A Patient's Journey: Can High-Grade PIN Be 'Great News'?

Excerpt:

“This summer, I ended a 3-year vacation from prostate biopsies. I expected the best after years of good news.

“In early August, my urologist, Brian Helfand, MD, PhD, of NorthShore University HealthSystem, called me with what he called ‘great news.’

“I wasn’t so sure about that.

“The overall picture was this: Helfand said the pathologist found “no evidence of malignancy” in slide after slide — 13 all told.

“But one biopsy stood out. So the news wasn’t all great.”

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Is Keytruda Better than Opdivo?

Excerpt:

“Recent clinical trial results are likely to lead doctors to treat more patients who have a common form of lung cancer with a Merck drug at the expense of a Bristol-Myers Squibb medication at least until more data emerges, oncologists and analysts say.

“The yet-to-be-published studies involve drugs in a new class designed to enable the body’s immune system to fight cancer.

“A recent trial of Merck’s Keytruda (pembrolizumab) showed that it worked better than chemotherapy as an initial treatment for advanced non-small cell lung cancer (NSCLC) in patients with high levels of the PDL1 protein, believed to help identify those most likely to benefit from this type of immunotherapy.”

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Melanoma Tx Tied to Neurologic Disorder

Excerpt:

“Researchers reported two cases of demyelinating polyradiculoneuropathy after treatment with pembrolizumab (Keytruda) for advanced melanoma.

“The report, in a letter published Wednesday in the New England Journal of Medicine, raises concerns about serious, perhaps irreversible, and previously unknown adverse effects from this class of drug, which targets the PD-1 immune checkpoint pathway. These immunotherapies, offering a whole new way of attacking cancer, have generated excitement across the oncology community in recent years.

“The first patient was receiving treatment for recurrent nasal-cavity melanoma, and developed symptoms consistent with Guillain-Barré syndrome 8 weeks after beginning pembrolizumab therapy (2 mg/kg every 3 weeks), according to Philippe Saiag, MD, PhD, of Versailles Saint-Quentin-en-Yvelines University in Versailles, France, and colleagues.”

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Radiation Plus ADT Boosts Survival in Metastatic Prostate Ca (CME/CE)

Excerpt:

“A large contemporary analysis of men with metastatic prostate cancer has found that adding radiotherapy to androgen deprivation therapy resulted in substantially better survival than androgen deprivation alone.

“With a median follow-up of 5.1 years, giving prostate radiotherapy plus androgen deprivation was associated on univariate analysis with a longer median overall survival of 53 versus 29 months, for a hazard ratio of 0.562 (95% CI 0.498-0.635, P0.001). The effect held in multivariate, propensity score, and landmark analyses — with the last yielding improved overall survival estimates at 3, 5, and 8 years, reported Chad. G. Rusthoven, MD, of University of Colorado School of Medicine, Denver, and colleagues in the Journal of Clinical Oncology.

“The estimates were 62% versus 43% for 3 years, 49% versus 25% for 5 years, and 33% versus 13% for 8 years (HR 0.562, 95% CI 0.498-0.635, P0.001).”

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Advanced Breast Cancer Slowed with Avastin Combo (CME/CE)

Excerpt:

“Adding bevacizumab (Avastin) to letrozole (Femara) improved progression-free survival (PFS) in estrogen receptor-positive metastatic breast cancer (ER+MBC) but not other outcomes, an open-label, multicenter phase III trial showed.

“While median PFS increased by 4.6 months in patients who received combined therapy versus letrozole alone, there was no significant difference in overall survival (hazard ratio 0.87; 95% CI 0.65-1.18; P=0.188), Maura N. Dickler, MD, of Memorial Sloan Kettering Cancer Center in New York City, and colleagues reported online in the Journal of Clinical Oncology.

“In addition, there was a marked increase in grade 3 to 4 toxicities, particularly hypertension (24% versus 2%) and proteinuria (11% versus 0%), the researchers said, emphasizing that the role of bevacizumab in this setting will need to be clarified with research on predictive markers.”

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NSCLC Drug Hits Speed Bump on Road to FDA Approval

Excerpt:

“The FDA should wait for results of an ongoing phase III clinical trial before deciding whether to approve the EGFR inhibitor rociletinib for non-small cell lung cancer (NSCLC), advisers recommended today.

“The Oncologic Drugs Advisory Committee (ODAC) voted 12-1 in favor of the delay, although several committee members acknowledged that the drug demonstrated activity in two phase II trials submitted in support of the application for accelerated approval. Others, however, expressed a desire to see more compelling efficacy data from the larger, phase III trial, and some expressed uncertainty about about how to interpret the drug’s safety, specifically a 33% incidence of QT-prolongation in the single-arm phase II trials.

“Additionally, FDA staff review of the trial data ‘revealed high variability of systemic exposure to rociletinib and its major metabolites. Rociletinib demonstrated nonlinear pharmacokinetics, as systemic exposures did not increase when the dose increased from 500 mg to 1000 mg.’ ”

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Aromasin Plus OFS May Reduce Risk of Recurrent Breast Ca (CME/CE)

Excerpt:

“Premenopausal women with hormone receptor-positive, HER2-negative breast cancer may benefit from exemestane (Aromasin) plus ovarian function suppression (OFS) versus tamoxifen with or without OFS, analysis of recurrence-risk data from the TEXT and SOFT trials has indicated.

“Those with a high recurrence risk may experience a 10% to 15% improvement in the 5-year breast cancer-free interval (BCFI) with aromatase inhibitor (AI) exemestane plus OFS, while those at intermediate risk may experience an improvement of at least 5% with the same regimen, according to Meredith M. Regan, ScD, of Dana-Farber Cancer Institute in Boston, MA, and colleagues.

“Patients at lowest risk of recurrence had minimal benefit with exemestane plus OFS, the study showed, which is online in the Journal of Clinical Oncology.”

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Opdivo Plus Yervoy Gets FDA OK for Melanoma

“Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.

“The indication includes both BRAF-wild type and BRAF-mutant melanoma. At the same time, the FDA expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma.

“Granted by the FDA’s accelerated approval process, the indication is the seventh for nivolumab, both indications leave the door open for the FDA to request confirmatory data or clinical trials. The approvals increase the number of nivolumab indications to seven, including four in melanoma, all granted since late 2014.”


Immunotherapy Is Game-Changer for Oncology

“New immunotherapy drugs to treat a wide swathe of cancers, are the game changers of 2015, according to dozens of oncologists who responded to MedPage Today.

“When we asked oncologists about ‘game-changers’ in 2015, 37 of the 50 cited immunotherapy drugs.

“One reason for the clear consensus: It was a year in which checkpoint inhibitors spread into new tumor types.

” ‘Initially found to be useful in such immune-sensitive malignancies as melanoma, renal cell carcinoma, and Hodgkins disease,’ said Robert J. Mayer, MD, of the Dana-Farber Cancer Institute in Boston. ‘It has now shown major promise in more difficult cancers such as squamous cell and adenocarcinomas of the lung and even a subset (microsatellite unstable) of colon cancer, gastric cancer, and esophageal cancer.’ “