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Table of Contents
Year : 2020  |  Volume : 3  |  Issue : 2  |  Page : 401-402

Only 9 weeks or complete 12 months of adjuvant trastuzumab in Indian early-stage breast cancer patients: Is it the practice-changing approach in a resource-constrained setting?

Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India

Date of Submission08-Mar-2020
Date of Decision09-Mar-2020
Date of Acceptance09-Mar-2020
Date of Web Publication19-Jun-2020

Correspondence Address:
Chaturbhuj R Agrawal
Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, New Delhi - 110 085
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/CRST.CRST_75_20

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How to cite this article:
Agrawal CR, Domadia K, Goyal P. Only 9 weeks or complete 12 months of adjuvant trastuzumab in Indian early-stage breast cancer patients: Is it the practice-changing approach in a resource-constrained setting?. Cancer Res Stat Treat 2020;3:401-2

How to cite this URL:
Agrawal CR, Domadia K, Goyal P. Only 9 weeks or complete 12 months of adjuvant trastuzumab in Indian early-stage breast cancer patients: Is it the practice-changing approach in a resource-constrained setting?. Cancer Res Stat Treat [serial online] 2020 [cited 2021 Dec 4];3:401-2. Available from: https://www.crstonline.com/text.asp?2020/3/2/401/287265

We have read with great interest the article by Manuprasad et al.,[1] which, to the best of our knowledge, is the largest analysis regarding short-course adjuvant trastuzumab in breast cancer from the Indian subcontinent, and we would like to congratulate the authors for this. To summarize, this was a retrospective analysis of 129 early-stage breast cancer patients who had received only 9 weeks of adjuvant trastuzumab with chemotherapy, and it was concluded that this strategy of short-duration trastuzumab is feasible in a low-resource country like ours with favorable outcomes considering the high treatment cost and minimal benefits.[2]

We agree with the authors that the high cost is the biggest hurdle in administering the entire 12 months of adjuvant trastuzumab, but this was in the past and with the available generic versions of trastuzumab, this issue has been addressed to a large extent. We agree that in the prior study by Adusumilli et al.,[3] only one-third of the patients (35.8%) received adjuvant trastuzumab, but this was a retrospective study that recruited patients from January 2007 to December 2013, and the cost of adjuvant trastuzumab quoted was around ₹1,000,000, but, since then, the times have changed, and now, the cost of generic trastuzumab has decreased by approximately 65% (approximately ₹340,000 for 17 vials). The above statistics may not hold true in future, and presently, the drug is more affordable for the majority of patients.

The benefits of adjuvant trastuzumab versus no trastuzumab are well documented, but the optimal duration has always been debated upon. Unfortunately, the available literature as of now is is somewhat contradictory. On the one hand, the PHARE trial [4] indicated that 6 months of adjuvant trastuzumab therapy was not noninferior to 12 months, whereas on the other hand, the PERSEPHONE trial [5] showed no compromised efficacy with less cardiotoxicity with the same duration of trastuzumab. However, the patient profile in PERSEPHONE was very favorable, i.e., 59% had node-negative disease and 69% had estrogen receptor (ER)-positive disease. In this trial, the benefits of shortened trastuzumab regimen were limited to subgroups of patients who were ER positive, received anthracyclines as part of their chemotherapy regimen and with sequential trastuzumab, however longer follow-up may unveil further facts. Data are further very limited for the 9-week duration. The FinHer study [6] primarily compared docetaxel with vinorelbine, however the patients also received 9 weeks of trastuzumab compared with no trastuzumab. The results were numerically similar to 1 year of trastuzumab, but the study was not powered to comment upon statistical significance. The Short-HER trial [7] again compared 9 weeks versus 1 year of therapy; the noninferiority of 9-week therapy was not proven, but shorter duration decreased cardiac side effects and can be given in those at very low risk of recurrence. A recent meta-analysis from China [8] again concluded that 1 year of adjuvant treatment has survival benefits and should be preferred whenever feasible, while shorter duration may serve as an alternative for patients with cardiac disease and those with lower recurrence risk.

In this study by Manuprasad et al., the notable drawbacks are its retrospective design, no arm of 3-weekly trastuzumab and only single-arm study with limited follow-up, and lack of timely cardiac evaluations. There remains an unmet need of a randomized controlled trial in the Indian population [9] before finalizing the 9-week option of trastuzumab as the approved option. At present, complete 12 months of adjuvant trastuzumab continues to be the standard of care, but shorter duration may be considered for the limited patient population having the lowest risk of recurrence or if finances are not available for 12 months of even generic trastuzumab.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Manuprasad A, Shenoy PK, Jones J, Vinin NV, Dharmarajan A, Muttath G. Short-course adjuvant trastuzumab in breast cancer: Experience from a tertiary cancer center in rural India. Cancer Res Stat Treat 2020;3:69.  Back to cited text no. 1
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Akram Hussain SM. Molecular-based screening and therapeutics of breast and ovarian cancer in low- and middle-income countries. Cancer Res Stat Treat 2020;3:81-4.  Back to cited text no. 2
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Adusumilli P, Konatam ML, Gundeti S, Bala S, Maddali LS. Treatment challenges and survival analysis of human epidermal growth factor receptor 2-positive breast cancer in real world. Indian J Med Paediatr Oncol 2017;38:22-7.  Back to cited text no. 3
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Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, et al. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): Final analysis of a multicentre, open-label, Phase 3 randomised trial. Lancet 2019;393:2591-8.  Back to cited text no. 4
Earl HM, Hiller L, Vallier AL, Loi S, McAdam K, Hughes-Davies L, et al. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised Phase 3 non-inferiority trial. Lancet 2019;393:2599-612.  Back to cited text no. 5
Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, et al. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: Final results of the FinHer Trial. J Clin Oncol 2009;27:5685-92.  Back to cited text no. 6
Conte P, Frassoldati A, Bisagni G, Brandes AA, Donadio M, Garrone O, et al. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: Final results of the Phase III randomized Short-HER study‡. Ann Oncol 2018;29:2328-33.  Back to cited text no. 7
Chen L, Zhou W, Hu X, Yi M, Ye C, Yao G. Short-duration versus 1-year adjuvant trastuzumab in early HER2 positive breast cancer: A meta-analysis of randomized controlled trials. Cancer Treat Rev 2019;75:12-9.  Back to cited text no. 8
Noronha V. Making a case for cancer research in India. Cancer Res Stat Treat 2018;1:71-4.  Back to cited text no. 9
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This article has been cited by
1 Authorsę reply to Agarwal et al. and Venniyoor
Avaronnan Manuprasad,PraveenKumar Shenoy,Joneetha Jones,NV Vinin,Adarsh Dharmaraj,Geetha Muttath
Cancer Research, Statistics, and Treatment. 2020; 3(2): 402
[Pubmed] | [DOI]


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