7081 Background: Cisplatin is one of the most active drugs available in MPM while bortezomib has ... more 7081 Background: Cisplatin is one of the most active drugs available in MPM while bortezomib has shown some activity in single agent phase II studies against MPM. This was a prospective phase II study of cisplatin and bortezomib (CB) in the first line treatment of MPM. Methods: Patients with histological proven MPM, with performance status (PS) 0/1, were eligible. The doses were cisplatin 75mg/m2 /3 wks and bortezomib 1.3mg/m2 day 1, 4, 8, 11 every 3 wks. The primary end-point was progression free survival rate at 18 wks (PFSR=18). The 2-stage Simon design (a=0.1; b = 0.05, P0=0.50 and P1=0.675) was used. In the first step of the study 37 eligible patients were planned. If more than 19 patients were alive and free of progression at 18 wks the total sample size was increased to 76 eligible patients. Results: Between 2007 and 2010 82 patients were entered. The median follow-up time is 32.3 months The median age was 55 years (range: 22-77yrs), male/female: 55/27 , PS 0/1: 9/73, Stage T...
7564 Background: Elderly patients (pts) achieve a similar survival benefit, with acceptable toxic... more 7564 Background: Elderly patients (pts) achieve a similar survival benefit, with acceptable toxicity, from first-line chemotherapy for the treatment of advanced NSCLC compared with their younger counterparts. There have been no second-line trials specifically designed for elderly pts and few data exist on the efficacy and tolerability of second-line therapy in this population. Moreover, little if any information exists on the frequency of administration of second-line chemotherapy in these pts. Methods: The files of 2004 pts with advanced NSCLC enrolled into first-line chemotherapy trials performed by HORG from 1995 to 2007 were reviewed. A total of 600 pts who received second-line chemotherapy within the context of clinical trials were identified. Patients’ data were analysed for efficacy and toxicity according to age. Results: Second-line chemotherapy was administered in 24% and 34% of pts ≥65 and <65 years old after failure of prior therapy (p=0.0001). A total of 219 (24.8%) o...
14574 Background: The GC combination has become a standard of care for advanced TCC. D has demons... more 14574 Background: The GC combination has become a standard of care for advanced TCC. D has demonstrated broad single agent activity in many solid tumors including bladder cancer. We evaluated the safety and the activity of their sequential administration in patients (pts) with locally advanced or metastatic TCC who have not received prior chemotherapy. Methods: Chemotherapy-naïve pts with histologically proven locally advanced or metastatic TCC were enrolled. G 1100 mg/m2 was administered over 30-minutes IV on days 1 and 15, C 80 mg/m2 on day 1 with the adequate hydration and D 80 mg/m2 over 1 h on day 15. Results: From 4/2004–12/2005, 26 pts (25 male, 1 female), median age 65.5 years (range, 48–75), (PS 0/1/2: 16/8/2) were enrolled onto the study. The majority (19pts, 73.1%) had metastatic disease. A median of 4 cycles (range 1–9) was given for a total of 113 cycles. There were 12 delayed cycles due to toxicity and 15 dose reductions. Three (16.7%) complete responses (CRs) and 6 (3...
7605 Background: To compare the docetaxel/gemcitabine (DG) combination versus gemcitabine (G) as ... more 7605 Background: To compare the docetaxel/gemcitabine (DG) combination versus gemcitabine (G) as first-line treatment of elderly patients with advanced non-small cell lung cancer (NSCLC). Methods: ...
7519 Background: To compare the efficacy of MTA and ERL as second-line treatment of patients with... more 7519 Background: To compare the efficacy of MTA and ERL as second-line treatment of patients with advanced/metastatic NSCLC. Methods: Pts were randomized either to MTA (500 mg/m2 on d1, every 3 wee...
668 Background: To evaluate whether the detection of peripheral blood (PB) HER2 mRNA+ positive ce... more 668 Background: To evaluate whether the detection of peripheral blood (PB) HER2 mRNA+ positive cells in patients with breast cancer could be another marker of the micrometastatic disease. Methods: The sensitivity and specificity of HER2 mRNA detection by nested RT-PCR were investigated using MCF-7 and ARH-77 cells as well as blood from healthy women and patients with colorectal, early and metastatic breast cancer. PB from 216 patients with operable breast cancer, obtained before initiation of any adjuvant therapy, was tested for the presence of HER2 mRNA+ positive cells. Results: In dilution experiments the nested RT-PCR assay for HER2 mRNA was capable of detecting up to 105 MCF-7 tumor cells in 105 normal peripheral blood mononuclear cells; no signal was detected with the HER2- ARH-77 cells. No HER2 mRNA+ cells could be detected in the peripheral blood of 31 healthy women, as well as the peripheral blood and the bone marrow of 20 patients with colorectal cancer. Detection rates for HER2 mRNA+ cells in th...
The present study was a phase I/II study to determine the maximum tolerated doses (MTDs) and dose... more The present study was a phase I/II study to determine the maximum tolerated doses (MTDs) and dose-limiting toxicities of the biweekly carboplatin/gemcitabine combination and evaluate its safety and efficacy in patients aged ≥ 70 years with advanced squamous non-small-cell lung cancer (NSCLC). Patients aged ≥ 70 years with advanced or metastatic squamous NSCLC received escalated doses of carboplatin (area under the curve [AUC] 2-2.5 intravenously) and gemcitabine (800-1100 mg/m(2) intravenously) every 2 weeks (phase I). In the phase II, the drugs were administered at their previously defined MTDs (carboplatin, AUC 2.5; gemcitabine, 1100 mg/m(2)). The primary endpoint was the overall response rate. A total of 69 patients were enrolled (phase I, n = 15). The median age was 76 years (range, 70-84 years); 52 patients had stage IV disease, and 61 and 8 patients had Eastern Cooperative Oncology Group performance status of 0 to 1 and 2, respectively. The MTDs could not be reached at the predefined last dose levels. The dose-limiting toxicities were grade 5 renal toxicity and grade 3 thrombocytopenia. In the phase II study, the overall response rate was 35.8% (95% confidence interval [CI], 23.0%-48.8%). In the intention-to-treat analysis, the median progression-free survival was 6.7 months (95% CI, 4.2-8.8 months), and the median overall survival was 13.3 months (95% CI, 7.1-19.6 months). Grade 3 or 4 neutropenia was observed in 7 patients (12.3%), grade 3 or 4 thrombocytopenia in 4 patients (7.1%), and grade 2 or 3 fatigue in 10 patients (17.5%). One toxic death occurred in the phase I of the study. The biweekly regimen of gemcitabine and carboplatin showed satisfactory efficacy and a favorable toxicity profile in elderly patients with advanced or metastatic squamous cell NSCLC.
Improvements in our understanding of the molecular biology of cancer have shifted management of l... more Improvements in our understanding of the molecular biology of cancer have shifted management of lung cancer toward molecular-guided, individualized treatment. Development of epidermal growth factor receptor tyrosine kinase inhibitors, erlotinib and gefitinib, represent the best example of this approach. Erlotinib was tested as second/third line treatment in unselected population of patients and demonstrated a statistically significant prolongation of overall survival, while gefitinib was shown to be non-inferior to docetaxel as second line treatment. The discovery of EGFR activating mutations facilitated the selection of patients most likely to benefit from erlotinib/gefitinib. These drugs in patients with EGFR activating mutations offer an increased progression free survival and significantly higher response rates compared to chemotherapy. The purpose of this paper is to present the relevant clinical data, describe the predictive markers available for TKIs treatment in NSCLC, and d...
Despite the fact that Non-Small Cell Lung Cancer (NSCLC) represents the leading cause of cancer-r... more Despite the fact that Non-Small Cell Lung Cancer (NSCLC) represents the leading cause of cancer-related death in the western, after two decades of intensive clinical research, there still remains a substantial lack of consensus regarding the appropriate chemotherapeutic management of patients with advanced stage disease. For patients with metastatic disease and good performance status, what is considered "standard" treatment is a platinum-based doublet. Several meta-analyses have been performed in order to answer several questionable issues in the treatment of these patients. Their conclusions could be used as an effective instrument for resolving various clinical questions, such as advantage of chemotherapy for advanced NSCLC and identification of the most active combinations and most active agents, or treatment duration and thus providing more reliable evidence for clinical practice.
Non-small-cell lung cancer (NSCLC) remains by far the major cause of cancer-related death in the ... more Non-small-cell lung cancer (NSCLC) remains by far the major cause of cancer-related death in the Western world in both men and women. The majority of patients will be diagnosed with metastatic disease, and chemotherapy doublets remain the cornerstone of treatment for these patients. However, chemotherapy has a minimal impact on long-term survival and prognosis remains poor for these patients. Further improvement in treatment is likely to require incorporation of novel targeted therapies. Among these agents, inhibitors of the epidermal growth factor receptor (EGFR) have demonstrated significant activity in the first-, second- or third-line treatment of NSCLC. The purpose of current paper is to present the evidence for using several proposed molecular biomarkers as a tool for selection of NSCLC patients for anti-EGFR treatment. According to current data, EGFR mutation status appears to be the strongest predictor for the selection of NSCLC patients to first-line treatment with EGFR tyr...
To evaluate the incidence of central nervous system (CNS) involvement in patients with breast can... more To evaluate the incidence of central nervous system (CNS) involvement in patients with breast cancer treated with a taxane-based chemotherapy regimen and to determine predictive factors for CNS relapse. The medical files of patients with early breast cancer (n = 253) or advanced stage breast cancer (n = 239) as well of those with other solid tumors (n = 336) treated with or without a taxane-based chemotherapy regimen during a 42-month period were reviewed. HER2/neu overexpression was identified by immunohistochemistry, whereas cytokeratin 19 (CK-19) mRNA-positive circulating tumor cells (CTCs) in the peripheral blood were identified by real-time PCR. The incidence of CNS relapse was similar in patients suffering from breast cancer or other solid tumors (10.4% and 11.4%, respectively; P = 0.517). The incidence of CNS relapse was significantly higher in breast cancer patients with advanced disease (P = 0.041), visceral disease and bone disease (P = 0.036), in those who were treated wi...
TO THE EDITOR: We read with interest the article by Casellas et al. in a recent issue of TheAmeri... more TO THE EDITOR: We read with interest the article by Casellas et al. in a recent issue of TheAmerican Journal of Gastroenterology ( 1 ). The authors recommend a new, 9-item, short questionnaire for assessing health-related quality of life (HRQOL) in patients with inflammatory bowel ...
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a disease-specific questionnaire for asses... more The Inflammatory Bowel Disease Questionnaire (IBDQ) is a disease-specific questionnaire for assessing health-related quality of life. The main objective of this study is to assess three main areas of the validation of the Greek IBDQ: internal validity, designating items to dimensions, and selecting items for a short form. An additional aim is to present alternative validation methods for improved and robust results. A total of 134 patients with IBD, including 74 with ulcerative colitis (UC) and 60 with Crohn's disease (CD), completed the Greek IBDQ. Internal validity was assessed by using standard methods and multiple correlation analysis. Factor analysis of the 32 items of the questionnaire was carried out to identify the underlying dimensions, using principal factor analysis and maximal likelihood. For selecting items for a short form, three methods of linear regression analysis were used. All items had adequate convergent validity (except item 11 in the CD group) and acceptab...
To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxe... more To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxel in combination with oxaliplatin (L-OHP) as first-line treatment of patients with advanced breast (ABC) and non-small cell lung cancer (NSCLC). Fifty-two patients (26 with NSCLC and 26 with ABC), who had not received prior chemotherapy for metastatic disease, were enrolled. The patients' median age was 64 years, and 42 (71%) had a performance status (WHO) 0-1. Docetaxel was given as a 1-hour infusion after standard premedication on day 1 and L-OHP as a 2 to 6-hour infusion on day 2 every 3 weeks. Doses were escalated at increments of 10 mg/m2. The DLT1 was reached at the doses of docetaxel 75 mg/m2 and L-OHP 80 mg/m2. The addition of rhG-CSF permitted further dose escalation (DLT2: docetaxel 90 mg/m2 and L-OHP 130 mg/m2). The dose-limiting events were grade 4 neutropenia, febrile neutropenia, grades 3 or 4 diarrhea and grade 3 fatigue. Out of 239 delivered cycles, grades 3 or 4 neut...
Methods of Cancer Diagnosis, Therapy and Prognosis, 2008
... K., Noel, D., Pinter, T., VanBelle, S., Vorobiof, D., Duarte, R., Gil, GM, Bodrogi, I., Murra... more ... K., Noel, D., Pinter, T., VanBelle, S., Vorobiof, D., Duarte, R., Gil, GM, Bodrogi, I., Murray, E., Yelle, L., von Minckwitz, G., Korec, S., Simmonds, P ... Conte, PF, Baldini, E., Gennari, A., Michelotti, A., Salvadori, B., Tibaldi, C., Danesi, R., Innocenti, F., Gentile, A., Dell&#x27;Anna, R., Biadi, O ...
7081 Background: Cisplatin is one of the most active drugs available in MPM while bortezomib has ... more 7081 Background: Cisplatin is one of the most active drugs available in MPM while bortezomib has shown some activity in single agent phase II studies against MPM. This was a prospective phase II study of cisplatin and bortezomib (CB) in the first line treatment of MPM. Methods: Patients with histological proven MPM, with performance status (PS) 0/1, were eligible. The doses were cisplatin 75mg/m2 /3 wks and bortezomib 1.3mg/m2 day 1, 4, 8, 11 every 3 wks. The primary end-point was progression free survival rate at 18 wks (PFSR=18). The 2-stage Simon design (a=0.1; b = 0.05, P0=0.50 and P1=0.675) was used. In the first step of the study 37 eligible patients were planned. If more than 19 patients were alive and free of progression at 18 wks the total sample size was increased to 76 eligible patients. Results: Between 2007 and 2010 82 patients were entered. The median follow-up time is 32.3 months The median age was 55 years (range: 22-77yrs), male/female: 55/27 , PS 0/1: 9/73, Stage T...
7564 Background: Elderly patients (pts) achieve a similar survival benefit, with acceptable toxic... more 7564 Background: Elderly patients (pts) achieve a similar survival benefit, with acceptable toxicity, from first-line chemotherapy for the treatment of advanced NSCLC compared with their younger counterparts. There have been no second-line trials specifically designed for elderly pts and few data exist on the efficacy and tolerability of second-line therapy in this population. Moreover, little if any information exists on the frequency of administration of second-line chemotherapy in these pts. Methods: The files of 2004 pts with advanced NSCLC enrolled into first-line chemotherapy trials performed by HORG from 1995 to 2007 were reviewed. A total of 600 pts who received second-line chemotherapy within the context of clinical trials were identified. Patients’ data were analysed for efficacy and toxicity according to age. Results: Second-line chemotherapy was administered in 24% and 34% of pts ≥65 and <65 years old after failure of prior therapy (p=0.0001). A total of 219 (24.8%) o...
14574 Background: The GC combination has become a standard of care for advanced TCC. D has demons... more 14574 Background: The GC combination has become a standard of care for advanced TCC. D has demonstrated broad single agent activity in many solid tumors including bladder cancer. We evaluated the safety and the activity of their sequential administration in patients (pts) with locally advanced or metastatic TCC who have not received prior chemotherapy. Methods: Chemotherapy-naïve pts with histologically proven locally advanced or metastatic TCC were enrolled. G 1100 mg/m2 was administered over 30-minutes IV on days 1 and 15, C 80 mg/m2 on day 1 with the adequate hydration and D 80 mg/m2 over 1 h on day 15. Results: From 4/2004–12/2005, 26 pts (25 male, 1 female), median age 65.5 years (range, 48–75), (PS 0/1/2: 16/8/2) were enrolled onto the study. The majority (19pts, 73.1%) had metastatic disease. A median of 4 cycles (range 1–9) was given for a total of 113 cycles. There were 12 delayed cycles due to toxicity and 15 dose reductions. Three (16.7%) complete responses (CRs) and 6 (3...
7605 Background: To compare the docetaxel/gemcitabine (DG) combination versus gemcitabine (G) as ... more 7605 Background: To compare the docetaxel/gemcitabine (DG) combination versus gemcitabine (G) as first-line treatment of elderly patients with advanced non-small cell lung cancer (NSCLC). Methods: ...
7519 Background: To compare the efficacy of MTA and ERL as second-line treatment of patients with... more 7519 Background: To compare the efficacy of MTA and ERL as second-line treatment of patients with advanced/metastatic NSCLC. Methods: Pts were randomized either to MTA (500 mg/m2 on d1, every 3 wee...
668 Background: To evaluate whether the detection of peripheral blood (PB) HER2 mRNA+ positive ce... more 668 Background: To evaluate whether the detection of peripheral blood (PB) HER2 mRNA+ positive cells in patients with breast cancer could be another marker of the micrometastatic disease. Methods: The sensitivity and specificity of HER2 mRNA detection by nested RT-PCR were investigated using MCF-7 and ARH-77 cells as well as blood from healthy women and patients with colorectal, early and metastatic breast cancer. PB from 216 patients with operable breast cancer, obtained before initiation of any adjuvant therapy, was tested for the presence of HER2 mRNA+ positive cells. Results: In dilution experiments the nested RT-PCR assay for HER2 mRNA was capable of detecting up to 105 MCF-7 tumor cells in 105 normal peripheral blood mononuclear cells; no signal was detected with the HER2- ARH-77 cells. No HER2 mRNA+ cells could be detected in the peripheral blood of 31 healthy women, as well as the peripheral blood and the bone marrow of 20 patients with colorectal cancer. Detection rates for HER2 mRNA+ cells in th...
The present study was a phase I/II study to determine the maximum tolerated doses (MTDs) and dose... more The present study was a phase I/II study to determine the maximum tolerated doses (MTDs) and dose-limiting toxicities of the biweekly carboplatin/gemcitabine combination and evaluate its safety and efficacy in patients aged ≥ 70 years with advanced squamous non-small-cell lung cancer (NSCLC). Patients aged ≥ 70 years with advanced or metastatic squamous NSCLC received escalated doses of carboplatin (area under the curve [AUC] 2-2.5 intravenously) and gemcitabine (800-1100 mg/m(2) intravenously) every 2 weeks (phase I). In the phase II, the drugs were administered at their previously defined MTDs (carboplatin, AUC 2.5; gemcitabine, 1100 mg/m(2)). The primary endpoint was the overall response rate. A total of 69 patients were enrolled (phase I, n = 15). The median age was 76 years (range, 70-84 years); 52 patients had stage IV disease, and 61 and 8 patients had Eastern Cooperative Oncology Group performance status of 0 to 1 and 2, respectively. The MTDs could not be reached at the predefined last dose levels. The dose-limiting toxicities were grade 5 renal toxicity and grade 3 thrombocytopenia. In the phase II study, the overall response rate was 35.8% (95% confidence interval [CI], 23.0%-48.8%). In the intention-to-treat analysis, the median progression-free survival was 6.7 months (95% CI, 4.2-8.8 months), and the median overall survival was 13.3 months (95% CI, 7.1-19.6 months). Grade 3 or 4 neutropenia was observed in 7 patients (12.3%), grade 3 or 4 thrombocytopenia in 4 patients (7.1%), and grade 2 or 3 fatigue in 10 patients (17.5%). One toxic death occurred in the phase I of the study. The biweekly regimen of gemcitabine and carboplatin showed satisfactory efficacy and a favorable toxicity profile in elderly patients with advanced or metastatic squamous cell NSCLC.
Improvements in our understanding of the molecular biology of cancer have shifted management of l... more Improvements in our understanding of the molecular biology of cancer have shifted management of lung cancer toward molecular-guided, individualized treatment. Development of epidermal growth factor receptor tyrosine kinase inhibitors, erlotinib and gefitinib, represent the best example of this approach. Erlotinib was tested as second/third line treatment in unselected population of patients and demonstrated a statistically significant prolongation of overall survival, while gefitinib was shown to be non-inferior to docetaxel as second line treatment. The discovery of EGFR activating mutations facilitated the selection of patients most likely to benefit from erlotinib/gefitinib. These drugs in patients with EGFR activating mutations offer an increased progression free survival and significantly higher response rates compared to chemotherapy. The purpose of this paper is to present the relevant clinical data, describe the predictive markers available for TKIs treatment in NSCLC, and d...
Despite the fact that Non-Small Cell Lung Cancer (NSCLC) represents the leading cause of cancer-r... more Despite the fact that Non-Small Cell Lung Cancer (NSCLC) represents the leading cause of cancer-related death in the western, after two decades of intensive clinical research, there still remains a substantial lack of consensus regarding the appropriate chemotherapeutic management of patients with advanced stage disease. For patients with metastatic disease and good performance status, what is considered "standard" treatment is a platinum-based doublet. Several meta-analyses have been performed in order to answer several questionable issues in the treatment of these patients. Their conclusions could be used as an effective instrument for resolving various clinical questions, such as advantage of chemotherapy for advanced NSCLC and identification of the most active combinations and most active agents, or treatment duration and thus providing more reliable evidence for clinical practice.
Non-small-cell lung cancer (NSCLC) remains by far the major cause of cancer-related death in the ... more Non-small-cell lung cancer (NSCLC) remains by far the major cause of cancer-related death in the Western world in both men and women. The majority of patients will be diagnosed with metastatic disease, and chemotherapy doublets remain the cornerstone of treatment for these patients. However, chemotherapy has a minimal impact on long-term survival and prognosis remains poor for these patients. Further improvement in treatment is likely to require incorporation of novel targeted therapies. Among these agents, inhibitors of the epidermal growth factor receptor (EGFR) have demonstrated significant activity in the first-, second- or third-line treatment of NSCLC. The purpose of current paper is to present the evidence for using several proposed molecular biomarkers as a tool for selection of NSCLC patients for anti-EGFR treatment. According to current data, EGFR mutation status appears to be the strongest predictor for the selection of NSCLC patients to first-line treatment with EGFR tyr...
To evaluate the incidence of central nervous system (CNS) involvement in patients with breast can... more To evaluate the incidence of central nervous system (CNS) involvement in patients with breast cancer treated with a taxane-based chemotherapy regimen and to determine predictive factors for CNS relapse. The medical files of patients with early breast cancer (n = 253) or advanced stage breast cancer (n = 239) as well of those with other solid tumors (n = 336) treated with or without a taxane-based chemotherapy regimen during a 42-month period were reviewed. HER2/neu overexpression was identified by immunohistochemistry, whereas cytokeratin 19 (CK-19) mRNA-positive circulating tumor cells (CTCs) in the peripheral blood were identified by real-time PCR. The incidence of CNS relapse was similar in patients suffering from breast cancer or other solid tumors (10.4% and 11.4%, respectively; P = 0.517). The incidence of CNS relapse was significantly higher in breast cancer patients with advanced disease (P = 0.041), visceral disease and bone disease (P = 0.036), in those who were treated wi...
TO THE EDITOR: We read with interest the article by Casellas et al. in a recent issue of TheAmeri... more TO THE EDITOR: We read with interest the article by Casellas et al. in a recent issue of TheAmerican Journal of Gastroenterology ( 1 ). The authors recommend a new, 9-item, short questionnaire for assessing health-related quality of life (HRQOL) in patients with inflammatory bowel ...
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a disease-specific questionnaire for asses... more The Inflammatory Bowel Disease Questionnaire (IBDQ) is a disease-specific questionnaire for assessing health-related quality of life. The main objective of this study is to assess three main areas of the validation of the Greek IBDQ: internal validity, designating items to dimensions, and selecting items for a short form. An additional aim is to present alternative validation methods for improved and robust results. A total of 134 patients with IBD, including 74 with ulcerative colitis (UC) and 60 with Crohn's disease (CD), completed the Greek IBDQ. Internal validity was assessed by using standard methods and multiple correlation analysis. Factor analysis of the 32 items of the questionnaire was carried out to identify the underlying dimensions, using principal factor analysis and maximal likelihood. For selecting items for a short form, three methods of linear regression analysis were used. All items had adequate convergent validity (except item 11 in the CD group) and acceptab...
To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxe... more To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxel in combination with oxaliplatin (L-OHP) as first-line treatment of patients with advanced breast (ABC) and non-small cell lung cancer (NSCLC). Fifty-two patients (26 with NSCLC and 26 with ABC), who had not received prior chemotherapy for metastatic disease, were enrolled. The patients' median age was 64 years, and 42 (71%) had a performance status (WHO) 0-1. Docetaxel was given as a 1-hour infusion after standard premedication on day 1 and L-OHP as a 2 to 6-hour infusion on day 2 every 3 weeks. Doses were escalated at increments of 10 mg/m2. The DLT1 was reached at the doses of docetaxel 75 mg/m2 and L-OHP 80 mg/m2. The addition of rhG-CSF permitted further dose escalation (DLT2: docetaxel 90 mg/m2 and L-OHP 130 mg/m2). The dose-limiting events were grade 4 neutropenia, febrile neutropenia, grades 3 or 4 diarrhea and grade 3 fatigue. Out of 239 delivered cycles, grades 3 or 4 neut...
Methods of Cancer Diagnosis, Therapy and Prognosis, 2008
... K., Noel, D., Pinter, T., VanBelle, S., Vorobiof, D., Duarte, R., Gil, GM, Bodrogi, I., Murra... more ... K., Noel, D., Pinter, T., VanBelle, S., Vorobiof, D., Duarte, R., Gil, GM, Bodrogi, I., Murray, E., Yelle, L., von Minckwitz, G., Korec, S., Simmonds, P ... Conte, PF, Baldini, E., Gennari, A., Michelotti, A., Salvadori, B., Tibaldi, C., Danesi, R., Innocenti, F., Gentile, A., Dell&#x27;Anna, R., Biadi, O ...
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