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Showing 401 - 450Addition of First-Line Veliparib to Chemotherapy in Advanced Squamous Cell NSCLC: No Survival Benefit in Current Smokers, but Potential Benefit Among Biomarker-Selected Patients
In a phase III trial reported in the Journal of Clinical Oncology, Suresh S. Ramalingam, MD, of Winship Cancer Institute, Emory University School of Medicine, and colleagues found that the addition of the PARP inhibitor veliparib to platinum-based chemotherapy did not improve overall survival in...
Study Reveals Gaps in Code Status Discussions Among Patients With High-Risk AML
Oncologists and health-care professionals who treat patients with high-risk acute myeloid leukemia (AML) are missing important opportunities to have end-of-life discussions at earlier stages in the disease course, when patients are best able to discuss their options and preferences. These findings...
Asciminib for Philadelphia Chromosome–Positive Chronic Myeloid Leukemia
On October 29, 2021, the oral kinase inhibitor asciminib was granted accelerated approval for adults with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase previously treated with at least two tyrosine kinase inhibitors and regular approval for adults with...
Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
On November 17, 2021, the immunotherapeutic agent pembrolizumab was granted approval for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.1 Supporting Efficacy Data...
Adding Pembrolizumab to Chemotherapy Improves Overall and Progression-Free Survival in First-Line Treatment of Advanced Esophageal Cancer
As reported in The Lancet by Jong-Mu Sun, MD, of Samsung Medical Center, Sungkyunkwan University, Seoul, and colleagues, an interim analysis in the phase III KEYNOTE-590 trial has shown that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free...
FDA Approves Pembrolizumab for the Adjuvant Treatment of Stage IIB or IIC Melanoma
On December 3, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients aged 12 years and older with stage IIB or IIC melanoma following complete resection. KEYNOTE-716 Efficacy was evaluated in KEYNOTE-716, a...
Neoadjuvant Chemoradiation Plus Pembrolizumab Shows No Effect on Tumor-Infiltrating Lymphocytes in Pancreatic Cancer
The addition of the checkpoint inhibitor pembrolizumab to neoadjuvant chemoradiation has failed to overcome the immunosuppressive microenvironment of pancreatic cancer, according to data presented by Osama E. Rahma, MD, and colleagues at the Society for Immunotherapy of Cancer (SITC) 2021 Annual...
High Response Rate With Venetoclax in Previously Treated Patients With Waldenström’s Macroglobulinemia
In a phase II study reported in the Journal of Clinical Oncology, Castillo et al found that venetoclax produced a high major response rate in previously treated patients with Waldenström’s macroglobulinemia. As stated by the investigators, “BCL2 is overexpressed and confers prosurvival signaling in ...
Cancer Incidence and Patterns in Individuals With Pathogenic/Likely Pathogenic Germline TP53 Variants
In an observational cohort study reported in The Lancet Oncology, de Andrade et al identified cancer incidence and patterns in individuals meeting criteria for Li-Fraumeni syndrome on the basis of presence of pathogenic or likely pathogenic germline TP53 variants. As stated by the investigators,...
KEYNOTE-564 Trial: Adjuvant Pembrolizumab Improves Disease-Free Survival in High-Risk Renal Cell Carcinoma
As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, and colleagues, an interim analysis of the phase III KEYNOTE-564 trial has showed improved disease-free survival with adjuvant pembrolizumab vs placebo after nephrectomy in high-risk...
Pembrolizumab Plus Chemotherapy With or Without Bevacizumab in First-Line Treatment of Advanced Cervical Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 13, 2021, pembrolizumab in combination with...
NETTER-1 Trial: Final Overall Survival Analysis of Lu-177 Dotatate Plus Long-Acting Octreotide vs High-Dose Long-Acting Octreotide for Midgut Neuroendocrine Tumors
As reported in The Lancet Oncology by Jonathan R. Strosberg, MD, and colleagues, the final overall survival analysis of the pivotal phase III NETTER-1 trial has shown an approximate 12-month benefit with the addition of lutetium-177 (Lu-177) dotatate to long-acting octreotide in patients with...
Accelerated Radiation Therapies Move Forward in Early Breast Cancer
Two studies reported at the 2021 American Society for Radiation Oncology (ASTRO) Annual Meeting provide evidence in support of the use of accelerated radiation therapies as safe alternatives to standard radiotherapy options following breast-conserving surgery. The phase III MC1635 trial showed...
From Cancer Survivor to Citizen Astronaut
When I was diagnosed with osteosarcoma of my left femur nearly 20 years ago, I remember telling my parents that I didn’t want to die. The diagnosis was terrifying because all the people I knew who had cancer had passed away, and I thought this cancer would kill me, too. That evening, my dad went...
Evorpacept Alone and Combined With Pembrolizumab or Trastuzumab for Advanced Solid Tumors
In the phase I ASPEN-01 study reported in The Lancet Oncology, Nehal Lakhani, MD, and colleagues found evidence of activity of the CD47-blocking protein evorpacept in combination with pembrolizumab or trastuzumab for the treatment of advanced solid tumors. As stated by the investigators, “Both...
Newer Agents on the Horizon for Refractory or Relapsed DLBCL
Although treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) remains challenging, some newer therapies on the horizon offer promise, including bispecific antibodies, anti-CD47 antibodies, antibody-drug conjugates, and chimeric antigen receptor (CAR) T-cell therapy,...
FDA Expands Eligibility for COVID-19 Vaccine Boosters
On November 19, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals aged 18 years and older after completion of primary vaccination with any ...
FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
On November 17, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of disease recurrence following nephrectomy or nephrectomy and resection of metastatic lesions....
President Biden Nominates Robert M. Califf, MD, MACC, as FDA Commissioner
President Joseph Biden has nominated Robert M. Califf, MD, MACC, for the position of Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf is an internationally recognized expert in clinical trial research, health disparities, health-care quality, and cardiovascular medicine....
Risks and Benefits Associated With Gastrostomy Tubes for Patients With Cancer
In a study published by Gauvin et al in JNCCN–Journal of the National Comprehensive Cancer Network, researchers examined over 200 patients with gastrostomy tubes and highlighted the need for a multidisciplinary approach to palliative care decision-making for patients with cancer. A gastrostomy tube ...
FDA Approves Asciminib for Philadelphia Chromosome–Positive CML
On October 29, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor asciminib (Scemblix) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with two or more tyrosine...
Addition of Vincristine, Topotecan, and Cyclophosphamide to Five-Drug Interval-Compressed Chemotherapy for Ewing Sarcoma
As reported in the Journal of Clinical Oncology by Leavey et al, the phase III Children’s Oncology Group AEWS1031 trial showed no improvement in event-free or overall survival with the addition of vincristine, topotecan, and cyclophosphamide (VTC) to standard five-drug interval-compressed...
FDA Expands Cetuximab Label for Encorafenib Combination in BRAF V600E Mutation–Positive Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for the EGFR inhibitor cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test,...
Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical Cancer
On September 20, 2021, tisotumab vedotin-tftv, a tissue factor-directed antibody and microtubule inhibitor conjugate, was granted accelerated approval for the treatment of adults with recurrent or metastatic cervical cancer who have had disease progression on or after chemotherapy.1 Supporting...
FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer
On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...
KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer
The latest analysis of the phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III trial to ...
Camrelizumab/Apatinib for High-Risk Chemorefractory or Relapsed Gestational Trophoblastic Neoplasia
In a Chinese single-institution phase II trial (CAP 01) reported in The Lancet Oncology, Cheng et al found that the PD-1 inhibitor camrelizumab in combination with the antiangiogenic agent apatinib produced a high rate of complete responses in women with high-risk chemorefractory or relapsed...
Adjuvant Pembrolizumab Shows Efficacy in High-Risk Stage II Melanoma in Adults and Children Older Than 12
Adjuvant pembrolizumab reduced the risk of recurrence in adults and children older than age 12 with high-risk stage II (AJCC 8th edition, stage IIB/IIC) melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial, presented during the European Society for...
Donations to St. Jude Children’s Research Center Soar; Inspiration4 SpaceX Journey Exceeds $200 Million Goal
On September 15, 2021, SpaceX launched the Inspiration4 mission, sending four civilians on a 3-day trip orbiting the earth. The passengers were the first to travel on an all-civilian space journey in an effort to further scientific and aerospace research while at the same time raise funds for...
Liver Biopsy for Evaluation of Hepatitis Associated With Immunotherapy
In a retrospective cohort study reported in a research letter in JAMA Oncology, Li et al found that the performance of liver biopsy in patients with grade ≥ 3 alanine aminotransferase (ALT) elevations during immune checkpoint inhibitor therapy was associated with a delayed start of corticosteroid...
FDA Expands Cetuximab Label With Combination of Encorafenib for Pretreated BRAF V600E Mutation–Positive Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adult patients with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, after prior...
Overall Survival With the Bispecific Fusion Protein Tebentafusp for Metastatic Uveal Melanoma
In an interim analysis of the phase III IMCgp100-202 trial reported in The New England Journal of Medicine, Nathan et al found that tebentafusp, a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector, significantly improved overall survival vs...
Pembrolizumab and Lenvatinib in Advanced Endometrial Carcinoma
On July 21, 2021, pembrolizumab in combination with lenvatinib was granted regular approval for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient who have disease progression following prior systemic therapy in any...
Paradox Between Cost and Hematopoietic Cell Transplant Rate in Latin America
In this installment of The ASCO Post’s Global Oncology series, Guest Editor Chandrakanth Are, MBBS, MBA, FRCS, FACS, spoke with Gregorio Jaimovich, MD, Director of the Bone Marrow Transplant Program at Favaloro University Hospital in Buenos Aires. Distinguished expert on radiation therapy and bone...
Lenvatinib Plus Pembrolizumab for First-Line Treatment of Advanced Renal Cell Carcinoma
On August 10, 2021, the combination of lenvatinib plus pembrolizumab was approved for first-line treatment of adults with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings from the three-arm, open-label, phase III CLEAR trial (Study 307/KEYNOTE-581;...
IASLC Announces Lifetime Achievement Awards
In conjunction with the 2021 World Conference on Lung Cancer, the International Association for the Study of Lung Cancer (IASLC) presented the following lifetime achievement awards. Paul A. Bunn, Jr, Scientific Award David Carbone, MD, PhD, received the Paul A. Bunn, Jr, Scientific Award. This...
ASCO 2021: Roundup of Studies You May Have Missed
As ASCO Annual Meeting attendees know by now, clinicians don’t have to be at McCormick Place to hear practice-changing findings and forward-looking advances in the field of oncology. Interesting content was no exception at the 2021 conference, so in addition to covering the biggest news from the...
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for the use of a single booster dose to be administered at least 6 months after completion of the primary series in individuals aged 65 years and older;...
FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...
Lenvatinib/Pembrolizumab Improves Survival in Advanced Endometrial Cancer in a Phase III Trial
In the first report from the pivotal phase III KEYNOTE-775/Study 309 trial, the combination of lenvatinib, a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3 kinases, and the PD-1 inhibitor pembrolizumab significantly improved multiple outcomes compared with standard single-agent chemotherapy in ...
Recent FDA Approvals in Endometrial Cancer
In recent months, the U.S. Food and Drug Administration approved two treatment options for patients with endometrial cancer, which are summarized herein. Dostarlimab-gxly for dMMR Endometrial Cancer On April 22, 2021, the FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for adult...
Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With KRAS Inhibitor in Lung Cancer
The KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses extended to all...
KEYNOTE-564: Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma
Adjuvant pembrolizumab following surgery significantly improved disease-free survival compared with placebo among patients with high-risk clear cell renal cell carcinoma (RCC), according to the international phase III KEYNOTE-564 study presented at the Plenary session during the 2021 ASCO Annual...
An Oncologist’s Prescription: Humanity and Love
Cancer care is one of the most technical and scientific of all medical disciplines. Oncologists must keep abreast of a dizzying array of novel treatment options coming out of the laboratory while delivering empathetic care for the physical and emotional needs of their patients with cancer....
Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...
FIFTY for FIFTY Campaign to Commemorate the National Cancer Act’s 50th Anniversary
The American Association for Cancer Research (AACR) Foundation has announced its FIFTY for FIFTY fundraising and awareness campaign in recognition of the 50th anniversary of the National Cancer Act. With this campaign, the AACR Foundation is committing to raise at least $50,000 for the AACR and...
Pembrolizumab for High-Risk, Early-Stage Triple-Negative Breast Cancer
On July 26, 2021, pembrolizumab was approved for high-risk, early-stage, triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and continued as adjuvant treatment.1 Pembrolizumab was also granted regular approval in combination with chemotherapy for locally...
Neoadjuvant Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab for Muscle-Invasive Bladder Cancer
In a phase II study reported in the Journal of Clinical Oncology, Tracy L. Rose, MD, MPH, and colleagues found that neoadjuvant therapy with pembrolizumab, gemcitabine, and primarily split-dose cisplatin resulted in pathologic downstaging (< pT2N0) in more than half of patients undergoing...
Global Breast Cancer Survival: Estimated Impact of Scaling Up Access to Treatment/Imaging Modalities and Quality of Care
In a study reported in The Lancet Oncology, Ward et al estimated the improvements in global overall survival for female breast cancer that could be achieved via increased availability of treatment and imaging modalities, as well as improvements in quality of care. Study Details The study used a...
Addition of Pembrolizumab to Chemotherapy for the First-Line Treatment of Advanced Esophageal Cancer: KEYNOTE-590
As reported in The Lancet by Sun et al, the phase III KEYNOTE-590 trial showed that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free survival in patients with advanced esophageal and Siewert type 1 gastroesophageal junction (GEJ) cancers....
