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breast cancer

Véronique Diéras, MD, on HER2-Negative, BRCA-Mutated Breast Cancer: Veliparib Plus Carboplatin/Paclitaxel

Véronique Diéras, MD, of Institut Curie Paris & Saint Cloud, discusses results from the phase III BROCADE 3 trial, which investigated the PARP inhibitor veliparib in combination with carboplatin/paclitaxel in patients with advanced HER2-negative, germline BRCA–mutated breast cancer (Abstract...

hepatobiliary cancer

Tim Meyer, PhD, and Lorenza Rimassa, MD, on Advanced Hepatocellular Carcinoma: CELESTIAL Trial of Cabozantinib

Tim Meyer, PhD, of the University College London, and Lorenza Rimassa, MD, of Humanitas Research Hospital, Milan, discuss their phase III findings on prognostic and predictive factors of cabozantinib vs placebo in previously treated liver cancer, and outcomes based on clinical characteristics and...

breast cancer
immunotherapy

Peter Schmid, MD, PhD, on Triple-Negative Breast Cancer: KEYNOTE-522 Trial of Pembrolizumab Plus Chemotherapy

Peter Schmid, MD, PhD, of Queen Mary University of London Barts Cancer Institute, discusses pathologic complete response data from a phase III study of pembrolizumab/chemotherapy vs placebo/chemotherapy as neoadjuvant treatment, followed by pembrolizumab vs placebo as 6-month adjuvant treatment for ...

gynecologic cancers
immunotherapy

Isabelle Ray-Coquard, MD, PhD, on Ovarian Cancer: Olaparib Plus Bevacizumab

Isabelle Laure Ray-Coquard, MD, PhD, of the Centre Leon Bérard, discusses phase III study findings in patients with newly diagnosed, advanced ovarian cancer who received olaparib plus first-line bevacizumab maintenance treatment. Compared with placebo plus bevacizumab, olaparib improved...

Robin L. Jones, MD, MBBS, on Advanced Angiosarcoma: TAPPAS Trial of a Novel Monoclonal Antibody Plus Pazopanib

Robin L. Jones, MD, MBBS, of The Royal Marsden/Institute of Cancer Research, discusses the first phase III study in angiosarcoma, which showed no difference in outcome between pazopanib vs pazopanib plus the novel monoclonal antibody TRC105 (Abstract 1667O).

skin cancer
immunotherapy

Paolo A. Ascierto, MD, on Melanoma: Results From CheckMate 238 on Adjuvant Nivolumab vs Ipilimumab

Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori, Napoli, discusses phase III study findings confirming the superior activity of nivolumab vs ipilimumab in resected stage III/IV melanoma in terms of regression-free survival after a minimum follow-up of 36 months (Abstract 1310O).

colorectal cancer

ESMO 2019: ctDNA as a Marker for Disease-Free Survival With Oxaliplatin Treatment in Stage III Colon Cancer

Patients with advanced colon cancer and plasma samples containing circulating tumor DNA (ctDNA) were less likely to achieve 2-year disease-free survival with oxaliplatin-based adjuvant treatment than patients with ctDNA-negative samples, according to findings presented at the European Society for...

gynecologic cancers

ESMO 2019: Studies Show PARP Inhibitors Improve Survival, Reduce Risk of Disease Recurrence or Death in Newly Diagnosed Ovarian Cancer

Two studies presented at the European Society for Medical Oncology (ESMO) 2019 Congress showed the efficacy of poly ADP ribose polymerase (PARP) inhibitors in patients with newly diagnosed ovarian cancer. In the PRIMA/ENGOT-OV26/GOG-3012 study, presented by González Martín et al (Abstract LBA1;...

solid tumors

ESMO 2019: Tailored Treatment vs Empiric Chemotherapy for Cancer of an Unknown Primary

Treatment tailored by comprehensive molecular gene-expression analysis of tumors from patients with carcinomas of an unknown primary site did not improve progression-free survival vs empiric chemotherapy consisting of cisplatin/gemcitabine. Fizazi et al presented these findings at the European...

skin cancer
immunotherapy

ESMO 2019: 5-Year Survival and Response With Nivolumab/Ipilimumab in Advanced Melanoma

An update of results of the phase III CheckMate 067 trial at 5 years presented by Larkin et al at the European Society for Medical Oncology (ESMO) 2019 Congress showed that both nivolumab in combination with ipilimumab and nivolumab alone provided significant improvements in overall survival,...

xospata

ADMIRAL Study Finds Gilteritinib Effective Across Mutation Cohorts of Acute Myeloid Leukemia

The novel FLT3 inhibitor gilteritinib prolonged survival in patients with FLT3-mutated relapsed or refractory acute myeloid leukemia (AML) across all mutation cohorts, including NPM1, DNMT3A, DNMT3A/NPM1, and WT1, with the greatest benefit seen in patients with NPM1 and DNMT3A co-mutations,...

lemtrada
imbruvica
zydelig
medrol
arzerra
rituxan
venclexta

Final Results of RESONATE Trial Show Long-Term Benefit of Ibrutinib in Relapsed or Refractory CLL

After 6 years of follow-up, extended treatment with ibrutinib showed sustained progression-free survival benefit and depth of response in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), including those with high-risk genomic features,...

hepatobiliary cancer
immunotherapy

ESMO 2019: First-Line Immunotherapy Shows Clinical Benefit in Advanced Hepatocellular Carcinoma

New data have shown a trend toward clinically meaningful improvements in survival and response rates and a favorable safety profile with first-line immunotherapy compared to current standard treatment for advanced hepatocellular carcinoma (HCC). The data, reported by Yau et al at the European...

multiple myeloma

FDA Approves Daratumumab Combination for Transplant-Eligible Patients With Multiple Myeloma

On September 26, 2019, the U.S. Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone for newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Efficacy was investigated ...

inrebic
jakafi

SOHO 2019: Fedratinib in Patients With Myelofibrosis: JAKARTA Trials Update

In analyses reported at the 2019 Society of Hematologic Oncology (SOHO) Annual Meeting and published in Clinical Lymphoma, Myeloma & Leukemia, Harrison et al identified response rates to the JAK2 inhibitor fedratinib among patients with myeloproliferative neoplasm–associated intermediate- or...

skin cancer
immunotherapy

Treatment-Free Survival as an Outcome Measure of Nivolumab/Ipilimumab Therapy in Advanced Melanoma

In a pooled analysis reported in the Journal of Clinical Oncology, Regan et al evaluated treatment-free survival as an outcome measure among patients with advanced melanoma receiving nivolumab/ipilimumab or either agent alone in the CheckMate 067 and 069 trials. Study Details The study involved...

CMS Expands Coverage of CAR T-Cell Therapy for Medicare Beneficiaries

The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor T-cell (CAR T-cell) therapy for certain patients with cancer. As outlined in ...

calquence
leukeran
imbruvica
gazyva
arzerra
rituxan
venclexta

Update on Treatments Under Study for Chronic Lymphocytic Leukemia

The ASCO Post has offered comprehensive coverage of the 2019 ASCO Annual Meeting. To complement this news coverage, here are featured clinical trials of several treatments in chronic lymphocytic leukemia (CLL). They focus on the monoclonal antibody obinutuzumab in combination therapy in the CLL14...

temodar

CATNON Trial Shows Concurrent Temozolomide May Offer Benefit in IDH-Mutant Anaplastic Glioma

Concurrent temozolomide treatment during radiotherapy did not increase overall survival in patients with anaplastic gliomas without 1p/19q co-deletion, according to data from the second interim and first molecular analysis of the EORTC randomized phase III intergroup CATNON trial.1 However, benefit ...

bavencio
inlyta
sutent

Avelumab Plus Axitinib in Advanced Renal Cell Carcinoma

Earlier this year, avelumab was approved for use in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III -JAVELIN Renal 101 trial (ClinicalTrials.gov identifier...

cyramza
nexavar

Ramucirumab in Hepatocellular Carcinoma

Earlier this year, ramucirumab was approved as a single agent for hepatocellular carcinoma in patients who have an alpha-fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib.1,2 Supporting Efficacy Data Approval was based on findings in the double-blind phase III...

head and neck cancer

Addition of Induction Gemcitabine/Cisplatin to Chemoradiotherapy in Nasopharyngeal Carcinoma

In a Chinese phase III trial reported in The New England Journal of Medicine, Zhang et al found that the addition of gemcitabine/cisplatin induction chemotherapy to standard platinum-based chemoradiotherapy improved recurrence-free survival vs chemoradiotherapy alone in locoregionally advanced...

prostate cancer

Andrew Kneebone, MD, on an ANZUP Trial on Adjuvant vs Early Salvage Radiotherapy After Prostatectomy

Andrew Kneebone, MD, of Royal North Shore Hospital, discusses phase III study findings showing that at 5 years, biochemical control was similar between adjuvant and early salvage radiotherapies, the latter sparing half of the men potential side effects of radiotherapy without any significant...

cns cancers

Erica H. Bell, PhD, on Low-Grade Gliomas: Subgroup Analysis of the NRG Oncology/RTOG 9802 Trial

Erica H. Bell, PhD, of The Ohio State University, discusses phase III findings from a prognostic and predictive molecular subgroup analysis of radiotherapy vs radiotherapy plus procarbazine/lomustine/vincristine in high-risk low-grade gliomas (Abstract 161).

velcade
darzalex
revlimid
xifaxan

Tailoring Upfront Daratumumab Treatment for Some Patients With Multiple Myeloma

The monoclonal antibody daratumumab has been widely embraced for the treatment of multiple myeloma, but for newly diagnosed patients, its benefit has been proved only in some patients, according to Craig Hofmeister, MD, MPH, Associate Professor of Medicine at the Winship Cancer Institute of Emory...

vidaza
tibsovo

SOHO 2019: Ivosidenib/Azacitidine for Newly Diagnosed AML

Findings from a phase Ib study of the combination of the mutant IDH1 inhibitor ivosidenib plus azacitidine for patients with IDH1-mutated, newly diagnosed acute myeloid leukemia (AML) ineligible for intensive treatment showed that the combination was well tolerated and produced more responses than...

herceptin

Flaxseed

The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Ting Bao, MD, DABMA, MS, and Jyothirmai Gubili, MS, focus on flaxseed because...

prostate cancer

Daniel E. Spratt, MD, on the Impact of Antiandrogen Treatment in Prostate Cancer: NRG Oncology/RTOG 9601 Trial

Daniel E. Spratt, MD, of the University of Michigan, discusses phase III study findings showing that 2 years of antiandrogen therapy increased cardiac and neurologic toxicities, as well as mortality from causes other than prostate cancer, in men with low levels of prostate-specific antigen after...

lung cancer
immunotherapy

Andreas Rimner, MD, on the PACIFIC Trial: Durvalumab for Stage III NSCLC

Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, discusses study findings showing that, for patients with stage III non–small cell lung cancer, durvalumab reduced the rate of and time to disease progression vs placebo and also reduced the number of new distant lesions (Abstract LBA6).

darzalex
decadron
pomalyst

SOHO 2019: Melflufen for Patients With Late-Stage, Relapsed or Refractory Multiple Myeloma Refractory to Daratumumab and/or Pomalidomide

In a presentation of updated efficacy and safety data from the phase II HORIZON trial, Paul G. Richardson, MD, and colleagues found that melflufen, a lipophilic peptide-conjugated alkylator, showed activity in patients with late-stage relapsed or refractory multiple myeloma refractory to...

lymphoma

Final Results of a Phase III Trial of PET-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma

As reported in the Journal of Clinical Oncology by Fuchs et al, final results of the German Hodgkin Study Group phase III HD16 trial in early-stage favorable Hodgkin lymphoma indicate that combined modality therapy (CMT) is associated with better progression-free survival vs chemotherapy alone...

kadcycla
herceptin

Adjuvant Treatment With Ado-trastuzumab Emtansine in HER2-Positive Early Breast Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Earlier this year, ado-trastuzumab emtansine (T-DM1) was...

blenoxane
lipodox
etopophos
revlimid
rituxan
marqibo

Current Controversies in Lymphoma: From the Role of Liquid Biopsy to Ways to Improve Upon Standard Chemotherapy

Two topics that hematologists are currently grappling with were addressed at the 2019 Debates and Didactics Conference in Sea Island, Georgia, sponsored by Emory University Winship Cancer Institute, by Editor-in-Chief of The ASCO Post, James O. Armitage, MD, FASCO.1 They focus on the emerging role ...

issues in oncology

Suboptimal Insurance Linked to Worse Survival Outcomes in Positive Clinical Trials

Findings from a recent SWOG study could cast doubt on the generalizability of treatment effects observed in positive clinical trials, especially among underinsured patients. According to data presented at the 2019 ASCO Quality Care Symposium,1 patients with Medicaid or no insurance had no observed...

yervoy
keytruda
opdivo
alimta

Tumor Mutational Burden Disappoints as Biomarker for Treatment Response in Exploratory Analyses of Nonsquamous NSCLC

Tumor mutational burden failed to prove effective as a biomarker for response to chemotherapy plus checkpoint inhibitor or chemotherapy alone as first-line treatment for nonsquamous non–small cell lung cancer (NSCLC) in two different exploratory analyses of KEYNOTE trials.1,2 In both analyses,...

darzalex
revlimid
pomalyst

Benefits Reported With Addition of Isatuximab to Pomalidomide and Dexamethasone in Resistant Multiple Myeloma

In patients with relapsed or refractory multiple myeloma, isatuximab in combination with pomalidomide and low-dose dexamethasone nearly doubled progression-free survival when compared with pomalidomide and dexamethasone alone, with a manageable safety profile, according to data from a phase III...

prostate cancer

FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer

On September 17, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved by the FDA in 2018 for patients with nonmetastatic castration-resistant prostate cancer. TITAN Trial...

lung cancer
immunotherapy

ASTRO 2019: Patterns of Disease Progression in Patients With Unresectable Stage III NSCLC: Analysis of the PACIFIC Trial

Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, presented an update of the landmark PACIFIC trial at the 61st Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Abstract LBA-6). In earlier reports from the randomized phase III trial, Antonia et al had evaluated...

gemzar
onivyde
lynparza
eloxatin

POLO Trial: Maintenance Olaparib in Germline BRCA-Mutated Metastatic Pancreatic Cancer

As reported in The New England Journal of Medicine by Talia Golan, MD, of Sheba Medical Center, Tel Aviv University, and colleagues, the phase III POLO trial showed that maintenance treatment with the poly (ADP ribose) polymerase (PARP) inhibitor olaparib improved progression-free survival vs...

prostate cancer

ASTRO 2019: Long-Term Hormone Therapy May Increase Other-Cause Mortality in Men With Prostate Cancer Receiving Early Salvage Radiotherapy

Findings from the randomized phase III NRG Oncology/RTOG 9601 trial were initially reported in 2017, and showed that the addition of 2 years of antiandrogen therapy to postsurgical radiation treatment for men with recurrent prostate cancer increased their long-term overall survival rate. That study ...

gynecologic cancers
immunotherapy

Bevacizumab/Niraparib vs Niraparib Alone for Platinum-Sensitive Recurrent Ovarian Cancer

In the phase II NSGO-AVANOVA2/ENGOT-ov24 trial reported in The Lancet Oncology, Mansoor Raza Mirza, MD, and colleagues found that the combination of bevacizumab plus niraparib prolonged progression-free survival vs niraparib alone in women with platinum-sensitive recurrent ovarian cancer. Study...

lung cancer
immunotherapy

ASTRO 2019: SBRT After Disease Progression on Immunotherapy Increases PFS in Patients With Metastatic NSCLC

Non–small cell lung cancer (NSCLC) accounts for the vast majority of all lung cancers—between 80% and 85% of those diagnosed in the United States—and is among the most deadly cancers for both men and women, exceeding the mortality rate of colon, breast, and pancreatic cancers combined. The results...

breast cancer

Meta-analysis of Chemotherapy and Hormonal Treatments for Postmenopausal Women With Metastatic Breast Cancer

In a systematic review and network meta-analysis reported in The Lancet Oncology, Giuliano et al found that progression-free survival in postmenopausal women with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer was improved with first- or second-line CDK4/6 inhibitors plus...

lung cancer
immunotherapy

WCLC 2019: KEYNOTE-024 Survival Update Shows Benefit With Pembrolizumab vs Chemotherapy in Advanced NSCLC

First-line pembrolizumab monotherapy provides durable long-term overall survival benefit compared to chemotherapy in patients with advanced non–small cell lung cancer (NSCLC), according to data from the KEYNOTE-024 trial presented by Martin Reck, MD, PhD, at the International Association for the...

lung cancer
immunotherapy

WCLC 2019: Final Overall Survival Results of IMpower131 Trial in Advanced Squamous NSCLC

Patients with stage IV squamous non–small cell lung cancer (NSCLC) with high programmed cell death ligand 1 (PD-L1) expression treated with atezolizumab and chemotherapy experienced longer overall survival rates than those treated with chemotherapy alone. The data from the IMpower131 trial were...

cns cancers

Quality of Life and Neurocognitive Function With Lomustine/Temozolomide for MGMT-Methylated Glioblastoma

In an analysis of the phase III CeTeG/NOA-09 trial reported in The Lancet Oncology, Weller et al found no clinically relevant differences in health-related quality of life or neurocognitive function in patients with newly diagnosed MGMT-methylated glioblastoma treated with lomustine/temozolomide vs ...

lipodox
gemzar
lynparza
hycamtin

Olaparib Monotherapy Improves Outcomes in BRCA-Mutated, Platinum-Sensitive Relapsed Ovarian Cancer

Compared with treatment with nonplatinum-based chemotherapy, monotherapy with the PARP (poly [ADP ribose] polymerase) inhibitor olaparib led to statistically significant and clinically relevant improvements in overall response rate and progression-free survival in women with germline...

lung cancer
immunotherapy

WCLC 2019: Pooled Analysis of CheckMate 017 and 057: 5-Year Outcomes With Nivolumab vs Docetaxel in Previously Treated NSCLC

Pooled data on two clinical trials demonstrated patients with previously treated non–small cell lung cancer (NSCLC) treated with nivolumab had a greater than fivefold increase in 5-year overall survival rate compared to treatment with the chemotherapy docetaxel. Scott Gettinger, MD, of Yale...

breast cancer

Alpelisib for PIK3CA-Mutated Advanced Breast Cancer

On May 24, 2019, alpelisib was approved for use in combination with fulvestrant for postmenopausal women, and men, with hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, as detected by a U.S. Food and Drug Administration (FDA)-approved test following...

immunotherapy
gastroesophageal cancer

Pembrolizumab in Advanced Esophageal Squamous Cell Cancer With PD-L1 Expression of CPS ≥ 10

On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug...

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