The objective of this retrospective study was to evaluate the efficacy of albumin-bound paclitaxel(nab-paclitaxel) treatment and the required supportive care for severe adverse events.

Hand-foot syndrome( HFS) has been reported to be the most common adverse effect of capecitabine, with an incidence of more than 50%. AboundTM, containing β-hydroxy-β-methyl butyric acid( HMB), L-glutamine, and L-arginine is effective in the treatment of decubitus ulcers and in wound healing; however, whether AboundTM is efficacious for HFS caused by capecitabine is not clear. This study aimed at evaluating the effectiveness of AboundTM in the recovery from HFS caused by capecitabine. Capecitabine administration was discontinued in 6 patients with more than grade 2 HFS, and AboundTM was administered. The time to recovery was examined. The median time to recovery to less than grade 1 HFS was 10 days( range, 4-14 days). The grade of HFS decreased following the administration of AboundTM. The findings of this study suggest that AboundTM is effective against HFS caused by capecitabine.

Public knowledge-based application for paclitaxe(l PAC) has been approved for advanced or recurrent esophageal cancer. We investigated the feasibility of weekly PAC chemotherapy as a second-line or subsequent regimen for metastatic or recurrent esophageal cancer.

The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled "Overseas Drug Safety Information" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the "Overseas Drug Safety Information" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.

A questionnaire survey on postoperative adjuvant chemotherapy for gastric cancer was conducted for 76 hospitals affiliated with the Hiroshima Oncology Group of Gastric Cancer in Hiroshima prefecture in January 2011. Responses were obtained from 29 hospitals, including 12 core cancer treatment hospitals, and the following results were obtained. The percentage of patients completing 1 year of oral S-1 was >70%, affecting approximately 75% of the entire hospital cohort. Dose reduction was conducted in approximately 30% of patients because of age, poor PS, and renal insufficiency. The standard S-1 regimen (4 weeks of S-1 treatment followed by 2 weeks of rest)was adopted in almost half of the patients, whereas the rest of the patients received another treatment schedule such as 2 weeks of treatment followed by 1 week of rest. Dose reduction and withdrawal of S-1 due to adverse events were conducted more frequently in hospitals with low completion rates of 1-year S- 1 treatment than those with a high completion rate. S-1 was most commonly discontinued because of subjective adverse events and patient request, although the discontinuation rate according to objective adverse events such as bone marrow depression was not very high. The fact that some hospitals had high completion rates suggested the importance of supplementary tools for patient IC.

Chemotherapy-induced nausea and vomiting(CINV)is the most unpleasant side effect for patients receiving cancer chemotherapy. Moderately emetic anticancer drugs show a wide range of emetic frequencies, and the use or nonuse of antiemetics is optionally described without specifics. In the present study, we clarified the state of CINV presentation caused by moderately emetic anticancer drugs using the MASCC Antiemesis Tool, a nausea-and-vomiting evaluation tool developed by the Multinational Association of Supportive Care in Cancer(MASCC)for patients with colorectal cancer. Of the 32 subjects, 5 (15.6%)had vomiting and 22(68.8%)experienced nausea. The timing of their occurrence and their nausea scores were accurately and easily clarified. This study's findings suggested that the current regimens need to be reviewed, particularly because all patients exhibited late nausea; therefore, we modified our antiemetic regimens through the Cancer Chemotherapy Regimen Review Board of this hospital. After the modification was introduced, significant improvement was seen in the control of both acute and late nausea/vomiting.

In 2011, trastuzumab was approved via public knowledge-based application for administration over 30 minutes from the second round if the first infusion is well tolerated. However, cardiovascular strain and the trastuzumab-specific side effect of infusion reaction induced by an increase in the infusion rate on administering trastuzumab with 250 mL saline over 30 minutes need to be considered. To address these concerns, we evaluated trastuzumab administration with a reduced volume of 100 mL saline over 30 minutes. This method was well tolerated without an increase in the frequency of infusion reaction on retrospective comparison of the 2 administration methods. Thus, administration of trastuzumab with 100 mL of saline over 30 minutes considerably reduces infusion time, benefiting both patients and healthcare providers.

Fulvestrant, a pure estrogen receptor antagonist with no known agonist effects, was approved in September 2011 for the treatment of hormone-receptor positive metastatic breast cancer(MBC)in postmenopausal women in Japan. Here, we present a retrospective review of data from 73 heavily pretreated patients who received a high-dose regimen of fulvestrant in our hospital. Patients received a median of 3 endocrine therapies(range: 1-7)prior to the fulvestrant regimen. Partial response was observed in 4 patients, and 10 patients experienced stable disease for more than 6 months(objective response rate: 5.5%; clinical benefit rate: 19.2%). The median time to progression was 2.8 months. Fulvestrant was well tolerated; however, Grade 3 neuropathy at the injection site was observed in 2 patients. Of 12 patients, 3 responded to endocrine therapy following fulvestrant treatment. Our clinical experience indicates that fulvestrant can be administered to patients pretreated with several lines of endocrine therapy, although its efficacy as first- or second-line endocrine therapy has been demonstrated in clinical trial settings.

Chemotherapy and radiotherapy administered to cancer patients can be harmful because of their effect on normal cells as well as cancer cells, and cause many adverse events. The oral cavity is one of the sites most vulnerable to the direct and indirect effects of cancer therapy. Severe adverse events of the oral cavity can not only reduce a patient's QOL, but also disrupt cancer treatment. We discuss the concept of oral management by maintenance of the oral environment.

A 66-year-old man with hepatocellular carcinoma (HCC) and suspicion of lung metastasis consulted us because of an abnormal chest shadow as seen on a radiograph. He had been treated with sorafenib for 2 months. A chest CT scan showed cavitating nodules in the left upper lobe that were present before therapy with sorafenib, and infiltrative shadows in the subpleural areas of the right upper lobe. The shadows were diagnosed, at least in part, as pulmonary tuberculosis by using a nucleic acid amplification test for Mycobacterium tuberculosis in the sputum that yielded a positive result. Treatment with antituberculosis drugs resulted in a good clinical response. However, the patient died of HCC. We concluded that the nodule in the right upper lobe was old pulmonary tuberculosis, because it did not change during the course of the disease and because the cavities in the left upper lobe were active lesions. Sorafenib is a molecularly targeted agent that has been proven effective for treating advanced HCC with extrahepatic metastasis. It may also cause necrosis within lung metastases as an anti-tumor effect. Therefore, pulmonary tuberculosis, including reactivation, should be considered in the differential diagnosis when treating a patient with sorafenib.

Oxaliplatin is a platinum salt that is particularly effective for treating gastrointestinal tumors. However, some reports state that oxaliplatin-based chemotherapy triggers fatal thrombocytopenia. Myelosuppression is recognized as the main cause of oxaliplatin-related thrombocytopenia, and other mechanisms for this side effect have been suggested, including splenic sequestration of platelets related to oxaliplatin-induced liver damage and immune thrombocytopenia. Other causes of thrombocytopenia such as thrombotic thrombocytopenic purpura, immune thrombocytopenic purpura, heparin-induced thrombocytopenia, and pseudothrombocytopenia should also be considered. We encountered 3 patients who developed fatal thrombocytopenia after oxaliplatin-based chemotherapy and describe the differential diagnosis of fatal thrombocytopenia here.

Tumor lysis syndrome(TLS)induced by chemotherapy for solid tumors is rare. We report a case of a 59-year-old woman with breast cancer who developed TLS. She underwent surgery to treat breast cancer in 1992. 19 years after surgery, however, she was diagnosed with multiple bone metastases(disease free interval, 13 years and 3 months). In March 2011, gemcitabine regimen was initiated(1,250mg/m2, 14 days followed by a 7-day rest period)because of worsening of multiple bone metastases. The patient was immediately admitted and treated for suspected TLS when she presented at our hospital with symptoms such as depressed level of consciousness, serious anemia, hypercalcemia, hyperuricemia, and liver/renal dysfunction on day 16 of the first line of regimen. Rasburicase was found to be effective for hyperuricemia.

This report summarizes the use of gemcitabine for the treatment of malignant lymphoma. Gemcitabine is a deoxycytidine antagonist that has characteristics different from those of the deoxycytidine antagonist cytarabine(Ara-C). International guidelines based on the results of recent clinical studies recommend the use of gemcitabine as monotherapy and in combination therapy, particularly for relapsed and refractory malignant lymphomas. Clinical studies on gemcitabine monotherapy up to 2012 reported response rates of 51-75% for peripheral T -cell lymphoma and cutaneous T-cell lymphoma. Regarding combination therapy, the GDP regimen consisting of gemcitabine, dexamethasone, and cisplatin was associated with response rates of 62-70% for relapsed or refractory Hodgkin lymphoma and 45-53% for relapsed or refractory non-Hodgkin lymphoma, thereby displaying comparable efficacy to existing salvage chemotherapy regimens. The GDP regimen has a favorable safety profile and is also associated with favorable autologous transplantation rates, which suggests its potential as induction chemotherapy before autologous transplantation. Concerning adverse reactions requiring clinical caution, lung disorder was reported in 8 of 27 patients(30%)who received a regimen of gemcitabine in combination with bleomycin.

In contrast to conventional single-target drugs, multicomponent Kampo medicines are designed to achieve therapeutic effects through multiple drug targets. This article discusses recent advances in mechanistic studies and the clinical effects of eight representative Kampo formulations (Rikkunshito, Hangeshashinto, Daikenchuto, Goshajinkigan, Yokukansan, and the tonics Hochuekkito, Juzentaihoto, and Ninjinyoeito) for the treatment of adverse effects caused by anticancer drugs such as anorexia, oral mucositis, diarrhea, neurotoxicity, abnormal behavior, malaise, weakness, and thrombocytopenia, which Western pharmaceuticals fail to address adequately.

A 67-year-old man with castration-resistant prostate cancer associated with multiple bone metastases had been treated with zoledronic acid and docetaxel. Although there was no evidence of damage around the right lower jaw bone, the patient complained of pain in May 2011, which worsened during the next 2 weeks and was followed by difficulty with breathing. Computed tomographic (CT) findings of the cervical area showed swelling of the cervical tissue with air and tightening of the trachea, suggesting cellulitis caused by gas gangrene. He was intubated and treated with antibiotics. On the 12th hospital day, CT scan revealed a pharyngeal abscess and we performed a drainage operation. On the 20th hospital day, bone of the intraoral lower jaw was exposed, revealing that the infection was caused by osteonecrosis. Additional CT findings showed the abscess extending to the mediastinum and multiple liver metastases. Although antibiotic therapy was continued, the patient died of liver failure on the 61st day.