bims-mesote Biomed News
on Mesothelioma
Issue of 2023–01–01
two papers selected by
Laura Mannarino, Humanitas Research
  1. An Investigation of Cancer-Directed Surgery for Different Histologic Subtypes of Malignant Pleural Mesothelioma.
  2. Clinical efficacy and safety of nivolumab in malignant non-pleural mesothelioma: A multicenter, open-label, single-arm, Japanese phase II trial (VIOLA) protocol.
  1. Chest. 2022 Dec 24. pii: S0012-3692(22)04340-9. [Epub ahead of print]
    An Investigation of Cancer-Directed Surgery for Different Histologic Subtypes of Malignant Pleural Mesothelioma.
    Arian Mansur, Alexandra Potter, Alexander J Zurovec, Krithika V Nathamuni, R Ryan Meyerhoff, Mark F Berry, Augustine Kang, Chi-Fu Jeffrey Yang.
       BACKGROUND: The role of cancer-directed surgery in the treatment of stage I-IIIA malignant pleural mesothelioma (MPM) by histologic subtypes remains controversial. The objective of this study was to evaluate the survival of the different histologic subtypes for stage I-IIIA MPM stratified by cancer-directed surgery and nonoperative management.
    RESEARCH QUESTION: How is the histologic subtype, clinical stage, and use of cancer-directed surgery with MPM associated with overall survival?
    STUDY DESIGN AND METHODS: Overall survival of patients with stage I-IIIA epithelioid, sarcomatoid, and biphasic MPM in the National Cancer Database from 2004-2017 who underwent cancer-directed surgery (i.e., surgery with or without chemotherapy + radiation) or chemotherapy with or without radiation ('nonoperative management') was evaluated using KaplanMeier analysis, multivariable Cox proportional hazards analysis, and propensity score-matched analysis.
    RESULTS: Of 2,285 patients with stage I-IIIA MPM who met inclusion criteria, histologic subtype was epithelioid in 71% of patients, sarcomatoid in 12% of patients, and biphasic in 17% of patients. Median survival was 20 months in the epithelioid group, 8 months in the sarcomatoid group, and 13 months in the biphasic group (P < 0.01). Among patients who underwent surgery, median survival was 25 months in the epithelioid group, 8 months in the sarcomatoid group, and 15 months in the biphasic group (P < 0.01). In multivariable Cox proportional hazards analyses, surgery was associated with improved survival in the epithelioid group (P < 0.01) but not in the sarcomatoid (P = 0.63) or biphasic (P = 0.21) groups. These findings were consistent in propensity score-matched analyses for each MPM histology.
    INTERPRETATION: In this national analysis, cancer-directed surgery was found to be associated with improved survival for stage I-IIIA epithelioid MPM but not for biphasic or sarcomatoid MPM.
    Keywords:  Cancer; Mesothelioma; Outcomes; Pleura; cancer-directed surgery
    DOI:  https://doi.org/10.1016/j.chest.2022.12.019
  2. Oncology. 2022 Dec 23.
    Clinical efficacy and safety of nivolumab in malignant non-pleural mesothelioma: A multicenter, open-label, single-arm, Japanese phase II trial (VIOLA) protocol.
    Kozo Kuribayashi, Masataka Igeta, Takashi Daimon, Ibu Maede, Shinichiro Suna, Rika Okamoto, Takashi Kijima.
       BACKGROUND: There is no authorized treatment for malignant non-pleural mesothelioma (MNPM) worldwide. In contrast to malignant pleural mesothelioma (MPM), MNPM has not been investigated, and no treatment has been established due to its rarity.
    OBJECTIVES: This multicenter, open-label, single-arm, Japanese phase II trial aims at evaluating the efficacy and safety of nivolumab, an immune checkpoint inhibitor, in advanced or metastatic MNPM treatment.
    METHODS: This phase II trial commenced in October 2020. Twenty-three patients with advanced or metastatic MNPM who meet the inclusion and exclusion criteria were enrolled from five institutions within 2 years. Regardless of prior therapy, 240 mg of nivolumab will be administered intravenously to MNPM patients every 2 weeks to investigate its efficacy and safety until disease progression or unacceptable toxicities are detected, or the patient's condition meets the withdrawal criteria.
    RESULTS: The primary endpoint is the objective response rate by central assessment following the Response Evaluation Criteria in Solid Tumors version 1.1. The secondary endpoints include disease control rate, overall survival, progression-free survival, adverse events, and treatment-related adverse events.
    CONCLUSIONS: This is the first prospective investigator-initiated trial to evaluate the effect of nivolumab monotherapy for MNPM.
    DOI:  https://doi.org/10.1159/000528791
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