Gemcitabine Plus Vinorelbine Compared With Cisplatin Plus Vinorelbine or Cisplatin Plus Gemcitabine for Advanced Non–Small-Cell Lung Cancer: A Phase III Trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group

Gridelli, Cesare; Gallo, Ciro; Shepherd, Frances A.; Illiano, A; Piantedosi, Francovito; Robbiati, Sergio; Manzione, Luigi; Barbera, Santi; Frontini, L.; Veltri, Enzo; Findlay, B.; Cigolari, S.; Myers, Robert E.; Ianniello, Giovanni Pietro; Gebbia, Vittorio; Gasparini, Giampietro; Fava, Sergio; Hirsh, Vera; Bezjak, Andrea; Seymour, Lesley; Perrone, Francesco

doi:10.1200/jco.2003.06.099

Cited by 227 publications

(194 citation statements)

References 37 publications

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“…Nonetheless, although several advantages in toxicity and specific QoL items, no difference in global QoL, measured by questions 29 and 30 of the EORTC C-30 questionnaire, was found. This observation, that we already reported in another trial (Gridelli et al, 2003), opens questions regarding sensitivity of the different QoL items, either general or specific, during the course of the disease.…”

Section: Discussionmentioning

confidence: 52%

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study

Gridelli

Gallo²,

Maïo³

et al. 2004

Br J Cancer

147

109

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Docetaxel (75 mg m À2 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m À2 for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, p75 years, ECOG PS p2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77 -1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3 -4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival.

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Section: Discussionmentioning

confidence: 52%

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study

Gridelli

Gallo²,

Maïo³

et al. 2004

Br J Cancer

147

109

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“…The GEMVIN study was conducted with adult (o70 years) patients, randomly assigned either combination of vinorelbine (25 mg m À2 , days 1 and 8) plus gemcitabine (1000 mg m À2 , days 1 and 8) or cisplatin-based chemotherapy: cisplatin (80 mg m À2 , day 1) plus either gemcitabine (1200 mg m À2 , days 1 and 8) or vinorelbine (30 mg m À2 , days 1 and 8) for six cycles of 21 days (Gridelli et al, 2003b). The study aimed to assess whether the combination of gemcitabine and vinorelbine improved QoL, without shortening survival, compared to standard platinumcontaining regimens.…”

Section: Patientsmentioning

confidence: 99%

Prevalence and management of pain in Italian patients with advanced non-small-cell lung cancer

Maïo¹,

Gridelli²,

Gallo³

et al. 2004

Br J Cancer

116

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Pain is a highly distressing symptom for patients with advanced cancer. WHO analgesic ladder is widely accepted as a guideline for its treatment. Our aim was to describe pain prevalence among patients diagnosed with advanced non-small-cell lung cancer (NSCLC), impact of pain on quality of life (QoL) and adequacy of pain management. Data of 1021 Italian patients enrolled in three randomised trials of chemotherapy for NSCLC were pooled. QoL was assessed by EORTC QLQ-C30 and LC-13. Analgesic consumption during the 3 weeks following QoL assessment was recorded. Adequacy of pain management was evaluated by the Pain Management Index (PMI). Some pain was reported by 74% of patients (42% mild, 24% moderate and 7% severe); 50% stated pain was affecting daily activities (30% a little, 16% quite a bit, 3% very much). Bone metastases strongly affected presence of pain. Mean global QoL linearly decreased from 64.9 to 36.4 from patients without pain to those with severe pain (Po0.001). According to PMI, 616 out of 752 patients reporting pain (82%) received inadequate analgesic treatment. Bone metastases were associated with improved adequacy and worst pain with reduced adequacy at multivariate analysis. In conclusion, pain is common in patients with advanced NSCLC, significantly affects QoL, and is frequently undertreated. We recommend that: (i) pain self-assessment should be part of oncological clinical practice; (ii) pain control should be a primary goal in clinical practice and in clinical trials; (iii) physicians should receive more training in pain management; (iv) analgesic treatment deserves greater attention in protocols of anticancer treatment.

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“…Other CAR designs have been developed by Taves (1974), Wei (1978), Nordle and Brantmark (1977), Signorini et al (1993), Heritier et al (2005), and Hu and Hu (2012). Clinical trials that use these designs include Iacono et al (2006), Jakob et al (2012), Anderson et al (2000), Gridelli et al (2003), Krueger et al (2007), Molander et al (2007, and Ohtori et al (2012). A detailed discussion of CAR procedures can be found in Rosenberger and Sverdlov (2008).…”

Section: Introductionmentioning

confidence: 99%

Sequential Monitoring of Covariate-Adaptive Randomized Clinical Trials

Hu¹,

Hu²

2018

STAT SINICA

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The sequential monitoring of covariate-adaptive randomized clinical trials is standard in modern clinical studies. However, the validity of this sequential procedure is not well studied in the literature. Clinical trialists therefore implement the procedure and perform data analysis based on the theory of the sequential monitoring of fixed designs, and many clinical trials are open to question. In this paper, we study the theoretical properties of the sequential procedure and propose some important adjustments to classical statistical inference. Under different scenarios, we derive the asymptotic joint distribution of the sequential test statistics. Further, we estimate the decreased variability of the estimated treatment effect due to covariate-adaptive randomization, so that the sequential test statistics can be adjusted to be an asymptotic Brownian motion and the type I error rate can be controlled in real trials. Numerical results from simulation and the redesign of a clinical trial support our theoretical findings, showing that our procedure can control the type I error rate well, and also demonstrating the advantages of our method in terms of power and early stopping. Both theoretical and numerical results provide important guidance for future practical clinical trials using covariate-adaptive randomization procedures.

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Gemcitabine Plus Vinorelbine Compared With Cisplatin Plus Vinorelbine or Cisplatin Plus Gemcitabine for Advanced Non–Small-Cell Lung Cancer: A Phase III Trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group

Cited by 227 publications

References 37 publications

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study

Prevalence and management of pain in Italian patients with advanced non-small-cell lung cancer

Sequential Monitoring of Covariate-Adaptive Randomized Clinical Trials

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