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Purpose: Hypofractionated external beam radiation therapy (EBRT) is a standard of care option for localized prostate cancer. To inform clinical practice we quantified patients' preferences for convenience, efficacy, and toxicity risks, of conventional, moderate hypofractionation, and stereotactic radiation therapy regimens., Methods and Materials: We used a discrete choice experiment with a voluntary sample consisting of patients treated with EBRT for localized prostate cancer at our academic cancer center. In 2019, 58 participants, mean (SD) age of 72.9 (7.1) years, agreed to complete an in-person 1:1 discrete choice experiment. Each participant made 12 choices between 2 unique EBRT scenarios, each described by 5 attributes: (1) treatment time; (2) fiducial markers; and risk of (3) prostate specific antigen recurrence; (4) acute and (5) late GI or GU toxicity. Patient preferences were estimated using mixed multinomial logistic regression, and prespecified subgroups with conditional logistic regression., Results: All attributes were statistically significant, thus influenced participants' choices. Risks of prostate specific antigen recurrence (β = -2.581), late (β = -1.854), and acute (β = -1.005) toxicity were most important to participants (P < .001 for each), followed by EBRT length (β = -0.728; P = .017) and fiducial marker implantation (β = -0.563; P = .004). Older (β = -0.063; 95% confidence interval, -0.12, -0.01) and rural (β = -0.083; 95% CI -0.14, -0.02) participants significantly preferred shorter EBRT and were less willing-to-extend treatment to reduce toxicity risk., Conclusions: Patients with prostate cancer place importance on EBRT attributes, and some are willing to trade-off increased risk of toxicity for improved convenience. Our findings promote shared clinical decision-making because patients are interested in learning about the trade-offs involved., (Copyright © 2021 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Purpose: Although the year after cancer treatment is challenging for all cancer survivors, older adults (≥60 years) face additional challenges due to age-related decline and high rates of comorbidity. There is a paucity of research on how health service interruptions from the COVID-19 pandemic have impacted the experience of older cancer survivors. In this study we explore older cancer survivors' reflections on the pandemic and their suggestions for future care delivery when traditionally offered resources are not available., Methods: We conducted 1:1 telephone interviews with adults 60 years and older previously diagnosed with breast and colorectal cancer and recently (≤12 months) discharged from their cancer care team. We analyzed the data using descriptive thematic analysis., Results: The mean sample (n = 30) age was 72.1 years (SD 5.8, Range 63-83) of whom 57% identified as female. Participants described personal and societal implications of the pandemic. that affected their ability to navigate social support, and public and clinical landscapes. These reflections informed their suggestions for future health care delivery, such as how they could have been better prepared to self-manage their post-cancer treatment journey. Participants recommendations were grouped into four sub-themes: 1) enhanced baseline information; 2) facilitate caregiver support and engagement; 3) greater technology integration; and 4) sustained use and public appreciation of personal protective equipment., Conclusion: Older cancer survivors appreciate the needed shift to virtual appointments and services during the COVID-19 pandemic. Specific strategies to bolster older adults existing strengths and improve their readiness to engage in these measures are critical., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The effectiveness of patient decision aids (PtDA) is rarely evaluated in the "real world" where patients vary in their preferences related to decision support., Purpose: To determine how Canadian patients use and evaluate our widely available PtDA for early-stage prostate cancer treatment with its 8 components., Methods: Google Analytics and online tracking provided usage information. A Usability Assessment (UA) following the PtDA provided evaluation data; main outcomes [scale: 1 (strongly disagree) to 5 (strongly agree)] were (a) the aid was helpful, and (b) I would recommend it to other patients., Results: Usage data were from 993 users, and UAs from 168 of them. Mean "helpfulness" score was 4.1(5 max); mean "recommend" score was 4.2 (5 max). For each PtDA component, there was no significant difference on each main outcome, between those who used it and those who did not., Conclusion: Overall, patients who completed the UA rated the PtDA as helpful and would recommend it to other patients. The widely available PtDA accommodated expected variation in decision support desired, and helpfulness was not associated with variation in components used., Practice Implication: The internet can be an effective medium for making appropriately designed decision support widely available to prostate cancer patients., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (i.p.) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelial ovarian cancer (EOC)., Patients and Methods: We carried out a multicenter, two-stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (i.v.) NACT followed by optimal (<1 cm) debulking surgery were randomized to one of the three treatment arms: (i) i.v. carboplatin/paclitaxel, (ii) i.p. cisplatin plus i.v./i.p. paclitaxel, or (iii) i.p. carboplatin plus i.v./i.p. paclitaxel. The primary end point was 9-month progressive disease rate (PD9). Secondary end points included progression-free survival (PFS), overall survival (OS), toxicity, and quality of life (QOL)., Results: Between 2009 and 2015, 275 patients were randomized; i.p. cisplatin containing arm did not progress beyond the first stage of the study after failing to meet the pre-set superiority rule. The final analysis compared i.v. carboplatin/paclitaxel (n = 101) with i.p. carboplatin, i.v./i.p. paclitaxel (n = 102). The intention to treat PD9 was lower in the i.p. carboplatin arm compared with the i.v. carboplatin arm: 24.5% (95% CI 16.2% to 32.9%) versus 38.6% (95% CI 29.1% to 48.1%) P = 0.065. The study was underpowered to detect differences in PFS: HR PFS 0.82 (95% CI 0.57-1.17); P = 0.27 and OS HR 0.80 (95% CI 0.47-1.35) P = 0.40. The i.p. carboplatin-based regimen was well tolerated with no reduction in QOL or increase in toxicity compared with i.v. administration alone., Conclusion: In women with stage IIIC or IVA EOC treated with NACT and optimal debulking surgery, i.p. carboplatin-based chemotherapy is well tolerated and associated with an improved PD9 compared with i.v. carboplatin-based chemotherapy., Clinical Trial Number: clinicaltrials.gov, NCT01622543., (© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Purpose: Radiation therapy plays an important curative role for patients with locally advanced cervical cancer (LACC). There are no standards to define best practice. The purpose of this study was to develop a suite of radiation therapy key quality-of-care indicators (KQIs) for the curative management of LACC based on expert consensus., Methods and Materials: A modified Delphi method was used after identifying candidate KQIs. Round 1 involved surveying all Canadian gynecology radiation oncologists. The current and anticipated future (5 years) importance and current achievability of each KQI was ranked. Round 2 consisted of a facilitated face-to-face meeting with a smaller expert panel to discuss, revise, and develop consensus on the KQIs., Results: The literature review identified 83 candidate KQIs. Survey response was 71%. Round 2 yielded a final suite of 40 KQIs in the following categories: pretreatment assessment, external beam radiation therapy, brachytherapy, follow-up, and expertise/workload. A prominent theme was the importance of having KQIs to measure the current state, evolution, and future uptake of magnetic resonance-guided brachytherapy., Conclusions: To our knowledge, this is the first study establishing radiation therapy KQIs in LACC based on expert consensus. These KQIs should be used to guide programmatic direction and resource allocation to assure consistent and optimal patient care., (Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.)

Purpose: Incident investigation, reporting, and learning are core elements of quality improvement in radiation treatment. This report describes the development of a Canadian National System for Incident Reporting in Radiation Treatment (NSIR-RT), focusing especially on the taxonomy., Methods and Materials: The NSIR-RT was developed to provide a framework in Canada for reporting and analyzing radiation treatment incidents. A key objective was to assure compatibility with other international reporting systems to facilitate future information exchange. The Canadian community was engaged at every step of the development process through Delphi consensus building and inter-user agreement testing to promote awareness of the system and motivate broad-based utilization across the country., Results: The final taxonomy was comprised of 6 data groups (impact, discovery, patient, details, treatment delivery, and investigation) and 33 data categories with predefined menu options. There was a high level agreement within the Canadian community about the final suite of data categories, and broad alignment of these categories with the World Health Organization and other American and European radiation treatment incident classifications., Conclusions: The Canadian NSIR-RT taxonomy will be implemented as an online, web-based reporting and analysis system. It is expected that the taxonomy will evolve and mature over time to meet the changing needs of the Canadian radiation treatment community and support radiation treatment incident learning on a global scale., (Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Purpose: To identify the information that post-menopausal women with hormone-receptor positive, early-stage breast cancer want, to help them decide among six treatment options for adjuvant-endocrine therapy., Methods: We surveyed women with early-stage breast cancer who were eligible for adjuvant endocrine-therapy 3-18 months earlier. Participants rated the importance of getting each of 95 questions answered before this decision is made (options: essential/desired/not important/avoid). For questions rated essential or desired, participants identified the purpose(s) for having the question answered: to help them understand, make the decision, plan, or other. Participants indicated the role they played in their actual decision and the role they would prefer if the decision was made today. They also indicated whether they felt they had had a choice of endocrine therapy treatments., Results: 188 of 343 questionnaires were returned (response rate 55%). Mean age was 67 yr (range 38-88 yr); 76% were married, and 39% had secondary school education or less. On average, respondents rated 18 questions (range 0-94) essential for decision making. Each question was rated essential for decision making by ≥ 7% of participants but only 1 question by >50%. Regarding roles, 89% of respondents had participated in their actual decision and would want to again; an additional 9% had not participated in their actual decision but would want to at the time of the survey. The percentage of respondents who felt they had no choice of endocrine therapy treatments varied between centres, 25% vs 41% and 49%., Conclusions: Most patients want to participate in the decision but they vary widely in the amount and which specific details they want to help them make the decision., Implication: The wide variation in questions considered important means the support should be tailored to the needs of the individual patient., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objective: To identify questions that post-menopausal women with receptor-positive early-stage breast cancer want answered before their adjuvant-endocrine-therapy decision is made., Methods: We surveyed patients eligible for adjuvant-endocrine therapy in the previous 3-18 months. Participants rated the importance of getting each of 95 questions answered before the decision is made (options: essential/desired/not important or no opinion/avoid). For each question rated "essential"/"desired", the participant also identified the purpose(s) for the answer: to help her understand, decide, plan, or other reason(s)., Results: The response rate was 55% (188/343). Participants rated a mean of 57 (range: 1-95) questions "essential", 80 (range: 1-95) "essential" or "desired", and 2 (range: 0-27) "avoid". Every question was "essential" to ≥31% of participants, and "essential"/"desired" to ≥63%. All but eleven questions were rated as "avoid" by ≥1 participant. The most frequent purposes for "essential" questions were to: understand their situations (mean 45, range: 0-95), decide (mean 18, range: 0-94), and plan (mean 13, range: 0-95)., Conclusion: Many patients want a lot of information before this decision is made but there is wide variation within the group in both the number and in which questions they want answered., Practice Implications: Patient education in this setting needs to be tailored to the needs of the individual patient., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

We conducted a randomized, controlled trial comparing thalidomide-prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival,progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide-prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P < .0001) and more frequent venous thromboembolism (7.3% vs none; P = .0004). Median survival after first disease recurrence was 27.7 months with thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomide-prednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit.

Background: In the CALYPSO trial, carboplatin-pegylated liposomal doxorubicin (CD) demonstrated superior therapeutic index versus carboplatin-paclitaxel (CP) in patients with recurrent ovarian cancer. This paper reports the health-related quality of life (HRQoL) findings., Materials and Methods: HRQoL was measured with the EORTC QoL-QC30 questionnaire and OV28 ovarian cancer module. Mean change scores from baseline in HRQoL subscales (five functional scales and global health status) in each arm and the proportion of patients improved or worsened were calculated every 3 months until 12 months., Results: Compliance was 90% at baseline and 76%, 64%, 57% at 3, 6, and 9 months, respectively. Baseline HRQoL showed already impaired global scores (mean 62/100) and considerable symptom burden (90% of patients reporting nonzero scores). Global QoL and abdominal symptom scores improved over time in both arms; at 6 months, 36% of patients met criteria for improved symptoms. Treatment with CD resulted in less peripheral neuropathy (9.8 versus 24.2), fewer other chemotherapy side-effects (9.5 versus 16.2), and less impact on body image (3.8 versus 10.4) versus CP (all P<0.02) at 6 months., Conclusions: These patient-reported outcomes confirm the overall lower toxicity of CD versus CP. The improved disease-related outcomes achieved with CD were not at the expense of QoL.

Background: Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer., Methods: Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633., Results: Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4-8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70-78 vs 66%, 60-70; hazard ratio [HR] 0·77, 95% CI 0·61-0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0·5%) in the ADT only group, two (0·3%) in the ADT and RT group; diarrhoea grade >3, four patients (0·7%) vs eight (1·3%); urinary toxicity grade >3, 14 patients (2·3%) in both groups)., Interpretation: The benefits of combined modality treatment--ADT and RT--should be discussed with all patients with locally advanced prostate cancer., Funding: Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Introduction: The National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) Quality of Life (QOL) Committee was initiated in 1986., Purpose: The purpose of this review is to describe the evolution of the Committee's work and to highlight key developments such as the formulation of a policy regarding health-related quality-of-life (HRQOL) assessment, the provision of guidelines to ensure completion of HRQOL data within the protocol requirements, the rationale behind the choice of HRQOL instruments, the timing of assessments and the development of data analytic methods. These developments are illustrated with examples from CTG studies., Recommendations: There is a lack of concordance between conventional toxicity data and HRQOL data and comparative studies designed to elucidate these differences are to be encouraged. Also, more studies are required to compare different analytic strategies and to determine how much missing data is acceptable, particularly in oncology studies where attrition is inevitable.

The study was designed to compare the information priorities of Italian early-stage prostate cancer patients to those of their health-care professionals. Doctors (urologists and oncologists), nurses, radiation therapy technologist (RTs), and patients treated with radiotherapy in Northern Italy were surveyed. Respondents rated the importance of addressing each of 78 questions as: essential, important, or superfluous. We compared priorities between pairs of groups by correlating the percentage of each group that rated each question (a) essential and (b) superfluous. We assessed within-group agreement by identifying questions that >50% of one response. Fifty-nine doctors, 53 nurses, and 45 RTs (overall 70% response rate) and 50 patients (91% response rate) participated. All correlations between professional groups were high (all >0.74). All professional group-patient correlations were significant but much lower than those among the professionals. More importantly, there was considerable variation within each group: within each group, almost all questions were rated essential by some members but less than seven of the 78 questions were rated so by half (or more) of its members. In addition, almost all questions were also rated superfluous by some members of each profession. We concluded that the professional groups appear to agree with one another on questions essential and those superfluous to address more than they agree with a group of their patients. More importantly, there is considerable disagreement within each group. The results imply that the professionals cannot assume that their own information priorities are the same as those of their patients.

The purpose of this study was to determine how people weigh both median survival time and 1-year survival probability when considering a choice between palliative Cisplatin-based chemotherapy with best supportive care (C+BSC) versus best supportive care alone (BSC) as treatment for advanced non-small cell lung cancer (NSCLC). Sixty people, previously treated for cancer, were interviewed as surrogate patients making a treatment decision. The interview included a structured description of the treatment options, and trade-off exercises used to clarify the participants' attitudes pertaining to the survival probabilities associated with each treatment.Participants' attitudes ranged from choosing the more toxic treatment if it offered no survival advantage to declining C+BSC no matter how large its advantage. Fifty-seven percent of participants would choose chemotherapy if the 1-year survival were 10% higher with C+BSC than with BSC alone. For 44 participants (76%), both their median survival and 1-year survival thresholds for accepting C+BSC were consistent, and for two (3%), neither threshold was consistent with their stated treatment preference. For the remaining 12 (21%), one threshold was discordant, but in all cases, this threshold was less relevant to his/her decision. Participants' thresholds could not be predicted reliably on the basis of patient age, sex, education, preferred role in treatment decision making, or previous treatment with chemotherapy. All but one participant recommended the interview as a decision-support strategy for actual patients. The findings suggest that patients with advanced NSCLC should be offered more than one treatment option, and that a systematic process for educating patients and for eliciting their preferences is desirable. The process described herein has potential for use in this clinical setting.

Background: Substantial lack of consensus exists regarding the appropriate management of patients with locally advanced non-small cell lung cancer (NSCLC). The purpose of the present study was to investigate why published clinical trials have not resolved this uncertainty, and to examine the potential of current randomized studies to resolve the major controversies regarding the treatment of locally advanced NSCLC., Methods: A literature search identified papers addressing the therapy of locally advanced NSCLC published in the English language from January 1966 through May 1993. The treatment modalities studied in these trials were recorded. The CD-ROM Physician Data Query database was used to identify ongoing studies in NSCLC. For phase III trials in stage III NSCLC, the treatment modalities, eligibility criteria, outcome measures, and statistical considerations were recorded., Results: A total of 164 reports of phase III trials were identified, representing 11% of the 1516 publications meeting search criteria. A wide range of comparisons have been reported; the number of study arms, the number of different modalities employed as control arms, and the number of modalities employed as investigational arms increased over time. Eighteen active phase III protocols open to patients with stage III NSCLC were identified. In trials which enrolled patients with stage IIIB disease, therapy in control arms employed six different strategies of surgery, radiation, or chemotherapy, alone or in combination, and investigational arms were equally heterogeneous. Variation was also present in the spectrum of disease stages studied, in patient eligibility criteria, and in the clinical outcome measures investigated. The magnitude of improvement in survival sought was varied in its absolute magnitude, in the selection of survival probability for the control arm, and in the time point of its evaluation., Implications: We demonstrated diversity in research practice reflected in five major types of variation: (i) selection of control arms, (ii) selection of study investigational arms, (iii) choice of eligibility criteria, (iv) outcome measures selected for study, and (v) type and magnitude of benefit sought in the primary outcome measure. This variation has important implications regarding the inability of these studies to address some fundamental management controversies, and the ability to generalize the results of these trials to the general population of NSCLC patients. This diversity reflects a poorly defined process for setting the goals of clinical research. The generation of future trials may be improved by strategies that identify the most important controversies, identify important outcome measures, improve consensus among physicians, and provide the opportunity to incorporate patients' preferences in this clinical situation.

Because of lack of agreement concerning the toxicity of paraquat to the pulmonary microvasculature, we have undertaken an electron microscopic study of lungs of paraquat-treated rats. Rats were injected with paraquat or sterile water (controls) intraperitoneally; the animals were then killed at 24-h intervals for 10 days post-injection. In the control animals, lung ultrastructure remained normal throughout the study. In treated animals, the initial evidence of alveolar epithelial injury occurred 24 h post-paraquat. By 48 h, severe fragmentation and desquamation of membranous pneumocytes occurred, and both alveolar and interstitial edema were present. Epithelial damage was maximal 72-96 h post-paraquat. Pulmonary capillary endothelial abnormalities were less extensive than the alveolar epithelial lesions. Endothelial damage was first observed 48 h post-paraquat. In endothelial cells on the septal (thick) side of the capillaries, the number of pinocytotic vesicles was significantly increased (P less than 0.05) from 48 to 96 h post-paraquat. In endothelium adjacent to damaged epithelium, abnormalities included hydration, fragmentation, discontinuity, and widened intercellular junctions; these were maximal 72-96 h post-paraquat. Although other mechanisms are probably important, damaged pulmonary capillary endothelium seems to be a factor favoring paraquat-induced pulmonary edema.