Pain Response After Stereotactic Body Radiation Therapy Versus Conventional Radiation Therapy in Patients With Bone Metastases-A Phase 2 Randomized Controlled Trial Within a Prospective Cohort.

PURPOSE: Pain response after conventional external beam radiation therapy (cRT) in patients with painful bone metastases is observed in 60% to 70% of patients. The aim of the VERTICAL trial was to investigate whether stereotactic body radiation therapy (SBRT) improves pain response. METHODS AND MATERIALS: This single-center, phase 2, randomized controlled trial was conducted within the PRESENT cohort, which consists of patients referred for radiation therapy of bone metastases to our tertiary center. Cohort participants with painful bone metastases who gave broad informed consent for randomization were randomly assigned to cRT or SBRT. Only patients in the intervention arm received information about the trial and were offered SBRT (1 × 18 Gy, 3 × 10 Gy, or 5 × 7 Gy), which they could accept or refuse. Patients who refused SBRT underwent standard cRT (1 × 8 Gy, 5 × 4 Gy, or 10 × 3 Gy). Patients in the control arm were not informed. Primary endpoint was pain response at 3 months after radiation therapy. Secondary outcomes were pain response at any point within 3 months, mean pain scores, and toxicity. Data were analyzed intention to treat (ITT) and per protocol (PP). This trial was registered with Clinicaltrials.gov, NCT02364115. RESULTS: Between January 29, 2015, and March 20, 2019, 110 patients were randomized. ITT analysis included 44 patients in the cRT arm and 45 patients in the SBRT arm. In the intervention arm, 12 patients (27%) declined SBRT, and 7 patients (16%) were unable to complete the SBRT treatment. In ITT, 14 of 44 patients (32%; 95% confidence interval [CI], 18%-45%) in the control arm and 18 of 45 patients (40%; 95% CI, 26%-54%) in the SBRT arm reported a pain response at 3 months (P = .42). In PP, these proportions were 14 of 44 (32%; 95% CI, 18%-45%) and 12 of 23 patients (46%; 95% CI, 27%-66%), respectively (P = .55). In ITT, a pain response within 3 months was reported by 30 of 44 control patients (82%; 95% CI, 68%-90%) and 38 of 45 patients (84%; 95% CI, 71%-92%) in the SBRT arm (P = .12). In PP, these proportions were 36 of 44 (82%; 95% CI, 68%-90%) and 26 of 27 patients (96%; 95% CI; 81%-100%), respectively (P = .12). No grade 3 or 4 toxicity was observed in either arm. CONCLUSIONS: SBRT did not significantly improve pain response in patients with painful bone metastases. One in 4 patients preferred to undergo cRT over SBRT, and 1 in 5 patients starting SBRT was unable to complete this treatment. Because of this selective dropout, which can be attributed to the character of the intervention, the trial was underpowered to detect the prespecified difference in pain response.

[Developments in radiotherapy: image-guided and minimally invasive]. / Ontwikkelingen in de radiotherapie: beeldgestuurd, ablatief en minimaal-invasief.

Radiotherapy is a long-standing treatment method which makes use of ionising radiation for the treatment of patients with malignancies. Radiotherapy is currently undergoing major evolvements. The treatment method has gone from being imprecise and was often accompanied by unpreventable side effects to a high-precision therapy which can compete with surgery and other focal curative and less toxic treatment strategies. Through the improved quality of imaging and the availability of new techniques, it became possible to use both anatomical and functional information to accurately determine the position and characteristics of the tumour in space and time. Imaging is also used to enhance the guidance of x-rays during the actual treatment. This enables the reduction of radiotherapy margins and a decrease in the radiation dose aimed at normal tissues.- For many indications, therefore, the delivery of the complete radiation dose can be reduced to only a few fractions, which is not only very effective, but is especially beneficial for the patient.

[Cohort multiple randomized controlled trial: a solution for the evaluation of multiple interventions]. / 'Cohort multiple randomized controlled trial': een oplossing voor de evaluatie van multipele interventies.

The standard randomized controlled trial (RCT) does not appear to be the most suitable design for the fast and efficient simultaneous evaluation of multiple interventions for the same condition. The cohort multiple randomized controlled trial (cmRCT) design offers the opportunity to perform randomized trials for multiple interventions simultaneously and is a promising alternative for the classic RCT. The basis of the cmRCT is an observational cohort of patients with the same condition. The patients will generally undergo standard treatment. The patient characteristics are captured at baseline and outcome measures are captured at fixed points of time. Eligible patients within the observational cohort are identified for each new intervention, some of whom will be randomly selected and offered the new intervention. The other eligible patients will not be approached and will undergo the standard treatment. The same process can be simultaneously repeated for other interventions. Advantages include the ability to facilitate multiple simultaneous randomized evaluations, the improved comparability between trials and the patient-centered informed consent procedure.

[Happiness and cancer]. / Geluk en kanker.

Television, newspapers and social media suggest that cancer patients hold their fate in their own hands: they can improve their chances of survival by means of positive thinking or by adopting a fighting mentality. Nevertheless, there is no convincing scientific evidence of a link between one's personality or coping mechanisms and survival. Studies that do show a positive association are generally of inferior methodology and substantially smaller than studies with null findings. Psychotherapeutic interventions may improve the quality of life, lifestyle and treatment compliance in patients with cancer, but no randomized controlled trials or meta-analyses having survival as a primary endpoint have shown any positive effects of psychotherapy on survival. There is also no solid evidence that the 'cancer experience' does enrich one's life or lead to personal growth or happiness. In conclusion, positive thinking and a fighting mentality do not improve chances of survival, adequate treatment does.