Trial of Vindesine plus Mitomycin in Stage-3 Non-small Cell Lung Cancer

Kris, Mark G.; Gralla, Richard J.; Kelsen, David P.; Casper, Ephraim S.; Burke, M. T.; Fiore, John J.; Cibas, Irene; Heelan, Robert T.

doi:10.1378/chest.87.3.368

Cited by 26 publications

(8 citation statements)

References 7 publications

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“…All trials -including the present as well -investigated relatively small groups of patients. Also the treatment regimens varied slightly from the form applied today only one trial focused on second-line treatment (Kris et al, 1985). Data that could be generated with those former trials correlate with today's rates in many ways.…”

Section: Discussionmentioning

confidence: 99%

Mitomycin C and Vinorelbine for second-line chemotherapy in NSCLC – a phase II trial

et al. 2007

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Single-agent therapy with Docetaxel or Pemetrexed is the current therapy of choice for second-line treatment in advanced nonsmall-cell lung cancer (NSCLC). The role of older agents was underattended over the last years. This study presents the combination of Mitomycin C and Vinorelbine in pretreated patients. Forty-two patients (stage IIIB and IV, pretreated with platinum-based chemotherapy) received 8 mg m À2 Mitomycin C on day 1 and 25 mg m À2 Vinorelbine on days 1 and 8 of a 28-day cycle. End points were objective tumour response, survival, and toxicity. Additionally, quality of life (QoL) was assessed. Five patients (11.9 %) achieved partial responses and 13 patients (31.9%) stable disease. Progression-free survival was 16 weeks. The median overall survival was 8.5 month. Eleven patients (26.2 %) suffered from grade 3 or 4 neutropenia and four patients (9.52%) from grade 3 or 4 anaemia. Evaluation of QoL showed that some items ameliorated during therapy. The therapeutic concept including Mitomycin C and Vinorelbine offers an efficacious and well-tolerated regimen, with relatively low toxicity. Objective response and survival data correlate with other second-line studies using different medication. As costs of Mitomycin C and Vinorelbine are lower compared with current drugs of choice, this regimen is likely to be cost-saving.

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Section: Discussionmentioning

confidence: 99%

Mitomycin C and Vinorelbine for second-line chemotherapy in NSCLC – a phase II trial

et al. 2007

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“…Several studies have been published investigating mitomycin containing combination chemotherapies, but its role in these combinations remains still unclear. Platinum-based combinations included vindesine [8][9][10], cisplatin/vinblastine (MVP) [11,12] and isofosfamide/cisplatin (MIC) [12], with recently published 1-year survival rates of 35% for MIC/MVP [12]. In a phase II trial the combination of mitomycin and third generation agent docetaxel as a second-line treatment in 38 patients with advanced NSCLC was recently investigated [13].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of combination chemotherapy with mitomycin and vinorelbine for the treatment of advanced non-small cell lung cancer

et al. 2008

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“…Einhorn, 1986Crino, 1988-90 Bonomi, 1990Luedke, 1990Fukuoka, 1991Shinkai, 1991Weick, 1991Mylonakis, 1992 Gandara, 1993 Crino, 1988−90 Bonomi, 1990Luedke, 1990Fukuoka, 1991Shinkai, 1991Weick, 1991Mylonakis, 1992Gandara, 1993Masutani, 1996 OVERALL 0.0 1.3 2.5 3.75 5.0 On the 4 prospective phase II trials found in the literature (Table 4), 3 deal with a combination of MMC with vindesine (Kris et al, 1985;Sculier et al, 1986, Bonomi et al, 1989) and 1 with cisplatin and vinblastine (Gridelli et al, 1992). The ELCWP quality score for phase II trials ranged from 21.1% to 75% with a median of 61.1%.…”

Section: Question 2: Does MMC Improve the Results When Added To Othermentioning

confidence: 99%

The role of mitomycin in the treatment of non-small cell lung cancer: a systematic review with meta-analysis of the literature

Sculier¹,

Ghisdal²,

Berghmans³

et al. 2001

Br J Cancer

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In the 1990s, chemotherapy has been shown able to improve survival of patients presenting with advanced non-small cell lung cancer (NSCLC, 1995). The survival benefit was obtained with first-generation active cytostatic agents -mainly ifosfamide, vinblastine, vindesine, mitomycin (MMC) -in combination with cisplatin (Donnadieu et al, 1991). New active drugs -the second generation -have appeared during the last decade, including gemcitabine, paclitaxel, docetaxel, vinorelbine and irinotecan. Their role in addition or in place of the first-generation agents, which should not be considered as obsolete for the unique reason that they are older and less fashionable, has yet to be defined (Meert et al, 1999).In this context, we have performed a systemic review of the literature about the role of one of the first-generation drugs, mitomycin (MMC), in the management of NSCLC. In order to determine if it is worthy to further conduct trials with that agent, we have searched answers to the 3 following questions: (1) is MMC an active drug against NSCLC? (2) does MMC improve the results when added to other active agents? (3) is MMC useful for salvage therapy? We have performed this investigation by using a methodology similar to that we have already used to conduct evidencebased medicine analyses of the literature. MATERIAL AND METHODSTo be eligible for the systematic review, a trial had to fulfil the following criteria: to deal only with NSCLC, to have been published as a full paper in the English or French language, to have a prospective design and to assess the effect of MMC in a randomized trial or in a first-line or second-line phase II trial according to the studied question.Trials were identified by an electronic search (Medline) in addition to the use of the personal bibliography of one of the authors and by consulting the references reported in the selected articles.Each trial was read and assessed for methodology by 12 investigators, including 11 physicians and 1 biostatistician. Each investigator independently extracted the data from the articles and disagreements were resolved by consensus. Randomized trials were evaluated for methodology by 2 quality scores calculated on the basis of the data reported in the publications: the score proposed by Chalmers et al (1981) and used by Marino in two meta-analyses (Marino et al, 1994(Marino et al, , 1995; and the score proposed by the ELCWP (European Lung Cancer Working Party) (Mascaux et al, 2000). Phase II trials were assessed by the ELCWP score for phase II studies (Meert et al, 1999).The result of a phase III trial was considered as conclusive if the P value for the statistical test comparing the survival distributions between arms for the overall patients populations was <0.05 in favour of the experimental arm. The trial was then called 'positive'. In the other situations (statistically significant survival benefit for the control arm or non-statistically significant difference in survival distributions), it was called 'negative'.The association between the quality s...

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Trial of Vindesine plus Mitomycin in Stage-3 Non-small Cell Lung Cancer

Cited by 26 publications

References 7 publications

Mitomycin C and Vinorelbine for second-line chemotherapy in NSCLC – a phase II trial

Mitomycin C and Vinorelbine for second-line chemotherapy in NSCLC – a phase II trial

Efficacy and safety of combination chemotherapy with mitomycin and vinorelbine for the treatment of advanced non-small cell lung cancer

The role of mitomycin in the treatment of non-small cell lung cancer: a systematic review with meta-analysis of the literature

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