plus Rituximab in Indolent NHL: Time to Replace Rituximab Monotherapy?

With increasing knowledge on the key role of the tumor microenvironment in lymphomagenesis, treatments for indolent B-cell lymphoma, especially follicular lymphoma, are mechanistically moving toward a more immunomodulatory approach. Chemotherapy-free regimens are an attractive alternative to...

cns cancers

Targeted Brachytherapy May Improve Outcomes in Recurrent Brain Tumors

For recurrent, previously irradiated brain tumors, innovative treatment with surgically targeted brachytherapy yielded good local control and overall survival, as compared to historic controls, neurosurgeons reported at the 2019 Annual Scientific Meeting of the American Association of Neurological...

colorectal cancer

ASCO Guideline Recommends Shorter-Course Adjuvant Chemotherapy for Some Patients With Stage III Colon Cancer

In a clinical practice guideline released April 15, an ASCO Expert Panel outlined the latest recommendations for the duration of adjuvant chemotherapy with a fluoropyrimidine and oxaliplatin for patients with completely resected stage III colon cancer.1 New recommendations were based on the results ...

bladder cancer

Sacituzumab Govitecan Shows Activity in Heavily Pretreated Bladder Cancer

PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...

bladder cancer

Adjuvant Sequential Chemotherapy Plus Radiotherapy vs Radiotherapy Alone for Locally Advanced Bladder Cancer

A phase III Egyptian trial presented by Mohamad S. Zaghloul, MD, et al at the 2019 Genitourinary Cancers Symposium focused on the benefit of adjuvant chemotherapy in patients with locally advanced bladder cancer treated with postoperative radiotherapy.1 Researchers compared postoperative...

prostate cancer

Enzalutamide Plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer

Adding enzalutamide to androgen-deprivation therapy (ADT) significantly prolonged radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer, reducing the risk of disease progression or death by 61% compared with ADT plus placebo, according to the results of the ...

Expert Point of View: Efrat Dotan, MD, and Colin D. Weekes, MD, PhD

Efrat Dotan, MD, Associate Professor, Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, commented on this study. “This abstract presents the interim analysis of a phase II study evaluating the use of maintenance therapy with the poly (ADP-ribose) polymerase PARP inhibitor...

pancreatic cancer

Study Shows Rucaparib Active as Maintenance Therapy in Pancreatic Cancer

The poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib holds promise as maintenance therapy for advanced, platinum-sensitive, BRCA- or PALB2-mutated pancreatic cancer, according to an interim analysis of an ongoing phase II clinical trial presented at the 2019 Annual Meeting of the American...

kidney cancer
immunotherapy

Front-Line Therapy in Advanced Renal Cell Carcinoma: Developing a New Standard

THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...

kidney cancer
immunotherapy

KEYNOTE-427: Pembrolizumab Shows Activity in Advanced Non–Clear Cell Kidney Cancer

IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Kidney cancers with a...

hematologic malignancies

Evidence Builds for Treating Smoldering Myeloma

In patients with intermediate- to high-risk smoldering multiple myeloma, treatment with single-agent lenalidomide, vs observation, led to a 72% reduction in the risk of disease progression at 3 years.1 Results of the phase III E3A06 study were presented at a press briefing in advance of the 2019...

skin cancer
immunotherapy

Predicting Response to Immunotherapy in Squamous Cell Carcinoma

According to a study published by Kacew et al in the European Journal of Cancer, copy number alterations in the chromosome 3q arm may be linked to immunotherapy response in patients with cutaneous squamous cell carcinoma. In fact, this and other genetic markers may prove to be useful...

cns cancers
solid tumors
leukemia
multiple myeloma
sarcoma

FDA Pipeline: Designations in Myeloma, Adenoid Cystic Carcinoma, and Kaposi Sarcoma, Plus ODAC Votes

This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...

issues in oncology

Control Arm Quality in Randomized Oncology Trials Leading to FDA Approval

In a study reported in JAMA Oncology, Hilal et al found that 17% of recent cancer drug approvals based on randomized controlled trials featured a suboptimal control arm. Study Details The study involved analysis of a total of 145 studies that led to 143 drug approvals between January 2013 and...

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