Abstract P4-14-07: Outcome with use of 12 weeks of adjuvant or neoadjuvant trastuzumab in a resource constrained setting
Authors: Ghosh J , Joy Phillip DS , Ghosh J , Gupta S , Bajpai J , Gulia S , Parmar V , Nair N , Budrukkar AN , Jalali R , Desai SB , Sawant S , Dhir AA , Kembhavi S , Hawaldar R , Banavali SD , Badwe RA 
Published: May 2016

Background: Adjuvant trastuzumab has improved overall survival in women with HER2 receptor positive breast cancer. However, only a small fraction (4%) of eligible patients in resource constrained settings have access to this drug. A patient assistance program of 12 weeks of adjuvant or neoadjuvant trastuzumab was thus started for those who did not have any access to trastuzumab due to financial constraints. We undertook a retrospective analysis of outcomes in women who were enrolled between January 2011 to December 2012 in this patient assistance program.

Methods: Patients received four cycles of anthracycline based chemotherapy (AC/CAF/ EC/CEF) and 12 doses of weekly paclitaxel (80mg/m2) with trastuzumab (4mg/kg loading followed by 2mg/kg) in the neoadjuvant or adjuvant setting in either sequence (anthracycline followed by taxane trastuzumab or taxane trastuzumab followed by anthracycline). Patients received adjuvant hormonal therapy depending on the hormone receptor status. The primary endpoint of this analysis was disease free survival (DFS).

Results: A total of 103 patients with HER2 receptor positive breast cancer were analysed. The median age was 46 (24-65) years, 50% were premenopausal, 60.7% had stage III disease (86.8% had node positive disease) and 37% patients had ER and or PR positive disease. Forty patients (38.8%) had breast conserving surgery while the rest had modified radical mastectomy. At a median follow-up of 34 (7-46) months the 3-year DFS and overall survival was 77.2% and 82.7% respectively. Among patients who developed recurrence one had only local recurrence, 4 had both local and distant recurrence and 11 had distant metastasis alone. Of the 15 patients who developed distant metastasis 7 had brain involvement . Symptomatic cardiac dysfunction developed in four patients, two of whom died while in the other 2 ejection fraction recovered. The results are summarised in the table.

Patient Characteristic and outcome with 12 weks of adjuvant or neoadjuvant TrastuzumabNumber of PatientsNode Positive (%)Hormone Positive (%)DFS at 3 yearsOS at 3 yearsBrain Mets(%)Grade 3/4 Cardiac Toxicity(%)10386.83777.282.76.83.9

Conclusions: These results suggest that 12 weeks of neoadjuvant or adjuvant trastuzumab is an acceptable alternative in patients who lack access to full 1 year of trastuzumab.

Citation Format: Ghosh J, Joy Phillip DS, Ghosh J, Gupta S, Bajpai J, Gulia S, Parmar V, Nair N, Budrukkar AN, Jalali R, Desai SB, Sawant S, Dhir AA, Kembhavi S, Hawaldar R, Banavali SD, Badwe RA. Outcome with use of 12 weeks of adjuvant or neoadjuvant trastuzumab in a resource constrained setting. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-14-07.