Details
Category: Volume 11 Issue 07 July 2023
Hits: 343

Title: Prospective Study to Compare Outcomes Following Hypofractionated Radiotherapy versus Conventional Radiotherapy in Carcinoma Breast

Authors: Dr Vivek Kumar Pandey, Dr S.N Prasad, Dr M.Q.Baig, Dr. Jitendra Kumar Verma, Dr Pramod Kumar Singh, Dr Archana Singh, Dr Ansu Goel, Dr M. Waseem Raza

 DOI: https://dx.doi.org/10.18535/jmscr/v11i7.04

Abstract

Background: Breast cancer is now the most common cancer worldwide (GLOBOCAN, 2020). It is the most common cancer among women in developed countries. The age standardized incidence rate of breast cancer in India is 25.8% per 100,000 women (GLOBOCAN, 2020). By 2020, breast cancer overtook cervical cancer as the most common type of cancer among all women in India. Breast irradiation has been shown to reduce the risk of local recurrence after breast-conserving surgery from about 30% to <10% at 10 years.

Aims & Objectives: Randomize Breast carcinoma into two arms - Arm A :- 39GY in 13 fractions over 2.3 weeks & Arm B:- 50 GY in 25 fractions over 5weeks. Compare locoregional response in two arms 4 weeks after completion of radiation therapy and at the end of six months of follow up. Compare acute and chronic toxicities in the two arms.

Method: Total 43 patients were included in the study, 21 belonged to ARM A and 22 belonged to ARM B, Patients were randomised to 50 Gy in 25 fractions over 5 weeks or to 39Gy in 13 fractions over 2.3 weeks. Randomisation was arranged via lottery system by opting chit from a box of multiple chits. Randomisation was blinded. Normal tissue effects in the breast, arm, and shoulder were assessed by RTOG criteria for skin reactions, patient self-reported assessments, and physician assessments.

ARM A = (39Gy in 13 fractions over 2.3 weeks)

ARM B = (50 Gy in 25 fractions over 5 weeks)

Result: At the end of radiotherapy all 43 patients ( 21 in Arm A and 22 in Arm B) were assessed for acute skin toxicity, in arm A, 09(42.86%) patients had grade I reaction, 11(52.38%) patients had grade II reaction,1(4.76%) patients had grade III reaction and no patients had grade IV reaction while in arm B 2(9.09%) patients had grade I reaction, 11(50%) patients had grade II reaction,7(31.82%) patients had grade III reaction and 2(9.09%) patients had grade IV reaction. Arm with 39 Gy have less no. of grade III&IV reactions 1(4.76%) as compared with 50 Gy arm 9(40.91%), which is statistically very significant (p-). At the time of analysis, 1(2.23%) patients had experienced a local-regional relapse in arm A as compared with arm B no patients had local-regional relapse, which is statistically not significant (p-). After median follow-up of 9.42 month rate of distant relapse was higher in the 39 Gy group 2(4.65%) in comparison to 50 Gy group 1(2.32%), which is statistically not significant (p-), which contributed to the higher rates of disease-free survival and overall survival in the 50 Gy group.

Conclusion: After surgery for breast cancer, a radiotherapy schedule delivering 39 Gy in 13 fractions over 2.3 weeks seems to offer significantly less acute toxicity as well as cosmetic appearance which is statistically significant. But in terms of loco regional recurrence as well as distant recurrence 39 Gy schedule appears to be less effective especially in advanced stage, although data was statistically not significant.

Keywords: Breast Cancer, Adjuvent Radiotherapy, Hypo-fractionation Radiotherapy, Coventional Radiotherapy, Acute skin toxicity.

References

  1. Hyuna Sung, Jacques Ferlay, ME, Rebecca L. Siegel, Mathieu Laversanne, Isabelle Soerjomataram, Ahmedin Jemal, Freddie Bray. Global Cancer Statistics 2020 : GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. 2021 May ; 71 (3) : 209-249.
  2. Gouri Shankar Bhattacharyya , Dinesh C. Doval , Chirag J. Desai, Harit Chaturvedi, Sanjay Sharma and S.P. Somashekhar : Overview of Breast Cancer and Implications of Overtreatment of Early-Stage Breast Cancer: An Indian Perspective DOI: 10.1200/GO.20.00033 JCO Global Oncology no. 6 (2020) 789-798. Published online June 8, 2020.
  3. The START Trialists Group : The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr 1; 9(4): 331–341. doi: 10.1016/S1470-2045(08)70077-9.
  4. Allison KH, Hammond MEH, Dowsett M, Estrogen and Progesterone Receptor Testing in Breast Cancer : ASCO/CAP Guideline Update. J Clin Oncol. 2020 ; 38 (12) : 1346-1366. doi:10.1200/JCO.19.02309.
  5. Burke, S. Faithfull, H. Probst : Radiation induced skin reactions during and following radiotherapy: A systematic review of interventions, Radiography, Volume 28, Issue 1, 2022, Pages 232-239, ISSN 1078-817.
  6. Krug D, Baumann R, Combs SE : Moderate hypofractionation remains the standard of care for whole-breast radiotherapy in breast cancer: Considerations regarding FAST and FAST-Forward. Strahlenther Onkol. 2021 ; 197 (4) : 269-280. doi:10.1007/s00066-020-01744-3.
  7. Haussmann, J, Corradini, S, Nestle-Kraemling, C. : Recent advances in radiotherapy of breast cancer. Radiat Oncol 15, 71 (2020). https://doi.org/10.1186/s13014-020-01501-x.
  8. Bruce G. Haffty, Qifeng Yang, Michael Reiss, Thomas Kearney, Susan A. Higgins, Joanne Weidhaas, Lyndsay Harris, Willam Hait, and Deborah Toppmeyer. Journal of Clinical Oncology 2006 24:36, 5652-5657.
  9. Martin, A. Villar, A. Sole-Calvo, R. Gonzalez, B. Massuti, J. Lizon, C. Camps, A. Carrato, A. Casado, M.T. Candel, J. Albanell, J. Aranda, B. Munarriz, J. Campbell, E. Diaz-Rubio : Doxorubicin in combination with fluorouracil and cyclophosphamide (i.v. FAC regimen, day 1, 21) versus methotrexate in combination with fluorouracil and cyclophosphamide (i.v. CMF regimen, day 1, 21) as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM group, Annals of Oncology, Volume 14, Issue 6, 2003, Pages 833-842, ISSN 0923-7534.
  10. Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012 ; 15 (4) : 373-380. doi:10.4048/jbc.2012.15.4.373.
  11. Cytoprotective Efficacy of Amifostine Against Radiation- Induced Rectal Toxicity: Objective and Subjective Grading Scales for Radiomucositis-Scientific Figure on ResearchGate. Available from: https://www.researchgate.net/figure/WHO-Toxicity-Criteria-and-RTOG-Acute-Radiation-Morbidity-Scoring-Criteria_tbl2_5387232 [accessed 30 May, 2022].
  12. Chagpar AB. Techniques to reduce positive margins in breast-conserving surgery. In Chen W, ed. UpToDate. Waltham, Mass.: UpToDate, 2021. https://www.uptodate.com. Accessed July 7, 2021.

Corresponding Author

Dr Vivek Kumar Pandey

Junior Resident Third Year, Department of Radiation Oncology J. K. Cancer Institute, G. S.V.M. Medical College Kanpur -208002, Uttar Pradesh, India