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supportive care

Antidepressant Drug Has ‘Clinically Meaningful’ Effect on Chemotherapy-induced Painful Neuropathy

The oral antidepressant duloxetine (Cymbalta) at 60 mg/d improved chemotherapy-induced painful neuropathy in a randomized, double-blind, placebo-controlled, phase III trial.1 Overall, 59% of patients treated with duloxetine experienced some pain relief, 33% reported at least a 30% decrease in pain, ...

breast cancer

Improving Outcomes and Prediction in Ductal Carcinoma in Situ

Risk stratification and outcomes can be improved for women with ductal carcinoma in situ (DCIS), according to two studies presented at the 2012 ASCO Annual Meeting. RTOG 9804 Findings from the Radiation Therapy Oncology Group (RTOG) 9804 trial suggested that even for DCIS patients whose prognosis...

breast cancer

Everolimus Approved for Advanced Breast Cancer

The FDA has approved everolimus tablets (Afinitor) for use in combination with exemestane to treat postmenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer after failure of treatment with letrozole or anastrozole. The approval was based on a randomized,...

Expert Point of View: Grant McArthur, MB, BS, PhD

Grant McArthur, MB, BS, PhD, Head of the Cancer Therapeutics Program at the Peter MacCallum Cancer Centre in Melbourne, Australia, congratulated the investigators on a rapidly accrued, well-conducted, and ethical study that encouraged crossover to the active arm. He noted that regorafenib is an...

solid tumors

Striking Activity Shown for Regorafenib in Advanced GIST

Regorafenib, an orally administered investigational tyrosine kinase inhibitor that has shown activity in chemorefractory metastatic colorectal cancer, markedly delayed disease progression in patients with treatment-refractory metastatic gastrointestinal stromal tumor (GIST) in the phase III GRID...

prostate cancer
health-care policy

Senate Legislation Urges Federal Research Support to Improve Early Detection of Prostate Cancer

U.S. Senator John F. Kerry (D-MA) led unanimous passage of Senate Resolution 493 to recognize prostate cancer as an epidemic striking African American men disproportionately, with 250% higher mortality and 60% higher incidence. This bipartisan legislation urges federal agencies to support research...

breast cancer

Taxane-induced Neuropathy Does Not Correlate with Improved Outcomes in Operable Breast Cancer

An analysis of 4,554 patients who received adjuvant weekly paclitaxel and other taxane-based regimens in the E1199 trial “demonstrated that taxane-induced peripheral neuropathy does not correlate with improved outcomes in patients with operable breast cancer,” investigators reported in the Journal...

cns cancers

Chemotherapy plus Radiation Improved Progression-free Survival in Adults with Low-grade Glioma

Adult patients with supratentorial low-grade glioma who received chemotherapy with PCV (procarbazine [Matulane], lomustine [CeeNu], and vincristine) in addition to radiation therapy had improved progression-free survival but not overall survival compared to patients receiving radiotherapy alone,...

multiple myeloma

Carfilzomib: New Drug with Accelerated Approval for Multiple Myeloma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In July 2012, carfilzomib (Kyprolis) was granted...

leukemia

Liposomal Vincristine Approved in Acute Lymphoblastic Leukemia

The FDA has approved vincristine sulfate liposome injection (Marqibo) to treat adults with Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL). Administered once a week, liposomal vincristine is approved for patients whose leukemia has relapsed two or more times, or whose leukemia...

breast cancer

No Advantage to Longer Adjuvant Chemotherapy in Women with Early Breast Cancer: CALGB 40101 Trial

The ideal duration of adjuvant therapy for women with lower-risk primary breast cancer remains unknown. The National Surgical Adjuvant Breast and Bowel Project (NSABP) B-15 trial, reported more than 20 years ago, found no difference in outcomes between six cycles of cyclophosphamide, methotrexate,...

breast cancer

EMILIA Study: T-DM1 Significantly Improves Overall Survival in HER2-positive Metastatic Breast Cancer

Updated results from the phase III EMILIA study showed that trastuzumab emtansine (T-DM1) significantly improved overall survival of people with HER2-positive metastatic breast cancer compared to the combination of lapatinib and capecitabine (Xeloda). The new data were reported in a press release...

lung cancer

Biomarker-driven Adaptive Trial Design Proving Informative in Non–Small Cell Lung Cancer

Biomarker-driven adaptive trial design is an accelerated strategy for targeted drug development that is proving informative in non–small cell lung cancer (NSCLC), according to Roy S. Herbst, MD, PhD, Chief of Medical Oncology and Associate Director of Translational Research at Yale Cancer Center,...

lymphoma

Management of a Patient  with Systemic Anaplastic Large Cell Lymphoma following Failure of One or More Combination Regimens

Case Summary presented by Steven M. Horwitz, MD, Assistant Attending, Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York. This is a case of a 49-year-old woman who developed an enlarged right axillary lymph node. The woman had noticed some discomfort under her right arm, which she...

prostate cancer

Novel Drugs Enhance—but Complicate—Prostate Cancer Treatment

Three emerging agents for castration-resistant prostate cancer are extending lives and defining their roles in the treatment scenario, according to William Oh, MD, of Mount Sinai School of Medicine, New York, who commented on new data at the Best of ASCO Boston meeting. “We are talking about...

SIDEBAR: How Should SWOG 9346 Be Interpreted?

The findings of Southwest Oncology Group (SWOG) 9346 sparked controversy at the ASCO Annual Meeting, and the interpretations were debated at an official postpresentation discussion. At the Best of ASCO Boston meeting, William K. Oh, MD, of Mount Sinai School of Medicine, New York—who also served as ...

prostate cancer

Continuous Androgen Deprivation Remains Standard of Care in Newly Diagnosed Metastatic Prostate Cancer

Continuous androgen deprivation therapy remains the standard of care for newly diagnosed hormone-sensitive metastatic prostate cancer, according to the phase III Southwest Oncology Group (SWOG) 9346 intergroup trial presented at this year’s ASCO Plenary Session.1 Study Rationale The large...

colorectal cancer

Evidence Is Changing Colorectal Cancer Treatment Landscape

Key colorectal cancer studies presented at this year’s ASCO Annual Meeting are changing the treatment landscape in this disease, according to Michael Overman, MD, of The University of Texas MD Anderson Cancer Center, who reviewed the data at the Best of ASCO San Diego meeting. The mix included...

leukemia

New Agents Are Achieving Deeper Responses in CML

As tyrosinse kinase inhibitors become increasingly effective in treating chronic myeloid leukemia (CML), major molecular responses (≥ 3-log reduction in BCR-ABL transcripts) are being achieved for a growing percentage of patients. “In the new era of tyrosinse kinase inhibitors, we are learning how...

lymphoma

ABVD and BEACOPP Yield Equivalent Survival in Hodgkin Lymphoma

In the EORTC 20012 randomized phase III trial comparing eight cycles of ABVD vs eight cycles of BEACOPP, Hodgkin lymphoma patients achieved equivalent overall survival with either regimen, but BEACOPP was more toxic.1 “Our approach, and that of most U.S. centers, is to use ABVD,” Michael E....

lymphoma

Which Rituximab-based Regimen Works Best in Non-Hodgkin Lymphoma?

The treatment of non-Hodgkin lymphoma (NHL) patients has been recently informed by several important studies, which were discussed at the Best of ASCO Boston meeting by Michael E. Williams, MD, of the University of Virginia Cancer Center in Charlottesville. Bendamustine Outperforms R-CHOP in NHL...

SIDEBAR: Browsing the Anti-HER2 Options

“Where do current findings leave us in terms of anti-HER2 therapy options?” asked Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Center, Boston, who moderated the Best of ASCO Boston meeting. New drugs are joining trastuzumab (Herceptin) and lapatinib (Tykerb), and there will be some juggling...

breast cancer

Refining Current Treatments and Looking Ahead in HER2-positive Breast Cancer

In a study presented at the ASCO Plenary Session, trastuzumab emtansine (T-DM1), the antibody-drug conjugate linking trastuzumab (Herceptin) to a cytotoxic agent, improved progression-free survival by 3.2 months, representing a 35% reduction in risk of progression in the phase III EMILIA trial.1...

breast cancer

Cytotoxic Chemotherapy for Breast Cancer: Are We Done Tweaking It?

While novel targeted agents may grab the headlines in the treatment of breast cancer, oncologists still debate the optimal delivery of conventional cytotoxic chemotherapy, still a vital component of treatment. At the Best of ASCO Boston meeting, Steven J. Isakoff, MD, PhD, of Massachusetts General...

cns cancers

Paclitaxel Poliglumex Gets Orphan Drug Designation for Glioblastoma Multiforme

Cell Therapeutics, Inc, recently announced that paclitaxel poliglumex (OPAXIO) has been granted orphan drug designation by the FDA for the treatment of glioblastoma multiforme. Orphan designation was granted based on preliminary activity seen from phase II results of paclitaxel poliglumex when...

breast cancer

Starting Over after Cancer Treatment

When bloody discharge started oozing from the nipple on my left breast, I knew instinctively that it was serious. Although I was just 43, having lost two aunts to breast cancer, I knew my family history increased my risk for developing the disease. So when I saw my gynecologist for an exam, I was...

solid tumors
breast cancer
leukemia

New Studies Explore Exposure to Cancer-causing Agents

Key studies on cancer epidemiology and prevention delivered both reassuring and not-so-reassuring findings on exposure to agents believed to be cancer-promoting. Kala Visvanathan, MD, MHS, of The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine and School of Public Health, Baltimore,...

sarcoma

For Advanced Sarcomas, New Agents Prolong Remission but Not Survival

“We are beginning to understand the molecular biology underlying a portion of the 80 or so subtypes of sarcomas, and we hope this will lead to subtype-specific treatments,” said William D. Tap, MD, of Memorial Sloan-Kettering Cancer Center, New York, at the Best of ASCO Boston meeting. “And in...

solid tumors

New Drug Application Submitted for Regorafenib to Treat GIST

Bayer HealthCare and Onyx Pharmaceuticals recently announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for the oral multikinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose...

Pivotal Trials in Head and Neck Cancers Yield Mixed Results

The latest research in head and neck cancer reported at this year’s ASCO Annual Meeting presents a mixed picture, according to George R. Blumenschein, Jr, MD, Associate Professor at The Unviersity of Texas MD Anderson Cancer Center, Houston, who presented the data at the Best of ASCO San Diego...

prostate cancer

Enzalutamide for Metastatic Castrate-resistant Prostate Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In August 31, enzalutamide (Xtandi) was approved for the ...

leukemia

Bosutinib in Chronic Myelogenous Leukemia Patients with Resistance or Intolerance of Prior Therapy

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In September 4, 2012, bosutinib (Bosulif) was approved...

Neuropathy Not Predictive of Outcomes with Adjuvant Taxane Therapy in Breast Cancer

Neuropathy is a common and potentially disabling adverse effect of taxane therapy, particularly weekly paclitaxel. A number of recent studies have identified single nucleotide polymorphisms that appear to increase risk of grade 2 to 4 neuropathy in patients with breast cancer who receive taxanes....

breast cancer

In DCIS, Radiotherapy Benefits ‘Good Risk’ Patients

Radiation therapy will improve outcomes for patients with ductal carcinoma in situ (DCIS), even if they are considered at low risk for recurrence, according to the Radiation Therapy Oncology Group (RTOG) 9804 trial.1 But the follow-up time is short, and the findings still leave some wiggle room,...

Novel Device May Eliminate Need for Re-excision after Lumpectomy

A novel device employed during breast surgery reduces the need for re-excision due to positive margins. This lessens patient anxiety, lowers treatment costs, and helps preserve the cosmetic appearance of the breast, according to a large prospective study reported at the 2012 Breast Cancer...

Expert Point of View: Stephen E. Jones, MD

In a debate about the benefit of anthracycline therapy at the Symposium, Stephen E. Jones, MD, of US Oncology Research, The Woodlands, Texas, advocated for greater use of non–anthracycline-containing regimens. Dr. Jones was the principal investigator of US Oncology Research Trial 9735,1 which found ...

Breast Cancer Symposium Features Surgical Data, Updated Results from BOLERO-2, and Other Important News

The annual Breast Cancer Symposium, held September 13 to 15 in San Francisco, is jointly sponsored by ASCO, the American Society for Radiation Oncology, the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Cancers, and the Society of...

skin cancer

Vismodegib: Novel Agent for Treating Advanced Basal Cell Carcinoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In January 2012, vismodegib (Erivedge) was approved...

Role of Crizotinib in Previously Treated ALK-positive Advanced NSCLC

In yet another success story for personalized medicine, a targeted therapy extended survival in patients whose cancers expressed the target. Crizotinib (Xalkori), the first-in-class ALK inhibitor, extended progression-free survival and improved response rates compared with single-agent chemotherapy ...

breast cancer

SIDEBAR: Dealing with the Toxicity of Everolimus/Exemestane

While packing a punch in terms of clinical benefit, everolimus plus exemestane can also be a tough pill to swallow for many patients. The management of the potential toxicities associated with this new regimen was addressed at the 2012 Breast Cancer Symposium by Matthew J. Ellis, MB, PhD, of...

breast cancer

Will mTOR Inhibitors Change the Treatment of Endocrine-sensitive HER2-negative Breast Cancer?

For the treatment of endocrine-sensitive metastatic breast cancer, the combination of an mTOR inhibitor and an endocrine agent represents a promising new option. At the 2012 Breast Cancer Symposium, the 18-month update of BOLERO-2, which tested therapy with everolimus (Afinitor) plus exemestane,...

SIDEBAR: Cardiac Events Evaluated in Trastuzumab Studies

The effect of duration on cardiac events was a key question for the PHARE and HERA trials to answer. In general, longer duration of treatment was associated with more cardiac events, especially declines in left-ventricular function, but overall the risks were low. Cardiac Endpoints In the PHARE...

breast cancer

One Year of Trastuzumab Remains the Standard of Care in HER2-positive Breast Cancer

For HER2-positive early breast cancer, 1 year of treatment with trastuzumab (Herceptin)—rather than 6 months or 2 years—remains the standard of care, based on two pivotal studies presented at the 2012 European Society for Medical Oncology (ESMO) Congress. The optimal duration of anti-HER2 adjuvant ...

issues in oncology

Nab-paclitaxel Approved in First-line Metastatic NSCLC

The FDA has approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who are not candidates for ...

skin cancer

Combination of BRAF and MEK Inhibitors Paves Way for Phase III Studies in BRAF-mutated Metastatic Melanoma

Two late-breaking studies presented at the 2012 European Society for Medical Oncology (ESMO) Congress highlight the promising potential of combining dual BRAF and MEK inhibitors for the treatment of BRAF-mutated metastatic melanoma. A phase II study showed that combining full doses of the BRAF...

lymphoma

Novel Mechlorethamine Gel Considered Safe and Effective for Treatment of Mycosis Fungoides

A novel mechlorethamine, 0.02%, gel produced comparable or higher response rates (depending on the measurement used) than did mechlorethamine, 0.02%, compounded ointment, in a randomized controlled, multicenter study among 260 patients with stage IA to IIA mycosis fungoides, the most common form of ...

Explaining Research to Patients

Everyone understands the need for medical research, especially regarding cancer. However, only a minority of the public understand what is actually involved in taking part in a clinical trial. As professionals, we are responsible for designing relevant studies, for their conduct and analysis, and...

lung cancer

Sorafenib Fails to Improve Survival as Third- or Fourth-line Treatment of Advanced Non–Small Cell Lung Cancer

Third- or fourth-line therapy with sorafenib (Nexavar) failed to extend overall survival in patients with advanced non–small cell lung cancer (NSCLC), according to the main results of the phase III MISSION trial. However, a post hoc biomarker analysis of MISSION suggested that patients with...

Rituximab Infusion Approved for NHL

The FDA recently approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with non-Hodgkin lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during cycle 1.  Patients with clinically significant cardiovascular disease and high...

FDA Approves New Use of Pemetrexed in the Maintenance Setting for NSCLC

The FDA has expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (Alimta) for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non–small cell lung cancer (NSCLC) followed by pemetrexed maintenance in...

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