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immunotherapy

Extended-Interval vs Standard-Interval Dosing of Single-Agent Pembrolizumab

In a retrospective cohort study performed in U.S. veterans reported in JAMA Oncology, Strohbehn et al found that a minority of patients receiving singe-agent pembrolizumab for cancer received the extended-interval dosing of 400 mg every 6 weeks. Analysis of efficacy measured as the time to...

hepatobiliary cancer

FDA Grants Accelerated Approval to Futibatinib for Previously Treated Patients With FGFR2-Mutated Cholangiocarcinoma

On September 30, the U.S. Food and Drug Administration (FDA) granted accelerated approval to futibatinib (Lytgobi) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or...

lymphoma
immunotherapy

Changing the Algorithm for Relapsed or Refractory Large B-Cell Lymphomas

Despite a significant potential for cure, relapsed and refractory large B-cell lymphomas (LBCL) comprise the most common cause of lymphoma-related mortality. Sequential relapses reflect the limits of repeated exposure to chemotherapy, even when delivered at high doses. More than 30 years ago,...

Expert Point of View: Benjamin Besse, MD, PhD

Discussant of the IMpower010 abstract, Benjamin Besse, MD, PhD, Professor and Head of Clinical Research at Institute Gustave Roussy, Villejuif, France, said there is enough evidence to use adjuvant immunotherapy in stage II–IIIA resected non–small cell lung cancer (NSCLC), calling the increased...

lung cancer

IMpower010: Early Survival Data Favor Atezolizumab Over Best Supportive Care in Resected NSCLC With PD-L1 Expression ≥ 50%

Early results from the IMpower010 trial showed an overall survival trend favoring adjuvant atezolizumab vs best supportive care for patients with PD-L1–positive (tumor expression ≥ 1%), stage II–IIIA (UICC/AJCC staging system, 7th ed), resected non–small cell lung cancer (NSCLC). These data were...

lung cancer

NADIM Trial: Neoadjuvant Chemoimmunotherapy Improved Survival in Resectable, Stage IIIA NSCLC

In patients with resectable, stage IIIA non–small cell lung cancer (NSCLC), the addition of neoadjuvant nivolumab to platinum-based chemotherapy significantly improved overall survival compared with neoadjuvant chemotherapy alone, according to data presented by Mariano Provencio, MD, PhD, at the...

supportive care
symptom management

FDA Approves Sodium Thiosulfate to Reduce the Risk of Ototoxicity Associated With Cisplatin

On September 20, the U.S. Food and Drug Administration (FDA) approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized (nonmetastatic) solid tumors. Efficacy was evaluated in two multicenter,...

Expert Point of View: Jacek Jassem, MD

Abstract discussant, Jacek Jassem, MD, of the Medical University of Gdansk, in Poland, underscored smoking as the most important cause of lung cancer, noting that between 85% and 90% of patients with lung cancer are current or former smokers. “Lung cancer screening, which has recently become...

lung cancer

High-Intensity Intervention Helps One-Third of Participants in Lung Cancer Screening Program Quit Smoking

Despite significant advancements in cancer therapy, a primary means to avoid lung cancer is prevention, and smoking cessation is the most basic intervention. Unfortunately, for long-term smokers, that intervention can sometimes be the most challenging. According to data presented during the...

kidney cancer
immunotherapy

Adjuvant Atezolizumab Does Not Improve Disease-Free Survival in Patients With Renal Cell Carcinoma

Adjuvant therapy with the anti–PD-L1 therapy atezolizumab failed to improve disease-free survival compared to placebo in patients with renal cell carcinoma (RCC) at high risk of recurrence after resection, according to results of the phase III IMmotion010 trial presented by Axel Bex, MD, PhD, at...

colorectal cancer

FRESCO-2: Fruquintinib for Patients With Refractory Metastatic Colorectal Cancer

Researchers reported study results showing that fruquintinib, a small-molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR), significantly improved overall survival and progression-free survival in patients with refractory metastatic colorectal cancer. Findings...

skin cancer
immunotherapy

Neoadjuvant Cemiplimab in Patients With Stage II to IV Cutaneous Squamous Cell Carcinoma

In an international, multicenter phase II clinical trial, 63.3% of patients with stage II to IV cutaneous squamous cell carcinoma saw their tumors nearly or completely eradicated when treated with the anti–PD-1 agent cemiplimab-rwlc before surgery. The results were presented by Gross et al at the...

skin cancer
immunotherapy

SWOG S1801: Neoadjuvant and Adjuvant Pembrolizumab for Patients With Stage IIIB to IV Melanoma

Patients with high-risk melanoma who received the anti–PD-1 therapy pembrolizumab both before and after surgery to remove cancerous tissue had a significantly lower risk of their cancer recurring than similar patients who received the drug only after surgery. These results from a study by the SWOG...

prostate cancer

PRESTO: Treatment Beyond Androgen-Deprivation Therapy for Relapsed Patients With High-Risk Prostate Cancer

Aggarwal et al presented data from PRESTO (AFT-19) at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA63), the first trial to evaluate whether intensifying treatment beyond androgen-deprivation therapy (ADT) by adding apalutamide with or without abiraterone acetate plus...

breast cancer

TROPiCS-02 Update: Sacituzumab Govitecan Improves Overall Survival in Previously Treated Patients With Hormone Receptor–Positive, HER2-Negative Breast Cancer

An overall survival benefit has now emerged for sacituzumab govitecan-hziy in patients with previously treated hormone receptor–positive/HER2-negative locally recurrent inoperable or metastatic breast cancer, according to a planned second interim analysis of the phase III TROPiCS-02 trial. These...

solid tumors

Nirogacestat for Progressive Desmoid Tumors: DeFi Trial

Significant improvements in progression-free survival and response rate—combined with reduced symptoms and better quality of life—were reported as outcomes of a new treatment approach for patients with desmoid tumors, benign but locally aggressive and invasive soft-tissue tumors. Through targeting...

kidney cancer
immunotherapy

COSMIC-313: Cabozantinib, Nivolumab, and Ipilimumab in Previously Untreated Patients With Advanced Renal Cell Carcinoma

A targeted kinase inhibitor added to a two-drug immunotherapy combination slowed the progression of advanced kidney cancer in previously untreated patients, according to research led by Toni K. Choueiri, MD. Dr. Choueiri, who is the Director of the Lank Center for Genitourinary Cancer at...

kidney cancer
immunotherapy

PROSPER RCC: Neoadjuvant Nivolumab Prior to Nephrectomy Followed by Additional Nivolumab in Patients With Renal Cell Carcinoma

The ECOG-ACRIN Cancer Research Group presented data from PROSPER RCC (EA8143), the first randomized phase III trial of neoadjuvant immunotherapy in patients with kidney cancer, at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA67). Patients with high-risk renal cell...

multiple myeloma

Bispecific Antibodies and the Dawn of a New Era in Treatment of Multiple Myeloma

“I think the biggest innovations of the 21st century will be at the intersection of biology and technology. A new era is beginning!”  —Steve Jobs Relapsed and refractory multiple myeloma remains a treatment challenge. Promising responses have been demonstrated with bispecific antibodies, with a...

issues in oncology

How EQRx Aims to Reengineer the Health-Care System to Produce More Effective, Less Costly Cancer Drugs

The numbers are dizzying. The costs of cancer care in the United States are rising so fast that by 2030, it is projected the national cancer-attributable costs will total more than $246 billion, up from $183 billion in 2015—a 34% increase.1 And although the total global economic burden of cancer is ...

Wall Street Doesn’t Believe in This Target

March 2, 2009. Just published in the Journal of Clinical Investigation.1 And we even got the cover. Twists and turns of heat shock protein-90 (Hsp90), the chaperone, the evolutionary capacitor. Great name and important cancer target. People smiled when I talked about this at the Hsp90 conference....

head and neck cancer

Concurrent Chemoradiation Therapy With Weekly Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma

When combined with radiotherapy as definitive treatment of locally advanced head and neck squamous cell carcinoma, cisplatin at a dose of 40 mg/m2 weekly is noninferior to cisplatin at 100 mg/m2 every 3 weeks, according to the results of the ConCERT trial.1 These findings were presented by Atul...

multiple myeloma

Final Analysis of GRIFFIN Study Presented for Daratumumab-Based Investigational Quadruplet Regimen in Newly Diagnosed, Transplant-Eligible Patients With Multiple Myeloma

The randomized phase II GRIFFIN study evaluated the investigational use of daratumumab in combination with lenalidomide, bortezomib, and dexamethasone (RVd), followed by maintenance therapy with daratumumab and lenalidomide, compared to RVd followed by maintenance therapy with lenalidomide alone,...

lung cancer
immunotherapy

DART Trial: Concurrent Radiotherapy Plus Durvalumab Active in Older Patients With Locally Advanced Lung Cancer

Interim results of a phase II study have demonstrated the safety and feasibility of treating elderly and frail patients with locally advanced non–small cell lung cancer (NSCLC) with the monoclonal antibody durvalumab during and after radiation therapy, without chemotherapy. The results of a...

head and neck cancer

De-escalation of Radiation Therapy for HPV-Positive, Intermediate-Risk Oropharyngeal Cancer

De-escalated adjuvant radiotherapy appears to be safe in patients with surgically resectable, human papillomavirus (HPV)--positive oropharyngeal cancers, particularly in patients without extranodal extension or pN2 disease by American Joint Committee on Cancer (AJCC) 8th edition. These findings...

head and neck cancer
immunotherapy

Tislelizumab Plus Chemotherapy Improves Progression-Free Survival in Nasopharyngeal Cancer

The addition of the checkpoint inhibitor tislelizumab to first-line chemotherapy significantly reduced the risk of disease progression or death by 50% and, despite a 49% crossover rate, numerically boosted overall survival in patients with recurrent or metastatic nasopharyngeal cancer, Zhang et al...

head and neck cancer

Head and Neck Cancer 2021–2022 Almanac

Head and neck cancer is the seventh most common cancer in the world, with 1.1 million new diagnoses reported annually.1 In the United States, the incidence of oral and pharyngeal cancers is over 54,000 cases per year, resulting in over 11,000 yearly deaths.2 Although smoking and alcohol consumption ...

leukemia
lymphoma
myelodysplastic syndromes

FDA Approves Pemigatinib for Patients With Myeloid/Lymphoid Neoplasms and FGFR1 Rearrangement

On August 26, the U.S. Food and Drug Administration (FDA) approved pemigatinib (Pemazyre), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Myeloid/lymphoid neoplasms with...

neuroendocrine tumors
gastrointestinal cancer

Etoposide/Cisplatin vs Irinotecan/Cisplatin in Advanced Digestive System Neuroendocrine Carcinoma

In a Japanese phase III trial (TOPIC-NEC) reported in JAMA Oncology, Morizane et al found no difference in overall survival with etoposide/cisplatin (EP) vs irinotecan/cisplatin (IP) in chemotherapy-naive patients with advanced digestive system neuroendocrine carcinoma. Study Details The open-label ...

prostate cancer

MRI-Guided Ultrasound Focal Therapy May Delay or Avoid Prostatectomy or Radiotherapy in Patients With Intermediate-Risk Prostate Cancer

MRI-guided focused ultrasound focal therapy produced “a high degree of success” and “a low rate of genitourinary adverse events” when used to treat select patients with intermediate-grade prostate cancer, Behfar Ehdaie, MD, MPH, and colleagues reported in The Lancet Oncology.1 Dr. Ehdaie is...

symptom management
supportive care

FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-vs-Host Disease

On August 24, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for pediatric patients aged at least 1 year with chronic graft-vs-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. iMAGINE Trial...

prostate cancer

Long-Term Benefit of Radiotherapy Confirmed in Advanced Prostate Cancer: STAMPEDE Trial Follow-up

Radiotherapy to the prostate in addition to standard treatment may improve survival for some men with advanced prostate cancer without detriment to quality of life, long-term study results from the STAMPEDE trial confirmed. These findings were published by Chris C. Parker, MD, and colleagues in...

breast cancer

APHINITY Trial in Patients With HER2-Positive Early Breast Cancer: Update at 8 Years

Updated results from the adjuvant APHINITY trial in HER2-positive early breast cancer, now with a median follow-up of 8.4 years, confirmed the benefit of adding pertuzumab to trastuzumab plus chemotherapy in preventing invasive disease recurrences, but as yet no statistically significant overall...

Expert Point of View: Katrina S. Pedersen, MD, MS

Katrina S. Pedersen, MD, MS, Assistant Professor of Medicine at Washington University School of Medicine, St. Louis, said while the results of the phase II -SEQUENCE trial1 are encouraging and the drugs are available to translate into the clinic without delay, phase III validation would be needed...

pancreatic cancer

Sequencing Therapies May Improve Overall Survival in Metastatic Pancreatic Cancer

In the first-line treatment of metastatic pancreatic cancer, the sequencing of nab-paclitaxel plus gemcitabine with FOLFOX (fluorouracil, leucovorin, oxaliplatin) resulted in a significant improvement in overall survival at 12 months and in all other efficacy endpoints as compared with the standard ...

solid tumors

Snapshots of Studies of Interest Presented at ASCO 2022

The 2022 ASCO Annual Meeting was filled with important science, engaging data, and several practice-changing abstracts, many of which have been covered in detail on other pages or in earlier issues of The ASCO Post. There were numerous high-impact studies and attendees, whether present at the...

colorectal cancer

Study Tests Strategy for Reducing Colorectal Cancer Risk Among Patients With Familial Adenomatous Polyposis

Researchers from the Mayo Clinic Comprehensive Cancer Center and the Mayo Clinic Center for Individualized Medicine are studying the rare genetic condition called familial adenomatous polyposis, looking for potential ways to prevent colorectal cancer in the general population at an earlier, more...

breast cancer
immunotherapy

T-DXd Shows High Intracranial Response Rate in Patients With Active Brain Metastases From HER2-Positive Breast Cancer

In the investigator-initiated, prospective, open-label, single-arm phase II TUXEDO-1 study conducted among patients with newly diagnosed or progressive brain metastases from HER2-positive breast cancer, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) yielded responses according...

gastroesophageal cancer

RATIONALE-306: Survival Benefit Attained With Tislelizumab in Advanced Esophageal Cancer

In patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of the checkpoint inhibitor tislelizumab to first-line chemotherapy significantly improved overall survival vs chemotherapy alone, according to an interim analysis of the global phase III RATIONALE-306 trial....

genomics/genetics

Pralsetinib Achieves Tissue-Agnostic Benefits for Patients With RET Fusion–Positive Cancers

The highly selective RET inhibitor pralsetinib was well tolerated and demonstrated robust, durable responses in patients with RET fusion–positive cancers regardless of tumor type, according to results from the international phase I/II ARROW trial. Results from the trial were published in Nature...

issues in oncology

Characteristics of Data Supporting FDA Initial Approval and Subsequent Indications for New Cancer Drugs

In a study reported in the Journal of Clinical Oncology, Michaeli and Michaeli described data supporting U.S. Food and Drug Administration (FDA) initial approval and subsequent indications for new cancer drugs from 2003 through 2021. Study Details Clinical trial evidence supporting approval for...

lung cancer
genomics/genetics
immunotherapy

Study Finds Adding Tremelimumab and Durvalumab to Chemotherapy Improves Overall Survival in Metastatic NSCLC Regardless of KRAS/STK11/KEAP1 Mutations

Patients with metastatic non–small cell lung cancer (NSCLC) who received a combined therapy of tremelimumab, durvalumab, and chemotherapy experienced longer overall survival compared with those who received chemotherapy alone, regardless of STK11, KEAP1, or KRAS mutational status. These findings...

prostate cancer

FDA Approves Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer

On August 5, 2022, the U.S. Food and Drug Administration approved darolutamide (Nubeqa) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer. The evaluation of efficacy was based on ARASENS (ClinicalTrials.gov identifier NCT02799602), a...

cns cancers

Outcomes With Postconsolidation Dinutuximab-Based Immunotherapy for Neuroblastoma

In an analysis reported in the Journal of Clinical Oncology, Desai et al described outcomes with postconsolidation dinutuximab-based immunotherapy for high-risk neuroblastoma in a cohort of patients from the Children’s Oncology Group ANBL0032 trial following cessation of randomized treatment. Study ...

multiple myeloma

ATLAS Trial: Risk-Adapted Triplet Maintenance Therapy May Benefit Some Patients With Multiple Myeloma

For newly diagnosed patients with multiple myeloma participating in the international phase III ATLAS trial, use of carfilzomib, lenalidomide, and dexamethasone (KRd) as maintenance therapy after induction and autologous stem cell transplantation (ASCT) significantly reduced the risk of disease...

colorectal cancer

CAIRO5 Determines Optimal Approach to Colorectal Liver Metastases

In the phase III CAIRO5 study, conducted by the Dutch Colorectal Cancer Group, triplet vs doublet chemotherapy plus bevacizumab significantly increased progression-free survival, response rate, and the rate of R0/R1 resections, with and without ablation, in patients with initially unresectable...

lymphoma

ECHELON-1 Trial: Brentuximab Vedotin With Chemotherapy Offers Survival Benefit in Stage III or IV Hodgkin Lymphoma

Brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (a regimen known as A+AVD) significantly reduced the risk of mortality vs standard treatment with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in patients with previously untreated stage III or IV classical Hodgkin...

breast cancer

PALOMA-2: No Overall Survival Benefit Reported With Palbociclib/Letrozole in Advanced Breast Cancer

The final overall survival analysis of the phase III PALOMA-2 trial has shown no significant benefit for palbociclib given with letrozole, vs letrozole and placebo, as a first-line treatment in hormone receptor–positive, HER2-negative metastatic breast cancer.1 The results were reported at the 2022 ...

breast cancer

Study Finds Radiation Therapy May Be Safely Omitted for Some Older Patients With Luminal A Breast Cancer

For some patients aged 55 or older with early-stage, low-risk breast cancer, endocrine therapy following breast-conserving surgery may be sufficient without the need for postoperative radiation therapy, according to the results of the prospective LUMINA trial, reported at the 2022 ASCO Annual...

breast cancer

Changing the Natural History of ER-Positive, HER2-Negative Breast Cancer With the Introduction of CDK4/6 Inhibition

It has been 14 years since a collaboration between the University of California, Los Angeles (UCLA) and Pfizer identified a unique role for cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in estrogen receptor (ER)-positive human cell line models and demonstrated that these agents act...

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