Yttrium-90 ibritumomab tiuxetan is clinically active in patients with advanced diffuse large B-cell lymphoma ineligible for stem-cell transplantation
Researchers have reported that yttrium-90 ibritumomab tiuxetan (Zevalin®; Biogen Idec, Bayer Schering Pharma) has clinical activity in patients with advanced diffuse large B-cell lymphoma who were unable to undergo stem-cell transplantation, in a study reported in the journal Blood this week.
Yttrium-90 ibritumomab tiuxetan is a monoclonal antibody bound via a linker (tiutexan) to the radioisotopes Yttrium-90 or Indium-11, targeting the CD20 antigen on normal and malignant B-lymphocytes. As a result, radiation is directed against CD20 positive cells, inducing cellular damage on the target and neighboring cells.
Yttrium-90 ibritumomab tiuxetan is currently indicated for for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with rituximab-refractory follicular NHL.
In the current Phase II study, elderly patients with first relapsed or primary refractory diffuse large B-cell lymphoma and ineligible for stem-cell transplantation received a single dose of yttrium-90 ibritumomab tiuxetan. Patients had previously been treated with chemotherapy or chemotherapy plus rituximab. Those patients who had previously been treated with chemotherapy were further divided into a) patients in whom induction therapy had failed and b) patients who had relapsed after achieving a complete response.
The overall response rate was higher in patients who had previously received chemotherapy than those who had previously received chemotherapy plus rituximab (52.5% vs. 19%, respectively). The complete response/complete response unconfirmed rates were higher in patients who had previously received chemotherapy and either failed induction therapy or relapsed after achieving a complete response (24% and 39.5%, respectively) than those patients who had previously been treated with chemotherapy plus rituximab (12%). Median progression free and overall survival were also higher in patients who had previously received chemotherapy than those who had previously received chemotherapy plus rituximab.
Two patients died from thrombocytopenic cerebral bleeding following administration of therapy. Haematologic adverse events were mild to moderate in nature.
Author’s conclusions: ‘Yttrium-90 ibritumomab is active in patients with relapsed and refractory diffuse large B-cell lymphoma and its further evaluation in phase 3 studies is ongoing'.
Source: http://bloodjournal.hematologylibrary.org/cgi/content/abstract/110/1/54
Wednesday, June 20, 2007
Tuesday, June 12, 2007
Dasatinib shows promising clinical benefit in patients with chronic myelogenous leukaemia who have failed first-line imatinib
Researchers have reported that the oral dual BCR/ABL and family tyrosine kinase inhibitor, Sprycel® (dasatinib), achieves higher response rates compared with high-dose imatinib, in a Phase II study of patients with imatinib-resistant chronic-phase (CP) chronic myelogenous leukemia (CML), in a study published in the journal Blood this week.
Imatinib, which inhibits the BCR-ABL tyrosine kinase implicated in the pathophysiology of CML, is the therapy of choice for previously untreated chronic-phase CML, achieving complete cytogenetic remission in up to 80% of patients. However, most patients treated with imatinib usually harbor minimal residual disease that eventually leads to disease recurrence.
Dasatinib, is approximately 300 times more potent against BCR-ABL than imatinib, and is currently approved for the second-line treatment of imatinib-resistant CML. In this setting, dasatinib has been shown to induce complete cytogenetic remission in 75% of imatinib-intolerant patients and 40% of imatinib-resistant patients.
In the current study, patients with CP CML resistant to imatinib were randomized to receive 140 mg dasatinib or high-dose imatinib (800 mg). At 15 months, the proportion of patients with a complete haematological response was significantly higher in patients receiving dasatanib versus imatinib (93% vs. 82%, respectively; P = .034), which included complete cytogenetic responses (40% vs. 16%, respectively; P = .004). In addition, the proportion of patients with a major molecular response was significantly higher with dasatinib versus imatinib (16% versus 4%, respectively; P = 0.038). Treatment failure was lower and progression-free survival higher in patients receiving dasatinib versus imatinib (P < .001), although the duration of benefit is not known because of the brief follow-up period.
Superficial oedema and fluid retention were more common in patients receiving imatinib, and pleural effusion was more common with dasatinib. Grade 3 to 4 non-hematologic toxicity was minimal. Cytopenias were more frequent and severe with dasatinib.
Author’s conclusions: ‘Dasatinib represents a safe and effective therapy for CP CML resistant to conventional imatinib doses with improved cytogenetic and molecular response rates and progression-free survival relative to high-dose imatinib.’
Source: http://bloodjournal.hematologylibrary.org/cgi/content/abstract/109/12/5143
NOTE: A preliminary study presented at ASCO this year suggested that dasatinib mayshow promising clinical benefit as first-line treatment of chronic-phase (CP) chronic myelogenous leukemia (CML) http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=47&abstractID=31679
Researchers have reported that the oral dual BCR/ABL and family tyrosine kinase inhibitor, Sprycel® (dasatinib), achieves higher response rates compared with high-dose imatinib, in a Phase II study of patients with imatinib-resistant chronic-phase (CP) chronic myelogenous leukemia (CML), in a study published in the journal Blood this week.
Imatinib, which inhibits the BCR-ABL tyrosine kinase implicated in the pathophysiology of CML, is the therapy of choice for previously untreated chronic-phase CML, achieving complete cytogenetic remission in up to 80% of patients. However, most patients treated with imatinib usually harbor minimal residual disease that eventually leads to disease recurrence.
Dasatinib, is approximately 300 times more potent against BCR-ABL than imatinib, and is currently approved for the second-line treatment of imatinib-resistant CML. In this setting, dasatinib has been shown to induce complete cytogenetic remission in 75% of imatinib-intolerant patients and 40% of imatinib-resistant patients.
In the current study, patients with CP CML resistant to imatinib were randomized to receive 140 mg dasatinib or high-dose imatinib (800 mg). At 15 months, the proportion of patients with a complete haematological response was significantly higher in patients receiving dasatanib versus imatinib (93% vs. 82%, respectively; P = .034), which included complete cytogenetic responses (40% vs. 16%, respectively; P = .004). In addition, the proportion of patients with a major molecular response was significantly higher with dasatinib versus imatinib (16% versus 4%, respectively; P = 0.038). Treatment failure was lower and progression-free survival higher in patients receiving dasatinib versus imatinib (P < .001), although the duration of benefit is not known because of the brief follow-up period.
Superficial oedema and fluid retention were more common in patients receiving imatinib, and pleural effusion was more common with dasatinib. Grade 3 to 4 non-hematologic toxicity was minimal. Cytopenias were more frequent and severe with dasatinib.
Author’s conclusions: ‘Dasatinib represents a safe and effective therapy for CP CML resistant to conventional imatinib doses with improved cytogenetic and molecular response rates and progression-free survival relative to high-dose imatinib.’
Source: http://bloodjournal.hematologylibrary.org/cgi/content/abstract/109/12/5143
NOTE: A preliminary study presented at ASCO this year suggested that dasatinib mayshow promising clinical benefit as first-line treatment of chronic-phase (CP) chronic myelogenous leukemia (CML) http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=47&abstractID=31679
Saturday, June 09, 2007
A healthy lifestyle may improve survival after breast cancer diagnosis
American researchers have reported that physically active women who eat a high vegetable and fruit diet have improved survival regardless of obesity according to a study published this week in the Journal of Clinical Oncology.
The authors of this study followed about 1,500 women diagnosed and treated for early-stage breast cancer. The combination of eating ≥5 daily servings of vegetables and fruits plus taking regular exercise equivalent to walking 30 minutes/day per week was associated with a 44% increase in survival. In addition, there was no apparent effect of obesity on survival.
Author’s conclusions: A minority of breast cancer survivors follow a healthy lifestyle that includes both recommended intakes of vegetables and fruits and moderate levels of physical activity. The strong protective effect observed suggests a need for additional investigation of the effect of the combined influence of diet and physical activity on breast cancer survival.
Source: http://jco.ascopubs.org/cgi/content/abstract/25/17/2345
American researchers have reported that physically active women who eat a high vegetable and fruit diet have improved survival regardless of obesity according to a study published this week in the Journal of Clinical Oncology.
The authors of this study followed about 1,500 women diagnosed and treated for early-stage breast cancer. The combination of eating ≥5 daily servings of vegetables and fruits plus taking regular exercise equivalent to walking 30 minutes/day per week was associated with a 44% increase in survival. In addition, there was no apparent effect of obesity on survival.
Author’s conclusions: A minority of breast cancer survivors follow a healthy lifestyle that includes both recommended intakes of vegetables and fruits and moderate levels of physical activity. The strong protective effect observed suggests a need for additional investigation of the effect of the combined influence of diet and physical activity on breast cancer survival.
Source: http://jco.ascopubs.org/cgi/content/abstract/25/17/2345
Thursday, June 07, 2007
Cisplatin superior to carboplatin for first-line treatment of non-small-cell lung cancer
Researchers have reported a higher response rate for cisplatin compared with carboplatin when used to treat non-small cell lung cancer (NSCLC) according to results presented in this month’s Journal of the National Cancer Institute.
Pooled data from nine clinical trials comparing cisplatin to carboplatin as first-line treatment of patients with stage IIIb-IV non-small-cell lung cancer were analysed. The author’s found a significantly higher objective response rate (ORR) with cisplatin versus carboplatin (30% versus 24%, respectively; P<.001). There was a trend towards increased survival in patients receiving cisplatin, compared with those patients receiving carboplatin. In addition, cisplatin was more effective in prolonging survival in cases treated with third-generation regimens and in those with non-squamous histology.
Author’s conclusions: ‘Our individual patient data meta-analysis suggests that cisplatin-based chemotherapy is slightly superior to carboplatin-based chemotherapy in terms of response rate and, in certain subgroups, in prolonging survival without being associated with an increase in severe toxic effects. Therefore, cisplatin-based third-generation regimens should remain the standard reference for the treatment of selected patients with advanced-stage NSCLC and of those with earlier-stage disease.
Cisplatin-based chemotherapy was associated with more severe nausea and vomiting and nephrotoxicity, wherease severe thrombocytopenia was more frequent during carboplatin-based chemotherapy.
Source: http://jnci.oxfordjournals.org/cgi/content/abstract/99/11/847
Researchers have reported a higher response rate for cisplatin compared with carboplatin when used to treat non-small cell lung cancer (NSCLC) according to results presented in this month’s Journal of the National Cancer Institute.
Pooled data from nine clinical trials comparing cisplatin to carboplatin as first-line treatment of patients with stage IIIb-IV non-small-cell lung cancer were analysed. The author’s found a significantly higher objective response rate (ORR) with cisplatin versus carboplatin (30% versus 24%, respectively; P<.001). There was a trend towards increased survival in patients receiving cisplatin, compared with those patients receiving carboplatin. In addition, cisplatin was more effective in prolonging survival in cases treated with third-generation regimens and in those with non-squamous histology.
Author’s conclusions: ‘Our individual patient data meta-analysis suggests that cisplatin-based chemotherapy is slightly superior to carboplatin-based chemotherapy in terms of response rate and, in certain subgroups, in prolonging survival without being associated with an increase in severe toxic effects. Therefore, cisplatin-based third-generation regimens should remain the standard reference for the treatment of selected patients with advanced-stage NSCLC and of those with earlier-stage disease.
Cisplatin-based chemotherapy was associated with more severe nausea and vomiting and nephrotoxicity, wherease severe thrombocytopenia was more frequent during carboplatin-based chemotherapy.
Source: http://jnci.oxfordjournals.org/cgi/content/abstract/99/11/847
Wednesday, June 06, 2007
Increased coffee consumption may reduce the risk of liver cancer
Swedish researchers have reported that an increase in consumption of 2 cups of
coffee per day is associated with a reduced risk of liver cancer, in a study reported in May’s issue of the journal Gastroenterology.
The authors, Drs Susanna Larsson and Alicja Wolk, pooled data in a meta-analysis of nine clinical studies (5 cohort and 4 case-control studies) involving 2,260 cases and 239,146 non-cases.
They found an inverse association between coffee consumption and risk of liver cancer that was statistically significant in 6/9 studies. The authors reported that an increase in coffee consumption of 2 cups per day was association with 43% reduction in risk of liver cancer.
The authors note several lines of evidence that a protective effect of coffee consumption on liver is biologically plausible. For example, coffee contains antioxidants such as chlorogenic acids, and animal studies have shown an inhibitory effect of coffee and chlorogenic acids on liver cancer
Author’s conclusions ‘Findings from this meta-analysis indicate
that coffee consumption may reduce the risk of liver cancer. The mechanisms involved and the substances in coffee that may be responsible for the relation remain to be elucidated.’
Source: http://www.gastrojournal.org/article/PIIS0016508507005689/abstract
Swedish researchers have reported that an increase in consumption of 2 cups of
coffee per day is associated with a reduced risk of liver cancer, in a study reported in May’s issue of the journal Gastroenterology.
The authors, Drs Susanna Larsson and Alicja Wolk, pooled data in a meta-analysis of nine clinical studies (5 cohort and 4 case-control studies) involving 2,260 cases and 239,146 non-cases.
They found an inverse association between coffee consumption and risk of liver cancer that was statistically significant in 6/9 studies. The authors reported that an increase in coffee consumption of 2 cups per day was association with 43% reduction in risk of liver cancer.
The authors note several lines of evidence that a protective effect of coffee consumption on liver is biologically plausible. For example, coffee contains antioxidants such as chlorogenic acids, and animal studies have shown an inhibitory effect of coffee and chlorogenic acids on liver cancer
Author’s conclusions ‘Findings from this meta-analysis indicate
that coffee consumption may reduce the risk of liver cancer. The mechanisms involved and the substances in coffee that may be responsible for the relation remain to be elucidated.’
Source: http://www.gastrojournal.org/article/PIIS0016508507005689/abstract
Monday, June 04, 2007
Sorafenib improves survival in advancer liver cancer
Researchers have found that sorafenib (Nexavar®) increases survival in patients with advanced hepatocellular carcinoma (HCC), in a study presented at this years' American Society of Clinical Oncology meeting in Chicago.
Sorafenib is a multi-kinase inhibitor that targets several tyrosine kinases and serine/threonine kinases involved in tumor cell proliferation and angiogenesis.
Sorafenib, is currently approved in the United States for treating approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy
In this Phase III trial, 602 patients with advanced HCC received sorafenib or placebo. Sorafenib significantly increased overall survival by 44%, compared with those patients receiving placebo (p=0.0006). The incidence of adverse side effects was similar between the two groups (52% percent in the sorafenib group and 54% for placebo). Patients who received sorafenib lived a median of 10.7 months compared with 7.9 months for those who received a placebo. Time to cancer progression was also significantly longer with sorafenib vs. placebo (5.5 vs. 2.8 months). Due to these positive findings, the study was terminated early.
Author’s conclusions ‘Sorafenib was well tolerated and is the first agent to demonstrate a statistically significant improvement in overall survival for pts with advanced HCC. This effect is clinically meaningful and establishes sorafenib as first-line treatment for these patients.
Researchers have found that sorafenib (Nexavar®) increases survival in patients with advanced hepatocellular carcinoma (HCC), in a study presented at this years' American Society of Clinical Oncology meeting in Chicago.
Sorafenib is a multi-kinase inhibitor that targets several tyrosine kinases and serine/threonine kinases involved in tumor cell proliferation and angiogenesis.
Sorafenib, is currently approved in the United States for treating approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy
In this Phase III trial, 602 patients with advanced HCC received sorafenib or placebo. Sorafenib significantly increased overall survival by 44%, compared with those patients receiving placebo (p=0.0006). The incidence of adverse side effects was similar between the two groups (52% percent in the sorafenib group and 54% for placebo). Patients who received sorafenib lived a median of 10.7 months compared with 7.9 months for those who received a placebo. Time to cancer progression was also significantly longer with sorafenib vs. placebo (5.5 vs. 2.8 months). Due to these positive findings, the study was terminated early.
Author’s conclusions ‘Sorafenib was well tolerated and is the first agent to demonstrate a statistically significant improvement in overall survival for pts with advanced HCC. This effect is clinically meaningful and establishes sorafenib as first-line treatment for these patients.
Temsirolimus (Torisel) approved by the FDA for the treatment of advanced renal cell carcinoma
Approval was based on data published in The New England Journal of Medicine last week (http://scienceweekly.blogspot.com/2007_05_01_archive.html).
In the US, renal cell carcinoma is diagnosed in approximately 51,000 people per year and accounts for about 85 percent of all U.S. adult kidney cancer. Torisel is manufactured by Wyeth Pharmaceuticals, Inc.
Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01644.html
Approval was based on data published in The New England Journal of Medicine last week (http://scienceweekly.blogspot.com/2007_05_01_archive.html).
In the US, renal cell carcinoma is diagnosed in approximately 51,000 people per year and accounts for about 85 percent of all U.S. adult kidney cancer. Torisel is manufactured by Wyeth Pharmaceuticals, Inc.
Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01644.html
Adjuvant interferon prolongs relapse-free survival in advanced melanoma
European researchers have reported that long-term adjuvant therapy with pegylated interferon-alpha2b (PEG-IFN; INTRON® A) improves relapse-free survival, compared with observation alone, in results presented at the American Society of Clinical Oncology meeting in Chicago this week.
In this Phase III study, patients with stage III melanoma received PEG-IFN for up to 5 years or were clinically observed during the study. Relapse-free survival (RFS) was significantly higher with PEG-IFN (34.8 months) versus clinical observation (25.5 months) over the 5 years of the study.
There was no significant difference between the study arms in either distant metastasis-free survival (DMFS) or overall survival (OS) in the entire population. However, patients with only microscopic nodal involvement (sentinel node-positive) seemed to have better outcomes, in terms of both RFS and DMFS.
Author’s conclusions: ‘Long term PEG-IFN therapy in stage III melanoma had a significant and sustained impact on RFS, but not on DMFS and OS. Patients with only microscopic nodal involvement (sentinel node positive) seemed to have greater benefit in terms of both RFS and DMFS. Similar better effects of adjuvant IFN therapy in pts with lower disease burden are observed in 2 consecutive EORTC trials (18952 and 18991) involving 2644 pts.’
Source: http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=47&abstractID=32118
European researchers have reported that long-term adjuvant therapy with pegylated interferon-alpha2b (PEG-IFN; INTRON® A) improves relapse-free survival, compared with observation alone, in results presented at the American Society of Clinical Oncology meeting in Chicago this week.
In this Phase III study, patients with stage III melanoma received PEG-IFN for up to 5 years or were clinically observed during the study. Relapse-free survival (RFS) was significantly higher with PEG-IFN (34.8 months) versus clinical observation (25.5 months) over the 5 years of the study.
There was no significant difference between the study arms in either distant metastasis-free survival (DMFS) or overall survival (OS) in the entire population. However, patients with only microscopic nodal involvement (sentinel node-positive) seemed to have better outcomes, in terms of both RFS and DMFS.
Author’s conclusions: ‘Long term PEG-IFN therapy in stage III melanoma had a significant and sustained impact on RFS, but not on DMFS and OS. Patients with only microscopic nodal involvement (sentinel node positive) seemed to have greater benefit in terms of both RFS and DMFS. Similar better effects of adjuvant IFN therapy in pts with lower disease burden are observed in 2 consecutive EORTC trials (18952 and 18991) involving 2644 pts.’
Source: http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=47&abstractID=32118
Sunday, June 03, 2007
Ginseng may reduce cancer-related fatigue
Researchers have reported that the herb ginseng may reduce cancer-related fatigue, in a study presented at this years’ American Society of Clinical Oncology meeting in Chicago.
In the current study, patients with a life expectancy of at least 6 months and a history of cancer-related fatigue for at least the previous month took either placebo, ginseng 750 mg/day, ginseng 1,000 mg/day or ginseng 2,000 mg/day for eight weeks.
Patients taking ginseng 1,000 mg/day or 2,000 mg/day acheived greated reductions in fatigue, than those patients taking ginseng 750 mg/day or placebo. Twenty-five percent of patients taking ginseng 1,000 mg/day and 27% of patients taking ginseng 2,000 mg/day reported that their fatigue levels were moderately better or much better, compared with 10% of patients taking ginseng 750 mg/day and 10% of patients taking placebo.
Author’s conclusions: ‘This randomized pilot trial provided data to suggest that American Ginseng doses of 1000-2000 mg/d may be effective for alleviating cancer related fatigue. Therefore, further study of American Ginseng in cancer survivors appears warranted.’
Researchers have reported that the herb ginseng may reduce cancer-related fatigue, in a study presented at this years’ American Society of Clinical Oncology meeting in Chicago.
In the current study, patients with a life expectancy of at least 6 months and a history of cancer-related fatigue for at least the previous month took either placebo, ginseng 750 mg/day, ginseng 1,000 mg/day or ginseng 2,000 mg/day for eight weeks.
Patients taking ginseng 1,000 mg/day or 2,000 mg/day acheived greated reductions in fatigue, than those patients taking ginseng 750 mg/day or placebo. Twenty-five percent of patients taking ginseng 1,000 mg/day and 27% of patients taking ginseng 2,000 mg/day reported that their fatigue levels were moderately better or much better, compared with 10% of patients taking ginseng 750 mg/day and 10% of patients taking placebo.
Author’s conclusions: ‘This randomized pilot trial provided data to suggest that American Ginseng doses of 1000-2000 mg/d may be effective for alleviating cancer related fatigue. Therefore, further study of American Ginseng in cancer survivors appears warranted.’
Arsenic trioxide improves survival in acute promyelocytic leukemia
Researchers have reported that adding arsenic trioxide to stand therapy significantly improves survival in adults with newly diagnosed acute promyelocytic leukemia (APL), in a study presented at the American Society of Clinical Oncology meeting, in Chicago today.
Standard treatment for APL involves three phases of treatment known as induction, consolidation and maintenance therapy.
In this multi-centre, Phase III study, patients received standard consolidation therapy plus two courses of arsenic trioxide therapy or standard consolidation therapy alone. At 3 years, event-free survival was significantly higher in the standard consolidation therapy plus arsenic trioxide arm (77%), compared with the standard consolidation therapy arm (59%).
Author’s conclusions ‘The addition of 2 courses of arsenic trioxide consolidation following remission induction significantly improves survival’
Researchers have reported that adding arsenic trioxide to stand therapy significantly improves survival in adults with newly diagnosed acute promyelocytic leukemia (APL), in a study presented at the American Society of Clinical Oncology meeting, in Chicago today.
Standard treatment for APL involves three phases of treatment known as induction, consolidation and maintenance therapy.
In this multi-centre, Phase III study, patients received standard consolidation therapy plus two courses of arsenic trioxide therapy or standard consolidation therapy alone. At 3 years, event-free survival was significantly higher in the standard consolidation therapy plus arsenic trioxide arm (77%), compared with the standard consolidation therapy arm (59%).
Author’s conclusions ‘The addition of 2 courses of arsenic trioxide consolidation following remission induction significantly improves survival’
Saturday, June 02, 2007
First-line cetuximab plus chemotherapy prolongs survival in head and neck cancer
European researchers have reported that adding cetuximab to a first-line chemotherapy regimen that includes cisplatin or carboplatn significantly prolongs survival in patients with advanced squamous cell carcinoma of the head and neck (SCCHN) in data presented at this years’ American Society of Clinical Oncology Meeting in Chicago.
In this Phase III study, patients received cetuximab plus cisplatin or carboplatin and 5-fluoruracil (cetuximab group), or cisplatin or carboplatin plus 5-fluoruracil (control group). Median overall survival was significantly longer in the cetuximab group, compared with the control group (10.1 months vs. 7.4 months).
Author’s conclusions: ‘The addition of cetuximab to standard chemotherapy results in a clinically meaningful survival benefit. The observed median survival time of 10.1 months is among the longest ever reported in a phase III trial for these patients. Analysis of secondary endpoints is ongoing.’
Source: to be provided when available
European researchers have reported that adding cetuximab to a first-line chemotherapy regimen that includes cisplatin or carboplatn significantly prolongs survival in patients with advanced squamous cell carcinoma of the head and neck (SCCHN) in data presented at this years’ American Society of Clinical Oncology Meeting in Chicago.
In this Phase III study, patients received cetuximab plus cisplatin or carboplatin and 5-fluoruracil (cetuximab group), or cisplatin or carboplatin plus 5-fluoruracil (control group). Median overall survival was significantly longer in the cetuximab group, compared with the control group (10.1 months vs. 7.4 months).
Author’s conclusions: ‘The addition of cetuximab to standard chemotherapy results in a clinically meaningful survival benefit. The observed median survival time of 10.1 months is among the longest ever reported in a phase III trial for these patients. Analysis of secondary endpoints is ongoing.’
Source: to be provided when available
Friday, June 01, 2007
Cetuximab shows promising activity in advanced squamous cell carcinoma of the head and neck
European investigators have reported that single-agent cetuximab (Erbitux) shows promising activity and tolerability in patients with advanced squamous cell carcinoma of the head and neck (SCCHN), in results published in the Journal of Clinical Oncology.
Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR) on tumour cells and impairs tumour cell growth and proliferation.
In this Phase II study, patients with advanced SCCHN and disease progression after platinum-based chemotherapy received single-agent cetuximab (single-agent phase). If patients experienced further disease progression, they received cetuximab in combination with platinum-based chemotherapy (combination therapy phase).
In the single-agent phase, the overall response rate (ORR) was 13%, disease control rate (DCR) was 46% and median time-to-progression (TTP) was 70 days. In the combination therapy phase, the ORR was 0%, DCR ws 26% and TTP was 50 days. Median overall survival was 178 days. Treatment was generally well tolerated.
Author’s conclusions ‘Single-agent cetuximab was active and generally well tolerated in the treatment of recurrent and/or metastatic SCCHN that progressed on platinum therapy. Response was comparable to that seen with cetuximab plus platinum combination regimens in the same setting.’
Source: http://jco.ascopubs.org/cgi/content/abstract/25/16/2171
European investigators have reported that single-agent cetuximab (Erbitux) shows promising activity and tolerability in patients with advanced squamous cell carcinoma of the head and neck (SCCHN), in results published in the Journal of Clinical Oncology.
Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR) on tumour cells and impairs tumour cell growth and proliferation.
In this Phase II study, patients with advanced SCCHN and disease progression after platinum-based chemotherapy received single-agent cetuximab (single-agent phase). If patients experienced further disease progression, they received cetuximab in combination with platinum-based chemotherapy (combination therapy phase).
In the single-agent phase, the overall response rate (ORR) was 13%, disease control rate (DCR) was 46% and median time-to-progression (TTP) was 70 days. In the combination therapy phase, the ORR was 0%, DCR ws 26% and TTP was 50 days. Median overall survival was 178 days. Treatment was generally well tolerated.
Author’s conclusions ‘Single-agent cetuximab was active and generally well tolerated in the treatment of recurrent and/or metastatic SCCHN that progressed on platinum therapy. Response was comparable to that seen with cetuximab plus platinum combination regimens in the same setting.’
Source: http://jco.ascopubs.org/cgi/content/abstract/25/16/2171
Genetic test accurately predicts for gefitinib sensitivity in non-small cell lung cancer
American researchers have reported that use of a test to detect amplification of the epidermal growth factor receptor (EGFR) gene predicts sensitivity to gefitinib (IRESSA) in advanced non-small-cell lung cancer (NSCLC), in a study published in the Journal of Clinical Oncology.
Gefitinib was the first in a new class of anti-cancer drugs known as EGFR-tyrosine kinase inhibitors, which target the EGFR on tumour cells, a molecule involved in cellular processes involved in the promotion of tumor growth.
In this prospective study of 42 advanced NSCLC patients, amplification of the EGFR gene as determined by EGFR-FISH analysis in tumour samples (EGFR-FISH positivity) was associated with a significantly higher response rate and longer time-to-progression, compared with no amplication of the EGFR gene (EGFR-FISH negativity). However, the follow-up time was too short to allow for testing any differences in survival between treatment groups.
Author's conclusions: 'Gefitinib is active and well tolerated in patients with trial characteristics, and EGFR FISH analysis is an accurate predictor for such therapy.'
Source: http://jco.ascopubs.org/cgi/content/abstract/25/16/2248
Note: Following disappointing Phase III data in advanced NSCLC AstraZeneca voluntarily withdrew the European submission for IRESSA and regulatory authorities in the USA and Canada limited the use of IRESSA to those patients already experiencing benefit from the drug (see http://www.iressa.com/iressaHCP/9898_12838_0_0_0.aspx?mid=27)
American researchers have reported that use of a test to detect amplification of the epidermal growth factor receptor (EGFR) gene predicts sensitivity to gefitinib (IRESSA) in advanced non-small-cell lung cancer (NSCLC), in a study published in the Journal of Clinical Oncology.
Gefitinib was the first in a new class of anti-cancer drugs known as EGFR-tyrosine kinase inhibitors, which target the EGFR on tumour cells, a molecule involved in cellular processes involved in the promotion of tumor growth.
In this prospective study of 42 advanced NSCLC patients, amplification of the EGFR gene as determined by EGFR-FISH analysis in tumour samples (EGFR-FISH positivity) was associated with a significantly higher response rate and longer time-to-progression, compared with no amplication of the EGFR gene (EGFR-FISH negativity). However, the follow-up time was too short to allow for testing any differences in survival between treatment groups.
Author's conclusions: 'Gefitinib is active and well tolerated in patients with trial characteristics, and EGFR FISH analysis is an accurate predictor for such therapy.'
Source: http://jco.ascopubs.org/cgi/content/abstract/25/16/2248
Note: Following disappointing Phase III data in advanced NSCLC AstraZeneca voluntarily withdrew the European submission for IRESSA and regulatory authorities in the USA and Canada limited the use of IRESSA to those patients already experiencing benefit from the drug (see http://www.iressa.com/iressaHCP/9898_12838_0_0_0.aspx?mid=27)
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