Randomized trial of palliative two-fraction versus more intensive 13-fraction radiotherapy for patients with inoperable non-small cell lung cancer and good performance status

Macbeth, Fergus; Bolger, J. J.; Hopwood, Penelope; Bleehen, N. M.; Cartmell, J.; Girling, D J; Machin, David; Stephens, R.; Bailey, A.J.

doi:10.1016/s0936-6555(96)80041-0

Cited by 208 publications

(120 citation statements)

References 19 publications

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“…These studies are heterogenous in terms of the eligibility criteria, assessment of symptomatic benefit, treatment and staging procedures, the latter reflecting that some of these were reported in the 1980s. In comparison to our own study, similar patient cohorts and radiation schedules were assessed in the trials reported by the RTOG (Simpson et al, 1985) and the MRC (Macbeth et al, 1996). The overall radiological response and OS observed in the study reported here are comparable, and in particular may approach schedules with higher biological effective doses.…”

Section: Discussionsupporting

confidence: 63%

“…Local relapse ranged from 49% for the 40-Gy split course group to 67% for the 40-Gy continuous cohort (Simpson et al, 1985). In the MRC study, the first site of definite/suspected relapse was the primary site in 33% of the F2 and 38% of the F13 patients, and for distant sites 39% in both (Macbeth et al, 1996).…”

Section: Discussionmentioning

confidence: 99%

“…The palliative benefits reported in our trial are consistent with the reported literature subject to dose and fractionation. The level of benefit relative to the these studies may have been underestimated due to the short time interval from treatment completion to the final assessment of symptom benefit (Simpson et al, 1985;Macbeth et al, 1996;Sundstrom et al, 2004). In the MRC study (Macbeth et al, 1996), symptom response was assessed by the Rotterdam Symptom Checklist for the duration of the trial.…”

Section: Discussionmentioning

confidence: 99%

“…A subgroup who have good performance status, limited metastatic involvement and require palliation of local symptoms have been treated with various regimens of high-dose palliative radiotherapy (HDPR), ranging from 30 Gy in 10 fractions to 42 Gy in 15 fractions or equivalent (MRC Lung Cancer Working Party, 1992;Macbeth et al, 1996;Ball et al, 1997;Plataniotis et al, 2002;Kramer et al, 2003;Sundstrom et al, 2004). High-dose palliative radiotherapy has been shown to provide an excellent palliative benefit through the reduction of local symptoms in 80 -90% of patients, and also benefits in terms of global quality of life (QOL) (Schaafsma and Coy, 2000;Bezjak et al, 2002;Sundstrom et al, 2004).…”

mentioning

confidence: 99%

“…However, a large retrospective analysis (Quddus et al, 2001) as well as randomised studies have confirmed that, relative to hypofractionated regimens, HDPR in patients with good performance status provides a greater benefit in terms of local symptom palliation, global QOL and survival, possibly in a dose-dependent manner (Simpson et al, 1985;Teo et al, 1988;Macbeth et al, 1996;Reinfuss et al, 1999;Gaze et al, 2001;Bezjak et al, 2002;Kramer et al, 2003). These observations though have not been consistent (MRC Lung Cancer Working Party, 1991;Nestle et al, 2000;Sundstrom et al, 2004).…”

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confidence: 99%

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A phase I trial of high-dose palliative radiotherapy plus concurrent weekly Vinorelbine and Cisplatin in patients with locally advanced and metastatic NSCLC

et al. 2005

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The role of concurrent chemoradiotherapy (CRT) in patients with non-small-cell lung cancer (NSCLC) unsuitable for radical therapy but who require locoregional treatment has not been defined. The aims of this phase I trial were thus to develop a novel regimen of weekly chemotherapy concurrent with high-dose palliative RT (40 Gy/20 fractions) and assess its tolerability, objective and symptomatic response rates. Eligible patients had stage I -IIIB NSCLC unsuitable for radical RT or limited stage IV disease, ECOG PSp1 and required locoregional therapy. Treatment was RT (40 Gy/20 fractions/5 per week) and weekly Vinorelbine plus Cisplatin escalated in six planned dose levels (DLs). At 4 weeks post-RT, patients received two cycles of Cisplatin 80 mg m À2 day 1 þ Vinorelbine 25 mg m À2 days 1, 8, 15. Dose-limiting toxicities (DLTs) were defined in the CRT phase. Disease-related symptoms were assessed by the Lung Cancer Symptom Scale. In all, 24 patients accrued, stage IIIB (n ¼ 12) and IV disease (n ¼ 10). The highest administered dose was at DL 4, Vinorelbine 30 mg m À2 þ Cisplatin 20 mg m À2 with DLTs of grade 4 neutropenia in two of three patients. No grade 3 or 4 nonhaematological toxicities were observed. The overall radiological response rate was 65% (n ¼ 23: complete response 4% and partial response 61%) and infield FDG-PET responses were seen in 89% (n ¼ 18). There was an improvement or stabilisation of symptoms and quality of life. Dose level 3, Vinorelbine 25 mg m À2 þ Cisplatin 20 mg m À2 , is recommended for further assessment. This regimen was tolerable and produced meaningful responses for patients for whom locoregional control is required, but who are unsuitable for radical CRT.

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Section: Discussionsupporting

confidence: 63%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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confidence: 99%

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A phase I trial of high-dose palliative radiotherapy plus concurrent weekly Vinorelbine and Cisplatin in patients with locally advanced and metastatic NSCLC

et al. 2005

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Management of Cancer Pain

Burton

Rajagopal

Cleeland³

et al. 2004

JAMA

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Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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ImportanceApproximately 50% of all patients with cancer have an indication for radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with the aim of alleviating symptoms. Symptoms are best assessed by patient-reported outcomes (PROs), yet their reliable interpretation requires adequate reporting in publications.ObjectiveTo investigate the use and reporting of PROs in clinical trials of palliative radiotherapy.Evidence ReviewThis preregistered systematic review searched PubMed/Medline, EMBASE, and the Cochrane Center Register of Controlled Trials for clinical trials of palliative radiotherapy published from 1990 to 2020. Key eligibility criteria were palliative setting, palliative radiotherapy as treatment modality, and clinical trial design (per National Institutes of Health definition). Two authors independently assessed eligibility. Trial characteristics were extracted and standard of PRO reporting was assessed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. The association of the year of publication with the use of PROs was assessed by logistic regression. Factors associated with higher CONSORT-PRO adherence were analyzed by multiple regression. This study is reported following the PRISMA guidelines.FindingsAmong 7377 records screened, 225 published clinical trials representing 24 281 patients were eligible. Of these, 45 trials (20%) used a PRO as a primary end point and 71 trials (31%) used a PRO as a secondary end point. The most prevalent PRO measures were the Numeric Rating Scale/Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials). A more recent year of publication was significantly associated with a higher chance of PROs as a secondary end point (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03) but not as primary end point. Adherence to CONSORT-PRO was poor or moderate for most items. Mean (SD) adherence to the extension adherence score was 46.2% (19.6%) for trials with PROs as primary end point and 31.8% (19.8%) for trials with PROs as a secondary end point. PROs as a primary end point (regression coefficient, 9.755 [95% CI, 2.270-17.240]; P = .01), brachytherapy as radiotherapy modality (regression coefficient, 16.795 [95% CI, 5.840-27.751]; P = .003), and larger sample size (regression coefficient, 0.028 [95% CI, 0.006-0.049]; P = .01) were significantly associated with better PRO reporting per extension adherence score.Conclusions and RelevanceIn this systematic review of palliative radiotherapy trials, the use and reporting of PROs had room for improvement for future trials, preferably with PROs as a primary end point.

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Randomized trial of palliative two-fraction versus more intensive 13-fraction radiotherapy for patients with inoperable non-small cell lung cancer and good performance status

Cited by 208 publications

References 19 publications

A phase I trial of high-dose palliative radiotherapy plus concurrent weekly Vinorelbine and Cisplatin in patients with locally advanced and metastatic NSCLC

A phase I trial of high-dose palliative radiotherapy plus concurrent weekly Vinorelbine and Cisplatin in patients with locally advanced and metastatic NSCLC

Management of Cancer Pain

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

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