A phase II study evaluating the cisplatin and epirubicin combination in patients with unresectable malignant pleural mesothelioma

Berghmans, Thierry; Lafitte, Jean-Jacques; Paesmans, Marianne; Stach, B.; Berchier, M.C.; Wackenier, Peggy; Lecomte, Jean-Paul; Collon, Thierry; Mommen, Paul; Sculier, Jean-Paul

doi:10.1016/j.lungcan.2005.05.007

Cited by 23 publications

(11 citation statements)

References 20 publications

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“…This is, however, in accordance with the 54% grade 3 or 4 leukopenia confined with cisplatin and epirubicin in MPM (Berghmans et al, 2005) and lower than the 81% of NSCLC patients who had grade 3 or 4 granulocytopenia in the randomised SWOG trial using same doses of cisplatin and vinorelbine as the current study (Wozniak et al, 1998). It is, however, considerably higher than was observed in the randomised trials in MPM patients with cisplatin and pemetrexed (18%, Vogelzang et al, 2003) or cisplatin and raltitrexed (7%, van Meerbeeck et al, 2005).…”

Section: Discussionsupporting

confidence: 83%

Cisplatin and vinorelbine first-line chemotherapy in non-resectable malignant pleural mesothelioma

2008

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The aim was to evaluate the activity of cisplatin and vinorelbine in previously untreated, inoperable patients having histologically verified malignant pleural mesothelioma (MPM), normal organ function, and performance status 0 -2. Treatment was vinorelbine 25 mg m À2 i.v. weekly and cisplatin 100 mg m À2 i.v. every 4 weeks with hydration and standard prophylactic antiemetic treatment. Patients gave written informed consent. Characteristics of 54 consecutive patients were: males 85%, epithelial subtype 74%, IMIG stages III and IV 35 and 46%, performance status 0, 1, and 2, 26, 69, and 6%, and median age 63 years (31 -78 years). CTC grade 3 or 4 toxicity occurred with respect to leukocytopenia (48% of patients, grade 4 in 13%), nausea (13%), neurotoxicity (11%), nephrotoxicity (4%), and other toxicities (9%). There were no toxic deaths. The median number of cycles was four. The fraction of patients alive at 1-, 2-, and 3-years were 61, 31, and 4%, respectively, and median survival and median time to progression were 16.8 months (0.5 to 46.4 þ months) and 7.2 months (1.6 to 40.6 þ months). There were two CRs and 14 PRs (response rate 29.6%). Cisplatin and intravenous vinorelbine is a highly active regimen in MPM with a response rate and survival comparable to the most active regimens so far reported.

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Section: Discussionsupporting

confidence: 83%

Cisplatin and vinorelbine first-line chemotherapy in non-resectable malignant pleural mesothelioma

2008

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“…The high-dose regimen of gemcitabine and epirubicin had a confirmed response rate, median duration of response, median overall survival, and median time to disease progression that were comparable to other combination regimens, 10,12,22,23,26,27 but was found to have significant hematologic toxicity. Although the low-dose regimen had better hematologic toxicity, it was not found to have significant clinical activity against MPM.…”

Section: Discussionmentioning

confidence: 77%

“…11 When given in combination with cisplatin, the response rate was reported to be 19%, with a median survival of 13.3 months. 12 There is preclinical evidence of cytotoxic synergy between gemcitabine and epirubicin. 13 Patients with MPM often experience symptoms.…”

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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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“…Cisplatin has also been tested in combination with other older chemotherapeutic agents, such as anthracyclines, mitomycin, methotrexate and vinblastine (15,(34)(35)(36)(37). However, these phase II trials do not suggest any possible advantage of these regimens, either in terms of activity or of toxicity, compared with the combination of cisplatin with pemetrexed or gemcitabine.…”

Section: First-line Combination Ctmentioning

confidence: 99%

Chemotherapy treatment in malignant pleural mesothelioma: a difficult history

et al. 2018

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Malignant pleural mesothelioma (MPM) is a rare neoplasm that typically arises from mesothelial surfaces of the pleural cavity. Despite treatment improvements, it carries a dismal prognosis. The majority of patients either have unresectable disease or are not candidates for surgery due to medical comorbidities or old age. For such patients, chemotherapy (CT) represents the gold-standard treatment. To date, combination CT with cisplatin plus pemetrexed represents the most widely used regimen in first-line setting for patients with unresectable MPM. Other first-line options are currently available, including the use of raltitrexed instead of pemetrexed combined with platinum. In this review, we discuss the role of CT in MPM mainly focusing on the results of the trials conducted in first-line setting.

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A phase II study evaluating the cisplatin and epirubicin combination in patients with unresectable malignant pleural mesothelioma

Cited by 23 publications

References 20 publications

Cisplatin and vinorelbine first-line chemotherapy in non-resectable malignant pleural mesothelioma

Cisplatin and vinorelbine first-line chemotherapy in non-resectable malignant pleural mesothelioma

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

Chemotherapy treatment in malignant pleural mesothelioma: a difficult history

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