Short-Term Outcomes from a Randomized Screening Phase II Non-inferiority Trial Comparing Omentectomy and Omentum Preservation for Locally Advanced Gastric Cancer: the TOP-G Trial.

BACKGROUND: Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial's secondary endpoints. METHODS: The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ : UMIN000005421). The key eligibility criteria were histologically confirmed cT2-4a and N0-2 gastric adenocarcinoma. Short-term surgical outcomes, including morbidity and mortality, were compared between the omentectomy group (group A, control arm) and the omentum-preserving surgery group (group B, test arm). All procedures were performed via an open approach. Based on a non-inferiority margin of 7%, statistical power of 0.7, and type I error of 0.2, the sample size was set to 250 patients. RESULTS: A total of 251 patients were eligible and randomized (group A: 125 patients, group B: 126 patients) between April 2011 and October 2018. After excluding patients who had peritoneal metastasis or laparotomy history, safety outcomes were analyzed for 247 patients. Group A had a significantly longer median operation time (225 min vs. 204 min, p = 0.022) and tended to have greater median blood loss (260 mL vs. 210 mL p = 0.073). The incidences of morbidity were similar and < 10% in both groups (8% vs. 9%, p = 1.000). There was no mortality in either group. CONCLUSIONS: Operative risk was generally similar between omentectomy and omentum-preserving surgery for locally advanced gastric cancer.

Perianal metastasis of non-small cell lung cancer.

We herein present the case of a 36-year-old woman who developed perianal metastasis of non-small cell lung cancer that was diagnosed based on the presence of symptoms mimicking a hemorrhoid. The patient initially underwent radiotherapy for a left superior sulcus tumor, then subsequently complained of a perianal mass that had prolapsed and bled. The tumor was removed via resection. Histologically, the mass was diagnosed as poorly differentiated carcinoma and considered to be a metastatic lesion arising from the primary lung cancer.

[A case of postmenopausal breast cancer becoming HER2 positive after neoadjuvant hormone therapy].

A 75-year-old woman presented to a local doctor with a lump in the right breast. On physical examination, a tumor measuring 24mm was palpable in the BD area of her right breast. Mammography showed category 5 disease, and ultrasonography revealed a tumor measuring 24×16 mm. A mammotome biopsy provided a diagnosis of invasive ductal carcinoma of the breast(ER 7/PgR 4/HER2 1+), and the tumor was classified as stage IIA(T2N0M0)according to the UICC-TNM classification. She was recommended surgery but she rejected this option and underwent hormone therapy with anastrozole (1mg/day). One year and 8months after beginning the treatment, ultrasonography showed the tumor to measure 7.0×5.7 mm, and hormone therapy resulted in a partial response(PR). The patient hoped to undergo an operation, so she was referred to our hospital, and a right partial mastectomy and sentinel node biopsy was performed. A histopathological exami- nation indicated scirrhous carcinoma, 18mm, nuclear grade 1, f, ly1, v0, n0, ER 3/PgR 3/HER2 3+. The curative effect was grade 1a. The tumor had become HER2 positive, so the patient was then administered radiotherapy and trastuzumab and anastrozole as adjuvant therapy. Herein, we report our experience with a case of breast cancer that only became HER2 positive after hormone therapy, and also provide some bibliographic comments on this occurrence.

[Three patients with local recurrence of ER-positive breast cancer for whom anastrozole was clinically effective].

We treated three postmenopausal female patients with unresectable local recurrence from breast cancer. All pathological diagnoses of the local recurrence lesions were ER-positive breast cancer. For treatment, we administered anastrozole to these three patients. One has been stable disease for 25 months after taking anastrozole. Another has also showed stable disease for 18 months, and the last patient has been a partial response. We performed a biopsy from a recurring lesion on these three patients, and made a diagnosis of ER-positive breast cancer. This strategy of unresectable local recurrence revealed that these three patients could have had a stable condition for a long duration by taking anastrozole.

Phase II study on the combination of irinotecan plus cisplatin as a second-line therapy in patients with advanced or recurrent gastric cancer.

A pilot phase II study was conducted to evaluate the efficacy and safety of the combined administration of irinotecan (CPT-11) plus cisplatin (CDDP) as a second-line therapy for advanced or recurrent gastric cancer. Between November, 2006 and May, 2009, 18 patients were enrolled in this study. The patients were required to have received prior chemotherapy with S-1 (n=17), an orally administered 5-fluorouracil (5-FU) prodrug, or S-1 plus CDDP (n=1). CPT-11 and CDDP were administered at a dose of 60 and 30 mg/m2, respectively, on days 1 and 15 of a 4-week treatment cycle. The regimen was repeated until the occurrence of unacceptable toxicity, disease progression, or patient refusal. The primary endpoint of this study was the response rate (RR). In the second-line setting, 2 cases of complete response (CR), 1 of partial response (PR) and 7 of stable disease (SD) were identified. The RR was 16.7% and the disease control rate (DCR) was 55.6%. The median survival time (MST) and progression-free survival (PFS) was 282 and 111 days, respectively. As regards hematological toxicity, the major adverse effect during the second-line of chemotherapy was grade 3-4 leukopenia (22.2%). In addition, with regard to non-hematological toxicities, the major adverse effect during the second-line chemotherapy was grade 3-4 loss of appetite (11.1%). There was no mortality attributable to the adverse effects of the drugs. Findings of the present study suggested that CPT-11 and CDDP combination therapy in a second-line setting is an effective regimen in the treatment of advanced gastric cancer.

[Multiple hepatic metastases and ovarian metastases of colon cancer responding to combined therapy with S-1 and CPT-11--a case report].

We report a patient with multiple hepatic metastases and ovarian metastases of transverse colon cancer treated by combination of S-1 and CPT-11. The patient was a 51-year-old woman with cancer of the transverse colon and multiple hepatic metastases. She had undergone surgery. Resection of the transverse colon and left ovary was performed because left ovarian metastases were found during the operation. After the operation, the patient was given chemotherapy with S-1 (120 mg/body on days 1-14) and CPT-11 (150 mg/body on day 1). After completion of 11 courses of chemotherapy, abdominal CT scans revealed that the LDAs of the liver had disappeared, so the patient was judged to have achieved CR. No adverse event was observed. This case suggests that the combination of S-1 and CPT-11 may be an effective regimen for advanced colon cancer with multiple hepatic metastases.

[An institution-randomized trial of 5-fluorouracil and l-leucovorin therapy given monthly versus every two months to patients with advanced colorectal carcinoma].

The aim of this study was to evaluate the efficacy and toxicity of 5-fluorouracil (5-FU) and l-leucovorin (l-LV) given at the same dose intensity and administered monthly (given weekly for 3 weeks followed by a week of rest; arm A) or every 2 months (given weekly for 6 weeks followed by 2 weeks rest; arm B) to patients with advanced colorectal carcinoma. The dose of 5-FU was 500 mg/body or 750 mg/body, with an average dose of 432.8 mg/m2. A total of 7 institutions participated in this multi-center study and were randomly divided into 2 groups of arms A and B. Thirty-three patients were entered into arm A and 21 into B. The overall response rate was significantly (p = 0.007) greater in arm B (23.5%) than in arm A (0%). The most frequently observed toxicity was diarrhea, which was observed in 6.5% of arm A and in 33.3% of arm B, marking a significant difference (p = 0.034). These data suggest that a monthly 5-FU/l-LV regimen might be less toxic than a 2-months regimen and less effective at the dose given as above. Further study is needed to evaluate the efficacy of a monthly regimen.