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Background: Stereotactic Ablative Body Radiotherapy (SABR) is the standard of care for medically inoperable patients with Stage I NSCLC. The adoption of SABR and its association with cancer outcomes requires characterization., Aim: We described the management of biopsy-proven Stage I NSCLC with SABR, surgery, non-SABR curative radiotherapy (RT) and observation in Ontario, Canada, between 2010 and 2019. Temporal and geographic trends in practice and survival outcomes were analyzed., Methods: This was a retrospective population-based cohort study conducted by linking electronic radiotherapy (RT) records to a population-based cancer registry., Results: A total of 12,065 patients were identified, 61.7 % underwent surgery, 17.9 % received SABR, 8.6 % received non-SABR curative RT and 11.7 % were observed. Between 2010 and 2019, the utilization of surgery decreased (63.8 % to 49.9 %, p < 0.0001), while SABR use increased (7.5 % to 24.4 %, p < 0.0001), non-SABR curative RT use increased (6.7 % to 9.6 %, p < 0.0014) and patients observed decreased (14.4 % to 12.0 %, p < 0.0001). Substantial variation in practice exists across Ontario. Two- yr CSS improved for the entire cohort (81.9 % to 85.0 %, p < 0.0001). While there was improvement in 2 yr CSS for surgical patients (92.1 %% to 95.7 %, p < 0.001), survival for patients who received SABR, Non-SABR curative RT and observation remained stable., Conclusion: There has been an increase in SABR utilization and a reduction in surgical utilization with a corresponding increased survival of stage I patients in Ontario between 2010 and 2019. Substantial differences in practice patterns exist across health regions, suggesting the need for strategies to improve access to SABR in many jurisdictions., 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 © 2024 Elsevier B.V. All rights reserved.)

Purpose: Adjuvant chemotherapy for early stage non-small-cell lung cancer (NSCLC) is now the standard of care, but there is little information regarding its impact on quality of life (QOL). We report the QOL results of JBR.10, a North American, intergroup, randomized trial of adjuvant cisplatin and vinorelbine compared with observation in patients who have completely resected, stages IB to II NSCLC., Patients and Methods: QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and a trial-specific checklist at baseline and at weeks 5 and 9 for those who received chemotherapy and at follow-up months 3, 6, 9, 12, 18, 24, 30 and 36. A 10-point change in QOL scores from baseline was considered clinically significant., Results: Four hundred eighty-two patients were randomly assigned on JBR.10. A total of 173 patients (82% of the expected) in the observation arm and 186 (85% of expected) in the chemotherapy arm completed baseline QOL assessments. The two groups were comparable, with low global QOL scores and significant symptom burden, especially pain and fatigue, after thoracotomy. Changes in QOL during chemotherapy were relatively modest; fatigue, nausea, and vomiting worsened, but there was a reduction in pain and no change in global QOL. Patients in the observation arm showed considerable improvements in QOL by 3 months. QOL, except for symptoms of sensory neuropathy and hearing loss, in those treated with chemotherapy returned to baseline by 9 months., Conclusion: The findings of this trial indicate that the negative effects of adjuvant chemotherapy on QOL appear to be temporary, and that improvements (with a return to baseline function) are likely in most patients.

Purpose: This multi-institutional Phase III randomized study compared 10 Gy single-fraction radiotherapy (RT) with 20 Gy in five fractions in the palliation of thoracic symptoms from lung cancer., Methods and Materials: The primary end point was palliation of thoracic symptoms at 1 month after RT, evaluated by a patient-completed daily diary card. Secondary end points included quality of life, toxicity, and survival., Results: Most (69%) of 230 patients randomized had locally advanced disease unsuitable for curative treatment. The treatment arms were well balanced with respect to the known prognostic factors. At 1 month after RT, no difference was found in symptom control between the two arms, as judged by the daily diary scores. The changes in the scores on the Lung Cancer Symptom Scale indicated that the fractionated RT (five fractions) group had greater improvement in symptoms related to lung cancer (p = 0.009), pain (p = 0.0008), ability to carry out normal activities (p = 0.037), and better global quality of life (p = 0.039). The European Organization for Research and Treatment of Cancer QLQ-C30 scores showed that patients receiving five fractions had a greater improvement in scores with respect to pain (p = 0.04). No significant difference was found in treatment-related toxicity. Patients who received five fractions survived on average 2 months longer (p = 0.0305) than patients who received one fraction., Conclusion: Although the two treatment strategies provided a similar degree of palliation of thoracic symptoms, the difference in survival between the two study arms was of a clinically relevant magnitude.

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.

Purpose: To describe the outcome of involved-field radiotherapy in patients with early-stage non-small-cell lung cancer (NSCLC)., Methods and Materials: A written policy for the radical treatment of early-stage NSCLC with involved-field radiotherapy was adopted at our center in 1986. The sites of known disease were treated to a dose of 52.5 Gy in 20 daily fractions over 4 weeks without elective irradiation of radiologically uninvolved regional nodes. We have reviewed the outcome of this policy in 102 patients treated with radiotherapy alone between 1986 and 1995., Results: The patients' median age was 71.5 years. The stage distribution was as follows: T1, 33.3%; T2, 56.9%; T3, 8.8%; and T4, 1.0%. Only 5 cases were N1; the remainder were N0. Most patients (76.5%) were not surgical candidates because of co-morbidity. Ninety-three percent had a CT of the thorax as part of their initial staging, while mediastinoscopy was performed in only 16.7%. Overall survival was 35% at 3 years and 16% at 5 years. Recurrence free survival was 23.9% at 3 years and 13. 9% at 5 years. Cause-specific survival was 43.5% at 3 years and 26. 8% at 5 years. Of those who recurred, 68.9% had a local component of failure at initial relapse, and 49.2% failed locally without evidence of regional or distant metastases. Isolated regional nodal relapse at initial failure occurred in only 6.6% of recurrences. There were no treatment interruptions due to acute toxicity and no treatment-related deaths., Conclusion: Involved-field radiotherapy alone cures a small but significant number of patients with early-stage NSCLC. This approach is recommended in patients who are unfit for surgery and who have severely compromised pulmonary function that would preclude the use of wide-field radiotherapy. The dose used in this study was well tolerated, but produced suboptimal local control rates.

This study examined responses of 21 lung cancer outpatients to questions about their desired and actual levels of involvement in treatment decisions, and about information needed for treatment decision-making. A 'treatment trade-off' interview was used to assess patients' preferences for hypothetical treatment options. Desired roles in decisions are examined in relation to treatment preference and information needs. Forty-three percent of patients recalled desiring an active/collaborative role in their real treatment decision. For 29% of patients, there was a discrepancy between their recalled desired role and their recalled actual role; in each of these cases the patient had been less involved in the decision than they had desired. At the time of the interview (mean 26 months post-treatment), 57% of patients desired an active or collaborative role in treatment decisions. The majority of patients rated the following types of information as 'essential' to treatment decisions: details of the treatment regimen, early and late side-effects, survival, and effects of treatment on disease symptoms. The data suggest that: we should be attentive to the individual's desired role in treatment decisions at each step of care to avoid a mismatch between desired and actual involvement; desired role in decision-making does not predict treatment preference; and patients generally want a wide variety of information on treatment options in order to participate in treatment decisions., (Copyright 1999 John Wiley & Sons, Ltd.)

The study was designed to evaluate a treatment-tradeoff method for its potential in helping lung cancer patients make treatment decisions. A treatment-tradeoff interview was conducted to determine how patients weighed potential survival benefits against the potential toxicities of different treatment options: 1) low-dose versus high-dose radiotherapy, and 2) high-dose radiotherapy versus combination chemo-radiotherapy. Fifty-six patients who had experienced cancer and 20 clinic staff participated; twenty of these participants repeated the interview in an assessment of response consistency. The treatment-tradeoff method proved feasible: all staff and 53 of the 56 patients were able to complete the process. A wide range of threshold scores across participants was observed for both tradeoffs. Sixty percent of the patients would accept the more toxic combination therapy over high-dose radiotherapy if the former offered a 10% absolute improvement in three-year survival. The method also proved reliable: test-retest correlations were high (tau ranged from 0.7 to 0.87 and r from 0.82 to 0.94) and test-retest mean score differences were low (1.3-4.2). The most clinically useful measure of consistency was a "preference consistency" index, which revealed that most patients declared the same treatment preference at test and retest. The authors conclude that, while there is great interindividual variability in willingness to accept aggressive treatments for lung cancer, patients' values can be consistently elicited with the tradeoff method. The method has potential for clinical application in decision making and for health-care policy development.

Purpose: The optimal management of locally advanced non-small-cell lung cancer (NSCLC) has not been established. While combined-modality treatments have been shown to increase the survival of patients with this illness, the appropriate balance between the benefit of increased quantity of life and the quality-of-life costs of the more toxic treatment combinations remains unresolved. Decision analysis has been promoted as useful when medical decisions must be made under conditions of uncertainty. We consider the potential of this method to guide therapy in locally advanced NSCLC., Methods: We developed two types of decision models that addressed the choice between radiation alone and combined chemotherapy-radiation therapy in locally advanced NSCLC. The models were constructed using the principles of decision analysis., Results: The models successfully replicated results of relevant clinical trials published in the literature. The analyses of both models showed that the treatment decision was sensitive to patients' values, despite significant increases in survival rates. The models clarified a need for further validation of the three fundamental components: structuring the decision, determining the probabilities of events, and assigning utilities to treatment outcomes., Conclusion: In the setting of NSCLC, the models suggest that quality-of-life considerations are important in the treatment choice. Further research is required to identify the health states critical to the decision, the probabilities for occurrence of these health states, and valid measures of their utility.

Purpose: To determine how patients weigh potential survival benefits against the potential toxicity of different treatment strategies for locally advanced non-small cell lung cancer (NSCLC). Specifically, we were interested in what improvement in survival probability patients would want to have before accepting more toxic therapy., Patients and Methods: Fifty-six outpatients who had experienced lung cancer (n = 22) or prostate cancer (n = 34), and 20 clinic nurses and radiation therapy technologists participated. A treatment trade-off interview was conducted with each participant that compared low-dose versus high-dose radiotherapy and high-dose radiotherapy versus combination chemo-radiotherapy. Preferences for treatments were assessed by systematically increasing the hypothetical survival advantage of the more toxic treatment until the person reached his or her threshold for choosing the more toxic treatment., Results: A wide range of thresholds was observed for both groups. The distributions of survival advantage thresholds for lung cancer and prostate cancer patients were not significantly different but were generally lower thresholds than those declared by staff. If the 3-year survival advantage was 10%, 60% of patients and 15% of staff would consider combination therapy over high-dose radiotherapy. Within patients, apparent willingness to consider more toxic treatments was not significantly related to age, sex, education, or preferred role in decision making. The treatment trade-off method had good test-retest reliability., Conclusion: There is great interindividual variability in willingness to accept aggressive treatments for locally advanced NSCLC. When choosing NSCLC treatment, each patient should be provided with comprehensive information about the options so that he or she may express his or her preferences should he or she wish to participate in the decision.

Non-small cell lung cancer is the most common cause of cancer death in both males and females. Despite this high incidence and mortality, comparatively little research has addressed the palliative treatment of thoracic symptoms. Until recently, information regarding the indications and effectiveness of radiation in this setting was obtained from retrospective reviews of single institutional experiences. More recently, three major randomized trials from the UK Medical Research Council (1991, 1992, 1994) have addressed the use of external beam radiation in randomized comparisons of different dose and fractionation strategies for patients with non-small cell lung cancer and symptoms due to intra-thoracic tumor. These studies show that shorter fractionation schemes provide equivalent palliation and essentially equivalent survival in the patient groups studied. Moreover, they provide estimates of the probability of successful palliation of common symptoms, and estimates of the toxicity of each regimen. A panel of oncologists with expertise in radiation oncology, medical oncology and epidemiology discussed the above trial results and a literature review. The panel concluded that radiation was indicated in the palliation of hemoptysis, chest pain, dysphagia, and dyspnea, and that the results of the MRC studies provided reasonable estimations of the efficacy and toxicity of radiation in this setting. These studies show that symptoms are more often than not improved with palliative radiotherapy (symptom improvement rates ranged from about 50 to 85%) and that palliation lasted for a substantial portion of the patients' remaining survival. The panel could not reach uniform consensus on the appropriate fractionation for radiation given with palliative intent. The panel agreed that favourable patients with stage IIIB NSCLC should be offered combined modality therapy with the intent of prolonging survival, and that patient preferences regarding the risks and benefits of this therapy should be considered. Further study was recommended, namely, a randomized trial evaluating five fractions of radiation vs a single fraction, using patient-based evaluation of palliation. The panel also recommended phase II development of a combined chemotherapy and low-dose radiation protocol appropriate for future study.

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.