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hematologic malignancies
leukemia

Data Favoring Maintenance Therapy in Older Patients With AML Accumulate

The use of maintenance therapy in older patients with acute myeloid leukemia (AML) is theoretically sensible, but its clinical value remains uncertain. The phase III HOVON97 randomized study demonstrated that maintenance therapy with the hypomethylating agent azacitidine may improve disease-free...

multiple myeloma

Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma

As reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, Alexandra Hospital, and colleagues in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis)...

breast cancer

Serum Bone Biomarkers in Early Breast Cancer and Risk of Bone Metastasis

In a study reported in the Journal of the National Cancer Institute, Brown et al found that the serum bone biomarkers P1NP, CTX, and 1-CTP showed good prognostic ability for bone metastasis in patients in the phase III AZURE (BIG01/04) trial of adjuvant zoledronic acid in early breast cancer....

gynecologic cancers

Kathleen M. Schmeler, MD: A Gynecologic Oncology Activist for Underserved Women

Kathleen M. Schmeler, MD, Associate Professor in the Department of Gynecologic Oncology at The University of Texas MD Anderson Cancer Center and the Lyndon B. Johnson Hospital, was given the “Heroes in Medicine” award from Physician’s Weekly in May 2016. Her primary work is in cervical cancer...

multiple myeloma

Results From Phase III ARROW Study of Once-Weekly Carfilzomib in Relapsed or Refractory Multiple Myeloma

TOPLINE RESULTS of the phase III ARROW trial (ClinicalTrials.gov identifier NCT02412878) were recently announced by Amgen. The study showed carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed patients with relapsed or refractory multiple myeloma to live 3.6 months ...

cns cancers

Does Treatment With Tumor-Treating Fields Plus Temozolomide Influence Quality of Life in Patients With Newly Diagnosed Glioblastoma?

A DETAILED quality-of-life analysis of the phase III EF-14 trial of tumor-treating fields (Optune) in combination with temozolomide for the treatment of newly diagnosed glioblastoma was published by Taphoorn et al in JAMA Oncology.1 This secondary endpoint analysis showed the addition of...

lung cancer
immunotherapy

Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients With Advanced NSCLC

On February 15, updated results were made available from the phase III JAVELIN Lung 200 trial comparing avelumab (Bavencio) to docetaxel in patients with unresectable, recurrent, or metastatic non–small cell lung cancer (NSCLC) whose disease progressed after treatment with a...

lung cancer
immunotherapy

FDA Expands Approval of Durvalumab to Reduce the Risk of NSCLC Progression

On February 16, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. “This is the first treatment...

EXPERT POINT OF VIEW: Matthew J. Ellis, MB, PhD

Matthew J. Ellis, MB, PhD, Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston, commented on the POETIC trial for The ASCO Post. “This is a wonderful study that validates a point that our research team has also made over the years—that Ki67 is much more...

solid tumors
breast cancer

Perioperative Aromatase Inhibitors: No Effect on Recurrence, but Ki67 Level Important

Updated analysis from the United Kingdom’s POETIC trial found no evidence that perioperative aromatase inhibitor therapy slows or prevents time to recurrence of breast cancer. However, the study did show that tumor Ki67 levels after 2 weeks of perioperative aromatase inhibitor therapy are...

solid tumors
breast cancer

SABCS Highlights Focus on Predicting Residual Tumor Burden, Therapy-Related Arm Morbidity, Lifestyle and Cancer Risk

We have covered many of the important presentations from the 2017 San Antonio Breast Cancer Symposium in the pages of The ASCO Post and in our online Evening News. Here are summaries of additional noteworthy studies presented at the meeting. We hope you will find them of interest. Predicting...

hepatobiliary cancer

First-Line Lenvatinib vs Sorafenib in Unresectable Hepatocellular Carcinoma

In a phase III noninferiority trial reported in The Lancet, Kudo et al found that first-line lenvatinib was noninferior to sorafenib in overall survival of patients with unresectable hepatocellular carcinoma. Study Details In the open-label trial, 954 patients from 154 sites in 20 countries in...

solid tumors
pancreatic cancer

LAPACT Trial Confirms Efficacy of Nab-Paclitaxel Plus Gemcitabine as Induction Therapy in Pancreatic Cancer

Patients newly diagnosed with locally advanced pancreatic cancer who received induction therapy with nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) and gemcitabine achieved a time to treatment failure and median progression-free survival that exceeded the protocol-specified target by more...

EXPERT POINT OF VIEW: Jordi Bruix, MD, PhD and Flavio G. Rocha, MD

Discussant Jordi Bruix, MD, PhD, Head of the Barcelona Clinic Liver Cancer Group at the University of Barcelona in Spain, said the results of the CELESTIAL trial show that cabozantinib (Cabometyx) provides a clinically meaningful survival benefit to patients with advanced hepatocellular carcinoma ...

solid tumors

Cabozantinib Improves Survival in Advanced Hepatocellular Carcinoma

Patients with previously treated advanced hepatocellular carcinoma derived a survival benefit from cabozantinib (Cabometyx), in the phase III CELESTIAL trial.1 “Cabozantinib represents a new treatment option for patients with advanced hepatocellular carcinoma after prior systemic anticancer...

solid tumors
head and neck cancer

Laryngeal Preservation: All Patients Need a Voice

Following the publication of two landmark studies in the United States,1,2 laryngeal preservation with combined chemoradiotherapy has become standard practice as opposed to laryngectomy for patients with locally advanced laryngeal cancer. The Department of Veterans Affairs Laryngeal Cancer Study...

prostate cancer

Long-Term Survival Outcomes With Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer

Analysis of long-term survival outcomes in the phase III CHAARTED trial showed a survival advantage with the addition of docetaxel to androgen-deprivation therapy (ADT) in patients with hormone-sensitive metastatic prostate cancer, although no advantage was observed among patients with low-volume...

kidney cancer

2018 GU CANCERS SYMPOSIUM: Tivozanib in Combination With Nivolumab in Metastatic RCC

Preliminary results from the phase II portion of the TiNivo study, a phase Ib/II multicenter trial of oral tivozanib in combination with intravenous (IV) nivolumab (Opdivo) for the treatment of metastatic renal cell carcinoma (RCC) were presented by Escudier et al at the 2018 Genitourinary Cancers...

breast cancer
immunotherapy

Neoadjuvant Trastuzumab Biosimilar vs Trastuzumab in HER2-Positive Early Breast Cancer

In a phase III trial reported in the Journal of Clinical Oncology, Pivot et al found equivalence of the trastuzumab biosimilar SB3 and the reference trastuzumab (Herceptin) in producing breast pathologic complete response in the neoadjuvant treatment of patients with HER2-positive early breast...

kidney cancer

METEOR Trial Follow-up: Quality of Life in Metastatic RCC

In a study reported in the Journal of Clinical Oncology, Cella et al found little difference in quality-of-life (QOL) outcomes between the cabozantinib (Cabometyx) and everolimus (Afinitor) groups in the phase III METEOR trial. The study investigated these treatments in patients with metastatic...

breast cancer
survivorship

2018 SURVIVORSHIP: Exercise Speeds Improvement in Arm Mobility After Surgery for Breast Cancer

New findings from a clinical trial of women with breast cancer suggest that guided exercise with a physical therapist after lymph node dissection helps women regain their range of arm motion more quickly. These findings will be presented by Paskett et al at the upcoming 2018 Cancer Survivorship...

breast cancer
colorectal cancer
survivorship

2018 SURVIVORSHIP: Exercising During Chemotherapy for Breast or Colon Cancer Has Long-Term Benefits

A follow-up study to a randomized clinical trial reveals that exercising during adjuvant chemotherapy helps people engage in more physical activity years later. Four years later, people with breast or colon cancer who had participated in an 18-week exercise program while receiving chemotherapy...

prostate cancer

Eric J. Small, MD, on Prostate Cancer: Results From the SPARTAN Trial

Eric J. Small, MD, of the University of California, San Francisco, discusses phase III findings on apalutamide vs placebo in patients with nonmetastatic castration-resistant prostate cancer (Abstract 161).

kidney cancer
immunotherapy

Sumanta K. Pal, MD, on RCC: Results From Two Clinical Trials

Sumanta K. Pal, MD, of the City of Hope Comprehensive Cancer Center, discusses phase III study findings from IMmotion151, which looked at atezolizumab plus bevacizumab vs sunitinib in untreated metastatic renal cell carcinoma (RCC), and results from a safety and efficacy trial of axitinib in...

prostate cancer

Maha Hussain, MD, on Prostate Cancer: Results From the PROSPER Trial

Maha Hussain, MD, of Northwestern University, discusses phase III findings on enzalutamide in men with nonmetastatic castration-resistant prostate cancer (Abstract 3).

kidney cancer

Daniel J. George, MD, on RCC: Study Results on Adjuvant Treatment

Daniel J. George, MD, of Duke University Medical Center, discusses phase III findings on adjuvant sunitinib in patients with high-risk renal cell carcinoma, in an exploratory pharmacogenomic analysis (Abstract 576).

bladder cancer
immunotherapy

Thomas Powles, MD, on Urothelial Carcinoma: Results From the IMvigor211 Trial

Thomas Powles, MD, of Barts Cancer Institute, discusses phase III study findings on atezolizumab vs chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma, with an emphasis on immune biomarkers, tumor mutational burden, and clinical outcomes (Abstract 409).

bladder cancer

Joaquim Bellmunt, MD, PhD, on Urothelial Cancer: Results From the KEYNOTE-045 Trial

Joaquim Bellmunt, MD, PhD, of the Dana-Farber Cancer Institute, discusses phase III 2-year follow-up findings on pembrolizumab vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (Abstract 410).

breast cancer

Synchronous Distant and Locoregional Recurrence in Stage II and III Breast Cancer

In a study of National Cancer Database data reported in the Journal of Clinical Oncology, Neuman et al found that synchronous distant recurrence was identified in 27% of women with stage II or III breast cancer experiencing locoregional recurrence. Study Details The study—an American...

prostate cancer

2018 GU CANCERS SYMPOSIUM: Antiandrogenic Therapy in Nonmetastatic Castration-Resistant Prostate Cancer

Results from the phase III PROSPER trial in patients with nonmetastatic castration-resistant prostate cancer were presented by Hussain et al at the 2018 Genitourinary Cancers Symposium (Abstract 3). The results show that the use of enzalutamide (Xtandi) plus androgen-deprivation therapy (ADT)...

kidney cancer
immunotherapy

2018 GU CANCERS SYMPOSIUM: Combination Therapy Shows Antitumor Activity in Advanced Renal Cell Carcinoma

Combining the antiangiogenic agent axitinib (Inlyta) with the immunotherapy pembrolizumab (Keytruda) was found to have promising antitumor activity and no unexpected side effects in an early-phase clinical trial in patients with advanced kidney cancer who had not been previously treated. The full...

breast cancer

ASCO/CCO Focused Guideline Update on Role of Bone-Modifying Agents in Metastatic Breast Cancer

AS REPORTED BY Catherine Van Poznak, MD, FASCO, of the University of Michigan, Ann Arbor, and colleagues in the Journal of Clinical Oncology, ASCO and Cancer Care Ontario (CCO) have collaborated in providing a focused update for the ASCO clinical practice guideline on the role of bone-modifying...

bladder cancer
immunotherapy

Avelumab in Advanced Urothelial Carcinoma: Further Study Needed to Clarify its Role

AS REVIEWED in this issue of The ASCO Post, Patel and colleagues have presented data from the phase I JAVELIN study evaluating avelumab (Bavencio) in platinum-refractory patients with advanced urothelial carcinoma.1 The drug is active with durable responses when compared with historical...

breast cancer

Updates of Key Studies Differ on Relative Benefit of Nab-Paclitaxel in Breast Cancer

TWO IMPORTANT STUDIES, both updates of earlier findings and presented at the 2017 San Antonio Breast Cancer Symposium, provided different findings as to the relative benefit of nanoparticle albumin-bound (nab)-paclitaxel (Abraxane), vs solvent-based paclitaxel in breast cancer.  “The two studies...

breast cancer

Adjuvant Zoledronic Acid in Early Breast Cancer: Is 5 Years Better?

THE PHASE III SUCCESS A trial, presented at the 2017 San Antonio Breast Cancer Symposium, found no benefit for extending the use of intravenous zoledronic acid from 2 years to 5 years.1  “At this time point, our study showed no difference in disease-free survival or overall survival between 5 years ...

breast cancer
immunotherapy

Trastuzumab for 9 Weeks Fails to Show Noninferiority in HER2-Positive Breast Cancer

ANOTHER TRIAL has validated that 1 year of adjuvant trastuzumab (Herceptin) remains the standard in HER2-positive breast cancer, but the margin of difference, compared with just 9 weeks of the drug, was slim, based on the findings of the phase III SOLD trial reported at the 2017 San Antonio Breast...

breast cancer

Precision Medicine: Hope or Hype?

ALTHOUGH PRECISION medicine may be a recent discovery in some fields, it is an old story in the field of breast cancer, and one that has been exceptionally important in terms of managing the disease, according to George Sledge, MD, FASCO, Professor of Medicine and Medical Oncologist at the...

hematologic malignancies
immunotherapy

Daratumumab Shows Efficacy in Amyloid Light-Chain Amyloidosis

DARATUMUMAB (DARZALEX) may be an effective treatment for systemic amyloid light-chain (AL) amyloidosis, according to phase II studies reported at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition.1,2 While the cohorts were small and the arms uncontrolled, the findings...

lymphoma

Long-Term Follow-up in Follicular Lymphoma: SWOG Phase III Trial Reports Outcomes

As reported in the Journal of Clinical Oncology by Shadman et al, long-term follow-up of patients with previously untreated advanced-stage follicular lymphoma in the phase III SWOG-S0016 trial has shown continued good outcomes with both R-CHOP (rituximab [Rituxan] plus cyclophosphamide,...

cns cancers

Does Treatment With Tumor-Treating Fields Plus Temozolomide Influence Quality of Life in Patients With Newly Diagnosed Glioblastoma?

A detailed quality-of-life analysis of the phase III EF-14 trial of tumor-treating fields (Optune) in combination with temozolomide for the treatment of newly diagnosed glioblastoma was published by Taphoorn et al in JAMA Oncology. This secondary endpoint analysis demonstrated that the...

lung cancer
immunotherapy

Superior Progression-Free Survival With First-Line Nivolumab Plus Ipilimumab vs Chemotherapy in NSCLC With High Tumor Mutation Burden

The ongoing phase III CheckMate-227 study met its coprimary endpoint of progression-free survival with a combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy in patients with first-line advanced non­–small cell lung cancer (NSCLC) whose tumors have a high (≥ 10...

multiple myeloma

For Patients Treated for Myeloma, Antibiotic Prophylaxis May Reduce Infections and Deaths

IN PATIENTS undergoing treatment of multiple myeloma, the prophylactic use of levofloxacin significantly reduced febrile episodes and deaths, without increasing healthcare-associated infections or carriage of key nosocomial pathogens, in a large multicenter study from the United Kingdom.1 The...

breast cancer

Nab-Paclitaxel vs Paclitaxel in Neoadjuvant Treatment of HER2-Negative Breast Cancer

In a European phase III trial (ETNA) reported in JAMA Oncology, Gianni et al found no significant difference in pathologic complete response rate with nab-paclitaxel (Abraxane) vs paclitaxel followed by an anthracycline regimen in neoadjuvant treatment for HER2-negative breast cancer. Study...

kidney cancer
immunotherapy

2018 GU CANCERS SYMPOSIUM: Adding Immunotherapy to Standard Treatment Slows Growth of Advanced Kidney Cancer—With Fewer Side Effects

In a phase III clinical trial of patients with previously untreated metastatic renal cell cancer combining the immunotherapy atezolizumab (Tecentriq) with the targeted therapy bevacizumab (Avastin) delayed cancer growth by about 3 months longer than sunitinib, another targeted therapy. The benefit...

prostate cancer

2018 GU CANCERS SYMPOSIUM: Apalutamide Delays Prostate Cancer Metastases by More Than 2 Years

Findings from the phase III placebo-controlled SPARTAN trial suggest that apalutamide is an effective treatment for men with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease and for whom no approved treatments exist. Men who received...

gastrointestinal cancer

EXPERT POINT OF VIEW: Stephen Leong, MD

STEPHEN LEONG, MD, of the University of Colorado Comprehensive Cancer Center, Aurora, discussed the RAINFALL findings at the symposium, commenting, “The study did meet its primary endpoint of progression-free survival; however, it was disappointing not to see a benefit in overall survival or...

gastrointestinal cancer

Ramucirumab/Chemotherapy in Gastric Cancer: ‘Positive’ Trial but Insufficient Benefit

BASED ON EFFICACY seen in the second-line setting for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma, ramucirumab (Cyramza) was evaluated as first-line therapy in the international phase III RAINFALL trial. Although the study met its primary endpoint, with a 25%...

breast cancer

Bone-Modifying Agents in Metastatic Breast Cancer: Time to De-escalate Dosing Intervals

AS REVIEWED in this issue of The ASCO Post, ASCO and Cancer Care Ontario (CCO) have issued an updated guideline on the role of bone-modifying agents in metastatic breast cancer.1 The updated guideline supports a change in clinical practice for our patients with breast cancer and bone metastasis....

global cancer care

Changing Negative Perceptions on the Impact of Clinical Trials in Brazil

CLINICAL TRIALS are an essential research tool to advance medical knowledge and patient care. Traditionally, the majority of pharmaceutical-sponsored clinical trials have been implemented in Western Europe and North America. More recently, however, large pharmaceutical companies have increased...

solid tumors

Health-Related Quality of Life in Everolimus-Treated Patients With Neuroendocrine Tumors

As reported in The Lancet Oncology by Pavel and colleagues, no significant difference in deterioration of health-related quality of life was observed with everolimus (Afinitor) vs placebo in the phase III RADIANT-4 trial, which included patients with advanced nonfunctional well-differentiated...

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