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With a plethora of new oncology research at your disposal, it can be difficult to keep track of the latest innovations and findings. Oncology Times is offering our readers summaries of the newest studies to keep you abreast of advancements across the spectrum of oncology care.



Palbociclib & Letrozole in Advanced Breast Cancer

A previous phase II study showed that progression-free survival (PFS) was longer with palbociclib plus letrozole than with letrozole alone in the initial treatment of postmenopausal women with estrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Researchers conducted a phase III study designed to confirm and expand the efficacy and safety data of this treatment option (NEJM 2016;375:1925-36). This double-blind study, randomly assigned, in a 2:1 ratio, 666 postmenopausal women with ER-positive, HER2-negative breast cancer, who had not had prior treatment for advanced disease, to receive palbociclib plus letrozole or placebo plus letrozole. Researchers concluded that among patients with previously untreated ER-positive, HER2-negative advanced breast cancer, palbociclib combined with letrozole resulted in significantly longer PFS than that with letrozole alone, however the rates of myelotoxicity effects were higher with palbociclib-letrozole.



Race and mortality risk after radiation therapy in men treated with or without androgen-suppression therapy for favorable-risk prostate cancer

African American men are more likely than non-African American men to have comorbid illnesses that could interact with androgen-deprivation therapy (ADT) and impact survival. In a recent study, researchers investigated the impact that race had on the risk of all-cause mortality (ACM) and other-cause mortality (OCM) among men treated for favorable-risk prostate cancer (Cancer 2016;122(23):3608-14). Between 1997 and 2013, 7252 men with low-risk or favorable intermediate-risk prostate cancer were treated with brachytherapy with neoadjuvant ADT (n = 1501) or without neoadjuvant ADT (n = 5751) for a 4-month median duration. With a median follow-up of 8.04 years, 869 men (12.0%) died: 48 (5.52%) of prostate cancer and 821 (94.48%) of other causes. There was a significant association between African American race and an increased risk of both ACM and OCM compared to non-African American men who received ADT but not among those who did not receive ADT. Researchers concluded that ADT use may shorten survival in African American men with favorable-risk prostate cancer; therefore, its reservation for the treatment of higher risk cases, for which level 1 evidence supports its use, should be considered.



Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial

An open-label, phase 3, multicentre, randomised controlled trial aimed to compare cisplatin, fluorouracil, and docetaxel (TPF) induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone (Lancet Oncol 2016;17(11):1509-20). Two-hundred forty one patients were assigned to induction chemotherapy plus concurrent chemoradiotherapy and 239 to concurrent chemoradiotherapy alone. After a median follow-up of 45 months, researchers reported the 3-year failure-free survival was 80 percent in the induction chemotherapy plus concurrent chemoradiotherapy group and 72 percent in the concurrent chemoradiotherapy alone group (hazard ratio 0.68, 95% CI 0.48-0.97; p=0.034). The study authors concluded that the addition of TPF induction chemotherapy to concurrent chemoradiotherapy significantly improved failure-free survival in locoregionally advanced nasopharyngeal carcinoma with acceptable toxicity. However, long-term follow-up is required to determine long-term efficacy and toxicities.



Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma

Researchers investigated immunomodulatory activity of nivolumab in a hypothesis-generating prospective mRCC trial (Clin Cancer Res 2016;22(22):5461-71). Data showed the median overall survival (OS) was 16.4 months [10.1 to not reached (NR)] for nivolumab 0.3 mg/kg, NR for 2 mg/kg, 25.2 months (12.0 to NR) for 10 mg/kg, and NR for treatment-naive patients. Median percent change from baseline in tumor-associated lymphocytes was 69 percent (CD3+), 180 percent (CD4+), and 117 percent (CD8+). Of 56 baseline biopsies, 32 percent had >=5 percent PD-L1 expression, and there was no consistent change from baseline to on-treatment biopsies. Researchers noted that immunomodulatory effects of PD-1 inhibition were demonstrated through multiple lines of evidence across nivolumab doses. Biomarker changes from baseline reflect nivolumab pharmacodynamics in the tumor microenvironment. These data may inform potential combinations, concluded study authors.



Phase III trial comparing 3-6 months of adjuvant FOLFOX4/XELOX in stage II-III colon cancer: safety and compliance in the TOSCA trial

The current standard of care for radically resected stage III colon cancer and an accepted option for high-risk stage II is 6 months of oxaliplatin-based adjuvant chemotherapy. However, researchers argue a shorter duration of therapy, if equally efficacious, would be beneficial for patients and health care systems. TOSCA is an open-label, phase III, multicenter, noninferiority trial that randomized patients with high-risk stage II or stage III radically resected colon cancer to receive 3 months (arm 3 m) versus 6 months (arm 6 m) of FOLFOX4/XELOX (Ann Oncol 2016;27(11):2074-81). Treatment completion rate without any modification was 35 percent versus 12 percent and with delays or dose reduction 52 percent versus 44 percent in arm 3 and 6 m, according to researchers. TOSCA is the first trial comparing 3 months versus 6 months of adjuvant chemotherapy completing accrual within the international initiative of treatment duration evaluation. High compliance to treatment in control arm will allow a correct assessment of potential differences between the two treatment durations, researchers noted.


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