Durvalumab after chemoradiotherapy in non-small cell lung cancer with EGFR mutation: A real-world study (HOT2101).

Durvalumab has been administered to patients with unresectable stage III non-small cell lung cancer (NSCLC). However, it remains unclear whether durvalumab benefits these patients with epidermal growth factor receptor (EGFR) mutation. We conducted a retrospective, multicenter study of patients with EGFR mutation who received chemoradiotherapy (CRT) between June 2018 and March 2021. We assessed patient characteristics, efficacy of durvalumab, and durvalumab safety before and after targeted therapy. We collected data on a total of 673 patients, of whom 401 (59.6%) underwent EGFR mutation testing. Fifty-one patients were EGFR positive and 311 were EGFR negative. In the EGFR-positive group, there were higher proportions of females, never-smokers, and patients with adenocarcinoma histology. Of the 51 patients in the positive group and 311 in the negative group who received CRT, 45 (88.2%) and 247 (79.4%) received durvalumab, with median progression-free survival of 23.0 and 24.2 months in the positive and negative groups, respectively (hazard ratio 1.03; 95% confidence interval: 0.64-1.67). The main adverse event was pneumonitis (positive group: 62.2%; 4.4% grade 3; negative group: 62.3%; 6.9% grade 3). No treatment-related deaths were observed. Of the 45 patients in the positive group who received durvalumab, 14 (31.1%) received targeted therapy after durvalumab at the data cutoff. One patient discontinued targeted therapy after developing pneumonitis. In patients with unresectable stage III NSCLC with EGFR mutation, durvalumab after CRT is potentially safe and effective. This may be a suitable treatment sequence for these patients.

Current status of first-line treatment with pembrolizumab for non-small-cell lung cancer with high PD-L1 expression.

It is not clear whether pembrolizumab monotherapy (MONO) or pembrolizumab plus platinum-based chemotherapy (COMB) should be selected for patients with advanced non-small-cell lung cancer (NSCLC) exhibiting high PD-L1 expression (tumor proportion score ≥ 50%). We performed a retrospective, multicenter study of 300 patients with NSCLC exhibiting high PD-L1 expression who received MONO or COMB as first-line treatment between December 2018 and January 2020. We reviewed the medical records of all consecutive patients with no driver mutations, and assessed the patient characteristics, therapeutic regimens, treatment periods, and adverse events. In total, 166 (55%; median age: 74 years) and 134 (45%; median age: 68 years) patients received MONO and COMB, respectively. Patients were younger and had better performance status (0-1) in the COMB group (p < 0.01). With a median follow-up time of 10.6 (range: 0.1-20.6) months, the median progression-free survival was 7.1 months with MONO and 13.1 months with COMB. The objective response rate was 42.2% with MONO and 67.9% with COMB. With respect to treatment discontinuation, 36 out of 166 (21.7%) and 28 out of 134 (20.1%) patients discontinued MONO and COMB, respectively. In conclusion, COMB may be a promising option for first-line treatment for NSCLC with high PD-L1 expression and good performance status.

Clinicopathological features and outcomes in patients with late recurrence of renal cell carcinoma after radical surgery.

OBJECTIVES: To characterize patients experiencing late recurrence after primary radical surgery for renal cell carcinoma and to approach the mechanism of late recurrence. METHODS: We retrospectively analyzed 657 consecutive patients who underwent radical surgery for pathologically confirmed ≤stage III renal cell carcinoma in a single institution between January 1981 and December 2008. Early or late recurrence was defined as a recurrence occurring before or after 60 months after primary surgery. RESULTS: Of 657 patients, 96 (14.6%) experienced early recurrence, and 41 (6.2%) developed late recurrence. Patients with late recurrence had smaller diameter of primary tumor (median 5 cm vs 8 cm, P < 0.001), lower pathological stage (P < 0.001) and lower nuclear grade (P = 0.004) at primary surgery than those with early recurrence. On multivariate analysis, vascular invasion (including microscopic and gross invasion) was the predictor of late recurrence (P < 0.01, HR 3.79). Overall survival and disease-specific survival after recurrence were longer in patients with late recurrence (median 64 and 76 months, respectively) than in those with early recurrence (34.5 and 35 months, respectively; P = 0.008 and 0.002). CONCLUSIONS: These results suggest that micrometastasis at the time of surgery associated with vascular invasion at primary tumor site and their relatively lower malignant potential could lead to late recurrence. Further studies are warranted for better understanding and managing late recurrence of renal cell carcinoma.

Effect of preoperative chemotherapy on survival of patients with upper urinary tract urothelial carcinoma clinically involving regional lymph nodes.

OBJECTIVES: To determine the effect of preoperative chemotherapy on survival in patients with upper urinary tract urothelial carcinoma clinically involving regional lymph nodes. METHODS: We retrospectively analyzed 55 consecutive patients who received radical nephroureterectomy with or without preoperative chemotherapy for upper urinary tract urothelial carcinoma clinically involving regional lymph nodes at a single institution between January 1991 and December 2013. RESULTS: Median follow up was 18 months (range 2-193). Of 55 patients, 24 (43.6%) received preoperative chemotherapy (study group) and 31 (56.4%) underwent primary surgery (control group). Preoperative chemotherapy consisted of two to four cycles (median 3) of cisplatin-containing regimens. The fraction of patients with lower pathological T stage and N stage than clinical T stage and N stage was higher in the study group (29.2% and 54.2%) compared with the control group (3.2% and 16.1%; P = 0.013 and 0.010, respectively). The 5-year overall survival rate was significantly higher in the study group than in the control group (44.0% vs 12.9%, log-rank, P = 0.003). In multivariate analysis incorporating age at diagnosis, Eastern Cooperative Oncology Group Performance Status, clinical N stage and the number of removed lymph nodes, preoperative chemotherapy was a predictor of better overall survival (P = 0.047, HR 0.47, 95% CI 0.22-0.99). CONCLUSIONS: Preoperative chemotherapy might provide better survival outcomes in patients with upper urinary tract urothelial carcinoma clinically involving regional lymph nodes.

Extensive-Disease Small-Cell Lung Cancer With Severe Immune-Related Adverse Events Due to Atezolizumab Maintaining a Complete Response for Two Years: A Case Report.

A 75-year-old male with diabetes mellitus was referred to our hospital with an abnormal shadow on chest radiography, based on which he was diagnosed with extensive-disease small-cell lung cancer (ED-SCLC; cT2bN2M1a). The first-line therapy comprised atezolizumab, carboplatin, and etoposide. After four cycles, the patient achieved complete response (CR), and maintenance therapy was initiated with atezolizumab. However, even though CR was maintained, maintenance therapy was discontinued after 16 cycles due to persistent grade 2 anorexia and fatigue. Simultaneously, the HbA1c decreased to 5.5%, and antidiabetic therapy was discontinued. Six months after the last dose of atezolizumab, the patient visited the emergency room because of anorexia, dry mouth, and fatigue. Laboratory findings were as follows: blood glucose was 668 mg/dL, glycated hemoglobin (HbA1c) was 8.8%, urine ketone was 2+, sodium (Na) was 127 mmol/L, potassium (K) was 6.5 mmol/L, creatinine (Cre) was 1.43 mg/dL, and arterial pH was 7.29. Based on these findings, his presentation was consistent with fulminant type 1 diabetes mellitus (T1DM) complicated by diabetic ketoacidosis (DKA). Regular continuous insulin and saline administration was initiated in the intensive care unit, and acidosis and electrolyte abnormalities were corrected. His C-peptide was <0.03 ng/mL. His insulin secretory capacity was considered to be depleted, and he required continuous subcutaneous insulin injections. Glutamic acid decarboxylase and insulin autoantibodies were absent. The complete response persisted without further therapy until two years since the event.

Real-world first-line treatment with pembrolizumab for non-small cell lung carcinoma with high PD-L1 expression: Updated analysis.

BACKGROUND: Selecting pembrolizumab monotherapy (MONO) or pembrolizumab plus platinum-based chemotherapy (COMB) for patients with nonsmall cell lung cancer (NSCLC) and high programmed death-ligand 1 (PD-L1) expression is an important issue in clinical practice. We previously conducted a retrospective multicenter observational study of patients with NSCLC and high PD-L1 expression who received MONO or COMB as a first-line treatment. Here, we report updated data and evaluate the long-term outcomes. METHODS: We performed a retrospective multicenter study of 298 patients with NSCLC and high PD-L1 expression who received MONO or COMB as first-line treatment between December 2018 and January 2020. We reviewed the medical records and assessed the clinical efficacy and toxicity using a prolonged data cutoff. RESULTS: In total, 164 (median age: 74 years) and 134 (median age: 68 years) patients received MONO and COMB, respectively; patients who received COMB were younger and had better performance statuses (0-1). At the prolonged data cutoff, the median follow-up was 20.2 (range: 0.1-41.4) months. The median progression-free survivals were 7.5 and 13.1 months, and overall survivals (OSs) were 17.2 and 33.7 months for MONO and COMB, respectively. Treatment discontinuation rates were 21.9% and 20.1% for the MONO and COMB, respectively. With prolonged follow-up, although COMB demonstrated an OS benefit and higher objective response rate than MONO, in the propensity score matching analysis COMB didn't demonstrate a significant benefit compared to the MONO. CONCLUSIONS: COMB may be effective as a first-line treatment for NSCLC with high PD-L1 expression in a selected subset of patients.

The RENAL nephrometry score and the PADUA classification for the prediction of perioperative outcomes in patients receiving nephron-sparing surgery: feasible tools to predict intraoperative conversion to nephrectomy.

OBJECTIVE: To evaluate the potential of the RENAL nephrometry score and the PADUA classification in the prediction of perioperative outcomes represented by intraoperative conversion to nephrectomy in patients with renal tumors for which nephron-sparing surgery (NSS) was attempted. METHODS: Recent 100 open NSSs attempted for cT1 renal tumors at a single institution were studied retrospectively. RESULTS: With the RENAL, the operation time and ischemia time were longer in the high complexity group (p = 0.01 and p = 0.03, respectively), and blood loss was seemingly greater in this group (394 vs. 220 and 167 ml, p = 0.09). Conversion to nephrectomy was more frequent in the high complexity (4 procedures, 33.3%) than in the low (0%) and moderate (1 procedures, 1.5%) groups (p < 0.01). Regarding the PADUA, the operation time, blood loss and ischemia time increased according to the complexity (p = 0.04, p = 0.02, and p = 0.02, respectively). Conversion to nephrectomy was more frequent in the high complexity (4 procedures, 22.2%) than in the low (0%) and moderate (1 procedure, 1.8%) groups (p < 0.01). In patients with achieved NSS, postoperative estimated glomerular filtration rate was more impaired in the high complexity group in the PADUA (p = 0.02), although not significant in the RENAL (p = 0.11). CONCLUSIONS: Both the RENAL and PADUA are useful in the prediction of conversion to nephrectomy in addition to NSS-associated perioperative outcomes.

Pseudo-outbreak of Mycobacterium lentiflavum at a general hospital in Japan.

BACKGROUND: Mycobacterium lentiflavum is a slow-growing nontuberculous mycobacterium that is widely distributed in soil and water systems, but it is sometimes pathogenic to humans. Although cases of M. lentiflavum infections are rare, 22 isolates of M. lentiflavum were identified at a single hospital in Japan. We suspected a nosocomial outbreak; thus, we conducted transmission pattern and genotype analyses. METHODS: Cases of M. lentiflavum isolated at Kushiro City General Hospital in Japan between May 2020 and April 2021 were analyzed. The patient samples and environmental culture specimens underwent whole-genome sequencing (WGS). Additionally, we retrospectively collected clinical data from patient medical records. RESULTS: Altogether, 22 isolates of M. lentiflavum were identified from sputum and bronchoalveolar lavage samples. Clinically, the instances with M. lentiflavum isolates were considered contaminants. In the WGS analysis, 19 specimens, including 18 patient samples and 1 environmental culture from the hospital's faucet, showed genetic similarity. The frequency of M. lentiflavum isolation decreased after we prohibited the use of taps where M. lentiflavum was isolated. CONCLUSIONS: WGS analysis identified that the cause of M. lentiflavum pseudo-outbreak was the water used for patient examinations, including bronchoscopy.

External validation of the UCSF-CAPRA (University of California, San Francisco, Cancer of the Prostate Risk Assessment) in Japanese patients receiving radical prostatectomy.

OBJECTIVE: In 2005, the University of California, San Francisco developed the Cancer of the Prostate Risk Assessment (UCSF-CAPRA) score as a new risk stratification tool. The UCSF-CAPRA, which ranges from 0 to 10 points, consists of five clinical variables, prostate-specific antigen, Gleason score, T stage, percent of positive biopsies and age. The aim of this study was to validate the UCSF-CAPRA score for Japanese prostate cancer patients receiving radical prostatectomy using the contemporary Gleason grading. METHODS: From 1999 to 2010, 211 men who underwent radical prostatectomy were used for validation. Biochemical progression-free survival was calculated using the Kaplan-Meier method and the UCSF-CAPRA and D'Amico risk categories were compared using the log-rank method. The concordance index (c-index) for the UCSF-CAPRA and D'Amico risk classification was calculated. RESULTS: Using the UCSF-CAPRA score, 85 (40.3%), 106 (50.2%) and 20 (9.5%) subjects were stratified as 0-2 points (low risk), 3-5 points (intermediate risk) and 6-10 points (high risk). Using the D'Amico risk criteria, 66 (31.3%), 89 (42.2%) and 56 (26.5%) were stratified as low-, intermediate- and high-risk groups, respectively. The Kaplan-Meier analysis showed that the UCSF-CAPRA divided the patients significantly into each risk category. There was no significant difference between low and intermediate in the D'Amico risk classification. The c-index of the UCSF-CAPRA and D'Amico classification was 0.755 and 0.713, respectively. CONCLUSION: The UCSF-CAPRA is an acceptable risk category tool comparable to that of the D'Amico risk classification for Japanese prostate cancer patients receiving radical prostatectomy in the contemporary Gleason grading era.

Primary solitary fibrous tumor (SFT) in the retroperitoneum.

BACKGROUND: Solitary fibrous tumor (SFT) is an infrequent but distinct neoplasm, which generally arises from submesothelial connective tissue in the pleura. SFT is rarely recognized in extrathoracic sites, and histologically identical conditions have also been reported in the retroperitoneum, although their pathophysiology has not been extensively investigated. METHODS: We present four cases of primary SFT in the retroperitoneum, and review 37 similar cases in the previous literature. RESULTS: About 40% of patients were asymptomatic, and 19.2% and 15.4% presented with an abdominal mass and urinary symptoms, respectively. The tumor size ranged between 2 and 26 (mean 9.1) cm. Sixty-three percent of tumors showed nonspecific development with haphazard distribution of bland short spindle or polygonal cells with or without collagenous bundles and stromal hyalinization. In 22.0%, hemangiopericytomatous appearance was seen. About 15% of cases showed histologically malignant characteristics. The tumor cells were immunoreactive for vimentin in all cases, CD34 in 91% and Bcl-2 in 86%. All tumors were excised, and in 85.4% of cases, tumors did not recur postoperatively for 6 to 48 months. No significant difference was found between the recurrence rate of histologically benign and malignant cases. Cases positive for both CD34 and Bcl-2 had no recurrence. CONCLUSIONS: The identification of SFT in the retroperitoneum is of importance because histopathological indicators of malignancy are not necessarily associated with clinical malignant potential in many cases of retroperitoneal SFT. Retroperitoneal SFT showing typical pathological features with expression of CD34 and Bcl-2 is associated with a favorable outcome following excision.

Perioperative antibiotics in radical cystectomy with ileal conduit urinary diversion: efficacy and risk of antimicrobial prophylaxis on the operation day alone.

OBJECTIVE: To determine the optimum schedule for perioperative antimicrobial prophylaxis (AMP) for bladder cancer patients submitted to radical cystectomy with ileal conduit urinary diversion. METHODS: We studied 77 consecutive bladder cancer patients who underwent radical cystectomy with ileal conduit. The 1-day group (n = 33) received pre-, intra- and postoperative administrations of 2 g of piperacillin on the operation day alone; the 3-day group (n = 44) received antibiotics for 3 days or more (same schedule as the 1-day group on the operation day and every 12 h thereafter). The study was designed and postoperative complications including surgical-site infection (SSI) were defined according to the modified Centers for Disease Control and Prevention criteria. RESULTS: No significant differences were found between the 1-day group and 3-day group in terms of total SSI (18.1% vs 20.5%), superficial incisional SSI (12.1% vs 13.6%), deep incisional SSI (12.1% vs 13.6%), space SSI (12.1% vs 11.4%), postoperative ileus (18.2% vs 11.4%), febrile urinary tract infections (15.2% vs 15.9%) or pneumonia (3.0% vs 4.3%), respectively. In both groups, disease stage and patients' underlying conditions such as diabetes did not have an influence on the incidence of postoperative complications. CONCLUSION: One-day AMP had equivalent efficacy to that of the standard prophylaxis protocol for preventing septic complications following radical cystectomy with ileal conduit. This finding supports the hypothesis that delivery of antibiotics on the operation day is critical in this setting.

A new ENG mutation in a Japanese family with hereditary hemorrhagic telangiectasia and pulmonary arteriovenous malformations.

We present a case series of four siblings with hereditary hemorrhagic telangiectasia (HHT) and pulmonary arteriovenous malformations (PAVM). The patients' mother has HHT. Case 1: A 22-year-old man developed dyspnea and epistaxis. CT revealed a large PAVM, treated by segmentectomy. Case 2: A 27-year-old woman developed epistaxis and dyspnea. CT revealed three PAVMs, treated by partial resection. Case 3: A 20-year-old woman developed dyspnea. CT revealed multiple PAVMs, treated with endovascular occlusion of the largest one. Case 4: A 12-year-old woman developed epistaxis. CT revealed multiple PAVMs, observed without treatment. Genetic testing identified a new mutation, ENG c.1517T>C (p.Leu506Pro), in all patients and their mother. We suspect that HHT in these patients may be associated with this ENG mutation.

Occult Thyroid Follicular Carcinoma Diagnosed as Metastasis to the Chest Wall.

Chest wall tumors are relatively rare, and hematogenous metastasis to the chest wall is very rare. We herein describe a rare case of occult thyroid carcinoma as metastasis to the chest wall in an 80-year-old woman. The patient received detailed examinations of the chest wall tumor, and the results suggested that she had occult thyroid carcinoma. Surgery was then performed to remove all of her thyroid. As a result, she was diagnosed with follicular carcinoma of the thyroid. We report an extremely rare case of occult thyroid carcinoma diagnosed as hematogenous metastasis to the chest wall.

Total and free prostate-specific antigen indexes in prostate cancer screening: value and limitation for Japanese populations.

AIM: To assess the efficacy and limitation of free/total prostate-specific antigen ratio (f/tPSA) at a single institution in Japan, focusing on the avoidance of pointless prostate biopsies. METHODS: In total, 631 men between 44 and 93 years old (mean 69.8 years) with elevated PSA underwent power-Doppler ultrasoundgraphy-guided transrectal 10-core prostate biopsies at Niigata Cancer Center Hospital, and their histological features were investigated with total PSA (tPSA) and f/tPSA. RESULTS: PCa was detected in 126 of 134 patients (94.3%) with tPSA of 26 ng/mL or higher. The detection rate was 59.4% for tPSA of 21-25 ng/mL, followed by 39.2% for 16-20 ng/mL, 30.0% for 11-15 ng/mL, 20.0% for 4.1-10 ng/mL and 7.6% for = or <4.0 ng/mL. f/tPSA of the PCa group was significantly lower than that of non-malignamt disorders in any tPSA ranges (mean 0.122 vs. 0.160, P<0.001). Receiver-operating characteristics analyses showed that f/tPSA (AUC:0.664) performed more valuably than tPSA (AUC:0.559) in patients with tPSA between 3.0-10 ng/mL (P<0.01). Although f/tPSA of 0.250 for the cut-off value might miss 1.8% PCa patients, it potentially spares 9.2% of unnecessary biopsies. CONCLUSION: f/tPSA is more valuable compared with tPSA alone for the prediction of the occurrence of PCa. We recommend 0.250 as the cut-off value for f/tPSA in PCa screening for Asian men having so-called grey-zone tPSA.

Outcomes of locally advanced prostate cancer: a single institution study of 209 patients in Japan.

AIM: To investigate the outcomes for Asian populations with locally advanced/clinical stage III prostate cancer (PCa) treated with currently prevailing modalities. METHODS: We reviewed the record of 209 patients with clinical stage III PCa, who were treated at Niigata Cancer Center Hospital between 1992 and 2003. Treatment options included hormone therapy-combined radical prostatectomy (RP+HT), hormone therapy-combined external beam irradiation (EBRT+HT) and primary hormone therapy (PHT). RESULTS: The 5- and 10-year overall survival rates were 80.3% and 46.1% in all cohorts, respectively. The survival rates were 87.3% and 66.5% in the RP+HT group, 94.9% and 70.0% in the EBRT+HT group and 66.1% and 17.2% in the PHT group, respectively. A significant survival advantage was found in the EBRT+HT group compared with that in the PHT group (P < 0.0001). Also, the RP+HT group had better survival than the PHT group (P = 0.0107). The 5- and 10-year disease-specific survival rates for all cases were 92.5% and 80.0%, respectively. They were 93.8% and 71.4% in the RP+HT group, 96.6% and 93.6% in the EBRT+HT group and 88.6% and 62.3% in the PHT group, respectively. A survival advantage was found in the EBRT+HT group compared with the PHT group (P = 0.029). No significant difference was found in disease-specific survival between the EBRT+HT and RP+HT groups or between the RP+HT and PHT groups. CONCLUSION: Although our findings indicate that radiotherapy plus HT has a survival advantage in this stage of PCa, we recommend therapies that take into account the patients'social and medical conditions for Asian men with clinical stage III PCa.

[Significance of re-measurement of prostate specific antigen before prostate biopsy].

To examine the natural change of prostate-specific antigen (PSA), we compared two PSA values, the first value with which we decided to perform prostate biopsy and the value obtained by remeasurement just before biopsy. To exclude cases with extremely high PSA, we examined 288 cases in which PSA was less than 50 ng/ml for comparison. Of the 288 cases, 93 were diagnosed with prostate cancer (CaP). The interval between the two PSA measurements was 1-90 days (average of 31.4 days). The first and second values were an average of 13.0 and 11.7 ng/ml, respectively, and the second value was significantly lower than the first value. When we divided them into CaP cases and non-CaPthe two cases, a significant difference between PSA values was found only in the non-CaP cases. Moreover, in the non-CaP cases with some clinical symptoms, the difference in PSA was marked between the first and second values, which averaged 11.2 and 9.2 ng/ml, respectively. When we decide to perform a biopsy, we should recognize that PSA sometimes is lower on re-measurement. Particularly in symptomatic cases, it is worth re-measuring PSA, which may save unnecessary biopsies.

[Prognosis of prostate cancer with elevated prostatic acid phosphatase].

To evaluate the significance of prostatic acid phosphatase (PAP), we analyzed 1,029 prostate cancer patients who were treated at the Niigata Cancer Center. We classified clinically localized prostate cancer with elevated PAP as stage DO. When stage DO was not taken into acount, the 5-year cause-specific survival rate for stage A, B, C and D was 94.7, 97.9, 87.7 and 42.4%, respectively. Taking stage DO into account, the cause-specific survival curve for stage DO patients was similar to those for stage B,C patients. The 5-year cause-specific survival rate for stage DO was 92.2% considering above 3 ng/ml as elevated PAP. A significant correlation was found between PAP and cause-specific survival for all cases but no correlation was found for non-metastatic disease patients. The significance of PAP in the staging of prostate cancer is limited.

[Clinical analysis of 1,000 patients with prostate cancer].

OBJECTIVES: Treatment outcomes for prostate cancer in our hospital were reported. MATERIALS AND METHODS: We analyzed 1,009 patients with prostate cancer treated at Niigata Cancer Hospital between 1983 and 2003. RESULTS: As for the clinical stage, 20 cases belonged to Stage I, 367 cases to Stage II, 269 cases to Stage III and 353 cases to Stage IV. The overall 5-year survival rate of the all 1,009 cases was 59.0%, comprising 78.2% for stage I, 82.0% for Stage II, 76.0% for Stage III and 30.0% for Stage IV cases. Disease-specific 5-year survival rates for Stage I, II, III and IV were 100%, 96.8%, 89.3% and 41.1% respectively. In Stage III patients, the radiotherapy (with endocrine therapy) group showed longer cause-specific survival than the endocrine therapy group (p = 0.0056). CONCLUSIONS: Our result suggest that the radiotherapy with endocrine therapy is useful for Stage III prostate cancer.

[Chemo-endocrine therapy for newly diagnosed stage D2 prostate cancer].

We evaluated 175 patients with newly diagnosed stage D2 prostate cancer who had been treated in our hospital between 1992 and 2003 to compare chemo-endocrine therapy with endocrine therapy alone. One hundred and thirty seven patients were treated with endocrine therapy alone. The other 38 patients received chemo-endocrine therapy, which included medical or surgical castration with/without antiandrogen plus VIP (Vincristine, Ifosfamide, Peplomycin) regimen or other cytotoxic agents. The patients treated with chemo-endocrine therapy had a significantly better prognosis than the patients treated with endocrine therapy alone (p<0.05), although treatment was not randomized. The cause-specific survival rates at 5 years for the chemo-endocrine therapy group and the endocrine therapy group were 61.6% and 34.8%, respectively. These data suggest that chemo-endocrine therapy is a potentially effective treatment for newly diagnosed stage D2 prostate cancer.