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| LETTER TO THE EDITOR |
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| Year : 2021 | Volume
: 4
| Issue : 4 | Page : 809-810 |
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Nivolumab in relapsed malignant mesothelioma: Is it ‘CONFIRM’ed?
Archana Sasi, Ajay Gogia
Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
| Date of Submission | 12-Dec-2021 |
| Date of Decision | 13-Dec-2021 |
| Date of Acceptance | 13-Dec-2021 |
| Date of Web Publication | 29-Dec-2021 |
Correspondence Address:
Ajay Gogia
Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi - 110 029
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/crst.crst_317_21
How to cite this article:
Sasi A, Gogia A. Nivolumab in relapsed malignant mesothelioma: Is it ‘CONFIRM’ed?. Cancer Res Stat Treat 2021;4:809-10 |
The phase III placebo-controlled randomized trial by Fennell et al. studied single agent nivolumab in the salvage setting in mesothelioma and observed a significant progression free survival (PFS) (3.2 vs. 1.8 months) and overall survival (OS) (10.2 vs. 6.9 months) benefit with nivolumab compared to placebo.[1] We laud the authors for their efforts for improving the therapeutic armamentarium of a disease with dismal outcomes and a pressing need for change in the treatment landscape. However, we would like to express our concerns pertaining to the translation of the demonstrated survival benefits of nivolumab into clinical practice.
It has been seen previously that >40% of patients presenting with relapsed mesothelioma are considered ineligible for recruitment in randomized controlled trials of immunotherapy (as was the case with Fennell et al.'s study) on account of strict eligibility criteria.[2] This could significantly dilute the small statistically significant benefit that immunotherapy seemingly confers. In a real-world analysis of Dutch patients with relapsed mesothelioma, the median PFS and OS in patients treated with nivolumab were 2.3 months and 6.7 months, respectively.[3] The median OS was not reached in the subset of patients who achieved partial response with immunotherapy, which was about 10% of the entire cohort.[3] It would be interesting to analyze the OS in the sub-group of patients achieving partial response in the CONFIRM[1] trial as well.
In addition, we believe that placebo was not an appropriate choice as a comparator in this trial. Second-line chemotherapy may be an option in the salvage setting as recommended by international guidelines.[4] Even the recent PROMISE-meso trial did not show evidence of a survival benefit with pembrolizumab over gemcitabine-based chemotherapy in relapsed mesothelioma.[5] We believe that to establish a more expensive treatment modality as the standard of care, we must have strong evidence of an advantage over current treatment practices.
A better characterization of this cohort by molecular profiling of the tumor and its microenvironment is therefore imperative to understand which patients truly stand to benefit from immunotherapy.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | |  |
| 1. | Fennell DA, Ewings S, Ottensmeier C, Califano R, Hanna GG, Hill K, et al. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): A multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol 2021;22:1530-40.  |
| 2. | Lau B, Boyer M, Lee JH, Kao S. Clinical trials eligibility of patients with malignant pleural mesothelioma: Use of novel therapies and outcomes. Clin Lung Cancer 2020;21:378-83.e1. |
| 3. | Cantini L, Belderbos RA, Gooijer CJ, Dumoulin DW, Cornelissen R, Baart S, et al. Nivolumab in pre-treated malignant pleural mesothelioma: Real-world data from the Dutch expanded access program. Transl Lung Cancer Res 2020;9:1169-79. |
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| 5. | Popat S, Curioni-Fontecedro A, Dafni U, Shah R, O'Brien M, Pope A, et al. A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: The European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial. Ann Oncol 2020;31:1734-45. |
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