Biomedical subjects

Toshimasa Tsujinaka

Publications and source records attributed to Toshimasa Tsujinaka.

At least 19 recordsLinked to original sources

PubMed2006

Influence of overweight on surgical complications for gastric cancer: results from a randomized control trial comparing D2 and extended para-aortic D3 lymphadenectomy (JCOG9501).

BACKGROUND: The impact of overweight on the outcome of gastrectomy with lymphadenectomy is controversial, and data from a well-controlled, randomized study are needed to identify a possible relationship. METHODS: We used data from 523 patients registered for a prospective randomized trial comparing D2 and extended para-aortic D3 lymphadenectomy to compare the effects of body mass index (BMI) and the extent of lymphadenectomy for the development of general or major surgical complications (anastomotic leakage, abdominal abscess, and pancreatic fistula). RESULTS: Seventy-seven patients were classified as overweight with BMI >or= 25, and 38 and 39 of these patients underwent a D2 or D3 lymphadenectomy, respectively. Among the 446 patients classified as nonoverweight with BMI < 25, 225 received D2 and 221 received D3 lymphadenectomy. Surgical complications, operation time, and blood loss were statistically significantly associated with BMI, and logistic regression analysis revealed that overweight directly affected the occurrence of surgical complications even after considering operation time and blood loss as intermediate factors instead of outcome variables. Among patients undergoing D2 lymphadenectomy, being overweight increased the risk for surgical complications and blood loss, whereas overweight was associated with only blood loss and operation time among patients receiving D3 lymphadenectomy. CONCLUSIONS: Overweight increased the risk of surgical complications in patients undergoing gastrectomy both directly and indirectly through operation time and blood loss. The impact of overweight on surgical complications was more evident in patients undergoing a D2 dissection.

Aged↗

PubMed2006

Phase II study of protracted irinotecan infusion and a low-dose cisplatin for metastatic gastric cancer.

AIM: To test protracted irinotecan infusion plus a low-dose cisplatin in this Phase II trial to decrease its toxicity. METHODS: The eligibility criteria were: (1) histologically proven measurable gastric cancer; (2) performance status of 0 or 1; (3) no prior chemotherapy or completion of prior therapy at least 4 wk before enrollment; (4) adequate function of major organs; (5) no other active malignancy; and (6) written informed consent. The regimen consisted of irinotecan (60 mg/m(2)) on d 1 and 15 by 24-h infusion and cisplatin (10 mg/m(2)) on d 1, 2, 3, 15, 16, and 17. Treatment was repeated every 4 wk. RESULTS: Thirty-one patients were registered between April 2000 and January 2001. The response rate for all 31 patients, 20 patients without prior chemotherapy, and 11 patients with prior chemotherapy was 52% (16/31), 60% (12/20), and 36% (4/11), respectively. The median survival time was 378 d. The median number of courses given to all patients was 2. Grade 4 neutropenia occurred in 11 (35%) patients, while grade 3 to 4 diarrhea or nausea occurred in 1 (3%) and 3 (10%) patients, respectively. Fatigue was minimal as grade 1 fatigue was found only in 3 (10%) patients. Other adverse events were mild and no treatment-related deaths occurred. CONCLUSION: This regimen showed a high level of activity and acceptable toxicity in patients with metastatic gastric cancer.

Adult↗

PubMed2006

Genetic polymorphisms of alcohol and aldehyde dehydrogenases, and drinking, smoking and diet in Japanese men with oral and pharyngeal squamous cell carcinoma.

The genetic polymorphisms of aldehyde dehydrogenase-2 (ALDH2), alcohol dehydrogenase-1B (ADH1B, previously called ADH2), and ADH1C (previously called ADH3) affect the metabolism of alcohol. The inactive ALDH2 encoded by ALDH2*1/*2 and the less-active ADH1B encoded by ADH1B*1/*1 increase the risk of esophageal squamous cell carcinoma in East Asian drinkers. This case-control study involved 96 Japanese men with oral and pharyngeal squamous cell carcinoma (hypopharyngeal cancer in 43 patients and oral/oropharyngeal cancer in 53) and 642 cancer-free Japanese men. The risk of the cancers overall and of hypopharyngeal cancer was increased 3.61- and 10.08-fold, respectively, by ALDH2*1/*2 among moderate-to-heavy drinkers (9+ units/week; one unit = 22 g of ethanol), but the risk of oral/oropharyngeal cancer was not significantly affected by the ALDH2 genotype. The results obtained with a simple alcohol flushing questionnaire were essentially comparable with those obtained by ALDH2 genotyping. Among moderate-to-heavy drinkers, men with the less-active ADH1B*1/*1 had a significantly higher risk of the cancers overall, of hypopharyngeal cancer, and of oral/oropharyngeal cancer (OR = 5.56, 7.21 and 4.24, respectively). In view of the linkage disequilibrium between ADH1B and ADH1C, the ADH1C genotype does not significantly affect cancer risk. The significant independent risk factors for oral and pharyngeal cancer overall among moderate-to-heavy drinkers were inactive ALDH2*1/*2, less-active ADH1B*1/*1, frequent drinking of strong alcohol beverages straight, smoking, and lower intake of green-yellow vegetables. Educating these risks for cancer of the upper aerodigestive tract could be a useful new strategic approach to the prevention of these cancers in Japanese.

Adult↗

PubMed2006

An icteric type hepatocellular carcinoma with no detectable tumor in the liver: report of a case.

A 70-year-old man was admitted to our hospital with obstructive jaundice. Computed tomography revealed a tumor in the left intrahepatic bile duct extending to the common bile duct without any significant lesions in the liver. Cholangiography showed a filling defect due to an intraductal tumor. Cytology of the bile juice was negative and tumor markers were carcinoembryonic antigen 5.7 ng/ml, carbohydrate antigen 19-9 49 U/ml, alpha-fetoprotein 9 ng/dl, and PIVKA-II 19 200 AU/ml. With a preoperative diagnosis of hilar bile duct carcinoma, a laparotomy was performed. The common bile duct was filled with a tumor and it extended into the bilateral intrahepatic bile ducts. The intraductal tumor was removed together with the extrahepatic bile ducts. An intraoperative histological examination of the tumor showed a well-differentiated hepatocellular carcinoma. No lesions were detected in the liver by ultrasonography, palpation during the operation, or a computed tomography scan after the operation. At 1 year postoperatively, no recurrence has been seen in this patient.

Aged↗

PubMed2006

Multicenter phase II study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer.

BACKGROUND: In Japan, antimicrobial prophylaxis (AMP) is typically administered for 3 to 4 days postoperatively for clean-contaminated operations such as distal gastrectomy. This far exceeds the recommended 2h or less laid out by the Centers for Disease Control (CDC) guidelines for the prevention of surgical-site infections (SSIs), after a clean-contaminated operation. METHODS: Patients with gastric cancer, which was curable by distal gastrectomy with D2 lymphandectomy, were assigned to a multicenter phase II study. One gram of cefazolin within 3 min of the first surgical incision and intraoperative supplements of g of cefazolin every h were administered. AMP was not administered after skin closure unless postoperative infection occurred. The occurrence of SSIs was monitored until postoperative day 30 as the primary endpoint of this study. RESULTS: In 56 patients, three SSIs (5.4%) and one remote site infection (1.8%) developed. No other postoperative infections were observed. CONCLUSION: Our data indicate that the CDC guidelines regarding AMP may also be sufficient for patients undergoing clean-contaminated operations in Japan.

Anti-Bacterial Agents↗

PubMed2006

Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer.

Our objective was to evaluate the efficacy and safety of capecitabine in chemotherapy-naive patients with unresectable advanced or metastatic gastric cancer. An open-label multicenter phase II study was conducted for previously untreated patients with advanced or metastatic gastric cancer. Oral capecitabine 828 mg/m2 twice daily was given on days 1-21 every 4 weeks. Baseline characteristics of 60 enrolled patients were: male/female 49/11, median age 64 years (range 28-74), good performance status (ECOG 0-1) in 98% of patients and 27 patients had prior gastrectomy (45%). A median of 4 treatment cycles were administered (range 1-37). Five patients were excluded from the efficacy analysis because they did not meet eligibility criteria. The overall response rate (RR) in the evaluable patient population (n=55) was 26% [95% confidence interval (95% CI) 15-39%] and a further 29% of patients had stable disease. The overall RR in the intent-to-treat population (n=60) was 23% (95% CI 13-36.0%). Median time to progression in the evaluable patient population was 3.4 months (95% CI 1.8-6.1) and overall survival time in the intent-to-treat population was 10.0 months (95% CI 6.4-13.6). The most frequent grade 3/4 drug-related adverse event was hand-foot syndrome (13%), but this was readily managed by treatment interruption and dose reduction. No patients developed grade 3/4 drug-related diarrhea, vomiting, leukopenia or thrombocytopenia. We conclude that this 4-week regimen of capecitabine showed promising activity and was well tolerated as first-line therapy for advanced/metastatic gastric cancer. Further investigation of this regimen is warranted.

Administration, Oral↗

PubMed2006

Esophageal squamous cell carcinoma and aldehyde dehydrogenase-2 genotypes in Japanese females.

BACKGROUND: Aldehyde dehydrogenase-2 (ALDH2) is the key enzyme for elimination of acetaldehyde, an established animal carcinogen produced after drinking. In persons with inactive ALDH2, the body fails to metabolize acetaldehyde rapidly, leading to excessive accumulation of acetaldehyde. Inactive heterozygous ALDH2 enhances the risk of esophageal squamous cell carcinoma (SCC) in Japanese male drinkers. METHODS: We studied whether this is the case for women. The risk factors of esophageal SCC were examined in 52 Japanese women with esophageal SCC and 412 cancer-free Japanese women. RESULTS: The increasing trend in cancer risk according to the quantity of alcohol consumption was significantly steeper in women with inactive heterozygous ALDH2 than in those with active ALDH2 [adjusted odds ratios (ORs) (95% confidence intervals (CIs)) per +7 U/wk increment of alcohol drinking were 3.91 (2.09-7.31) and 1.39 (0.92-2.09), respectively; p = 0.006 for difference in OR; 1 Ut = 22 g of ethanol]. The results obtained using an alcohol-flushing questionnaire were essentially comparable with those obtained by ALDH2 genotyping [adjusted ORs (95% CIs) per +7 U/wk increment of alcohol drinking were 3.94 (1.87-8.31) and 1.46 (0.96-2.23) in those with and without flushing, respectively; p = 0.021 for difference in OR]. The risk of esophageal cancer was markedly higher in heavy drinkers with ALDH2*1/*2 than in never/rare drinkers with ALDH2*1/*1 [adjusted OR (95% CI) = 59.1 (4.65-750)]. Other independent significant risk factors of esophageal SCC were smoking, a preference for hot food or drinks, and lower intake of green and yellow vegetables. CONCLUSIONS: Japanese men and women shared several common risk factors of esophageal SCC, including drinking with inactive heterozygous ALDH2.

Adult↗

PubMed2006

[FOLFOX].

In metastatic colorectal cancer, a combination of Leucovorin (LV) and fluorouraci (l FU) with oxaliplatin (FOLFOX) is a standard first-line regimen. The two limiting toxicities of FOLFOX are neutropenia and the specific reversible sensory neuropathy of oxaliplatin. The cumulative neurotoxicity often requires therapy to be stopped. Immediate hypersensitive reactions (anaphylaxis) have been noted as often as to 0.6 percent. We should pay sufficient attention to side effects of FOLFOX.

Anaphylaxis↗

PubMed2005

Phase I and pharmacokinetic study of S-1 combined with weekly paclitaxel in patients with advanced gastric cancer.

OBJECTIVE: A dose-escalation study of weekly paclitaxel combined with S-1, a novel oral fluoropyrimidine, was performed to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the dose-limiting toxicities (DLTs) in advanced gastric cancer. PATIENTS AND METHODS: Twelve patients were enrolled. S-1 was given orally at a fixed dosage of 40 mg/m(2) b.i.d. for 14 consecutive days, followed by a 1-week rest. Paclitaxel was scheduled to be given intravenously on days 1 and 8 at a dose of 50, 60, 70 or 80 mg/m(2), depending on the DLTs. Treatment was repeated every 3 weeks. A pharmacokinetic study was conducted in an additional 5 patients on days 7 and 8 during the first course given at the RD. RESULTS: The MTD of paclitaxel was presumed to be 60 mg/m(2), because 50.0% of patients (2/4) developed DLTs (mainly grade 3 anorexia). DLT was observed in 1 out of 8 patients at a dose of 50 mg/m(2). Therefore, the RD of paclitaxel was estimated to be 50 mg/m(2). The preliminary response rate was 62.5% (5/8) at the RD. There were no significant pharmacokinetic interactions between S-1 and paclitaxel. An adequate plasma paclitaxel concentration for an antineoplastic effect was achieved with weekly doses of 50 mg/m(2). CONCLUSION: Weekly paclitaxel combined with S-1 was demonstrated to exhibit a tolerable toxicity profile with therapeutic plasma concentration at the dose of 50 mg/m(2). This regimen could represent a novel and low toxic combination for advanced gastric cancer.

Administration, Oral↗

PubMed2005

Phase I study of S-1 combined with irinotecan (CPT-11) in patients with advanced gastric cancer (OGSG 0002).

OBJECTIVE: A dose-escalation study of irinotecan (CPT-11) combined with S-1, a novel oral fluoropyrimidine, was performed to determine the maximum-tolerated dose (MTD), recommended dose (RD) and dose-limiting toxicities (DLTs) in advanced gastric cancer. METHODS: S-1 was administered orally at 80 mg/m(2)/day for 21 consecutive days followed by a 2 week rest. CPT-11 was given intravenously on days 1 and 15 of each course, at an initial dose of 40 mg/m(2)/day, stepping up to 60, 80, 100 or 120 mg/m(2)/day depending on the DLT. Courses were repeated every 5 weeks, unless disease progression or severe toxicity was observed. At a level of the RD, five patients were added to conduct a pharmacokinetic (PK) study. RESULTS: A total of 24 patients were entered in this study. The MTD of CPT-11 was considered to be 100 mg/m(2), because 50% of the patients (3/6) developed DLTs, diarrhea and rash. Therefore, the RD of CPT-11 was set at the dose immediately below 80 mg/m(2). The overall response rate (RR) by the criteria of the Japanese Research Society of Gastric Cancer was 58.3% (14/24) and the RR at the RD was 66.7% (6/9), suggesting promising clinical efficacy. There were no significant differences between the PK parameters of S-1 on days 10 and 15. CONCLUSIONS: S-1 with CPT-11 can be combined safely without CPT-11 effect on S-1 PK data and holds promise as an effective regimen for advanced gastric cancer.

Adult↗

PubMed2005

Sequential treatment with irinotecan and doxifluridine: optimal dosing schedule in murine models and in a phase I study for metastatic colorectal cancer.

BACKGROUND: Irinotecan (CPT-11) and doxifluridine (5'-DFUR) are active agents against colorectal cancer. Each drug, however, has the possibility of causing diarrhea. METHODS AND RESULTS: First, we determined the optimal dosing regimen in murine models. CPT-11 (i.v., q2d x 3) and 5'-DFUR (p.o., qd x 14) were administered to mice bearing a human colorectal cancer xenograft model. Diarrhea was stronger in the simultaneously administered schedule but not much stronger in the sequentially administered schedule compared with monotherapies. Both schedules yielded similar antitumor efficacies. Next, we conducted a phase I study combining CPT-11 on days 1 and 15, and 5'-DFUR on days 3-14 and 17-28 every 5 weeks in 19 patients with metastatic colorectal cancer. The doses of CPT-11 ranged from 80 to 150 mg/m2 and those of 5'-DFUR from 800 to 1,200 mg. Diarrhea of grade 3/4 developed in only 1 patient at 100 mg/m2/800-mg doses. Dose-limiting toxicities were hyperbilirubinemia and skipping doses due to fatigue at 150 mg/m2/1,200-mg doses. CONCLUSION: For the phase II study, the recommended dose was set at CPT-11 150 mg/m2 and 5'-DFUR 800 mg.

Adult↗

PubMed2005

Patient-controlled dietary schedule improves clinical outcome after gastrectomy for gastric cancer.

Although studies have shown that early oral feeding after abdominal surgery is feasible, the optimal dietary schedule has not been established. This study was conducted prospectively to compare the clinical outcome of patient-controlled dietary schedule with that of conventional dietary schedule after gastric resection for early cancer. Patients in the patient-controlled diet (PC) group (n = 53) received a solid diet on demand; patients in the conventional regimen (CR) group (n = 50) received a solid diet from postoperative day (POD) 10. All patients underwent distal gastrectomy for early gastric cancer. A liquid diet was tolerated by the PC group on POD 2, and a solid diet was taken on POD 6 after gastrectomy, earlier than in the CR group. The postoperative hospital stay was 18.5 +/- 5.9 days (10-40) in the PC group, versus 21.7 +/- 8.8 days (14-57) in the CR group (p = 0.02). Patients in the PC group had a higher daily oral intake of calories on POD 10 than those in the CR group (p = 0.02). Changes in body weight and serum albumin during the postoperative period and after discharge, and the incidence of complications and variances from clinical pathways did not show significant differences between the two groups. The PC schedule was feasible after distal gastrectomy for early gastric cancer. It improved the clinical outcome, with a shorter postoperative hospital stay and a higher oral energy intake on early phase, compared with the CR schedule. Moreover, the PC approach was useful for establishing the optimal dietary schedule and improving the clinical pathway.

Adult↗

PubMed2005

Mean corpuscular volume, alcohol flushing, and the predicted risk of squamous cell carcinoma of the esophagus in cancer-free Japanese men.

BACKGROUND: Because some of the causes of increased mean corpuscular volume (MCV) and esophageal squamous cell carcinoma (ESCC), including alcoholism, acetaldehyde exposure, smoking, and poor nutrition are common to both, macrocytosis has been used as a predictor of early ESCC in Japanese alcoholics. We examined whether this was also true in the Japanese general population. METHODS: This study compared the MCV of 522 cancer-free Japanese men with his risk of ESCC as defined using drinking, smoking, dietary habits and aldehyde dehydrogenase-2 (ALDH2) genotype in a previous case-control study of ESCC involving them as control subjects. RESULTS: MCV was significantly correlated with ESCC risk predicted by drinking combined with ALDH2 genotype, smoking, or fruit intake. Men at higher risk of ESCC were more frequent in the groups with higher MCV (p < 0.0001 for trend). The replies to a questionnaire about facial flushing in response to alcohol showed that the trend was more prominent in men with current/former flushing, a surrogate marker for inactive ALDH2, than in men with no flushing (p < 0.0001). In comparison with the mean risk of men with MCV < or = 93 fl (lowest quartile), that of current/former flushing men with MCV > or = 99 fl (highest quartile) was 6.35-fold higher, whereas that of never-flushing men with MCV > or = 99 fl was 2.50-fold higher. The sensitivity and specificity of the combination of moderate-to-heavy drinking and either MCV > or = 99 fl or current/former flushing, either 30+ pack-years or MCV > or = 99 fl or either 30+ pack-years or current/former flushing for detection of high-risk persons ranking in the top 10%, was 85% and 84%, 94% and 76%, or 98% and 77%, respectively. CONCLUSIONS: MCV and alcohol flushing might be used to better select candidates to screen this high-mortality-rate cancer not only in alcoholics but also in nonalcoholic Japanese men.

Adult↗

PubMed2005

[Phase I study of the combination of nedaplatin (NED), adriamycin (ADM), and 5-fluorouracil (5-FU) (NAF) for treatment of unresectable advanced esophageal cancer].

BACKGROUND: Esophageal cancer has a poor prognosis. Several strategies including chemotherapy (CDDP+5-FU), either alone or with radiotherapy, have been used to improve the prognosis. However, since CDDP itself has substantial toxicities, including renal and gastrointestinal toxicities, newer platinum analogues, such as nedaplatin (NED) have been developed, and it is of interest to test this new platinum analogue in a combination chemotherapy. METHODS: We conducted a phase I-II study using a combination of NED (3 levels, 60-80 mg/m2 on day 1), ADM (30 mg/m2 on day 1), and 5 FU (700 mg/m2 on day 1-5) for treatment of previously untreated advanced esophageal squamous cell carcinoma. Cycles were repeated every 28 days. The objectives were to determine dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), recommended dose (RD) for a phase II study, and to determine antitumor effects. RESULTS: Phase I: 12 patients (pts) (male/female=11/1) were evaluable. The median age was 65 (range 46-74), PS 0/1=7/5. At level 1, 1 pt developed DLT (grade 4, neutropenia). At level 2, 2 pts developed DLT (grade 4 neutropenia and grade 3 diarrhea). Level 2 (70 mg/m2) was determined as the MTD, and a level 1 dose (60 mg/m2) was recommended. Phase II: 7 pts (male/female=4/3) are at RD of level 1 at the present time. Median age 62 (range 46-75). The median number of cycles on phase II study at RD was 2 (range 1-3). 4 PRs were obtained. The response rate was 57.1%. Median survival time (MST) was not reached at the time. CONCLUSIONS: This combination therapy appears to be highly effective and generally well tolerated for advanced esophageal cancer.

Aged↗

PubMed2005

[A case of unknown primary squamous cell carcinoma in the neck showing a high response with combined chemotherapy including nedaplatin, adriamycin and 5-fluorouracil].

We report a case of a 54-year-old man with unknown primary squamous cell carcinoma in the bilateral neck. The patient was treated with chemotherapy and radiation therapy, because his right common carotid artery was invaded by the right neck tumor, and a complete curative operation was not considered possible. We chose instead combination chemotherapy with nedaplatin, adriamycin and 5-fluorouracil (NAF), because it was reported that NAF was available for advanced squamous cell carcinoma of the esophagus. After 3 cycles of NAF chemotherapy, the patient showed a partial response of approximately an 86% decrease in the right neck tumor for over three months. In addition to NAF, radiation therapy was performed. In the CT findings after chemotherapy and radiation therapy, the patient showed a complete response in the bilateral neck tumors. Unknown primary squamous cell carcinoma in the neck has been treated by combination therapy consisting of chemotherapy, radiation therapy and surgery. The regime of 5-fluorouracil and cisplatin is said to be an effective treatment for unknown primary squamous cell carcinoma in the neck. Based on our experience, NAF would be available as chemotherapy for unknown primary squamous cell carcinomas in the neck.

Antibiotics, Antineoplastic↗

PubMed2005

[Clinical outcome of the use of self-expandable metallic stents (SEMS) for palliation of patients with malignant upper GI obstruction caused by incurable gastric cancer].

Ten patients with malignant upper gastrointestinal obstruction caused by incurable gastric cancer underwent an endoscopic placement of self-expandable metallic stents for palliation. There were 6 male and 4 female patients aged 39-98 (median, 65.5). The site of obstruction was the cardia in 2, the pylorus in 4, the duodenum in 1, and surgical anastomosis in 3 patients. All the patients were unable to take food orally. Stent deployment was technically successful in all patients. After the stent insertion, 80% of patients resumed solid diet. The median survival time after the insertion was 129 days. The median length of home stay after the procedure was 54.5 days. Although chemotherapy was added in 5 patients after the insertion, there were no significant differences either in survival time or in home stay between the patients with and without chemotherapy. No procedure-related mortality was observed. Mediastinitis occurred in 1 patient, and the remaining 9 patients had no serious complications. Stent migration was observed in 2 patients, and stent occlusion due to tumor ingrowth occurred in 4 patients.

Adult↗

PubMed2005

[A case of successful resection for recurrent intraductal papillary mucinous adenocarcinoma].

Intraductal papillary-mucinous neoplasms (IPMN) of the pancreas have recently been defined and classified by the World Health Organization. In addition, many cases of IPMN continue to be recognized frequently. We report a case of a 65-year-old female who underwent surgical resection of the pancreas twice within a period of 6 months for primary and recurrent IPMN. We first performed distal pancreatectomy with splenectomy for IPMN in the pacreatic body. A histopathological study revealed invasive adenocarcinoma and the negative margin of the pancreatic duct. A cystic mass in the uncinate process of the gland was identified by CT scan 6 months after the initial surgery. Complete pancreaticoduodenectomy was performed. Recurrent IPMN consisted of adenosquamous cell carcinoma. She currently is alive without evidence of disease at 3 years from the second resection. Recurrent disease in the residual pancreas suggests that a long-term surveillance is critical.

Adenocarcinoma, Mucinous↗

PubMed2005

[Assessment of goserelin treatment in adjuvant therapy for premenopausal patients with breast cancer in Japan-zoladex breast cancer study group trial-B].

OBJECTIVE: Goserelin (GOS) therapy in an adjuvant setting for estrogen receptor(ER)-positive premenopausal patients with breast cancer was assessed in a randomised comparative study. METHODS: ER positive premenopausal patients with n + or n 0 and T > or = 3 cm received tamoxifen (TAM) 20 mg/day, GOS 3.6 mg/4 weeks or GOS + TAM for 2 years, and the clinical efficacy and safety of these regimens were assessed. RESULTS: In the data analysis of total 207 patients, hazard ratios of disease free survival (DFS) and overall survival (OS) in the GOS group compared to the TAM group were 0.87 and 2.10,respectively. The incidence of adverse drug reactions was similar (42-55%) in all three groups. Since the number of patients in this study did not reach the target number, the efficacy could not be assessed from a statistical aspect. Therefore,meta-analysis with similar foreign studies(ZIPP) was implemented. The results of meta-analysis showed that the hazard ratios of DFS and OS in the GOS group compared to the non-GOS group were 0.83 and 0.85, respectively. CONCLUSION: Although the analysis of 207 patients did not show any statistically significant difference between each of the treatment groups, the results of meta-analysis showed a significant prolongation of DFS in the GOS group. Also high tolerability of GOS was suggested. From these results, GOS was considered highly useful in adjuvant therapy for ER-positive premenopausal patients with breast cancer.

Adult↗