The effectiveness and safety of platinum-based pemetrexed and platinum-based gemcitabine treatment in patients with malignant pleural mesothelioma

Our plain-English summary of The effectiveness and safety of platinum-based pemetrexed and platinum-based gemcitabine treatment in patients with malignant pleural mesothelioma, by G. Ak, S. Metintas, M. Akarsu, et al (BMC Cancer, 2015).

The study

• Authors: G. Ak, S. Metintas, M. Akarsu, M. Metintas
• Journal: BMC Cancer
• Published: 2015;15:510
• Cited by: 12 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Background: We aimed to evaluate the efficiency and safety of cis/carboplatin plus gemcitabine, which was previously used for mesothelioma but with no recorded proof of its efficiency, compared with cis/carboplatin plus pemetrexed, which is known to be effective in mesothelioma, in comparable historical groups of malignant pleural mesothelioma.

Methods: One hundred and sixteen patients received cis/carboplatin plus pemetrexed (group 1), while 30 patients received cis/carboplatin plus gemcitabine (group 2) between June 1999 and June 2012. The two groups were compared in terms of median survival and adverse events to chemotherapy.

Results: The mean ages of groups 1 and 2 were 60.7 and 60.8 years, respectively. Most of the patients (78.1%) had epithelial type tumors, and 47% of the patients had stage IV disease. There was no difference between the two groups in terms of age, gender, asbestos exposure, histology, stage, Karnofsky performance status, presence of pleurodesis, prophylactic radiotherapy, second-line chemotherapy and median hemoglobin and serum albumin levels. The median survival time from diagnosis to death or the last day of follow up with a 95% confidence interval was 12 ± 0.95 months (95% CI: 10.15-13.85) for group 1 and 11.0 ± 1.09 months (95% CI: 8.85-13.15) for group 2 (Log-Rank: 0.142; p = 0.706). The median survival time from treatment to death or the last day of follow-up with a 95% confidence interval was 11.0 ± 0.99 months (95% CI: 9.06-12.94) for group 1 and 11.0 ± 1.52 months (95% CI: 8.02-13.97) for group 2 (Log-Rank: 0.584; p = 0.445). The stage and Karnofsky performance status were found to be significant variables on median survival time by univariate analysis. After adjusting for the stage and Karnofsky performance status, the chemotherapy schema was not impressive on median survival time (OR: 0.837; 95% CI: 0.548-1.277; p = 0.409). The progression free survival was 7.0 ± 0.61 months for group I and 6.0 ± 1.56 months for group II (Log-Rank: 0.522; p = 0.470). The treatment was generally well tolerated, and the side effects were similar in both groups.

Conclusions: The study indicates that platinum-based gemcitabine is effective and a safe schema in malignant pleural mesothelioma. Further research should include large randomized phase III trials comparing these agents.

In plain English

This non-randomized study from a university hospital in Eskisehir, Turkey, compared two first-line chemotherapy combinations for malignant pleural mesothelioma in groups treated in different periods. Thirty patients treated between June 1999 and September 2005 received cisplatin or carboplatin plus gemcitabine, and 116 treated between October 2005 and June 2012 received cisplatin or carboplatin plus pemetrexed. Nearly all patients had been exposed to asbestos; fiber types were not reported. Median survival from diagnosis was 12.0 months (95% CI 10.15 to 13.85) with pemetrexed and 11.0 months (95% CI 8.85 to 13.15) with gemcitabine (p = 0.706, not statistically significant). Progression-free survival was 7.0 months (95% CI 5.079 to 8.20) and 6.0 months (95% CI 2.94 to 9.06) (p = 0.470), and objective response rates were 32.7% and 36.7% (p = 0.700). After adjusting for stage and Karnofsky performance status, the regimen was not significantly related to survival. Serious side effects were similar in both groups, with no toxic deaths. The authors concluded that platinum-based gemcitabine is effective and safe in malignant pleural mesothelioma and called for randomized phase III trials comparing the regimens.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Non-randomized comparison of two historical treatment groups of malignant pleural mesothelioma patients at a single university hospital, with the groups treated in different time periods
• Who was studied: 146 patients with malignant pleural mesothelioma treated at Eskisehir Osmangazi University Hospital, Turkey. They were selected from 343 patients diagnosed there between June 1999 and June 2012. Group 1 had 116 patients, treated October 2005 to June 2012. Group 2 had 30 patients, treated June 1999 to September 2005. Mean ages were 60.7 and 60.8 years.
• Exposure: The study compared treatments: cisplatin or carboplatin plus pemetrexed (group 1) versus cisplatin or carboplatin plus gemcitabine (group 2). Asbestos exposure was recorded as a patient characteristic: 113 of 116 (97.4%) in group 1 and 29 of 30 (96.7%) in group 2. Fiber types and sources were not reported.
• Main results:
  • Median survival from diagnosis was 12.0 ± 0.95 months (95% CI 10.15 to 13.85) for group 1 (pemetrexed) and 11.0 ± 1.09 months (95% CI 8.85 to 13.15) for group 2 (gemcitabine). The difference was not statistically significant.
  • Median survival from the start of treatment was 11.0 ± 0.99 months (95% CI 9.06 to 12.94) for group 1 and 11.0 ± 1.52 months (95% CI 8.02 to 13.97) for group 2 (p = 0.445).
  • Stage and Karnofsky performance status were significant variables for survival (p = 0.002 and p = 0.045). After adjusting for them, the chemotherapy regimen was not significantly related to survival (reported as OR 0.837; 95% CI 0.548 to 1.277; p = 0.409).
  • Progression-free survival was 7.0 ± 0.61 months (95% CI 5.079 to 8.20) for group I and 6.0 ± 1.56 months (95% CI 2.94 to 9.06) for group II (p = 0.470).
  • Objective response rates were 32.7% in group I and 36.7% in group II, not significantly different.
  • One-year survival was 58.6% for group I and 56.6% for group II. Two-year survival was 20.7% and 13.3%. Three-year survival was 9.5% and 10%.
  • Side effects were similar in both groups. For example, grade III and IV neutropenia occurred in 19 (16.3%) of group I and 3 (10.0%) of group II patients, and grade III and IV thrombocytopenia in 6 (5.1%) and 4 (13.3%). No toxicity difference reached p less than 0.05, and there were no toxic deaths.
• The authors' conclusion: The authors concluded that platinum-based gemcitabine is an effective and safe regimen in malignant pleural mesothelioma. They called for randomized controlled phase III trials comparing platinum doublets with antifolates against platinum doublets with gemcitabine or vinorelbine.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Pemetrexed (Alimta), Gemcitabine, Pleural Mesothelioma, Carboplatin, Mesothelioma, Median Survival, Chemotherapy, Asbestos Exposure.

Related studies

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• Malignant peritoneal mesothelioma in a child: chemotherapy with gemcitabine and platinum was effective for the disease unresponsive to other treatments — S. Kobayashi, T. Waragai, et al. (2014)
• Comparison of cisplatin plus pemetrexed and cisplatin plus gemcitabine for the treatment of malignant pleural mesothelioma in Japanese patients — T. Shukuya, T. Takahashi, et al. (2014)
• DNA repair polymorphisms and treatment outcomes of patients with malignant mesothelioma treated with gemcitabine-platinum combination chemotherapy — N. Erčulj, V. Kovač, et al. (2012)
• Safety and effectiveness of pemetrexed in patients with malignant pleural mesothelioma based on all-case drug-registry study — K. Kuribayashi, S. Voss, et al. (2012)
• A phase II study of the combination of gemcitabine and imatinib mesylate in pemetrexed-pretreated patients with malignant pleural mesothelioma — P.A. Zucali, M. Perrino, et al. (2020)

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