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Maintenance pazopanib in ovarian cancer
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Angiogenesis has been shown to play an important part in the growth of ovarian cancer and VEGF is a key driver of the process. Pazopanib, a tyrosine kinase inhibitor, acts via inhibition of the intracellular tyrosine kinase of VEGF and platelet-derived growth factor receptor (PDGFR). In a randomised study, Andreas du Bois and colleagues assessed the efficacy of pazopanib in patients with ovarian cancer who had shown a response to standard treatment and who had raised cancer antigen 125. The researchers randomly assigned 940 patients with histologically confirmed cancer of the ovary, fallopian tube, or peritoneum (FIGO stages II–IV), and with no evidence of progression after primary treatment consisting of surgery and at least five cycles of platinum-taxane chemotherapy, to receive pazopanib
800 mg once daily or placebo for up to 24 months. Progression-free survival was the primary endpoint of the study. The results showed that maintenance pazopanib increased progression-free survival compared with placebo (median 17·9 vs 12·3 months; hazard ratio 0·77, 95% CI 0·64–0·91; p=0·0021). The most frequent grade 3 or 4 adverse events among 477 patients in the pazopanib group were hypertension (147 [31%]), neutropenia (47 [10%]), liver-related toxic effects (45 [9%]), diarrhoea (39 [8%]), thrombocytopenia (12 [3%]), and palmarplantar erythema (nine [2%]). Treatment was discontinued due to adverse events in 33% of patients in the pazopanib group, compared with 6% in placebo. No difference in overall survival was seen between the groups.
Hani Gabra (Imperial College London, London, UK), comments: “Quite apart from the issues of toxicity, this study shows that targeting of VEGF receptors (as well as PDGFR) in a maintenance montherapy setting using oral multikinase tyrosine kinase inhibitors impacts on progression-free survival to the same magnitude as other anti-angiogenic strategies”. Katherine Taylor, acting chief executive of Ovarian Cancer Action (London, UK), says: “Whilst we welcome the modest improvement in progression-free survival this study suggests, for patients the ultimate goal is overall survival. We seek further research that can indicate improvement in this area so that there are more options available for women with ovarian cancer.”
Sovereign, Ism/Science Photo Library
Maintenance pazopanib in ovarian cancer
Published Online September 26, 2014 http://dx.doi.org/10.1016/ S1470-2045(14)70264-5 For du Bois and colleagues’ study see J Clin Oncol 2014; published online Sept 15. DOI:10.1200/JCO.2014.55.7348
Ahmadur Rahman
Assessment and approval of drugs to be reviewed in the UK The UK has abandoned proposed changes to the way it approves new treatments for the National Health Service (NHS) in favour of a far wider review of how drugs are developed, assessed, and adopted. The National Institute for Health and Care Excellence (NICE) currently uses a measure called the qualityadjusted life year to quantify whether a new drug will benefit patients and is good value for money. However, in July, 2013, the Department of Health asked NICE to develop additional mechanisms to assess both the burden of illness and the wider effect a drug might have on society—eg, through enabling people to return to work. It also proposed the removal of NICE’s end-of-life criteria, currently applied if a drug is expensive yet offers the only hope of extending life. NICE released its proposals for consultation in March, 2014, but after
receiving more than 900 comments from individuals and organisations, they have been shelved. Cancer patient groups were concerned that the proposals might have discriminated against older patients and reduced the availability of new drugs for people with terminal illness. Meanwhile, pharmaceutical companies said they would have done little to address the changing nature of drug pipelines and the need for new methods of assessment. “The industry is generating more and more targeted medicines aimed at smaller numbers of patients, and with that the evidence base for assessing them is changing”, says Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry (London, UK). Instead, NICE has proposed a far wider review of the NHS’ arrangements for supporting innovation within the drugs industry and the assessment of new
www.thelancet.com/oncology Vol 15 November 2014
treatments. “It’s clear that just changing NICE’s methods will not overcome concerns about how the NHS accesses new treatments”, says NICE chief executive Andrew Dillon. “We also need to look at the model of pharmaceutical research and development, the expectations that companies and patient groups have about how risk and reward is shared between the industry and a publicly funded NHS, and at the arrangements for commissioning expensive new treatments.” The decision has been welcomed by patient groups and the pharmaceutical industry alike. “We urgently need a system that values drugs—particularly for those reaching end of life—and that doesn’t bias against treatments for older people”, says Sarah Mee, policy and evidence manager for Prostate Cancer UK.
Published Online September 26, 2014 http://dx.doi.org/10.1016/ S1470-2045(14)70321-3 For more on drug approval see Editorial Lancet Oncol 2014; 15: 1039
Linda Geddes e530
Angiogenesis has been shown to play an important part in the growth of ovarian cancer and VEGF is a key driver of the process. Pazopanib, a tyrosine kinase inhibitor, acts via inhibition of the intracellular tyrosine kinase of VEGF and platelet-derived growth factor receptor (PDGFR). In a randomised study, Andreas du Bois and colleagues assessed the efficacy of pazopanib in patients with ovarian cancer who had shown a response to standard treatment and who had raised cancer antigen 125. The researchers randomly assigned 940 patients with histologically confirmed cancer of the ovary, fallopian tube, or peritoneum (FIGO stages II–IV), and with no evidence of progression after primary treatment consisting of surgery and at least five cycles of platinum-taxane chemotherapy, to receive pazopanib
800 mg once daily or placebo for up to 24 months. Progression-free survival was the primary endpoint of the study. The results showed that maintenance pazopanib increased progression-free survival compared with placebo (median 17·9 vs 12·3 months; hazard ratio 0·77, 95% CI 0·64–0·91; p=0·0021). The most frequent grade 3 or 4 adverse events among 477 patients in the pazopanib group were hypertension (147 [31%]), neutropenia (47 [10%]), liver-related toxic effects (45 [9%]), diarrhoea (39 [8%]), thrombocytopenia (12 [3%]), and palmarplantar erythema (nine [2%]). Treatment was discontinued due to adverse events in 33% of patients in the pazopanib group, compared with 6% in placebo. No difference in overall survival was seen between the groups.
Hani Gabra (Imperial College London, London, UK), comments: “Quite apart from the issues of toxicity, this study shows that targeting of VEGF receptors (as well as PDGFR) in a maintenance montherapy setting using oral multikinase tyrosine kinase inhibitors impacts on progression-free survival to the same magnitude as other anti-angiogenic strategies”. Katherine Taylor, acting chief executive of Ovarian Cancer Action (London, UK), says: “Whilst we welcome the modest improvement in progression-free survival this study suggests, for patients the ultimate goal is overall survival. We seek further research that can indicate improvement in this area so that there are more options available for women with ovarian cancer.”
Sovereign, Ism/Science Photo Library
Maintenance pazopanib in ovarian cancer
Published Online September 26, 2014 http://dx.doi.org/10.1016/ S1470-2045(14)70264-5 For du Bois and colleagues’ study see J Clin Oncol 2014; published online Sept 15. DOI:10.1200/JCO.2014.55.7348
Ahmadur Rahman
Assessment and approval of drugs to be reviewed in the UK The UK has abandoned proposed changes to the way it approves new treatments for the National Health Service (NHS) in favour of a far wider review of how drugs are developed, assessed, and adopted. The National Institute for Health and Care Excellence (NICE) currently uses a measure called the qualityadjusted life year to quantify whether a new drug will benefit patients and is good value for money. However, in July, 2013, the Department of Health asked NICE to develop additional mechanisms to assess both the burden of illness and the wider effect a drug might have on society—eg, through enabling people to return to work. It also proposed the removal of NICE’s end-of-life criteria, currently applied if a drug is expensive yet offers the only hope of extending life. NICE released its proposals for consultation in March, 2014, but after
receiving more than 900 comments from individuals and organisations, they have been shelved. Cancer patient groups were concerned that the proposals might have discriminated against older patients and reduced the availability of new drugs for people with terminal illness. Meanwhile, pharmaceutical companies said they would have done little to address the changing nature of drug pipelines and the need for new methods of assessment. “The industry is generating more and more targeted medicines aimed at smaller numbers of patients, and with that the evidence base for assessing them is changing”, says Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry (London, UK). Instead, NICE has proposed a far wider review of the NHS’ arrangements for supporting innovation within the drugs industry and the assessment of new
www.thelancet.com/oncology Vol 15 November 2014
treatments. “It’s clear that just changing NICE’s methods will not overcome concerns about how the NHS accesses new treatments”, says NICE chief executive Andrew Dillon. “We also need to look at the model of pharmaceutical research and development, the expectations that companies and patient groups have about how risk and reward is shared between the industry and a publicly funded NHS, and at the arrangements for commissioning expensive new treatments.” The decision has been welcomed by patient groups and the pharmaceutical industry alike. “We urgently need a system that values drugs—particularly for those reaching end of life—and that doesn’t bias against treatments for older people”, says Sarah Mee, policy and evidence manager for Prostate Cancer UK.
Published Online September 26, 2014 http://dx.doi.org/10.1016/ S1470-2045(14)70321-3 For more on drug approval see Editorial Lancet Oncol 2014; 15: 1039
Linda Geddes e530