Hypofractionated Palliative Radiotherapy (17 Gy per two fractions) in Advanced Non–Small-Cell Lung Carcinoma Is Comparable to Standard Fractionation for Symptom Control and Survival: A National Phase III Trial

2004 ◽  
Vol 22 (5) ◽  
pp. 801-810 ◽  
Author(s):  
Stein Sundstrøm ◽  
Roy Bremnes ◽  
Ulf Aasebø ◽  
Steinar Aamdal ◽  
Reidulv Hatlevoll ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Symptom Relief ◽  
Small Cell ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Small Cell Lung ◽  
European Organization ◽  
Significant Difference

Purpose To investigate whether the effect of hypofractionated thoracic radiotherapy (TRT) is comparable to more standard fractionated radiotherapy (RT) in advanced non–small-cell lung cancer (NSCLC). Patients and Methods A total of 421 patients with locally advanced stage III or stage IV NSCLC tumors were included. Inclusion criteria were inoperable, disease too advanced for curative radiotherapy, and chest symptoms or central tumor threatening the airways. Patients were randomly assigned to three arms: A, 17 Gy per two fractions (n = 146); B, 42 Gy per 15 fractions (n = 145); and C, 50 Gy per 25 fractions (n = 130). Four hundred seven patients were eligible for the study; 395 patients (97%) participated in the health-related quality-of-life (HRQOL) study. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-lung cancer–specific module (LC13) were used to investigate airway symptom relief and changes in HRQOL. Assessments were performed before TRT and until week 54. Clinicians' assessments of symptom improvement were at 2, 6, and 14 weeks after completion of TRT. The patients were observed for a minimum of 3 years. Results Baseline prognostic data were equally distributed in the treatment groups. Patient compliance with respect to the HRQOL investigation was minimum 74%. HRQOL and symptom relief were equivalent in the treatment arms. No significant difference in survival among arms A, B, and C was found, with median survival 8.2, 7.0, and 6.8 months, respectively. Conclusion Our data indicate that protracted palliative TRT renders no improvement in symptom relief, HRQOL, or survival when compared with short-term hypofractionated treatment in advanced NSCLC.

scholarly journals Feasibility of quality of life assessment in a randomized phase III trial of small cell lung cancer

1992 ◽  
Vol 3 (10) ◽  
pp. 825-831 ◽  
Author(s):  
C. Hürny ◽  
J. Bernhard ◽  
R. Joss ◽  
Y. Willems ◽  
F. Cavalli ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Life Assessment ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Quality Of Life Assessment ◽  
Phase Iii Trial

Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Marimastat After Response to First-Line Chemotherapy in Patients With Small-Cell Lung Cancer: A Trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organization for Research and Treatment of Cancer

2002 ◽  
Vol 20 (22) ◽  
pp. 4434-4439 ◽  
Author(s):  
Frances A. Shepherd ◽  
Giuseppe Giaccone ◽  
Lesley Seymour ◽  
Channa Debruyne ◽  
Andrea Bezjak ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
National Cancer Institute ◽  
Partial Remission ◽  
Small Cell ◽  
Small Cell Lung ◽  
European Organization

PURPOSE: Increased expression of metalloproteinases is associated with poor prognosis in small-cell lung cancer (SCLC). This trial was undertaken to determine whether adjuvant treatment with the metalloproteinase inhibitor marimastat could prolong survival in responding patients with SCLC after chemotherapy. PATIENTS AND METHODS: SCLC patients in complete or partial remission were eligible. They were stratified by radiotherapy (early, late, or none), stage (extensive or limited), response (complete or partial), and cooperative group (National Cancer Institute of Canada-Clinical Trials Group or European Organization for Research and Treatment of Cancer). They were randomized to receive marimastat 10 mg or placebo orally bid for up to 2 years. RESULTS: There were 532 eligible patients (266 marimastat and 266 placebo). Stage was limited for 279 patients (52%) and extensive for 253 (48%). Best response to induction therapy was complete remission for 176 patients (33%), partial remission for 341 (64%), and 15 patients (3%) had undergone surgical resection. The median time to progression for marimastat patients was 4.3 months compared with 4.4 months for placebo patients (P = .81). Median survivals for marimastat and placebo patients were 9.3 months and 9.7 months, respectively (P = .90) Toxicity was generally limited to musculoskeletal symptoms (18% grade 3/4 for marimastat). Dose modifications for musculoskeletal toxicity were required in 90 patients (33%) on the marimastat arm, and 87 (32%) permanently stopped marimastat because of toxicity. Patients on marimastat had significantly poorer quality of life at 3 and 6 months. CONCLUSION: Treatment with marimastat after induction therapy for SCLC did not result in improved survival and had a negative impact on quality of life.

Review of end points of phase III clinical trials with combination chemotherapy regimens for non-small cell lung cancer evaluating importance of quality of life.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19119-e19119
Author(s):  
Kumar Prabhash ◽  
Ganesh Divekar ◽  
Minish Mahendra Jain ◽  
Bharatsinha Baburao Bhosale
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
End Points

e19119 Background: Systemic combination chemotherapy is accepted as a standard of care for patients with advanced non-small cell lung cancer (NSCLC). Substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. Quality of life (QOL) analysis will help to customize chemotherapy to improve outcome in NSCLC patients. Methods: Using PUBMED database, a review of randomized controlled phase III trials of advanced NSCLC published in last 5 years reporting comparative safety and efficacy between chemotherapeutic regimens as end points was conducted. An evaluation of end points, difference in efficacy endpoints, QOL analysis, and final conclusion was conducted. Results: The search criteria identified 51 trials (33,481 patients). Out of these 51 clinical trials, 16 trials showed difference in efficacy (13 survival endpoint, 1 ORR (objective response rate), 2 survival without grade 3/4 toxicity) and 11 trials used validated QOL instruments and were included for review. Two trials; one comparing pemetrexed/cisplatin with gemcitabine/cisplatin, and other comparing cisplatin/weekly vinoralbine with cisplatin/vinoralbine on day 1 and 8; showed difference with QOL; though not statistically significant. The QOL reporting/analysis techniques were heterogeneous. Two trials used QOL as primary endpoint. Safety reporting included percentage adverse events with treatment arms. Conclusions: Based on our review, it seems critical to have QOL as an endpoint while evaluating newer combination chemotherapeutic regimens for NSCLC. Secondly, it is unlikely that a major difference exists in the global QOL associated with standard chemotherapy regimens for NSCLC. An effort to have uniform QOL assessment across trials evaluating newer combination regimens for NSCLC will help to customize treatment.

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