miércoles, 31 de agosto de 2016
PD-1 Inhibitor-Related Pneumonitis Risk Highest For NSCLC, RCC Patients
PD-1 Inhibitor-Related Pneumonitis Risk Highest For NSCLC, RCC Patients
Programmed cell death 1 inhibitor-associated pneumonitis patient risk groups identified
Date: 19 Aug 2016
Author: Lynda Williams, Senior medwireNews Reporter
Topic: Cancer Immunology and Immunotherapy / Renal Cell Cancer / Non-Small-Cell Lung Cancer, Metastatic / Melanoma and other Skin Tumours / Complications of Treatment
medwireNews: Patients with non-small-cell lung cancer (NSCLC) or renal cell carcinoma (RCC) have a higher risk of developing pneumonitis related to programmed cell death 1 (PD-1) inhibition than those with melanoma, a meta-analysis demonstrates.
Patients who receive nivolumab PD-1 inhibitor therapy concurrently or sequentially with the CTLA-4 inhibitor ipilimumab or a peptide vaccine also have an increased risk of the side effect compared with patients given nivolumab monotherapy, the study authors report in JAMA Oncology.
“The underlying reasons for these observations remain to be further investigated; however, the results again demonstrate the different susceptibilities of developing PD-1 inhibitor–related pneumonitis among patients with different tumor types and varying effect on their clinical course and outcome”, they write.
The review included 4496 patients participating in one of five NSCLC studies, three RCC studies or 12 melanoma trials of pembrolizumab or nivolumab, of whom 2.7% developed any grade of pneumonitis and 0.8% grade 3 or more severe pneumonitis.
Both NSCLC patients and RCC patients had significantly higher rates than melanoma patients for all-grade pneumonitis (4.1 and 4.1 vs 1.6%, respectively), while NSCLC patients also had a significantly higher rate of grade 3 or higher pneumonitis than melanoma trial participants (1.8 vs 0.2%).
Patients who received combination therapy also had a significantly increased risk of all-grade and grade 3 or more severe pneumonitis than those given PD-1 inhibitor monotherapy, at 6.6% versus 1.6% and 1.5% versus 0.2%, respectively.
After adjusting for a range of confounding factors, including agents and trial phases, NSCLC was confirmed as a significant and independent predictor of both all-grade and grade 3 and higher pneumonitis (odds ratio [OR]=1.43 and 2.85, respectively), as was RCC diagnosis for all-grade pneumonitis (OR=1.59), compared with melanoma.
In addition, multivariate analysis found no difference in the risk of pneumonitis between use of pembrolizumab and nivolumab, but confirmed that combination therapy was significantly associated with both all-grade and grade 3 or higher events (OR=2.04 and 2.86, respectively).
Subgroup analysis indicated that patients who received nivolumab plus ipilimumab were significantly more likely to develop all-grade and grade 3 or higher pneumonitis than those given ipilimumab alone (OR=2.13 and 2.78, respectively). Nivolumab plus peptide vaccine also significantly predicted an increased risk of all-grade pneumonitis (OR=1.54) but not grade 3 or higher events.
Finally, the team reports four pneumonitis-related deaths in NSCLC patients taking monotherapy and one such death in a melanoma patient taking combination therapy but no mortality in RCC cases.
Mizuki Nishino, from the Dana-Farber Cancer Institute in Boston, Massachusetts, USA, and co-authors note that their research into pneumonitis is focused only on two early PD-1 inhibitors and three key indications and highlights the “significant lack of knowledge of this entity in terms of its risk factors, diagnostic workup strategy, and optimal management guidelines.”
They conclude: “We strongly believe that systematic investigations of a collection of individual cases of PD-1 inhibitor–related pneumonitis from multiple studies across different institutions will significantly contribute to characterize a full spectrum of clinical and radiographic manifestations of this entity and will serve as the first step to address these remaining clinically urgent questions.”
References
Nishino M, Giobbie-Hurder A, Hatabu H, et al. Incidence of programmed cell death 1 inhibitor-related pneumonitis in patients with advanced cancer. A systematic review and meta-analysis. JAMA Oncol 2016; Advance online publication 18 August. doi:10.1001/jamaoncol.2016.2453
Prostate Cancer: Number Of Docetaxel Cycles Key To Mainsail OS Outcomes
Number Of Docetaxel Cycles Key To Mainsail OS Outcomes
Number of docetaxel cycles linked to overall survival in the Mainsail metastatic castration-resistant prostate cancer trial
Date: 30 Aug 2016
Author: By Lynda Williams, Senior medwireNews Reporter
Topic: Anti-Cancer Agents & Biologic Therapy / Prostate Cancer
medwireNews: The overall survival (OS) of patients with metastatic, castration-resistant prostate cancer treated with docetaxel is significantly associated with the number of treatment cycles they receive, suggests post hoc analysis of the Mainsail trial.
Describing the relationship as a “robust and independent effect”, the researchers say the findings have “important implications for the optimal administration of docetaxel chemotherapy”.
They therefore recommend in JAMA Oncology: “To provide the greatest survival gain by docetaxel chemotherapy, those patients who appear to benefit by clinical or radiological evidence and who tolerate the chemotherapy well should continue beyond 6, and perhaps even beyond 10 cycles, until disease progression occurs or unacceptable adverse effects dictate otherwise.”
The phase III Mainsail trial showed that combined docetaxel, prednisone and lenalidomide (DPL) was inferior to docetaxel, prednisone and placebo (DP) for OS in 1059 patients with metastatic castration-resistant prostate cancer, write Ronald de Wit, from Erasmus MC Cancer Institute in Rotterdam, the Netherlands, and co-authors.
They explain that increased toxicity associated with the DPL combination resulted in patients receiving a median of six docetaxel cycles compared with a median of eight cycles for patients randomly assigned to receive the DP regime.
Analysis of the intention-to-treat population confirmed that OS was significantly higher for patients in both the DPL and DP groups receiving eight or more docetaxel cycles than those given fewer cycles, with a similar pattern using a cut off of six and 10 cycles.
Initial multivariate analysis taking into consideration a raft of confounding factors confirmed that OS was significantly associated with treatment, being better with DP than DPL, at a significant hazard ratio (HR) of 1.626.
But when the number of docetaxel cycles was added into the multivariate analysis, receipt of eight or more cycles was a significant and independent predictor of superior OS, with a HR of 1.909 versus fewer cycles, and type of treatment was no longer a significant factor.
OS after docetaxel was also significantly associated with baseline measures of lactose dehydrogenase, albumin and haemoglobin, and ECOG performance status.
Sensitivity analysis on a subgroup of patients who received more than four cycles of docetaxel and did not stop treatment because of disease progression confirmed that treatment arm did not significantly influence OS.
When the treatment arms were combined, patients who received at least 10 cycles of docetaxel had significantly longer OS than those given 8–10 or 5–7 cycles (median 33.0 vs 26.9 and 22.8 months, respectively). And this pattern was true when the two treatment arms were assessed separately, the researchers say.
“Enhanced toxic effects by the addition of lenalidomide to docetaxel in the experimental arm resulted in a lower cumulative dose of docetaxel, reflected by fewer docetaxel cycles administered and more frequent dose reductions”, they summarise, adding that the findings “strongly suggest that the differences in the cumulative docetaxel exposure caused the worse OS in the experimental arm.”
Ronald de Wit et al therefore conclude: “These findings imply that the total dose of docetaxel, as reflected in [the total] number of cycles achieved, contributes to the eventual survival gain by chemotherapy in the patient population with [metastatic castration-resistant prostate cancer].”
References
de Morrée ES, Vogelzang NJ, Petrylak DP, et al. Association of survival benefit with docetaxel in prostate cancer and total number of cycles administered. A post hoc analysis of the Mainsail Study. JAMA Oncol; Advance online publication 25 August 2016
doi:10.1001/jamaoncol.2016.3000
Latest NICE Medtech Innovation Briefings and Technology Appraisal Guidance Recommendations for Cancer
Latest NICE Medtech Innovation Briefings and Technology Appraisal Guidance Recommendations for Cancer
August 2016 recommendations cover different cancer types and conditions
Date: 29 Aug 2016
Topic: Breast cancer / Genitourinary cancers / Haematologic malignancies / Lung and other thoracic tumours / Gastrointestinal cancers
In August 2016, NICE issued two medtech innovation briefings on Axxent electronic brachytherapy system for early stage breast cancer and OSNA for colon cancer staging, as well as several technology appraisal guidance documents, in particular for cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel, bosutinib for previously treated chronic myeloid leukaemia, pemetrexed maintenance treatment for non-squamous non-small cell lung cancer after pemetrexed and cisplatin, ramucirumab for previously treated locally advanced or metastatic non-small cell lung cancer, degarelix for treating advanced hormone-dependent prostate cancer, and trifluridine–tipiracil for previously treated metastatic colorectal cancer.
Axxent electronic brachytherapy system for early stage breast cancer
NICE has developed a medtech innovation briefing (MIB) on Axxent electronic brachytherapy system for early stage breast cancer.
The technology described in this briefing is the Axxent electronic brachytherapy (eBx) system. It delivers single‑dose intraoperative radiotherapy (SD‑IORT) during breast-conserving surgery for people with early‑stage breast cancer.
The innovative aspects are that it incorporates a miniaturised isotope-free 50 kV X-ray source, and is provided to any suitable hospital as a managed service using a mobile platform.
The intended place in therapy for the Axxent eBx system is in the current NHS pathway for patients offered SD‑IORT in place of external beam radiotherapy (EBRT), which is usually given in daily radiotherapy sessions for 3 weeks.
The key points from the evidence summarised in this briefing are from 6 non-comparative studies including 452 patients. There is a lack of robust evidence evaluating the Axxent eBx system for early‑stage breast cancer. In general, SD‑IORT using Axxent eBx was well tolerated with a low rate of adverse events and good cosmetic outcomes.
Key uncertainties around the evidence are that the available studies include patients for whom the technology is not recommended by the manufacturer, and there is a lack of long-term follow-up evidence.
The cost per patient of the Axxent eBx managed service is £3,750 (excluding VAT). There is no capital equipment purchase, maintenance cost or servicing charge. In comparison, external beam radiotherapy costs £3,433 per patient (15 fractions) in addition to the initial purchase and maintenance costs of a linear accelerator.
MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.
More information about NICE advice [MIB76], you can find here.
OSNA for colon cancer staging
NICE has developed a medtech innovation briefing (MIB) on OSNA for colon cancer staging.
The technology described in this briefing is the OSNA in vitro diagnostic molecular assay system. It is used for detecting lymph node metastases in people with colon cancer.
The innovative aspects of OSNA are that unlike standard histopathology, OSNA can analyse the whole lymph node as well as partial lymph nodes. This may improve cancer staging accuracy because it reduces tissue allocation bias.
The intended place in therapy would be as an alternative to standard post-operative histopathology for lymph node staging in people after surgical resection for early stage colon cancer.
The key points from the evidence summarised in this briefing are from 3 prospective observational studies including 253 people. The studies found that the diagnostic performance of OSNA was better than standard histopathology and that the results with OSNA led to upstaging from lymph node negative to lymph node positive in up to one-quarter of the study population.
A key uncertainty around the evidence is that none of the studies investigated OSNA for analysing the whole lymph node, which is described as a key innovation for the system.
The average cost per patient (including capital, maintenance, and disposable costs) ranges from £568 to £608 (excluding VAT), depending on the cost of disposables (reagents and consumables).
More information about NICE advice [MIB77], you can find here.
Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel
Evidence-based recommendations on cabazitaxel (Jevtana) for patients with prostate cancer that has come back after it was treated with docetaxel; this guidance has been re-issued after a change to the commercial arrangements in August 2016. This change does not affect cost effectiveness. The following sections of the guidance have been updated: recommendation 1.1; sections 2.3, 3.20, 3.34, 3.36, 4.19, 4.21, 4.32 and 5.4; and the table summarising the appraisal committee’s key conclusions.
This guidance replaces NICE technology appraisal guidance on cabazitaxel for hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen (TA255). It does not cover the use of cabazitaxel for patients who have had docetaxel and then abiraterone, enzalutamide or radium‑223 dichloride because the committee was not presented with evidence about the clinical and cost effectiveness of cabazitaxel for this population.
Recommendations from the NICE technology appraisal guidance [TA391], published on 25 May 2016 and last updated on 24 August 2016:
1.1 Cabazitaxel in combination with prednisone or prednisolone is recommended as an option for treating metastatic hormone‑relapsed prostate cancer in people whose disease has progressed during or after docetaxel chemotherapy, only if:
the person has an eastern cooperative oncology group (ECOG) performance status of 0 or 1
the person has had 225 mg/m2 or more of docetaxel
treatment with cabazitaxel is stopped when the disease progresses or after a maximum of 10 cycles (whichever happens first).
In addition, cabazitaxel is recommended only if:
the company provides cabazitaxel with the discount in the patient access scheme agreed with the Department of Health, and
NHS trusts purchase cabazitaxel in accordance with the commercial access agreement between the company and NHS England, either:
in pre‑prepared intravenous infusion bags, or
in vials, at a reduced price that includes a further discount reflecting the average cost of waste per patient.
1.2 When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.
1.3 This guidance is not intended to affect the position of patients whose treatment with cabazitaxel was started within the NHS before this guidance was published and whose treatment with cabazitaxel is not recommended in this NICE guidance. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned forMay 2019.
More information about the NICE technology appraisal guidance [TA391], you can find here.
Bosutinib for previously treated chronic myeloid leukaemia
Evidence-based recommendations on bosutinib (Bosulif) for previously treated chronic myeloid leukaemia in adults; this guidance is a Cancer Drugs Fund reconsideration of bosutinib for previously treated chronic myeloid leukaemia (TA299). This guidance replaces TA299.
Recommendations from the NICE technology appraisal guidance [TA401] published on 24 August 2016:
1.1 Bosutinib is recommended as an option, within its marketing authorisation, for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, when:
they have previously had 1 or more tyrosine kinase inhibitor and
imatinib, nilotinib and dasatinib are not appropriate and
the company provides bosutinib with the discount agreed in the patient access scheme (as revised in 2016).
Next review is planned for August 2019.
More information about the NICE technology appraisal guidance [TA401], you can find here.
Pemetrexed maintenance treatment for non-squamous non-small cell lung cancer after pemetrexed and cisplatin
Evidence-based recommendations on pemetrexed (Alimta) for locally advanced or metastatic non-squamous non-small cell lung cancer in adults who have had pemetrexed and cisplatin; this guidance is a Cancer Drugs Fund reconsideration of pemetrexed maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small cell lung cancer (TA309). This guidance replaces TA309.
Recommendations from the NICE technology appraisal guidance [TA402], published on 24 August 2016:
1.1 Pemetrexed is recommended as an option for the maintenance treatment of locally advanced or metastatic non‑squamous non‑small cell lung cancer in adults when:
their disease has not progressed immediately after 4 cycles of pemetrexed and cisplatin induction therapy
their Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1 at the start of maintenance treatment and
the company provides the drug according to the terms of the commercial access agreement as agreed with NHS England.
1.2 When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.
1.3 This guidance is not intended to affect the position of patients whose treatment with pemetrexed was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned forAugust 2019.
More information about the NICE technology appraisal guidance [TA402], you can find here.
Ramucirumab for previously treated locally advanced or metastatic non-small cell lung cancer
Evidence-based recommendations from the NICE technology appraisal guidance [TA403], published on 24 August 2016,on ramucirumab (Cyramza) for locally advanced or metastatic non-small cell lung cancer in adults who have had platinum-based chemotherapy:
1.1 Ramucirumab, in combination with docetaxel, is not recommended within its marketing authorisation for treating locally advanced or metastatic non-small cell lung cancer in adults whose disease has progressed after platinum-based chemotherapy.
1.2 This guidance is not intended to affect the position of patients whose treatment with ramucirumab was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned for August 2019.
More information about NICE technology appraisal guidance [TA403], you can find here.
Degarelix for treating advanced hormone-dependent prostate cancer
Evidence-based recommendations from the NICE technology appraisal guidance [TA404], published on 24 August 2016, on degarelix (Firmagon) for advanced hormone-dependent prostate cancer in adults with spinal metastases:
1.1 Degarelix is recommended as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the NHS in June 2016.
1.2 This guidance is not intended to affect the position of patients whose treatment with degarelix was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned for August 2019.
More information about the NICE technology appraisal guidance [TA404], you can find here.
Trifluridine–tipiracil for previously treated metastatic colorectal cancer
Evidence-based recommendations from the NICE technology appraisal guidance [TA405], published on 24 August 2016, on trifluridine–tipiracil (Lonsurf) for previously treated metastatic colorectal cancer in adults:
1.1 Trifluridine–tipiracil is recommended, within its marketing authorisation, as an option for treating metastatic colorectal cancer, that is:
in adults who have had previous treatment with available therapies including fluoropyrimidine-, oxaliplatin- or irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and anti-epidermal growth factor receptor (EGFR) agents, or when these therapies are not suitable, and
only when the company provides trifluridine–tipiracil with the discount agreed in the patient access scheme.
Next review is planned for August 2019.
More information about the NICE technology appraisal guidance [TA405], you can find here.
August 2016 recommendations cover different cancer types and conditions
Date: 29 Aug 2016
Topic: Breast cancer / Genitourinary cancers / Haematologic malignancies / Lung and other thoracic tumours / Gastrointestinal cancers
In August 2016, NICE issued two medtech innovation briefings on Axxent electronic brachytherapy system for early stage breast cancer and OSNA for colon cancer staging, as well as several technology appraisal guidance documents, in particular for cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel, bosutinib for previously treated chronic myeloid leukaemia, pemetrexed maintenance treatment for non-squamous non-small cell lung cancer after pemetrexed and cisplatin, ramucirumab for previously treated locally advanced or metastatic non-small cell lung cancer, degarelix for treating advanced hormone-dependent prostate cancer, and trifluridine–tipiracil for previously treated metastatic colorectal cancer.
Axxent electronic brachytherapy system for early stage breast cancer
NICE has developed a medtech innovation briefing (MIB) on Axxent electronic brachytherapy system for early stage breast cancer.
The technology described in this briefing is the Axxent electronic brachytherapy (eBx) system. It delivers single‑dose intraoperative radiotherapy (SD‑IORT) during breast-conserving surgery for people with early‑stage breast cancer.
The innovative aspects are that it incorporates a miniaturised isotope-free 50 kV X-ray source, and is provided to any suitable hospital as a managed service using a mobile platform.
The intended place in therapy for the Axxent eBx system is in the current NHS pathway for patients offered SD‑IORT in place of external beam radiotherapy (EBRT), which is usually given in daily radiotherapy sessions for 3 weeks.
The key points from the evidence summarised in this briefing are from 6 non-comparative studies including 452 patients. There is a lack of robust evidence evaluating the Axxent eBx system for early‑stage breast cancer. In general, SD‑IORT using Axxent eBx was well tolerated with a low rate of adverse events and good cosmetic outcomes.
Key uncertainties around the evidence are that the available studies include patients for whom the technology is not recommended by the manufacturer, and there is a lack of long-term follow-up evidence.
The cost per patient of the Axxent eBx managed service is £3,750 (excluding VAT). There is no capital equipment purchase, maintenance cost or servicing charge. In comparison, external beam radiotherapy costs £3,433 per patient (15 fractions) in addition to the initial purchase and maintenance costs of a linear accelerator.
MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.
More information about NICE advice [MIB76], you can find here.
OSNA for colon cancer staging
NICE has developed a medtech innovation briefing (MIB) on OSNA for colon cancer staging.
The technology described in this briefing is the OSNA in vitro diagnostic molecular assay system. It is used for detecting lymph node metastases in people with colon cancer.
The innovative aspects of OSNA are that unlike standard histopathology, OSNA can analyse the whole lymph node as well as partial lymph nodes. This may improve cancer staging accuracy because it reduces tissue allocation bias.
The intended place in therapy would be as an alternative to standard post-operative histopathology for lymph node staging in people after surgical resection for early stage colon cancer.
The key points from the evidence summarised in this briefing are from 3 prospective observational studies including 253 people. The studies found that the diagnostic performance of OSNA was better than standard histopathology and that the results with OSNA led to upstaging from lymph node negative to lymph node positive in up to one-quarter of the study population.
A key uncertainty around the evidence is that none of the studies investigated OSNA for analysing the whole lymph node, which is described as a key innovation for the system.
The average cost per patient (including capital, maintenance, and disposable costs) ranges from £568 to £608 (excluding VAT), depending on the cost of disposables (reagents and consumables).
More information about NICE advice [MIB77], you can find here.
Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel
Evidence-based recommendations on cabazitaxel (Jevtana) for patients with prostate cancer that has come back after it was treated with docetaxel; this guidance has been re-issued after a change to the commercial arrangements in August 2016. This change does not affect cost effectiveness. The following sections of the guidance have been updated: recommendation 1.1; sections 2.3, 3.20, 3.34, 3.36, 4.19, 4.21, 4.32 and 5.4; and the table summarising the appraisal committee’s key conclusions.
This guidance replaces NICE technology appraisal guidance on cabazitaxel for hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen (TA255). It does not cover the use of cabazitaxel for patients who have had docetaxel and then abiraterone, enzalutamide or radium‑223 dichloride because the committee was not presented with evidence about the clinical and cost effectiveness of cabazitaxel for this population.
Recommendations from the NICE technology appraisal guidance [TA391], published on 25 May 2016 and last updated on 24 August 2016:
1.1 Cabazitaxel in combination with prednisone or prednisolone is recommended as an option for treating metastatic hormone‑relapsed prostate cancer in people whose disease has progressed during or after docetaxel chemotherapy, only if:
the person has an eastern cooperative oncology group (ECOG) performance status of 0 or 1
the person has had 225 mg/m2 or more of docetaxel
treatment with cabazitaxel is stopped when the disease progresses or after a maximum of 10 cycles (whichever happens first).
In addition, cabazitaxel is recommended only if:
the company provides cabazitaxel with the discount in the patient access scheme agreed with the Department of Health, and
NHS trusts purchase cabazitaxel in accordance with the commercial access agreement between the company and NHS England, either:
in pre‑prepared intravenous infusion bags, or
in vials, at a reduced price that includes a further discount reflecting the average cost of waste per patient.
1.2 When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.
1.3 This guidance is not intended to affect the position of patients whose treatment with cabazitaxel was started within the NHS before this guidance was published and whose treatment with cabazitaxel is not recommended in this NICE guidance. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned forMay 2019.
More information about the NICE technology appraisal guidance [TA391], you can find here.
Bosutinib for previously treated chronic myeloid leukaemia
Evidence-based recommendations on bosutinib (Bosulif) for previously treated chronic myeloid leukaemia in adults; this guidance is a Cancer Drugs Fund reconsideration of bosutinib for previously treated chronic myeloid leukaemia (TA299). This guidance replaces TA299.
Recommendations from the NICE technology appraisal guidance [TA401] published on 24 August 2016:
1.1 Bosutinib is recommended as an option, within its marketing authorisation, for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, when:
they have previously had 1 or more tyrosine kinase inhibitor and
imatinib, nilotinib and dasatinib are not appropriate and
the company provides bosutinib with the discount agreed in the patient access scheme (as revised in 2016).
Next review is planned for August 2019.
More information about the NICE technology appraisal guidance [TA401], you can find here.
Pemetrexed maintenance treatment for non-squamous non-small cell lung cancer after pemetrexed and cisplatin
Evidence-based recommendations on pemetrexed (Alimta) for locally advanced or metastatic non-squamous non-small cell lung cancer in adults who have had pemetrexed and cisplatin; this guidance is a Cancer Drugs Fund reconsideration of pemetrexed maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small cell lung cancer (TA309). This guidance replaces TA309.
Recommendations from the NICE technology appraisal guidance [TA402], published on 24 August 2016:
1.1 Pemetrexed is recommended as an option for the maintenance treatment of locally advanced or metastatic non‑squamous non‑small cell lung cancer in adults when:
their disease has not progressed immediately after 4 cycles of pemetrexed and cisplatin induction therapy
their Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1 at the start of maintenance treatment and
the company provides the drug according to the terms of the commercial access agreement as agreed with NHS England.
1.2 When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.
1.3 This guidance is not intended to affect the position of patients whose treatment with pemetrexed was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned forAugust 2019.
More information about the NICE technology appraisal guidance [TA402], you can find here.
Ramucirumab for previously treated locally advanced or metastatic non-small cell lung cancer
Evidence-based recommendations from the NICE technology appraisal guidance [TA403], published on 24 August 2016,on ramucirumab (Cyramza) for locally advanced or metastatic non-small cell lung cancer in adults who have had platinum-based chemotherapy:
1.1 Ramucirumab, in combination with docetaxel, is not recommended within its marketing authorisation for treating locally advanced or metastatic non-small cell lung cancer in adults whose disease has progressed after platinum-based chemotherapy.
1.2 This guidance is not intended to affect the position of patients whose treatment with ramucirumab was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned for August 2019.
More information about NICE technology appraisal guidance [TA403], you can find here.
Degarelix for treating advanced hormone-dependent prostate cancer
Evidence-based recommendations from the NICE technology appraisal guidance [TA404], published on 24 August 2016, on degarelix (Firmagon) for advanced hormone-dependent prostate cancer in adults with spinal metastases:
1.1 Degarelix is recommended as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the NHS in June 2016.
1.2 This guidance is not intended to affect the position of patients whose treatment with degarelix was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Next review is planned for August 2019.
More information about the NICE technology appraisal guidance [TA404], you can find here.
Trifluridine–tipiracil for previously treated metastatic colorectal cancer
Evidence-based recommendations from the NICE technology appraisal guidance [TA405], published on 24 August 2016, on trifluridine–tipiracil (Lonsurf) for previously treated metastatic colorectal cancer in adults:
1.1 Trifluridine–tipiracil is recommended, within its marketing authorisation, as an option for treating metastatic colorectal cancer, that is:
in adults who have had previous treatment with available therapies including fluoropyrimidine-, oxaliplatin- or irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and anti-epidermal growth factor receptor (EGFR) agents, or when these therapies are not suitable, and
only when the company provides trifluridine–tipiracil with the discount agreed in the patient access scheme.
Next review is planned for August 2019.
More information about the NICE technology appraisal guidance [TA405], you can find here.
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