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lung cancer

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...

lung cancer
immunotherapy

Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC

Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...

breast cancer

Extended Follow-up of PALOMA-3 Supports Survival Benefit of Palbociclib Plus Fulvestrant in Advanced Breast Cancer

An updated analysis of the PALOMA-3 randomized, placebo-controlled trial demonstrated continued superiority for the combination of palbociclib (CDK4/6 inhibitor) plus fulvestrant over fulvestrant plus placebo in women with hormone receptor–positive, HER2-negative advanced breast cancer whose...

breast cancer

Expert Point of View: Melinda Telli, MD

EA1131 study discussant, Melinda Telli, MD, Associate Professor of Medicine at Stanford University, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, commented: “At this point, capecitabine remains preferred as...

breast cancer

EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer

In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...

leukemia

Fixed-Dose, First-Line Ibrutinib/Venetoclax Combination Achieves Durable Remissions in CLL

The combination of fixed-duration, first-line treatment with ibrutinib plus venetoclax achieved complete responses in more than half of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), based on the primary analysis of the fixed-dose cohort of the phase II CAPTIVATE ...

leukemia

ELEVATE-RR Trial: Acalabrutinib as Effective as Ibrutinib, With Fewer Cardiac Effects, in Resistant CLL

Acalabrutinib was equally efficacious with less toxicity when compared directly with ibrutinib in patients with previously treated relapsed or refractory chronic lymphocytic leukemia (CLL), according to the results of an open-label, randomized, noninferiority phase III trial presented at the 2021...

breast cancer
genomics/genetics

OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer

Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...

skin cancer

Targeting LAG-3 and PD-1 With Relatlimab and Nivolumab: A New Option Under Study in Advanced Melanoma

Immune checkpoint inhibition has been established as an effective treatment for patients with metastatic melanoma. A novel immunotherapeutic combination—this one targeting the LAG-3 (lymphocyte-activation gene 3) and PD-1 immune checkpoints—delayed the time to disease progression significantly more ...

Expert Point of View: Kunle Odunsi, MD, PhD and Lilian T. Gien, MD, MSc

Comments on the OUTBACK trial were provided by invited discussant Kunle Odunsi, MD, PhD, Professor of Obstetrics and Gynecology, Dean for Oncology, and Director of the University of Chicago Medicine Comprehensive Cancer Center. Lilian T. Gien, MD, MSc, Associate Professor of Oncology at the...

gynecologic cancers

OUTBACK: No Benefit for Adjuvant Chemotherapy in Cervical Cancer

In women with locally advanced cervical cancer, adjuvant chemotherapy adds no benefit to standard cisplatin-based chemoradiation, results of the international phase III OUTBACK study have shown,1 as reported at the 2021 ASCO Annual Meeting by Linda R. Mileshkin, MD, Professor of Medical Oncology at ...

Expert Point of View: Rana R. McKay, MD

Invited discussant of the KEYNOTE-564 trial, Rana R. McKay, MD, Associate Professor of Medicine and Urology at the University of California San Diego, offered these comments about the trial results. “This is a positive study, showing a 32% reduction in the risk of recurrence or death with adjuvant ...

kidney cancer

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...

prostate cancer

VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer

Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...

head and neck cancer

CheckMate 648: First-Line Nivolumab Regimens Improve Survival in Esophageal Squamous Cell Carcinoma

As first-line treatment of advanced esophageal squamous cell carcinoma, nivolumab-containing regimens improved overall survival over standard-of-care chemotherapy, according to the first results of the global phase III CheckMate 648 trial presented at the 2021 ASCO Annual Meeting by Ian Chau, MD,...

Expert Point of View: Anthony TC Chan, MD

The invited discussant of the JUPITER-02 study was Anthony TC Chan, MD, the Li Shu Fan Medical Foundation Professor of Clinical Oncology at Hong King Cancer Institute and Sir YK Pao Centre for Cancer at the Chinese University of Hong Kong. He noted that anti–PD-1/L1 therapies are at the forefront...

head and neck cancer

Novel Monoclonal Antibody Emerges as Potential First-Line Standard in Nasopharyngeal Cancer

A new first-line standard of care may be emerging for recurrent or metastatic nasopharyngeal carcinoma, based on the findings of the global phase III JUPITER-02 trial presented at the 2021 ASCO Annual Meeting by investigators from China.1 In the study, toripalimab, an anti–PD-1 monoclonal antibody, ...

lung cancer

EMPOWER-Lung 1: Cemiplimab-rwlc Improves Outcomes in First-Line Treatment of NSCLC With Brain Metastases

First-line treatment with cemiplimab-rwlc monotherapy improved overall survival, progression-free survival, and objective response rates compared with chemotherapy in patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression of at least 50% and clinically stable treated brain...

gynecologic cancers
immunotherapy

Nivolumab vs Gemcitabine or Pegylated Liposomal Doxorubicin: What Regimen Improves Survival in Platinum-Resistant Ovarian Cancer?

In a Japanese phase III trial (NINJA) reported in the Journal of Clinical Oncology, Hamanishi et al found that nivolumab did not improve overall survival vs chemotherapy with either gemcitabine or pegylated liposomal doxorubicin in platinum-resistant epithelial ovarian cancer. Study Details In the...

issues in oncology

Inclusion of Women in Oncology Clinical Trials From 2000 to 2020

In a study reported in a research letter in JAMA Oncology, Jenei et al found that women with cancer have been underrepresented in global oncology drug trials over the past 20 years, with underrepresentation persisting through the present in multiple cancer types.    Study Details The study involved ...

lung cancer
immunotherapy

Neoadjuvant Atezolizumab Under Study for Resectable Pleural Mesothelioma

Neoadjuvant atezolizumab combined with pemetrexed and cisplatin, followed by surgical resection and maintenance atezolizumab, proved safe and feasible and offered hints of benefit in patients with resectable pleural mesothelioma. Results from a small multicenter study were presented by Boris...

lung cancer
immunotherapy

Maintenance Durvalumab: Increased Utilization Could Improve NSCLC Outcomes

Maintenance durvalumab—the recommended maintenance treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC) following chemoradiation—remains significantly underutilized, according to research presented by Liu et al at the International Association for the Study of Lung...

breast cancer
survivorship

Effect of Mindfulness Meditation and Survivorship Education on Depressive Symptoms in Younger Breast Cancer Survivors

In a phase III trial (Pathways to Wellness) reported in the Journal of Clinical Oncology, Julienne E. Bower, PhD, and colleagues found that both mindfulness meditation and survivorship education interventions significantly reduced depressive symptoms in younger breast cancer survivors. Study...

lung cancer
immunotherapy

POSEIDON Trial: Dual Checkpoint Blockade Plus Chemotherapy Improves Survival in First-Line Metastatic NSCLC

Findings from the phase III POSEIDON trial showed significantly improved progression-free and overall survival in patients with metastatic non–small cell lung cancer (NSCLC) who received first-line durvalumab and tremelimumab plus chemotherapy vs chemotherapy alone. These findings were presented by ...

lung cancer
immunotherapy

IMpower010 Study of Atezolizumab in Resectable NSCLC: Benefits Observed Regardless of Stage, Type of Prior Treatment

In an exploratory analysis of the pivotal phase III IMpower010 trial—which found that adjuvant atezolizumab significantly improved disease-free survival in resectable non–small cell lung cancer (NSCLC)—benefit was shown regardless of the type of surgery or the chemotherapy doublet received by the...

lung cancer

No Overall Survival Benefit With Lurbinectedin/Doxorubicin in Small Cell Lung Cancer

As a second-line treatment for patients with small cell lung cancer (SCLC), lurbinectedin plus doxorubicin failed to improve overall survival in the multicenter ATLANTIS trial, but it did provide other benefits, Luis Paz-Ares, MD, PhD, and colleagues reported at the International Association for...

prostate cancer

TITAN Confirms Survival Benefit of Apalutamide Plus ADT in Metastatic Prostate Cancer: Now, Move Therapy Forward

As reported in the Journal of Clinical Oncology by Chi et al1—and summarized in this issue of The ASCO Post—the prespecified final overall survival analysis of the phase III TITAN trial1-3 has confirmed a clear overall survival and radiographic progression-free survival benefit with the combination ...

leukemia

ELEVATE-RR Trial: Acalabrutinib as Effective as Ibrutinib, With Fewer Cardiac Effects, in Resistant CLL

Acalabrutinib was equally efficacious with less toxicity when compared directly with ibrutinib in patients with previously treated relapsed or refractory chronic lymphocytic leukemia (CLL), according to the results of an open-label, randomized, noninferiority phase III trial presented at the 2021...

multiple myeloma
immunotherapy

Treatment of Relapsed Myeloma: Options Include New Drugs, Novel Combinations

The treatment paradigm for multiple myeloma continues to evolve at a rapid pace with the introduction of new drugs and the development of drug combinations, particularly the initial approach to the treatment of newly diagnosed multiple myeloma.1 One major shift in the treatment of newly diagnosed...

multiple myeloma
immunotherapy

Subcutaneous Daratumumab Added to Pomalidomide Plus Dexamethasone Improves Progression-Free Survival in Multiple Myeloma

As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous (SC) daratumumab to oral...

prostate cancer

Lutetium-177–PSMA-617: A First-in-Class Radioligand Therapeutic in Metastatic Prostate Cancer

Based on the findings of the phase III VISION trial, reported by Sartor et al1 and summarized in this issue of The ASCO Post, lutetium-177–PSMA-617 (LuPSMA) is the first of the prostate-specific membrane antigen–targeted cancer theranostics to demonstrate a survival-prolonging benefit for men with...

prostate cancer

Adding LuPSMA to Standard Care Improves Outcomes in Castration-Resistant Prostate Cancer

As reported in The New England Journal of Medicine by Oliver Sartor, MD, of the School of Medicine, Tulane University, and colleagues, the phase III VISION trial has shown prolonged progression-free and overall survival with lutetium-177–PSMA-617 (LuPSMA) radioligand therapy plus standard care vs...

multiple myeloma

Daratumumab and Hyaluronidase-fihj With Pomalidomide Plus Dexamethasone in Multiple Myeloma

On July 9, 2021, daratumumab and hyaluronidase-fihj was approved for use in combination with pomalidomide and dexamethasone (Pd) for treatment of adults with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.1 Supporting...

prostate cancer

Maintained Benefit of Apalutamide Plus Androgen-Deprivation Therapy Shown in Metastatic Castration-Sensitive Prostate Cancer

As reported in the Journal of Clinical Oncology by Kim N. Chi, MD, of BC Cancer and Vancouver Prostate Centre, and colleagues, the final overall survival analysis of the phase III TITAN trial showed significant benefit of apalutamide plus androgen-deprivation therapy vs placebo plus...

gastroesophageal cancer

Reduced-Intensity Chemotherapy for Older, Frail Patients With Advanced Gastroesophageal Cancer

Patients who had advanced gastroesophageal cancer but were considered unsuitable for full-dose chemotherapy because of their advanced age and/or frailty “had an improved patient experience with no significant detriment in cancer control” when treated with reduced-intensity chemotherapy in the phase ...

immunotherapy
gastroesophageal 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...

bladder cancer

Enfortumab Vedotin-ejfv in Urothelial Cancer

On July 9, 2021, enfortumab vedotin-ejfv, an antibody-drug conjugate targeting nectin-4, was granted regular approval. The agent is indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and platinum chemotherapy or...

Yale Cancer Center Names Barbara Burtness, MD, Interim Associate Director for Diversity, Equity, and Inclusion

Barbara Burtness, MD, Professor of Medicine (Medical Oncology), has been appointed Interim Associate Director for Diversity, Equity, and Inclusion at Yale Cancer Center. “Dr. Burtness’ leadership and innovative ideas will ensure that we emphasize an inclusive culture, with increased diversity in...

lymphoma
immunotherapy

Assumptions, Data … and More Questions!

I read with great interest the results from the phase II ZUMA-12 study of axicabtagene ciloleucel, presented during the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 But the results raised several questions for me. Axicabtagene ciloleucel, an autologous anti-CD19...

lung cancer
immunotherapy

Several Studies Show Rovalpituzumab Tesirine Is Ineffective Against SCLC

Four independent studies published in the Journal of Thoracic Oncology demonstrate that rovalpituzumab tesirine (Rova-T), a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3), is not effective against small cell lung cancer (SCLC). An accompanying editorial by...

lung cancer

Ensartinib Shows Superior Efficacy to Crizotinib in Advanced ALK-Positive NSCLC: eXalt3 Trial

As reported in JAMA Oncology by Leora Horn, MD, MSc, FRCPC, and colleagues, the phase III eXalt3 trial has shown significantly prolonged progression-free survival with ensartinib vs crizotinib in patients with advanced, recurrent, or metastatic anaplastic lymphoma kinase (ALK)-positive non–small...

skin cancer
immunotherapy

Phase II Trial Evaluates Oncolytic Coxsackievirus A21 for Unresectable Advanced Melanoma

In a phase II trial reported in the Journal of Clinical Oncology, Robert H.I. Andtbacka, MD, and colleagues found that intratumoral injection of the oncolytic RNA virus Coxsackievirus A21 (V937) was well tolerated and produced responses in some patients with unresectable stage III or stage IV...

bladder cancer
immunotherapy

FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma

On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label...

breast cancer
immunotherapy

Evandro de Azambuja, MD, PhD, Comments on the BERENICE Trial

The invited discussant for the BERENICE trial was Evandro de Azambuja, MD, PhD, Head of the Medical Support Team at the Institut Jules Bordet in Brussels. He concluded from the study that pertuzumab plus trastuzumab, combined with an anthracycline/taxane regimen given every 2 weeks or every 3...

breast cancer
immunotherapy

Safety, Efficacy of Neoadjuvant Pertuzumab Plus Trastuzumab Maintained in Final Analysis of BERENICE Trial

Long-term cardiac safety and efficacy have been confirmed for pertuzu­mab plus trastuzumab in patients with early breast cancer, in an update of the phase II BERENICE trial reported at the 2021 ESMO Breast Cancer Virtual Congress.1 Chau T. Dang, MD, of the Breast Medicine Service at Memorial Sloan...

gastroesophageal cancer
immunotherapy

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....

skin cancer

Are Triplets Necessary for BRAF-Mutated Melanoma?

Where does triplet therapy fit in the treatment of patients with stage IV BRAF-mutated melanoma? Is there strong evidence for combining a BRAF inhibitor, MEK inhibitor, and checkpoint inhibitor? Ragini Kudchadkar, MD, Chair of the Protocol Review and Monitoring Committee at Winship Cancer Institute ...

lung cancer
immunotherapy

Study Highlights Gaps Between Lung Cancer Treatment Recommendations and Real-World Use of Durvalumab

A recent study published by Ronden et al in JTO Clinical and Research Reports highlights the gap between treatment guidelines and real-world care with the monoclonal antibody durvalumab for patients with non–small cell lung cancer. Researchers studied treatment decision-making by three Dutch...

lung cancer

First-Line Veliparib Plus Platinum-Based Chemotherapy in Current Smokers With Advanced Squamous Cell NSCLC

In a phase III trial reported in the Journal of Clinical Oncology, Suresh S. Ramalingam, MD, and colleagues found that the addition of the poly (ADP-ribose) polymerase inhibitor veliparib to platinum-based chemotherapy did not improve overall survival in current smokers with previously untreated...

breast cancer
symptom management

Pharmacologic Cardioprotection in Women With Nonmetastatic Breast Cancer Receiving Anthracycline-Based Chemotherapy

In an interim analysis of the Italian phase III SAFE trial reported in JAMA Oncology, Livi et al found that a cardioprotective strategy using ramipril and/or bisoprolol reduced the risk of myocardial dysfunction in women with nonmetastatic breast cancer receiving anthracycline-based chemotherapy....

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