J Bajpai1, S Kagwade2, A Chandrasekharan2, S Dandekar2, S Kanan3, Y Kembhavi2, J Ghosh2, S D Banavali2, S Gupta2
1Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India. Electronic address: dr_jyotibajpai@yahoo.co.in.
2Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
3Statistician Department, Tata Memorial Hospital, Mumbai, India.
An open label randomised single centre study with 51 female Indian breast cancer patients was used to evaluate the effect of the Paxman scalp cooling device on preventing CIA among women undergoing (neo) adjuvant chemotherapy (CT) containing both anthracyclines and taxanes. Subjects were stratified by the sequence of CT (A or T first) and randomised to scalp cooling (SC) or no scalp cooling (control) arm in a 2:1 ratio. SC was initiated 30 min prior to each treatment cycle, with scalp temperature maintained throughout infusion and for 90 min afterwards.
The primary end point (PEP) was successful hair preservation (HP) assessed clinically and by review of 5 photographs, using the CTCAE version 4.0 scale for alopecia (grade 0 = no hair loss, grade 1 = < 50% hair loss, not requiring a wig) after 4 cycles or 12 weeks of CT. Success was defined as grade 0 and 1 alopecia, and failure as grade 2 alopecia (>50% hair loss, requiring the use of a wig). Participant withdrawals after completion of one cycle of CT were deemed treatment failures. The secondary end point (SEP) comprised a hair regrowth (HR) assessment at 6 and 12 weeks (defined as attainment of grade 0/1 alopecia post completion of all CT). For further validation, independent observers from outside the study, and the subject themselves, also assessed hair loss and regrowth.
Other SEP were device related adverse events (AE) determined by patient reported symptoms and by scalp examination and tolerance to scalp cooling.
51 patients were randomised to SC (34) or control (17) in a 2:1 ratio. Twenty-five (49%) patients received A followed by T and the two arms were balanced with respect to this factor. Hair preservation rate was 56.3% with scalp cooling compared to 0% for non-cooling (control).
Hair regrowth at 6 weeks post chemotherapy was also higher for scalp cooling at 89% compared to 12% for control and at 12 weeks 100% of the cooling group had hair regrowth compared to 59% for control.
For SC patients 55% self-reported hair preservation at the end of CT compared to 18% of the control. Six weeks after treatment ended this reduced to 79% for SC and 47% for control.
Overall, the SC device was well tolerated with no serious adverse events, and most participants perceived it as reasonably comfortable based on a comfort scale and verbal questioning. No patient had developed scalp metastases after a median follow-up of 17.1 [inter quartile range (IQR) 13.3-21.8] months.
The study had a relatively small sample size and the primary end point was successful hair preservation after 4 cycles of CT, which could be higher than the efficacy at the end of all the cycles. However, majority had attained grade 2 alopecia after 1-2 cycles of CT.
