Abstract 1637
Background
The only randomized trial of SC to prevent the distressing chemo-toxicity, CIA did not evaluate its effect on hair regrowth (HR) and was conducted in a predominantly taxane (T) treated population. We conducted a randomized trial of SC in a setting of anthracycline (A) and taxane chemotherapy and assessed its effect on CIA and HR.
Methods
Non-metastatic breast cancer women undergoing (neo)adjuvant chemotherapy were randomized to receive SC using Paxman scalp cooling system during every cycle of chemotherapy, or no SC. The primary end point was successful hair preservation (HP) assessed clinically and by review of 5 photographs, using the CTCAE version 4.0 scale (defined as grade 0 = no, grade1 = < 50% hair loss, not requiring a wig) after the 4 cycles or 12 weeks of chemotherapy. Secondary endpoints were HR at 6 and 12 weeks after completion of chemotherapy, adverse events and comparative quality of life scores.
Results
Between December 2016 and July 2018, 51 patients, with median age 38 (21-58) years, were randomized to SC (34) or control arm (17) in a 2:1 ratio. 25/51 (49%) patients received A followed by T and two arms were balanced with respect to this factor. Modified intension to treat population (32) comprised of women who received at least one cycle of chemotherapy. HP rate was significantly higher in SC arm (18/32, 56.3%) compared to control arm (0/17, 0%; difference 56.3%, 95% CI 31%-73%, P = 0.000004). HR was higher in SC arm compared to control at 6 weeks (89% vs 12%; difference 77%, 95% CI 49%-88%, p < 0.001) and 12 weeks (100% vs 59%; difference 41%, 95% CI 8%-64%, p = 0.0003). HP after 4 cycles was higher in patients receiving T versus those receiving A (77% vs 33%, p = 0.0307). Patient reported hair loss at primary endpoint evaluation landmark was significantly lower in SC versus control arm (45% vs 82%, p = 0.016) with compulsive head cover use of 47 % in SC vs 100% in controls (p = 0.0001). Of 33 patients who started on SC, 23(69%) patients experienced grade 1-2 cold related adverse effects in SC arm with no grade 3-4 events.
Conclusions
Women with breast cancer receiving A or T chemotherapy were significantly more likely to have <50% hair loss after chemotherapy, had superior hair regrowth and improved patient reported outcomes, if scalp cooling was used.
Clinical trial identification
CTRI/2017/02/007896.
Editorial acknowledgement
Legal entity responsible for the study
Jyoti Bajpai.
Funding
Orbis Paxman Hair Loss Prevention System.
Disclosure
J. Bajpai: Research grant / Funding (institution), No Personal Financial disclosures to declare: Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Novartis; Research grant / Funding (institution), No Personal Financial disclosures to declare: Roche; Research grant / Funding (institution), No Personal Financial disclosures to declare: Samsung Bioepis Co. Ltd; Research grant / Funding (institution), No Personal Financial disclosures to declare: Sun Pharma; Leadership role, No Personal Financial disclosures to declare: Immuno-oncology Society of India(I-OSI); Leadership role, No Personal Financial disclosures to declare: Indian Society of Medical and Paediatric Oncology (ISMPO) ; Leadership role, No Personal Financial disclosures to declare: Indian cooperative Oncology network (ICON); Leadership role, No Personal Financial disclosures to declare: Teenage and Young Cancer Association (TYA). S. Gupta: Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Roche; Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Sanofi; Research grant / Funding (institution), No Personal Financial disclosures to declare: Johnson & Johnson; Research grant / Funding (institution), No Personal Financial disclosures to declare: Amgen; Research grant / Funding (institution), No Personal Financial disclosures to declare: Celltrion; Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Oncosten; Research grant / Funding (institution), No Personal Financial disclosures to declare: Novartis; Research grant / Funding (institution), No Personal Financial disclosures to declare: Intas; Research grant / Funding (institution), No Personal Financial disclosures to declare: Eisai; Research grant / Funding (institution), No Personal Financial disclosures to declare: Biocon; Advisory / Consultancy, No Personal Financial disclosures to declare: DRL; Advisory / Consultancy, No Personal Financial disclosures to declare: Biocon; Advisory / Consultancy, No Personal Financial disclosures to declare: Pfizer; Advisory / Consultancy, No Personal Financial disclosures to declare: Core diagnostics. All other authors have declared no conflicts of interest.
Resources from the same session
5553 - Cytokine genetic variations and worse quality of life among family caregivers of head and neck cancer patients in palliative care
Presenter: Daniel Pequeno
Session: Poster Display session 1
Resources:
Abstract
4321 - Health-related quality of life of advanced melanoma survivors treated with CTLA-4 immune checkpoint inhibition: a matched cohort study
Presenter: Annelies Boekhout
Session: Poster Display session 1
Resources:
Abstract
779 - Capecitabine vs Cisplatin along with concurrent radiotherapy in the treatment of inoperable lower esophageal cancers focusing on TWISTT score and QOL
Presenter: Goutham Anugu
Session: Poster Display session 1
Resources:
Abstract
5914 - Cancer, Mental Health and End Life Simulation (CAMhELS): A novel effectiveness evaluation.
Presenter: Asanga Fernando
Session: Poster Display session 1
Resources:
Abstract
2597 - Cancer patients’ expectations and understanding about their disease
Presenter: Mónica Pinho
Session: Poster Display session 1
Resources:
Abstract
5187 - Impact of patients’ death on oncologists and coping strategies: An online survey
Presenter: Soumaya Labidi
Session: Poster Display session 1
Resources:
Abstract
4579 - Clinical benefit from late lines of therapy offered to patients treated in a tertiary referral centre
Presenter: Andrea Sbrana
Session: Poster Display session 1
Resources:
Abstract
5058 - Preparedness for caregiving in caregivers of cancer patients
Presenter: Hatice Yakar
Session: Poster Display session 1
Resources:
Abstract
5917 - Oncologic Emergency Medicine in the real world: A survey and proposal for improvement
Presenter: Carintia Dorta Pérez
Session: Poster Display session 1
Resources:
Abstract
4077 - The Reality of Critical Cancer Patients in a Polyvalent Intensive Care Unit
Presenter: Tiago Filipe Da Cruz Tomas
Session: Poster Display session 1
Resources:
Abstract