A multicentre phase II study of cisplatin and gemcitabine for malignant mesothelioma

Nowak, Anna K.; Byrne, Michael; Williamson, Raymond; Ryan, Graeme B.; Segal, Amanda; Fielding, David; Mitchell, Paul; Musk, Arthur W.; Robinson, Bruce

doi:10.1038/sj.bjc.6600505

Cited by 204 publications

(109 citation statements)

References 25 publications

(19 reference statements)

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“…In a single-institution study of mesothelioma, based on a four weekly regimen of cisplatin and gemcitabine in malignant mesothelioma, a response rate of 48% with a median survival of 9.5 months and an estimated 1 year survival of 41% was observed (Byrne et al, 1999). Recently, a response rate of 34% was reported in a multicentre study, using the same regimen (Nowak et al, 2000).…”

Section: Discussionmentioning

confidence: 99%

Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Haarst¹,

Baas

Manegold³

et al. 2002

Br J Cancer

131

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Malignant pleural mesothelioma is a notoriously chemoresistant tumour. However, a recent single institution study showed an impressive activity of gemcitabine and cisplatin. Our aim is to investigate the efficacy and toxicity of a gemcitabine and cisplatin combination in selected and chemo-naive patients with histologically proven malignant pleural mesothelioma. Method: Gemcitabine 1250 mg m 72 was administered on day 1 and day 8 and cisplatin 80 mg m 72 was administered on day 1 in a 3-week cycle with a maximum of six cycles. Response and toxicity evaluations were performed according to WHO and NCIC-CTC criteria. Pathology and radiology were centrally reviewed. Results show that in 25 evaluable patients, four PR were observed (ORR 16%, 95% CI 1 -31%). Responses of seven patients were unevaluable. No unexpected toxicity occurred. Time to progression was 6 months (5 -7 months) with a median survival from registration of 9.6 months (95% CI 8 -12 months). In conclusion this trial excludes with 90% power a response rate of greater than 30% in patients with malignant pleural mesothelioma using a combination of gemcitabine and cisplatin at the proposed dose and schedule.

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Section: Discussionmentioning

confidence: 99%

Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Haarst¹,

Baas

Manegold³

et al. 2002

Br J Cancer

131

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“…Furthermore, nine of 10 responding patients experienced significant relief of chest pain and dyspnoea. Subsequently, a multicentre study was initiated, evaluating the same chemotherapy regimen in 53 MPM patients (Novak et al, 2002). A response rate of 33% was achieved and the median survival time was 11.2 months.…”

Section: Nucleoside Analoguesmentioning

confidence: 99%

Chemotherapy for malignant pleural mesothelioma: past results and recent developments

Tomek¹,

Emri

Krejcy³

et al. 2003

Br J Cancer

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This review summarises the results of previously conducted clinical trials, and subsequently presents data arising from all phase II -III studies on chemotherapy of malignant pleural mesothelioma (MPM) published since the last relevant overview. While response rates exceeding 30% have barely been achieved with established cytotoxic drugs in MPM therapy, novel chemotherapeutic agents and their combinations appear more promising. This applies especially to the antimetabolites, and in particular to pemetrexed that produced response rates of up to 45% in combination with platinum compounds. Raltitrexed combined with oxaliplatin has also been shown to be effective, and gemcitabine -applied as a single agent or in combination with cisplatin -as well as vinorelbine appear to improve the quality of life in patients presenting with MPM. Data can now be more precisely analysed by increasingly implemented randomised studies, applying a standardised staging system, and distinguishing prognostic groups. While chemotherapy for MPM remains a challenging task, important steps have clearly been made in the past years to combat this aggressive disease. The publication of pemetrexed with cisplatin phase III results in a peer-reviewed journal may soon establish a standard of care.

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“…Should the higher dose of gemcitabine and epirubicin be recommended for clinical use? With many similar active regimens with less toxicity currently available, 8,9,22 the routine use of this regimen at either the high or low dose is not recommended and newer agents should be explored in clinical trials. QOL indicates quality of life; SD, standard deviation.…”

Section: Discussionmentioning

confidence: 99%

“…[8][9][10] In addition, the anthracycline derivative epirubicin has been studied in patients with MPM, with a single-agent response rate of 15% and a median survival of 40 weeks. 11 When given in combination with cisplatin, the response rate was reported to be 19%, with a median survival of 13.3 months.…”

mentioning

confidence: 99%

A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma

Okuno

Delaune

Sloan

et al. 2008

Cancer

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BACKGROUND.The North Central Cancer Treatment Group (NCCTG) conducted a phase 2 study to evaluate the antitumor activity of the combination of gemcitabine and epirubicin in patients with pleural mesothelioma who received no more than 1 prior chemotherapy regimen.METHODS.A total of 23 patients were accrued between August 2001 and April 2002 and received gemcitabine at a dose of 1000 mg/m2 intravenously over 30 minutes weekly every 2 weeks and epirubicin at a dose of 90 mg/m2 intravenously on Day 1 on an every‐21‐days cycle (high‐dose patient group). Between August 2002 and April 2004, an additional 45 patients were treated at a reduced dose of gemcitabine of 750 mg/m2 and epirubicin at a dose of 70 mg/m2 with the same schedule (low‐dose patient group).RESULTS.In the high‐dose patient group, the confirmed response rate was 13% (95% confidence interval [95% CI], 3–34%). The median survival was 9.3 months (95% CI, 7.4–10.7 months) and the median time to disease progression was 6.3 months (95% CI, 3.0–7.6 months). In the low‐dose patient group, the confirmed response rate was 7% (95% CI, 0–28%). The median survival was 5.7 months (95% CI, 4.7–8.7 months) and the median time to disease progression was 4.2 months (95% CI, 2.7–5.6 months). Toxicity was moderate to severe. In the high‐doseand low‐dose groups, 87% and 60% of patients, respectively, experienced at least 1 adverse event of grade 4 or higher (according to National Cancer Institute Common Toxicity Criteria [version 2.0]). The quality of life remained similar from baseline to the end of the 2 cycles of treatment in the high‐dose group but worsened in the low‐dose group.CONCLUSIONS.In the current study, the combination regimen of gemcitabine and epirubicin was found to demonstrate minimal antitumor activity against pleural mesothelioma. Cancer 2008. © 2008 American Cancer Society.

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A multicentre phase II study of cisplatin and gemcitabine for malignant mesothelioma

Cited by 204 publications

References 25 publications

Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Chemotherapy for malignant pleural mesothelioma: past results and recent developments

A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma

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