Effectiveness of eribulin as first-line or second-line chemotherapy for HER2-negative hormone-resistant advanced or metastatic breast cancer: findings from the multi-institutional, prospective, observational KBCRN A001: E-SPEC study.

BACKGROUND: The optimal positioning of eribulin treatment remains unclear. This study aimed to investigate the effectiveness of eribulin administration as first- and second-line chemotherapy in patients with endocrine-resistant advanced or metastatic breast cancer (AMBC) in the real-world clinical setting. METHODS: This multi-institutional prospective cohort study enrolled patients with triple-negative AMBC or estrogen receptor-positive AMBC refractory to at least one previous endocrine therapy. The overall survival (OS) from the start of first-line (OS1) and second-line chemotherapy (OS2) was assessed. Data analysis included real-world chemotherapy sequences of first- to third-line chemotherapy regimens. The adjusted hazard ratio (HR) with 95% confidence interval (CI) for treatment regimen comparison was calculated using a stratified proportional hazards model. RESULTS: Among 201 patients enrolled, 180 were included in the final analysis. Eribulin was administered as first- and second-line chemotherapy to 46 (26.6%) and 70 (47.9%) patients, respectively. Median OS1 and OS2 were 2.25 (95% CI 1.07-2.68) and 1.75 (95% CI, 1.28-2.45) years for first- and second-line eribulin, respectively. Oral 5-FU followed by eribulin had a numerically longer OS1 (2.84 years) than the other sequences. Among patients who proceeded to second-line or later chemotherapy, the median OS1 for those treated with anthracycline or taxane as first- or second-line (n = 98) was 2.56 years (95% CI 2.27-2.74), while it was 2.87 years (95% CI 2.20-4.32) for those who avoided anthracycline and taxane as first- and second-line (n = 48) (adjusted HR, 1.20; 95% CI 0.70-2.06). In the exploratory analysis, OS1 was 2.55 (95% CI 2.14-2.75) and 2.91 years (95% CI 2.61-4.32) for those aged < 65 and ≥ 65 years, respectively (adjusted HR of ≥ 65, 0.91; 95% CI 0.56-1.46). CONCLUSIONS: Eribulin or oral 5-FU administration in first- and second-line chemotherapy without anthracycline/taxane was acceptable in the real-world setting. TRIAL REGISTRATION: This study is registered with Clinical Trials.gov (NCT 02,551,263).

Effectiveness and safety of surgical glove compression therapy as a prophylactic method against nanoparticle albumin-bound-paclitaxel-induced peripheral neuropathy.

BACKGROUND: We have developed a surgical glove (SG)-compression therapy and reported that this method significantly reduced the overall occurrence of grade 2 or higher nanoparticle albumin-bound-paclitaxel (nab-PTX)-induced peripheral neuropathy (PN) from 76.1% to 21.4%. In this multicenter single-arm confirmatory study, we investigated the efficacy and safety of SG-compression therapy for the prevention of nab-PTX-induced PN, compared with the incidence of grade 2 or higher PN in published literature as controls. PATIENTS AND METHODS: Primary breast cancer patients who received 260 mg/m2 of nab-PTX were eligible for this study. Patients wore two SGs (one size smaller than the tight-fitting size) in each hand for 90 min. PN was evaluated at each treatment cycle using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and the Patient Neurotoxicity Questionnaire (PNQ). The temperature of each fingertip was measured using thermography. RESULTS: Between October 2016 and June 2017, 58 patients were evaluated. The incidence of CTCAE grade 2 or higher PN was as low as 13.8% following SG-compression therapy. A goodness-of-fit test proved that the overall incidence of 13.8% grade 2 or higher PN in this study was comparable to the hypothesis-predicted value (13%). No adverse events, including compression intolerance or skin disorders caused by use of SG, were observed. SG-compression therapy significantly reduced the temperature of each fingertip by 1.3°C-2.3 °C compared to pre-chemotherapy level. CONCLUSIONS: This study suggested the safety and efficacy of SG-compression therapy for the amelioration of CIPN. CLINICAL TRIAL NUMBER: UMIN 000024836.

[Two-Stage Radical Resection of a Case of Colon Cancer with Abdominal Wall Invasion and Cholangiocarcinoma].

A woman in her 50s was admitted to our hospital with fever and lower abdominal swelling. Abdominal CT/MRI examinations revealed irregular thickening of the transverse colon wall, which was attached to a subcutaneous abscess. An abdominal wall mass, a patent urachus, and a tumor in the 5th segment of the liver were also noted. Colonoscopy revealed type 2 advanced transverse colon cancer. The solitary, sessile tumor was observed at the apex of the bladder under cystoscopy, suggesting the formation of the urachal carcinoma. Transcutaneous liver biopsy obtained from the liver tumor indicated adenocarcinoma, which was morphologically different from the existing transverse colon cancer. Right hemicolectomy with resection of the umbilicus, abdominal wall, urachus, and part of the bladder wall was performed. Diagnosis of the transverse colon cancer invading the abdominal wall and bladder was confirmed by histopathological examination. Hepatectomy was performed in the next surgery, and the tumor was histopathologically diagnosed as an intrahepatic cholangiocarcinoma. Both the transverse colon cancer and the intrahepatic cholangiocarcinoma were radically resected. Radical surgical diagnostic resection may be valuable in cases of multicentric cancers of unknown primary origin, if radical resection of each individual tumor is required.

[A Case of Esophageal Carcinoma with Large Intramural Metastasis to the Stomach].

We report a rare case of esophageal carcinoma with gastric wall metastasis. A 73-year-old man with dysphagia underwent endoscopy and upper GI series and chest-abdominal computed tomography, revealing esophageal carcinoma and gastric cancer, which was diagnosed as squamous cell carcinoma by biopsy. The esophageal carcinoma was located in the lower thoracic esophagus(Lt). Total gastrectomy was performed. The resected specimen showed a type 3 tumor measuring 7×7 cm in the anterior wall of the stomach. Pathologically, the depth of invasion of the stomach was SE. He died 3 months after the operation. Esophageal carcinoma with gastric intramural metastasis is very rare and has a dismal prognosis. We report a rare case of esophageal carcinoma with large intramural metastasis to the stomach.

[A Case of Triple Negative Spindle Cell Carcinoma of the Breast and Improved Quality of Life Following Irinotecan Chemotherapy].

We report a case of triple negative spindle cell carcinoma of the breast, responsive to irinotecan chemotherapy. A 49-year old woman who had a tumor in the chest wall with a skin ulcer visited our hospital. After being diagnosed with triple negative spindle cell carcinoma of the breast, she underwent surgery, adjuvant chemotherapy, and radiation at the other hospital. Fourteen months after the surgery, she developed an ipsilateral breast tumor as a result of local recurrence. Since eribulin and paclitaxel plus bevacizumab chemotherapies were not effective, she was transferred to our hospital, and we administered irinotecan as third-line chemotherapy. Skin lesions and effusion were reduced and her quality of life improved for 4 months.

[A Case of Unresectable Locally Advanced Pancreatic Cancer Resulted in R0 Surgery after Chemotherapy].

A 67-year-old man visited our hospital for jaundice. Abdominal dynamic CT showed the hypovascular tumor at the head of the pancreas that surrounded superior mesenteric artery(SMA)at an angle of 220 degree. No metastasis in lymph nodes and other organs was observed. We diagnosed the tumor unresectable locally advanced(UR-LA)pancreatic cancer. Chemotherapy was administered with gemcitabine and nab-paclitaxel(GEM+nab-PTX)and achieved partial response. Regression in size and in range around SMA to an angle of 150 was observed. We assessed it possible to resect the tumor curatively, and performed subtotal stomach preserving pancreaticoduodenectomy and dissection of the plexus around the SMA, resulted in R0 surgery. Adjuvant chemotherapy was administered, and no recurrence was observed up to present, more than a year. It is suggested that GEM+nab-PTX can be effective as the primary therapy against UR-LA pancreatic cancer.

[Recurrent Gastric Carcinoma(Endocrine Cell Type)Successfully Treated with Multidisciplinary Therapy - A Case Report].

A 62-year-old woman was diagnosed with carcinoma of the stomach at another hospital. Distal gastrectomy with D2 dissection was performed and she was referred to our hospital. Histopathological and immunopathological examinations showed the tumor to be composed of adenocarcinoma and neuroendocrine carcinoma. The patient was followed until 4 months after the operation when an abdominal computed tomographic(CT)scan showed a metastatic tumor at S2 and S5/6 of the liver. No other organ metastases were found, and a hepatectomy was performed. The primary tumor of the stomach consisted of adenocarcinoma and neuroendocrine carcinoma; however, the resected metastatic liver tumor consisted of only neuroendocrine carcinoma. Liver and lung metastases appeared 2 months after the operation, and we started chemotherapy with VP-16 and cisplatin. After 8 courses of treatment, the lung metastases showed a CR, and the liver metastasis was SD. She is alive without lung metastases 9 months after the hepatectomy.

[A Case of Rectal Cancer Successfully Treated with Surgery and Stereotactic Radiotherapy for Metachronous Lung Metastases].

A 64-year-old woman underwent polypectomy for a rectal polyp(Isp). Pathological findings were invasion of the submucosa( 3,500 mm diameter), and she underwent anterior resection for rectal cancer(RS, pT1b, pN0, cM0, Stage I )without adjuvant chemotherapy. Lung masses were found in her right(8mm)and left lung(7mm). The tumors enlarged during the 4 month follow-up period. We decided to perform left partial pneumonectomy. The tumor was diagnosed as a lung metastasis from colon cancer by pathology. Because the right tumor was located towards the center, performing right pneumonectomy would have been quite invasive and we feared occult metastases. We decided to apply SRT(50 Gy)to the right tumor. The tumor shrunk and became a scar after treatment. There were no complications such as radiation pneumonitis. The patient was in good health without any recurrence for 12 months after SRT. Surgical resection is an optimal method to control lung metastasis from colon cancer if the lesion is operable. However, in the case of a tumor centrally located, surgical resection may cause deterioration of lung function. There are also cases with contraindications for surgery due to co-morbidities. In addition, there is no consensus on observation periods to exclude occult metastases. SRT can be an effective treatment for lung metastases from colon cancer when there are bilateral lung metastases and no metastases outside the lungs.