Chemotherapy management of malignant pleural mesothelioma: a phase II study comparing two popular chemotherapy regimens

Our plain-English summary of Chemotherapy management of malignant pleural mesothelioma: a phase II study comparing two popular chemotherapy regimens, by E.E. Habib, E.S. Fahmy (Clinical & Translational Oncology, 2013).

The study

• Authors: E.E. Habib, E.S. Fahmy
• Journal: Clinical & Translational Oncology
• Published: 2013;15(11):965-8
• Type of article: Randomized trial
• Cited by: 8 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Purpose: The aim of this prospective, phase II clinical study is to evaluate the activity of gemcitabine and cisplatin in comparison to pemetrexed and carboplatin in patients with malignant pleural mesothelioma.

Patients And Methods: The patients were recruited from May 2008 to May 2011. One group included 21 cases who received cisplatin and gemcitabine. The other group included 19 cases who received pemetrexed and carboplatin.

Results: Response is superior in the pemetrexed group (p = 0.041). The median follow-up was 18 months (range 6-30 months). Cumulative survival at 1.5 years was 57.8 % for the pemetrexed carboplatin group. For the gemcitabine cisplatin group, the cumulative survival proportion at 1.5 years was 41 % (p = 0.0599).

Conclusions: Pemetrexed plus carboplatin are a step forward in the treatment of mesothelioma, the prognosis for these patients remains poor. Cheaper combinations as gemcitabine and cisplatin may be considered sufficient to treat cases with advanced mesothelioma.

In plain English

This prospective phase II study at Cairo University, Egypt, compared two chemotherapy combinations in people with untreated malignant pleural mesothelioma that could not be removed surgically. Between May 2008 and May 2011, patients were randomly assigned to cisplatin plus gemcitabine (21 patients) or pemetrexed plus carboplatin (19 patients). The two groups differed in sex and age. The article did not report the patients' asbestos exposure. Response was judged by combining scan results with changes in symptoms. It was seen in 15 patients (78.9 %) in the pemetrexed group and 10 (47.6 %) in the gemcitabine group (p = 0.041). After a median follow-up of 18 months, survival at 1.5 years was 57.8 % with pemetrexed-carboplatin and 41 % with gemcitabine-cisplatin, a difference that was not statistically significant (p = 0.0599). Nausea or vomiting, low platelet counts, diarrhea and hearing loss were more common with gemcitabine-cisplatin. The authors concluded that pemetrexed and carboplatin was active and well tolerated, with an advantage in response rate but not survival. They added that cheaper combinations such as gemcitabine and cisplatin may be considered sufficient for advanced mesothelioma.

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: prospective phase II randomized clinical trial comparing two chemotherapy regimens
• Who was studied: 40 patients with histologically proven, untreated, non-resectable malignant pleural mesothelioma referred to the Center of Clinical Oncology, Faculty of Medicine, Cairo University, Egypt, recruited May 2008 to May 2011. 21 received cisplatin and gemcitabine and 19 received pemetrexed and carboplatin.
• Exposure: This is a treatment study. The comparison was cisplatin 80 mg/m2 on day 1 plus gemcitabine 1 g/m2 on days 1, 8 and 15 every 28 days, versus pemetrexed 500 mg/m2 plus carboplatin (AUC 5) every 21 days, each for six cycles. Asbestos exposure was not reported. Industrial versus non-industrial residence was 15/4 in the pemetrexed group and 18/3 in the gemcitabine group.
• Main results:
  • The groups differed significantly only in sex and age. Male/female was 10/9 in the pemetrexed-carboplatin group and 19/2 in the gemcitabine-cisplatin group (p 0.012). Mean age was 49.5 versus 62.2 years.
  • Response rate (complete plus partial response, assessed by combining radiologic data with change in clinical symptoms) was 15 of 19 (78.9 %) in the pemetrexed-carboplatin group and 10 of 21 (47.6 %) in the gemcitabine-cisplatin group, p = 0.041.
  • Median follow-up was 18 months (range 6 to 30 months).
  • Cumulative survival at 1.5 years was 57.8 % in the pemetrexed-carboplatin group and 41 % in the gemcitabine-cisplatin group. The difference was not statistically significant (p = 0.0599).
  • After marked regression, seven patients in the pemetrexed group and four in the gemcitabine group were referred for and had surgery.
  • Toxicity was higher with cisplatin. Nausea/vomiting occurred in 1/19 (pemetrexed-carboplatin) versus 21/21 (gemcitabine-cisplatin), p less than 0.001. Thrombocytopenia was 5/19 versus 14/21 (p 0.014), diarrhea 0/19 versus 10/21 (p 0.001), and hearing loss 0/19 versus 9/21 (p 0.001). Leukopenia (8/19 versus 15/21, p 0.109) and anemia (13/19 versus 18/21, p 0.265) differences were not significant.
• The authors' conclusion: The authors concluded that pemetrexed and carboplatin was active and well tolerated, with an advantage only in response rate and no survival benefit. They wrote that the prognosis remains poor and that cheaper combinations such as gemcitabine and cisplatin may be considered sufficient for advanced mesothelioma.

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: Chemotherapy, Pleural Mesothelioma, Gemcitabine, Cisplatin, Pemetrexed (Alimta), Carboplatin, Mesothelioma, Prognosis.

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