34 results on '"Predictive factors"'
Search Results
2. Occult lymph node metastasis is not a favorable factor for resected NSCLC patients
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Jing-Sheng Cai, Fan Yang, and Xun Wang
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Non-small cell lung cancer ,Occult lymph node metastasis ,Survivals ,Predictive factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background This study was to compare the clinical presentations and survivals between the non-small cell lung cancer (NSCLC) patients with occult lymph node metastasis (OLNM) and those with evident lymph node metastasis (ELNM). We also intended to analyze the predictive factors for OLNM. Methods Kaplan–Meier method with log-rank test was used to compare survivals between groups. Propensity score matching (PSM) was used to reduce bias. The least absolute shrinkage and selection operator (LASSO)-penalized Cox multivariable analysis was used to identify the prognostic factors. Random forest was used to determine the predictive factors for OLNM. Results A total of 2,067 eligible cases (N0: 1,497 cases; occult N1: 165 cases; evident N1: 54 cases; occult N2: 243 cases; evident N2: 108 cases) were included. The rate of OLNM was 21.4%. Patients with OLNM were tend to be female, non-smoker, adenocarcinoma and had smaller-sized tumors when compared with the patients with ELNM. Survival curves showed that the survivals of the patients with OLNM were similar to those of the patients with ELNM both before and after PSM. Multivariable Cox analysis suggested that positive lymph nodes (PLN) was the only prognostic factor for the patients with OLNM. Random forest showed that clinical tumor size was an important predictive factor for OLNM. Conclusions OLNM was not rare. OLNM was not a favorable sign for resected NSCLC patients with lymph node metastasis. PLN determined the survivals of the patients with OLNM. Clinical tumor size was a strong predictive factor for OLNM.
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- 2023
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3. A novel PEGylated form of granulocyte colony-stimulating factor, mecapegfilgrastim, for peripheral blood stem cell mobilization in patients with hematologic malignancies
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Jingjing Wen, Qiaolin Zhou, Lin Shi, Fang Xu, Yiping Liu, Jing Su, Ya Zhang, Wen Qu, and Jing Yue
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Pegylated granulocyte-colony stimulating factor ,Mecapegfilgrastim ,Hematologic malignancies ,Hematopoietic stem cell mobilization ,Lymphocyte count ,Predictive factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background The Pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) has longer half-life and is given once only, which is more comfortable for patients. We aimed to evaluate the efficacy of mecapegfilgrastim for hematopoietic stem cell (HSC) mobilization in patients with hematologic malignancies and to explore the potential factors related to HSC mobilization. Methods A retrospective analysis was performed on patients who underwent HSC mobilization in the hematology department of Mianyang Central Hospital from April 2016 to November 2022. The number of CD34 + cells collected was compared between the patients receiving mecapegfilgrastim (PEG group) and those receiving recombinant human granulocyte colony-stimulating factor (rhG-CSF group), and the possible factors for mobilization failure were analyzed. Results The success rates of collecting CD34 + cells in the PEG group and rhG-CSF group were 80.6% and 67.7%, respectively (χ = 1.444, P = 0.229). The median CD34 + cell counts were 3.62 × 10^6/kg and 2.92 × 10^6/kg (P = 0.178), respectively. After combination with plerixafor for mobilization, the median number of CD34 + cells collected in the PEG group and rhG-CSF group were 3.64 × 10^6/kg and 3.92 × 10^6/kg, respectively, with no significant difference (P = 0.754). There was no significant difference in hematopoietic cell recovery or infection between the groups (P > 0.05). Multivariate analysis showed that more than 5 cycles of chemotherapy (OR = 15.897, 95% CI: 1.766-143.127, P = 0.014), a precollection WBC count
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- 2023
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4. Risk factors for postoperative recurrence in patients with stage II colorectal cancer
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Zhi-Zhong Xiong, Ming-Hao Xie, Xian-Zhe Li, Long-Yang Jin, Feng-Xiang Zhang, Shi Yin, Hua-Xian Chen, and Lei Lian
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Colorectal cancer ,Predictive factors ,Recurrence ,Stage II ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Recurrences are the main reasons for unfavorable outcomes for patients with stage II colorectal cancer (CRC). To obtain a clear understanding of the high-risk factors, further investigation is warranted. The present study aimed to analyze the risk factors associated with postoperative recurrence in patients with stage II CRC. Methods Eligible patients with pathologically confirmed stage II CRC were enrolled in the study retrospectively based on a prospectively maintained database from April 2008 to March 2019. The Kaplan–Meier method were used to calculate the overall survival (OS) rate and the cumulative recurrence rate. Univariate and multivariable Cox regression analyses were performed to identify risk factors for recurrence. Results There were 2515 patients included, of whom 233 (9.3%) developed local or distant recurrence. Recurrence was associated with a significantly worse 5-year OS (45.4% vs. 95.5%, p < 0.0001). The 5-year cumulative recurrence rate was 13.0% in patients with stage II CRC. On multivariable Cox analysis, tumor size (Hazard Ratio (HR) [95% confidence interval (CI)] = 1.79[1.38, 2.33]), preoperative carbohydrate antigen (CA) 125 level (HR [95% CI] = 1.78[1.17, 2.70]), preoperative CA 199 level (HR [95% CI] = 1.56[1.09, 2.22]), and ulcerating tumor (HR [95% CI] = 1.61[1.19, 2.17]) were found to be associated with postoperative recurrence. Adjuvant chemotherapy was associated with a lower cumulative recurrence rate in patients with these risk factors (p = 0.00096). Conclusion The tumor diameter, preoperative CA125 level, preoperative CA199 level, and an ulcerative tumor can predict postoperative recurrence in patients with stage II CRC, and postoperative chemotherapy could reduce the cumulative recurrence rate in patients with these high-risk factors.
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- 2023
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5. Identification of characteristics predictive of long-term survival with durvalumab or durvalumab plus tremelimumab in metastatic urothelial carcinoma.
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Alt, Marie, Stecca, Carlos, Lin, Yian, Kazeem, Gbenga, Goluboff, Erik T., and Sridhar, Srikala S.
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TRANSITIONAL cell carcinoma , *LYMPHOCYTE count , *IMMUNE checkpoint inhibitors , *NEUTROPHIL lymphocyte ratio , *LACTATE dehydrogenase , *METASTASIS - Abstract
Background: This retrospective analysis of data from clinical trials in metastatic urothelial carcinoma (mUC) was conducted to determine baseline patient characteristics associated with long-term survival (LTS) following treatment with immune checkpoint inhibitors. Methods: Data for this analysis were from patients with platinum-refractory mUC who received durvalumab or durvalumab plus tremelimumab in phase 1/2 studies. The primary outcome measure was LTS. Patients were categorised as overall survival (OS) ≥ 2 years (from first dose) or OS < 2 years. A univariable analysis assessed independent associations with LTS and multivariable logistic regression was employed including each variable with P ≤ 0.05 as covariates. Results: Among 360 patients, 88 (24.4%) had OS ≥ 2 years and 272 (75.6%) had OS < 2 years. In univariable analysis, several baseline characteristics and laboratory measurements were associated with LTS including sex, ECOG PS, PD-L1 expression, prior surgery, time from initial diagnosis, lymph node-only involvement, visceral disease, haemoglobin level, absolute neutrophil count, neutrophil–lymphocyte ratio and lactate dehydrogenase level. In multivariable analysis, LTS was significantly associated with ECOG PS, PD-L1 expression, haemoglobin level and absolute neutrophil count. Conclusions: Several baseline clinical characteristics and laboratory measurements were associated with LTS for patients with platinum-refractory mUC treated with durvalumab or durvalumab plus tremelimumab. [ABSTRACT FROM AUTHOR]
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- 2023
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6. Occult lymph node metastasis is not a favorable factor for resected NSCLC patients.
- Author
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Cai, Jing-Sheng, Yang, Fan, and Wang, Xun
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LYMPHATIC metastasis , *NON-small-cell lung carcinoma , *OCCULTISM , *PROPENSITY score matching , *RANDOM forest algorithms - Abstract
Background: This study was to compare the clinical presentations and survivals between the non-small cell lung cancer (NSCLC) patients with occult lymph node metastasis (OLNM) and those with evident lymph node metastasis (ELNM). We also intended to analyze the predictive factors for OLNM. Methods: Kaplan–Meier method with log-rank test was used to compare survivals between groups. Propensity score matching (PSM) was used to reduce bias. The least absolute shrinkage and selection operator (LASSO)-penalized Cox multivariable analysis was used to identify the prognostic factors. Random forest was used to determine the predictive factors for OLNM. Results: A total of 2,067 eligible cases (N0: 1,497 cases; occult N1: 165 cases; evident N1: 54 cases; occult N2: 243 cases; evident N2: 108 cases) were included. The rate of OLNM was 21.4%. Patients with OLNM were tend to be female, non-smoker, adenocarcinoma and had smaller-sized tumors when compared with the patients with ELNM. Survival curves showed that the survivals of the patients with OLNM were similar to those of the patients with ELNM both before and after PSM. Multivariable Cox analysis suggested that positive lymph nodes (PLN) was the only prognostic factor for the patients with OLNM. Random forest showed that clinical tumor size was an important predictive factor for OLNM. Conclusions: OLNM was not rare. OLNM was not a favorable sign for resected NSCLC patients with lymph node metastasis. PLN determined the survivals of the patients with OLNM. Clinical tumor size was a strong predictive factor for OLNM. [ABSTRACT FROM AUTHOR]
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- 2023
- Full Text
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7. A novel PEGylated form of granulocyte colony-stimulating factor, mecapegfilgrastim, for peripheral blood stem cell mobilization in patients with hematologic malignancies.
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Wen, Jingjing, Zhou, Qiaolin, Shi, Lin, Xu, Fang, Liu, Yiping, Su, Jing, Zhang, Ya, Qu, Wen, and Yue, Jing
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GRANULOCYTE-colony stimulating factor , *HEMATOLOGIC malignancies , *LYMPHOCYTE count , *BLOOD cells , *STEM cells , *STEM cell transplantation , *HEMATOPOIETIC stem cells - Abstract
Background: The Pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) has longer half-life and is given once only, which is more comfortable for patients. We aimed to evaluate the efficacy of mecapegfilgrastim for hematopoietic stem cell (HSC) mobilization in patients with hematologic malignancies and to explore the potential factors related to HSC mobilization. Methods: A retrospective analysis was performed on patients who underwent HSC mobilization in the hematology department of Mianyang Central Hospital from April 2016 to November 2022. The number of CD34 + cells collected was compared between the patients receiving mecapegfilgrastim (PEG group) and those receiving recombinant human granulocyte colony-stimulating factor (rhG-CSF group), and the possible factors for mobilization failure were analyzed. Results: The success rates of collecting CD34 + cells in the PEG group and rhG-CSF group were 80.6% and 67.7%, respectively (χ = 1.444, P = 0.229). The median CD34 + cell counts were 3.62 × 10^6/kg and 2.92 × 10^6/kg (P = 0.178), respectively. After combination with plerixafor for mobilization, the median number of CD34 + cells collected in the PEG group and rhG-CSF group were 3.64 × 10^6/kg and 3.92 × 10^6/kg, respectively, with no significant difference (P = 0.754). There was no significant difference in hematopoietic cell recovery or infection between the groups (P > 0.05). Multivariate analysis showed that more than 5 cycles of chemotherapy (OR = 15.897, 95% CI: 1.766-143.127, P = 0.014), a precollection WBC count < 32 × 10^9/L (OR = 14.441, 95% CI: 2.180-95.657, P = 0.006) and a precollection to premobilization lymphocyte ratio < 1.7 (OR = 11.388, 95% CI: 2.129–60.915, P = 0.004) were independent risk factors for HSC mobilization failure. Conclusions: The HSC mobilization efficacy of mecapegfilgrastim in patients with hematologic malignancies was comparable to that of rhG-CSF, and combination with plerixafor for mobilization was feasible and effective. Patients with more than 5 cycles of chemotherapy before HSC mobilization, a precollection WBC count lower than 32 × 10^9/L, and a precollection lymphocyte count less than 1.7 times the premobilization lymphocyte count have a high probability of HSC mobilization failure. [ABSTRACT FROM AUTHOR]
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- 2023
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8. Risk factors for postoperative recurrence in patients with stage II colorectal cancer.
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Xiong, Zhi-Zhong, Xie, Ming-Hao, Li, Xian-Zhe, Jin, Long-Yang, Zhang, Feng-Xiang, Yin, Shi, Chen, Hua-Xian, and Lian, Lei
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PREOPERATIVE risk factors , *DISEASE relapse , *COLORECTAL cancer , *DISEASE risk factors , *CA 125 test , *ADJUVANT chemotherapy , *CANCER relapse , *HEREDITARY nonpolyposis colorectal cancer - Abstract
Background: Recurrences are the main reasons for unfavorable outcomes for patients with stage II colorectal cancer (CRC). To obtain a clear understanding of the high-risk factors, further investigation is warranted. The present study aimed to analyze the risk factors associated with postoperative recurrence in patients with stage II CRC. Methods: Eligible patients with pathologically confirmed stage II CRC were enrolled in the study retrospectively based on a prospectively maintained database from April 2008 to March 2019. The Kaplan–Meier method were used to calculate the overall survival (OS) rate and the cumulative recurrence rate. Univariate and multivariable Cox regression analyses were performed to identify risk factors for recurrence. Results: There were 2515 patients included, of whom 233 (9.3%) developed local or distant recurrence. Recurrence was associated with a significantly worse 5-year OS (45.4% vs. 95.5%, p < 0.0001). The 5-year cumulative recurrence rate was 13.0% in patients with stage II CRC. On multivariable Cox analysis, tumor size (Hazard Ratio (HR) [95% confidence interval (CI)] = 1.79[1.38, 2.33]), preoperative carbohydrate antigen (CA) 125 level (HR [95% CI] = 1.78[1.17, 2.70]), preoperative CA 199 level (HR [95% CI] = 1.56[1.09, 2.22]), and ulcerating tumor (HR [95% CI] = 1.61[1.19, 2.17]) were found to be associated with postoperative recurrence. Adjuvant chemotherapy was associated with a lower cumulative recurrence rate in patients with these risk factors (p = 0.00096). Conclusion: The tumor diameter, preoperative CA125 level, preoperative CA199 level, and an ulcerative tumor can predict postoperative recurrence in patients with stage II CRC, and postoperative chemotherapy could reduce the cumulative recurrence rate in patients with these high-risk factors. [ABSTRACT FROM AUTHOR]
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- 2023
- Full Text
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9. Role of autophagy-related protein in the prognosis of combined hepatocellular carcinoma and cholangiocarcinoma after surgical resection
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Daw-Shyong Perng, Chao-Ming Hung, Hung-Yu Lin, Paul Morgan, Yao-Chun Hsu, Tsung-Chin Wu, Pei-Min Hsieh, Jen-Hao Yeh, Pojen Hsiao, Chih-Yuan Lee, Yu-Chan Li, Ya-Chin Wang, Yaw-Sen Chen, and Chih-Wen Lin
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Combined hepatocellular carcinoma and cholangiocarcinoma ,Autophagy ,LC3 ,Prognosis ,Predictive factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Autophagy-related proteins may predict postresection overall survival (OS) and disease-free survival (DFS) in patients with combined hepatocellular carcinoma and cholangiocarcinoma (cHCC-CC). Methods We prospectively investigated how these proteins affect clinical prognosis in 40 patients who underwent hepatectomy for cHCC-CC from 2011 to 2019 at a Taiwanese hospital. Levels of autophagy-related proteins, namely LC3, Beclin-1, and p62, were immunohistochemically assessed in patient tumor and non-tumor tissues. Results We noted that LC3 expression was significantly correlated with mild clinicopathological characteristics, including macrovascular invasion, lymph node metastasis, American Joint Committee on Cancer and Barcelona Clinic Liver Cancer stages, recurrence, and mortality. Ten patient showed tumor recurrence, and 15 patients died. Postresection 5-year OS and DFS rates were 43.7 and 57.4%, respectively. Cox regression analysis showed that high intratumoral LC3 expression was significantly associated with improved OS [hazard ratio (HR; 95% confidence interval (CI)): (1.68–26.9), p = 0.007], but multiple tumors and microvascular invasion was significantly correlated with poor OS [HR (95% CI): 0.03 (0.01–0.34), p = 0.004, and 0.07 (0.01–0.46), p = 0.006, respectively]. Furthermore, high LC3 expression and cirrhosis had improved DFS [HR (95% CI): 51.3 (2.85–922), p = 0.008, and 17.9 (1.05–306), p = 0.046, respectively]. The 5-year OS and DFS rates were respectively 61.2 and 74.6% in high LC3 expression patients and 0 and 0% in those with low LC3 expression. Conclusion High LC3 expression in tumors is significantly associated with mild clinicopathological characteristics and favorable clinical prognosis in patients with cHCC-CC after resection.
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- 2021
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10. Predictive factors of disease-free survival after complete pathological response to neoadjuvant radiotherapy for rectal adenocarcinoma: retrospective case series
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Amine Souadka, Mohammed Anass Majbar, Amine Benkabbou, Badr Serji, Tarik Souiki, Sidi Mohammed Bouchentouf, Mourad Abid, Basma El Khannousi, Tijani El Harroudi, Hadj Omar El Malki, Mohammed Raiss, Lahsen Ifrine, Khalid Mazaz, Aziz Zentar, Raouf Mohsine, Abdelilah Souadka, Abdelkader Belkouchi, Mohammed Ahallat, Abdelmalek Hrora, and on behalf of the Moroccan Society of Surgery
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Rectal neoplasm ,Neoadjuvant treatment ,Complete pathological response ,Disease-free survival ,Predictive factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This study aimed to evaluate predictive factors for disease free survival after complete pathological response (CPR) in cases of low rectal adenocarcinoma. Materials and methods From January 2005 to December 2013, all patients with low rectal adenocarcinoma who underwent neoadjuvant chemoradiotherapy followed by total mesorectal excision and achieved CPR were included at 7 Moroccan and 1 Algerian centres. Predictive factors for disease-free survival were analysed by uni and multivariate analysis. Results Eigthy-four (12.1%) patients achieved a CPR (ypT0N0). Multivariate analysis revealed that both poorly differentiated tumors (OR, 9.23; 95 CI 1.35–62.82; P = 0.023) and the occurrence of perineal sepsis (OR, 13.51; 95 CI 1.96–93.12; P = 0.008) were independently associated with impaired DFS. Conclusions Patients with low rectal cancer who exhibited a CPR after neoadjuvant therapy have good prognoses; however, the occurrence of perineal sepsis and/or poor initial differentiation may be associated with impaired DFS in these patients. Trial registration: The study was retrospectively registered the 28th July 2018 in ClinicalTrials.gov register with the reference NCT03601689.
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- 2019
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11. Role of autophagy-related protein in the prognosis of combined hepatocellular carcinoma and cholangiocarcinoma after surgical resection.
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Perng, Daw-Shyong, Hung, Chao-Ming, Lin, Hung-Yu, Morgan, Paul, Hsu, Yao-Chun, Wu, Tsung-Chin, Hsieh, Pei-Min, Yeh, Jen-Hao, Hsiao, Pojen, Lee, Chih-Yuan, Li, Yu-Chan, Wang, Ya-Chin, Chen, Yaw-Sen, and Lin, Chih-Wen
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HEPATOCELLULAR carcinoma , *PROGNOSIS , *OVERALL survival , *SURGICAL excision , *CHOLANGIOCARCINOMA , *DISEASE relapse - Abstract
Background: Autophagy-related proteins may predict postresection overall survival (OS) and disease-free survival (DFS) in patients with combined hepatocellular carcinoma and cholangiocarcinoma (cHCC-CC).Methods: We prospectively investigated how these proteins affect clinical prognosis in 40 patients who underwent hepatectomy for cHCC-CC from 2011 to 2019 at a Taiwanese hospital. Levels of autophagy-related proteins, namely LC3, Beclin-1, and p62, were immunohistochemically assessed in patient tumor and non-tumor tissues.Results: We noted that LC3 expression was significantly correlated with mild clinicopathological characteristics, including macrovascular invasion, lymph node metastasis, American Joint Committee on Cancer and Barcelona Clinic Liver Cancer stages, recurrence, and mortality. Ten patient showed tumor recurrence, and 15 patients died. Postresection 5-year OS and DFS rates were 43.7 and 57.4%, respectively. Cox regression analysis showed that high intratumoral LC3 expression was significantly associated with improved OS [hazard ratio (HR; 95% confidence interval (CI)): (1.68-26.9), p = 0.007], but multiple tumors and microvascular invasion was significantly correlated with poor OS [HR (95% CI): 0.03 (0.01-0.34), p = 0.004, and 0.07 (0.01-0.46), p = 0.006, respectively]. Furthermore, high LC3 expression and cirrhosis had improved DFS [HR (95% CI): 51.3 (2.85-922), p = 0.008, and 17.9 (1.05-306), p = 0.046, respectively]. The 5-year OS and DFS rates were respectively 61.2 and 74.6% in high LC3 expression patients and 0 and 0% in those with low LC3 expression.Conclusion: High LC3 expression in tumors is significantly associated with mild clinicopathological characteristics and favorable clinical prognosis in patients with cHCC-CC after resection. [ABSTRACT FROM AUTHOR]- Published
- 2021
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12. The efficacy and toxicity of cabazitaxel for treatment of docetaxel-resistant prostate cancer correlating with the initial doses in Japanese patients
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Naoki Terada, Toshiyuki Kamoto, Hiromasa Tsukino, Shoichiro Mukai, Shusuke Akamatsu, Takahiro Inoue, Osamu Ogawa, Shintaro Narita, Tomonori Habuchi, Shinichi Yamashita, Koji Mitsuzuka, Yoichi Arai, Shuya Kandori, Takahiro Kojima, Hiroyuki Nishiyama, Yoshiaki Kawamura, Yuki Shimizu, Toshiro Terachi, Motohiko Sugi, Hidefumi Kinoshita, Tadashi Matsuda, Yusuke Yamada, Shingo Yamamoto, Hiromi Hirama, Mikio Sugimoto, Yoshiyuki Kakehi, Toshihiko Sakurai, and Norihiko Tsuchiya
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Prostate cancer ,Cabazitaxel ,Dosage ,Efficacy ,Toxicity ,Predictive factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background We analyzed the efficacy and toxicity of cabazitaxel (CBZ) at high and low initial doses in Japanese patients with docetaxel-resistant castration-resistant prostate cancer (CRPC). Methods We retrospectively evaluated 118 patients who received CBZ for docetaxel-resistant CRPC in 10 university hospitals in Japan between 2014 and 2016. The rate of decrease of prostate-specific antigen (PSA), adverse events, progression-free survival (PFS), and overall survival (OS) were compared between patients receiving initially high (≥22.5 mg/m2, n = 36) and low (≤20 mg/m2, n = 80) CBZ doses. Factors associated with survival and grade 4 neutropenia were evaluated. Results PSA values decreased by > 50% in 22 patients (19%), with a higher frequency in the high-dose group than in the low-dose group (29 and 14%, P = 0.073). The median PFS time for the all-patient, high- and low-dose groups was 2.8 months (95% confidence interval [CI] 1.9–4.4), 2.1 months (1.2–5.5), and 3.0 months (2.0–4.4), respectively (P = 0.904). The median OS times were 16.3 months (95% CI 9.7–30.9), 30.9 months (11.8–47.4), and 10.2 months (8.6–20), respectively (P = 0.020). In multivariate analyses, PFS was significantly associated with existing bone metastasis at diagnosis (P = 0.005) and OS with PSA > 100 ng/ml (P = 0.007), hemoglobin
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- 2019
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13. Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study
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Yoshihiko Tomita, Hirotsugu Uemura, Mototsugu Oya, Nobuo Shinohara, Tomonori Habuchi, Yosuke Fujii, Yoichi Kamei, Yoshiko Umeyama, Angel H. Bair, and Brian I. Rini
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Axitinib ,Benefit with dose titration ,First-line ,Metastatic renal cell carcinoma ,Predictive factors ,Survival benefit ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background A prospective, randomised phase II study demonstrated clinical benefit of axitinib dose titration in a subset of treatment-naïve patients treated with axitinib for metastatic renal cell carcinoma. This analysis evaluated patient baseline characteristics that may impact overall survival (OS) with axitinib dose titration. Methods Following a 4-week lead-in period during which all patients received axitinib 5 mg twice-daily (bid); patients meeting the predefined randomisation criteria were randomly assigned to receive axitinib 5 mg bid plus either axitinib or placebo titration. In exploratory analyses, patients were grouped into those who achieved OS ≥24 versus
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- 2019
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14. The prognostic value of the Tau protein serum level in metastatic breast cancer patients and its correlation with brain metastases
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Amélie Darlix, Christophe Hirtz, Simon Thezenas, Aleksandra Maceski, Audrey Gabelle, Evelyne Lopez-Crapez, Hélène De Forges, Nelly Firmin, Séverine Guiu, William Jacot, and Sylvain Lehmann
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Tau protein ,Breast cancer ,Brain metastases ,Tumor markers ,Predictive factors ,Prognostic factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Metastatic breast cancer (MBC) prognosis is variable, depending on several clinical and biological factors. A better prediction of a patient’s outcome could allow for a more accurate choice of treatments. The role of serum biomarkers in predicting outcome remains unclear in this setting. Tau, a microtubule-associated protein, is a neuronal marker that is also expressed in normal breast epithelial cells and cancer cells. Its tissue expression is associated with prognosis in MBC. However, the prognostic value of Tau serum levels in these patients is unknown. We aimed at evaluating the prognostic value of Tau (and other classical biomarkers) in MBC patients, and to assess its association with the presence of brain metastases (BM). Methods 244 MBC patients treated at our institution (2007–2015) were retrospectively selected. The usual MBC clinical and pathological variables were collected, altogether with CA15–3, CEA and HER2 extra-cellular domain (ECD) serum levels. Tau serum levels were measured with a novel immunoassay (digital ELISA) using Single Molecule Array (Simoa) technology. Overall survival (OS) was estimated with the Kaplan-Meier method. To investigate prognostic factors, a multivariate analysis was performed. Cut-offs were set using the Youden index method associated with receiver-operating characteristics (ROC) curves to evaluate the accuracy of biomarkers to identify patients with BM. Results With a median follow-up of 40.8 months, median OS was 15.5 months (95%CI 12.4–20.2). Elevated serum levels of Tau were independently associated with a poor outcome in the whole population as well as in patients with (n = 86) and without BM (n = 158). Median serum Tau levels tended to be higher in patients with BM (p = 0.23). In univariate analysis, patients with BM had an increased risk of serum Tau > 3.17 pg/mL (OR = 2.2, p = 0.049). In multivariate analysis, high values of Tau (OR = 3.98, p = 0.034) accurately identified patients with BM in our cohort. Conclusions Tau is a new biomarker of interest in MBC. Its serum level could represent an independent prognostic factor in these patients (both with and without BM). It also seems to be associated with the presence of BM. A validation of these results in an independent set of MBC patients is necessary to confirm these findings.
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- 2019
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15. Elevated platelet count is a negative predictive and prognostic marker in locally advanced rectal cancer undergoing neoadjuvant chemoradiation: a retrospective multi-institutional study on 965 patients
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Claudio Belluco, Marco Forlin, Paolo Delrio, Daniela Rega, Maurizio Degiuli, Silvia Sofia, Matteo Olivieri, Salvatore Pucciarelli, Matteo Zuin, Giovanni De Manzoni, Alberto Di Leo, Stefano Scabini, Luigi Zorcolo, and Angelo Restivo
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Platelets ,Thrombocytosis ,Rectal Cancer ,Neoadjuvant chemoradiation ,Predictive factors ,Prognostic factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background In patients with locally advanced rectal cancer treated by neoadjuvant chemoradiation, pathological complete response in the surgical specimen is associated with favourable long-term oncologic outcome. Based on this observation, nonoperative management is being explored in the subset of patients with clinical complete response. Whereas, patients with poor response have a high risk of local and distant recurrence, and appear to receive no benefit from standard neoadjuvant chemoradiation. Therefore, in order to develop alternative treatment strategies for non responding patients, predictive and prognostic factors are highly needed. Accumulating clinical observations indicate that elevated platelet count is associated with poor outcome in different type of tumors. In this study we investigated the predictive and prognostic impact of elevated platelet count on pathological response and long-term oncologic outcome in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation. Methods A total of 965 patients were selected from prospectively maintained databases of seven Centers within the SICO Colorectal Cancer Network. Patients were divided into two groups based on a pre-neoadjuvant chemoradiation platelet count cut-off value of 300 × 109/L identified by receiver operating characteristic curve considering complete pathological response as the outcome. Results Complete pathological response rate was lower in patients with elevated platelet count (12.8% vs. 22.1%, p = 0.001). Mean follow-up was 50.1 months. Comparing patients with elevated platelet count with patients with not elevated platelet count, 5-year overall survival was 69.5% vs.76.5% (p = 0.016), and 5-year disease free survival was 63.0% vs. 68.9% (p = 0.019). Local recurrence rate was higher in patients with elevated platelet count (11.1% vs. 5.3%, p = 0.001), as higher was the occurrence of distant metastasis (23.9% vs. 16.4%, p = 0.007). At multivariate analysis of potential prognostic factors EPC was independently associated with worse overall survival (HR 1.40, 95% CI 1.06–1.86), and disease free survival (HR 1.37, 95% CI 1.07–1.76). Conclusions In locally advanced rectal cancer elevated platelet count before neoadjuvant chemoradiation is a negative predictive and prognostic factor which might help to identify subsets of patients with more aggressive tumors to be proposed for alternative therapeutic strategies.
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- 2018
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16. Efficacy and safety profile of drug-eluting beads transarterial chemoembolization by CalliSpheres® beads in Chinese hepatocellular carcinoma patients
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Guan-Hui Zhou, Jun Han, Jun-Hui Sun, Yue-Lin Zhang, Tan-Yang Zhou, Chun-Hui Nie, Tong-Yin Zhu, Sheng-Qun Chen, Bao-Quan Wang, Zi-Niu Yu, Hong-Liang Wang, Li-Ming Chen, Wei-Lin Wang, and Shu-Sen Zheng
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DEB-TACE ,CalliSpheres® ,Hepatocellular carcinoma (HCC) ,Efficacy ,Safety ,Predictive factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background This study aimed to investigate the efficacy and safety of drug eluting beads transarterial chemoembolization (DEB-TACE) treatment by CalliSpheres® in Chinese patients with hepatocellular carcinoma (HCC) as well as the predicting factors for response. Methods 99 patients with HCC were consecutively enrolled in this study. All participants were treated by CalliSpheres® DEB-TACE. Clinical response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Common Terminology Criteria for Adverse Events (CTCAE) was used to assess the adverse events and liver dysfunction during and after the operation. Results Post treatment, 16 patients (16.2%) achieved CR and 59 (59.6%) achieved PR, the ORR was 75.8%. Subgroup analysis showed that patients with higher BCLC stage were of worse CR and ORR rates, and the CR as well as ORR between patients with cTACE history and patients without cTACE history were similar. Univariate logistic regression analysis displayed that number of nodules > 3, higher BCLC stage and previous cTACE might be correlated with worse ORR but with no statistical significance. As to liver function, CTCAE grades of laboratory indexes for liver function were increased at 1 week compared to baseline and recovered to the baseline grades at 1–3 months post operation. Besides, most of the common adverse events were light and moderate in our study. Conclusions In conclusion, DEB-TACE by CalliSpheres® was efficient and well tolerated in Chinese HCC patients, and BCLC stage, number of nodules and cTACE history were possibly correlated with treatment response.
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- 2018
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17. Predictive factors of disease-free survival after complete pathological response to neoadjuvant radiotherapy for rectal adenocarcinoma: retrospective case series.
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Souadka, Amine, Majbar, Mohammed Anass, Benkabbou, Amine, Serji, Badr, Souiki, Tarik, Bouchentouf, Sidi Mohammed, Abid, Mourad, El Khannousi, Basma, El Harroudi, Tijani, El Malki, Hadj Omar, Raiss, Mohammed, Ifrine, Lahsen, Mazaz, Khalid, Zentar, Aziz, Mohsine, Raouf, Souadka, Abdelilah, Belkouchi, Abdelkader, Ahallat, Mohammed, Hrora, Abdelmalek, and Moroccan Society of Surgery
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RECTAL cancer , *PROGRESSION-free survival , *ABDOMINOPERINEAL resection , *ADENOCARCINOMA , *MULTIVARIATE analysis - Abstract
Background: Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This study aimed to evaluate predictive factors for disease free survival after complete pathological response (CPR) in cases of low rectal adenocarcinoma.Materials and Methods: From January 2005 to December 2013, all patients with low rectal adenocarcinoma who underwent neoadjuvant chemoradiotherapy followed by total mesorectal excision and achieved CPR were included at 7 Moroccan and 1 Algerian centres. Predictive factors for disease-free survival were analysed by uni and multivariate analysis.Results: Eigthy-four (12.1%) patients achieved a CPR (ypT0N0). Multivariate analysis revealed that both poorly differentiated tumors (OR, 9.23; 95 CI 1.35-62.82; P = 0.023) and the occurrence of perineal sepsis (OR, 13.51; 95 CI 1.96-93.12; P = 0.008) were independently associated with impaired DFS.Conclusions: Patients with low rectal cancer who exhibited a CPR after neoadjuvant therapy have good prognoses; however, the occurrence of perineal sepsis and/or poor initial differentiation may be associated with impaired DFS in these patients.Trial Registration: The study was retrospectively registered the 28th July 2018 in ClinicalTrials.gov register with the reference NCT03601689. [ABSTRACT FROM AUTHOR]- Published
- 2019
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18. The efficacy and toxicity of cabazitaxel for treatment of docetaxel-resistant prostate cancer correlating with the initial doses in Japanese patients.
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Terada, Naoki, Kamoto, Toshiyuki, Tsukino, Hiromasa, Mukai, Shoichiro, Akamatsu, Shusuke, Inoue, Takahiro, Ogawa, Osamu, Narita, Shintaro, Habuchi, Tomonori, Yamashita, Shinichi, Mitsuzuka, Koji, Arai, Yoichi, Kandori, Shuya, Kojima, Takahiro, Nishiyama, Hiroyuki, Kawamura, Yoshiaki, Shimizu, Yuki, Terachi, Toshiro, Sugi, Motohiko, and Kinoshita, Hidefumi
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CASTRATION-resistant prostate cancer , *PROSTATE , *PROSTATE cancer , *BONE metastasis , *PROSTATE-specific antigen - Abstract
Background: We analyzed the efficacy and toxicity of cabazitaxel (CBZ) at high and low initial doses in Japanese patients with docetaxel-resistant castration-resistant prostate cancer (CRPC).Methods: We retrospectively evaluated 118 patients who received CBZ for docetaxel-resistant CRPC in 10 university hospitals in Japan between 2014 and 2016. The rate of decrease of prostate-specific antigen (PSA), adverse events, progression-free survival (PFS), and overall survival (OS) were compared between patients receiving initially high (≥22.5 mg/m2, n = 36) and low (≤20 mg/m2, n = 80) CBZ doses. Factors associated with survival and grade 4 neutropenia were evaluated.Results: PSA values decreased by > 50% in 22 patients (19%), with a higher frequency in the high-dose group than in the low-dose group (29 and 14%, P = 0.073). The median PFS time for the all-patient, high- and low-dose groups was 2.8 months (95% confidence interval [CI] 1.9-4.4), 2.1 months (1.2-5.5), and 3.0 months (2.0-4.4), respectively (P = 0.904). The median OS times were 16.3 months (95% CI 9.7-30.9), 30.9 months (11.8-47.4), and 10.2 months (8.6-20), respectively (P = 0.020). In multivariate analyses, PFS was significantly associated with existing bone metastasis at diagnosis (P = 0.005) and OS with PSA > 100 ng/ml (P = 0.007), hemoglobin < 12 g/dl (P = 0.030), and low initial CBZ dose (P = 0.030). Grade 4 neutropenia occurred in 53 patients (45%) and was associated with a low CBZ dose (hazard ratio 0.21, 95% CI 0.08-0.59, P = 0.002).Conclusions: CBZ at a higher initial dose may have similar response rate and response duration, but longer survival duration after treatment with higher toxicity than a lower initial dose for docetaxel-resistant CRPC in Japanese patients. [ABSTRACT FROM AUTHOR]- Published
- 2019
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19. The prognostic value of the Tau protein serum level in metastatic breast cancer patients and its correlation with brain metastases.
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Darlix, Amélie, Hirtz, Christophe, Thezenas, Simon, Maceski, Aleksandra, Gabelle, Audrey, Lopez-Crapez, Evelyne, De Forges, Hélène, Firmin, Nelly, Guiu, Séverine, Jacot, William, and Lehmann, Sylvain
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METASTATIC breast cancer , *TAU proteins , *BRAIN metastasis , *BREAST cancer , *CANCER prognosis , *BIOLOGICAL tags , *BLOOD testing - Abstract
Background: Metastatic breast cancer (MBC) prognosis is variable, depending on several clinical and biological factors. A better prediction of a patient's outcome could allow for a more accurate choice of treatments. The role of serum biomarkers in predicting outcome remains unclear in this setting. Tau, a microtubule-associated protein, is a neuronal marker that is also expressed in normal breast epithelial cells and cancer cells. Its tissue expression is associated with prognosis in MBC. However, the prognostic value of Tau serum levels in these patients is unknown. We aimed at evaluating the prognostic value of Tau (and other classical biomarkers) in MBC patients, and to assess its association with the presence of brain metastases (BM).Methods: 244 MBC patients treated at our institution (2007-2015) were retrospectively selected. The usual MBC clinical and pathological variables were collected, altogether with CA15-3, CEA and HER2 extra-cellular domain (ECD) serum levels. Tau serum levels were measured with a novel immunoassay (digital ELISA) using Single Molecule Array (Simoa) technology. Overall survival (OS) was estimated with the Kaplan-Meier method. To investigate prognostic factors, a multivariate analysis was performed. Cut-offs were set using the Youden index method associated with receiver-operating characteristics (ROC) curves to evaluate the accuracy of biomarkers to identify patients with BM.Results: With a median follow-up of 40.8 months, median OS was 15.5 months (95%CI 12.4-20.2). Elevated serum levels of Tau were independently associated with a poor outcome in the whole population as well as in patients with (n = 86) and without BM (n = 158). Median serum Tau levels tended to be higher in patients with BM (p = 0.23). In univariate analysis, patients with BM had an increased risk of serum Tau > 3.17 pg/mL (OR = 2.2, p = 0.049). In multivariate analysis, high values of Tau (OR = 3.98, p = 0.034) accurately identified patients with BM in our cohort.Conclusions: Tau is a new biomarker of interest in MBC. Its serum level could represent an independent prognostic factor in these patients (both with and without BM). It also seems to be associated with the presence of BM. A validation of these results in an independent set of MBC patients is necessary to confirm these findings. [ABSTRACT FROM AUTHOR]- Published
- 2019
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20. Role of autophagy-related protein in the prognosis of combined hepatocellular carcinoma and cholangiocarcinoma after surgical resection
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Yao-Chun Hsu, Yu-Chan Li, Jen-Hao Yeh, Yaw-Sen Chen, Chih-Yuan Lee, Tsung-Chin Wu, Paul Morgan, Daw-Shyong Perng, Pojen Hsiao, Chih-Wen Lin, Pei-Min Hsieh, Chao-Ming Hung, Ya-Chin Wang, and Hung-Yu Lin
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Male ,0301 basic medicine ,Cancer Research ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Cirrhosis ,medicine.medical_treatment ,Autophagy-Related Proteins ,Combined hepatocellular carcinoma and cholangiocarcinoma ,Gastroenterology ,Cholangiocarcinoma ,03 medical and health sciences ,0302 clinical medicine ,Surgical oncology ,Internal medicine ,Autophagy ,LC3 ,Genetics ,medicine ,Humans ,Prospective Studies ,RC254-282 ,business.industry ,Proportional hazards model ,Research ,Liver Neoplasms ,Hazard ratio ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Cancer ,Middle Aged ,Prognosis ,medicine.disease ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Hepatocellular carcinoma ,Female ,Hepatectomy ,Liver cancer ,business ,Predictive factors - Abstract
Background Autophagy-related proteins may predict postresection overall survival (OS) and disease-free survival (DFS) in patients with combined hepatocellular carcinoma and cholangiocarcinoma (cHCC-CC). Methods We prospectively investigated how these proteins affect clinical prognosis in 40 patients who underwent hepatectomy for cHCC-CC from 2011 to 2019 at a Taiwanese hospital. Levels of autophagy-related proteins, namely LC3, Beclin-1, and p62, were immunohistochemically assessed in patient tumor and non-tumor tissues. Results We noted that LC3 expression was significantly correlated with mild clinicopathological characteristics, including macrovascular invasion, lymph node metastasis, American Joint Committee on Cancer and Barcelona Clinic Liver Cancer stages, recurrence, and mortality. Ten patient showed tumor recurrence, and 15 patients died. Postresection 5-year OS and DFS rates were 43.7 and 57.4%, respectively. Cox regression analysis showed that high intratumoral LC3 expression was significantly associated with improved OS [hazard ratio (HR; 95% confidence interval (CI)): (1.68–26.9), p = 0.007], but multiple tumors and microvascular invasion was significantly correlated with poor OS [HR (95% CI): 0.03 (0.01–0.34), p = 0.004, and 0.07 (0.01–0.46), p = 0.006, respectively]. Furthermore, high LC3 expression and cirrhosis had improved DFS [HR (95% CI): 51.3 (2.85–922), p = 0.008, and 17.9 (1.05–306), p = 0.046, respectively]. The 5-year OS and DFS rates were respectively 61.2 and 74.6% in high LC3 expression patients and 0 and 0% in those with low LC3 expression. Conclusion High LC3 expression in tumors is significantly associated with mild clinicopathological characteristics and favorable clinical prognosis in patients with cHCC-CC after resection.
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- 2021
21. Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study
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Nobuo Shinohara, Yosuke Fujii, Hirotsugu Uemura, Yoshiko Umeyama, Tomonori Habuchi, Mototsugu Oya, Angel H. Bair, Yoshihiko Tomita, Brian I. Rini, and Yoichi Kamei
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0301 basic medicine ,Male ,Cancer Research ,medicine.medical_specialty ,Axitinib ,Metastatic renal cell carcinoma ,Urology ,Phases of clinical research ,Antineoplastic Agents ,Placebo ,lcsh:RC254-282 ,Benefit with dose titration ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Renal cell carcinoma ,Statistical significance ,Genetics ,medicine ,Humans ,Neoplasm Metastasis ,Carcinoma, Renal Cell ,Aged ,business.industry ,Proportional hazards model ,First-line ,Middle Aged ,medicine.disease ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Kidney Neoplasms ,Discontinuation ,Exact test ,030104 developmental biology ,Treatment Outcome ,Oncology ,Withholding Treatment ,Survival benefit ,030220 oncology & carcinogenesis ,Disease Progression ,Female ,business ,Predictive factors ,medicine.drug ,Research Article - Abstract
Background A prospective, randomised phase II study demonstrated clinical benefit of axitinib dose titration in a subset of treatment-naïve patients treated with axitinib for metastatic renal cell carcinoma. This analysis evaluated patient baseline characteristics that may impact overall survival (OS) with axitinib dose titration. Methods Following a 4-week lead-in period during which all patients received axitinib 5 mg twice-daily (bid); patients meeting the predefined randomisation criteria were randomly assigned to receive axitinib 5 mg bid plus either axitinib or placebo titration. In exploratory analyses, patients were grouped into those who achieved OS ≥24 versus
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- 2019
22. Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study
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Tomita, Yoshihiko, Uemura, Hirotsugu, Oya, Mototsugu, Shinohara, Nobuo, Habuchi, Tomonori, Fujii, Yosuke, Kamei, Yoichi, Umeyama, Yoshiko, Bair, Angel H., and Rini, Brian I.
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- 2019
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23. Correlation between ERK1 and STAT3 expression and chemoresistance in patients with conventional osteosarcoma.
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Salas, Sébastien, Jiguet-Jiglaire, Carine, Campion, Loic, Bartoli, Catherine, Frassineti, Frédéric, Deville, Jean-Laurent, De Paula, André Maues, Forest, Fabien, Jézéquel, Pascal, Gentet, Jean-Claude, and Bouvier, Corinne
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STAT proteins , *PROTEIN expression , *SERINE/THREONINE kinases , *OSTEOSARCOMA , *CANCER chemotherapy , *DRUG resistance in cancer cells , *THERAPEUTICS - Abstract
Background: The standard therapy regimen of conventional osteosarcoma includes neoadjuvant chemotherapy followed by surgical resection and postoperative chemotherapy. The percentage of necrotic tissue following induction chemotherapy is assessed by using the Huvos grading system, which classifies patients as "poor responders" (PR) and "good responders" (GR). The aim of this study was to identify molecular markers expressed differentially between good and poor responders to neoadjuvant chemotherapy in order to predict the response to chemotherapy in conventional osteosarcomas before beginning treatment. Methods: Suppression Substractive Hybridization (SSH) was performed by using cDNA from frozen biopsy specimens. Expression of selected relevant genes identified by SSH was validated by using QRT-PCR. Immunohistochemistry (IHC) on tissue microarray (TMA) sections of 52 biopsies was performed to investigate protein expression in an independent cohort. Results: ERK1 and STAT3 mRNA level were significantly different between PR and GR in an independent cohort. Phosphorylated STAT3 and ERK1 expressions by IHC on TMA were correlated with poor response to chemotherapy. Conclusions: Our results suggest that ERK1 and STAT3 expression are good predictive markers for chemotherapy response and that inhibitors might be used in combination with common chemotherapeutic drugs in conventional osteosarcomas. [ABSTRACT FROM AUTHOR]
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- 2014
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24. Efficacy and safety profile of drug-eluting beads transarterial chemoembolization by CalliSpheres® beads in Chinese hepatocellular carcinoma patients
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Shusen Zheng, Hong-Liang Wang, Li-Ming Chen, Sheng-Qun Chen, Jun Han, Guan-Hui Zhou, Chun-Hui Nie, Bao-Quan Wang, Tong-Yin Zhu, Jun-Hui Sun, Tan-Yang Zhou, Yue-Lin Zhang, Zi-Niu Yu, and Weilin Wang
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Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Efficacy ,Subgroup analysis ,Gastroenterology ,lcsh:RC254-282 ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,Drug Delivery Systems ,0302 clinical medicine ,Asian People ,CalliSpheres® ,DEB-TACE ,Statistical significance ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Genetics ,medicine ,Humans ,Chemoembolization, Therapeutic ,Hepatocellular carcinoma (HCC) ,Adverse effect ,Aged ,Epirubicin ,Antibiotics, Antineoplastic ,business.industry ,Liver Neoplasms ,Common Terminology Criteria for Adverse Events ,Middle Aged ,medicine.disease ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Microspheres ,BCLC Stage ,Oncology ,Doxorubicin ,Response Evaluation Criteria in Solid Tumors ,030220 oncology & carcinogenesis ,Hepatocellular carcinoma ,Female ,Liver function ,Safety ,business ,Predictive factors ,Research Article - Abstract
Background This study aimed to investigate the efficacy and safety of drug eluting beads transarterial chemoembolization (DEB-TACE) treatment by CalliSpheres® in Chinese patients with hepatocellular carcinoma (HCC) as well as the predicting factors for response. Methods 99 patients with HCC were consecutively enrolled in this study. All participants were treated by CalliSpheres® DEB-TACE. Clinical response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Common Terminology Criteria for Adverse Events (CTCAE) was used to assess the adverse events and liver dysfunction during and after the operation. Results Post treatment, 16 patients (16.2%) achieved CR and 59 (59.6%) achieved PR, the ORR was 75.8%. Subgroup analysis showed that patients with higher BCLC stage were of worse CR and ORR rates, and the CR as well as ORR between patients with cTACE history and patients without cTACE history were similar. Univariate logistic regression analysis displayed that number of nodules > 3, higher BCLC stage and previous cTACE might be correlated with worse ORR but with no statistical significance. As to liver function, CTCAE grades of laboratory indexes for liver function were increased at 1 week compared to baseline and recovered to the baseline grades at 1–3 months post operation. Besides, most of the common adverse events were light and moderate in our study. Conclusions In conclusion, DEB-TACE by CalliSpheres® was efficient and well tolerated in Chinese HCC patients, and BCLC stage, number of nodules and cTACE history were possibly correlated with treatment response.
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- 2018
25. Evaluation of the prognostic role of centromere 17 gain and HER2/topoisomerase II alpha gene status and protein expression in patients with breast cancer treated with anthracycline-containing adjuvant chemotherapy: pooled analysis of two Hellenic Cooperative Oncology Group (HeCOG) phase III trials
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Fountzilas, George, Dafni, Urania, Bobos, Mattheos, Kotoula, Vassiliki, Batistatou, Anna, Xanthakis, Ioannis, Papadimitriou, Christos, Kostopoulos, Ioannis, Koletsa, Triantafillia, Tsolaki, Eleftheria, Televantou, Despina, Timotheadou, Eleni, Koutras, Angelos, Klouvas, George, Samantas, Epaminontas, Pisanidis, Nikolaos, Karanikiotis, Charisios, Sfakianaki, Ioanna, Pavlidis, Nicholas, and Gogas, Helen
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CENTROMERE , *DNA topoisomerase II , *GENE expression , *DRUG therapy , *TRASTUZUMAB , *IMMUNOHISTOCHEMISTRY - Abstract
Background: The HER2 gene has been established as a valid biological marker for the treatment of breast cancer patients with trastuzumab and probably other agents, such as paclitaxel and anthracyclines. The TOP2A gene has been associated with response to anthracyclines. Limited information exists on the relationship of HER2/TOP2A gene status in the presence of centromere 17 (CEP17) gain with outcome of patients treated with anthracyclinecontaining adjuvant chemotherapy. Methods: Formalin-fixed paraffin-embedded tumor tissue samples from 1031 patients with high-risk operable breast cancer, enrolled in two consecutive phase III trials, were assessed in a central laboratory by fluorescence in situ hybridization for HER2/TOP2A gene amplification and CEP17 gain (CEP17 probe). Amplification of HER2 and TOP2A were defined as a gene/CEP17 ratio of >2.2 and ⩾2.0, respectively, or gene copy number higher than 6. Additionally, HER2, TopoIIa, ER/PgR and Ki67 protein expression was assessed by immunohistochemistry (IHC) and patients were classified according to their IHC phenotype. Treatment consisted of epirubicin-based adjuvant chemotherapy followed by hormonal therapy and radiation, as indicated Results: HER2 amplification was found in 23.7% of the patients and TOP2A amplification in 10.1%. In total, 41.8% of HER2-amplified tumors demonstrated TOP2A co-amplification. The median (range) of HER2, TOP2A and CEP17 gain was 2.55 (0.70-45.15), 2.20 (0.70-26.15) and 2.00 (0.70-26.55), respectively. Forty percent of the tumors had CEP17 gain (51% of those with HER2 amplification). Adjusting for treatment groups in the Cox model, HER2 amplification, TOP2A amplification, CEP17 gain and HER2/TOP2A co-amplification were not associated with time to relapse or time to death. Conclusion: HER2 amplification, TOP2A amplification, CEP17 gain and HER2/TOP2A co-amplification were not associated with outcome in high-risk breast cancer patients treated with anthracycline-based adjuvant chemotherapy [ABSTRACT FROM AUTHOR]
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- 2013
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26. Elevated platelet count is a negative predictive and prognostic marker in locally advanced rectal cancer undergoing neoadjuvant chemoradiation: a retrospective multi-institutional study on 965 patients
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Belluco, Claudio, Forlin, Marco, Delrio, Paolo, Rega, Daniela, Degiuli, Maurizio, Sofia, Silvia, Olivieri, Matteo, Pucciarelli, Salvatore, Zuin, Matteo, De Manzoni, Giovanni, Di Leo, Alberto, Scabini, Stefano, Zorcolo, Luigi, and Restivo, Angelo
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- 2018
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27. The efficacy and toxicity of cabazitaxel for treatment of docetaxel-resistant prostate cancer correlating with the initial doses in Japanese patients
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Toshiro Terachi, Hiromi Hirama, Hiromasa Tsukino, Tomonori Habuchi, Yoshiaki Kawamura, Takahiro Inoue, Toshiyuki Kamoto, Mikio Sugimoto, Shoichiro Mukai, Shuya Kandori, Shinichi Yamashita, Hidefumi Kinoshita, Hiroyuki Nishiyama, Norihiko Tsuchiya, Shintaro Narita, Koji Mitsuzuka, Yuki Shimizu, Motohiko Sugi, Yoshiyuki Kakehi, Shusuke Akamatsu, Yusuke Yamada, Tadashi Matsuda, Toshihiko Sakurai, Osamu Ogawa, Yoichi Arai, Shingo Yamamoto, Takahiro Kojima, and Naoki Terada
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0301 basic medicine ,Male ,Cancer Research ,Docetaxel ,Gastroenterology ,Prostate cancer ,0302 clinical medicine ,Japan ,Antineoplastic Combined Chemotherapy Protocols ,Aged, 80 and over ,Cabazitaxel ,Hazard ratio ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Progression-Free Survival ,Prostatic Neoplasms, Castration-Resistant ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Toxicity ,Taxoids ,Predictive factors ,medicine.drug ,Research Article ,medicine.medical_specialty ,Neutropenia ,Efficacy ,Antineoplastic Agents ,lcsh:RC254-282 ,03 medical and health sciences ,Dosage ,Internal medicine ,Genetics ,medicine ,Humans ,Adverse effect ,Aged ,Proportional Hazards Models ,Retrospective Studies ,business.industry ,Prostate-Specific Antigen ,medicine.disease ,Confidence interval ,030104 developmental biology ,Logistic Models ,Drug Resistance, Neoplasm ,business - Abstract
Background We analyzed the efficacy and toxicity of cabazitaxel (CBZ) at high and low initial doses in Japanese patients with docetaxel-resistant castration-resistant prostate cancer (CRPC). Methods We retrospectively evaluated 118 patients who received CBZ for docetaxel-resistant CRPC in 10 university hospitals in Japan between 2014 and 2016. The rate of decrease of prostate-specific antigen (PSA), adverse events, progression-free survival (PFS), and overall survival (OS) were compared between patients receiving initially high (≥22.5 mg/m2, n = 36) and low (≤20 mg/m2, n = 80) CBZ doses. Factors associated with survival and grade 4 neutropenia were evaluated. Results PSA values decreased by > 50% in 22 patients (19%), with a higher frequency in the high-dose group than in the low-dose group (29 and 14%, P = 0.073). The median PFS time for the all-patient, high- and low-dose groups was 2.8 months (95% confidence interval [CI] 1.9–4.4), 2.1 months (1.2–5.5), and 3.0 months (2.0–4.4), respectively (P = 0.904). The median OS times were 16.3 months (95% CI 9.7–30.9), 30.9 months (11.8–47.4), and 10.2 months (8.6–20), respectively (P = 0.020). In multivariate analyses, PFS was significantly associated with existing bone metastasis at diagnosis (P = 0.005) and OS with PSA > 100 ng/ml (P = 0.007), hemoglobin
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- 2019
28. Elevated platelet count is a negative predictive and prognostic marker in locally advanced rectal cancer undergoing neoadjuvant chemoradiation: a retrospective multi-institutional study on 965 patients
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M. Zuin, Alberto Di Leo, Stefano Scabini, Claudio Belluco, Salvatore Pucciarelli, Paolo Delrio, Matteo Olivieri, Giovanni de Manzoni, Silvia Sofia, Maurizio Degiuli, Daniela Rega, Marco Forlin, Angelo Restivo, and Luigi Zorcolo
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Male ,Cancer Research ,Multivariate analysis ,Colorectal cancer ,Kaplan-Meier Estimate ,Gastroenterology ,0302 clinical medicine ,Surgical oncology ,Medicine ,Aspirin ,Neoadjuvant chemoradiation ,Pathological response ,Platelets ,Predictive factors ,Prognostic factors ,Rectal Cancer ,Thrombocytosis ,Platelet ,030212 general & internal medicine ,Neoplasm Metastasis ,Aged, 80 and over ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Prognosis ,Magnetic Resonance Imaging ,Neoadjuvant Therapy ,Oncology ,030220 oncology & carcinogenesis ,Female ,Research Article ,medicine.drug ,medicine.medical_specialty ,lcsh:RC254-282 ,03 medical and health sciences ,Internal medicine ,Genetics ,Humans ,Pathological ,Aged ,Neoplasm Staging ,Proportional Hazards Models ,Retrospective Studies ,Receiver operating characteristic ,Rectal Neoplasms ,business.industry ,Chemoradiotherapy, Adjuvant ,medicine.disease ,business ,Biomarkers ,Follow-Up Studies - Abstract
Background In patients with locally advanced rectal cancer treated by neoadjuvant chemoradiation, pathological complete response in the surgical specimen is associated with favourable long-term oncologic outcome. Based on this observation, nonoperative management is being explored in the subset of patients with clinical complete response. Whereas, patients with poor response have a high risk of local and distant recurrence, and appear to receive no benefit from standard neoadjuvant chemoradiation. Therefore, in order to develop alternative treatment strategies for non responding patients, predictive and prognostic factors are highly needed. Accumulating clinical observations indicate that elevated platelet count is associated with poor outcome in different type of tumors. In this study we investigated the predictive and prognostic impact of elevated platelet count on pathological response and long-term oncologic outcome in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation. Methods A total of 965 patients were selected from prospectively maintained databases of seven Centers within the SICO Colorectal Cancer Network. Patients were divided into two groups based on a pre-neoadjuvant chemoradiation platelet count cut-off value of 300 × 109/L identified by receiver operating characteristic curve considering complete pathological response as the outcome. Results Complete pathological response rate was lower in patients with elevated platelet count (12.8% vs. 22.1%, p = 0.001). Mean follow-up was 50.1 months. Comparing patients with elevated platelet count with patients with not elevated platelet count, 5-year overall survival was 69.5% vs.76.5% (p = 0.016), and 5-year disease free survival was 63.0% vs. 68.9% (p = 0.019). Local recurrence rate was higher in patients with elevated platelet count (11.1% vs. 5.3%, p = 0.001), as higher was the occurrence of distant metastasis (23.9% vs. 16.4%, p = 0.007). At multivariate analysis of potential prognostic factors EPC was independently associated with worse overall survival (HR 1.40, 95% CI 1.06–1.86), and disease free survival (HR 1.37, 95% CI 1.07–1.76). Conclusions In locally advanced rectal cancer elevated platelet count before neoadjuvant chemoradiation is a negative predictive and prognostic factor which might help to identify subsets of patients with more aggressive tumors to be proposed for alternative therapeutic strategies.
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- 2018
29. Efficacy and safety profile of drug-eluting beads transarterial chemoembolization by CalliSpheres® beads in Chinese hepatocellular carcinoma patients
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Zhou, Guan-Hui, Han, Jun, Sun, Jun-Hui, Zhang, Yue-Lin, Zhou, Tan-Yang, Nie, Chun-Hui, Zhu, Tong-Yin, Chen, Sheng-Qun, Wang, Bao-Quan, Yu, Zi-Niu, Wang, Hong-Liang, Chen, Li-Ming, Wang, Wei-Lin, and Zheng, Shu-Sen
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- 2018
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30. The outcome and predictive factors of sunitinib therapy in advanced gastrointestinal stromal tumors (GIST) after imatinib failure - one institution study
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Rutkowski Piotr, Bylina Elżbieta, Klimczak Anna, Świtaj Tomasz, Falkowski Sławomir, Kroc Jacek, Ługowska Iwona, Brzeskwiniewicz Magdalena, Melerowicz Wojciech, Osuch Czesław, Mierzejewska Ewa, Wasielewski Kacper, Woźniak Agnieszka, Grzesiakowska Urszula, Nowecki Zbigniew I, Siedlecki Janusz A, and Limon Janusz
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Sunitinib ,Genotype ,GIST ,Prognosis ,Predictive factors ,Arterial hypertension ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Gastrointestinal stromal tumors (GIST) mutational status is recognized factor related to the results of tyrosine kinase inhibitors therapy such as imatinib (IM) or sunitinib (SU). Arterial hypertension (AH) is common adverse event related to SU, reported as predictive factor in renal cell carcinoma. The aim of the study was to analyze the outcomes and factors predicting results of SU therapy in inoperable/metastatic CD117(+) GIST patients after IM failure. Methods We identified 137 consecutive patients with advanced inoperable/metastatic GIST treated in one center with SU (2nd line treatment). Median follow-up time was 23 months. Additionally, in 39 patients there were analyzed selected constitutive single nucleotide polymorphisms (SNPs) of VEGFA and VEGFR2 genes. Results One year progression-free survival (PFS; calculated from the start of SU) rate was 42% and median PFS was 43 weeks. The estimated overall survival (OS, calculated both from start of SU or IM) was 74 weeks and 51 months, respectively. One-year PFS was 65% (median 74 weeks) in 55 patients with AH vs. 22% (median 17 weeks) in patients without AH. Patients with primary tumors carrying mutations in KIT exon 9 or wild-type had substantially better 1-year PFS (68% and 57%; median 65.5 and 50.5 weeks, respectively) than patients having tumors with KIT exon 11 or PDGFRA mutations (34% and 15%; median 36.8 and 9 weeks, respectively). We identified two independent factors with significant impact on PFS and OS in univariate and multivariate analysis: primary tumor genotype and presence of AH. The most common adverse events during therapy were: fatigue, AH, hypothyroidism, hand and foot syndrome, mucositis, skin reactions, dyspepsia, and diarrhea. Two deaths were assessed as related to tumor rupture caused by reaction to SU therapy. The presence of C-allele in rs833061 and the T-allele in rs3025039 polymorphism of VEGFA were associated with significantly higher risk of hypothyroidism (OR: 10.0 p = 0.041 and OR: 10.5; p = 0.015, respectively). Conclusions We confirmed that many advanced GIST patients benefit from SU therapy with OS > 1.5 year. Primary tumor KIT/PDGFRA genotype and SU-induced AH, as surrogate of its antiangiogenic activity are two independent factors influencing both PFS and OS. Note The preliminary data of this study were presented during Annual Meeting of American Society of Clinical Oncology, 4-8 June 2011 and Connective Tissue Oncology Society Meeting, 26-28 October 2011 in Chicago, IL.
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- 2012
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31. Prognostic and predictive value of clinical and biochemical factors in breast cancer patients with bone metastases receiving 'metronomic' zoledronic acid
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Wang Zhonghua, Wang Biyun, Zhang Jian, Sun Si, Jia Zhen, Zhang Qunling, Xu Xiaofeng, Zhao Xinmin, and Hu Xichun
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Advanced breast cancer ,bone metastases ,zoledronic acid ,VEGF ,N-telopeptide ,prognosis ,predictive factors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background To assess prognostic and predictive effects of clinical and biochemical factors in our published randomized study of a weekly low dose (metronomic arm) versus a conventional dosage of zoledronic acid (conventional arm) in breast cancer patients with bone metastases. Methods Treatment outcome of 60 patients with bone metastases were used to assess impacts of following potential prognostic factors, estrogen receptor status, lymph node status, 2 year-disease free interval (DFI), numbers of chemotherapy regimens administered, interventions, and serum levels of VEGF, N-telopeptide of type I collagen (NTx), CEA, and CA 15-3. Results In univariate analyses, patients pretreated with 2 or fewer chemotherapy regimens, ER-positive tumors, 3 or fewer lymph nodes, DFI of more than 2 years, serum VEGF of less than 500 pg/mL after 3 months of intervention, serum CEA and CA 15-3 of less than ULN, and baseline serum NTx of less than 18 nM BCE had significantly longer progression free survival (PFS). The multivariate analysis showed that ER positivity (hazard ratio [HR], 0.295; 95% confidence interval [CI], 0.141-0.618; P = 0.001), serum VEGF of less than 500 pg/mL after 3 months of intervention (HR, 2.220; 95% CI, 1.136-4.338; P = 0.020), baseline serum NTx of less than 18 nM BCE (HR, 2.842; 95% CI, 1.458-5.539; P = 0.001), and 2 or fewer chemotherapy regimens received (HR, 7.803; 95% CI, 2.884-21.112; P = 0.000) were associated with a better PFS. When evaluating the predictive effect of the biochemical factors, an interaction between NTx and zoledronic acid intervention was shown (P = 0.005). The HR of weekly low dose versus a conventional dosage of zoledronic acid was estimated to be 2.309 (99% CI, 1.067-5.012) in patients with baseline serum NTx of more than 18 nM BCE, indicating a superiority of weekly low dose of zoledronic acid. Conclusions ER, serum VEGF level after intervention, and numbers of chemotherapy regimens administered are prognostic but not predictive factors in breast cancer patients with bone metastases. Patients with baseline serum NTx of more than 18 nM BCE might benefit more from weekly low-dose of zoledronic acid. Trial registration ClinicalTrials.gov unique identifier: ClinicalTrials.gov: NCT00524849
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- 2011
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32. Correlation between ERK1 and STAT3 expression and chemoresistance in patients with conventional osteosarcoma
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André Maues De Paula, Sébastien Salas, Corinne Bouvier, Catherine Bartoli, Loïc Campion, Carine Jiguet-Jiglaire, Frederic Frassineti, Jean-Claude Gentet, Fabien Forest, Jean-Laurent Deville, and Pascal Jézéquel
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Male ,STAT3 Transcription Factor ,Cancer Research ,Adolescent ,medicine.medical_treatment ,Antineoplastic Agents ,Bone Neoplasms ,Chemotherapy response ,ERK1 ,STAT3 ,Surgical oncology ,Biopsy ,medicine ,Biomarkers, Tumor ,Genetics ,Humans ,Phosphorylation ,Child ,Chemotherapy ,Osteosarcoma ,Tissue microarray ,Mitogen-Activated Protein Kinase 3 ,medicine.diagnostic_test ,business.industry ,Induction chemotherapy ,medicine.disease ,Prognosis ,Gene Expression Regulation, Neoplastic ,Regimen ,Oncology ,Chemotherapy, Adjuvant ,Drug Resistance, Neoplasm ,Child, Preschool ,Cancer research ,Immunohistochemistry ,Female ,Conventional osteosarcomas ,business ,Predictive factors ,Research Article - Abstract
Background The standard therapy regimen of conventional osteosarcoma includes neoadjuvant chemotherapy followed by surgical resection and postoperative chemotherapy. The percentage of necrotic tissue following induction chemotherapy is assessed by using the Huvos grading system, which classifies patients as “poor responders” (PR) and “good responders” (GR). The aim of this study was to identify molecular markers expressed differentially between good and poor responders to neoadjuvant chemotherapy in order to predict the response to chemotherapy in conventional osteosarcomas before beginning treatment. Methods Suppression Substractive Hybridization (SSH) was performed by using cDNA from frozen biopsy specimens. Expression of selected relevant genes identified by SSH was validated by using QRT-PCR. Immunohistochemistry (IHC) on tissue microarray (TMA) sections of 52 biopsies was performed to investigate protein expression in an independent cohort. Results ERK1 and STAT3 mRNA level were significantly different between PR and GR in an independent cohort. Phosphorylated STAT3 and ERK1 expressions by IHC on TMA were correlated with poor response to chemotherapy. Conclusions Our results suggest that ERK1 and STAT3 expression are good predictive markers for chemotherapy response and that inhibitors might be used in combination with common chemotherapeutic drugs in conventional osteosarcomas.
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33. Prognostic and predictive value of clinical and biochemical factors in breast cancer patients with bone metastases receiving 'metronomic' zoledronic acid
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Biyun Wang, Jian Zhang, Zhonghua Wang, Xiaofeng Xu, Xichun Hu, Xinmin Zhao, Zhen Jia, Qunling Zhang, and Si Sun
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Oncology ,Adult ,medicine.medical_specialty ,N-telopeptide ,Cancer Research ,predictive factors ,medicine.medical_treatment ,Bone Neoplasms ,Breast Neoplasms ,lcsh:RC254-282 ,Young Adult ,zoledronic acid ,Breast cancer ,N-terminal telopeptide ,bone metastases ,Internal medicine ,medicine ,Biomarkers, Tumor ,Genetics ,Humans ,Progression-free survival ,Estrogen Receptor Status ,Aged ,Neoplasm Staging ,Chemotherapy ,Univariate analysis ,Bone Density Conservation Agents ,Diphosphonates ,business.industry ,Hazard ratio ,Imidazoles ,Middle Aged ,medicine.disease ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,VEGF ,Zoledronic acid ,Administration, Metronomic ,Female ,Advanced breast cancer ,prognosis ,business ,medicine.drug ,Research Article - Abstract
Background To assess prognostic and predictive effects of clinical and biochemical factors in our published randomized study of a weekly low dose (metronomic arm) versus a conventional dosage of zoledronic acid (conventional arm) in breast cancer patients with bone metastases. Methods Treatment outcome of 60 patients with bone metastases were used to assess impacts of following potential prognostic factors, estrogen receptor status, lymph node status, 2 year-disease free interval (DFI), numbers of chemotherapy regimens administered, interventions, and serum levels of VEGF, N-telopeptide of type I collagen (NTx), CEA, and CA 15-3. Results In univariate analyses, patients pretreated with 2 or fewer chemotherapy regimens, ER-positive tumors, 3 or fewer lymph nodes, DFI of more than 2 years, serum VEGF of less than 500 pg/mL after 3 months of intervention, serum CEA and CA 15-3 of less than ULN, and baseline serum NTx of less than 18 nM BCE had significantly longer progression free survival (PFS). The multivariate analysis showed that ER positivity (hazard ratio [HR], 0.295; 95% confidence interval [CI], 0.141-0.618; P = 0.001), serum VEGF of less than 500 pg/mL after 3 months of intervention (HR, 2.220; 95% CI, 1.136-4.338; P = 0.020), baseline serum NTx of less than 18 nM BCE (HR, 2.842; 95% CI, 1.458-5.539; P = 0.001), and 2 or fewer chemotherapy regimens received (HR, 7.803; 95% CI, 2.884-21.112; P = 0.000) were associated with a better PFS. When evaluating the predictive effect of the biochemical factors, an interaction between NTx and zoledronic acid intervention was shown (P = 0.005). The HR of weekly low dose versus a conventional dosage of zoledronic acid was estimated to be 2.309 (99% CI, 1.067-5.012) in patients with baseline serum NTx of more than 18 nM BCE, indicating a superiority of weekly low dose of zoledronic acid. Conclusions ER, serum VEGF level after intervention, and numbers of chemotherapy regimens administered are prognostic but not predictive factors in breast cancer patients with bone metastases. Patients with baseline serum NTx of more than 18 nM BCE might benefit more from weekly low-dose of zoledronic acid. Trial registration ClinicalTrials.gov unique identifier: ClinicalTrials.gov: NCT00524849
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34. Evaluation of the prognostic role of centromere 17 gain and HER2/topoisomerase II alpha gene status and protein expression in patients with breast cancer treated with anthracycline-containing adjuvant chemotherapy: pooled analysis of two Hellenic Cooperative Oncology Group (HeCOG) phase III trials
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Fountzilas, George, Dafni, U., Bobos, M., Kotoula, V., Batistatou, Anna, Xanthakis, I., Papadimitriou, C., Kostopoulos, I., Koletsa, T., Tsolaki, E., Televantou, D., Timotheadou, E., Koutras, A. K., Klouvas, G. D., Samantas, E., Pisanidis, N., Karanikiotis, C., Sfakianaki, I., Pavlidis, Nicholas, Gogas, H., Linardou, H., Kalogeras, K. T., Pectasides, Dimitrios, Dimopoulos, M. A., Pavlidis, Nicholas [0000-0002-2195-9961], and Kotoula, V. [0000-0002-8657-9732]
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Oncology ,Survival rate ,Gene Dosage ,Anthracycline ,Progesterone receptor ,Gene location ,Multiple cycle treatment ,Dna topoisomerases ,Breast cancer ,Trastuzumab ,Antineoplastic Combined Chemotherapy Protocols ,Odds Ratio ,Anthracyclines ,Disease free survival ,skin and connective tissue diseases ,Cancer hormone therapy ,Prognosis ,Immunohistochemistry ,Paclitaxel ,Genetic gain ,Human ,Gene dosage ,medicine.medical_specialty ,Centromere ,TOP2A Gene ,Major clinical study ,Prognostic factors ,Article ,Fluorescence ,Cancer grading ,Epidermal growth factor receptor 2 ,Taxanes ,Randomized controlled trials as topic ,Genetics ,Humans ,TopoIIa ,Phase 3 clinical trial (topic) ,Topoiia ,neoplasms ,Cyclophosphamide ,Aged ,Chromosome Aberrations ,Cancer prognosis ,Neoplasm grading ,Gene deletion ,Pair 17 ,TOP2A ,Dna topoisomerase (atp hydrolysing) ,medicine.disease ,Biological ,Clinical trial ,Erbb-2 ,Methotrexate ,chemistry ,Cancer adjuvant therapy ,Protein expression ,Neoplasm Grading ,Breast neoplasms ,Cancer Research ,Unclassified drug ,Receptor, ErbB-2 ,chemistry.chemical_compound ,Centromere 17 ,Clinical trials ,Randomized controlled trial (topic) ,Surgical oncology ,Estrogen receptor ,Overall survival ,Poly-ADP-Ribose Binding Proteins ,Middle aged ,In Situ Hybridization, Fluorescence ,Randomized Controlled Trials as Topic ,Fluorescence in situ hybridization ,Odds ratio ,Middle Aged ,Cancer size ,DNA-Binding Proteins ,Phenotype ,Tumor markers ,Female ,Top2a ,Fluorouracil ,Menopause ,In situ hybridization ,Predictive factors ,Research Article ,medicine.drug ,Receptor ,Adult ,Histopathology ,Breast Neoplasms ,Type ii ,Chromosomes ,Young Adult ,Her2 ,Antigens, Neoplasm ,HER2 ,Internal medicine ,Antineoplastic combined chemotherapy protocols ,Biomarkers, Tumor ,medicine ,Chromosome aberrations ,Human tissue ,Antigens ,Neoplasm Staging ,Epirubicin ,Gene amplification ,Topoisomerase ii alpha ,business.industry ,Cancer survival ,Dna-binding proteins ,Adjuvant chemotherapy ,DNA Topoisomerases, Type II ,Young adult ,Clinical Trials, Phase III as Topic ,Phase iii as topic ,Cancer research ,Neoplasm staging ,Neoplasm ,Oncogene neu ,Ki 67 antigen ,business ,Topoisomerase ii alpha gene ,Controlled study ,Chromosomes, Human, Pair 17 - Abstract
Background: The HER2 gene has been established as a valid biological marker for the treatment of breast cancer patients with trastuzumab and probably other agents, such as paclitaxel and anthracyclines. The TOP2A gene has been associated with response to anthracyclines. Limited information exists on the relationship of HER2/TOP2A gene status in the presence of centromere 17 (CEP17) gain with outcome of patients treated with anthracycline-containing adjuvant chemotherapy.Methods: Formalin-fixed paraffin-embedded tumor tissue samples from 1031 patients with high-risk operable breast cancer, enrolled in two consecutive phase III trials, were assessed in a central laboratory by fluorescence in situ hybridization for HER2/TOP2A gene amplification and CEP17 gain (CEP17 probe). Amplification of HER2 and TOP2A were defined as a gene/CEP17 ratio of >2.2 and ≥2.0, respectively, or gene copy number higher than 6. Additionally, HER2, TopoIIa, ER/PgR and Ki67 protein expression was assessed by immunohistochemistry (IHC) and patients were classified according to their IHC phenotype. Treatment consisted of epirubicin-based adjuvant chemotherapy followed by hormonal therapy and radiation, as indicated.Results: HER2 amplification was found in 23.7% of the patients and TOP2A amplification in 10.1%. In total, 41.8% of HER2-amplified tumors demonstrated TOP2A co-amplification. The median (range) of HER2, TOP2A and CEP17 gain was 2.55 (0.70-45.15), 2.20 (0.70-26.15) and 2.00 (0.70-26.55), respectively. Forty percent of the tumors had CEP17 gain (51% of those with HER2 amplification). Adjusting for treatment groups in the Cox model, HER2 amplification, TOP2A amplification, CEP17 gain and HER2/TOP2A co-amplification were not associated with time to relapse or time to death.Conclusion: HER2 amplification, TOP2A amplification, CEP17 gain and HER2/TOP2A co-amplification were not associated with outcome in high-risk breast cancer patients treated with anthracycline-based adjuvant chemotherapy.Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12611000506998 and ACTRN12609001036202. © 2013 Fountzilas et al.; licensee BioMed Central Ltd. 13
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