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Luspatercept May Reduce the Need for Transfusion in Lower-Risk Myelodysplastic Syndromes

IN THE RANDOMIZED, double-blind, phase III MEDALIST trial, the experimental drug luspatercept significantly reduced the need for frequent red blood cell transfusions in patients with lower-risk myelodysplastic syndromes (MDS) and ring sideroblasts. With luspatercept, 37.8% of patients remained...

Front-Line Ibrutinib Improves Progression-Free Survival in Older Patients With Chronic Lymphocytic Leukemia

IN A PHASE III TRIAL reported during the Plenary Session at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition and published in The New England Journal of Medicine, single-agent ibrutinib and ibrutinib/rituximab were associated with superior progression-free survival vs...

leukemia
myelodysplastic syndromes
lymphoma
multiple myeloma
immunotherapy

Highlights From the 2018 ASH Annual Meeting & Exposition

TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...

breast cancer

Expert Point of View: Carlos L. Arteaga, MD

CARLOS L. ARTEAGA, MD, Director of the Harold C. Simmons Comprehensive Cancer Center and Associate Dean of Oncology Programs at The University of Texas Southwestern Medical Center, Dallas, expressed some caution about the overall applicability of the findings of the PADDY trial. Primarily, he...

breast cancer

Prognostic Value of Disseminated Tumor Cells in Early Breast Cancer

IN THE PADDY TRIAL, involving more than 10,000 women with early invasive breast cancer, the presence of disseminated tumor cells at diagnosis or primary surgery was an independent prognostic factor for overall, disease-free, and distant disease–free survival. The study findings were presented at...

breast cancer

SABCS Presentations Offer New Data on Biomarkers and Novel Treatment Approaches in Early and Metastatic Breast Cancers

REPORTERS FOR The ASCO Post captured the following summaries of noteworthy studies presented at the 2018 San Antonio Breast Cancer Symposium. In HER2-Negative Metastatic Disease, CTCs Frequently HER2-Positive ALMOST HALF of all patients with HER2-negative metastatic breast cancer have circulating...

hepatobiliary cancer

BRAF/MEK Targeting May Yield Benefit in Treating Biliary Tract Cancer

ROUTINE TESTING for BRAF V600E mutations in patients with biliary tract cancer may prove to be a good idea, based on the findings of a phase II study in which treatment with dabrafenib plus trametinib showed activity.1 The results suggest there may be a benefit to testing patients with biliary...

colorectal cancer
immunotherapy

Expert Point of View: Michael J. Overman, MD

INVITED STUDY discussant Michael J. Overman, MD, Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, is a co-investigator on CheckMate 142, which led to the approval of another immunotherapy doublet—nivolumab plus ipilimumab—in patients...

colorectal cancer
immunotherapy

Durvalumab and Tremelimumab Combination Active in Refractory Microsatellite-Stable Colorectal Cancer

THE COMBINATION of durvalumab and tremelimumab prolonged median overall survival by 2.5 months compared with best supportive care alone in patients with advanced treatment-refractory colorectal cancer. These findings, which are from the randomized phase II Canadian Cancer Trials Group (CCTG) CO.26...

pancreatic cancer

Emerging Role for Neoadjuvant Treatment of Resectable Pancreatic Cancer

SEVERAL STUDIES presented at the 2019 Gastrointestinal Cancers Symposium evaluated the benefits of neoadjuvant treatment in patients with pancreatic cancer—and in patients deemed fully resectable, not just “borderline” resectable.1-3 Although the standard of care for resectable pancreatic ductal...

Expert Point of View: Kenneth Shain, MD, PhD, and Vincent Rajkumar, MD

In interviews with The ASCO Post, Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, and Vincent Rajkumar, MD, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, commented on the findings of the MAIA trial. “The study shows that...

hematologic malignancies
multiple myeloma

Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma: Outcomes From the MAIA Trial

In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab to lenalidomide and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract presentation by Thierry...

bladder cancer

Thomas Powles, MD, PhD, on Urothelial Carcinoma: Results From the RANGE Trial on Ramucirumab and Docetaxel

Thomas Powles, MD, PhD, of Queen Mary University of London, discusses phase III study findings on ramucirumab plus docetaxel vs placebo plus docetaxel in patients with advanced platinum-refractory urothelial carcinoma (Abstract 353).

Expert Point of View: Steven Gore, MD, Eyten Stein, MD, and Elihu H. Estey, MD

In discussions after these presentations, several points were made by several experts. To begin, Steven Gore, MD, Director of Hematologic Malignancies at Yale Medical School, called the study of venetoclax plus 10-day decitabine “very important,” but he raised the issue of appropriate dosing. He...

leukemia

Data Mount for Venetoclax as Add-on Therapy in Acute Myeloid Leukemia

The benefit of adding venetoclax to a hypomethylating agent or low-dose cytarabine in the front-line treatment of acute myeloid leukemia (AML) was evident from a number of studies reported at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (see Table 1). For elderly...

Expert Point of View: Ravi Vij, MD and Saad Usmani, MD

Ravi Vij, MD, Professor of Medicine at Washington University School of Medicine, St. Louis, and Saad Usmani, MD, Director of Plasma Cell Disorders at Levine Cancer Institute, Charlotte, North Carolina, spoke to The ASCO Post about the studies presented on chimeric antigen receptor (CAR) T-cell...

immunotherapy
multiple myeloma

Multiple Myeloma Pipeline Filled With CAR T-Cell Therapies

The burgeoning pipeline of chimeric antigen receptor (CAR) T-cell therapies targeting B-cell maturation antigen (BCMA) in multiple myeloma was on full display at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. A bispecific antibody also made its debut in this busy...

Expert Point of View: Mrinal S. Patnaik, MBBS and David P. Steensma, MD

Mrinal S. Patnaik, MBBS, Associate Professor of Internal Medicine and Oncology and a consultant in hematology at the Mayo Clinic, Rochester, commented on the MEDALIST trial for The ASCO Post. “Given its unique mode of action, relative ease of administration, and excellent tolerability,...

supportive care
hematologic malignancies

Luspatercept May Reduce the Need for Transfusion in Lower-Risk Myelodysplastic Syndromes

In the randomized, double-blind, phase III MEDALIST trial, the experimental drug luspatercept significantly reduced the need for frequent red blood cell transfusions in patients with lower-risk myelodysplastic syndromes (MDS) and ring sideroblasts. With luspatercept, 37.9% remained transfusion-free ...

breast cancer

Selected Abstracts From the San Antonio Breast Cancer Symposium

Each year, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, to offer his picks for the most important research presented at the 2018 San Antonio Breast Cancer ...

Expert Point of View: Harry H. Yoon, MD

Harry H. Yoon, MD, Associate Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, the invited discussant of the study presented by Janjigan et al, commented on the strong rationale for combining an anti-HER2 agent, anti–programmed cell death protein 1 (PD-1) agent, and chemotherapy....

immunotherapy
gastrointestinal cancer

First-Line Trastuzumab Plus Pembrolizumab Shows Efficacy in Patients With Metastatic Esophagogastric Cancer

When added to first-line chemotherapy in patients with untreated metastatic HER2-positive esophageal, gastroesophageal junction, and gastric adenocarcinoma, the combination of pembrolizumab and trastuzumab produced responses in 87% of patients, with 100% of patients experiencing disease control and ...

Expert Point of View: Martine Extermann, MD, PhD

As invited discussant of the GAMMA-1 trial, Martine Extermann, MD, PhD, of Moffitt Cancer Center and Research Institute, Tampa, Florida, first commented on the “teaser” in the findings—the potential for benefit of andecaliximab in older patients. “The drug works better in older patients. As a...

gastrointestinal cancer
head and neck cancer

Andecaliximab in Untreated Gastric or Gastroesophageal Junction Cancer

The large phase III GAMMA-1 trial failed to replicate the encouraging findings from a previous smaller study of andecaliximab plus chemotherapy in untreated HER2-negative gastric or gastroesophageal junction adenocarcinoma, according to Manish A. Shah, MD, of Weill Cornell Medicine/New York...

Expert Point of View: Harry H. Yoon, MD

KEYNOTE-181’s invited discussant, Harry H. Yoon, MD, Associate Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, said the findings have a “potentially immediate clinical impact” for second-line treatment of esophageal cancer, including esophageal squamous cell carcinoma and Siewert...

head and neck cancer

KEYNOTE-181: Pembrolizumab vs Chemotherapy in Second-Line Treatment of Advanced Esophageal Cancer

In the global phase III KEYNOTE-181 trial, pembrolizumab as second-line therapy for advanced esophageal cancer did not improve overall survival in the whole population, vs chemotherapy, but did improve survival for patients with strong expression of programmed cell death ligand 1 (PD-L1),...

leukemia

Expert Point of View: Elihu H. Estey, MD; Steven Gore, MD; and Mark J. Levis, MD, PhD

ELIHU H. ESTEY, MD, Professor of Medicine at the University of Washington and Director of Acute Myeloid Leukemia (AML) Clinical Research at the Fred Hutchinson Cancer Research Center, Seattle, added that with these “robust” outcomes, future trial patients may “not be eager to wind up in the...

leukemia

Use of Isocitrate Dehydrogenase Inhibitors in Induction Therapy for Newly Diagnosed AML

IN AN OPEN-LABEL phase I study of 153 patients newly diagnosed with acute myeloid leukemia (AML) and mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, treatment with standard chemotherapy plus the oral IDH inhibitors ivosidenib and enasidenib led to high response rates and possibly impressive ...

breast cancer

Expert Point of View: Virginia G. Kaklamani, MD; Monica Morrow, MD; and John Cole, MD

AT THE SAN ANTONIO Breast Cancer Symposium, several breast cancer experts interviewed by The ASCO Post noted that the approved dose of tamoxifen was arbitrarily set, and the optimal dose is actually unknown. Studies of lower-dose tamoxifen, therefore, are welcomed. Virginia G. Kaklamani, MD,...

breast cancer

Low-Dose Tamoxifen Halves Breast Cancer Risk in Women With Preinvasive Breast Lesions

A VERY LOW DOSE of tamoxifen—5 mg/d, given for 3 years rather than 5 years—halved the risk of breast cancer recurrence or new lesions over placebo in women with breast intraepithelial neoplasia, without producing the usual toxicities seen with the standard dose, Italian researchers reported at the...

breast cancer

International Trials Present New Findings in Treatment of Breast Cancer

The European Society for Medical Oncology (ESMO) 2018 Congress featured an assortment of study findings, many with far-reaching clinical implications for the treatment of patients with various cancers. Many of these trials were covered in-depth in recent issues of The ASCO Post. Here, we present...

immunotherapy
skin cancer

Optimal Duration of Checkpoint Inhibition in Melanoma Is No More Than 2 Years

For patients with advanced melanoma, the concept of treating to disease progression does not always apply. With many patients responding to checkpoint inhibition for years, when can treatment be safely discontinued? This important clinical question was addressed at the European Society for Medical...

Expert Point of View: Charles G. Drake, MD, PhD

“Bringing pembrolizumab (Keytruda) early into therapy is a bold move,” commented the invited discussant of this trial, Charles G. Drake, MD, PhD, Professor of Oncology and Immunology at the Herbert Irving Cancer Center at Columbia University, New York. The study enrolled patients who can be cured...

head and neck cancer
immunotherapy

Pembrolizumab Plus Chemoradiotherapy in HPV-Positive Head and Neck Cancer

The addition of pembrolizumab (Keytruda) to a chemoradiotherapy regimen yielded complete response rates of 85% in patients with human papillomavirus (HPV)-positive advanced squamous cell carcinoma of the head and neck. These findings from a phase Ib study were presented at the 2018 Society for...

Expert Point of View: Kenneth Shain, MD, PhD, and Vincent Rajkumar, MD

In interviews with The ASCO Post, Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, and Vincent Rajkumar, MD, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, commented on the findings of the MAIA trial. “The study shows that...

hematologic malignancies
multiple myeloma
immunotherapy

Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma

In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...

Expert Point of View: Eric P. Winer, MD, and Jame Abraham, MD

Commenting on the findings of the KATHERINE trial were Eric P. Winer, MD, Director of the Breast Oncology Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and the Thompson Senior Investigator in Breast Cancer Research andProfessor of Medicine at Harvard...

breast cancer

KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer

In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...

colorectal cancer
immunotherapy

Expert Point of View: Julien Taieb, MD

JULIEN TAIEB, MD, Professor of Medicine at Paris Descartes University in France, said the MODUL cohort was based on a clear rationale for adding atezolizumab (Tecentriq) to bevacizumab (Avastin) in the metastatic colorectal cancer setting. In immunodeficient mice, the combination of an...

colorectal cancer
immunotherapy

No Benefit for Atezolizumab Plus Standard of Care for Maintenance in Colorectal Cancer Subset

ADDING ATEZOLIZUMAB (Tecentriq) to a fluoropyrimidine plus bevacizumab (Avastin) did not improve outcomes for patients with BRAF wild-type metastatic colorectal cancer enrolled in the umbrella MODUL trial.1 “Despite activity in other, immune-responsive tumor types, there was no improvement in...

skin cancer
immunotherapy

Expert Point of View: Reinhard Dummer, MD

KEYNOTE-022’S invited discussant, Reinhard Dummer, MD, Professor of Dermatologic Oncology at the University Hospital Zurich Skin Cancer Center in Switzerland, told attendees, “We’ve been waiting for this small prospective randomized phase II trial, and the initial results appear very promising.”...

skin cancer
immunotherapy

Pembrolizumab Triplet Shows Activity in BRAF-Mutant Melanoma

AS FIRST-LINE treatment of advanced BRAF-mutant melanoma, pembrolizumab (Keytruda) added to dabrafenib (Tafinlar) and trametinib (Mekinist) produced a nonsignificant improvement in progression-free survival. It also increased the rate of grade 3 to 5 treatment-related adverse events in the phase II ...

skin cancer

Expert Point of View: Cara Haymaker, PhD

CARA HAYMAKER, PhD, of MD Anderson Cancer Center, said the researchers have made a “crucial” discovery: adoptive cellular therapy can be expanded beyond academic centers and be “taken to the masses.” Tumor-infiltrating lymphocytes can now be manufactured and shipped to patients treated at centers...

skin cancer

Using Tumor‑Infiltrating Lymphocytes to Treat Metastatic Melanoma

STEVEN A. ROSENBERG, MD, PhD, Chief of Surgery at the National Cancer Institute (NCI), began his pioneering research in adoptive cell transfer using interleukin (IL)-2 in the mid-1970s. His IL-2 studies were among the clinical trials that led to the first U.S. Food and Drug Administration approval ...

immunotherapy

Expert Point of View: Aung Naing, MD, FACP

AT THE 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting, Aung Naing, MD, FACP, of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, Houston, commented on studies evaluating novel drugs to be combined with programmed cell death ...

immunotherapy

Beyond Checkpoint Inhibitors: Novel Immunotherapy Combinations With Antitumor Activity

THE 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting hosted a meeting of the minds of the world’s premier cancer immunologists. In addition to the cutting-edge laboratory science explored and presented at the meeting, numerous phase I clinical trials and a few phase II studies offered ...

leukemia
geriatric oncology

Expert Point of View: Susan M. O’Brien, MD

THE STUDY’S discussant, Susan M. O’Brien, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, said the results of the Alliance North American Intergroup Study A041202—demonstrating that ibrutinib (Imbruvica) is more...

leukemia
geriatric oncology

Ibrutinib vs Standard of Care in Front-Line Treatment of Older Patients With Chronic Lymphocytic Leukemia

IBRUTINIB (IMBRUVICA) as a front-line agent proved superior to standard-of-care chemoimmunotherapy for chronic lymphocytic leukemia (CLL) in older patients in A041202, an Alliance-led National Clinical Trials Network study.1 At a follow-up of 38 months, the median progression-free survival was not ...

Palliative Care Trailblazer, Charles von Gunten, MD, PhD, Shares Insights With Advanced Practitioners

“The data are in, and they are clear and convincing. Palliative care leads to better outcomes for patients. The major challenge now is to make it part of standard cancer care everywhere in the United States and then everywhere else in the world, said Charles von Gunten, MD, PhD, a medical...

Expert Point of View: Sandro Pignata, MD

The study’s invited discussant, Sandro Pignata, MD, of the Istituto Nazionale Tumori di Napoli in Italy, called the data from AGO OVAR 2.21 “very strong.” He added: “We now have robust evidence from a trial of more than 600 patients, in which previous bevacizumab (Avastin) was allowed, that...

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