Looking a Gift Horse in the Mouth: Observations on NHS England's Interim Guidance on Pembrolizumab in Head and Neck Squamous Cell Cancer

Harrington, Kevin; Bhide, Shreerang A.; Förster, Martin; Good, James; Gunn, Lucinda; Kong, Anthony; Melcher, Alan; Metcalf, Robert; Nenclares, Pablo; Newbold, Kate; Nutting, Christopher M.; Prestwich, R.; Sacco, J.J.; Soliman, Heba; Wong, Kee H.

doi:10.1016/j.clon.2020.05.016

Cited by 7 publications

(3 citation statements)

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“…The benefit of being able to select pembrolizumab monotherapy or pembrolizumab-chemotherapy based on clinical factors has already been highlighted and appears to be essential in this patient group (as we described earlier) [11]. This, coupled with exploratory data suggesting that differing levels of PD-L1 expression may support different treatment strategies [12], means that access to both pembrolizumab monotherapy and in combination with chemotherapy is vital as we endeavour to optimally individualise treatment for our patients.…”

Section: Discussionmentioning

confidence: 94%

“…This is at odds with National Institute for Health and Care Excellence (NICE) guidance in England and Wales which recommends pembrolizumab monotherapy only in the same patient cohort [10]. Clinicians in NHS England have already voiced concerns about this decision [11]. Notably, in the KEYNOTE-048 study the overall survival (OS) curve for patients receiving pembrolizumab monotherapy was below the active control in the first 7-8 months of treatment before crossing over, with objective response rate (ORR) also lower in the pembrolizumab monotherapy arm [5].…”

Section: Introductionmentioning

confidence: 99%

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The UK Divide: Does having a Pembrolizumab-Chemotherapy option in head and neck cancer matter? Real-world experience of first-line palliative pembrolizumab monotherapy and pembrolizumab-chemotherapy combination in Scotland

Thapa

Cowell

Peters

et al. 2023

Preprint

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Objectives To provide real-world performance data and identify clinical factors associated with survival outcomes for patients receiving first-line pembrolizumab-containing treatment for head and neck squamous cell carcinoma (HNSCC) in the palliative setting. Materials and Methods We analysed the electronic records of patients who initiated pembrolizumab-containing treatment between 01/03/2020-30/09/2021. Outcomes included overall survival (OS), progression-free survival (PFS), duration of response (DOR), disease control rate (DCR). Data were compared with the KEYNOTE-048 study and clinical factors were evaluated for association with survival. Results Our cohort included 91 patients (median follow-up 10.8 months). For patients receiving monotherapy (n=76), 12-month and 24-month OS was 45% and 27%, respectively, 12-month PFS was 22%, median DOR was 13.3 months, and DCR was 56.6%. For patients receiving pembrolizumab-chemotherapy (n=15), 12-month OS was 60%, 12-month PFS was 20%, median DOR was 7.3 months and DCR was 60.0%. Experiencing ≥1 irAE (versus no irAEs), of any grade, was associated with favourable OS and PFS for patients receiving monotherapy in both univariable log-rank analysis (median OS 17.4 months versus 8.6 months, respectively, P=0.0033; median PFS 10.9 months versus 3.0 months, respectively, P<0.0001) and multivariable analysis (Cox proportional hazards regression: OS HR: 0.31, P=0.0009; PFS HR: 0.17, P<0.0001). Conclusion Our real-world data, first from a European population, support the KEYNOTE-048 study findings. Additionally, our data is first to show irAEs are associated with better outcomes in this patient group, adding to the growing body of evidence showing irAEs are generally a positive marker of PD-L1 inhibitor response.

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

The UK Divide: Does having a Pembrolizumab-Chemotherapy option in head and neck cancer matter? Real-world experience of first-line palliative pembrolizumab monotherapy and pembrolizumab-chemotherapy combination in Scotland

Thapa

Cowell

Peters

et al. 2023

Preprint

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“…[38] Despite this, it is acknowledged that ‘many oncology units across the UK have eschewed palliative SACT because of concerns relating to increased risks of adverse outcomes of COVID-19’. [30] Palliative SACT was delivered to 30 patients in our cancer network at the peak of the pandemic. No cases of COVID-19 infection have been detected in these patients.…”

Section: Discussionmentioning

confidence: 99%

Keep calm and carry on: safety, feasibility and early outcomes of head and neck cancer treatment during the COVID-19 pandemic

Walker

Campbell

Hay

et al. 2020

Preprint

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Background Patients with cancer are considered at higher risk of COVID-19 infection and increased severity of infection. Anti-cancer treatment may further increase those risks. The aim of this work is to report early outcomes in patients with head and neck cancer (HNC) treated during the pandemic. Materials and Methods A retrospective cohort study in a UK tertiary level oncology centre between 1st March and 23 June 2020, including patients with HNC who were either newly diagnosed, had developed new recurrent/metastatic disease, or were already scheduled to receive treatment during that period. Results 200 patients were evaluated. Median age was 64 years, 65.5% had multiple co-morbidities, 77.5% were current or ex-smokers and 59.5% lived in areas of deprivation. 99 patients were treated with 6 weeks of radical (chemo) radiotherapy. Systemic anti-cancer treatment was delivered to 40 patients. 2 (1.0%) patients with HNC had confirmed COVID-19 infection; 1 patient prior to primary radical RT - no delay to treatment was required and RT was completed as planned, 1 patient acquired COVID-19 after primary surgery but recovered well and started adjuvant RT 9.7 weeks after surgery. The proportion of patients receiving supportive care only (19.5%) was in keeping with that pre-COVID-19. The proportion of patients not completing (chemo) radiotherapy (3.4%) or with gaps in treatment (14.1%) was similar to pre-COVID-19. 30-day mortality after radical (chemo)radiotherapy was 2.3%, no higher than in previous years. Conclusions It is feasible and safe to deliver standard treatment for patients with HNC during the COVID-19 pandemic.

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Keep Calm and Carry on: Safety, Feasibility and Early Outcomes of Head and Neck Cancer Treatment During the COVID-19 Pandemic

Walker

Paterson

2021

Clinical Oncology

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Madam d Evaluating outcomes in patients treated during the first wave of the COVID-19 pandemic is paramount to developing future evidence-based practice.In early 2020 patients with cancer were thought to be particularly vulnerable to and that anti-cancer treatments may further increase that risk [2e4]. Guidance was issued on the modification of standard treatments for head and neck cancer (HNC) [5e10].We completed a retrospective cohort study of all patients with HNC treated in our UK tertiary level oncology centre during the peak of the first wave (1 March to 23 June 2020). In total, 200 patients were evaluated. The median age was 64 years; 65.5% had multiple comorbidities and 59.5% lived in areas of deprivation. In total, 115 received radical treatment: 46 palliative treatments and 39 supportive care.Ninety-nine patients received standard radical radiotherapy (65 Gy in 30 fractions). Despite attending daily for 6 weeks, no patient contracted COVID-19 while receiving radiotherapy. One third of these patients received concurrent cisplatin, mean dose density 150 mg/m 2 . The 30-day mortality rate for patients treated with (chemo)radiotherapy was 2.3%; comparable with previous outcomes in our centre (0.0e5.6% in 2016e2019) [11e14]. The proportion of patients not completing (chemo)radiotherapy was 3.4% or with gaps in treatment was 14.1%; also similar to pre-COVID-19.Systemic anti-cancer treatment was delivered without modification from standard regimens to 40 patients; six received palliative radiotherapy. No patient with HNC acquired COVID-19 while attending for palliative treatments.Our study population has multiple potential risk factors for COVID-19 and increased severity of infection. The infection rate in the region was significant with 416 cases per 100 000 population reported [15]. Despite this, our data suggest that it is feasible and safe to deliver standard treatment for patients with HNC during the COVID-19 pandemic.We hope this provides some reassurance to clinicians and patients with HNC in these challenging times.

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Looking a Gift Horse in the Mouth: Observations on NHS England's Interim Guidance on Pembrolizumab in Head and Neck Squamous Cell Cancer

Cited by 7 publications

References 7 publications

The UK Divide: Does having a Pembrolizumab-Chemotherapy option in head and neck cancer matter? Real-world experience of first-line palliative pembrolizumab monotherapy and pembrolizumab-chemotherapy combination in Scotland

The UK Divide: Does having a Pembrolizumab-Chemotherapy option in head and neck cancer matter? Real-world experience of first-line palliative pembrolizumab monotherapy and pembrolizumab-chemotherapy combination in Scotland

Keep calm and carry on: safety, feasibility and early outcomes of head and neck cancer treatment during the COVID-19 pandemic

Keep Calm and Carry on: Safety, Feasibility and Early Outcomes of Head and Neck Cancer Treatment During the COVID-19 Pandemic

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