Conference Correspondents

Nivolumab plus ipilimumab demonstrated improvement in overall survival for patients with metastatic uveal melanoma.

Phase 2 Study of Nivolumab plus Ipilimumab in Metastatic Uveal Melanoma

Nivolumab plus ipilimumab demonstrates deep and sustained confirmed responses for patients with metastatic uveal melanoma.

Benefits of Dual I-O Therapy in Metastatic Uveal Melanoma

The combination of nivolumab and ipilimumab offers deep and sustained responses and improved overall survival in malignant uveal melanoma.

Nivolumab plus Relatlimab in the Neoadjuvant and Adjuvant Settings for Patients with Resectable Clinical Stage III Melanoma

Neoadjuvant and adjuvant treatment with nivolumab plus relatlimab for resectable stage III melanoma achieved high pathologic complete response and major pathologic response rates.

Nivolumab plus Ipilimumab as First-Line Therapy in Patients with Advanced Melanoma: 6.5-Year Update from CheckMate-067

In a 6.5-year update of CheckMate-067, durable improvements in overall survival, progression-free survival, and objective response rate were observed with nivolumab plus ipilimumab over nivolumab alone as first-line therapy in patients with advanced melanoma, with no new safety signals.

Relatlimab plus Nivolumab versus Nivolumab Alone in First-Line Advanced Melanoma: Primary Results from RELATIVITY-047

First-line treatment with relatlimab plus nivolumab demonstrated a statistically significant progression-free survival benefit compared with nivolumab monotherapy in patients with advanced melanoma.

Dual Immune Checkpoint Inhibitors in Advanced Cutaneous Melanoma

Dual immunotherapy provides significant and durable benefits as first-line treatment and as neoadjuvant therapy in advanced melanoma.

Phase 2 Study of the Anti-TIGIT Antibody Tiragolumab plus Atezolizumab versus Placebo plus Atezolizumab as First-Line Treatment in Patients with PD-L1–Selected NSCLC: CITYSCAPE

Treatment for NSCLC using the combination of tiragolumab plus atezolizumab was more effective than treatment with placebo plus atezolizumab.

COAST: An Open-Label, Randomized, Phase 2 Platform Study of Durvalumab Alone or in Combination with Novel Agents in Patients with Locally Advanced, Unresectable, Stage III NSCLC

Durvalumab plus either oleclumab or monalizumab improved overall response rate, progression-free survival, and 10-month progression-free survival in locally advanced, unresectable, stage III NSCLC.

First-Line Nivolumab plus Ipilimumab in Unresectable Malignant Pleural Mesothelioma: 3-Year Update from CheckMate-743

The phase 3 CheckMate-743 trial demonstrated survival improvement over 3 years with first-line nivolumab plus ipilimumab for patients with unresectable malignant pleural mesothelioma.

Benefits of Dual I-O Therapy in NSCLC and Malignant Pleural Mesothelioma

Combinations of novel immunotherapy agents provide benefits over standard-of-care therapy in NSCLC and malignant pleural mesothelioma.

Four-Year Follow-Up Data for First-Line Nivolumab Combined with Ipilimumab in NSCLC: CheckMate-227

After more than 4 years of follow-up, patients with advanced NSCLC treated with nivolumab plus ipilimumab maintained overall survival rates.

First-Line Nivolumab plus Ipilimumab Combined with 2 Cycles of Chemotherapy in Patients with Stage IV/Recurrent NSCLC: 2-Year Update of CheckMate-9LA

Nivolumab plus ipilimumab combined with 2 cycles of chemotherapy for the treatment of advanced NSCLC demonstrates durable efficacy compared with 4 cycles of chemotherapy alone in a 2-year follow-up study.

Durvalumab Alone or in Combination with Tremelimumab and Chemotherapy versus Chemotherapy Alone as First-Line Treatment for Metastatic NSCLC: POSEIDON Study

Durvalumab plus standard-of-care chemotherapy and durvalumab with tremelimumab plus standard-of-care chemotherapy were both associated with better progression-free survival compared with standard-of-care chemotherapy alone in the treatment of metastatic NSCLC.

Benefits of Dual Immune Checkpoint Inhibitor Therapy in Metastatic NSCLC

Dual immune checkpoint inhibitor therapy provides significant and durable survival benefits over chemotherapy as first-line treatment in metastatic NSCLC.

2021 Midyear Review: Non–Small-Cell Lung Cancer

Every year, researchers and clinicians report on exciting advancements in the diagnosis and treatment of cancer. In 2021, despite the COVID-19 pandemic, developments in the management of lung cancer continue to be important and intriguing.

Combination of Nivolumab and Chemotherapy in Nonmetastatic Resectable NSCLC (CheckMate-816)

Combining nivolumab with a limited course of chemotherapy in resectable non–small-cell lung cancer (NSCLC) enhances rates of pathologic complete response compared with chemotherapy alone.

Acquired Resistance Mutations After Treatment of EGFR-Mutated Metastatic NSCLC with Osimertinib plus Savolitinib (TATTON)

Resistance to the combination of osimertinib plus savolitinib is predominantly mediated by acquired mutations in either MET, EGFR, or KRAS in patients with EGFR-mutated metastatic non–small-cell lung cancer (NSCLC).

Phase 3 Study of Tislelizumab Compared with Docetaxel in Advanced NSCLC (RATIONALE 303)

Based on results of the RATIONALE 303 trial, tislelizumab significantly prolonged median overall survival by more than 5 months in patients with advanced non–small-cell lung cancer (NSCLC) compared with docetaxel.

Randomized Phase 3 Study of Sintilimab versus Docetaxel in Advanced Squamous NSCLC (ORIENT-3)

Compared with docetaxel, sintilimab significantly prolonged median overall survival by more than 3 months in patients with advanced squamous non–small-cell lung cancer (NSCLC).

Safety Results of Phase 2 Study of Bintrafusp plus Chemotherapy in Advanced NSCLC (INTR@PID LUNG 024)

In patients with advanced squamous non–small-cell lung cancer (NSCLC), the combination of bintrafusp alfa and chemotherapy was well tolerated. The most common treatment-related adverse events were anemia, nausea, and pruritus.

Phase 2 Study of Osimertinib + Oleclumab in Progressive T790M-Negative EGFR-Mutated NSCLC

The combination of a novel CD73 inhibitor, oleclumab, and osimertinib was well tolerated and effective in patients with advanced EGFR-mutated and T790M-negative non–small-cell lung cancer (NSCLC).

Phase 2 Study of D-0316 in Patients with Advanced NSCLC and EGFR T790M Mutation

D-0316, a third-generation EGFR tyrosine kinase inhibitor (TKI), has antitumor activity and acceptable toxicity in patients with EGFR T790M–positive non–small-cell lung cancer (NSCLC) who progressed after EGFR-TKI treatment.

Phase 1 Trial of VS-6766, a Dual RAF-MEK Inhibitor, and Defactinib, an FAK Inhibitor

In patients with non–small-cell lung cancer and KRAS G12V mutations who were pretreated with chemotherapy and immunotherapy, the combination of VS-6766 and defactinib is active with an acceptable tolerability profile.

Phase 2 Study of DM-CHOC-PEN in Patients with NSCLC with Central Nervous System Involvement

In patients with non–small-cell lung cancer (NSCLC) that involves the central nervous system and who lack genetic rearrangements or tumor targets, DM-CHOC-PEN, a bis-alkylator of DNA, has produced long-term objective responses with manageable toxicities.

Phase 1 Study of Telisotuzumab Vedotin in Patients with c-Met–Mutated Advanced NSCLC

Telisotuzumab vedotin (teliso-V), an anti–c-Met antibody conjugated with a tubulin inhibitor payload, is active in selected patients with advanced c-Met–positive non–small-cell lung cancer (NSCLC).

Four-Year Update from CheckMate-227 Study of Nivolumab plus Ipilimumab in Advanced NSCLC

After 4 years’ follow-up, nivolumab combined with ipilimumab provides durable, long-term survival benefit compared with chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC) regardless of PD-L1 expression.

Atezolizumab versus Best Supportive Care After Adjuvant Chemotherapy for Resected NSCLC (IMpower010)

Adjuvant atezolizumab extends disease-free survival after adjuvant chemotherapy compared with best supportive care after adjuvant chemotherapy in patients with resected stage II/IIIA non–small-cell lung cancer (NSCLC).

Capmatinib in MET Exon 14–Mutated Advanced NSCLC (GEOMETRY Mono-1 Study)

Capmatinib offers deep and durable responses with a manageable toxicity for patients with MET exon 14–mutated advanced profile non–small-cell lung cancer (NSCLC) regardless of line of therapy.

Rucaparib in High Genomic Loss of Heterozygosity and/or BRCA1/2-Mutated NSCLC (Lung-MAP Sub-Study, S1900A)

As a marker of homologous recombination deficiency, genomic loss of heterozygosity does not predict efficacy of rucaparib in advanced non–small-cell lung cancer (NSCLC).

Racial Disparities in Biomarker Testing and Clinical Trial Enrollment in NSCLC

Rates of comprehensive biomarker testing and clinical trial participation were significantly lower for black patients with advanced non–small-cell lung cancer (NSCLC) in the United States compared with white patients.

Comparison of Aumolertinib and Gefitinib in First-Line Treatment of EGFR-Mutated NSCLC

Aumolertinib, a novel EGFR inhibitor, shows prolonged clinical benefit in a randomized
comparison with gefitinib as first-line therapy in advanced non–small-cell lung cancer (NSCLC) with EGFR
exon 19 del or L858R mutation.

Two-Year Update from CheckMate-9LA Study of Nivolumab plus Ipilimumab in Advanced NSCLC

With 2 years’ minimum follow-up, first-line use of nivolumab, ipilimumab, and chemotherapy offers durable survival relative to chemotherapy alone in patients with advanced non–small-cell lung cancer.

Anti–PD-L1 Therapy in Combination with Chemotherapy versus Immunotherapy Alone in First-Line NSCLC with PD-L1 Score 1% to 49%

Chemotherapy plus immunotherapy (IO) may improve efficacy outcomes over IO alone in most patients with advanced non–small-cell lung cancer (NSCLC) and programmed death ligand 1 (PD-L1) scores between 1% and 49%.

Pooled Analyses of Immune-Related Adverse Events and Efficacy from IMpower130, IMpower132, and IMpower150

Overall survival is longer for patients with advanced non–small-cell lung cancer who received atezolizumab and had immune-related adverse events versus patients who received atezolizumab and did not have immune-related adverse events.

Clinical Outcomes for Plasma-Based Genomic Profiling versus Tissue Testing in Advanced NSCLC (NILE)

Therapeutic outcomes based on plasma-based comprehensive genomic profiling are comparable to published tissue-based targeted therapy clinical outcomes in non–small-cell lung cancer (NSCLC).

Combination Therapies and New Molecular Targets—Presentations from AACR 2021

Dr David Spigel reviews potentially practice-changing data on EGFR-TKI combination therapies in NSCLC, new approaches to advanced NSCLC and CNS involvement, and hopeful early data with novel targeted agents.

Key Abstracts from ASCO 2021 in NSCLC

Dr Mark Socinski reviews a broad variety of studies, including the evolving role of EGFR inhibitors and immunotherapy in NSCLC, the benefits of immunotherapy plus chemotherapy, and the impact of immune-related adverse events on clinical outcomes in NSCLC.

Practice-Changing Data in NSCLC from ASCO 2021

Dr Mark Socinski provides his insights into important new data on EGFR inhibitors and immunotherapy in the first-line setting for NSCLC.

Exciting New Data Presented on NSCLC at AACR 2021

Dr David Spigel discusses key presentations on immunotherapy and targeted therapy in the neoadjuvant and adjuvant settings in NSCLC.

ASCO 2020 Lung Cancer Highlights

Although the American Society of Clinical Oncology (ASCO) 2020 meeting was held virtually because of the COVID-19 pandemic, hundreds of abstracts, posters, and presentations were still made available to inform clinicians on the latest developments in the treatment of lung cancer. This publication features some of the key highlights from the meeting, which can be used to improve the management and care of patients with the disease.

Impact of Immune-Related Adverse Events on Checkpoint Inhibitor Consolidation Therapy in Stage III NSCLC

Immune-related adverse events did not affect the clinical benefit of consolidation checkpoint inhibitor therapy after chemoradiation in stage III non–small-cell lung cancer.

Patterns of Acquired Resistance in Patients with NSCLC Who Receive PD-1 Inhibitors

The frequency and durability of outcomes associated with acquired resistance to PD-1 inhibition in non–small-cell lung cancer are presented.

Characteristics of Patients Who Achieve Long-Term Response with PD-1 Blockade

The characteristics of long-term responders to PD-1 blockade are presented.

Smoking Cessation and Lung Cancer: Recent Quitters Benefit Too

For oncologists and others who advocate for smoking cessation, it is important to know whether recent quitters who are diagnosed with lung cancer can achieve a survival benefit.

Weekly Epirubicin as Second-Line Therapy for Malignant Pleural Mesothelioma

Weekly epirubicin was evaluated as a potential “gentle” option for second-line chemotherapy in patients with malignant pleural mesothelioma after failure of first-line pemetrexed-based chemotherapy.

ADAURA Results: Osimertinib as Adjuvant Therapy for EGFR-Mutated NSCLC

Approximately 30% of patients with non–small-cell lung cancer present with early-stage (I-IIIA) disease and undergo surgery. Researchers assessed the use of adjuvant osimertinib in this population.

Retrospective Data Suggest Role for Immunotherapy in Patients with Large-Cell Neuroendocrine Carcinoma

Despite the approval of immune checkpoint inhibitors for patients with lung cancers, their role in rare pulmonary tumors, such as large-cell neuroendocrine carcinoma of the lung, has remained unclear.

Cediranib Combined with Olaparib Is Active in Patients with Platinum-Pretreated SCLC

Patients with platinum-pretreated small-cell lung cancer may benefit from combination use of cediranib, an oral VEGF inhibitor, and olaparib, a PARP inhibitor.

Nationwide Genomic Screening Network Can Be Effective in Identifying Rare Targetable Genetic Alterations

Developing novel targeted therapies for patients with cancer who have rare mutations, such as PI3K/AKT/mTOR pathway alterations, is particularly challenging for researchers.

Combination of Nivolumab, Ipilimumab, and Chemotherapy in Metastatic NSCLC

Combining nivolumab plus ipilimumab with 2 cycles of chemotherapy may be effective in patients undergoing first-line treatment for metastatic non–small-cell lung cancer.

3-Year Follow-Up Data for Nivolumab Combined with Ipilimumab in Treatment-Naïve NSCLC: CheckMate-227

After 3 years of follow-up, nivolumab combined with ipilimumab demonstrates sustained overall survival rates in treatment-naïve patients with advanced non–small-cell lung cancer.

CheckMate-9LA Evaluates Addition of Chemotherapy to NIVO + IPI in First-Line Advanced NSCLC

The addition of 2 cycles of chemotherapy to the combination of nivolumab and ipilimumab results in superior overall survival in treatment-naïve patients with advanced non–small-cell lung cancer.

Real-World Data for Nivolumab in Patients with Malignant Mesothelioma

Standard treatment for patients with advanced malignant pleural mesothelioma is predominantly chemotherapy-based. Nivolumab may be effective in these patients based on a retrospective real-world data assessment.

Immunotherapy Combined with Stereotactic Radiation in Early-Stage, Medically Inoperable NSCLC: Safety Analysis from I-SABR

Stereotactic ablative radiotherapy combined with immunotherapy (I-SABR) is well-tolerated in patients with early-stage, medically inoperable, isolated-recurrence non–small-cell lung cancer without lymph node or distant metastasis.

Meta-analysis of Checkpoint Inhibitor Trials in Front-Line NSCLC

Based on a meta-analysis of randomized trials in the first-line treatment of non–small-cell lung cancer, adding chemotherapy to immune checkpoint inhibitors (ICIs) improves response rates and progression-free survival in some patients compared with ICI monotherapy, but does not confer an overall survival benefit regardless of PD-L1 status.

Adjuvant Innovative Peptide Vaccine Therapy Shows Promising Activity in Early-Stage Triple Negative Breast Cancer

ESMO 2018 Wrap Up

A groundbreaking report presented today at ESMO conveyed data from an interim analysis of a phase 2b trial demonstrating that the combination of NPS + trastuzumab is safe and may provide clinically meaningful benefit to women with HER2 low-expressing breast cancer, with a particularly marked benefit in the subgroup with triple-negative breast cancer.

The Efficacy of Apatinib Treatment for Advanced Ovarian Cancer After Second-Line Chemotherapy Failure

In a prospective trial, the VEGFR-2 small-molecule inhibitor apatinib has shown promising efficacy and safety signals.

A Phase 1b and Randomized Phase 2 Trial of Pazopanib with or Without Fosbretabulin in Advanced Recurrent Ovarian Cancer

Although the combination of 2 antivascular agents showed preliminary efficacy, increased cardiac toxicity has resulted in premature discontinuation of the trial.

Initial Results from an Expansion Cohort Receiving Mirvetuximab Soravtansine/Pembrolizumab for Platinum-Resistant Ovarian Cancer: Initial Results from FORWARD II

The antibody-drug conjugate mirvetuximab soravtansine combined with pembrolizumab has a manageable safety profile and encouraging signals of clinical activity.

A Meta-Analysis to Evaluate the Risk for Fatigue in Patients Treated with Olaparib for Advanced Cancer

Fatigue and neuropathy were found to be common in patients treated with olaparib, and should be identified and managed early.

Breaking News from the 2018 Meeting of the European Society for Medical Oncology (ESMO)

A groundbreaking report presented today at ESMO conveyed data from an interim analysis of a phase 2b trial demonstrating that the combination of NPS + trastuzumab is safe and may provide clinically meaningful benefit to women with HER2 low-expressing breast cancer, with a particularly marked benefit in the subgroup with triple-negative breast cancer.

Oregovomab and Nivolumab as a Combinatorial Immunotherapy Strategy for Recurrent Epithelial Ovarian Cancer

Based on the tolerable safety profile established in phase 1b of the ORION-01 trial, the recommended dose for expansion/recommended phase 2 dose of the oregovomab/nivolumab combination immunotherapy has been established.

Maintenance Olaparib Following Platinum-Based Chemotherapy in Newly Diagnosed Patients with Advanced Ovarian Cancer and a BRCA1/2 Mutation: Results from the Phase 3 SOLO1 Trial

Results from the phase 3 SOLO1 trial demonstrate a substantial, unprecedented improvement in progression-free survival for olaparib versus placebo.

A Phase 2 Trial of Combination Nivolumab and Bevacizumab in Recurrent Ovarian Cancer

This combination of antiangiogenic and immune checkpoint blockade has clinical activity in women with recurrent ovarian cancer.

Association of PD-L1 Expression with Clinical Response to Pembrolizumab in Patients with Advanced Recurrent Ovarian Cancer

Results from the KEYNOTE-100 study show that expression of PD-L1 and inflamed T-cell–associated genes are associated with clinical response in advanced, recurrent ovarian cancer.

Long-Term Tolerability of Olaparib Tablets as Maintenance Therapy for Platinum-Sensitive Relapsed Ovarian Cancer

Similar to the capsule formulation, olaparib tablets have no cumulative toxicity, few late-onset adverse events, and a low rate of treatment discontinuation.

A Phase 2 Study of Durvalumab, a PD-L1 Inhibitor, and Olaparib in Recurrent Ovarian Cancer

Results suggest that the combination of durvalumab and olaparib was well-tolerated and had clinical activity in heavily pretreated, BRCA-wildtype ovarian cancer patients.

Clinical Characteristics of Ovarian Cancer Relapse in BRCA1/2 Germ-Line Mutation Carriers and Noncarriers

Analysis of high-grade serous ovarian cancers suggests that BRCA1/2-driven cancers have a more favorable mode of relapse than sporadic cancers.

Meta-Analysis of PARP-Inhibitor–Associated Gastrointestinal and Hepatic Toxicities

Early intervention and supportive care for gastrointestinal and hepatic toxicities should be considered for patients receiving PARP inhibitors.

Olaparib Maintenance Therapy in Patients with Platinum-Sensitive Relapsed Ovarian Cancer and Stable Disease

Olaparib maintenance may prolong progression-free survival in patients, regardless of the number of previous platinum-based chemotherapies.

A Phase 1/2 Study of Chemo-Immunotherapy with Durvalumab and Pegylated Liposomal Doxorubicin (PLD) in Platinum-Resistant Recurrent Ovarian Cancer

Durvalumab/PLD combination shows promising efficacy and a tolerable safety profile in women with platinum-resistant ovarian cancer.

Psychological Support vs Standard of Care Following Chemotherapy for Ovarian Cancer

Patients receiving psychological support in the OVPSYCH2 randomized study showed reduced fear of progression compared with those without support.

Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab vs Carboplatin/Gemcitabine/Bevacizumab in Patients with Recurrent Ovarian Cancer

The novel combination of carboplatin, pegylated liposomal doxorubicin, and bevacizumab has a promising safety and efficacy profile.

Phase 3 Trial of Lurbinectedin vs Pegylated Liposomal Doxorubicin or Topotecan in Platinum-Resistant Ovarian Cancer Patients

Promising safety results from the CORAIL trial suggest a place for lurbinectedin in treating platinum-resistant ovarian cancer.

Effect of Prior Chemotherapy Regimens on Rucaparib Treatment in Platinum-Sensitive Recurrent Ovarian Carcinoma

Progression-free survival associated with rucaparib is not affected by the number of prior chemotherapy regimens.

Test ESMO 2018 Article

test

Patient-Reported Health Status Is Improved by the Addition of Palbociclib to Fulvestrant Treatment

Using the EQ-5D Health Index during the course of treatment, this study compares patient-reported general health status during treatment with palbociclib (a cyclin-dependent kinase 4/6 inhibitor) plus fulvestrant (a complete estrogen receptor antagonist) compared with during treatment with fulvestrant alone.

Exploring the Relationship Between Progression-Free Survival and Overall Survival in Breast Cancer Patients Treated with Fulvestrant or Anastrozole

Progression-free survival (PFS) is often used as a surrogate for overall survival (OS) due to the challenges of measuring OS in relatively short-term trials, and is a practice that has been supported by previous analyses of breast cancer data. This analysis further examines the relationship between PFS and OS in advanced breast cancer.

Improved Sensitivity to Endocrine Therapy Following Treatment with Eribulin Mesylate

Eribulin mesylate is an inhibitor of microtubule dynamics that may play a role in reducing the abnormality of the tumor microenvironment (ie, increasing oxygenation). As hypoxic conditions may contribute to drug resistance, it is hypothesized that eribulin may enhance the efficacy of other therapies. In this study, the effects of eribulin on 2 endocrine therapies were evaluated.

Conversion of Biomarkers Between Primary Breast Cancer Tumor and Relapse May Have Prognostic Value

In a retrospective study of 45 breast cancer patients, the differential expression of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, and Ki-67 is evaluated in primary and relapsed tumors. The conversion rate of these biomarkers and their prognostic relevance are assessed.

Exploratory Biomarkers in MONARCH 1: A Phase 2 Study of Abemaciclib Monotherapy in HR+/HER2– Metastatic Breast Cancer

In this study, patients with advanced hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) breast cancer that have disease progression following antiestrogen therapy are treated with abemaciclib (a selective inhibitor of cyclin-dependent kinases 4 and 6) as a monotherapy. Exploratory biomarkers identified during this study are presented.

Next-Generation Sequencing Reveals Molecular Subtypes Beyond Those Defined by Hormone Receptor Expression

Breast carcinomas can be classified into 4 subtypes based on their hormone receptor expression: basal, luminal A, luminal B, and human epidermal growth factor receptor 2 overexpressed. This study uses comprehensive genomic profiling to further stratify tumors by their predicted sensitivity to a variety of therapies.

Claim Data Reveal Treatment and Toxicity Patterns Associated with Everolimus Use

Everolimus, an inhibitor of mammalian target of rapamycin, is approved for use in the United States and European Union in combination with exemestane (an aromatase inhibitor) for the treatment of postmenopausal women with advanced estrogen receptor–positive/human epidermal growth factor receptor 2–negative breast cancer. This retrospective study evaluates the patterns of care and complications associated with this treatment over a 5-year period (2009-2014).

Circulating Tumor Cell Counts May Have Prognostic Value in Determining First-Line Therapy in HR+/HER2– Metastatic Breast Cancer

In patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) metastatic breast cancer, the decision to treat first with hormone therapy or chemotherapy can be made at the discretion of the attending oncologist, or by taking into account the number of circulating tumor cells. This phase 3 study compares the outcome of these 2 methods.

Preliminary Safety and Efficacy of TAK-228 plus Exemestane or Fulvestrant in ER+/HER2– Metastatic Breast Cancer

TAK-228 is an investigational, oral, highly selective, ATP-competitive inhibitor of TORC1/2. By mitigating feedback within the PI3K/AKT/mTOR pathway, TAK-228 may restore sensitivity to endocrine therapies in patients who have progressed on such agents in combination with everolimus. This phase 1b/2 study evaluates the safety, pharmacokinetics, and preliminary efficacy of TAK-228 in combination with exemestane or fulvestrant.

Fulvestrant 500 mg Is Well-Tolerated and Efficacious in Women with Locally Advanced Breast Cancer

Fulvestrant (a complete estrogen receptor [ER] antagonist) represents an endocrine therapy for patients with ER-positive metastatic breast cancer who have disease progression after treatment with an antiestrogen. This study evaluates the clinical benefit rate of fulvestrant 500 mg monthly, defined as complete response, partial response, or stable disease lasting >24 weeks, in women with locally advanced breast cancer.

Phase 2 Trial Data on Metformin Do Not Support Further Investigation as a Breast Cancer Therapy

Preoperative Metabolic Profiles Are Prognostic for Breast Cancer Recurrence

First-Line Everolimus plus Letrozole in ER+/HER– Breast Cancer

The objective of this study is to evaluate the efficacy and safety of everolimus (an inhibitor of mammalian target of rapamycin) in combination with letrozole (an aromatase inhibitor) in postmenopausal women with advanced estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2–) breast cancer.

Antitumor Activity of PM01183 in BRCA-Associated Metastatic Breast Cancer

PM01183 (lurbinectedin) is an investigational compound that blocks transactivated transcription and induces the formation of double-strand breaks in a range of cancer lines. This study is designed to evaluate whether the presence of BRCA1/2 mutations can act as a prognostic indicator of response to PM01183 in patients with metastatic breast cancer.

Tumor Biomarker Analysis from the Phase 3 PALOMA-2 Trial

This study is designed to compare treatment with palbociclib (a cyclin-dependent kinase 4/6 inhibitor) in combination with letrozole (an aromatase inhibitor) versus placebo with letrozole in postmenopausal women with estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer. A secondary outcome measure of the study, the analysis of tumor tissue biomarkers, is presented here.

The FALCON Study: A Phase 3 Comparison of Fulvestrant and Anastrozole in ER+ Advanced Breast Cancer

Fulvestrant is a complete estrogen receptor (ER) antagonist currently approved for the treatment of ER-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. This phase 3 study compares first-line fulvestrant with anastrozole (an aromatase inhibitor) in postmenopausal women with ER-positive and/or progesterone receptor–positive advanced breast cancer.

Comparison of Sequential and Concomitant Adjuvant Trastuzumab Treatment in HER2+ Breast Cancer

The French SIGNAL and PHARE projects have collected data on more than 9800 patients with breast cancer since 2006. In evaluating the outcomes of sequential and concomitant administration of trastuzumab within this cohort, this study provides insight into the ideal administration protocol for patients with human epidermal growth factor receptor 2–positive (HER2+) breast cancer.

Outcome Disparities by Prognostic Indicators in HR+ Breast Cancer

The 21-gene Recurrence Score® is the result of a commercial genomic test that evaluates the likelihood that breast cancer will recur, and the likely benefit from chemotherapy and/or radiation therapy. This study evaluates disparities in hormone receptor–positive (HR+) breast cancer outcome by age and 21-gene Recurrence Score®.

Prognostic Role for Derived Neutrophil-to-Lymphocyte Ratio in Early Breast Cancer

Previous studies have reported that an elevated neutrophil-to-lymphocyte ratio is associated with an increased risk of relapse and worse survival in women with breast cancer. Additional data about the prognostic role for this biomarker in patients with early breast cancer are presented here.

Interim Phase 2 Results on Abemaciclib in Women with HR+/HER2– Breast Cancer