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multiple myeloma

Treating Earlier to Avoid Progression to Multiple Myeloma 

With an expanded list of drugs to treat multiple myeloma, experts are interested in whether treating precursor diseases to multiple myeloma can prevent progression to full-blown myeloma. In addition, new drugs are entering the armamentarium for treating multiple myeloma, noted Ruben Niesvizky, MD,...

Expert Point of View: Kjell Oberg, MD, PhD

Kjell Oberg, MD, PhD, Professor in the Department of Medical Sciences at the University Hospital in Uppsala, Sweden, discussed the CLARINET paper at the Presidential Session during the European Cancer Congress in Amsterdam. Dr. Oberg noted the curious observation that median progression-free...

neuroendocrine tumors

Extended-Release Lanreotide Significantly Delays Disease Progression in Patients With Neuroendocrine Tumors in Large Phase III CLARINET Trial

A strong antiproliferative response was shown for the somatostatin analog lanreotide (subcutaneous, extended-release formulation, Somatuline Autogel [Somatuline Depot in the United States]) in patients with gastroenteropancreatic neuroendocrine tumors, in the large multinational prospective phase...

Expert Point of View: Sibylle Loibl, MD

Sibylle Loibl, MD, of the German Breast Group and the Klinikum Offenbach in Germany, discussed the NeoALTTO findings at the European Cancer Congress, noting that this trial is one of several studies that all point to one conclusion: Pathologic complete response rates are lower in HER2-positive...

breast cancer

PIK3CA-Mutant Tumors Not Likely to Respond to Neoadjuvant HER2 Blockade

In early breast cancer patients receiving anti-HER2 therapy in the NeoALTTO trial, mutations in PIK3CA were associated with lower rates of pathologic complete response, according to a study reported at the 2013 European Cancer Congress by José Baselga, MD, Physician-in-Chief at Memorial...

breast cancer

Erratum

In the November 15 issue of The ASCO Post, the article, “Strong Showing for Ado-Trastuzumab Emtansine in Advanced HER2-Positive Heavily Pretreated Breast Cancer,” contained the following errors in the reported outcomes data for the TH3RESA trial: The article incorrectly stated the median survival...

Expert Point of View: Elzbieta Senkus-Konefka, MD, PhD

Elzbieta Senkus-Konefka, MD, PhD, of the Medical University of Gdansk, Poland, the formal discussant of the paper at the European Cancer Congress, took exception with the authors’ conclusion that radiotherapy may not be effective in all subtypes. “I don’t agree that luminal B and HER2-enriched...

breast cancer

Radiotherapy Benefit in Young Women With Node-Positive Breast Cancer May Vary by Intrinsic Subtypes

Radiation therapy appears to significantly decrease local recurrence in premenopausal women with node-positive and luminal A tumors, based on an analysis of two small but independent randomized series reported at the 2013 European Cancer Congress in Amsterdam.1 “Though not definitive, our study...

issues in oncology

African Americans Report Receiving Few Positive Recommendations by Physicians About Joining Clinical Trial 

A study among African American patients with cancer who had declined to participate in a therapeutic clinical trial found that few patients reported receiving a positive recommendation from their physician to participate in the trial. “Patients gave multiple refusal reasons,” researchers led by...

breast cancer
supportive care

No Significant Improvement With Decongestive Therapy vs More Conservative Approach to Treating Arm Lymphedema 

Daily manual lymphatic drainage and bandaging followed by compression garments did not result in significant improvement in lymphedema compared to a more conservative approach with compression garments only, according to a study evaluating 95 women previously treated for breast cancer with...

With the Goal of Curing Cancer, Ezra M. Greenspan, MD, Helped Usher in the Modern Era of Chemotherapy

Two events in Ezra M. Greenspan’s early adult life convinced him to pursue a career in medicine: the death of a college friend from pneumonia when the two were students at Cornell University College of Arts and Sciences and his own bout with the disease soon after. Saved by a local physician who...

issues in oncology

Developing Intermediate Endpoints in Immunotherapy

“The immune system holds tremendous potential for long-term sustained antitumor activity,” said James P. Allison, PhD, Immunology Chair, The University of Texas MD Anderson Cancer Center, Houston, as he opened a panel discussion at a meeting cosponsored by the Friends of Cancer Research and the...

lung cancer

Activation of Innovative Lung Cancer Master Protocol Officially Announced, Enrollment to Begin in March

At a recent meeting in Washington, DC, Friends of Cancer Research and the Engelberg Center for Health Care Reform at the Brookings Institution officially announced activation of the Lung Cancer Master Protocol, a new research strategy that has the potential to hurdle or bypass known clinical trial...

multiple myeloma

Meta-Analysis Upholds Benefit in Progression-Free Survival, but Not Overall Survival, With Lenalidomide Maintenance

Multiple myeloma patients derived a benefit from maintenance lenalidomide (Revlimid) treatment in terms of progression-free but not overall survival, according to a meta-analysis of four key trials presented at the 2013 American Society of Hematology (ASH) Annual Meeting.1 The study does little to...

breast cancer

Cautious Comments on the TARGIT-A Trial

Numerous randomized trials have demonstrated that whole-breast irradiation plays an important role after breast-conserving surgery for invasive breast cancer. A recent meta-analysis of these trials indicated that whole-breast irradiation decreased the risk of total breast cancer relapse events and...

lung cancer

Molecularly Targeted Therapy for Lung Cancer

INSIDE THE BLACK BOX is an occasional column offering insight into the FDA and its policies and procedures. This installment addresses a changing paradigm in the treatment of lung cancer, exemplified by concurrent approval of a companion diagnostic with each of several new targeted agents or new...

multiple myeloma

IFM 2005-02 Update Differs From CALGB 100104: Why? 

The updated analysis of the Intergroupe Francophone du Myelome (IFM) 2005-02 trial in newly diagnosed multiple myeloma patients showed that lenalidomide (Revlimid) maintenance prolongs progression-free survival after stem cell transplantation, but does not improve overall survival, according to...

multiple myeloma

Surprising Findings for Lenalidomide Maintenance in Updated IFM 2005-02 Analysis 

A new analysis of the multiple myeloma Intergroupe Francophone du Myelome (IFM) 2005-02 trial showed that lenalidomide (Revlimid) maintenance prolongs progression-free survival after stem cell transplantation, but does not improve overall survival.1 This is possibly attributed to the shorter...

Expert Point of View: Debu Tripathy, MD

Debu Tripathy, MD, Professor of Medicine, Co-Leader of the Women’s Cancer Program, and the Priscilla and Art Ulene Chair in Women’s Cancer at the University of Southern California Norris Cancer Center, Los Angeles, commented on the APT study for The ASCO Post. “In treating early-stage...

breast cancer

HER2-Positive Breast Cancer Patients With Small Tumors Benefit From Low-Toxicity Regimen 

There may be a benefit for treating small HER2-positive tumors—a breast cancer subset for whom treatment recommendations have not been established but for whom there is still risk of recurrence—and this can be done with little toxicity, according to a multicenter study presented at the 2013 San...

Expert Point of View: Carlos L. Arteaga, MD and David Cameron, MD, MRCP

After the IBIS-II presentation at the San Antonio Breast Cancer Symposium, Carlos L. Arteaga, MD, of Vanderbilt Ingram Cancer Center, Nashville, noted that women at high risk are afraid of developing breast cancer and that pharmacologic intervention may allay their anxiety. “Dr. Cuzick’s study...

breast cancer

Anastrozole Halves Risk of First Breast Cancer in High-Risk Postmenopausal Women 

Five years of treatment with anastrozole reduced the risk of breast cancer by 53% in postmenopausal women at high risk for developing the disease, according to an analysis of the International Breast Cancer Intervention Study (IBIS)-II trial. Anastrozole reduced the risk of estrogen...

multiple myeloma

Continuous Lenalidomide/Low-Dose Dexamethasone: A New Option for Older Patients With Newly Diagnosed Myeloma 

First-line treatment of newly diagnosed multiple myeloma using the Rd regimen (continuous lenalidomide [Revlimid] plus low-dose dexamethasone) was superior to standard triplet treatment with MPT (melphalan, prednisone, and thalidomide [Thalomid]) for 72 weeks, according to initial results of the...

lung cancer

Some Lung Cancers Detected by Low-Dose CT in National Lung Screening Trial May Be Indolent

More than 18% of all lung cancers detected by low-dose computed tomography in the National Lung Screening Trial (NLST) may be clinically insignificant. Overdiagnosis should be considered when describing the risks of [low-dose computed tomography] screening for lung cancer, according to a review of...

cns cancers

An Overview of the REGAL Trial and Anti-VEGF Therapies in Recurrent Glioblastoma

As published in the Journal of Clinical Oncology by Batchelor and colleagues1 and reviewed in a recent issue of The ASCO Post (November 15, 2013, page 106), the REGAL trial was a randomized, phase III, placebo-controlled, partially blinded trial evaluating the efficacy of cediranib, an...

breast cancer

Addition of Carboplatin to Standard Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Supported by SABCS Studies

The achievement of a pathologic complete response in patients with triple-negative breast cancer was boosted by the addition of carboplatin to a standard neoadjuvant chemotherapy regimen, and by the addition of veliparib, an investigational oral PARP inhibitor, plus carboplatin to a standard...

issues in oncology

FDA Programs to Expedite Drug and Biologic Product Development

With the advent of Breakthrough Therapy designation, there are now four FDA programs to expedite the development of promising new agents: Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval (Table 1). These programs complement one another and serve a common goal: to speed...

lymphoma

ASH Studies Confirm Benefit of Rituximab Maintenance in Follicular Lymphoma

Findings from two major studies presented at the 2013 American Society of Hematology Annual Meeting not only confirm the benefit of rituximab (Rituxan) maintenance in follicular lymphoma, but also indicate that the longer the maintenance period, the greater the impact on progression-free survival....

multiple myeloma

ASH Studies Refine Myeloma Treatment and Show Promise for New Agents

Multiple myeloma researchers moved the field forward at the 2013 American Society of Hematology (ASH) Annual Meeting, presenting evaluations of treatment schedules and reports of encouraging activity with compounds in development. Alternating vs Sequential Regimens In 231 newly diagnosed elderly...

breast cancer

Switching Chemotherapy Based on Elevated Circulating Tumor Cells Does Not Change Outcome in Metastatic Breast Cancer

Elevated circulating tumor cells were prognostic for survival but did not pan out as a marker for switching after one cycle of chemotherapy in patients with metastatic breast cancer. The phase III Southwest Oncology Group (SWOG) S0500 clinical trial, presented at the 2013 San Antonio Breast Cancer...

breast cancer

SABCS Highlights Include Findings in Triple-Negative Disease, Protective Effects of Exercise, and the Adherence-Copay Link

The San Antonio Breast Cancer Symposium brings together specialists from all over the world who focus on management of breast cancer. We have covered many of the important presentations in the pages of The ASCO Post and in our online Evening News. Below are summaries of additional noteworthy...

leukemia

FDA Approves CliniMACS CD34 Reagent System for the Prevention of Graft-vs-Host Disease in AML

The U.S. Food and Drug Administration (FDA) has approved the Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-vs-host disease in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic stem cell...

lymphoma

FDA Accepts New Drug Application for Idelalisib in Refractory Indolent Non-Hodgkin Lymphoma

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K-delta, for the treatment of refractory indolent non-Hodgkin lymphoma (NHL). The FDA has granted a standard review for the NDA, with a target review date of...

colorectal cancer

Maintenance Treatment With Capecitabine and Bevacizumab Is Effective in Metastatic Colorectal Cancer

In patients with metastatic colorectal cancer, maintenance treatment with capecitabine plus bevacizumab (Avastin) after induction treatment with capecitabine, oxaliplatin, and bevacizumab (CAPOX-B) significantly delayed disease progression, compared to observation, according to the final results of ...

gastrointestinal cancer

Ramucirumab Plus Paclitaxel Improves Overall Survival After First Progression in Metastatic Gastric Cancer

In the global phase III RAINBOW trial in patients with metastatic gastric cancer, the investigational monoclonal antibody ramucirumab significantly improved both progression-free and overall survival, when added to paclitaxel in second-line therapy, as reported at the 2014 Gastrointestinal Cancers...

Expert Point of View: Rebecca Miksad, MD, MPH

Rebecca Miksad, MD, MPH, Assistant Professor of Medicine at Harvard Medical School and Attending Physician, Gastrointestinal Medical Oncology, Beth Israel Deaconess Medical Center, Boston, discussed the findings at the symposium and the potential for immunotherapy in pancreatic cancer....

pancreatic cancer

Immunotherapy Duo Improves Survival in Metastatic Pancreatic Cancer

Overall survival was improved in metastatic pancreatic cancer patients through an innovative immunotherapy strategy in a multicenter study reported at the 2014 Gastrointestinal Cancers Symposium.1 “This is the first time a randomized study has shown that immunotherapy is effective in pancreatic...

breast cancer

The Canadian National Breast Screening Trial Had So Many Flaws That Its Results Should Not Be Used to Guide Screening Recommendations

If a randomized, controlled trial of therapy for breast cancer was submitted for publication in which 1. The drug being tested was old and ineffective, and 2. prior to randomization, the women underwent a clinical breast examination and the study coordinators knew who had the largest cancers, and...

breast cancer

Flaws in CNBSS Are Vast, Impact on Screening Recommendations Is Nil

The recent report from the Canadian National Breast Screening Study (CNBSS)—published in BMJ and reviewed in The ASCO Post, early release online—concluded that annual mammography in women aged 40 to 59 does not result in a reduction in mortality from breast cancer beyond that of physical...

breast cancer

No Mortality Benefit of Breast Cancer Mammography Screening in 25-Year Follow-up of Canadian National Breast Screening Study

As reported in BMJ by Anthony B. Miller, MD, Professor Emeritus at the Dalla Lana School of Public Health, University of Toronto, and colleagues, the 25-year follow-up of the Canadian National Breast Screening Study has shown no mortality benefit of annual mammography screening for breast cancer...

leukemia

First-Line Obinutuzumab/Chlorambucil Improves Outcomes Over Rituximab/Chlorambucil in Older CLL Patients With Comorbidities

Obinutuzumab (Gazyva) plus chloramubucil outperformed rituximab (Rituxan) plus chlorambucil (Leukeran) as first-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities in the large CLL 11 trial. Final results showed that obinutuzumab/chloramubucil improved overall...

Expert Point of View: Debu Tripathy, MD

Debu Tripathy, MD, Professor of Medicine, Co-Leader of the Women’s Cancer Program, and the Priscilla and Art Ulene Chair in Women’s Cancer at the University of Southern California Norris Cancer Center, Los Angeles, commented on the APT study for The ASCO Post. “In treating early-stage HER2-positive ...

breast cancer

HER2-Positive Breast Cancer Patients With Small Tumors Benefit From Low-Toxicity Regimen

There may be a benefit for treating small HER2-positive tumors—a breast cancer subset for whom treatment recommendations have not been established but for whom there is still risk of recurrence—and this can be done with little toxicity, according to a multicenter study presented at the 2013 San...

colorectal cancer
pancreatic cancer

GI Symposium Presentations Include Important Updates in Treatment and Prognosis of Pancreatic and Colorectal Cancers

More than 650 studies were presented at the 2014 Gastrointestinal Cancers Symposium, which attracted a multidisciplinary group of more than 3,500 medical, surgical, and radiation oncologists and gastroenterologists. The following briefs highlight a handful of noteworthy studies from the meeting....

colorectal cancer

Capecitabine Acceptable in Neoadjuvant Rectal Cancer Setting

As neoadjuvant therapy for rectal cancer, infusional fluorouracil (5-FU) and oral capecitabine achieve similar outcomes, and the addition of oxaliplatin confers no additional benefit, according to the mature results of the National Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 trial,...

Expert Point of View: Josep M. Llovet, MD

Josep M. Llovet, MD, Professor of Medicine at Mount Sinai Hospital, New York, commented on the findings reported by Faivre et al for The ASCO Post. “This is the first time a TGF-β inhibitor has been clinically tested in hepatocellular carcinoma, and the drug has a good safety profile. But this is a ...

colorectal cancer

Irinotecan Drug-Eluting Beads Improve Outcomes in Colorectal Cancer Patients With Liver Metastases

Irinotecan drug-eluting beads (DEBIRI) given simultaneously with FOLFOX (leucovorin, fluorouracil, oxaliplatin) and bevacizumab (Avastin) in patients with unresectable colorectal liver metastasis improved response rates, increased resectability, and prolonged hepatic progression–free survival in a...

kidney cancer

Sequencing Sorafenib and Sunitinib in Either Order Does Not Affect Survival in Metastatic Renal Cell Carcinoma

The explosion of new therapies for metastatic renal cell carcinoma is a welcome advance, but studies have not yet defined optimal sequencing of the newer therapies. According to the phase III SWITCH trial, it matters little whether therapy for metastatic renal cell carcinoma begins with sorafenib...

prostate cancer

PREVAIL Trial Shows Enzalutamide to Be a Promising Option for Metastatic Castration-Resistant Prostate Cancer

Encouraging results of the large phase III PREVAIL trial represent another positive milestone for men with metastatic castration-resistant prostate cancer. Enzalutamide (Xtandi) improved overall survival by 29% and reduced the risk of radiographic progression of disease by 81% in men who had not...

leukemia

Ibrutinib for Previously Treated Chronic Lymphocytic Leukemia

On February 12, 2014, ibrutinib (Imbruvica) was granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1,2 Ibrutinib previously received accelerated approval for the treatment of patients with mantle cell...

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