Risk Factors Associated With Unplanned Acute Care in Outpatient Chemotherapy With Oral Anticancer Drugs as Monotherapy or Combination Therapy With Injectable Anticancer Drugs.

BACKGROUND/AIM: Recently, the number of patients with cancer receiving outpatient chemotherapy using oral anticancer drugs has increased, but the currently available outpatient cancer chemotherapy is not safer than that available before. The present study aimed to identify risk factors associated with unplanned acute care (UAC) requiring outpatient chemotherapy-related consultation and hospitalisation. PATIENTS AND METHODS: We conducted a case- control study among 1,674 patients who received oral anticancer drug treatment either alone or in combination with injectable anticancer drugs at National Cancer Center Hospital East, Japan, between December 1, 2014, and November 30, 2015. RESULTS: Body mass index (BMI) was identified as a risk factor for UAC during chemotherapy. Patients with a BMI of <18.5 kg/m2, classified as underweight according to the World Health Organization classification of nutritional status, had a significantly higher risk of UAC. CONCLUSION: A low BMI immediately before the occurrence of chemotherapy-related UAC is a risk factor for adverse effects; therefore, underweight patients need more careful monitoring and supportive care.

Impact of concomitant medication on clinical outcomes in patients with advanced non-small cell lung cancer treated with immune checkpoint inhibitors: A retrospective study.

BACKGROUND: It has recently been suggested that concomitant medication may affect the clinical outcome of patients treated with immune checkpoint inhibitors (ICIs). However, only a few studies on the impact of concomitant medication on immune-related adverse events (irAEs) have previously been reported. Here, we aimed to determine the impact of concomitant medication on the efficacy and safety of ICIs. METHODS: We retrospectively analyzed the data of 300 patients treated with nivolumab or pembrolizumab for advanced non-small cell lung cancer (NSCLC) between January 2016 and July 2018. Multivariate logistic regression analysis was used to assess the effect of concomitant medication on treatment response or irAEs. A multivariate Cox proportional hazards model was used to evaluate concomitant medication-related factors associated with time-to-treatment failure or overall survival (OS). RESULTS: A total of 70 patients responded to treatment and 137 experienced irAEs. The response rate and incidence of irAEs in patients treated with ICIs were not significantly associated with concomitant medication. Multivariate analysis showed that the use of opioids was an independent factor (time-to-treatment failure: hazard ratio 1.39, p = 0.021, OS: hazard ratio 1.54, p = 0.007). CONCLUSIONS: The efficacy and safety of nivolumab or pembrolizumab in the treatment of patients with advanced NSCLC were not significantly influenced by concomitant medication. However, opioid usage might be associated with shorter OS in patients treated with these ICIs. Further mechanistic investigations should explore whether these associations are purely prognostic or contribute to ICI resistance.

Survey of serious adverse events and safety evaluation of oral anticancer drug treatment in Japan: A retrospective study.

The present study assessed the safety of outpatient oral anticancer chemotherapeutic drugs by investigating the type and frequency of serious adverse effects (SAEs). Emergency hospitalization, unplanned consultations and telephone calls were investigated in 1,832 patients who received oral anticancer drug treatment at the National Cancer Center Hospital East between December 1, 2014 and November 30, 2015. Oral cytotoxic anticancer and molecular targeted drugs were administrated to 1,140 (62.2%) and 692 (37.8%) patients, respectively. A total of 52 (2.8%) SAEs were reported, with 32 (2.8%) occurring following cytotoxic anticancer drug administration and 20 (2.9%) occurring after molecular targeted drug treatment. The most common SAE was gastrointestinal toxicity. The median time to SAE occurrence was 32 days (range, 5-1,705 days). The rate of unplanned consultations and telephone calls were 5.5 and 37.9% among all patients, respectively, with skin reactions being the most common reason for unplanned consultations. SAEs often occurred early after treatment initiation. It was concluded that measures against gastrointestinal toxicity are particularly important were administering chemotherapeutic agents.

Evaluation of community pharmacist ability to ensure the safe use of oral anticancer agents: a nationwide survey in Japan.

OBJECTIVES: A recent study of community pharmacists in Canada reported that they required additional education. We conducted a survey of community pharmacists to evaluate the adequacy of education and training in oral anticancer agents in Japan. METHODS: Between May and June 2014, community pharmacists were asked to complete a questionnaire by using two different survey strategies, one online and one via postal mail. RESULTS: Three hundred community pharmacists responded to an online survey and 283 community pharmacists responded to a mailed survey. Only 6-10% of respondents felt that they had received adequate education in oncology or oral chemotherapy. Although 81% of Japanese pharmacists had attended at least one continuing education event related to oncology in the past 2 years, only 54% felt comfortable dispensing oral anticancer agents and only 40% felt comfortable educating patients about oral chemotherapy. In a multivariate analysis, confidence in educating patients about oral chemotherapy was associated with an understanding of chemotherapy cycles and doses (odds ratio = 4.89, 95% confidence interval [2.53-9.45]) and the number of continuing education events they had attended (odds ratio = 1.67, 95% confidence interval [1.35-2.08]). CONCLUSIONS: This is the first report to evaluate whether community pharmacists are equipped to ensure the safe use of oral anticancer agents in Japan. The results are similar to those previously reported for Canadian pharmacists, namely a low rate of positive responses for education in oncology and oral chemotherapy, demonstrating a similar need for additional education and training in oral chemotherapy.

[The Usefulness of Outpatient Pharmacy Services in Adjuvant Chemotherapy for Gastric Cancer].

Outpatient pharmacy services were established since June 2009 for educating about the signs and symptoms that required treatment, explaining how to receive an emergency service, improving a patient's adherence, and managing side effects. In this study, we evaluated the usefulness of one of our outpatient pharmacy services, which aims to help patients receiving adjuvant chemotherapy including S-1 monotherapy for gastric cancer. In total, 34 and 80 patients received S-1 monotherapy without or with the intervention of outpatient pharmacy services, respectively; additionally, the median ages of the former and latter were 68 and 65 years, respectively. The treatment completion rates(82.4% versus 67.5%)were similar between the 2 groups(odds ratio[OR]: 0.45, 95% confidence interval[CI]: 0.16-1.21, p=0.106). Their emergency visit rates were 23.5% and 8.8%(OR: 0.31, 95% Cl: 0.10-0.94, p<0.05). Emergency hospitalization was required for 8.8% and 0% of the population from each group(OR: 0.00, 95% CI: not significant, p<0.05). We suggest that outpatient pharmacy services are useful because they are likely to improve a patient's safety.

The impact of pharmacist certification on the quality of chemotherapy in Japan.

Background In the Japanese healthcare system, board certification not only maintains the quality of daily practice but is also required for hospitals to receive healthcare reimbursement. To date, no data on the effects of the board certification system in Japanese hospitals have been reported. Objective We performed a survey to clarify the impact of pharmacist certification on the quality of chemotherapy. Setting A nationwide mailing survey was conducted in Japan. Method We surveyed oncology pharmacists from 388 cancer designated hospitals (DHs) and 984 randomly selected general hospitals (GHs). Main outcome measure Multivariate analysis of factors for compliance with standard cancer chemotherapy to clarify the impact of pharmacist certification on the quality of chemotherapy. Results The response rate was 70.6 % (274/388) at the DHs and 43.4 % (428/984) at the GHs. Of the 13 different regimens, 66.1 % (181/274) of DHs and 64.7 % (277/428) of GHs reported having experienced either improper doses or intervals of drug administration. The median number of improper regimens was 1 at both the DHs (range 0-15) and GHs (range 0-22). We identified two groups of hospitals, those with two or more improper regimens and those with one improper regimen or less. Univariate analysis showed significant differences in the number of DHs (p < 0.01), performance of more than 10 chemotherapies per day (p < 0.05), presence of more than 400 beds (p < 0.01) and the professional qualifications of oncology pharmacists or medical oncologists. From multivariate analysis, significant differences were observed in certifications from the Japanese Society of Pharmacy Healthcare and Sciences certified Senior Oncology Pharmacist (odds ratio 0.29, p < 0.01) and the Japanese Society of Medical Oncology certified oncologist (odds ratio 0.48, p < 0.01). Conclusion Board certification was more prevalent in the designated (cancer specialist) hospitals than general hospitals and adherence to appropriate therapy was better when the DH was involved. Board certification was shown to be beneficial in terms of adherence to adequate chemotherapy.

[Efficacy of Ipragliflozin in Patients with Steroid-Induced Hyperglycemia during Cancer Chemotherapy].

Steroid is a key drug in cancer chemotherapy-induced emesis. However, it may sometimes cause inadequately controlled hyperglycemia. Ipragliflozin is a novel selective sodium-dependent glucose cotransporter 2 inhibitor of urinary glucose excretion. In this case, we controlled steroid-induced hyperglycemia by administering ipragliflozin. The case was a 47-year-old man who was diagnosed with Stage IV esophageal cancer (T3N2M1). He had type 2 diabetes. He was treated with cisplatin (70 mg/m2; day 1) and 5-FU (700 mg/m2; days 1-4) as radiochemotherapy. Intravenous infusion of dexamethasone (9.9 mg) was administered on day 1, followed by additional doses (6.6 mg) for 3 days, as one of the emetic therapies. He received intensive insulin therapy during the first course of chemotherapy, but had Grade 3 hyperglycemia regardless. For the next treatment course, we additionally administered ipragliflozin along with dexamethasone. As a result, the hyperglycemia subsided to Grade 2. These findings suggest that ipragliflozin suppresses steroid-induced hyperglycemia.