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Vitamin D and Prevention of Cancer
In a trial comparing the effect of vitamin D and calcium supplementation with placebo on the incidence of cancer in over 2000 postmenopausal women, there was no difference between groups in the incidence of cancer at four years. An analysis by cancer site showed no difference in the incidence of breast cancer between the two groups; there were too few cancers at other sites to analyze. Although several study limitations may have contributed to the absence of an effect, including enrollment of patients with a relatively high baseline vitamin D level and permission to take vitamin D supplements (up to 800 international units daily) outside of the intervention, vitamin D supplementation for the prevention of cancer is not warranted.
Open Versus Laparoscopic Resection for Stage II or III Colon Cancer
In a trial involving over 1000 patients with stage II or III colon cancer, colon resection performed with complete mesocolic excision and central vascular ligation resulted in equally excellent five-year survivals (over 90 percent) whether surgery was performed open or laparoscopically. Thus, surgeons treating colon cancer have a choice of techniques, but must follow strict oncologic principles, including complete mesocolic excision, to ensure optimal outcomes.
Hypofractionated Radiation Therapy for Prostate Cancer
Historically, conventional schedules for external beam radiation therapy (RT) for localized prostate cancer have used daily doses given for seven to eight weeks. In the randomized PROFIT trial, a hypofractionated RT schedule (a larger dose per fraction given over four weeks) was noninferior in terms of both efficacy and toxicity to a conventional schedule, confirming results from three other phase III trials. For patients in whom costs and convenience are important considerations, hypofractionated RT is an appropriate alternative to a conventional schedule.
Survival With Laparoscopic Staging for Early Endometrial Carcinoma
The second largest randomized trial of total laparoscopic hysterectomy versus total abdominal hysterectomy for treatment of apparent stage I endometrial carcinoma reported similar disease-free survival at 4.5 years and overall survival for the two techniques. Based on these and previous data, laparoscopic hysterectomy appears to be a reasonable approach for initial management of women with apparent stage I endometrial cancer and may be preferable to open surgery because of lower perioperative morbidity.
Avelumab Immunotherapy for Metastatic Merkel Cell Carcinoma
Chemotherapy historically has been the standard approach to treating advanced Merkel cell carcinoma (MCC). Avelumab, a monoclonal antibody that blocks the PD-1 ligand (PD-L1), was approved by the US Food and Drug Administration based on a phase II study demonstrating a 32 percent response rate (23 percent partial and 9 percent complete), relatively durable remissions (six-month progression-free survival 40 percent), and a favorable side effect profile. Based upon these results, avelumab is our preferred treatment for patients with metastatic MCC.
Naldemedine for Opioid-Induced Constipation
The benefit of naldemedine, an oral peripherally acting opioid receptor antagonist, for opioid-induced constipation (OIC) was shown in two identically designed 12-week phase III randomized trials conducted in patients with noncancer chronic pain and OIC. In a preliminary report, naldemedine, compared with placebo, decreased constipation and was well tolerated with no signs or symptoms of opioid withdrawal or decrease in opioid analgesic efficacy. Naldemedine has been approved in the United States for OIC in adult patients with chronic noncancer pain. However, efficacy has also been shown for treatment of OIC in cancer patients, and naldemedine can be used off label in this population. The European Medicines Agency has approved naldemedine for treatment of OIC without restriction to noncancer pain.
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