Objective To evaluate the safety and efficacy of dosage-escalated sorafenib in pa-tients with metastatic renal cell carcinoma. Methods Twelve male patients and 4 female patients with median age of 53 (37-71 years) were included in this study. They were with refractory meta-static renal-clear-cell carcinoma and received sorafenib from 800 mg/d to 1200mg/d or 1800 mg/d gradually until intolerable or disease progression occurred. Overall response rate, toxicity and progres-sion free survival (PFS) were recorded and analyzed. Results The median follow-up was 11 months (9-16 months). The overall rate of objective response and disease control rate were 44%(7/16)and 81%(13/16), respectively. Serious adverse effects (≥Grade Ⅲ) included hand-foot skin reaction (25%, 4/16), mucositis (19%, 3/16), diarrhea (19%, 3/16), hypertension (12%, 2/16) and my-elosuppression (12%, 2/16). PFS for high risk patient was 9.2 months at the end of this study. Conclusions The dosage-escalated sorafenib could obtain a high response rate and prolong PFS of high-risk patients. The toxicities are tolerable for metastatic renal cell carcinoma patients treated with sorafenib.

Objective To evaluate the safety and efficacy of sorafenib as first line treatment in patients with metastatic renal cell carcinoma. Methods Eleven patients with metastatic renal cell carcinoma after radical nephrectomy and 1 patient with locally advanced renal cell carcinoma and unre-sectable primary renal tumor were eligible for this study. The regimen was oral intake of sorafenib (400 mg twice daily) until the disease progression or toxicity becoming intolerable. Results All pa-tients were evaluable for response and toxicity assessment. The overall objective response rate and dis-ease control rate were 25%(3/12) and 83%(10/12, 3 partial responses and 7 disease stabilizations). The actuarial 6-month progression-free survival was 83% (10/12), while the median survival time was 16 months. The most common adverse effects included hand-foot skin reaction, rash, alopecia and hy-pertension. Conclusion Sorafenib is effective and safe as first line treatment for patients with meta-static renal cell carcinoma.

Objective:To examine metastatic gastric cancer patients who underwent surgery after chemotherapy and to determine the factors affecting survival. Methods:Clinical data on metastatic gastric cancer patients who underwent surgery after chemotherapy were retrospectively analyzed. The overall survival data were evaluated through the Kaplan-Meier method, Log-rank test, and Cox haz-ards regression. Results:The median age was 46 (22~74), and the median overall survival rate (OS) was 19 months (4~59 months). Response to chemotherapy (23.0 m for PR and 14.5 m for SD, P=0.045) and resection of the primary tumor (23.0 and 5.5 m, respective-ly, P=0.017) affected OS. No single factor was related to OS according to Cox regression. Conclusion:Surgical removal of the primary tumor is recommended for metastatic gastric cancer patients with positive response to chemotherapy and with a primary tumor that can be resected.

Objective To evaluate the safety and efficacy of sorafenib for patients with advanced stage renal cell carcinoma.Methods The clinical data of 85 patients with advanced renal cell carcinoma were reviewed.These patients were treated by sorafenib 400 mg Bid,dose escalation of sorafenib(400 mg Bid 1-4 weeks;600 mg Bid 5-8 weeks;800 mg Bid since then) or sorafenib 400 mg Bid+NF-α,respectively,until intolerance or disease progression occurred.The primary end points were objective response,disease control rate and adverse effects rate.Results The data of 80 patients can be evaluated.The median follow-up duration was 72 weeks (4-108 weeks).One patient (1.2%) reached complete remission(CR),17 cases(21.2%) reached partial remission(PR),50 cases (62.5%) maintained stable disease (SD),and 12 cases (15%) progressed.The objective response (CR+PR) was 22.5%,disease control rate (CR+PR-SD)was 85.0%.By May 2009,only 18 patients died,progression free survival and overall survival were not available.The common side effects included hand-foot skin reaction (55.0%),mucosa hemorrhage (52.5%),diarrhea(40.0%),lassitude (35.0%),anorexia(22.5%),mucosa ulcer(20.0%),hypertension(15.0%) and baldness(15.0%)etc.Most of these side effects could be released by symptomatic treatment.Conclusion Sorafenib has good short term effect for patients with advanced renal cell carcinoma and is well tolerated.

Objective To evaluate the efficacy and safety of sorafenib in the treatment of Chi-nese patients with metastatic renal cell carcinoma. Methods This muhicenter phase Ⅱ clinical trial was performed from May 2006 to December 2006. Sixty-two patients with metastatic renal cell carci-noma not suitable for curative treatment were enrolled. All patients received oral sorafenib as single a-gent at the dose of 400 mg twice a day until disease progression or intolerable toxicities occurred. Re-salts Partial responses were recorded as best response in 11 patients, while complete remission was found in 1 patient and stable diseases were found in another 35 patients. According to the intents-to-treatment population, the overall response rate was 19.4% (12/62), and the disease control rate was 77.4%(48/62). The median progression free survival time was 9.6 months with 1-year progression-free survival rate of 41.9%. However, the median survival time had not reached due to the short fol-low-up. The most frequent adverse events included alopecia (66.1%), diarrhea (62.9%), hand-foot syndrome (58.1%), anorexia (40.3%), rash(37.1%), fatigue (37.1%), hypertension (35.5%), hoarseness(32.3%), joint pain (25.8%), hypophosphatemia (21.0%), fever (19.4%), nausea (19.4%), abnormal transeaminase( 11.3% ), elevated total bilirubicin( 16.1% ), leucopenia( 12.9% ), bleeding under nail(16.1%), and gum bleeding(11.3%). Grade 3 adverse events included hand-foot syndrome (16.1%), hypertension (12.9%), diarrhea(6.5%), hypophosphatemia (4.8%), joint pain (3.2%), and leucopenia(3.2%). Conclusions Sorafenib has prominent anti-tumor activity in Chi-nese metastatic renal cell cancer patients with most adverse events being grade 1 or 2. More attention should be paid to hypertension and cardio-cerebral vascular events during the application of sorafenib.

Objective:This study aims to determine the efficacy of chemotherapy and to identify potential chemotherapy agents for advanced primary duodenal carcinoma (PDC). Methods:Fifty-six patients with advanced PDC, who did and did not receive chemo-therapy, were involved in this study. Response rates (RR), disease control rates (DCR), progression-free survival (PFS), and overall sur-vival (OS) were analyzed. Results:The overall RR and DCR of 43 patients were 19.04%and 71.42%, respectively. The patients who re-ceived chemotherapy agents fluorourzcil and oxaliplatin exhibited higher RR compared with patients who received other chemotherapy combinations (35.29%vs. 7.69%, P=0.010 9). Palliative chemotherapy improved the OS of patients with advanced PDC compared with patients who did not receive chemotherapy (13.35 months vs. 5.65 months, HR=0.203, 95%CI:0.083 to 0.497, P=0.000 5). Compared with the use of other chemotherapy regimens, treatment with a fluorourzcil-based chemotherapy agent resulted in a longer PFS (5.08 months vs. 1.08 months, HR=0.004, 95%CI:0.000 to 0.315, P=0.013 2). Multivariate analysis indicated mucinous histology and lymph mode metastasis as factors predictive of poor prognosis in patients with advanced PDC. Conclusion:Palliative chemotherapy may im-prove the OS of patients with advanced PDC.

Objective To investigate the effect of tumor deposits (TD) on the prognosis of patients with stage III colon cancer, and to explore whether TD number included into regional lymph node count can predict the prognosis more accurately. Methods A retrospective cohort study was carried out. Case inclusion criteria: (1) primary colon cancer; (2) undergoing colon cancer radical operation; (3) definite pathological diagnosis; (4) colon cancer stage III according to AJCC 8th edition; (5) complete follow?up data; (6) without preoperative neoadjuvant treatment. Clinicopathological data of 296 patients undergoing colon cancer radical operation from January 2005 to December 2008 in the Cancer Hospital of Chinese Academy of Medical Sciences were retrospectively collected. The effect of TD and its amount on the prognosis was evaluated. Colon cancer TNM staging method based on the 8th edition of AJCC was compared with the modified TNM staging (mTNM) adjusted by the number of TD. The differences of the disease?free survival (DFS) and overall survival (OS) between groups were also examined. The Kaplan?Meier curve was used to analyze the survival, and prognostic factors were analyzed by Cox univariate and multivariate analyses. Results Among 296 patients with stage III colon cancer, 78 patients had TD. The median number of TD was 2 (1?10). Tumor T stage, N stage, vascular tumor thrombus and preoperative carcinoembryonic antigen (CEA) were associated with TD in patients with colon cancer (all P<0.05). The right hemicolon appears likely to have TD than left hemicolon, but the difference was not statistically significant (P=0.059). The median follow?up of the whole group was 71 (6?102) months. During the follow?up period, 129 patients (43.6%) had recurrence or metastasis, and 111 patients died (37.5%). The 5?year DFS in TD group was 44.9%, which was lower than that in the non?TD group (60.6%), with statistically significant difference (P=0.003). The 5?year OS in TD group was 50.0%, which was also lower than 67.0% in the non?TD group, and the difference was statistically significant (P=0.002). According to TD number, patients were divided into 3 groups: 1 TD (25 cases), 2?3 TD (32 cases), ≥4 TD (21 cases). The 5?year DFS in these 3 groups was 68%, 56.3%, and 0, respectively (P<0.001), and 5?year OS was 76%, 59.4%, and 4.8% respectively (P<0.001). Univariate analysis showed that TD presence (95% CI: 1.234?2.694, P=0.003) and TD number (95% CI: 3.531?14.138, P<0.001) were associated with the prognosis of patients with stage III colon cancer. At the same time, age, tumor N stage, tumor location, chemotherapy, and preoperative CEA elevation were also associated with the prognosis of stage III colon cancer patients (all P<0.05). Multivariate analysis revealed that TD presence (HR=1.957, 95 %CI: 1.269?3.017, P=0.002) and TD number (HR=8.020, 95% CI: 3.414?18.842, P<0.001) were still independent risk factors for the prognosis of patients with stage III colon cancer.According to the TD number counted as metastatic lymph nodes, in 78 patients with TD, 24 patients were upstaged in N stage, and 16 patients upstaged from TNM stage IIIB to stage IIIC. For 16 stage IIIB cases with staging modification, 30 unadjusted stage IIIB cases with TD, and 148 stage IIIB cases without TD, the 5?year OS was 37.5%, 73.3% and 76.4%, respectively with significant difference (P<0.001). However, for 16 patients adjusted as stage IIIC (mTNM), 32 patients with unchanged stage IIIC with TD (TNM, AJCC 8th edition), and 63 stage IIIC cases without TD, the 5?year OS was 37.5%, 36.4%, and 41.3%, respectively without significant difference (P=0.707). Conclusions TD presence and TD number are independent risk factors for prognosis of stage III colon cancerpatients. TNM staging evaluation with lymph node number including TD number can predict the prognosis of patients more accurately.

Objective To investigate the effect of tumor deposits (TD) on the prognosis of patients with stage III colon cancer, and to explore whether TD number included into regional lymph node count can predict the prognosis more accurately. Methods A retrospective cohort study was carried out. Case inclusion criteria: (1) primary colon cancer; (2) undergoing colon cancer radical operation; (3) definite pathological diagnosis; (4) colon cancer stage III according to AJCC 8th edition; (5) complete follow?up data; (6) without preoperative neoadjuvant treatment. Clinicopathological data of 296 patients undergoing colon cancer radical operation from January 2005 to December 2008 in the Cancer Hospital of Chinese Academy of Medical Sciences were retrospectively collected. The effect of TD and its amount on the prognosis was evaluated. Colon cancer TNM staging method based on the 8th edition of AJCC was compared with the modified TNM staging (mTNM) adjusted by the number of TD. The differences of the disease?free survival (DFS) and overall survival (OS) between groups were also examined. The Kaplan?Meier curve was used to analyze the survival, and prognostic factors were analyzed by Cox univariate and multivariate analyses. Results Among 296 patients with stage III colon cancer, 78 patients had TD. The median number of TD was 2 (1?10). Tumor T stage, N stage, vascular tumor thrombus and preoperative carcinoembryonic antigen (CEA) were associated with TD in patients with colon cancer (all P<0.05). The right hemicolon appears likely to have TD than left hemicolon, but the difference was not statistically significant (P=0.059). The median follow?up of the whole group was 71 (6?102) months. During the follow?up period, 129 patients (43.6%) had recurrence or metastasis, and 111 patients died (37.5%). The 5?year DFS in TD group was 44.9%, which was lower than that in the non?TD group (60.6%), with statistically significant difference (P=0.003). The 5?year OS in TD group was 50.0%, which was also lower than 67.0% in the non?TD group, and the difference was statistically significant (P=0.002). According to TD number, patients were divided into 3 groups: 1 TD (25 cases), 2?3 TD (32 cases), ≥4 TD (21 cases). The 5?year DFS in these 3 groups was 68%, 56.3%, and 0, respectively (P<0.001), and 5?year OS was 76%, 59.4%, and 4.8% respectively (P<0.001). Univariate analysis showed that TD presence (95% CI: 1.234?2.694, P=0.003) and TD number (95% CI: 3.531?14.138, P<0.001) were associated with the prognosis of patients with stage III colon cancer. At the same time, age, tumor N stage, tumor location, chemotherapy, and preoperative CEA elevation were also associated with the prognosis of stage III colon cancer patients (all P<0.05). Multivariate analysis revealed that TD presence (HR=1.957, 95 %CI: 1.269?3.017, P=0.002) and TD number (HR=8.020, 95% CI: 3.414?18.842, P<0.001) were still independent risk factors for the prognosis of patients with stage III colon cancer.According to the TD number counted as metastatic lymph nodes, in 78 patients with TD, 24 patients were upstaged in N stage, and 16 patients upstaged from TNM stage IIIB to stage IIIC. For 16 stage IIIB cases with staging modification, 30 unadjusted stage IIIB cases with TD, and 148 stage IIIB cases without TD, the 5?year OS was 37.5%, 73.3% and 76.4%, respectively with significant difference (P<0.001). However, for 16 patients adjusted as stage IIIC (mTNM), 32 patients with unchanged stage IIIC with TD (TNM, AJCC 8th edition), and 63 stage IIIC cases without TD, the 5?year OS was 37.5%, 36.4%, and 41.3%, respectively without significant difference (P=0.707). Conclusions TD presence and TD number are independent risk factors for prognosis of stage III colon cancerpatients. TNM staging evaluation with lymph node number including TD number can predict the prognosis of patients more accurately.

OBJECTIVETo evaluate the efficacy of combined modality treatment and determine the prognostic factors for small cell lung cancer (SCLC).

METHODSFrom January 1974 to December 1995, 1260 patients with SCLC treated were retrospectively evaluated, with limited lesions in 732 patients, extensive lesions in 500 and stage unrecorded in 28. 553 patients were alloted into chemotherapy + radiotherapy (C + R) group, 355 into C + R + C group, 97 into R + C group, 126 into C group, 64 into R group and 65 into surgery (S + C + R) group. Patients with limited lesions received 2 - 4 cycles of chemotherapy including COMC, COMP, COMVP and CE-CAP. Radiotherapy was given to a dose of 40 - 70 Gy/4 - 7 w. Radiation portals for patients with limited lesions encompassed the primary tumor, hilar lymphatic drainage areas, partial mediastinum and bilateral supraclavicular regions. Patients with extensive lesions mainly received chemotherapy with or without palliative irradiation.

RESULTSThe overall CR and PR rates were 26.7% and 52.3%. Local recurrence and distant metastasis rates were 58.8% and 61.5%. The 1-, 3- and 5-year survival rates were 50.2%, 14.7% and 11.7%, with median survival time of 12 months. The era, sex, age, tumor stage and treatment modality were all significant prognostic factors by both uni-variate and multi-variate analyses (P < 0.05). The result of S + C + R rated the best among these modalities and the result of C + R + C was superior to C + R, though the difference of which was not significant.

CONCLUSIONSurgical resection should be considered as one part of comprehensive therapy for small cell lung cancer patients with limited lesions whenever possible. On top of routine chemotherapy early administration of radiotherapy is advisable.

Adult ; Antineoplastic Combined Chemotherapy Protocols ; Carcinoma, Small Cell ; mortality ; therapy ; Combined Modality Therapy ; Female ; Humans ; Lung Neoplasms ; mortality ; therapy ; Male ; Middle Aged ; Radiotherapy ; Survival Rate ; Treatment Outcome

OBJECTIVETo analyze the characteristics of recurrence in gastric cancer patients after radical gastrectomy and adjuvant chemotherapy.

METHODSThe clinicopathological data of 110 gastric cancer patients who developed recurrence or second primary malignancies after radical gastrectomy and adjuvant chemotherapy with FOLFOX4 regimen or docetaxel plus FOLFOX4 regimen were analyzed retrospectively.

RESULTSThe median time to recurrence was 13.9 months (range, 1.7 to 63.1 months), and the median overall survival was 27.4 months (range, 6.9 to 90.7 months) in the whole group. The median survival time after recurrence was 10.1 months (range, 0.3 to 73.9 months). 82 (74.5%) patients had recurrence within 2 years after gastrectomy. The modes of surgical procedure and lymph node dissection influenced significantly on the time to recurrence (P<0.05 for both). Among the 110 patients with recurrence, 46 (41.8%) patients had peritoneal metastases, 33 (30.0%) had hematogenous metastases and 32 (29.1%) had locoregional lymph node metastases. Single, double, triple and quatro recurrences were observed at the first time of relapse in 78 (70.9%), 21(19.1%), 9(8.2%) and 2 cases (1.8%), respectively. Patients who developed simultaneous quatro recurrence had the poorest prognosis with a median overall survival of 15.2 months, significantly shorter than that of patients with single recurrence (31.8 months, P=0.003). Patients with peritoneal recurrence died most quickly ( mean 5.6 months), and patients with surgical field recurrence alone survived longest (mean 17.1 months).

CONCLUSIONSPeritoneal, hematogenous and locoregional lymph node metastases are the most frequent recurrences after radical gastrectomy and adjuvant chemotherapy in patients with gastric cancer. Single recurrence occurred in most patients at the first relapse. Combination with other adjuvant treatments should be considered besides adjuvant chemotherapy in gastric cancer patients after radical gastrectomy.

Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; therapeutic use ; Chemotherapy, Adjuvant ; Fluorouracil ; administration & dosage ; Gastrectomy ; methods ; Humans ; Leucovorin ; administration & dosage ; Lymph Node Excision ; Lymphatic Metastasis ; Neoplasm Recurrence, Local ; mortality ; Neoplasms, Second Primary ; Organoplatinum Compounds ; administration & dosage ; Prognosis ; Retrospective Studies ; Stomach Neoplasms ; mortality ; therapy ; Taxoids ; administration & dosage ; Time Factors