February 2016 News Roundup

February 27, 2016

In this news roundup we highlight new FDA indications, the overuse of advanced imaging in breast cancer, MAPK inhibition in melanoma, and more.

Many Early-Stage Breast Cancer Patients Undergo Unnecessary Imaging:

A study including nearly 30,000 women found that newly diagnosed early-stage breast cancer patients often undergo advanced imaging tests, in spite of recommendations against this practice. National guidelines recommend against CT, PET, and bone scans in these women, unless the patient has symptoms or blood test abnormalities. The new study included prospectively collected data on 29,170 women diagnosed with stage 0âIIB breast cancer at 25 health systems included in the Michigan Breast Oncology Quality Initiative. Of that cohort, 5,954 (20%) underwent at least one imaging test within 90 days of the diagnosis.

FDA Approves Everolimus for Lung, Gastrointestinal Neuroendocrine Tumors:

The US Food and Drug Administration (FDA) has approved everolimus (Afinitor) for the treatment of patients with unresectable locally advanced or metastatic neuroendocrine tumors of gastrointestinal or lung origin. The trial that led to the approval included 302 patients. Progression-free survival in patients receiving everolimus was 11 months vs 3.9 months in those on placebo (hazard ratio [HR], 0.48 [95% CI, 0.35â0.67];

FDA Approves Obinutuzumab for Follicular Lymphoma:

The FDA has approved obinutuzumab (Gazyva) in combination with bendamustine followed by monotherapy with obinutuzumab for treating follicular lymphoma patients who have relapsed after, or are refractory to, a rituximab-containing regimen. The study that led to the approval included 321 patients with follicular lymphoma randomized to either bendamustine with obinutuzumab (n = 155) or bendamustine alone (n = 166). On average, patients had received two prior therapies. Results of the study found that progression-free survival of patients treated with the combination was not reached vs 13.8 months in those treated with bendamustine alone (HR, 0.48 [95% CI, 0.34â0.68);

MAPK Inhibitor Combo Produces 2-Year Overall Survival in Metastatic Melanoma:

A median overall survival of longer than 2 years was achieved in a group of patients with metastatic melanoma assigned to treatment with the combination of two MAPK inhibitors, dabrafenib and trametinib, according to the results of an analysis of data taken from a four-part phase I/II study. The analysis included 78 patients with BRAF inhibitor-naive melanoma who were treated with dabrafenib 150 mg twice daily plus trametinib 2 mg daily. In fact, results showed that as many as one in five patients treated with the FDA-approved combination remained free of progression at 3 years. Image Â© Nasekomoe / Shutterstock.com.

Physical Exams Adequate to Detect Thyroid Cancer in Cancer Survivors:

The use of a standard yearly physical examination to screen for thyroid cancer among high-risk survivors of childhood and young adult cancers resulted in a negative predictive value of 100% for clinically relevant thyroid cancer and a significant cost savings compared with regular ultrasound screening. At Memorial Sloan Kettering Cancer Center, a long-term follow-up program has been established for high-risk survivors of cancer. Only if a physical exam is abnormal do patients get referred for a thyroid ultrasound. The study examined 585 survivors from 2005 to 2015. Among the 2,277 yearly visits, only 106 ultrasound examinations were ultimately performed. Using the Medicare cost of ultrasound this would amount to approximately $27,000, whereas yearly ultrasound screening would have cost nearly half a million dollars. Image Â© Photographee.eu / Shutterstock.com.

Weekly Paclitaxel Did Not Prolong PFS in Ovarian Cancer:

Assignment to a dose-dense regimen of paclitaxel given weekly did not prolong progression-free survival compared with paclitaxel given every 3 weeks in a group of patients with ovarian cancer treated with or without bevacizumab. However, data from the Gynecologic Oncology Group (GOG)-0262 study showed that in patients who did not elect to receive bevacizumab as part of their treatment, the weekly schedule of paclitaxel did significantly prolong progression-free survival compared with the every-3-week schedule. The study, which followed 692 patients for a median of 28 months, found that assignment to dose-dense weekly paclitaxel had no significant effect on progression-free survival (PFS) compared with paclitaxel every 3 weeks (14.7 months vs 14 months; hazard ratio [HR], 0.89 [98% CI, 0.74â1.06];

= .18). Image (ball-and-stick model of paclitaxel) Â© molekuul.be / Shutterstock.com.

Triage System Sharply Reduces ER Visits for Cancer Patients:

A simple quality improvement initiative involving an improved patient access center (PAC) and patient education resulted in a 60% reduction in the use of emergency room (ER) visits in oncology patients, according to a new study. The intervention’s first step included an overhaul of a PAC, with new training for staff to be able to recognize when symptoms relayed over the phone merited an ER referral. A new triage nurse was also hired, to handle consultation services. Participating oncology practices added appointment times for walk-in patients to daily schedules, to provide an alternative to an ER visit. In the second step, physicians educated patients on chemotherapy side effects, and how best to handle complications that arise outside of office hours. Patients also received a “chemotherapy passport.” This included information on which side effects may require an ER visit. Implementation of the system exceeded the goal, reducing ER visits by 60%. Image Â© cleanfotos / Shutterstock.com.

Less Neuropathy Seen With Lenalidomide Regimen in Myeloma:

Despite similar survival outcomes, patients with newly diagnosed multiple myeloma treated with lenalidomide, melphalan, and prednisone with lenalidomide maintenance (MPR-R) experienced lower rates of neurologic toxicity compared with patients treated with a standard regimen of thalidomide, melphalan, and prednisone with thalidomide maintenance (MPT-T), according to the results of the Dutch-Belgium Cooperative Trial Group for Hematology Oncology Group (HOVON) 87/Nordic Myeloma Study Group (NMSG) 18 trial. With a follow-up of 36 months, the overall survival for patients assigned MPT-T compared with MPR-R was 73% vs 84% at 2 years, 64% vs 69% at 3 years, and 52% vs 56% at 4 years. Patients assigned to MPT-T had significantly worse grade 3 or higher neuropathy compared with patients assigned to MPR-R (16% vs 2%), which the researchers said resulted in a significantly shorter duration of maintenance therapy (5 vs 17 months). Image Â© Tefi / Shutterstock.com.

At 5 Years, Nilotinib Offers Benefit Over Imatinib in CML:

Five-year results of the randomized phase III ENESTnd trial show a positive risk-benefit profile for nilotinib in patients with chronic myeloid leukemia (CML) in chronic phase, as compared to imatinib. Cardiovascular risk does seem to be slightly raised with nilotinib, but improvements in CML disease control likely outweigh those risks. By 5 years, 217 patients in the lower dose nilotinib group (300 mg twice daily; 77%), 217 patients in the higher dose nilotinib group (400 mg twice daily; 77.2%), and 171 imatinib patients (400 mg once daily; 60.4%) achieved a major molecular response. Progression to accelerated or blast phase was more likely with imatinib than with nilotinib. Images (ball-and-stick models of nilotinib and imatinib) Â© molekuul.be / Shutterstock.com.

Panobinostat Shows Promise in Phase I Sarcoma Trial:

A phase I trial found that panobinostat combined with epirubicin is well tolerated and could offer benefit in patients with refractory sarcoma. The study drug was administered on days 1, 3, and 5, followed by 75-mg/m

epirubicin on day 5, in 21-day cycles. Among 20 sarcoma patients, 12 were deemed to have received benefit from panobinostat. There was one response, and 11 patients had stable disease for longer than 3 months. The median progression-free survival in these patients was 3.4 months, and the median overall survival was 8.3 months. Image (ball-and-stick model of panobinostat) Â© molekuul.be / Shutterstock.com.

FDA Expands Palbociclib Approval for Breast Cancer:

The FDA has granted an expanded indication for the cyclin-dependent kinase 4/6 inhibitor palbociclib (Ibrance). The drug is now approved for use in combination with fulvestrant in women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed following endocrine therapy. In a study of 521 patients, women who received palbociclib plus fulvestrant had a median progression-free survival of 9.5 months, compared with 4.6 months in the fulvestrant plus placebo group, for a hazard ratio of 0.461 (95% CI, 0.360â0.591;

PSA Testing Declining Faster With Primary Care Physicians Than Urologists:

The 2012 change in guidelines regarding prostate-specific antigen (PSA) testing for prostate cancer had a different effect on testing rates depending on which physician specialty was doing the testing, according to a new study. Primary care physicians showed a marked decline in PSA tests administered, while urologists had only a slight drop in testing. The study included 113 patient visits to urologists and 1,109 to primary care physicians (PCPs). Among the PCP visits, the use of PSA testing declined from 36.5% in 2010 to 16.4% in 2012, for an odds ratio of 0.43 (95% CI, 0.23â0.81;

= .009). In contrast, the rate decreased among urologists from 38.7% only to 34.5%, for an odds ratio of 0.34 (95% CI, 0.10â1.20;

= .09). The authors noted that the difference between physician-specific testing practices was significantly significant (