Phase II trial of eribulin mesylate as a first- or second-line treatment for locally advanced or metastatic breast cancer: a multicenter, single-arm trial.

BACKGROUND: Eribulin mesylate is currently indicated as a sequential monotherapy to be administered after two chemotherapeutic regimens, including anthracycline and taxane treatments, for treatment of metastatic breast cancer. This open-label, multicenter phase II study was designed to evaluate the efficacy and safety of eribulin as a first- or second-line treatment for patients with metastatic breast cancer. METHODS: The primary objective was to determine the overall response rate. Secondary objectives were to evaluate progression-free survival and the safety profile. Patients were scheduled to receive eribulin mesylate 1.4 mg/m2 intravenously on days 1 and 8 of a 21-day cycle. Patients received the study treatment unless disease progression, unacceptable toxicity, or a request to discontinue from the patient and/or investigator eventuated. RESULTS: Between December 2012 and September 2015, 32 patients with metastatic breast cancer were enrolled at 10 participating clinical institutions in Japan, and toxicity and response rates were evaluated. The overall response rate was 43.8% (95% confidence interval [CI] 26.5-61.0). The clinical benefit and tumor control rates were 56.3% (95% CI 39.0-73.5) and 78.1% (95% CI 63.8-92.5), respectively. Median progression-free survival was 8.3 months (95% CI 7.1-9.4). A subgroup analysis did not identify any factors affecting the efficacy of eribulin. The most common adverse events were neutropenia (71.9%), alopecia (68.7%), and peripheral neuropathy (46.9%). As a first- or second-line therapy, eribulin showed sufficient efficacy for metastatic breast cancer compared with taxane and capecitabine treatment in previous clinical trials. The safety profile of eribulin was acceptable. CONCLUSIONS: Eribulin may be another option for first-line chemotherapeutic regimens for metastatic breast cancer. TRIAL REGISTRATIONS: This trial was retrospectively registered at the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (ID number: UMIN000010334 ). Date of trial registration: April 1st, 2013.

Endoscopic biliary drainage as a bridging procedure to single-stage surgery for perforated choledochal cyst: a case report and review of the literature.

Choledochal cyst (CC)-a congenital anomaly of the bile duct-is rare. We report a 28-year-old woman complaining of epigastralgia who was transferred to our hospital. Physical examination revealed severe tenderness to abdominal palpation without symptoms of diffuse peritonitis. Urgent contrast-enhanced abdominal computed tomography indicated the dilated common bile duct (CBD) was perforated, with a presumed diagnosis of perforated CC. Endoscopic external biliary drainage was performed immediately as a bridging procedure to the definitive surgery. Additional evaluations confirmed a type IVa CC, according to Todani's classification, but no signs of malignancy. Twenty-two days after biliary drainage, laparotomy was performed. A large cystic mass was found in the CBD with a perforated scar on the right-side wall. Because inflammation around the pancreas head was too severe to perform cyst excision safely, the patient underwent subtotal stomach-preserving pancreatoduodenectomy. The postoperative course was uneventful, and the patient was discharged on the 29th postoperative day. Pathologic examination of a specimen showed no malignancy, and the patient has remained well during the 3-year follow-up. Our experience with this case suggests that definitive single-stage surgery for perforated CC in an adult can be performed safely owing to external biliary drainage as a bridging procedure, if manifestation of diffuse peritonitis is not evident.

[Complete clinical and pathological response to mFOLFOX6 neoadjuvant chemotherapy in a case of advanced rectal cancer].

The patient was a 78-year-old woman with a chief complaint of abdominal bloating and constipation who was referred to us and was examined for an AV 12-15 cm, circumferential type 2 rectal cancer. The pathological diagnosis was adenocarcinoma (tub1+tub2). T4 and N2 were suspected based on the CT findings, and because the CEA value was high, the patient was treated with 7 courses of mFOLFOX6 neoadjuvant chemotherapy followed by salvage surgery(low anterior resection+D3). Examination of the surgical specimen revealed chronic inflammatory cell infiltration, including histiocytes accompanied by ulceration, and fibrosis was observed down to SS. No viable cancer cells were detected, and the tumor response was evaluated as a pathological CR. mFOLFOX6 appeared to be effective as neoadjuvant chemotherapy for advanced rectal cancer.

[A case of recurrent breast cancer with carcinomatous pleurisy successfully treated with combined chemoendocrine-therapy of CTF (CPA, THP and 5-FU) and anastrozole following instillation therapy 12 years after radical mastectomy].

A 52-year-old female underwent radical mastectomy at the age of 41 for left breast cancer (n0, positive for ER). After a few years of adjuvant TAM therapy, follow-up was stopped at the age of 50 with no recurrence. She had suffered from symptoms of cold since January 2001 and came to our hospital complaining dyspnea on February 11. CXP showed pleural effusion of the entire thoracic cavity and she was admitted to the hospital immediately. Pleural exudate cytodiagnosis showed carcinomatous pleurisy; however, dyspnea and thoracic effusion were improved by continuous thoracic drainage and instillation therapy. Various examinations demonstrated that the carcinomatous pleurisy was due to recurrent breast cancer. They also showed local recurrence, left supraclavicular lymph node metastasis and multiple bone metastasis. Thus, combined chemoendocrine-therapy of CTF (CPA, THP and 5-FU) and anastrozole was administered. After 6 cycles of CTF, the carcinomatous pleurisy, local recurrence and left supraclavicular lymph node metastasis were diagnosed as CR by CXP, chest CT and US and multiple bone metastasis were diagnosed as PR by bone scintigram. The patient continues to be treated on an outpatient basis with no recurrence about one year after the beginning of the treatment (6 months after CTF 6 cycles) and she is taking anastrozole continuously.