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The Puzzle Table

The ASCO Post is pleased to reproduce installments of the “Art of Oncology” as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...

Seven Leaders Join MD Anderson Cancer Center Board of Visitors

The University of Texas MD Anderson Cancer Center Board of Visitors welcomed seven new members at its annual meeting in early November: Randy A. Foutch, Winell Herron, Cyvia Wolff, Isabella Arjona-Zappala, R. Stan Marek, Jr, Walker N. Moody, and Jerry Simon. The Board of Visitors is a...

Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer

Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...

issues in oncology

FDA Helps Streamline Approval Process for Supplemental Drug Indications

As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...

WHAT SHOULD PUMA DO?

Puma should invest in developing an escalating-dose schedule for neratinib (Nerlynx). If one plans on giving a drug for a year, and starts after finishing a year of effective adjuvant therapy, there is no hurry to begin at full, intolerable doses. Starting at a lower dose and escalating slowly as...

solid tumors
breast cancer

Neratinib Is Approved: Should We Reject It Anyway?

The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...

supportive care
lung cancer

Providing a Safe Haven for Patients With Advanced Lung Cancer

In 1996, Jimmie C. Holland, MD, the Wayne E. Chapman Chair in Psychiatric Oncology at Memorial Sloan Kettering Cancer Center (MSK) in New York, decided to launch the cancer center’s Lung Cancer Survivorship Program after she had a startling encounter with a patient. “The woman said to me, ‘Would...

St. John’s Wort

The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Jun J. Mao, MD, MSCE, and Jyothirmai Gubili, MS, explore the role of St....

Fulvestrant Monotherapy for Postmenopausal Women With Advanced Breast Cancer

On August 28, 2017, fulvestrant (Faslodex) was approved at 500 mg as monotherapy for expanded use in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who have not received previous endocrine therapy.1 Supporting Efficacy Data Approval was based on improved...

NIH Research Program Partners With National Library of Medicine to Advance Precision Medicine

THE NATIONAL INSTITUTES OF HEALTH’S All of Us Research Program and the National Library of Medicine (NLM) have teamed up to raise awareness about the program, a landmark effort to advance precision medicine. Through this 3-year pilot program, the National Network of Libraries of Medicine has...

ASCO Kicks Off Strategic Planning to Support Women in Oncology

Women in oncology aren’t ascending the leadership ladder at rates anywhere close to their male counterparts—and ASCO wants to fix that. The most recent report on “The State of Women in Academic Medicine” from the Association of American Medical Colleges (AAMC) said that although women make up...

Columbia and NewYork-Presbyterian Receive $700 Million Donation for Cancer Research and Care

Columbia University and NewYork-Presbyterian announced that Florence Irving and her late husband, Herbert Irving, have given $700 million to the two institutions to advance research and clinical programs for the treatment of cancer. The Irvings’ historic gift will have a profound impact on research ...

lymphoma

Obinutuzumab in Previously Untreated Follicular Lymphoma

On November 16, 2017, obinutuzumab (Gazyva) was granted regular approval in combination with chemotherapy, followed by obinutuzumab monotherapy for patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular...

breast cancer

Exercise Counteracts Fatigue, Pain in Women With Advanced Breast Cancer

A SUPERVISED and individualized exercise program can reduce fatigue and pain while improving cardiovascular health and quality of life in women being treated for advanced breast cancer, according to research presented by Eduardo Oliveira, PhD, Professor of Exercise Physiology and Exercise Cancer...

breast cancer

Disease Progression and Deterioration of Health-Related Quality of Life in Advanced Breast Cancer

IN PATIENTS WITH estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer, better quality of life may be prolonged by delaying the progression of the disease, according to an ongoing quality-of-life assessment from the PALOMA-2 study, presented by Nadia Harbeck, MD, PhD, of...

solid tumors
lung cancer

Lung Cancer in Never Smokers: A Complex Clinical Phenomenon

Despite advances in prevention, early detection, and treatments, lung cancer remains the leading cause of cancer-related death in the United States. Although cigarette smoking is the main cause of lung cancer, about 10% of these patients are lifelong never smokers for whom the molecular...

leukemia

Bosutinib for First-Line Use in Chronic Myeloid Leukemia: Is Three a Crowd?

BOSUTINIB ( BOSULIF) is the latest tyrosine kinase inhibitor that has shown a superior molecular response profile when compared with imatinib.1,2 An orally available dual SRC/ABL1 inhibitor, the drug was shown in preclinical studies to have a potent inhibitory activity against BCR-ABL1 and minimal ...

Balancing Opioid Use to Relieve Cancer-Related Pain and Protecting Patients From Addiction and Death

According to the Centers for Disease Control and Prevention (CDC), from 1999 to 2015, more than 183,000 people have died in the United States from overdoses related to prescription opioids, including methadone, oxycodone, and hydrocodone.1 To stem the epidemic in prescription opioid–related use and ...

lymphoma

Front-Line Brentuximab Plus AVD vs Standard ABVD in Advanced Hodgkin Lymphoma

FRONT-LINE TREATMENT of advanced Hodgkin lymphoma with brentuximab vedotin (Adcetris) plus doxorubicin/ vinblastine/dacarbazine (A+AVD) achieved superior outcomes compared with the standard four-drug regimen of doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD). The substitution of brentuximab...

issues in oncology

Sexual Problems and Cancer: ASCO Clinical Practice Guideline Adaptation of CCO Guideline

As reported in the Journal of Clinical Oncology by Jeanne Carter, PhD, of Memorial Sloan Kettering Cancer Center, and colleagues, ASCO has issued a clinical practice guideline adaptation of the Cancer Care Ontario (CCO) guideline on interventions to address sexual problems in people with cancer....

gastroesophageal cancer
gastrointestinal cancer

Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma

The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...

legislation

Nearly 100 Leading Cancer Researchers and Physician-Scientists Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Medical Research

On December 6, the American Association for Cancer Research (AACR) delivered a letter from the current AACR President and Past Presidents—as well as Fellows of the AACR Academy that include 18 Nobel Laureates—to urge leaders in the House and Senate to “move quickly to finalize a...

gynecologic cancers

FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...

solid tumors

Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors

Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...

lymphoma

ASH 2017: ALCANZA Trial: Brentuximab Vedotin in CD30-Expressing Cutaneous T-Cell Lymphoma

Updated results from the phase III ALCANZA clinical trial evaluating brentuximab vedotin (Adcetris) in CD30-expressing cutaneous T-cell lymphoma (CTCL) were presented by Horwitz et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1509). The presentation...

hematologic malignancies

ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura

In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...

breast cancer

BELLE-3 Trial: Combination Therapy in Resistant Advanced Breast Cancer

The phase III BELLE-3 trial has shown prolonged progression-free survival but a worse safety profile with the addition of the pan-phosphoinositide 3-kinase inhibitor buparlisib to fulvestrant (Faslodex) in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast...

lung cancer

Study Suggests Racial Differences in Lung Tumor Biology

According to research by the American Cancer Society, lung cancer is the second most common cancer in men and women in the United States and is the leading cause of cancer-related death. In addition, among all populations, African Americans tend to have the highest lung cancer incidence and...

hematologic malignancies

ASH 2017: Rapid Responses, Few Adverse Effects Seen With Targeted Agent in Phase I Trial in Systemic Mastocytosis

In a phase I trial, patients with an advanced or aggressive form of systemic mastocytosis, a rare blood disorder, had rapid and durable responses with few adverse effects following treatment with an investigational drug that targets the genetic mutation found in more than 90% of cases. Results were ...

lymphoma

ASH 2017: Addition of Brentuximab Vedotin to Multidrug Regimen Reduces Risk of First-Line Treatment Failure in Advanced Hodgkin Lymphoma

Patients with advanced Hodgkin lymphoma (HL) who were treated with a multidrug regimen that included the targeted agent brentuximab vedotin (Adcetris) had a 23% reduction in the risk of disease progression, death, or the need for additional therapy, compared with patients who received the standard...

lymphoma

Tanaya Shree, MD, PhD, on DLBCL Survivors: Long-Term Effects

Tanaya Shree, MD, PhD, of Stanford University Medical Center, discusses findings from a large population-based study suggesting lasting effects of lymphoma and its treatments: an increased incidence of autoimmune and infectious diseases (Abstract 198).

hematologic malignancies
issues in oncology

ASH 2017: Direct Oral Anticoagulant May Reduce Recurrence of VTE in Patients With Cancer

People with cancer have an increased risk of developing blood clots, with roughly one in five experiencing venous thromboembolism (VTE). International guidelines recommend treatment using low–molecular-weight heparin, an anticoagulant that is injected subcutaneously; however, new results from ...

Chemotherapy Foundation Honors Oncology Pioneer James F. Holland, MD, FASCO, and Actor-Comedian Martin Short

On November 8, 2017, the Chemotherapy Foundation held a benefit in New York City to raise funding to support an investigator in ovarian cancer research selected for the 2018 Research Grant Program. The event coincided with the 35th Annual Chemotherapy Foundation Symposium and honored oncology...

FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers

On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...

breast cancer

SABCS 2017: Phase III EMBRACA Trial Meets Primary Endpoint

Patients with advanced HER2-negative breast cancer with germline BRCA mutations had significantly prolonged progression-free survival when treated with the poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib, compared with those who received chemotherapy of physician’s choice, according...

hematologic malignancies

Untangling the Controversies of Hematopoietic Cell Transplantation

BOOKMARK Title: Hematopoietic Cell Transplants: Concepts, Controversies, and Future DirectionsEditors: Hillard M. Lazarus, MD; Robert Peter Gale, MD, PhD, DSc (hon), FACP; Armand Keating, MD, FRCP(C); Andrea Bacigalupo, MD; Reinhold Munker, MD; Kerry Atkinson, MBBS, MD, DTM&H, FRCP, FRACP; and...

Love Triumphs Amid a Battle With Cancer

BOOKMARK Title: The Red Devil: To Hell With Cancer—and BackAuthor: Katherine Russell RichPublisher: CrownDate Published: October 1999Price: $23.95, hardcover, 256 pages Over the past year or so, there have been several best-selling memoirs of people fighting and ultimately losing their battle with ...

hematologic malignancies
leukemia

Perlmutter Cancer Center Expands Clinical Leukemia Program

NYU Langone Health has announced that nationally renowned physician and researcher Raoul Tibes, MD, PhD, Associate Professor of Hematology and Medical Oncology at NYU School of Medicine, will lead efforts to expand the clinical and investigative leukemia programs at its Perlmutter Cancer Center....

hematologic malignancies

Liposome-Encapsulated Daunorubicin and Cytarabine for AML Subtypes

On August 3, 2017, a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) was approved for treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.1,2 This is the first U.S. Food and Drug...

hematologic malignancies
lymphoma

Acalabrutinib in Previously Treated Mantle Cell Lymphoma

On October 31, 2017, the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) was granted accelerated approval for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.1,2 Supporting Efficacy Data Approval was based on objective response...

solid tumors

Future Directions for CAR T-Cell Therapy

Chimeric antigen receptor (CAR) T-cell therapy burst upon the scene as an innovative approach to the treatment of hematologic malignancies, mainly for patients who have exhausted all other treatment options. Recently two CAR T-cell products were approved by the U.S. Food and Drug Administration...

Seattle Translational Tumor Research Presents Precision-Medicine Grant Winners

Five cross-disciplinary research groups involving scientists from Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, and Seattle Cancer Care Alliance have received $100,000 in awards from Fred Hutchinson Cancer Research Center–based Seattle Translational Tumor...

hematologic malignancies
lymphoma

Born in Chicago, Lymphoma Specialist Sonali M. Smith, MD, Never Left the Windy City

Nationally recognized lymphoma expert Sonali M. Smith, MD, was born and reared in Chicago to a mother who was a pediatrician and allergist, and a father who was an engineer. Her parents were first-generation immigrants from India who placed the value of education second to none. “I became used to...

Read the Inaugural ASCO Connection: Cancer Policy Issue

ASCO Connection has released ASCO Connection: Cancer Policy, a supplemental issue that provides the latest information and analysis related to cancer policy news and updates on ASCO’s ongoing advocacy efforts.  This inaugural special edition serves as a “year in review” of ASCO’s legislative...

issues in oncology

CMS Finalizes 340B Cuts, Part B Drugs in Quality Payment Program, 2018 Physician Fee Schedule

The Centers for Medicare & Medicaid Services (CMS) released its final rule on the 2018 Hospital Outpatient Prospective Payment System (PPS). In the rule, CMS finalized a proposal to cut reimbursement for separately paid drugs under the 340B Drug Pricing Program (340B) from average sales price...

supportive care
palliative care

Walther Cancer Foundation Endows New ASCO Special Award and Lecture for Palliative and Supportive Care

The Walther Cancer Foundation, Inc., a private foundation based in Indianapolis, Indiana, has endowed a new ASCO award and lecture bearing its name to be presented annually at the Palliative and Supportive Care in Oncology Symposium. This grant represents a new foray for the foundation as it...

Highlights From the Conquer Cancer Foundation’s Third Annual Career Development Retreat

The Conquer Cancer Foundation of ASCO is committed to supporting the research and career development of young researchers through its Grants & Awards Program. In October 2017, Conquer Cancer hosted its third Scientific and Career Development Retreat at ASCO Headquarters in Alexandria,...

hematologic malignancies

Answers to Hematology Expert Review Questions

Question 1  Which statement about epidemiology and clinical features of atypical CML is correct? Correct answer: C. Symptoms of atypical CML may be related to anemia and thrombocytopenia. Expert PerspectiveThe exact incidence of atypical CML is unknown, but the median patient age at diagnosis is in ...

hematologic malignancies
lymphoma

Follicular Lymphoma: Is the Road to Cure Paved With Gallium?

The roadside along the path to curing follicular lymphoma is riddled with the debris of failed cytotoxic regimens. For decades, clinical trials unsuccessfully pitted various chemotherapy combinations against each other. It took but a single, noncytotoxic molecule, rituximab (Rituxan), to forever...

issues in oncology

Shifting Landscape of Oncology Drug Development and Approvals

Future oncology drug development and approvals will be faster and more efficient as well as take the patient experience more into account, said Richard Pazdur, MD, Director of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA). The Center was established as part of...

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