“Participation in a mindfulness-based stress reduction program yields robust and sustained improvement in cancer-related cognitive impairment, a prevalent and potentially debilitating condition that affects attention, memory and executive function in survivors, according to a new study from the Regenstrief Institute and Indiana University School of Medicine.
“Although cancer-related cognitive impairment, sometimes referred to as chemo brain or post-cancer cognitive fuzziness, is common among survivors—disrupting social relationships, work ability, self-confidence, and quality of life—clinicians have few treatment options to offer. Cognitive deficits have been seen to persist for more than a decade following cancer treatment for many survivors.
” ‘Randomized Controlled Pilot Trial of Mindfulness-based Stress Reduction for Breast and Colorectal Cancer Survivors: Effects on Cancer-related Cognitive Impairment,’ published online in advance of print in the Journal of Cancer Survivorship, is the first randomized clinical trial to evaluate the effects of mindfulness-based stress reduction, known as MBSR, on fatigued breast and colorectal cancer survivors, the majority of whom had been treated with chemotherapy.”
“Preliminary data from COMET, a phase 2 randomized trial sponsored by Novocure (NASDAQ: NVCR), show that the use of Tumor Treating Fields (TTFields) therapy is safe in the treatment of brain metastases originating from non-small cell lung cancer (NSCLC). The results of a preliminary analysis of the ongoing European study were presented Nov. 20 at the 20 th Annual Society for Neuro-Oncology Meeting in San Antonio.
“The preliminary analysis of the randomized COMET trial included 17 patients, six of whom were treated with TTFields plus supportive care and 11 of whom received supportive care alone, following stereotactic radiosurgery with or without surgical resection of the brain metastases. Patients treated with TTFields plus supportive care received TTFields applied to the brain at the specific frequency of 150 kHz, which has been shown in preclinical studies to be the optimal frequency for inhibiting mitosis of NSCLC cells. In both arms of the study, a total of 26 adverse events were reported, most of which stemmed from the underlying NSCLC. A single event, mild dermatitis, was the only complication linked to TTFields therapy. No serious adverse events related to TTFields therapy were reported.”
“Dual HER2 blockade with trastuzumab and lapatinib was no better than trastuzumab alone in producing pathologic complete responses (pCR) in metastatic HER2-positive breast cancer patients in the neoadjuvant setting, according to a new study. Those with hormone receptor–negative disease did see an improvement with the dual blockade.
“ ‘In randomized neoadjuvant trials, dual HER2 targeting generally results in higher pCR rates, but the magnitude of this effect has varied,’ wrote study authors led by Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill. The new trial was a three-arm study of preoperative therapy in 305 patients with stage II/III HER2-positive breast cancer; 118 patients were randomized to paclitaxel along with trastuzumab and lapatinib, 120 to paclitaxel with trastuzumab alone, and another 67 to paclitaxel along with only lapatinib. That last trial arm was closed early. Results were published online ahead of print in the Journal of Clinical Oncology.”
“Hypofractionated radiation therapy yielded a similar rate of DFS and toxicity profile as conventional radiotherapy among men with low-risk prostate cancer, according to results of a randomized phase 3 non-inferiority study presented at the ASTRO Annual Meeting.
“Given in larger doses over a shorter period, hypofractionated radiation therapy is being studied as a possible improved treatment option for some patients.
“Howard Sandler, MD, MS, FASTRO, professor and chair of the department of radiation oncology at Cedars Sinai Medical Center in New York, and colleagues sought to evaluate whether the hypofractionated therapy schedule — or 70 Gy in 28 fractions over 5.6 weeks — resulted in a 5-year DFS that was not lower than that of the conventional schedule, or 73.8 Gy in 41 fractions over 8.2 weeks, by more than 7%.”
“The radiopharmaceutical Lu-Dotatate (177Lutetium DOTATATE; Lutathera) demonstrated an unprecedented 79% reduction in the risk of progression or death compared with high-dose octreotide LAR (60 mg) in patients with progressive, metastatic midgut neuroendocrine tumors (NETs), according to results from NETTER-1 trial presented by Jonathan Strosberg, MD, at the 2015 NANETS Symposium.”
” ‘The findings were, in my opinion, extraordinarily impressive, the median progression-free survival improved by nearly 80%, which is fairly unprecedented in oncologic studies,’ said Strosberg, a medical oncologist and researcher at the Moffitt Cancer Center. ‘The finding is important because limited therapeutic options exist for such patients, who comprise 20% to 45% of neuroendocrine tumor cases.’ ”
“The NETTER-1 trial is the first prospective, randomized, phase III study for patients with midgut NETs, specifically those in the ileum and cecum. Patients in the trial had progressed on prior therapy with octreotide at 30 mg and had inoperable, somatostatin receptor positive tumors.”
The biggest news in melanoma treatment from the 2015 American Society of Clinical Oncology (ASCO) annual meeting was undoubtedly the report from a large, phase III, randomized clinical trial that compared a combination of two ‘checkpoint inhibitor’ drugs—nivolumab (Opdivo) and ipilimumab (Yervoy)—with the same drugs given alone.
In the CheckMate-067 trial, 945 previously untreated patients with unresectable stage III or IV melanoma were assigned to Opdivo alone, Opdivo plus Yervoy, or Yervoy alone. Continue reading…
“An immunotherapy combination for untreated melanoma reduced the risk of death or progression by more than half as compared with a drug currently used as a standard of care, a large randomized trial showed.
“Patients treated with nivolumab (Opdivo) and ipilimumab (Yervoy) had a median progression-free survival (PFS) of 11.5 months compared with 2.9 months for ipilimumab alone and 6.9 months with nivolumab monotherapy. Median PFS with the combination and with nivolumab alone increased to 14 months — more than four times greater than the PFS of patients who received only ipilimumab — among patients whose tumors tested positive for programmed death receptor ligand 1 (PD-L1), the target of nivolumab.
“The PFS improvement came at a price of increased toxicity, as grade 3/4 adverse events occurred twice as often with the combination as with ipilimumab monotherapy, but even patients who discontinued treatment because of side effects did better with the combination, as reported here at the American Society of Clinical Oncology meeting.”
“Alexander Spira, MD, PhD, FACP, medical oncology, hematology, Virginia Cancer Specialists, discusses the POPLAR study for non-small cell lung cancer (NSCLC).
“The phase II study randomized patients with NSCLC to atezolizumab (MPDL3280A) or docetaxel in the second- or third-line setting. Patients who were administered the anti-PD-L1 agent were treated until practitioners determined there was no longer a benefit, Spira says. Patients in the docetaxel arm were treated until disease progression.
“At the interim analysis, which is not yet final, there was improved survival with atezolizumab. A correlation was also found between PD-L1 expression and efficacy of the drug. A phase III study is ongoing. Results from this study could also potentially identify a biomarker, Spira adds.”
“Amgen AMGN 0.49% today announced results from a randomized, double-blind, placebo-controlled, multicenter Phase 3 study evaluating the treatment effect of adjuvant Prolia® (denosumab), 60 mg once every six months, therapy in postmenopausal women with early hormone receptor positive (HR+) breast cancer receiving aromatase inhibitor therapy. The trial met its primary endpoint of time from randomization to first clinical fracture (HR=0.5, 95 percent CI 0.39-0.65, p<0.0001). The observed 50 percent reduction in fractures between the Prolia and placebo arms, 92 versus 176, respectively, was similar in patients with normal bone health at baseline (n=1,872, HR=0.44, p<0.0001) and in patients who started the trial with early signs of bone loss (n=1,548, HR=0.57, p=0.0021). The data will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago today at 9:12 a.m. CT (abstract no. 504). In addition to the presentation, the paper was published online by The Lancet.
“This is the first Prolia trial to enroll patients independent of baseline bone mineral density (BMD) and with the majority in the normal BMD range. The study, which enrolled a total of 3,425 patients, was conducted by the Austrian Breast and Colorectal Cancer Study Group (ABCSG).
” ‘Fracture is a common side effect of aromatase inhibitors, which are an important first-line therapy for postmenopausal women with non-metastatic breast cancer,’ said principal investigator Michael Gnant, professor of surgery at Medical University of Vienna. ‘These encouraging data demonstrate the potential benefit of initiating Prolia simultaneously with aromatase inhibitor therapy, regardless of the patient’s baseline BMD, to decrease the risk of fracture.’ “