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
3181 - Effects of Three Products in the Prevention and Treatment of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
Presenter: Francesca Zannier
Session: Poster Display session 1
Resources:
Abstract
2433 - Boiling Histotripsy-induced Mechanical Ablation Modulates Tumour Microenvironment by Promoting Immunogenic Cell Death of Cancers
Presenter: Cheol-Hee Shin
Session: Poster Display session 1
Resources:
Abstract
2663 - The bacterial receptor NOD2 mediates LGR5+ intestinal stem cells protection against irradiation via mitophagy activation
Presenter: Antonin Levy
Session: Poster Display session 1
Resources:
Abstract
3213 - Pulse mode irradiation regimen of PDT results in high progression free and overall survival in mice with model tumor
Presenter: Alexey Bogdanov
Session: Poster Display session 1
Resources:
Abstract
3722 - Proton-sensitizing effect of small molecule inhibitor of P300 histone acetyltransferase C646 in human pancreatic cancer cells.
Presenter: Sungwon Shin
Session: Poster Display session 1
Resources:
Abstract
5805 - Red-Blood-Cell-Membrane-Enveloped Magnetic Nanoclusters as a Biomimetic Theranostic Nanoplatform for Bimodal Imaging Guided Cancer Photothermal Therapy
Presenter: sheng wang
Session: Poster Display session 1
Resources:
Abstract
5251 - Urine cell-free and extracellular vesicle cargo miRNAs as biomarkers for prostate cancer diagnosis
Presenter: Ivan Zaporozhchenko
Session: Poster Display session 1
Resources:
Abstract
3657 - Parkin, APEX1 and BCL2L1 Tissue Expression in Southern Brazilian Patients with Different Breast Cancer Molecular Subtypes
Presenter: Bianca Cabral
Session: Poster Display session 1
Resources:
Abstract
2839 - Obesity and prognosis in breast cancer
Presenter: Noha Ibrahim
Session: Poster Display session 1
Resources:
Abstract
5132 - SIPA1 is a modulator of HGF induced tumor metastasis via the regulation of tight junctions in lung adenocarcinoma cells
Presenter: Chang Liu
Session: Poster Display session 1
Resources:
Abstract