|LETTER TO EDITOR
|Year : 2019 | Volume
| Issue : 2 | Page : 272-273
Author reply to - Jain H. et al. and Tandon N. et al.
Bhausaheb Bagal, Avinash Bonda
Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, India
|Date of Web Publication||20-Dec-2019|
Room No. 24, 81, Main Building, Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai, Maharashtra; Homi Bhabha National Institute (HBNI), Mumbai
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Bagal B, Bonda A. Author reply to - Jain H. et al. and Tandon N. et al. Cancer Res Stat Treat 2019;2:272-3
We thank Jain et al. for reading our article and for comments about surrogate endpoints and cost implications of newer drugs. Given the long time taken for overall survival (OS) to mature, studies planned with surrogate endpoints will have to be carefully scrutinized for sample size, follow-up duration, patient-reported outcomes, nature of salvage therapy received, and mature OS data. Awareness among physicians and patients about potential fallacies of surrogate endpoints is important as highlighted by recent result of the BELLINI trial which failed to improve OS despite an improved progression-free survival with venetoclax in relapsed myeloma patients, due to excess deaths. However, such surrogate endpoints help generate data for regulatory approvals and provide early drug access. Financial toxicity and lack of access to drugs are issues that remains challenges in many countries besides India. Generics, biosimilars, and drug repurposing studies seem to be the way in which we can help our patients as physician researchers.
We appreciate the critical comments by Tandon et al. Limitation of response as an indicator of long-term outcome has to be acknowledged; however, response assessment techniques have evolved and so have the criteria, especially for deeper level of responses. In this context, achievement of minimal residual negativity seems consistently associated with improved survival and hence serves as an important comparator for efficacy of the regimen in the controlled studies. Potential role for regimens with cytotoxic drug combinations which will be particularly relevant in our setting, as discussed in the article, has been studied in few trials, but unfortunately is not the major focus of current induction studies, given the influx of newer agents with novel mechanisms of action.
With availability of few predictive biomarkers, personalized regimens may be possible in the near future. The CoMMpass study, looking at molecular lesions pointed at the heterogeneity of disease among the patients, however suggested that few subtypes could be targeted based on the molecular alterations. Currently, Myeloma-Developing Regimens Using Genomics (MyDRUG) study led by Dr. Shaji Kumar is looking at such an approach in the relapsed setting. Hopefully, we will see similar studies in newly diagnosed cases in the near future.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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