Cancer experts condemn cancer drug decision

Expert cancer clinicians have condemned a preliminary decision by the National Institute for Health and Care Excellence (NICE) not to approve use of the drug nivolumab (Opdivo) for the treatment of head and neck cancer on the NHS | OnMedica

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NICE has today issued new draft guidance which does not recommend nivolumab in this way, saying that it is not cost-effective.

Nivolumab is administered intravenously every two weeks and the drug works by blocking a protein on the surface of cells known as PD-L1, which reduces the activity of the body’s immune cells. There is more PD-L1 on cancerous cells which stops the immune system from attacking the tumour.

NICE said the anticipated marketing authorisation for nivolumab was for treating squamous cell carcinoma of the head and neck which has progressed during or after platinum-based chemotherapy.

The watchdog found that the evidence showed a significant improvement in overall survival rates in the short term after nivolumab. However, its value for money was considerably above that which is usually a cost-effective use of NHS resources.

Read the full commentary here

NICE draft guidance is available here

Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy

Pollard, A. et al. (2017) European Journal of Cancer Care. 26(2)

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Image source: mindfulness – Flickr // CC BY 2.0

People with head and neck cancer (HNC) experience elevated symptom toxicity and co-morbidity as a result of treatment, which is associated with poorer psychosocial and quality-of-life (QoL) outcomes.

This Phase I study examined whether an individualised mindfulness-based stress reduction (IMBSR) programme could be successfully used with HNC patients undergoing curative treatment.

After controlling for pre-intervention mindfulness, there was an association between higher post-intervention mindfulness and lower psychological distress and higher total, social and emotional QoL. This study offers important preliminary evidence than an IMBSR intervention can be administered to HNC patients during active cancer treatment. A randomised controlled trial is warranted to confirm these findings.

Read the full abstract here

Rare Thyroid Malignancies: an Overview for the Oncologist

Spielman, D.B. et al. Clinical Oncology. Published online: 24 February 2017

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Image Source: Nephron – Wikimedia // CC BY-SA 3.0

Image shows high magnification micrograph of medullary thyroid carcinoma.

Anaplastic thyroid cancer, medullary thyroid cancer, primary thyroid lymphoma and primary thyroid sarcoma are rare thyroid cancers that comprise 5–10% of all thyroid malignancies. Unlike well-differentiated thyroid cancers, these malignancies have few treatment options and carry a worse prognosis.

The literature surrounding these pathologies is limited, but remains an area of active research. Despite the rarity of these conditions, they remain an important part of the differential diagnosis for any thyroid nodule. Awareness of their presentation, work-up and management is critical for oncologists and head and neck surgeons. The purpose of this article is to provide a broad overview of these malignancies with an emphasis on emerging clinical research and therapies.

Read the abstract here

 

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck

Ferris, R.L. New England Journal of Medicine. Published online: 9 October 2016

N0009269 Cancer of the tongue

Image source: Wellcome Images // CC BY-NC-ND 4.0

Image shows photomicrograph of squamous cell carcinoma of the tongue.

Background: Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti–programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition.

Methods: In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). The primary end point was overall survival. Additional end points included progression-free survival, rate of objective response, safety, and patient-reported quality of life.

Results: The median overall survival was 7.5 months (95% confidence interval [CI], 5.5 to 9.1) in the nivolumab group versus 5.1 months (95% CI, 4.0 to 6.0) in the group that received standard therapy. Overall survival was significantly longer with nivolumab than with standard therapy (hazard ratio for death, 0.70; 97.73% CI, 0.51 to 0.96; P=0.01), and the estimates of the 1-year survival rate were approximately 19 percentage points higher with nivolumab than with standard therapy (36.0% vs. 16.6%). The median progression-free survival was 2.0 months (95% CI, 1.9 to 2.1) with nivolumab versus 2.3 months (95% CI, 1.9 to 3.1) with standard therapy (hazard ratio for disease progression or death, 0.89; 95% CI, 0.70 to 1.13; P=0.32). The rate of progression-free survival at 6 months was 19.7% with nivolumab versus 9.9% with standard therapy. The response rate was 13.3% in the nivolumab group versus 5.8% in the standard-therapy group. Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of the patients in the nivolumab group versus 35.1% of those in the standard-therapy group. Physical, role, and social functioning was stable in the nivolumab group, whereas it was meaningfully worse in the standard-therapy group.

Conclusions: Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy.

Read the full article here

Treatment of head and neck cancer

NICE prioritises four areas of head and neck cancer care for improvement.

NICE is consulting on a new draft quality standard to improve treatment of head and neck cancer that could prevent 250 people a year undergoing major surgery which is of no benefit.

Currently when scans can’t detect if cancer has spread to the lymph nodes in patients with early oral cavity cancer, the lymph nodes are surgically removed as a precaution.

The draft quality standard recommends those patients instead have a biopsy to remove the main lymph gland linked to the cancer to establish if it has spread and if further surgery is needed.

Effectiveness of critical care pathways for head and neck cancer surgery: A systematic review

 Gordon, S.A. & Reiter, E.R. Head & Neck. Published online: 8 July 2016

Image shows MRI of lateral neck showing cervical cord glioma.

Background: Critical care pathways (CCPs) are implemented within health care systems as a means to systematically decrease resource utilization, whereas maintaining a high level of care for patients with a specific diagnosis. Previous studies have shown equivocal results for CCPs in head and neck cancer surgery.

Methods: We conducted a systematic review evaluating studies of CCPs for head and neck cancer surgery, with individual outcome measures analyzed separately to describe the effect of each implemented pathway.

Results: Ten before and after studies were included for systematic review. Nine reported statistically significant decreases in median/mean length of stay and 5 reported statistically significant decreases in cost of care per case.

Conclusion: Although the results are encouraging and point toward the ability of CCPs to decrease length of stay and cost of care, the evidence cannot be considered exhaustive because of the studies’ inability to account for temporal trends. Further controlled studies are recommended to validate the benefits of CCPs.

Read the abstract here

Patient-reported outcomes, body composition, and nutrition status in patients with head and neck cancer: Results from an exploratory randomized controlled exercise trial

Capozzi, L. et al. Cancer. Article first published online: 1 February 2016

Background: Patients with head and neck cancer experience loss of weight and muscle mass, decreased functioning, malnutrition, depression, and declines in quality of life during and after treatment. The purpose of this exploratory randomized study was to determine the optimal timing for the initiation of a lifestyle and progressive resistance exercise training intervention (during or after radiation therapy), as determined by intervention adherence and by comparing between-group outcomes across 24 weeks.

Methods: Sixty patients with head and neck cancer were randomized to engage in a 12-week lifestyle intervention and progressive resistance-training program either during radiation treatment or immediately after completion. The primary outcome of body composition—specifically, lean body mass, body mass index, and body fat—as well as secondary outcomes of fitness, quality of life, depression, and nutrition status were evaluated.

Results: The progressive resistance-training intervention carried out during treatment did not significantly influence the primary outcome of body composition, despite a significant increase in weekly physical activity reported by the intervention group. A small-to-medium intervention effect was noted for some secondary outcomes, including fitness, quality of life, and nutrition status. Regardless of whether patients received the immediate or delayed progressive resistance-training intervention, the analysis revealed a main effect of time on body composition, fitness, quality of life, depression, and nutritional scores.

Conclusions: Although the intervention during treatment did not reduce the loss of lean body mass, delaying the exercise program until after treatment completion was associated with improved intervention adherence, a finding with important clinical implications

View the abstract here