Vinorelbine in pemetrexed-pretreated patients with malignant pleural mesothelioma

Our plain-English summary of Vinorelbine in pemetrexed-pretreated patients with malignant pleural mesothelioma, by P.A. Zucali, M. Perrino, E. Lorenzi, et al (Lung Cancer, 2014).

The study

• Authors: P.A. Zucali, M. Perrino, E. Lorenzi, G.L. Ceresoli, F. De Vincenzo, M. Simonelli, L. Gianoncelli, R. De Sanctis, L. Giordano, A. Santoro
• Journal: Lung Cancer
• Published: 2014;84(3):265-70
• Cited by: 42 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Background: Pemetrexed-platinum chemotherapy is the standard first-line treatment of unresectable malignant pleural mesothelioma (MPM). At progression, patients are generally selected to experimental trials, when available, or, in every-day clinical practice, they are offered second-line chemotherapy. The optimal treatment has not yet been defined. The aim of this retrospective, single-center study was to evaluate the activity and toxicity of vinorelbine administered to a consecutive series of pemetrexed-pretreated MPM patients.

Methods: Vinorelbine 25 mg/m(2) was administered intravenously as a single agent on days 1, 8 every three weeks, either as second-line (2L) or further-line (>2L) therapy. Treatment was repeated for a maximum of 6 cycles, until progression, or unacceptable toxicity.

Results: Fifty-nine patients were included in this analysis. Vinorelbine was given to 34 patients as 2L, and to 25 as > 2L treatment. The median age was 69 years (range 45-80). Forty-two patients (71.2%) had a good EORTC prognostic score. Partial response was observed in 9 (15.2%) cases, stable disease in 20 (33.9%). The overall disease control rate (DCR) was 49.1%. Median progression-free survival (PFS) and overall survival (OS) were 2.3 and 6.2 months, respectively. ECOG performance status (PS) (HR(0 vs. 1-2) 0.50; 95%CI: 0.3-0.8; p = 0.014) and PFS ≥ 6 months following first-line (FL) chemotherapy (HR(FL-PFS>6 ms vs. <6 ms) 0.50; 95%CI: 0.3-0.9; p = 0.031) were significantly associated to OS in multivariate analysis. No difference was observed in terms of DCR, PFS, and OS in relation to age, histology, sex, line of vinorelbine therapy, or response to FL treatment. Hematological toxicity was acceptable, with grade 3/4 neutropenia occurring in 5 (8.4%) patients, and there were no cases of febrile neutropenia. The main non-hematological toxicities were grade 2 fatigue in 17 (28.8%) and constipation in 7 (11.8%) patients.

Conclusions: Vinorelbine was moderately active in pemetrexed-pretreated MPM patients, with an acceptable toxicity profile, particularly in patients with ECOG-PS0 and FL-PFS ≥ 6 months.

Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

In plain English

This retrospective study from one Italian cancer center, in Rozzano, Milan, looked at 59 patients with malignant pleural mesothelioma that had progressed after pemetrexed-based chemotherapy. It studied drug treatment and does not discuss asbestos exposure. Between January 2001 and July 2012 they received vinorelbine alone, 25 mg/m2 into a vein on days 1 and 8 of each three-week cycle. For 34 patients this was second-line treatment and for 25 a later line. Tumors partly shrank in 9 patients (15.2%); the disease control rate was 49.1%. Median progression-free and overall survival were 2.3 and 6.2 months. In a multivariate analysis, two factors were associated with longer overall survival: ECOG performance status 0 versus 1 to 2 (hazard ratio 0.50, 95% confidence interval 0.3 to 0.8), and first-line progression-free survival of 6 months or more (hazard ratio 0.50, 95% confidence interval 0.3 to 0.9). Severe (grade 3 or 4) neutropenia occurred in 5 patients (8.4%), with no febrile neutropenia. The authors concluded vinorelbine was moderately active with acceptable toxicity. They noted the retrospective design prevented a formal quality-of-life analysis.

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: Retrospective, single-center study of a consecutive series of patients treated with chemotherapy
• Who was studied: 59 patients with malignant pleural mesothelioma (MPM) who had progressed after pemetrexed-based chemotherapy. They were treated with vinorelbine between January 2001 and July 2012 at the Humanitas Clinical and Research Center, Rozzano, Milan, Italy. There were 38 males and 21 females, median age 69 years (range 45–80). Thirty-four received vinorelbine as second-line and 25 as further-line treatment.
• Exposure: Not an asbestos exposure study. The treatment studied was single-agent intravenous vinorelbine, 25 mg/m2 on days 1 and 8 every 3 weeks. It was given for a maximum of 6 cycles, until progression, or until unacceptable toxicity.
• Main results:
  • Partial response occurred in 9 of the 59 patients (objective response rate 15.2%). Twenty patients (33.9%) had stable disease and 27 (45.8%) had progressive disease. No complete response was observed.
  • The overall disease control rate in the whole group was 49.1%.
  • In the whole group, median progression-free survival was 2.3 months (range 0.6–22.5 months).
  • In the whole group, median overall survival was 6.2 months (range 0.8–27.8 months).
  • At a median follow-up of 18.1 months, 50 patients had died and 9 were still alive.
  • In multivariate analysis for overall survival, ECOG performance status 0 versus 1–2 had a hazard ratio of 0.50 (95% CI 0.3–0.8; p = 0.014).
  • In multivariate analysis for overall survival, first-line progression-free survival of 6 months or more versus less than 6 months had a hazard ratio of 0.50 (95% CI 0.3–0.9; p = 0.031).
  • No difference in disease control, progression-free survival or overall survival was observed by age, histology, sex, response to first-line treatment, or line of therapy.
  • Grade 3 or 4 neutropenia occurred in 5 patients (8.4%), and no febrile neutropenia was reported.
  • The main non-hematological toxicities were grade 2 fatigue in 17 patients (28.8%) and constipation in 7 patients (11.8%).
  • Dose reduction occurred in 2 patients (5.1% of total cycles).
• The authors' conclusion: The authors concluded that vinorelbine was moderately active in pemetrexed-pretreated MPM patients, with an acceptable toxicity profile. They said this was particularly so in patients with ECOG performance status 0 and first-line progression-free survival of 6 months or more. They described it as a reasonable palliative option when a clinical trial is unavailable. They suggested its second-line role could be further evaluated in large prospective trials.
• Limitations the authors state:
  • Because the study was retrospective, a formal quality of life or symptom improvement analysis could not be done.
  • The authors noted that tumor measurement in mesothelioma is challenging because of its growth pattern.

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: Vinorelbine, Pemetrexed (Alimta), Pleural Mesothelioma, Chemotherapy, Unresectable, Progression-Free Survival, Overall Survival, ECOG Performance Status.

Related studies

• 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)
• Successful salvage chemotherapy with gemcitabine and vinorelbine in a malignant pleural mesothelioma patient previously treated with pemetrexed — T. Agatsuma, T. Koizumi, et al. (2010)
• 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)
• Vinorelbine and gemcitabine as second- or third-line therapy for malignant pleural mesothelioma — M.G. Zauderer, S.L. Kass, et al. (2014)
• Retreatment with pemetrexed-based chemotherapy in patients with malignant pleural mesothelioma — G.L. Ceresoli, P.A. Zucali, et al. (2011)
• Pemetrexed for malignant pleural mesothelioma: Is it a standard second-line therapy? — K. Tamura, Y. Fujiwara (2010)

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