An interim analysis of a small phase Ib study by O’Hara et al evaluating the CD40 agonistic monoclonal antibody APX005M in combination with gemcitabine and nab-paclitaxel with or without the programmed cell death protein 1 (PD-1) inhibitor nivolumab in untreated patients with metastatic...
The results of an analysis of pooled data from the phase Ib KEYNOTE-028 trial and the phase II KEYNOTE-158 study of the anti–programmed cell death protein 1 monoclonal antibody pembrolizumab in the treatment of advanced small cell lung cancer has found that the therapy provided antitumor...
A small phase I study by Navai et al investigated a combination of lymphodepletion chemotherapy and HER2-specific chimeric antigen receptor (CAR) T-cell therapy for pediatric and adult patients with advanced HER2-positive sarcoma. The combination showed promising antitumor activity and was found to ...
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report, including updates on regulatory reviews and initiatives, OCE programs, guidances, and more. Regulatory Reviews The OCE is tasked with clinical medical oncology reviews, irrespective...
In a phase Ib/II trial reported in the Journal of Clinical Oncology, Wei et al found that the combination of venetoclax and low-dose cytarabine produced a high response rate in previously untreated older patients with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy. In...
ASCO’S CONQUER CANCER FOUNDATION is pleased to announce the recipients of the Gastrointestinal Cancers, Genitourinary Cancers, and Clinical Immuno-Oncology Symposium Merit Awards. Conquer Cancer Merit Awards recognize oncology fellows’ and trainees’ high-quality research submitted in abstracts to...
ASCO HAS PUBLISHED a new guideline, “Safe Handling of Hazardous Drugs: ASCO Standards,” to promote the safety of pharmacists, nurses, and all staff who handle potentially dangerous medicines, such as chemotherapy compounds.1 Safety is pivotal in the entire drug workflow, including drug mixing and...
ASCO ENDORSES and reinforces the evidence-based American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO) Guideline published in 2018 in the Journal of Urology. ASCO’s endorsement of a guideline on clinically localized...
THE MANAGEMENT of localized prostate cancer remains controversial. Although the widespread use of prostate-specific antigen (PSA) testing has resulted in a dramatic increase in the diagnosis and treatment of prostate cancer, many men do not benefit from intervention because the disease is either...
AS REPORTED in The New England Journal of Medicine by Anna Bill-Axelson, MD, PhD, Lars Holmberg, MD, PhD, both of Uppsala University Hospital, and and colleagues, the 29-year follow-up of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) trial has shown that radical prostatectomy is...
IN PATIENTS with newly diagnosed multiple myeloma who responded well to induction therapy and underwent transplant, 2 years of maintenance therapy with ixazomib led to a 38% improvement in progression-free survival compared with placebo, according to the results of the phase III TOURMALINE-MM3...
THE ASCO POST asked Ajay K. Nooka, MD, MPH, Associate Professor, Division of Bone Marrow Transplant at Winship Cancer Institute, Emory University, to comment on studies involving daratumumab. “After the phase III SWOG S0777 trial demonstrated a survival benefit with a 3-drug induction regimen...
DARATUMUMAB APPEARS to be the “gift that keeps on giving” to the myeloma community. “It seems we can add daratumumab to almost anything and make the regimen better. It’s got good activity and a good safety profile,” said Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt...
THE PHASE III IMpassion130 trial, first reported at the European Society for Medical Oncology (ESMO) 2018 Congress1 and published in The New England Journal of Medicine,2 found that the combination of front-line atezolizumab plus nab-paclitaxel significantly improved disease-free and overall...
IN A MOVE that is a significant departure from current testing recommendations, the American Society of Breast Surgeons (ASBrS) recommends that genetic testing be available to all individuals newly diagnosed with breast cancer.1 The new recommendations expand on common restrictions by the National...
MULTIPLE POLY (ADP-ribose) polymerase (PARP) inhibitors are under study in metastatic prostate cancer and no clear winner has emerged yet. Some studies suggest that the best use of PARP inhibitors may be in patients whose cancers harbor DNA-repair defects and BRCA1/2 mutations, but other data...
ON DECEMBER 14, 2018, trastuzumab-pkrb (Herzuma) was approved as a biosimilar to trastuzumab for patients with HER2-overexpressing breast cancer.1 Trastuzumab-pkrb is indicated for adjuvant treatment of HER2-overexpressing breast cancer and metastatic HER2-overexpressing breast cancer.2 Health-care ...
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...
THE ANNUAL GASTROINTESTINAL CANCERS SYMPOSIUM took place earlier this year in San Francisco. In addition to important studies captured in our past few issues, The ASCO Post here briefly summarizes additional interesting studies. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Colon Cancer...
PATIENTS WITH advanced non–small cell lung cancer (NSCLC) may no longer have to come to the clinic every 2 weeks for treatment. According to a descriptive analysis of the phase IIIb/IV CheckMate 384 study, a more convenient dosing option of nivolumab has demonstrated convincing short-term safety...
As reported in the Journal of Clinical Oncology by Rosenthal et al, the phase III NRG Oncology RTOG 0521 trial showed that the addition of docetaxel to androgen suppression and radiotherapy improved overall and disease-free survival as well as the distant metastasis rate in patients with high-risk...
A new method of determining the sequence of molecules in DNA can be used to detect small fragments of cancerous genetic material in blood samples from patients with lung cancer with a high degree of accuracy, according research published by Li et al in Annals of Oncology. Liquid Biopsies and...
As reported in The Lancet Oncology by Meric-Bernstam et al, the combination of pertuzumab and trastuzumab showed activity in HER2-amplified metastatic colorectal cancer in the phase IIa multiple basket study MyPathway. The study is evaluating activity of targeted therapies in nonindicated tumor...
A treatment previously shown to treat the precancerous skin lesions called actinic keratosis now appears to also reduce the chance that these pretreated lesions will develop into squamous cell carcinoma. In a report published by Rosenberg et al in JCI Insight, researchers found that treatment with...
A study among epithelial ovarian cancer survivors from 25 cooperative Gynecologic Cancer Intergroup centers in France showed similar quality of life compared to healthy controls who were randomly selected from the electoral rolls, but persistent long-term fatigue. The researchers found depression,...
A study of over 64,000 women of childbearing age in the United States has found that infertility is associated with a higher risk of developing cancer compared to a group of over 3 million women without fertility problems—although the absolute risk is very low, at just 2%. These findings ...
Researchers have found the lower risk of breast cancer associated with multiple pregnancies and breastfeeding in the general population extends to those at the highest risk of breast cancer. These results were published by Terry et al in the JNCI Cancer Spectrum. Methods and Findings The...
In the phase II TBCRC 022 trial reported in the Journal of Clinical Oncology, Freedman et al found that the combination of neratinib and capecitabine was active against brain metastases in women with HER2-positive breast cancer. Modest activity of neratinib monotherapy had been found in previous...
Watch upcoming issues of The ASCO Post for news reports from the 2019 Multidisciplinary Thoracic Cancers Symposium, taking place March 14-16, 2019, in San Diego. Watch for reports on these presentations, plus much more. “Improved Overall Survival with Local Consolidative Therapy in...
In a French phase III trial reported in JAMA Oncology, Stéphane Oudard, MD, PhD, of Hôpital Européen Georges Pompidou, and colleagues found that the addition of docetaxel to androgen-deprivation therapy (ADT) did not improve prostate-specific antigen (PSA) progression-free survival in men with...
Most oncologists are comfortable treating lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) patients with cancer, according to a survey of 149 oncologists from 45 National Cancer Institute–designated Comprehensive Cancer Centers, but not as confident in their knowledge of the...
At the end of 2015, I was dying. I was just 50 years old and a wife and mother of 2 teenage boys. Twelve years earlier, I had been diagnosed with ductal carcinoma in situ in my left breast. Despite a modified radical mastectomy and removal of nearly all of the lymph nodes in my left underarm—which ...
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,...
On January 15, 2019, WebMD, an online and print health-care resource for consumers, presented its 2018 Health Heroes Award in New York City to 7 people who are making a difference in oncology care. The honorees include Karen M. Winkfield, MD, PhD, Associate Professor of Radiation Oncology at Wake...
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer. IMpower133 Approval was based on the IMpower133 study, a...
Two recent publications in The New England Journal of Medicine (NEJM), and the resulting drug approval applications that have already been filed, lead to concern that the basis of medical practice on valid evidence may be corrupted. Each involves statistically shaky analysis leading to a striking...
In the 20-plus years I have spent in hematologic oncology, I have been fortunate to have a ringside seat to watch “game-changing” advances come into our field—all-trans retinoic acid for acute promyelocytic leukemia, tyrosine kinase inhibitors starting with imatinib for chronic myeloid leukemia,...
As reported in The New England Journal of Medicine by Stephen J. Schuster, MD, of Abramson Cancer Center, University of Pennsylvania, and colleagues, the international phase II JULIET trial has shown high response rates with the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel in...
Researchers have shown that testosterone replacement may slow the recurrence of prostate cancer in low-risk patients. Findings from the study were presented by Towe et al at the European Association of Urology (EAU) 2019 Congress (Abstract 646). Practitioners have long regarded testosterone as a...
For more than 3 decades, the American Skin Association (ASA) and its affiliates have funded more than $50 million in grants to address the causes and treatments of melanoma, vitiligo, and psoriasis, as well as other skin diseases, and to search for cures. Recently, the American Skin Association...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on several different kinds of treatments for kidney cancer. These trials are evaluating gene therapy, immunotherapy, chemotherapy, radiotherapy, and combinations thereof....
In 2015, ASCO and the European Society for Medical Oncology (ESMO) introduced value frameworks that utilize algorithmic scales to evaluate the clinical benefit of cancer therapies and provide an objective assessment of outcomes and treatment toxicities experienced by patients.1,2 Although the two...
A new approach to cancer follow-up care is required to meet the needs of the growing population of cancer survivors in the United States, while also addressing provider shortages and rising costs, according to a new multiagency report. The report—published by Alfano et al in CA: A Cancer ...
In a linked Surveillance, Epidemiology, and End Results and Medicare study reported in the Journal of Clinical Oncology, Salz et al found that chronic opioid use varied by cancer among older cancer survivors. By 6 years after diagnosis, survivors were no more likely to be chronic opioid users...
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
The incidence of nonmelanoma skin cancer may be more common in recipients of kidney transplants vs patients on maintenance dialysis. Researchers looked to determine if the risk of nonmelanoma skin cancer is lower during periods of graft loss with a return to dialysis vs during periods of...
Treatment with conformal radiation therapy immediately following surgery in children with ependymoma may greatly improve survival. The findings were published by Merchant et al in the Journal of Clinical Oncology. “Historically, children under the age of 3 with ependymoma have a worse...
In a phase III trial reported in the Journal of Clinical Oncology, Gulley et al found that PROSTVAC, a viral vector-based immunotherapy, did not improve overall survival or 6-month event-free survival vs placebo in patients with asymptomatic or minimally symptomatic metastatic castration-resistant...
In a retrospective cohort study reported in The Lancet Oncology, Chanzá et al found evidence of activity of cabozantinib in advanced non–clear cell renal carcinoma. Cabozantinib is approved in metastatic renal cell carcinoma on the basis of studies in clear cell histology. As noted by ...
In the phase I/II SWOG S1313 trial, which was reported in the Journal of Clinical Oncology by Ramanathan et al, researchers found that the addition of pegylated recombinant human hyaluronidase (PEGPH20) to modified (m) FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) worsened...