[Investigation of Factors Related to Overall Survival in Patients Treated with Gemcitabine plus Paclitaxel(Albumin Suspension)for Advanced or Recurrent Pancreatic Cancer].

In cancer chemotherapy, identifying factors that may affect overall survival is clinically beneficial. In this study, we examined the factors associated with overall survival in patients treated with gemcitabine plus paclitaxel(albumin suspension) (GN)for pancreatic cancer. We included 91 pancreatic cancer patients who underwent GN therapy as the first-line treatment from January 2015-November 2021. In addition to survival from the start of therapy, the factors surveyed were patient background(gender, age, BMI, etc), dose at the start of treatment, baseline laboratory values, presence or absence of neutrophil count reduction, and modified Glasgow Prognostic Score(mGPS). Multivariate analysis showed that a neutrophil count reduction of Grade 3 or higher(p=0.004)and mGPS≤1(p=0.004)significantly increased overall survival. Consequently, 54.9% of patients(50/91)showed a neutrophil count reduction of Grade 3 or higher, and 35.2% of patients (32/91)showed expression of the first course. The study suggests that neutrophil count reduction of Grade 3 or higher and mGPS≤1 are indicators of prolonged overall survival. In particular, neutrophil count reduction had a high incidence in the first course; therefore, appropriate management is required from early stages of treatment. In addition, nutritional support care should be considered prior to starting treatment.

[Incidence of Immune-Related Adverse Events after Switching from a Conventional Regimen of Nivolumab and Pembrolizumab to the Extended Dosing Interval Regimen].

A new nivolumab and pembrolizumab monotherapy regimen with double the conventional dose and longer dosing intervals( the new regimen)has been approved. Here, we report the incidence of immune-related adverse events(irAEs)in the early phase of switching from the conventional regimen to the new regimen at Ogaki Municipal Hospital. Thirty-seven patients switched to the new regimen between October 2020 and February 2021: 7(18.9%)switched to nivolumab and 5 (14.3%)to pembrolizumab. Two of the 7 patients treated with nivolumab developed irAEs. One patient developed Grade 3 colitis on day 51 following the switch to the new regimen, and the treatment was discontinued. The other patient developed Grade 3 adrenal insufficiency on day 72 and was hospitalized. No irAEs were observed with pembrolizumab treatment. These results suggest that high-severity grade irAEs may occur early after switching to the new regimen.

[Examination of Actual Medical Material Cost and Cost Reduction Related to Exposure Prevention in the Preparation of Anticancer Drugs].

At Ogaki Municipal Hospital, we expanded the preparation of anticancer drugs using a closed system drug transfer device (CSTD)when revising medical fees in 2016. In this study, we investigated the number of regimens and number of preparations for outpatients in December 2017. Subsequently, the cost of all consumables related to the preparation of anticancer drugs was calculated. In total, 574 preparations of 68 regimens were conducted, with CSTD used in the preparation of 331 (57.7%)drugs. The cost associated with preparation of anticancer drugs was 1,608,163 yen/month, of which the CSTD cost was 1,135,315 yen/month(70.6%). Given the disproportionately high cost related to CSTD, we investigated for material cost reduction. Although CSTD has a mechanism for adjusting the differential pressure inside and outside the vial, the conditions were used to calculate medical fee; however, if we use what we do not have, we estimated that the facility burden would be reduced by 24.7%. CSTD can contribute not only to safety through exposure prevention but also to medical cost reduction through introduction of "Drug Vial Optimization." We believe it will continue to act as a medical evidence to reduce medical fee remuneration and ease the conditions of fee calculation.

Tolerability and safety of real-world use of pomalidomide in patients with relapsed/refractory multiple myeloma.

Pomalidomide (POM) is a second-generation immunomodulatory agent with proven efficacy in patients with relapsed/refractory multiple myeloma (RRMM) proven to be refractory to previous treatment with lenalidomide (LEN) and bortezomib. We herein conducted a retrospective analysis of 14 RRMM patients receiving POM to determine its tolerability and safety in the clinical setting. The median age of the patients was 72 years (range, 58-84 years), and 85.7% of the patients were aged >70 years. The most frequent treatment dose was 3 mg/day. POM dose reductions were required in 54.5% (6/11) of the patients. The patient data were compared among three age groups (<70, 70-75 and >75 years) and there was only significant difference in daily POM treatment dose. The tolerability of POM must be confirmed, particularly in elderly patients. Dose reduction from 4 to 3 mg occurred during the second cycle in 83.3% (5/6) of the patients. It is important to determine the tolerability of POM in the early phases of treatment. The most frequently reported grade 3/4 hematological adverse events were neutropenia (64.3%), anemia (64.3%) and thrombocytopenia (57.1%). Although the median number of treatment cycles was 4 (range, 1-13), 21.4% (3/14) of the patients with a performance status (PS) of 3 were administered only 1 treatment cycle. The tolerability of POM was low among patients with poor PS and an aggressive treatment introduction should be avoided. However, 21.4% (3/14) of the patients were able to continue treatment for >1 year and some patients received long-term therapy. POM does not require dose modification for renal function, and multiple capsule doses are available, which is an advantage of POM compared with LEN. POM may be administered to late-stage RRMM patients in a real-world clinical setting, but elderly patients or those with poor PS must be treated with caution. In this manner, the treatment options for RRMM patients may be expanded by assessing the tolerability and safety of POM.

The incidence and timing of leukocyte overshoot after pegfilgrastim administration.

INTRODUCTION: Pegfilgrastim is a PEGylated formulation of filgrastim with a long half-life. It is highly convenient and less burdensome for patients. However, white blood cell count may temporarily increase after administration; in particular, a leukocyte overshoot may be observed. The present study retrospectively examined the incidence and timing of leukocyte overshoot after pegfilgrastim administration. PATIENTS AND METHODS: Fifty-five patients (118 occasions of pegfilgrastim) were evaluated. Leukocyte overshoot was defined as white blood cell count ≥10,000/mm3 exceeding the reference value. RESULTS: Leukocyte overshoot was observed in 71.2% (84/118) occasions, in 76.4% (42/55) patients. The maximum white blood cell count ≥30,000/mm3 was observed in 30.5% (36/118) occasions in 45.5% (25/55) patients and was observed in 39.3% (33/84) occasions on day 1 after pegfilgrastim administration and 26.2% (22/84) on day 2. Leukocyte overshoot has been observed in only 23.1% (9/39) patients administered with normal granulocyte colony-stimulating factor. However, there were no patients with white blood cell counts ≥30,000/mm3. CONCLUSION: There was a higher frequency of occurrence of leukocyte overshoot in response to pegfilgrastim than in response to normal granulocyte colony-stimulating factor. High incidence of leukocyte overshoot was observed when blood was collected 1-2 days after administration of pegfilgrastim. It is important for patients to understand the characteristics of pegfilgrastim by conducting pharmaceutical guidance.

Chemotherapy continuity and incidence of febrile neutropenia with CHOP therapy in an outpatient setting.

The cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) regimen is considered to be a standard treatment for non-Hodgkin's lymphoma (NHL). Patients receiving CHOP chemotherapy often experience febrile neutropenia (FN) due to myelotoxicity. The proper management of FN is essential to guarantee a positive outcome of the NHL treatment. Therefore, the present study retrospectively examined chemotherapy continuity and the incidence of FN during CHOP therapy in an outpatient setting. The subjects were 136 patients who received CHOP chemotherapy between January 2012 and December 2014. A total of 31 patients unable to be treated in an outpatient setting were excluded from the study. Of the remaining 105 patients, 73 patients who did not require hospitalization during the chemotherapy treatment were included in the non-hospitalized group, and 32 patients who required hospitalization during chemotherapy treatment were included in the re-hospitalization group. The numbers of patients from these two groups who completed the planned treatment were 71 and 24, respectively (P<0.01). In addition, the duration of granulocyte-colony stimulating factor (G-CSF) treatment was 5.3±1.22 and 6.1±1.46 days, respectively (P<0.01). The numbers of patients experiencing FN in an outpatient setting were 14 and 19, respectively (P<0.01). During administration of primary prophylaxis with G-CSF, the incidence of FN was 21.0% (22/105) in cycle 1. In conclusion, the present study has revealed a requirement to educate patients about infection prevention prior to the first cycle of chemotherapy. Patients who require the administration of long- term G-CSF are at risk of unplanned re-hospitalization, and treating them with polyethylene glycol G-CSF to reduce the number of required injections should be considered as an option. Therefore, proper supportive therapy and management of infection are important to safely treat patients with CHOP in an outpatient setting.