Phase II study of gemcitabine plus docetaxel as second-line treatment in malignant pleural mesothelioma: a single institution study

Our plain-English summary of Phase II study of gemcitabine plus docetaxel as second-line treatment in malignant pleural mesothelioma: a single institution study, by I. Tourkantonis, N. Makrilia, M. Ralli, et al (American Journal of Clinical Oncology, 2011).

The study

• Authors: I. Tourkantonis, N. Makrilia, M. Ralli, C. Alamara, I. Nikolaidis, S. Tsimpoukis, A. Charpidou, A. Kotanidou, K. Syrigos
• Journal: American Journal of Clinical Oncology
• Published: 2011;34(1):38-42
• Cited by: 18 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Objective: The combinations of cisplatin-pemetrexed and cisplatin-gemcitabine are considered the standard systemic therapy for malignant pleural mesothelioma (MPM), which is a rapidly progressive tumor. The purpose of the present study is to evaluate the efficacy, safety, and clinical benefit of the gemcitabine plus docetaxel regimen in the second-line treatment of this disease.

Patients And Methods: A total of 37 patients with MPM were treated with the combination of docetaxel (80 mg/m) and gemcitabine (1000 mg/m) on day 1 and 14 of a 28-day cycle. The regimen was repeated for a maximum of 6 cycles or until disease progression or unacceptable toxicity.

Results: There was partial response of the disease in 7 patients (18.9%), whereas it remained stable in 23 patients (62.2%) and progressed in 7 patients (18.9%). The median time to disease progression was 7 months (range: 5.8-8.2 months) with a mean survival of 16.2 months (range: 13-19.3 months).

Conclusion: The biweekly administration of docetaxel and gemcitabine, along with granulocyte colony-stimulating factor support, constitutes a safe, tolerable, and convenient regimen for the treatment of MPM, suggesting that this combination may be a viable option, especially in previously treated patients.

In plain English

This was a phase II trial at one hospital in Athens, Greece. It tested two chemotherapy drugs, gemcitabine and docetaxel, given together on days 1 and 14 of each 28-day cycle as second-line treatment for malignant pleural mesothelioma. All 37 patients had already received carboplatin and pemetrexed, and their disease had progressed during that treatment. Asbestos exposure was recorded as a patient characteristic for 17 of the 37 (45.9%). Tumors partly shrank in 7 patients (18.9%), stayed stable in 23 (62.2%) and grew in 7 (18.9%). The median time until the disease progressed was 7 months. The text reported a mean overall survival of 16.2 months, while the figure legend gave a median overall survival of 15 months. None of the factors studied, including asbestos exposure and smoking, correlated with response. The most frequent grade 3 to 4 side effect was neutropenia, a drop in a type of white blood cell (27%). No chemotherapy-related deaths occurred. The authors concluded that the regimen, given with granulocyte colony-stimulating factor support, was safe, tolerable and convenient and may be a viable option. They called for more phase II trials to confirm the results.

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: Phase II clinical trial at a single institution. The primary endpoint was tumor response rate; the secondary endpoints were time to progression and overall survival.
• Who was studied: 37 patients with malignant pleural mesothelioma treated at the Oncology Unit of Sotiria General Hospital, Athens, Greece. All had disease that progressed during first-line carboplatin plus pemetrexed. 30 were male and 7 female; the median age was 66. Study dates are not given.
• Exposure: Treatment was gemcitabine 1000 mg/m2 followed by docetaxel 80 mg/m2 on days 1 and 14 of a 28-day cycle, for up to 6 cycles, with prophylactic granulocyte colony-stimulating factor support. Asbestos exposure was recorded only as a patient characteristic (17/37, 45.9%). No fiber types are given.
• Main results:
  • Among the 37 patients, there was partial response in 7 (18.9%), stable disease in 23 (62.2%) and progression in 7 (18.9%).
  • The authors reported an 'ORR' of 81.1% (30/37 patients). This figure equals partial response plus stable disease.
  • Median time to disease progression was 7 months (range: 5.8–8.2 months). Mean overall survival was 16.2 months (range: 13–19.3 months).
  • The figure legend gives a median overall survival of 15 months.
  • None of the factors studied, including asbestos exposure and smoking, correlated with response rate.
  • Grade 3–4 neutropenia was the most frequent adverse event, occurring in 27% (10 of 37 patients in Table 2). There were 2 episodes of febrile neutropenia (5.4%).
  • No chemotherapy-related deaths occurred.
  • Changes in lung function occurred in 2 patients, and one of them developed pneumonitis.
• The authors' conclusion: The authors concluded that biweekly docetaxel and gemcitabine, given with granulocyte colony-stimulating factor support, is a safe, tolerable and convenient regimen for malignant pleural mesothelioma. They said it may be a viable option, especially in previously treated patients, and suggested more phase II trials to confirm the results.

Topics

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

Medical terms in this study, explained in our Lexicon: Gemcitabine, Pleural Mesothelioma, Cisplatin, Pemetrexed (Alimta), Systemic Therapy, Disease Progression.

Related studies

• Phase I study of gemcitabine, docetaxel and imatinib in refractory and relapsed solid tumors — B. Saraiya, R. Chugh, et al. (2012)
• Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial — C. Pinto, P.A. Zucali, et al. (2021)
• Gemcitabine and vinorelbine as second-line or beyond treatment in patients with malignant pleural mesothelioma pretreated with platinum plus pemetrexed chemotherapy — G. Toyokawa, M. Takenoyama, et al. (2014)
• Carboplatin plus pemetrexed as first-line treatment of patients with malignant pleural mesothelioma: a phase II study — N. Katirtzoglou, I. Gkiozos, et al. (2010)
• Treatment of malignant pleural mesothelioma with carboplatin, liposomized doxorubicin, and gemcitabine: a phase II study — G. Hillerdal, J.B. Sorensen, et al. (2008)
• Phase I combination study of the PARP inhibitor veliparib plus carboplatin and gemcitabine in patients with advanced ovarian cancer and other solid malignancies — H.J. Gray, K. Bell-McGuinn, et al. (2018)

Browse more research in American Journal of Clinical Oncology, or return to medical research.