Hypofractionated Radiotherapy for breast cancer: Updated evidence

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1 2 rd Bangladesh Breast Cancer Conference, Dhaka, December 2017 Hypofractionated Radiotherapy for breast cancer: Updated evidence Tabassum Wadasadawala Associate Professor of Radiation Oncology Tata Memorial Centre Mumbai, INDIA

2 Changing paradigms of Radiotherapy in EBC Conventional dose and fractionation Radiobiological Paradigm Technological paradigm Hypofractionated RT for whole and partial breast irradiation

3 Impact of adjuvant radiation in breast cancer following BCS EBCTCG MA: Lancet 2011:378: Radiotherapy to the conserved breast halves the rate at which the disease recurs and reduces the breast cancer death rate by about a sixth Radiotherapy given in conventional fractionation over 5-6 weeks ALL patients undergoing BCS should receive adjuvant radiation

4 Postmastectomy RT: EBCTCG MA 2014 Reduction in LRR up to 15-18% and breast cancer mortality up to 8-10% PMRT becoming standard of care for all node positive women (indications for PMRT expanding) Recommended by recent GUIDELINES as well (Recht et al, Ann Surg 2017)

5 What is time, dose & fractionation (TDS)? Dose is amount of energy absorbed from the radiation beam which is required to control disease Time is overall time to deliver the prescribed dose Fractionation is division of total dose into no of separate fractions over the total treatment time Needed to increase tolerance Exploit difference in repair capacity of tumor and normal tissues Reduction in number of tumor cells with each dose 5

6 Conventional Hypofractionation Daily, 5-6 weeks 5 fractions per week Gy per fraction Pros and cons: Effective (most commonly practiced) Evidence based Inconvenient (5-6 weeks) Significant acute/late toxicity Daily, 2-4 weeks 2-5 fractions per week >2 Gy per fraction Reduction in total dose Pros and cons: Shortening of overall treatment time Resource sparing Cost effective Less acute and late toxicity

7 Radiobiological basis Alpha/beta ratio for breast cancer: low similar to that of normal breast tissue In contrast to the conventional belief of alpha/beta 10 for tumor Robust data to support this: START trials Endpoint α/β ratio (Gy) 95% CI Loco-regional relapse (A) Loco-regional relapse (pilot) Breast shrinkage Breast induration Telengiectasia Breast edema

8 When, Whom & How Hypofractionated radiotherapy: Whole breast Partial breast Simultaneous integrated boost Accelerated partial breast irradiation: Interstitial brachytherapy External beam Intra-operative Balloon brachytherapy 8

9 Hypofractionation: Whole breast

10 Safe for tumor control and late effects Haviland et al, Lancet 2013

11 UK FAST Trial Primary endpoint: 2 year change in photographic breast appearance α/β ratio estimated for breast shrinkage 2.5 Dose in-homogeneity had no greater impact on comparison of the two arms Yarnold J, Radio Oncol 2011, 2012

12 FAST-FORWARD Trial N=4000 Primary endpoint: Ipsilateral breast tumor control Sequential boost Gy in 2.0 Gy fractions allowed in all three arms pt1-3n0-1mo, BCS/MRM Only acute toxicity data published: encouraging (mild toxicity) Brunt M, Radio Oncol 2016

13 Zhou et al Surgical Oncology

14 Concerns with hypo-fractionation Recommends HFRT for 50 years, BCS, T1-2N0, not receiving chemotherapy Choosing Wisely campaign by the ASTRO Is HFRT safe for: Young women High grade tumors Large breast size Patients receiving systemic chemotherapy Pure DCIS Regional nodal irradiation Post-mastectomy women Lung and heart 14

15 Concerns with hypo-fractionation

16 Hypofractionation: RNI is safe (START trials) Median FU 10 years Haviland et al, R&O 2017, article in press

17 Hypofractionation: post mastectomy radiation is safe Phase 3 trial, median FU 52 months Primary endpoint LRR (8.4% vs. 6.0%, p value 0.396) 50 Gy/25# 43.5 Gy/15# Sun et al, ASTRO abstract 5, 2017

18 Hypofractionation: Partial breast (IMPORT LOW) Median FU 72 months 1.1% n-=675 n-=674 n-= % 0.5% Non inferiority trial with primary endpoint: Ipsi-lateral local tumor control Presumed 5 year LR rate in control arm: 2.5% Women 50 years with tumors up to 3 cm, N0-1 and clear margins (at least 2 mm) Coles C, Lancet Oncol

19 Hypo-fractionation with SIB (IMPORT HIGH) Women needing a tumor bed boost dose after breast conservation surgery, appropriate adjuvant systemic therapy, and whole-breast radiotherapy. Dose escalated simultaneous integrated boost (SIB) with intensity-modulated radiotherapy after conservation surgery 19

20 Conclusions: Hypofractionation Hypo-fractionation is here to stay Safe Effective Randomized studies confirm α β ratios between 3-4 However, it is also advisable to evaluate the safety of this approach in our own patient population 20

21 Rationale for Accelerated Partial Breast Irradiation: 15-30% drop out rate after BCT Lack of commitment to usual 5-6 weeks course of adjuvant RT Lack of access (distance, transport) (Athas et al: JNCI 92: , 2000) Logistics (ambulatory status, social support, temporary loss of employment) Prolonged waiting time Physician bias Availability of expertise & facility Cost Patient age (Ballard et al: JNCI 88: , 1996) Fear of radiation treatment Women opt for mastectomy though eligible for BCS or never receive RT after BCS even in the west Lazovich DA, JAMA, 1991

22 Strong clinico-pathological rationale 69-90% recurrences occur at the immediate vicinity of the primary tumor Incidence of elsewhere failures % Several studies on mastectomy specimens suggest residual disease may extend 1 to 2.5 cm margin around excision cavity Potential for reduced injury to the organs at risk (heart & lung) Cost effective (cuts down treatment visits, absence from work) Skowronek J, JCB 2012, Faverly DR Cancer 2001

23 A range of External beam & Brachytherapy techniques for APBI Interstitial Implant Mammosite Multi-lumen brachytherapy Intra-operative techniques 3DCRT / IMRT Seeds Electronic brachytherapy

24 APPROPRIATE SELECTION OF TECHNIQUE AND CASE: CRITICAL R SARIN, NATURE CLINICAL PRACTICE ONCOLOGY, 2005

25

26 Ongoing & published phase III trials of APBI

27 APBI: RECOMMENDATIONS

28 ASTRO-CS (TMH data): Does not predict risk of LR Author (ref) N Technique Median FU (months) Tsize (Median) Histology ASTRO CS group (Percent/LR) p value Suitable Cautionary Unsuitable Ferraro DJ, 2012 Wilkinson JB*, IBT cm IDC/DCIS/ ILC 1813 All except IORT cm IDC/DCIS 36.5% 28.7% 51.5% 19.8% NS at 5 years, ASTRO CS failed to predict LR, Overall 3.0% LRR or DFS 2.5% 46.9% 3.3% 16.7% 4.6% NS at 5 years Vicini FA 2011 MacHaffie DR, IBT 133 NR IDC 47.7% 2.6% 136 MammoSite cm IDC/DCIS 24.6% 1.6% 31.7% 7.8% 42.2% 4.8% 20.6% 2.5% 33.2% 6.6% NS at 10 years, ASTRO CS did not predict LR NS at 5 years TMH, IBT cm IDC 24.5% 0.0% 59.8% 7.4% 15.7% 6.2% 10 year LR not as per ASTRO CS group

29 Local recurrence (primary endpoint) 5.9% vs. 5.1% at median follow up of 10.2 years Radioth Oncol

30 N=1184, Duration: year outcome APBI WBI P value GEC-ESTRO Study LR 1.44% 0.92% 0.42 Conventional WBI + TBB vs. APBI using exclusively MIB Inclusion criteria: DFS 95.0% 94.5% yrs, OS ptis or pt1 2a ( 3 cm 95.5% diameter), 97.3% 0.11 pn0/pnmi, Late grade and M0 2-3 skin 3.2% 5.7% 0.08 Local excision Late grade least 2-32 mm margins 7.6% (ILC or DCIS, 6.3% at least 5 mm), 0.53 No LVSI subcutaneous Median follow-up was 6.6 yrs Median age 62 years Strnad Lancet 2015 &

31 4 studies 5415patients (2 RCTs and 2 non-rcts) IBTR significantly higher IORT vs WBI (RR 2.83) Overall mortality did not differ significantly Prudent selection of suitable patients with low risk of LR necessary 31

32 Median FU 36 months Grade 1/2 toxicities increased with APBI (P.001) 35% v 17% Telangiectasia, breast induration, breast pain increased Fat necrosis significantly more likely after APBI (3% v 0.9%; P.01). Conclusion- Cautioned against the use of 3D-CRT APBI outside the context of a controlled trial J Clin Oncol 31:

33 European Journal of Cancer (2015) Increase in dose conformity with more normal tissue sparing. >40 yrs, 25 mm 30 Gy to tumour bed in five non consecutive # 520 patients Median follow-up of 5.0 years IBTR rate was 1.5% in both 5-year OS 96.6% for WBI vs 99.4% for APBI Better results considering acute (p = ), late (p = 0.004), and cosmetic outcome (p = 0.045)with APBI 33

34 European Journal of Cancer (2015) Increase in dose conformity with more normal tissue sparing. >40 yrs, 25 mm 30 Gy to tumour bed in five non consecutive # 520 patients Median follow-up of 5.0 years IBTR rate was 1.5% in both 5-year OS 96.6% for WBI vs 99.4% for APBI Better results considering acute (p = ), late (p = 0.004), and cosmetic outcome (p = 0.045)with APBI 34

35 Conclusion: APBI Randomized and prospective data from interstitial brachytherapy series: reassuring and can be considered standard in selected women A word of caution for intra-operative techniques IMRT better than 3DCRT for APBI ASTRO-CS not useful for patient selection 35

36 THANK YOU FOR YOUR KIND ATTENTION

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