Adherence has become an important issue in modern oncology treatment. Most studies have included heterogeneous target tumor types, regimens, and therapy settings. Our study focused on capecitabine during capecitabine plus oxaliplatin (XELOX) treatment as an adjuvant therapy for colorectal cancer. The main aims of this study were to evaluate real-life adherence to capecitabine and to investigate candidate factors that might decrease adherence. We studied 338 consecutive patients who received XELOX treatment between December 1, 2011, and April 30, 2015, at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. Our study assessed adherence to capecitabine through patient-reported treatment diaries and interviewed nonadherents to determine the reasons for not taking capecitabine at a pharmaceutical outpatient clinic. We calculated the adherence rate in a cycle as: number of times the patient took capecitabine/28. Relative dose intensities and factors associated with deteriorating adherence to capecitabine were retrospectively surveyed from electronic patient records. Uni- and multivariate logistic regression analyses were used to investigate factors associated with optimal adherence. The study covered 282 patients who received 2,055 cycles of XELOX. Median adherence rate was 94.0% in the first cycle, and median relative dose intensity of capecitabine was 77.8%. The most common reasons for nonadherence were nausea/vomiting and diarrhea. The presence of the following factors was not significantly associated with adherence: ECOG performance status ≥1 (p = 0.715), clinical stage (p = 0.408), primary tumor site (p = 0.576), age ≥70 years at study entry (p = 0.757), female gender (p = 0.504), and not living alone (p = 0.579). The adherence rate from this study was significantly higher than the adherence from metastatic settings. Adherence-enhancing interventions for capecitabine in XELOX treatment as adjuvant therapy comprised management of nausea/vomiting and diarrhea.

Background: A novel oral agent that consists of trifluridine and tipiracil hydrochloride (TFTD) has been established as salvage-line treatment for metastatic colorectal cancer (mCRC). Adherence to TFTD is crucial to maintaining appropriate curative effects. This study sought to clarify adherence to TFTD and identify candidate factors deteriorating adherence at our institution. Methods: A total of 50 consecutive mCRC patients who received TFTD monotherapy between June 1, 2014 and July 31, 2015 were analyzed in this study. Adherence to TFTD was checked by pharmacists using a self-reported treatment diary and interviewing nonadherents at a pharmaceutical outpatient clinic. The adherence rate was defined as the number of patient intakes per 20 scheduled intakes in one cycle. We retrospectively surveyed the factors from the electronic patient record associated with reduced adherence. We measured relative dose intensity, defined as the dose intensity divided by the initial dose (each in milligrams per square meter per week). Results: Patient characteristics were as follows: males/females, 20/30; median age, 61 years (range, 34-83 years); performance status 0/1, 37/13. Median relative dose intensity of TFTD was 91.0%. Adherence rates were 95.0% for the first cycle of TFTD, 97.3% for the second cycle, 98.0% for the third cycle, and 98.2% for the fourth cycle. Factors associated with deteriorated adherence to TFTD were nausea/vomiting/decreased appetite (27.1%, 23 instances), pain (25.9%, 22 instances), neutropenia (11.8%, 10 instances), and missed dose (4.7%, 4 instances). Increased nonadherence to TFTD was associated with Eastern Cooperative Oncology Group performance status 1, while increased TFTD adherence in the first cycle was associated with prior regimens ≥4. Conclusions: The high frequency of treatment-related gastrointestinal disorder is the main factor affecting adherence to TFTD. Intensive supportive care in the management of these symptoms could assist adequate adherence to TFTD in mCRC patients.

Background/Aim: This study aimed was to clarify the impact of pegfilgrastim (PEG) 3.6 mg primary prophylaxis of febrile neutropenia (FN) on the average relative dose intensity (ARDI) of neoadjuvant/adjuvant FEC-100 for breast cancer. Materials and Methods: This retrospective, single-centre cohort study including 296 patients who received FEC-100 compared PEG and non-PEG groups. The PEG group received PEG 3.6 mg as a single subcutaneous injection in each study cycle. The primary endpoint was the ARDI of FEC-100. The secondary endpoints were patient percentage of ARDI≥85%, factors associated with ARDI≥85%, and reasons for reduced ARDI. Results: The PEG group showed significantly higher mean ARDI (95.6% versus 90.7%, p<0.001) and patient percentage of ARDI≥85% (93.0% versus 79.9%, p=0.001). PEG was significantly associated with ARDI≥85% (p=0.009). Neutropenia and FN, the main reasons for reduced ARDI, were significantly lower in the PEG group (p<0.05). Conclusion: Primary PEG 3.6 mg prophylaxis increased the ARDI of FEC-100.FEC-100 chemotherapy (fluorouracil, epirubicin, and cyclophosphamide) has been established as a standard neoadjuvant or adjuvant therapy for breast cancer (1-3) and is widely used in clinical practice (4, 5). In the phase II clinical study for FEC-100 chemotherapy in Japan, grade ≥3 neutropenia and febrile neutropenia (FN) occurred in 44% and 20% of patients, respectively, and dose reduction due to their toxicities was required in about 15% (6). Dose reduction and treatment delay due to toxicities affect relative dose intensity (RDI).In a comprehensive systematic review and meta-analysis of 17 randomised, controlled trials (RCTs), neutropenic events had a significant impact on RDI for patients receiving adjuvant anthracycline-based chemotherapy for early breast cancer. According to the results of this study, the decrease rate of RDI due to neutropenia was a mean of 8.9% and a median of 8.2%. Furthermore, of the patients with neutropenic events, 32% did not achieve an RDI of 85%, compared to 7% of patients in the group with no events (7). Bonadonna et al. (8) and Chirivella et al. (9) reported that patients who received an RDI≥85% have a significantly higher probability of survival. The French Adjuvant Study Group 05 Randomized Trial showed benefit in terms of disease-free survival and overall survival when the epirubicin dose was increased from 50 mg/m 2 to 100 mg/m 2 in FEC chemotherapy (10). Given the above results, maintaining RDI as high as possible might contribute greatly to survival.Updated guidelines from the American Society of Clinical Oncologists (ASCO) (11), the National Comprehensive Cancer Network (NCCN) (12), the European Organization for the Research and Treatment of Cancer (EORTC) (13), and the Japanese Society of Medical Oncology (JSMO) (14) recommend routine use of granulocyte colony-stimulating factors (G-CSF) for chemotherapy regimens with an FN risk ≥20%. For regimens with an FN risk of 10-20%, individual patient risk factors such as age and disease stage should be taken i...

Regorafenib is a multikinase inhibitor for the treatment of metastatic colorectal cancer. Regorafenib-induced hand-footskin reaction (HFSR) is a common side effect during treatment. The reported frequency of HFSR was 80% (Grade 3: 28%) of the Japanese subpopulation in the CORRECT trial; however, more detailed data regarding HFSR in terms of onset and sites of susceptibility are unclear. Additionally, the risk factors for regorafenib-induced severe HFSR are unknown. The aim of this study was to compare HFSR between the hands and feet and identify pre-existing risk factors for severe HFSR in Japanese patients receiving regorafenib. We retrospectively examined the onset and severity of HFSR in the hands and feet of patients with metastatic colorectal cancer treated with regorafenib from May 2013 to October 2015 in the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. In addition, we examined the possible association between pre-existing clinical factors and severe HFSR. Our results showed that no significant difference in the incidence of HFSR of any grade was observed between the hands (71%) and feet (74%) ( = 0.63). The incidence of grade 3 HFSR was more frequent in the feet (33%) than hands (8%) ( < 0.01). The onset of grade 3 HFSR was earlier in the feet than hands ( < 0.001). No pre-existing risk factor was identified. Our findings indicate that severe HFSR was more prevalent in the feet than hands, suggesting the need for appropriate screening for early detection and treatment of regorafenib-induced HSFR.

Adjuvant CAPOX can be safely administered to Japanese patients with stage II/III colon cancer.