Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404).

BACKGROUND: Previously, we conducted a randomized controlled trial (JCOG0404) for stage II/III colon cancer patients and reported that the long-term survival after open surgery (OP) and laparoscopic surgery (LAP) were almost identical; however, JCOG0404 suggested that survival of patients after LAP with tumors located in the rectosigmoid colon, cT4 or cN2 tumors, and high body mass index (BMI) might be unfavorable. AIM: To identify the patient subgroups associated with poor long-term survival in the LAP arm compared with the OP arm. METHODS: Patients aged 20-75, clinical T3 or deeper lesion without involvement of other organs, clinical N0-2 and M0 were included. The patients with pathological stage IV and R2 resection were excluded from the current analysis. In each subgroup, the hazard ratio for LAP (vs. OP) in overall survival (OS) from surgery was estimated using a multivariable Cox regression model adjusted for the clinical and pathological factors. RESULTS: In total, 1025 patients (OP, 511 and LAP, 514) were included in the current analysis. Adjusted hazards ratios for OS of patients with high BMI (>25 kg/m2), pT4, and pN2 in LAP were 3.37 (95% confidence interval [CI], 1.24-9.19), 1.33 (0.73-2.41), and 1.74 (0.76-3.97), respectively. In contrast, that of rectosigmoid colon tumors was 0.98 (0.46-2.09). CONCLUSIONS: Although LAP is an acceptable optional treatment for stage II/III colon cancer, the present subgroup analysis suggests that high BMI (>25 kg/m2), pT4, and pN2 except for RS were factors associated with unfavorable long-term outcomes of LAP in patients with colon cancer who underwent curative resection. (JCOG 0404: NCT00147134/UMIN-CTR: C000000105.).

[OPERATIONAL EXPERIENCE OF AUTOMATIC POSTING SYSTEM TO THE NATIONAL CLINICAL DATABASE USING FILEMAKER PRO].

We would like to introduce a semi-automated registration system for the National Clinical Database. Japan Surgery Society runs the National Clinical Database since January 2011. And automated registration system is long-awaited due to the number of cases and diverse items to register. Well-known database management system, FileMakerPro enabled collecting and registering the items to the web-site automatically. Still some items need to copy one by one, but after filling the data, all data would be input to the web page for registration. Merit for this automated system is increasing not only the efficiency of administration work but the quality and the usefulness of this database. This paper is to report the outline of the registration system to the NCD database.

Anatomical Resection of the Bile Duct: A Hidden Door to the Bile Duct.

BACKGROUND/AIMS: Pancreas-preserving resection of the bile duct has been attempted as an organ preserving procedures for the treatment of low-grade malignant neoplasms of the bile duct. The fact that the lower bile duct penetrates pancreas head to join the duodenum, makes those attempts one of the challenging procedures in biliary tract surgery. Here we present a novel and unique surgical technique for anatomically resecting lower bile duct, focusing on the anatomy of the pancreas head. METHODOLOGY: A patient with middle bile duct cancer underwent this procedure. Subsequent to Kocher's maneuver, pancreas head was dissected from the posterior side of the duodenum that was a key step to recognize the embryological fusion plane between the anterior and the posterior pancreatic segments. Along this fusion plane pancreas head was able to be divided and the covering pancreatic parenchyma was split open to expose the whole intrapancreatic bile duct. RESULTS: The patient had no signs of pancreatic fistula and post-operative course was uneventful. Negative surgical margins were obtained thanks to the presented technique. CONCLUSIONS: This procedure might be applicable for the treatment of bile duct neoplasms, in case of lesions spread to the lower bile duct. Otherwise that might require pancreatoduodenectomy.

Phase II trial of paclitaxel and cisplatin as neoadjuvant chemotherapy for locally advanced gastric cancer.

PURPOSE: Paclitaxel-cisplatin (TC) combination is effective and well tolerated in patients with unresectable gastric cancer. We investigated the efficacy and safety of TC for locally advanced gastric cancers in a neoadjuvant setting. METHODS: Patients received 2-4 courses of paclitaxel (80 mg/m(2)) and cisplatin (25 mg/m(2)) on days 1, 8, and 15 in a 4-weekly schedule, followed by radical gastrectomy. Primary endpoint was the pathological response rate: percentage of tumors in which one-third or more parts were affected. RESULTS: All 52 patients enrolled were eligible. Thirty-six (69.7 %) patients completed two or more courses of chemotherapy. Forty-three patients (82.7 %) underwent surgery, 33 (63.5 %) had R0 resection, and there was no treatment-related death. The pathological response was 34.6 % (95 % CI 22.0-49.1) for all registered patients; the null hypothesis of tumor response ≤10 % was rejected (p < 0.0001). The 3-year overall survival was 41.5 % (95 % CI 27.4-55.0). CONCLUSIONS: The neoadjuvant chemotherapy with TC was safe and effective for patients with locally advanced gastric cancer, and further study is needed to confirm the effectiveness of this regimen.

Combination chemotherapy with S-1 plus cisplatin for gastric cancer that recurs after adjuvant chemotherapy with S-1: multi-institutional retrospective analysis.

BACKGROUND: It is unclear whether S-1 plus cisplatin is effective for patients with recurrent gastric cancer after adjuvant S-1 chemotherapy. METHODS: We retrospectively evaluated the efficacy of S-1 plus cisplatin in patients whose gastric cancer recurred after adjuvant S-1 chemotherapy. RESULTS: In the 52 patients evaluated, the median duration of adjuvant S-1 chemotherapy was 8.1 months, and the median recurrence-free interval (RFI) since the last administration of adjuvant S-1 was 6.4 months. Among the 36 patients with measurable lesions, 7 achieved a complete or partial response, and 13 were evaluated as having stable disease, for an overall response rate of 19.4% and a disease control rate of 55.6%. For all patients, the median progression-free survival (PFS) was 4.8 months, and the median overall survival (OS) was 12.2 months. Compared with patients with an RFI of <6 months (n = 25), patients with an RFI of ≥6 months (n = 27) had a significantly higher response rate (5.0 vs. 37.5%, respectively), longer PFS (2.3 vs. 6.2 months, respectively), and longer overall survival (7.3 vs. 16.6 months, respectively). According to a multivariate Cox model including performance status (PS) and reason for discontinuation of adjuvant S-1, an RFI of 6 months was still significantly associated with PFS and OS. CONCLUSIONS: S-1 plus cisplatin is effective for patients with gastric cancer that recurs after adjuvant S-1 chemotherapy, especially for those with an RFI of ≥6 months.

A novel combined laparoscopic-endoscopic cooperative approach for duodenal lesions.

PURPOSE: A surgical approach with minimal invasion and excellent outcome for removal of duodenal lesions, using laparoscopic-endoscopic cooperative surgery (LECS), was established. PATIENTS AND METHODS: Two patients underwent the resection of duodenal lesions with our novel LECS approach. Case 1 (age: 49 years; male) had a 20-mm 0-IIa-like lesion (group IV tumor on biopsy) in the duodenal bulb. LECS interventions, performed under general anesthesia, employed a total of four trocars. The extent of lesions was determined with the endoscopic submucosal dissection (ESD) technique. The affected duodenal wall was then perforated before a one fifth turn resection was performed to expose lesions of the whole layer. A tumor, confirmed under laparoscopy, was turned over toward the abdominal cavity to facilitate resection. Case 2 (age: 49 years; female) had 20-mm 0-IIc lesions (group III adenoma) located at the second portion of the duodenum. LECS procedures for duodenal resection were performed in a manner similar to case 1 . A total of five trocars were used. RESULTS: Histologic diagnosis of the tumor in case 1 was tubular adenoma with moderate atypia (size: 20 x 12 mm). As for case 2, histopathologic findings confirmed a tubular adenoma with moderate atypia (size: 18 x 18 mm) and an adenoma-negative surgical margin. The postoperative courses, in both cases, were uneventful. CONCLUSIONS: Although only 2 cases were surgically intervened with limited experience, the present novel LECS approach allowed a reliable, adequate resection of tumors located in the duodenum, with abbreviated operation times (156-179 versus 202-229 minutes), minimal bleeding, less postoperative stress imposed on the surgeons, and an uneventful postoperative course, compared to conventional surgical methods.

[A case of complete response (CR) persisting for 3 years and 3 months from combination therapy of S-1 and CDDP in a patient with advanced gastric cancer with multiple liver metastases].

The case was a 70-year-old man with type-2 gastric cancer in the lesser curvature accompanied by multiple liver metastases. He received combination chemotherapy of S-1 and CDDP. S-1 was administered at 100 mg/body/day for 21 days followed by withdrawal for 14 days, and CDDP was prescribed at 80 mg/body/day div on day 8. After 3 courses of treatment, the multiple liver metastases disappeared. The primary gastric lesion had changed to a scar and endoscopic biopsy revealed no cancer cell. After the 4th course, we changed the therapy to S-1 alone and after that to UFT alone. Now, 3 years and 3 months after inducing CR, the patient continues to receive UFT with no regrowth of the tumor.

[A case of advanced gastric cancer responding to paclitaxel/CDDP neoadjuvant chemotherapy leading to pathologically complete response].

A 74-year-old male with advanced gastric cancer(cT3N1M0H0P0CY0, cStage III A)was treated with paclitaxel/ CDDP as neoadjuvant chemotherapy. Paclitaxel (80 mg/m(2)) and CDDP (25 mg/m(2)) were administered on days 1, 8 and 15 as one cycle. After the second course, a significant tumor reduction was obtained. Total gastrectomy, splenectomy, and D2 type nodal dissection were performed. The histological diagnosis revealed complete disappearance of cancer cells in the stomach and all of the lymph nodes, a so-called pathologically complete response. The patient has now been in good health without any recurrence for 9 months after surgery. This case suggests that neoadjuvant chemotherapy with paclitaxel/CDDP is a potential regimen for advanced gastric cancer.

[Weekly paclitaxel therapy for locoregional lymph node recurrence of estrogen-receptor-negative breast cancer].

We treated 7 patients with locoregional lymph node recurrence of estrogen-receptor-negative breast cancer with weekly paclitaxel (TXL) therapy. TXL was administered by 30-minute infusion at a dose of 80 mg/m2 after short premedication every week on an outpatient basis. Administration was continued for 3 weeks with a 1 week rest. Five patients had received prior anthracycline therapy. No patients had received prior therapy for recurrence. The median number of cycles was 4.9 cycles (range, 3-6 cycles). The overall response rate was 84% among 5 complete responders and 1 partial responder. Four of 5 complete responders relapsed after the completion of weekly TXL therapy. Grade 2 leukopenia occurred in 3 patients, and grade 1 peripheral neuropathy occurred in 1 patient. No patients had a serious side effect. Weekly TXL therapy is effective and well tolerated in patients with locoregional lymph node recurrence of estrogen-receptor-negative breast cancer, but the problem of recurrence to other sites after treatment remains to be solved.