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Year : 2019  |  Volume : 2  |  Issue : 2  |  Page : 272-273

Author reply to - Jain H. et al. and Tandon N. et al.

Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, India

Date of Web Publication20-Dec-2019

Correspondence Address:
Bhausaheb Bagal
Room No. 24, 81, Main Building, Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai, Maharashtra; Homi Bhabha National Institute (HBNI), Mumbai
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/CRST.CRST_97_19

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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

How to cite this URL:
Bagal B, Bonda A. Author reply to - Jain H. et al. and Tandon N. et al. Cancer Res Stat Treat [serial online] 2019 [cited 2020 Sep 23];2:272-3. Available from: http://www.crstonline.com/text.asp?2019/2/2/272/273710

We thank Jain et al. for reading our article[1] and for comments about surrogate endpoints and cost implications of newer drugs.[2] 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.[3] 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.[4] Generics, biosimilars, and drug repurposing studies seem to be the way in which we can help our patients as physician researchers.[5]

We appreciate the critical comments by Tandon et al.[6] 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.[6] 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.[8] Currently, Myeloma-Developing Regimens Using Genomics (MyDRUG) study led by Dr. Shaji Kumar is looking at such an approach in the relapsed setting.[9] Hopefully, we will see similar studies in newly diagnosed cases in the near future.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Bagal B, Bonda A. Induction therapy in newly diagnosed multiple myeloma: Current research scenario and questions for the future. Cancer Res Stat Treat 2019;2:76.  Back to cited text no. 1
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Jain H, Thorat J, Sharma N. Multiple myeloma: The paradox and the challenge. Cancer Res Stat Treat 2019;2:270-1.  Back to cited text no. 2
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Multilearning Group Inc. Phase 3 Study of Venetoclax or Placebo in Combination with... by Prof. Shaji Kumar. Available from: https://library.ehaweb.org/eha/2019/24th/273254/shaji.kumar.a.phase. 3.study.of.venetoclax.or.placebo.in.combination.with.html. [Last accessed on 2019 Nov 07].  Back to cited text no. 3
Philip CC, Mathew A, John M J. Cancer care: Challenges in the developing world. Cancer Res Stat Treat 2018;1:58-62.  Back to cited text no. 4
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Noronha V. Making a case for cancer research in India. Cancer Res Stat Treat 2018;1:71-4.  Back to cited text no. 5
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Tandon N, Devadas SK, Khanderia M. Changing landscape of induction therapy in newly diagnosed multiple myeloma. Cancer Res Stat Treat 2019;2:271-2.  Back to cited text no. 6
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Lahuerta JJ, Paiva B, Vidriales MB, Cordón L, Cedena MT, Puig N, et al. Depth of response in multiple myeloma: A pooled analysis of three PETHEMA/GEM clinical trials. J Clin Oncol 2017;35:2900-10.  Back to cited text no. 7
Lonial S, Nooka AK. Myeloma is not a single disease. J. Oncol Pract 2016;12:287-92.  Back to cited text no. 8
Myeloma-Developing Regimens Using Genomics (MyDRUG) – Full Text View. Available from: https://clinicaltrials.gov/ct2/show/NCT03732703. [Last accessed on 2019 Nov 06].  Back to cited text no. 9


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