Phase II Clinical Trial of First-line Eribulin Plus Trastuzumab for Advanced or Recurrent HER2-positive Breast Cancer.

BACKGROUND/AIM: Eribulin mesylate has been approved for advanced or metastatic breast cancers subjected to at least two previous chemotherapy regimens. The present multicenter, phase II, single-arm study assessed the efficacy and safety of a first-line regimen of eribulin plus trastuzumab for untreated advanced or metastatic HER2-positive breast cancer. PATIENTS AND METHODS: Enrolled patients received eribulin (1.4 mg/m2 intravenously; I.V.) on days 1 and 8 of each 21-day cycle, an initial trastuzumab dose (8 mg/kg I.V.) on day 1, and 6 mg/kg of trastuzumab on day 1 of each subsequent cycle. The primary endpoint was the response rate (RR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety. Twenty-eight patients (median age: 62.5 years) received a median of 12 (range: 2-53) cycles of eribulin plus trastuzumab. RESULTS: The RR was 53.6% [complete response (CR), 4; partial response (PR), 11] with a median PFS of 344 days. The clinical benefit rate was 64.0%. Grade 3/4 adverse events were observed in 12 (42.9%) patients. For details, neutropenia in 8 (28.6%) patients, peripheral neuropathy in 2 (7.1%) patients, interstitial pneumonia in 1 (3.6%) patient, ALT elevation in 1 (3.6%) patient, osteonecrosis of the jaw in 1 (3.6%) patient, and fatigue in 1 (3.6%) patient. The patient with osteonecrosis received denosumab, too. No symptomatic congestive heart failure was observed. CONCLUSION: Combination therapy of eribulin plus trastuzumab is acceptable in efficacy and safety, and a capable option for first-line advanced or recurrent HER2-positive breast cancer.

[A long-term survival case in advanced mucinous cystadenocarcinoma of the appendix using cytoreductive surgery and S-1/CDDP chemotherapy].

Prognosis of patients with advanced mucinous cystadenocarcinoma of the appendix (AMCA) is extremely poor. However, there has been no established treatment strategy. We preliminary report here a successfully treated case with AMCA using intensive cytoreductive surgery and chemotherapy. A 61-year-old woman had a right lower abdominal pain and was diagnosed as acute appendicitis. At surgery, about 5 cm tumor with mucosal fluid was detected at the distal part of the appendix. The tumor was invading the ileum and bladder. We performed appendectomy with tumor, partial resection of the small intestine and debridement of mucosal fluid. Histopathology revealed AMCA invading the ileum and bladder. After non curative surgery, we started S-1 plus cisplatin chemotherapy, which S-1 was given orally, twice daily for 3 consecutive weeks, and cisplatin was given intravenously on day 1, 8 and 15 followed by a 3-week rest period. After 6 courses starting with chemotherapy, a complete response was obtained. We followed by S-1 until two years after the initial surgery. At 36 months after the initial surgery, CT scan demonstrated a peritoneal recurrence. Then, she underwent intensive peritonectomy with intraperitoneal hyperthermic chemotherapy. Currently, she had no apparent recurrence for 59 months after initial surgery.