182P - A phase II randomised study of Adjuvant hypo-fractionated radiotherapy with Concurrent vs Sequential Letrozole in post-menopausal women with Hormon...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Breast Cancer
Surgery and/or Radiotherapy of Cancer
Presenter Rituraj Upadhyay
Citation Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362
Authors R. Upadhyay1, D.N. Sharma1, P. Julka2, G.K. Rath3
  • 1Radiation Oncology, All India Institute of Medical Sciences, 110029 - New Delhi/IN
  • 2Medical Oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIMS), 110029 - New Delhi/IN
  • 3Radiation Oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIMS), 110029 - New Delhi/IN

Abstract

Background

The sequence of hormonal therapy with adjuvant radiation(RT) is debated because of anticipated morbidity. We conducted a phase II study to evaluate feasibility and efficacy of concurrent and sequential letrozole along-with hypo-fractionated RT(HFRT).

Methods

A total of 50 Post-menopausal women with hormone-receptor positive, Stage I-III Breast cancer received adjuvant HFRT 42.5Gy/16fr/3weeks and were randomly assigned to either concurrent (arm A) or sequential letrozole (arm B). Letrozole was started 3 weeks before RT in the concurrent, and 3 weeks after RT in sequential group. Pulmonary toxicity was assessed by clinical examination, chest x-ray, pulmonary function tests and HRCT chest (if indicated) at baseline, at one and six months(m) post RT. Cosmetic outcome was reported in both arms with six parameters (Table) at 6 m post RT.

Results

A total of 48 patients(pts) were followed up for 6 m (25 in Arm A and 23 in Arm B). None of the pts developed acute pulmonary toxicities. Mean (R) FeV1 and FVC values at baseline, 1 and 6 m post RT were 1.8 l (1.6-1.9) and 2.2 l(2.1-2.4), 1.79 l(1.5-1.9) and 2.1 l(1.9-2.4) and 1.85 l(1.6-2) and 2.2 l(2-2.4) respectively, and were comparable. FeV1 and FVC remained within 80 to 120% of the baseline values in 37 pts (20 Arm A vs 17 Arm B, p = 0.5). FeV1 and FVC were reduced by more than 80% at 6 m in 3 pts of Arm A and 5 pts in Arm B, (p = 0.7), while this was improved by over 120% in 5 pts (2 vs 3, p = 1). RTOG grade 2-3 radiation dermatitis was seen in 33 pts (15 vs 18, p = 0.55) while 5 pts had grade 4 toxicity (2 vs 3, p = 1). There was no treatment interruption because of toxicity.Table:

182P

Cosmetic Outcome
Mild changeMarked change
ARM AARM BARM AARM B
Breast Shrinkage6523
Breast Hardness22 10
Breast Swelling100 0
Change in Skin appearance9833
Self-breast assessment141355
Photographic breast assessment151532

Overall, 18 pts had excellent cosmesis (7 vs 11, p = 0.4) while 32 had good cosmesis. (18 vs 14, p = 0.4).

Conclusions

HFRT along-with concurrent Letrozole is well tolerated. However, patients are being followed to assess loco-regional disease control and late toxicities.

Clinical trial identification

Legal entity responsible for the study

All India Institute of Medical Sciences

Funding

None

Disclosure

All authors have declared no conflicts of interest.