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gynecologic cancers
immunotherapy

Expert Point of View: Ana Oaknin, MD, PhD

The innovaTV 204 trial’s invited discussant, Ana Oaknin, MD, PhD, Head of the Gynecologic Cancer Program at Vall d’Hebron Institute of Oncology in Barcelona, was encouraged by the study’s findings. “Of note, the response rate was 24%, the time to response was short, and the median duration of...

colorectal cancer

Should Patients With a Complete Response to Neoadjuvant Chemoradiation for Rectal Cancer Also Undergo Surgery?

A nonsurgical treatment option for rectal cancer that preserves quality of life may be safe for selected patients, according to a new study comparing it with standard surgical treatment. These findings were published by Beard et al in the Journal of the American College of Surgeons and were...

myelodysplastic syndromes

Imetelstat in Lower-Risk MDS With High Transfusion Dependence

In the phase II portion of the phase II/III MDS3001 study reported in the Journal of Clinical Oncology, David P. Steensma, MD, and colleagues found that imetelstat—a first-in-class competitive inhibitor of telomerase enzymatic activity—markedly reduced the need for red blood cell transfusion in...

supportive care

Jing Li, MD, PhD, on Brain Metastases: Stereotactic Radiosurgery vs Whole-Brain Radiation Therapy

Jing Li, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses phase III results showing the use of stereotactic radiosurgery in patients with 4 to 15 brain metastases, compared with whole-brain radiotherapy, may better preserve cognitive function and minimize the interruption of ...

gynecologic cancers

SOLO-1 Trial: After 5 Years, Maintenance Olaparib Still Keeps Ovarian Cancer at Bay

The long-term results of the pivotal SOLO-1 trial have shown that maintenance olaparib more than doubles the 5-year disease-free survival time for patients who have newly diagnosed advanced ovarian cancer with BRCA mutations, according to an update presented at the European Society for Medical...

prostate cancer

Daniel E. Spratt, MD, on Prostate Cancer: Relugolix vs Leuprolide

Daniel E. Spratt, MD, of the University of Michigan Rogel Cancer Center, discusses phase III results of the HERO trial, which suggested benefits of the oral medication relugolix: a substantially faster time to castration with longer duration, fewer cardiac events, and a faster return to normal...

prostate cancer

Daniel E. Spratt, MD, on Prostate Cancer: Short-Term Adjuvant vs Neoadjuvant Hormone Therapy

Daniel E. Spratt, MD, of the University of Michigan Rogel Cancer Center, discusses a pooled analysis of two phase III trials showing adjuvant androgen-deprivation therapy (ADT) improves biochemical control and reduces distant metastasis when compared with a neoadjuvant approach, with no difference...

supportive care
pain management
palliative care

SBRT May Provide Superior Pain Relief From Spinal Metastases vs Conventional Radiotherapy

Stereotactic body radiation therapy (SBRT) was superior to conventional radiation therapy in reducing pain from spinal metastases in a phase II/III study reported by Arjun Sahgal, MD, and colleagues at the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract LBA 2). More...

head and neck cancer

Radiotherapy With Cisplatin vs Cetuximab in Previously Untreated Patients With Locoregionally Advanced Head and Neck Cancer

In the Swedish ARTSCAN III trial reported in the Journal of Clinical Oncology, Gebre-Medhin et al found that radiotherapy with concomitant cetuximab did not improve outcomes vs radiotherapy with cisplatin in patients with previously untreated, locoregionally advanced head and neck squamous cell...

prostate cancer

Paul Sargos, MD, on Prostate Cancer: Adjuvant or Early Salvage Radiotherapy Plus Androgen Deprivation

Paul Sargos, MD, of the Institut Bergonié, discusses phase III findings from the GETUG-AFU 17 study, which compared adjuvant vs early salvage radiotherapy, both combined with short-term androgen-deprivation therapy after radical prostatectomy for localized prostate cancer. Although lacking...

breast cancer

Juliane Hörner-Rieber, MD, on Breast Cancer: Boosting Intensity-Modulated and Conventional Radiotherapies

Juliane Hörner-Rieber, MD, of Heidelberg University Hospital, discusses phase III results of the MINT trial, which showed that conventionally fractionated intensity-modulated radiotherapy with a simultaneous integrated boost was noninferior to three-dimensional conformal radiotherapy followed by a...

supportive care
pain management

Arjun Sahgal, MD, on Reducing the Pain of Spinal Metastases: SBRT vs Palliative Radiotherapy

Arjun Sahgal, MD, of the Sunnybrook Health Sciences Centre, discusses results of the first phase III trial to suggest that dose escalation with stereotactic body radiotherapy may be superior to conventional palliative radiotherapy in improving pain outcomes for patients with spinal bone metastases...

supportive care

Stereotactic Radiosurgery May Delay Cognitive Deterioration vs WBRT in Patients With Numerous Brain Metastases

Stereotactic radiosurgery (SRS) may represent a new standard of care for patients with four or more brain metastases, replacing whole-brain radiation therapy (WBRT) in this setting, according to a phase III study presented at the virtual 2020 American Society for Radiation Oncology (ASTRO) Annual...

prostate cancer

Fluciclovine PET Imaging vs Conventional Imaging in Prostate Cancer

The addition of the radiotracer fluciclovine to positron-emission tomography (PET) imaging for treatment planning led to superior failure-free survival compared with conventional imaging in men with prostate cancer who had undergone radical prostatectomy and were experiencing biologic recurrence of ...

immunotherapy
skin cancer

Continued Benefit of First-Line Nivolumab vs Dacarbazine in Advanced BRAF Wild-Type Melanoma

The 5-year outcomes of the ­CheckMate 066 trial, reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, of Gustave Roussy, Villejuif, France,and colleagues, show continued benefit of first-line nivolumab vs dacarbazine in advanced BRAF wild-type melanoma and support evidence that ...

skin cancer

Recurrence-Free Survival Benefit Maintained With Adjuvant Nivolumab vs Ipilimumab in Stage IIIB–IIIC and IV Melanoma

As reported in The Lancet Oncology by Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, and colleagues, 4-year results of the CheckMate 238 trial show continued benefit of adjuvant nivolumab vs ipilimumab in recurrence-free survival and metastasis-free...

immunotherapy
skin cancer

Advanced Melanoma: Lenvatinib Plus Pembrolizumab After Disease Progression on Anti–PD-1 Therapy

Checkpoint inhibitors can be lifesaving for many patients with advanced melanoma, but those who experience disease progression currently have few treatment options. The combination of a tyrosine kinase inhibitor and an anti–PD-1 agent may offer some hope in this setting, according to a study of...

head and neck cancer

First-Line Pembrolizumab Plus Chemotherapy Improves Survival in Esophageal Cancer

As first-line therapy for advanced esophageal cancer, pembrolizumab added to chemotherapy improved overall survival in the KEYNOTE-590 population. Not only did patients with high PD-L1 expression benefit, the value of checkpoint inhibition was observed for the whole population, the trial’s...

FDA Awards Six Grants to Fund New Clinical Trials of Medical Products for Treatment of Rare Diseases

The U.S. Food and Drug Administration (FDA) announced it has awarded six new clinical trial research grants to principal investigators from academia and industry, totaling more than $16 million over the next 4 years. These grants, awarded through the Congressionally funded Orphan Products Grants...

Expert Point of View: Chiara Cremolini, MD, PhD

The KEYNOTE-177 invited discussant, Chiara Cremolini, MD, PhD, of the University of Pisa, Italy, welcomed the patient-reported outcomes of the study, noting that such data are frequently missing. “Unfortunately, quality of life is an often-disregarded issue in colorectal cancer clinical trials,”...

colorectal cancer

First-Line Pembrolizumab in Metastatic Colorectal Cancer: Quality of Life Also Improved

In KEYNOTE-177, the anti–PD-L1 antibody pembrolizumab reduced the risk of disease progression by 40% vs chemotherapy in a targeted subset of previously untreated patients with metastatic colorectal cancer. Now, in terms of health-related quality of life, pembrolizumab is also the clear favorite,...

prostate cancer

Ipatasertib/Abiraterone Combination Shows Potential in Metastatic Castration-Resistant Prostate Cancer With PTEN Loss

Ipatasertib plus abiraterone plus prednisone achieved significantly superior radiographic progression–free survival and antitumor activity compared with placebo plus abiraterone plus prednisonein patients with metastatic castration-resistant prostate cancer and PTEN loss, according to the results...

prostate cancer

Olaparib Improves Outcomes in Metastatic Castration-Resistant Prostate Cancer With BRCA1/2 Alterations

The PARP inhibitor olaparib reduced the risk of death by 31% compared with a second hormonal treatment (enzalutamide or abiraterone) in men with metastatic castration-resistant prostate cancer characterized by BRCA1, BRCA2, or ATM mutations, in the final analysis of the phase III PROfound trial...

solid tumors

Early-Phase Study Reports Progress in Targeting KRAS-Mutated Tumors With Sotorasib

Although KRAS is one of the most frequently mutated oncogenes in human cancers, an almost 4-decade long search for drugs that hit this target has been elusive—until now. Sotorasib (formerly called AMG-510), a small-molecule inhibitor of the KRAS G12C mutation, demonstrated clinical activity and...

lung cancer

EMPOWER-Lung 1 Trial: Cemiplimab Improves Survival Over Chemotherapy in Advanced NSCLC

The European Society for Medical Oncology (ESMO) Virtual Congress 2020 presented several abstracts with good news for patients with lung cancer. Long-term follow-up of immunotherapies showed excellent survival, a promising new ALK inhibitor improved outcomes compared with the standard of care, the...

bladder cancer
immunotherapy

Co-Leader of Immunotherapy Trial Reflects on ‘Practice-Changing’ Results in Advanced Bladder and Other Urinary Tract Cancers

In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...

Expert Point of View: Sjoukje Oosting, MD, PhD

Invited discussant of the xevinapant study, Sjoukje Oosting, MD, PhD, of the University Medical Center Groningen, the Netherlands, commented: “There is finally hope on the horizon that we can increase the cure rate of our patients with head and neck cancer, if these data are confirmed in a phase...

head and neck cancer

Novel IAP Blocker Plus Chemoradiotherapy Improved Outcomes in Head and Neck Cancer Trial

Xevinapant, an investigational inhibitor of apoptosis proteins (IAP) blocker, prolonged overall survival when added to standard chemoradiotherapy for locally advanced head and neck squamous cell carcinoma, according to an updated analysis of a randomized, placebo-controlled phase II study presented ...

Expert Point of View: Fatima Cardoso, MD

The encouraging results of the phase III ASCENT trial suggest that sacituzumab govitecan has clearly earned a place in the treatment algorithm for advanced triple-negative breast cancer, said the study’s invited discussant, Fatima Cardoso, MD, Director of the Breast Unit at the Champalimaud...

breast cancer
immunotherapy

Sacituzumab Govitecan Yields Survival Benefit as Third-Line Treatment in Triple-Negative Breast Cancer: ASCENT Trial

Based on results from a phase I/II clinical trial, the antibody drug conjugate sacituzumab govitecan was recently granted accelerated approval in the treatment of patients with advanced triple-negative breast cancer, contingent on a larger study confirming its benefit. The confirmatory phase III...

breast cancer

Should Body Mass Index Guide the Choice of Chemotherapy in Patients With Breast Cancer?

The rate of obesity is rising dramatically in the United States and Europe, with more than 60% of women in the United States1,2 and 50% of women in Europe3 classified as overweight or obese based on their body mass index (BMI). Obesity is associated with an increased risk of hormone...

lung cancer

Lorlatinib Improves Outcomes Over Crizotinib in First-Line Setting of ALK-Positive NSCLC: CROWN Trial

Lorlatinib significantly improved progression-free survival compared with crizotinib in the first-line treatment of patients with advanced ALK-positive non–small cell lung cancer (NSCLC), according to a planned interim analysis of the phase III CROWN trial presented at the European Society for...

lung cancer
kidney cancer
leukemia
solid tumors
gastroesophageal cancer
gastrointestinal cancer
pancreatic cancer
prostate cancer
genomics/genetics
immunotherapy

FDA Pipeline: Priority Reviews in EGFR-Mutant Lung Cancer, Advanced Renal Cell Carcinoma; Fast Track Designations in CLL and Solid Tumors

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....

neuroendocrine tumors

Surufatinib in Advanced Pancreatic Neuroendocrine Tumors

As reported in The Lancet Oncology by Xu et al, the Chinese phase III SANET-p trial has shown significantly improved progression-free survival with surufatinib vs placebo in patients with advanced pancreatic neuroendocrine tumors. Surufatinib is a novel small-molecule inhibitor that targets...

prostate cancer

Adjuvant vs Salvage Radiotherapy Plus Short-Term ADT After Radical Prostatectomy for Localized Prostate Cancer

As reported in The Lancet Oncology by Sargos et al, the French phase III GETUG-AFU 17 trial has shown no event-free survival benefit for adjuvant radiotherapy vs salvage radiotherapy—both with short-term androgen-deprivation therapy (ADT)—after radical prostatectomy in men with localized prostate...

lung cancer
genomics/genetics

Do Patients With Early-Stage NSCLC Have a Higher Tumor Mutational Burden Than Those With More Advanced Disease?

The tumors of patients with stage I and II non–small cell lung cancer (NSCLC) demonstrated a generally higher tumor mutational burden and more often displayed the mutational signature associated with tobacco smoking than those of patients with more advanced disease, according to findings presented...

colorectal cancer

ASTRO Issues Clinical Guideline on Radiation Therapy for Rectal Cancer

A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance for physicians who use radiation therapy to treat patients with locally advanced rectal cancer. Recommendations outline indications and best practices for pelvic radiation treatments, as well as the...

breast cancer

Are Delays in Breast Cancer Treatment as Harmful as Commonly Thought?

Delays in the treatment of breast cancer matter, but not as much “as we and our patients typically assume,” Richard J. Bleicher, MD, FACS, informed participants at the 22nd Annual Lynn Sage Breast Cancer Symposium.1 Some of these delays are unavoidable and others are tradeoffs that must be made to...

breast cancer

Final Efficacy Results From the ExteNET Trial: Neratinib in Pretreated Patients With HR-Positive, HER2-Positive Early Breast Cancer

In an analysis from the phase III ExteNET trial reported in Clinical Breast Cancer, Arlene Chan, MD, and colleagues found significant improvements in efficacy outcomes with the administration of neratinib vs placebo starting at 1 year or sooner after neoadjuvant/adjuvant trastuzumab-based therapy...

kidney cancer

Adjuvant Sorafenib vs Placebo in Patients With Kidney Cancer at Intermediate or High Risk of Relapse

In the phase III SORCE trial reported in the Journal of Clinical Oncology, Eisen et al found no benefit of sorafenib vs placebo as adjuvant therapy in patients with renal cell carcinoma at intermediate or high risk of disease recurrence. Study Details The double-blind trial included 1,711 patients...

head and neck cancer

Sentinel Node Biopsy vs Neck Node Dissection in Operable Oral or Oropharyngeal Cancer: Equivalence Trial

In a French phase III trial (Senti-MERORL) reported in the Journal of Clinical Oncology, Garrel et al found that sentinel node biopsy demonstrated oncologic equivalance to neck lymph node dissection in 2-year neck node recurrence–free survival in patients with operable cT1–T2N0 oral/oropharyngeal...

prostate cancer

Adjuvant vs Early Salvage Radiotherapy After Radical Prostatectomy in High-Risk Prostate Cancer

In a phase III noninferiority trial (RAVES) reported in The Lancet Oncology, Kneebone et al found that salvage radiotherapy did not meet noninferiority criteria for biochemical progression vs adjuvant radiotherapy, but was associated with nearly identical biochemical control rates and reduced...

Expert Point of View: Rodabe N. Amaria, MD

The value of adjuvant therapy for patients with resected stage III or IV melanoma—in the form of pembrolizumab and nivolumab—continues to be observed after approximately 4 years from the start of therapy, according to Rodabe N. Amaria, MD, Associate Professor of Melanoma Medical Oncology at The...

skin cancer

Long-Term Benefit of Adjuvant Immunotherapy Sustained in Stage III or IV Melanoma

The benefit of anti–PD-1 antibodies in the adjuvant treatment of patients with stage III or stage IV melanoma continues to be observed at around 4 years for both pembrolizumab and nivolumab, according to updates of pivotal trials presented at the European Society for Medical Oncology (ESMO) Virtual ...

multiple myeloma

Ixazomib Maintenance in Newly Diagnosed Patients With Multiple Myeloma Not Undergoing Stem Cell Transplant: TOURMALINE-MM4 Trial

As reported in the Journal of Clinical Oncology by Meletios A. Dimopoulos, MD, and colleagues, the phase III TOURMALINE-MM4 trial has shown that postinduction maintenance with ixazomib prolonged progression-free survival vs placebo in patients with newly diagnosed multiple myeloma not undergoing...

colorectal cancer

Addition of Oxaliplatin to Preoperative Capecitabine-Based Chemoradiation and Adjuvant Capecitabine in Locally Advanced Rectal Cancer

As reported in the Journal of Clinical Oncology by Schmoll et al, the phase III PETACC 6 trial has shown no benefit of the addition of preoperative and adjuvant oxaliplatin to preoperative capecitabine-based chemoradiation and adjuvant capecitabine in patients undergoing total mesorectal excision...

Expert Point of View: Bartosz Chmielowski, MD, PhD

COMBI-i’s invited discussant, Bartosz Chmielowski, MD, PhD, Associate Clinical Professor at the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, said this study is one of three key trials in which checkpoint inhibitors were combined with BRAF and MEK inhibitors. “This is...

skin cancer

COMBI-i Trial: No Statistical Benefit to Adding Spartalizumab to Dabrafenib/Trametinib in Melanoma

Patients with unresectable or metastatic melanoma harboring BRAF V600 mutations did not benefit from the addition of the anti–PD-1 antibody spartalizumab to dabrafenib and trametinib in the COMBI-i trial, which was presented at the European Society for Medical Oncology (ESMO) Virtual Congress...

lymphoma
immunotherapy

FDA Extends the Approval of Pembrolizumab for Patients With Classical Hodgkin Lymphoma

On October 14, the U.S. Food and Drug Administration (FDA) extended the approval of pembrolizumab (Keytruda) for the following indications:   Adult patients with relapsed or refractory classical Hodgkin lymphoma Pediatric patients with refractory classical Hodgkin lymphoma or classical Hodgkin...

breast cancer

Clinical Challenges of Managing Breast Cancer Brain Metastases

“Breast cancer brain metastases are a clinical challenge that are only increasing in incidence and are a consequence of advanced breast cancers, largely HER2-positive and triple-negative,” according to Carey K. Anders, MD, Professor of Medicine and Medical Director of the Duke Brain and Spine...

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