Mitomycin C plus vindesine or cisplatin plus epirubicin in previously treated patients with symptomatic advanced non-small-cell lung cancer

Gridelli, Cesare; Airoma, Giuseppe; Incoronato, Pasquale; Pepe, Rosario; Palazzolo, Giovanni; Rossi, Antonio; Bianco, Angelo Raffaele

doi:10.1007/bf00686314

Cited by 20 publications

(9 citation statements)

References 9 publications

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“…Similar results have been previously reported in phase II studies (Kakolyris et al, 2001). Several phase II studies have also shown that platinum-based chemotherapy regimens may be active in the second-line setting (Gridelli et al, 1992;Stathopoulos et al, 1999;Huisman et al, 2001;De Pas et al, 2001). It is interesting to note that despite the higher response rate achieved with IC, there was no difference in terms of quality of life between IC and C. We do not have a clear explanation for this observation, although we cannot exclude that it may be due to the similar tumour growth control rate achieved by the two regimens.…”

Section: Discussionsupporting

confidence: 88%

Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study

et al. 2005

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The aim of this study was to compare the irinotecan/cisplatin regimen with cisplatin as second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) pretreated with a taxane/gemcitabine regimen. Patients (n ¼ 147) with stage IV NSCLC pretreated with a taxane/gemcitabine regimen were randomly assigned to receive either irinotecan (110 mg m À2 , day 1 and 100 mg m À2 , day 8) and cisplatin (80 mg m À2 , day 8) (IC; n ¼ 74) or CDDP (80 mg m À2 , day 1) (C; n ¼ 73) every 3 weeks. Patients treated with IC and C had a median survival of 7.8 and 8.8 months, respectively (P ¼ 0.933). The 1-year survival rate was 34.3% for IC-treated patients and 31.7% for C-treated patients. Cox's regression analysis revealed that response to treatment (hazard ratio (HR) ¼ 2.787; 95% confidence interval (CI): 1.1578 -4.922) and performance status (HR ¼ 1.865; 95% CI: 1.199 -2.872) was independent prognostic factors for survival. Overall response rate was 22.5% (95% CI: 12.8 -32.2%) for IC-treated patients and 7.0% (95% CI: 1.15 -13.6%) for C-treated patients (P ¼ 0.012); tumour growth control (partial remission (PR) þ stable disease (SD)) was observed in 26 (38%) IC and 25 (36%) C patients (P ¼ 0.878). There was no difference in terms of quality of life between the two chemotherapy arms. The incidence of febrile neutropenia, grade 3 and 4 neutropenia and grade 3 and 4 diarrhoea was significantly higher in the IC-than the C-treated patients. Other toxicities were mild. There were no treatment-related deaths in either arm. The IC regimen did not confer a survival benefit compared with C as second-line treatment of patients with advanced NSCLC pretreated with a taxane/gemcitabine regimen, despite its better efficacy in terms of response rate.

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Section: Discussionsupporting

confidence: 88%

Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study

et al. 2005

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“…In the intent-to-treat population, response rate was 9% (95% CI: [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19]. It was 10% (95% CI: [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] in the 60 evaluable patients. There was no statistically significant difference in response rate between patients who had received and those who had not received cisplatin-based chemotherapy previously (2/8 versus 4/57 responders; p = 0.16).…”

Section: Resultsmentioning

confidence: 99%

“…The role of MMC as salvage chemotherapy remains largely undefined because of the limited number of published studies on this topic. Four phase II studies (Table 1) have been published combining MMC with vindesine [12][13][14], cisplatin or vinblastine [15] with response rates between 0% and 17%. Global response rate was 10.5% (95% confidence interval [CI]: 1.7-19.4) [11].…”

Section: Introductionmentioning

confidence: 99%

Mitomycin plus vinorelbine salvage chemotherapy in non-small cell lung cancer: A prospective study

Berghmans

Gourcerol²,

Lafitte³

et al. 2008

Lung Cancer

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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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Mitomycin C plus vindesine or cisplatin plus epirubicin in previously treated patients with symptomatic advanced non-small-cell lung cancer

Cited by 20 publications

References 9 publications

Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study

Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study

Mitomycin plus vinorelbine salvage chemotherapy in non-small cell lung cancer: A prospective study

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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