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
3158 - Tobacco Retail Access and Tobacco Cessation Among Head and Neck Cancer (HNC) Survivors
Presenter: Lawson Eng
Session: Poster Display session 1
Resources:
Abstract
5511 - ASSERT: A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Patients Treated for Moderate to Severe Hyponatremia Secondary to Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) in Italy (Lung Cancer Cohort)
Presenter: Rossana Berardi
Session: Poster Display session 1
Resources:
Abstract
3821 - Efficacy and safety of controlled ovarian stimulation with or without letrozole co-administration for fertility preservation: A systematic review and meta-analysis.
Presenter: Benedetta Bonardi
Session: Poster Display session 1
Resources:
Abstract
2168 - Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy
Presenter: Tineke Vandenbroucke
Session: Poster Display session 1
Resources:
Abstract
5855 - Update of the registry of young women with cancer by the International Network of Cancer, Infertility and Pregnancy
Presenter: Charlotte Maggen
Session: Poster Display session 1
Resources:
Abstract
5156 - Erectile dysfunction in patients with metastatic renal cell carcinoma
Presenter: Ilya Tsimafeyeu
Session: Poster Display session 1
Resources:
Abstract
4992 - Exercise level, interest and preferences in cancer patients.
Presenter: Alice Avancini
Session: Poster Display session 1
Resources:
Abstract
3427 - Filling the Gaps in Informed Consent for Advanced Cancer Patients considering Phase 1 Oncology Trials - an in-depth Qualitative Study of Key Stakeholders at a large United Kingdom Phase 1 unit
Presenter: Abhijit Pal
Session: Poster Display session 1
Resources:
Abstract
3537 - Breast Cancer Patients’ Quality of Life: Real World Data
Presenter: Thanos Kosmidis
Session: Poster Display session 1
Resources:
Abstract
4761 - High-sensitivity troponin as a cardiotoxicity biomarker in breast cancer treatment
Presenter: Joana Simões
Session: Poster Display session 1
Resources:
Abstract