Following surgical removal of the primary tumour, patients with stage I non-seminomatous germ cell tumours of the testis (NSGCTT-'testicular teratoma') have an overall risk of developing metastatic disease of 30% (Cullen, 1991). However, a subgroup of these patients, which can be identified histologically, has an increased risk of distant recurrence of 50% (Freedman et al., 1987). A recent MRC study has demonstrated that two courses of chemotherapy, administered not more than 6 weeks after surgery, will increase relapse-free and long-term survival rates to more than 98% in this 'high-risk' subgroup (Cullen et al., 1996). Stage I cases who are managed in a surveillance programme, with chemotherapy (typically four courses) reserved for those patients who relapse, enjoy an identical long-term survival rate (Read et al., 1992). Thus, there is a choice of two different management approaches for high-risk stage I teratoma patients; either immediate adjuvant chemotherapy, or the surveillance programme with chemotherapy only given on relapse. Both approaches lead to the same, excellent, survival prospects for this group of patients, but their attendant shortcomings are different.It is clear that some patients experience anxiety as a result of the uncertainty of surveillance (Moynihan, 1987). Prompted by this, we sought to investigate which management approach patients prefer. Newly diagnosed teratoma patients were asked to imagine risks of recurrence ranging from 10% to 90% and then to choose between: immediate adjuvant chemotherapy (AC); surveillance (S); or for the doctor to make the decision (DD), at each risk level.We also presented the same hypothetical scenario to different groups of controls, namely: subjects with the 'ultimate' experience, i.e. patients with testicular teratoma who have been through a surveillance programme, and others who have been treated with chemotherapy; those who might be considered to have the 'ultimate' knowledge, i.e. specialist testicular tumour oncologists; and two other groups of noncancer controls. Subjects and methodsNine separate groups, which might reasonably be expected to respond differently owing to varying experience or knowledge, were studied: 1. Newly diagnosed patients with stage I NSGCTT (New; n = 18). For this group it was a 'real-life' situation. surveillance, but then relapsed and undergone BEP chemotherapy and were in remission, presumed cured (Relsurv; n = 9). 7. Non-cancer controls-1; medical students having just had a lecture on NSGCTT (Students; n = 56). 8. Non-cancer controls -2; firemen (Firemen; n = 37). All the available officers at one fire station were selected. 9. Non-cancer controls -3; Specialist testicular tumour oncologists (Oncol; n = 18). These were all the oncologist members of the MRC testicular tumour working party responsible for managing the vast majority of cases in the UK.A specifically trained oncology nurse was responsible for administering a detailed information sheet and questionnaire to Correspondence: MH Cullen

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Pembrolizumab monotherapy or combination therapy is an approved treatment for various advanced non-small cell lung cancer (NSCLC) indications. We review published cost-effectiveness analyses (CEAs) of pembrolizumab as treatment for NSCLC and provide in-depth assessment of their methodologies. Fourteen studies were selected through searches of the PubMed database. Modeling approaches, survival and cost estimation, and utility analyses were compared and evaluated. These publications covered regulatory-approved pembrolizumab NSCLC indications based on the following randomized clinical trials: KEYNOTE-010 (one publication), KEYNOTE-024 (six), KEYNOTE-042 (four), KEYNOTE-189 (two), and KEYNOTE-407 (one). Differences were observed in health states (progression free, progressed disease, and death vs stable disease, progressed disease, death, and treatment discontinuation), modeling approaches (partitioned survival vs Markov), survival extrapolation/transition probability estimation, inclusion of additional costs to drug, disease management and adverse event costs (e.g., programmed death-ligand 1 [PD-L1] testing, subsequent treatment, terminal care), treatment duration approaches (trial-based time on treatment vs treat to progression), utility sources (trial data vs literature), and utility analyses (time to death vs progression status). Certain aspects of variability across models were problematic, including deviation from observed treatment utilization within trials and predicted long-term mortality risks for pembrolizumab higher than historical real-world NSCLC mortality data prior to the availability of pembrolizumab. Consequently, results differed even among studies examining the same population and comparator within similar time intervals. Differences in methodology across CEAs may lead to distinct results and conclusions. Payers and policy makers should carefully examine study designs and assumptions and choose CEAs with greater validity and accuracy for evidence-based decision-making.

Combinations of paclitaxel and radiation therapy or paclitaxel with other chemotherapy agents and radiation have been tested with variable results in patient populations. To date, three phase I trials have been conducted using paclitaxel alone in combination with radiotherapy for the treatment of patients with head and neck cancer. Dose-limiting toxicity in the 1-hour infusion was mucositis, whereas in the 24-h/wk infusion, fever was the dose-limiting toxicity. In the long-term infusion (24 h/d, 7 d/wk), no dose-limiting toxicity was seen at the doses of paclitaxel given. In two of the protocols in which biopsies were obtained, a G2/M block was observed. A phase I protocol using paclitaxel in combination with fluorouracil and hydroxyurea with radiation and a phase II protocol using paclitaxel with cisplatin in operable head and neck cancers have been reported. Preliminary results suggest that paclitaxel in combination with radiotherapy is a reasonable experimental treatment that deserves further study in patients with stage III and IV squamous cell carcinomas of the head and neck.

Introduction A new dosing schedule for the oncology immunotherapy pembrolizumab, every 6 weeks (Q6W), has been approved by the U.S. FDA, reducing the frequency of visits to infusion centers. We quantified the time spent by oncologists, nurses, patients, and caregivers per melanoma-related immunotherapy infusion visit to evaluate its potential impact. Methods Surveys were self-completed by 100 oncologists, 101 oncology nurses, and 100 patients with melanoma across the U.S. to quantify the time spent per infusion visit with pembrolizumab (Q3W or Q6W), nivolumab (Q2W or Q4W), or nivolumab+ipilimumab (nivolumab in combination: Q3W; nivolumab maintenance: Q2W or Q4W). Time measures included traveling, waiting, consultation, infusion, post-treatment observation, and caregiving. Respondents were also surveyed regarding the impact of the COVID-19 pandemic on infusion treatments. Results Responses deemed valid were provided by 89 oncologists, 93 nurses, and 100 patients. For each new [returning] patient treated with pembrolizumab, nivolumab or nivolumab+ipilimumab, oncologists reported to spend an average of 90 [64], 87 [60] and 101 [69] minutes per infusion visit (p-value for between-group difference = 0.300 [0.627]). For first [subsequent] treatment cycles, nurses reported spending 160 [145] average minutes per visit for nivolumab+ipilimumab, versus roughly 120 [110] for the single agents (p-value for between-group difference = 0.018 [0.022]). Patients reported to spend an average of 263, 382, and 224 minutes per visit at the center for pembrolizumab (N = 47), nivolumab (n = 34), and nivolumab+ipilimumab (n = 15) respectively (p-value for between-group difference = 0.0002). Patients also reported that their unpaid (N = 20) and paid caregivers (N = 41) spent with them an average of 966 and 333 minutes, respectively, from the day before to the day after the infusion visit. Conclusion Less frequent immunotherapy infusion visits may result in substantial time savings for oncologists, nurses, patients, and caregivers.