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24th August 2023
Artificial intelligence technologies could be utilised to reduce the time needed for contouring during radiotherapy treatment planning, according to draft guidance from NICE.
In June 2023, NICE guidance suggested lower intensity and shorter duration radiotherapy in breast cancer did not impact on breast cancer-related mortality or disease recurrence and therefore served as a suitable alternative to the current standard care.
Now, related draft guidance proposes that artificial intelligence (AI) technologies have the potential to help healthcare professionals to produce contours more quickly, which could improve workflow efficiency.
Evidence made available to NICE’s independent medical technologies advisory committee indicates how AI technologies generally produce similar quality contours of organs at risk as those carried out manually, with most only needing minor edits.
Currently, following a CT or MRI scan, a radiographer has to manually contour an image to highlight organs at risk of radiation damage, lymph nodes and the site of the cancer. The dose of radiotherapy is not only calculated to target the tumour site but also to prevent organs and healthy tissue from being damaged.
Clinical experts advising the independent NICE committee estimated a time saving of 10-30 minutes per plan, depending on the amount of editing needed, while the clinical evidence presented to the committee suggests it may range between three and 80 minutes of time saved per plan.
Sarah Byron, programme director for health technologies at NICE, said: ‘NHS colleagues working on the front line in radiotherapy departments are under severe pressure with thousands of people waiting for scans.
‘The role imaging plays in radiotherapy treatment planning is quite pivotal, so recommending the use of AI technologies to help support treatment planning alongside clinical oversight by a trained healthcare professional could save both time and money.‘
Health and social care secretary Steve Barclay added: ‘It’s hugely encouraging to see the first positive recommendation for AI technologies from a NICE committee, as I’ve been clear the NHS must embrace innovation to keep fit for the future.
‘These tools have the potential to improve efficiency and save clinicians’ thousands of hours of time that can be spent on patient care. Smart use of tech is a key part of our NHS Long Term Workforce Plan, and we’re establishing an expert group to work through what skills and training NHS staff may need to make best use of AI.‘
21st March 2023
UK researchers report that the findings of a 15-year follow-up trial of different interventions, showed that in men with an elevated prostate specific antigen test, prostate cancer mortality was low, irrespective of the assigned treatment intervention.
In 2020, there were more than 1.4 million new global cases of prostate cancer and and over 375,000 associated deaths, making it the second most common cancer in men. In the UK in 1999, the Prostate Testing for Cancer and Treatment (ProtecT) trial began in which men aged between 50 and 69 years of age received a prostate-specific antigen test. In cases where the test gave a value of 3·0 μg/L or higher, men were offered a biopsy and where localised prostate cancer was diagnosed, they were enrolled in a trial to evaluate the effectiveness of three different treatment interventions: active monitoring; prostatectomy or radiotherapy. In the current study, researchers have reported upon the findings after 15 years of follow-up, in which they were able to evaluate the effectiveness of the three different interventions. The primary outcome of the study was death from prostate cancer, as adjudicated by an independent cause-of-death committee
Prostate cancer mortality on follow-up
In total, 545 men were randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to radiotherapy. Follow-up data was available for 98% of the entire cohort.
In total, there were 45 deaths due to prostate cancer. However, prostate cancer mortality was broadly similar across the three groups: 3.1% in the active-monitoring group, 2.2% in the prostatectomy group and 2.9% in the radiotherapy group and this difference was not significant (p = 0.53 for group comparison). However, while the development of metastases was more common in the active monitoring group (9.4%), it was similar in the prostatectomy (4.7%) and radiotherapy groups (5.0%).
The authors concluded that given how prostate cancer-specific mortality was low regardless of the treatment assigned, the choice of therapy should involve weighing trade-offs between benefits and harms associated with different treatments options for men with localised prostate cancer.
Citation
Hamdy FC et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Eng J Med 2023
28th November 2022
Use of radiotherapy for 30 years in patients following breast conserving surgery in conjunction with chemotherapy or tamoxifen, reduces the risk of ipsilateral breast tumour recurrence but does not affect overall survival, according to the findings of follow-up study presented at the European Breast Cancer Conference in November 2022.
For a lot of women with early-stage breast cancer, breast-conserving surgery removes macroscopic disease although the presence of any remaining microscopic tumour tissue, if left untreated, could lead to loco-regional recurrence or life-threatening distant metastases. As a result, adjuvant radiotherapy, is often used and the evidence from over 10,000 women, suggests that radiotherapy to the conserved breast halves the rate at which the disease recurs and reduces the breast cancer death rate by about a sixth. In 1976, researchers began a randomised trial to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer. Results after 6 years showed that the relapse rate in the ipsilateral breast was 24.5% in the non-irradiated group compared to 5.8% following breast irradiation. But the researchers continued to monitor patients and the results showed that after 20 years of follow-up, there were no significant differences in overall survival among women who underwent mastectomy and those who underwent lumpectomy with or without postoperative breast irradiation. However, the study did show that the cumulative incidence of recurrent tumour in the ipsilateral breast was 14.3% in the women who underwent breast irradiation, compared with 39.2% in the women without irradiation. In the present Now, researchers are able to present 30-year survival data.
Radiotherapy and overall survival following breast cancer surgery
A total of 585 patients aged ≤70 years with early breast cancer, underwent local excision with a 1 cm margin, axillary node sampling or axillary node clearance.
Overall, researchers observed that ipsilateral breast tumour recurrence was found to be significantly lower in the radiotherapy group (Hazard ratio, HR = 0.39, 95% CI 0.27 – 0.55). For example, local recurrence (LR) after 10 years was 8.8% vs 31% (radiotherapy vs non-irradiated) but this difference reduced after 30 years and was 27.8% (95% CI 19 – 36.5) in the irradiated group and 42.7% (95% CI 35.8 – 49.6) in the non-irradiated group.
Furthermore, there was no difference in overall survival after 30 years (HR = 1.08, 95% CI 0.89 – 1.30, p = 0.43) and the proportion of survivors was broadly similar over time. For instance, overall survival at 10 years was 72.5% vs 70.8% (irradiated vs non-irradiated) and this difference was broadly similar after 30 years (23.7% vs 27.5%).
In a press release from the conference, lead researcher, Professor Ian Kunkler said, ‘We found that there is no long-term improvement in overall survival for those women having radiotherapy‘. He added that ‘The benefits of having radiotherapy in terms of fewer local recurrences are only accrued over the first ten years after radiotherapy; thereafter, the rate of local recurrence is similar whether or not patients had radiotherapy.’
Citation
Williams L et al. Randomised controlled trial of breast conserving therapy: 30 year analysis of the Scottish breast conservation trial. Abstract No 2. 13th European Breast Cancer Conference.
8th April 2022
A meta-analysis by researchers from Beijing Tongren Hospital, Capital Medical University, Beijing, China, has concluded that adding radiotherapy to immune checkpoint inhibitors (ICIs)for the treatment of patients with melanoma offers no overall survival benefit despite a significant improvement in 12-month progression-free survival.
According to the World Cancer Research Fund, melanoma is the 19th most commonly occurring cancer in men and women, with nearly 300,000 new cases reported in 2018. Among patients whose melanoma has undergone metastases, ICIs, monoclonal antibodies which target the programmed death cell protein 1 (PD-1), the programmed death-ligand 1 (PD-L1), or the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), represent the standard of care.
Nevertheless, while effective, when used as mono-therapy, ICIs produce an overall response rate ranging from 0% to 17%, though these figures increase to more than 33.3% when the agents are combined.
Radiotherapy is routinely used in treatment of solid cancers, such as hepatocellular carcinoma (HCC) and several preclinical and clinical studies have explored the efficacy of combining radiotherapy and ICIs in HCC and with promising outcomes. Moreover, a meta-analysis of 11 studies found that combining ICIs with radiotherapy showed better local efficacy than ICI mono-therapy for treating melanoma brain metastasis.
Despite this, few studies have systematically examined the combined effect of ICIs and radiotherapy in the treatment of patients with melanoma.
For the present study, the Chinese team set out to summarise the efficacy of radiotherapy in combination with ICIs in the treatment of non-brain metastatic melanoma. They included all available trials such as single-arm and control studies in which the endpoints of overall response rate (ORR), overall survival (OS) or progression-free survival (PFS) were reported. The team used regression analysis and presented their results using odds ratios.
Immune checkpoint inhibitors and radiotherapy outcomes
After an extensive literature search, 9 articles (7 retrospective studies and 2 prospective cohort trials) involving 624 patients were identified and included in the analysis.
Combing radiotherapy with ICIs led to a higher ORR compared with ICIs alone (35% vs 20.4%, p = 0.004) However, in terms of OS, the 12-month odds ratio (OR) comparing the combination to ICI treatment alone was 1.83 (95% CI 0.32 – 5.52, p = 0.69) and hence not significantly different.
While there was no significant difference between the two treatment options in PFS at 6-months (OR = 0.53, 95% CI 0.26 – 1.08, p = 0.08), this difference became significant at 12-months (OR = 0.48, 95% CI 0.29 – 0.80, p = 0.005).
Commenting on these findings, the authors highlighted that with most studies being retrospective in nature and no randomised trials, there was a need for prospective trials to further explore the efficacy of combining radiotherapy with ICIs in melanoma.
They concluded that while, at present, there was no evidence of a survival benefit by combining the two therapies, an improvement in PFS was evident but further high quality trials were required to confirm these findings.
Citation
Yin G et al. Efficacy of radiotherapy combined with immune checkpoint inhibitors in patients with melanoma: a systemic review and meta-analysis Melanoma Res 2022
16th March 2022
Radiotherapy use in cancer has been found to be associated with an increased risk of death from cardiovascular disease. This was according to the findings of a study by researchers from the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Cardiovascular diseases are responsible for an estimated 17.9 million deaths each year and cardiovascular disease and cancer are the leading causes of premature death across the world.
In the past few years, it has become recognised that there is actually a significant overlap in the risk factors for the development of both cardiovascular disease and cancer, providing opportunities for joint risk factor modification.
Despite the fact that radiotherapy use has become an increasingly integral part of much modern-day cancer therapy, it can increase the risk of cardiovascular events.
For example, in a 2017 meta-analysis that investigated the link between radiotherapy and long-term cardiovascular morbidity and mortality in patients with breast cancer, it was found that exposure of the heart to ionising radiation during radiotherapy increased the subsequent risk of coronary heart disease and cardiac mortality.
Given the potential heightened risk of cardiovascular disease death from radiation use in cancer therapy, the Chinese researchers set out to perform a comprehensive analysis to further examine the nature of this relationship in comparison to the general population.
They used data held within the Surveillance, Epidemiology and End Results (SEER) database and included individuals with a primary solid tumour at six different tumour sites and with a diagnostic data of between 1975 and 2014.
Radiation use and subsequent cardiovascular disease death
The team identified 2,214,944 patients with cancer from the SEER database, of whom 292,102 (13.2%) had died from a cardiovascular disease. A total of 718,979 patients had received radiotherapy and 1, 495,965 were in the ‘no radiotherapy’ group.
Overall, 67,003 (9.3%) of the radiotherapy group had subsequently died from a cardiovascular disease compared to 225,099 (15.1%) in the no radiotherapy group.
Using a standardised mortality ratio (SMR) to compare cardiovascular deaths among those who had cancer, the SMR was increased by 13% (SMR = 1.13, 95% CI 1.13 – 1.14). In other words, there was a higher incidence of cardiovascular disease deaths among those who had cancer compared to the general population.
In the multivariable analysis, radiotherapy use was considered to be an independent risk factor for some, but not all, forms of cancer. For example, lung and bronchus (hazard ratio, HR = 1.09, 95% CI 1.06 – 1.13), cervix uteri (HR = 1.47), corpus uteri (HR = 1.13) and bladder cancer (HR = 1.13).
In contrast, there was no significant association for several others such as stomach (HR = 1.03, 95% CI 0.93 – 1.13) and prostate cancer (HR = 0.99, 95% CI 0.97 – 1.00).
The authors concluded that radiotherapy use in patients with cancer does lead to an overall increased risk of cardiovascular death compared to the general population but that the risk is only significant for the certain cancers.
Nevertheless, they highlighted the importance of cardiovascular care in patients with cancer undergoing radiotherapy.
Citation
Liu E et al. Association Between Radiotherapy and Death From Cardiovascular Disease Among Patients With Cancer: A Large Population‐Based Cohort Study J Am Heart Assoc 2022.
12th November 2021
The use of oral arginine increased the effectiveness of radiation therapy in patient with unresectable brain metastases from solid tumours. This was the conclusion of a study by researchers from the Hematology and Oncology Division, Cornell University, New York, USA. Brain metastases (BMs) occur in 10% to 20% of adult patients with solid organ cancers and are 10 times more common than primary brain tumours. Use of compounds that improve blood flow to tumours might enhance the efficacy of both chemo- and radiotherapy and one suggested agent is nitric oxide (NO) which has been shown to act as an intrinsic radio-sensitiser in vivo.
For the present study, the US researchers considered the use of arginine, which is an endogenous substrate of the nitric oxide synthase enzyme, that naturally produces NO. Although its use in cancer patients has not previously been examined, data from patients with acute metabolic strokes has shown that administration of arginine therapy yields significant therapeutic benefit. Based on the fact that the amino acid appears to have a metabolic effect, the researchers measured levels of the tumour lactate concentration, in patients with BMs, which serves as a biomarker and driver of radio-resistance. The results showed that arginine consistently and significantly reduced tumour lactate concentrations in a small number of patients with BMs. Based on these findings the team undertook a proof-of-concept randomised trial to explore whether arginine increased the effect of radiation therapy in patients with unresectable BM from solid tumours.
Findings
A total of 63 patients with solid tumour cancers (including breast, melanoma and non-small cell lung cancer) and BMs were randomised to placebo (32) or oral arginine (10g) which was given 60 minutes before radiation therapy. Patients were followed for a median of 5 months and the overall response rate was 22% in the placebo group but 77.4% in the arginine arm, with a symptomatic response rate of 50% and 93.5% (placebo vs arginine, p = 0.002). In addition, the number of patients free from neurological progression at 6 months was 82% for arginine but only 20% for placebo. Finally, disease progression was observed in only 9.6% of those taking arginine compared to 43.7% of the placebo group.
The authors also reported that in those receiving arginine, functional imaging revealed a marked reduction in tumour lactate concentration, suggesting that the amino acid induced a metabolic effect on cancerous cells. They concluded that the amino acid could be used therapeutically in combination with radiation therapy in patients with brain metastases.
Citation
Marullo R et al. The metabolic adaptation evoked by arginine enhances the effect of radiation in brain metastases. Sci Adv 2021
20th September 2021
A squamous cell carcinoma on the head or neck is the sixth most common cancer globally, with around 890,000 new cases and 450,000 deaths in 2018. The main form of treatment is curative radiotherapy and in patients with locoregionally advanced cancers, prior scanning with fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) has been shown to have good diagnostic performance for the detection of regional nodal metastasis. However, where there is a delay between radiotherapy and the initial PET-CT scan, does this impact on radiotherapy planning and might it be necessary to perform a second scan prior to radiotherapy? This was the question posed by researchers from the Department of Radiation Oncology, Inselspital, Bern University Hospital, Bern, Switzerland. The team performed a retrospective analysis of patients with advanced head or neck squamous cell carcinoma and who had received two PET-CT scans prior to radiotherapy, to determine whether the second scan led to any modifications to radiotherapy treatment. The team looked for changes in the primary tumour, lymphatic spread and the presence of distant metastases between the two scans. They categorised any changes as minor if there were modifications to the RT plans such as dose changes and major where treatment moved from curative to palliative or the addition of induction chemotherapy, a switch to surgery or any additional diagnostic work-up that led to postponement or cancellation of treatment.
Findings
There were 32 newly diagnosed patients with locoregionally advanced squamous cell cancer with a median age of 64 years (34% female). The median interval between the initial scan for staging assessment and the second scan was 42.5 days. Just over half (53%) of patients had a grade 2 and 41% a grade 3 tumour. Fortunately, a major treatment change occurred in only 1 patient although nodal upstaging occurred in 10% (3/29) of patients. Minor treatment changes were required in 52% (16/31) of patients with new lymph node metastases detected in all 16 patients and in 6 cases, there was evidence of progression of the primary tumour size.
In discussing their findings, the authors noted that despite an initial PET-CT scan to assess tumour staging, a second scan identified the need for minor changes in just over half of all patients. Based on these findings, they called for the potential benefits of a second scan to be further investigated and validated. They also noted that the practice of undertaking a second scan of patients where the delay was more than four weeks has become the established practice at their hospital.
Citation
Elicin O et al. Impact of pre-treatment second look 18FDG-PET/CT on stage and treatment changes in head and neck cancer. Clin Trans Radiat Oncol 2021
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