26 Mitomycin, ifosfamide and cisplatin (MIC) in non-small cell lung cancer (NSCLC): 3. Results of a randomised trial evaluating palliation &amp; quality of life

Billingham, L.; Cullen, Michael; Woods, Jason; Chetiyawardana, A. D.; Joshi, Rohit; Cook, John; Woodroffe, C.M.

doi:10.1016/s0169-5002(97)89305-1

Cited by 22 publications

(10 citation statements)

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“…Controversy continues as to whether QL outcomes should be summarized, to simplify analysis and reporting (Barsevik et al, 1997;Billingham et al, 1997) at the risk of being clinically uninterpretable, or remain disaggregated, to provide a breadth of information which may, however, be difficult to present and absorb (MRC LCWP 1996a;1996b;Harper et al, 1997). Both approaches are numerically driven and may suffer from lack of clear indicators of clinical benefit.…”

Section: mentioning

confidence: 99%

Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer – a randomized trial with quality of life as the primary outcome

et al. 2000

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Three hundred patients with symptomatic, locally advanced or metastatic NSCLC not requiring immediate radiotherapy were enrolled into this randomized multicentre trial comparing gemcitabine + BSC vs BSC alone. Patients allocated gemcitabine received 1000 mg/m2on days 1, 8 and 15 of a 28-day cycle, for a maximum of six cycles. The main aim of this trial was to compare patient assessment of a predefined subset of commonly reported symptoms (SS14) from the EORTC QLQ-C30 and LC13 scales. The primary end-points were defined as (1) the percentage change in mean SS14 score between baseline and 2 months and (2) the proportion of patients with a marked (≥ 25%) improvement in SS14 score between baseline and 2 months sustained for ≥4 weeks. The secondary objectives were to compare treatments with respect to overall survival, and multidimensional QL parameters.The treatment groups were balanced with regard to age, gender, Karnofsky performance status (KPS) and disease stage (40% had metastatic disease). The percentage change in mean SS14 score from baseline to 2 months was a 10% decrease (i.e. improvement) for gemcitabine plus BSC and a 1% increase (i.e. deterioration) for BSC alone (P = 0.113, two-sample t -test). A sustained (≥ 4 weeks) improvement (≥25%) on SS14 was recorded in a significantly higher proportion of gemcitabine + BSC patients (22%) than in BSC alone patients (9%) (P = 0.0014, Pearson’s chi-squared test). The QLQ-C30 and L13 subscales showed greater improvement in the gemcitabine plus BSC arm (in 11 domains) than in the BSC arm (one symptom item). There was greater deterioration in the BSC alone arm (six domains/items) than in the gemcitabine + BSC arm (three QL domains). Tumour response occurred in 19% (95% CI 13–27) of gemcitabine patients. There was no difference in overall survival: median 5.7 months (95% CI 4.6–7.6) for gemcitabine + BSC patients and 5.9 months (95% CI 5.0–7.9) (log-rank, P = 0.84) for BSC patients, and 1-year survival was 25% for gemcitabine + BSC and 22% for BSC. Overall, 74 (49%) gemcitabine + BSC patients and 119 (79%) BSC patients received palliative radiotherapy. The median time to radiotherapy was 29 weeks for gemcitabine + BSC patients and 3.8 weeks for BSC. Patients treated with gemcitabine + BSC reported better QL and reduced disease-related symptoms compared with those receiving BSC alone. These improvements in patient-assessed QL were significant in magnitude and were sustained. © 2000 Cancer Research Campaign

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Section: mentioning

confidence: 99%

Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer – a randomized trial with quality of life as the primary outcome

et al. 2000

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“…Statements on palliative effects from treatment often pertain to physicians' ratings of performance status (Bakker et al, 1986;Ganz et al, 1989;Minet et al, 1987), although conclusive data on quality of life based upon patient self-ratings are sparse (BartelCopel et al, 1997). Nevertheless, several recent publications and reports on NSCLC have incorporated quality-of-life assessment in the treatment evaluation Maasilta et al, 1990;Sarna, 1990;Kosty et al, 1994;Pujol et al, 1994;Billingham et al, 1997;Helsing et al, 1998), indicating an increasing awareness of one of the primary therapeutic goals with currently available regimens, i.e. palliation.…”

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confidence: 99%

Phase II study of gemcitabine and vindesine in patients with previously untreated non-resectable non-small-cell lung cancer

et al. 1999

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Summary Because both vindesine and gemcitabine are active drugs in advanced non-small-cell lung cancer (NSCLC), with different modes of action and only partly overlapping toxicity, a phase II study was performed. Gemcitabine 1000 mg m -2 was given on days 1, 8 and 15 every 4 weeks, while vindesine 3 mg m -2 was administered weekly for 7 weeks, then every 2 weeks. A total of 42 patients with nonresectable NSCLC were included. The median age of patients was 56 years; 57% were men, 52% had adenocarcinoma, 31% squamous cell carcinoma and 17% had large-cell carcinoma. The performance status ranged from 0 to 2 with 83% in performance status 1. The majority (55%) had stage IV disease, while 40% had stage III B and 5% stage III A disease. WHO grade 3-4 leucopenia occurred in five patients (12%) and 9% had grade 4 neutropenia. Thrombocytopenia grade 3-4 was observed in six patients (15%). There were no septic death or bleeding episodes. One patient had a transient WHO grade 4 increase in bilirubin, and four patients had a decrease in glomerular filtration rate below the normal limit; one of these patients developed a non-reversible renal insufficiency. Ten patients (24%) complained of dyspnoea of uncertain mechanism, possibly involving bronchoconstriction. There were one complete and seven partial responses among 40 assessable patients (20%, 95% confidence limits 9-36%). Median response duration was 31 weeks (range 11-83 weeks) and median survival time 31 weeks (range 2-171 weeks). The current combination of gemcitabine and vindesine does not appear to be promising for further examination because of the toxicity and somewhat disappointing activity.

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“…Between 40% and 50% of patients with NSCLC present with metastatic disease, whereas local disease for 75% of the patients ultimately will recur in distant sites 1. The optimal management of these patients is controversial, but there is general agreement4 that cisplatin‐based chemotherapy, when compared with best supportive care alone, improves survival3 and quality of life27 and reduces symptoms. However, the survival benefit is small, with an increased median survival of 6 weeks and the 1‐year survival rate improved by only 10% (from 15% to 25%) 3.…”

Section: Discussionmentioning

confidence: 99%

Intracellular trafficking of RNASET2, a novel component of P‐bodies

Vidalino

Monti

Haase

et al. 2011

Biology of the Cell

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26 Mitomycin, ifosfamide and cisplatin (MIC) in non-small cell lung cancer (NSCLC): 3. Results of a randomised trial evaluating palliation & quality of life

Cited by 22 publications

References 0 publications

Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer – a randomized trial with quality of life as the primary outcome

Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer – a randomized trial with quality of life as the primary outcome

Phase II study of gemcitabine and vindesine in patients with previously untreated non-resectable non-small-cell lung cancer

Intracellular trafficking of RNASET2, a novel component of P‐bodies

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