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breast cancer

Older Chemotherapy Studies in Breast Cancer Coming of Age

Results of several long-running chemotherapy trials were reported at the 2012 ASCO Annual Meeting breast cancer oral session, reported in brief here. NSABP B-38 The final analysis of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-38 trial showed that the addition of gemcitabine...

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

Lapatinib Shows Value Similar to Trastuzumab in Neoadjuvant Regimens for Breast Cancer, but with Greater Toxicity

Lapatinib (Tykerb) proved valuable as a component of neoadjuvant chemotherapy for HER2-positive operable breast cancer in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-41 trial presented at the 2012 ASCO Annual Meeting by Andre Robidoux, MD, of the NSABP and the University of...

lung cancer

No Improvement in Overall Survival, Worse Toxicity with Motesanib Added to Chemotherapy in Non–Small Cell Lung Cancer

Two trials (E4599 and AVAiL) have suggested a benefit to adding the anti–vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab (Avastin) to chemotherapy in patients with advanced nonsquamous non–small cell lung cancer (NSCLC). Bevacizumab acts by binding directly to circulating...

gynecologic cancers

Adding Bevacizumab to Chemotherapy Improves Progression-free Survival in Platinum-sensitive Recurrent Ovarian Cancer

The addition of bevacizumab (Avastin) to gemcitabine and carboplatin, followed by bevacizumab until disease progression, resulted in significantly improved progression-free survival compared to gemcitabine and carboplatin plus placebo among women with platinum-sensitive recurrent ovarian, primary...

prostate cancer

Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer

Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted...

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...

thyroid cancer

Molecularly Targeted Treatment of Thyroid Cancer Rapidly Evolving

Recent advances in understanding the pathogenesis and altered signaling pathways in thyroid cancer are improving treatment options for this malignancy, especially for the subset of patients with medullary thyroid cancer and those with differentiated thyroid cancer that has metastasized, according...

supportive care
palliative care

Supportive Care Research Runs the Gamut from Genetic Markers of Treatment Side Effects to Neuropathic Pain Therapies

Attendees from around the world gathered for the Multinational Association for Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium on Supportive Care in Cancer, held June 28–30 in New York. Below are highlights from the meeting, representing...

colorectal cancer

FDA Approves Colon-cleansing Drug for Prep Prior to Colonoscopy

The FDA has approved sodium picosulfate, magnesium oxide, and citric acid (Prepopik) to help cleanse the colon in adults preparing for colonoscopy, Ferring Pharmaceuticals announced. The new solution is a low-volume, dual-acting stimulant and osmotic laxative. The FDA approval is based on data from ...

Kidney Transplant Recipients Switching to Sirolimus Had Lower Risk of Secondary Squamous Cell Carcinomas

Kidney transplant recipients with at least one previous cutaneous squamous cell carcinoma decreased their risk of developing new cutaneous squamous cell carcinomas by switching from calcineurin inhibitors (cyclosporine or tacrolimus) to sirolimus (Rapamune) in a multicenter phase III study. New...

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...

prostate cancer

Enzalutamide Significantly Prolonged Survival in Men with Castrate-resistant Metastatic Prostate Cancer

“Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy” in an international phase III, double-blind, placebo-controlled trial, investigators reported in The New England Journal of Medicine. Median overall survival, the...

Ziv-aflibercept with FOLFIRI in Metastatic Colorectal Cancer

In August 2012, the antiangiogenic agent ziv-aflibercept (Zaltrap) was approved for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer resistant to or progressing after an oxaliplatin-containing regimen.1,2 Approval was based on...

prostate cancer

FDA Grants Priority Review to Supplemental New Drug Application for Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer

Janssen Research & Development, LLC, announced that the FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for abiraterone acetate (Zytiga) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer ...

VEGF Pathway Biomarker for Outcome with Bevacizumab

No biomarkers are available to guide patient selection for treatment with the anti-VEGF monoclonal antibody bevacizumab (Avastin). Lambrechts and colleagues from VIB and KULeuven and University Hospital Gasthuisberg, Belgium, and F. Hoffmann-La Roche in Basel, Switzerland, have identified a locus...

Predictive Markers for Outcome with Pazopanib in Metastatic Renal Cell Cancer

Several targeted drugs are approved for treatment of metastatic renal cell cancer, but no validated biomarkers are available for prediction of clinical outcome of treatment with these agents. In a recent study, Tran and colleagues from The University of Texas MD Anderson Cancer Center in Houston,...

supportive care
palliative care

Dying Patients with Cancer Who Avoid Aggressive Care but Stay Connected with an Oncologist Have Better Quality of Life

Dying patients with cancer who avoided hospitalizations and life-prolonging measures, who worried less, prayed or meditated, were visited by a pastor, and maintained a therapeutic alliance with their oncologist had the highest quality of life at the end of life, according to a study recently...

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...

hepatobiliary cancer
skin cancer

NDA for Chemosaturation System to Treat Melanoma in the Liver

Delcath Systems, Inc, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for its chemosaturation system (CHEMOSAT) for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The system is designed to...

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,...

skin cancer

Exciting New Agents Offer Further Treatment Options for Metastatic Melanoma

“This is a very exciting time in melanoma,” said Michael Sabel, MD, of the University of Michigan, Ann Arbor. “For years, we chugged along with few options for systemic therapy. Then in 2010 and 2011, we saw melanoma data presented at ASCO plenary sessions. At ASCO 2012, we expanded in these areas...

solid tumors
kidney cancer

Another Tyrosine Kinase Inhibitor Joins the Lineup in Renal Cell Carcinoma

The novel tyrosine kinase inhibitor tivozanib was superior to sorafenib (Nexavar) for the treatment of advanced renal cell carcinoma in the phase III TIVO-1 trial.1 Tivozanib is a potent, selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, with a long half-life that is...

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...

SIDEBAR: Is Microsatellite Instability Status also Predictive in Stage II Disease?

“Microsatellite instability status is a validated prognostic marker in stage II colorectal cancer. It is the strongest prognostic marker we have in that group,” Dr. Overman commented. “The fact is that we should be getting this [test] consistently to help us make this discussion [of prognosis]...

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....

SIDEBAR: Is Watch and Wait the Best Strategy for Indolent NHL in the Rituximab Era?

Data from the RESORT and its planned subanalysis can guide oncologists in optimizing treatment for indolent non-Hodgkin lymphoma (NHL) with low–tumor burden advanced-stage disease, according to Michael E. Williams, MD, of the University of Virginia Cancer Center in Charlottesville. The phase III...

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: Does Lapatinib Prevent CNS Metastases in HER2-positive Breast Cancer?

Lapatinib has shown some efficacy against existing brain metastases in patients with HER2-positive breast cancer but not in preventing them in the first place, according to Hope S. Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller...

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...

New Therapies Capitalize on Lung Cancer’s Molecular Vulnerabilities

Research reported at this year’s ASCO Annual Meeting attests to the tremendous molecular diversity of non–small cell lung cancer (NSCLC) and the power of appropriately selected treatment, according to Leora Horn, MD, of Vanderbilt University Medical Center, who presented data on molecular findings...

Reduced Disease Progression in Patients with Continued Gemcitabine Maintenance or Erlotinib Switch Maintenance

A phase III study showed that progression-free survival was significantly prolonged with continuation maintenance with gemcitabine or switch maintenance with erlotinib (Tarceva) compared with observation in patients with advanced non–small cell lung cancer (NSCLC) who received first-line treatment...

supportive care

2012 Is ‘Banner Year’ for Research on Symptom Management

The year 2012 was “a banner year for symptom management,” according to Debra L. Barton, RN, PhD, of the Mayo Clinic, Rochester, Minnesota, who presented data on patient and survivor care at the Best of ASCO San Diego meeting. “I have been doing symptom management for about 20 years, and it seems...

head and neck cancer

Radiotherapy Not Helpful in Early-stage Parotid Acinic Cell Cancer

Adjuvant radiotherapy for patients with parotid acinic cell carcinoma “does not confer a therapeutic advantage in low-grade and early-stage tumors if resection is complete,” but the benefit for patients with higher-grade or higher-stage disease is uncertain because there were few of these patients...

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...

SIDEBAR: Trials Establish New Standard of Care for Anaplastic Oligodendroglioma

Long-term results of two cooperative group phase III trials have determined radiation therapy and chemotherapy is the new standard of care for newly diagnosed anaplastic oligodendroglioma with 1p19q loss,” commented Eric L. Chang, MD, of the USC Norris Cancer Hospital and Keck School of Medicine,...

cns cancers

Investigators’ Perseverance Pays Off in Treating Anaplastic Oligodendroglioma

The theme of this year’s key abstracts on central nervous system tumors is that “perseverance and analysis of long-term outcomes lead to practice-changing results and important insights,” according to Eric L. Chang, MD, of the USC Norris Cancer Hospital and Keck School of Medicine, Los Angeles, who ...

leukemia

Kinase Inhibitors Compared in First-line Treatment of CML

Bosutinib (Bosulif) is an oral dual Src/Abl kinase inhibitor that is active against many Bcr-Abl mutations associated with imatinib (Gleevec) resistance and that has reduced activity against nonspecific molecular targets associated with toxicities reported for other second-generation kinase...

Progress, Slow but Sure, Seen for Current Lung Cancer Therapies

This year, we have some abstracts that help move things forward in lung cancer, maybe at a little bit slower pace than in previous years. But there are important points that we can learn from some of these abstracts,” commented Karen L. Reckamp, MD, of the City of Hope, who presented findings on...

Successful Use of Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy May Hinge on Prior Experience

A review of 60 consecutive patients with peritoneal carcinomatosis who underwent cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC)—sometimes called “hot chemotherapy”—found 0% mortality and 33% morbidity, with “a significant reduction of grade III/IV morbidity,...

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